HospitalInspections.org

The facility failed to maintain compliance with federal laws related to Occupational Safety and Health Administration (OSHA), ensuring safe practices in the use of chemicals.

Finding:

OSHA guidelines for Healthcare Wide Guidelines, Hazardous Chemicals states in part, " ...Potential Hazards: Employee exposure to hazardous chemicals, such as pesticides, disinfectants, and hazardous drugs in the workplace.

Possible Solutions

OSHA requires that employers implement a written program that meets the requirements of the Hazard Communication Standard (HCS) to provide for worker training, warning labels, and access to Material Safety Data Sheets (MSDSs) ...

-Provide readily available Material Safety Data Sheets (MSDSs) for all hazardous chemicals.

-Train workers in potential chemical hazards and controls (engineering controls, work practices, PPE) necessary to prevent hazards in the work area [29 CFR 1910.1200(h)(3)].

-Clearly label as hazardous all hazardous chemicals such as those found in some soaps, disinfectants, and pesticides [29 CFR 1910.1200(f)].

Provide appropriate PPE: (e.g., gloves, goggles, splash aprons) when handling hazardous dishwashing detergents and chemicals [29 CFR 1910.132]. For more information see Healthcare Wide Hazards - (Lack of) Personal Protective Equipment.

Medical Services and First Aid: Where the eyes or body of any person may be exposed to injurious corrosive materials, provide suitable facilities for quick drenching or flushing of the eyes and body within the work area for immediate emergency use [29 CFR 1910.151(c)] ..."



A tour was conducted of the warehouse at Hospital (2) on the morning of 9/21/2019 with Staff #557 and revealed the following:


A. The facility's warehouse which houses hazardous chemicals did not have a decontamination shower area available in case of possible chemical exposure.

Staff #S557, Supply Chain Manager stated in part, "We don't have a shower or sink that I know of."


B. Facility Staff #S557 reported, he did not know where the Material Safety Data Sheets where in case of chemical exposure.

Based on record review and interview, the hospital failed to have a well-organized service in the Emergency Room with a plan of administrative authority and delineation of responsibilities for patient care in that the hospital directed and allowed 10 of 10 paramedics (Paramedic #499, Paramedic #500, Paramedic #501, Paramedic #502, Paramedic #503, Paramedic #504, Paramedic #505, Paramedic #506, 719 and 720) to function outside their scope of practice. (Scope includes: provide Advanced Life Support in the field (outside of the hospital) and function as an unlicensed personnel in the hospital) while providing patient care in a Healthcare Facility Setting.

This failed practice were identified in 2 of 2 hospital campuses which utilize paramedics in the emergency center, and nurses and patient care technicians who provide care and service to patients receiving hemodialysis treatment.


Findings:

The hospital personnel list provided on 9/17/2019 included eight paramedics/EMT (emergency medical technician) Personnel #S499, Personnel #S500, Personnel #S501, Personnel #S502, Personnel #S503, Personnel #S504, Personnel #S505, and Personnel #S506 who were hired in July 2019 with the plan to train them to work in the Emergency Center of hospital (1) to perform patient care. On the list of all Emergency Staff on 9/17/2019, the 8 were classified with the Job Title: Paramedic/EMT.


The Job Description for EMT/Paramedic as of date: 9/01/2019 states that the Paramedic "...Proficiently support the delivery of patient care services and assists in coordinating patient work flow...,. Transports patients, including those requiring cardiac monitoring....,assists with diagnostic and therapeutic procedures...Assists in admitting, transferring, and discharging of patients... Performs assigned tasks in a timely manner with minimal patient discomfort...Technical Functions: Proficiently performs delegated technical functions, including but not limited to: a. Phlebotomy, b. EKG, c. Sterilization as applicable, d. Vision and hearing screenings as applicable, e. Point of care testing as applicable, f. Initiates intravenous lines, g. Attaches monitoring devices to patient as appropriate, h. Works under direct supervision of a physician, i. Recognizes and assists in emergency situations, and performs advance life support including electrical cardiac defibrillation or cardioversion as indicated. 'Direct supervision' means supervision of an emergency medical technician-paramedic or licensed paramedic by a licensed physician who is present in the same area or an area adjacent to the area where an emergency medical technician-paramedic or licensed paramedic performs a procedure and who is immediately available to provide assistance and direction during the performance of the procedure. 'Advanced life support' means health care provided to sustain life in an emergency, life-threatening situation."


An interview was conducted with Personnel #S118 on 9/18/2019, at approximately 1:30 PM, in the Emergency Center. Personnel #S118 was asked about the use of Paramedics in the Emergency Center (EC). Personnel #S118 stated that they are used as unlicensed staff. Personnel #S118 was asked what could the Paramedics do in the EC. Personnel #S118 stated that they do the same duties as a Patient Care Technician (PCT). Personnel #S118 again was asked what the Paramedics were actually doing in the EC. Personnel #S118 said, they help with wheelchairs for the patients, they help with transport of a patient for special x-ray procedures or transport to the floor when admitted. Personnel #S118 said that they do venipuncture for point of care testing and start IV's. Personnel #S118 was asked if the PCT perform venipuncture for point of care testing and start IV's. Personnel #S118 stated that the PCT's do perform venipuncture after they have gone through training.


Personnel #S118 was informed that in the State of Texas, the Paramedic has a Scope of Practice that covers the duties on an ambulance and providing emergency medical care associated with an ambulance call; also in the State of Texas the Paramedic/EMT is considered an "unlicensed assistive personnel" (UAPs) when working in acute care settings, such as the ED.


Personnel #S118 stated that they had just started using their EMT/Paramedics in the EC and really do not know how it is going to go. Personnel #118 was informed that the scope of service for the EMT's/Paramedics is limited to performing duties in the "pre-hospital and inter-facility transport" settings.


An interview was conducted with Personnel #S309 on 9/24/2019, at approximately 11:30 a.m. in the Conference Room. Personnel #S309 wanted clarification about the Paramedics in the EC. Personnel #S309 had printed out the rules at Title 22 Part 9 Texas Medical Board Chapter 197 Emergency Medical Service.


Review of the documents mentioned above were discussed with Personnel #309 and the same portion of this Title 22 ..."The BON ( Board of Nursing) delegation rules view EMT's, Paramedics or other similarly trained staff as 'unlicensed assistive personnel's (UAP's) when working in acute care settings, such as the ED."

" The rules governing EMTs and Paramedics are located in Title 25, Texas Administrative Code, Section 157.2. This rule limits the scope of practice of EMTs/Paramedics to performing duties in the 'pre-hospital and inter-facility transport' settings...Therefore, whether certified or licensed, the BON delegation rules view EMT's, Paramedics, or other similarly trained staff as 'unlicensed assistive personnel' when working in acute care setting such as the ED...other laws outside of the BON's (Board of Nursing) jurisdiction may prohibit performance of certain tasks by unlicensed personnel, even if a physician is willing to delegate a task." Personnel #309 stated that she understood and would have to take care of this topic.


TITLE 22 EXAMINING BOARDS, PART 9 TEXAS MEDICAL BOARD, CHAPTER 197 EMERGENCY MEDICAL SERVICE

RULE §197.7 Physician Supervision of Emergency Medical Technician-Paramedic or Licensed Paramedic Care Provided in a Health Care Facility Setting (provide Advanced Life Support in the facility)...Advanced life support--Health care provided to sustain life in an emergency, life-threatening situation...Direct supervision - Supervision by a licensed physician who is present in the same area or an area adjacent to the area where an emergency medical technician-paramedic or licensed paramedic performs a procedure and who is immediately available to provide assistance and direction during the performance of the procedure...a person who is certified as an EMT-P or a LP, is acting under the delegation and direct supervision of a licensed physician, and is authorized to provide advanced life support by a health care facility, may in accordance with DSHS rules provide advanced life support in the facility's emergency or urgent care clinical setting, including a hospital emergency room and a freestanding emergency medical care facility...The supervising physician may use protocols, which may include standing delegation orders. Such instructions may not be used in lieu of communication with the supervising physician or of obtaining the physician's physical assistance and direction during the performance of a procedure...The physician who delegates to and directly supervises advanced life support in a healthcare facility as authorized in this section remains professionally and legally responsible for the patient care provided by the EMT-P or LP...The physician who delegates to and directly supervises an EMT-P or LP providing advanced life support must ensure that the EMT-P or LP meets all requirements under the law related to creating and maintaining a medical record documenting the patient encounter...adopted to be effective April 3, 2016, 41 TexReg 2315.


The BON (Texas Board of Nursing) delegation rules view EMTs, Paramedics, or other similarly trained staff as "unlicensed assistive personnel" (UAPs) when working in acute care settings, such as the ED.
https://www.bon.state.tx.us/faq_delegation. asp#t 7 - Paramedics/EMTs in the Emergency Department (ED)...Can an RN delegate starting a peripheral IV saline lock to an EMT/Paramedic in the Emergency Department (ED)? Some of the "techs" in our ED are "licensed paramedics" who also work for EMS. What other kinds of tasks can be delegated to Emergency Medical Technicians (EMTs)/Paramedics in the ED setting...The rules governing EMTs and Paramedics are located in Title 25, Texas Administrative Code, Section 157.2. This rule limits the scope of practice of EMTs/Paramedics to performing duties in the "pre-hospital and inter-facility transport" settings ...Therefore, whether certified or licensed, the BON delegation rules view EMTs, Paramedics, or other similarly trained staff as "unlicensed assistive personnel" (UAPs) when working in acute care settings, such as the ED...The BON's delegation Rule 224 is not prescriptive to specific procedures or tasks that may or may not be delegated. Rule 224 permits an RN to delegate starting a peripheral IV saline lock to an unlicensed person providing all of the delegation criteria are met...Other laws outside of the BON's jurisdiction may prohibit performance of certain tasks by unlicensed personnel, even if a physician is willing to delegate a task."


TITLE 22 EXAMINING BOARDS, PART 11 TEXAS BOARD OF NURSING, CHAPTER 224 DELEGATION OF NURSING TASKS BY REGISTERED PROFESSIONAL NURSES TO UNLICENSED PERSONNEL FOR CLIENTS WITH ACUTE CONDITIONS OR IN ACUTE CARE ENVIRONMENTS...Rule §224.8, "Delegation of Tasks...Discretionary Delegation Tasks...the manner in which the unlicensed person demonstrates competency of the delegated task...the mechanism for reevaluation of the competency...periodic re-demonstration of competency...the following are nursing tasks that are not usually within the scope of sound professional nursing judgment to delegate...sterile procedures-those procedures involving a wound or an anatomical site which could potentially become infected...non-sterile procedures, such as dressing or cleansing penetrating wounds and deep burns...invasive procedures-inserting tubes in a body cavity or instilling or inserting substances into an indwelling tube; and care of broken skin other than minor abrasions or cuts generally classified as requiring only first aid treatment...Nursing Tasks Prohibited from Delegation By way of example, and not in limitation, the following are nursing tasks that are not within the scope of sound professional nursing judgment to delegate...physical, psychological, and social assessment which requires professional nursing judgment, intervention, referral, or follow-up...formulation of the nursing care plan and evaluation of the client's response to the care rendered...the responsibility and accountability for client health teaching and health counseling (discharge instructions) which promotes client education and involves the client's significant others in accomplishing health goals; and administration of medications, including intravenous fluids, except by medication aides as permitted under §224.9 of this title (relating to The Medication Aide Permit Holder)..."


Rule §224.5, "RN Accountability for Delegated Tasks The RN nurse administrator or the RN who is responsible for nursing services in settings that utilize RN delegation in clients with acute care conditions or acute care environments shall be responsible for knowing the requirements of this rule and for taking reasonable steps to assure that registered nurse delegation is implemented and conducted in compliance with the Texas Nursing Practice Act and this chapter..."


Review of the Paramedics' Personnel Files documented training and competency evaluations revealed beyond the scope of practice for paramedics in the State of Texas:

Paramedic #S499, Paramedic #S500, Paramedic #501, Paramedics #S502, Paramedic #503, Paramedic #504, Paramedic #505, Paramedic #506

Completed the modules for:

Hemorrhage Control module

i-Stat General Post Test,

Early Heart Attack Care,

Stroke Education/Activation,

Point of Care Testing Glucometer Module,

Point of Care Testing Pregnancy Manual Module,

Restraint Annual unlicensed,

Blood Component Transportation,

EMTALA (Emergency Medical Treatment and Labor Act) Training Medical Equipment Management.


Paramedic S#499, Paramedic #S500, Paramedic S#501, Paramedic #S502, Paramedic #S503, Paramedic #S504, Paramedic #505, Paramedic #506

Mandatory Education Acknowledgement included education and competency validation of the following topics: EKG (electrocardiogram) 12 Lead Module/Skill; Impulse Module V, NIH Stroke Scale, POCT (Point of Care testing) Glucometer Module/Skill, POCT iStat module/skill, POCT Pregnancy Manual Module/Skill, Restraints Module/Skill, and Suicide/Homicide Risk Education.


Paramedics S#499, Paramedic #S500, Paramedic S#501, Paramedic #S502, Paramedic #S503, Paramedic S#504, Paramedic S#505, Paramedic S#506

Competency based clinical orientation tool Titled: Nurse Education was completed: STEMI protocol, stroke protocol, hypoglycemia guideline, DKA guidelines.


Paramedic #S503

Verbalizes policies, guidelines, standard of care, and resources: intubation tray/cart, chest tube bundle, medications/expiration dates, suction, oxygen transport tank, and cardiac monitor/defibrillation supplies and moderate sedation.


Paramedic S#499, Paramedic S#500, Paramedic S#501, Paramedic S#502, Paramedic S#505, Paramedic S#506

Competencies check off : phlebotomy, peripheral IV insertion, cervical spine alignment, blood cultures, EKG's, manual ventilation with BVM (bag, valve, mask) and airway adjuncts, and POC testing.


Paramedic S#499, Paramedic S#500, Paramedic S#501, Paramedic S#502

Verbalizes policies, guidelines, standard of care, and resources: ventilator settings/troubleshooting, cardiac monitoring, internal paddles, external paddles, basic cardiac rhythm recognition, advanced rhythm recognition, synchronized cardioversion, transcutaneous/transvenous pacing, hemodynamic setup and monitoring/arterial line set-up, fluid resuscitation/rapid infuser, massive blood transfusion procedure and set-up, Cricothyroidotomy set up, thoracotomy set up. The trauma management: MVC (motor vehicle collision), gunshot wounds, stab wounds, amputation, crush injuries, head injuries, spinal cord injuries, fall victims, aggravated assault, sexual assault, chest trauma, pelvic trauma, genitourinary trauma, extremity trauma, hanging/strangulation, drowning, burns and smoke inhalation.


Paramedic S#500

Management of critical medical problems: Verbalizes policies, guidelines, standard of care and resources. Demonstrates the skill safely effectively, and efficiently: ingestion, chest pain, CVA (cardiovascular accident), congestive heart failure (CHF), shortness of breath, altered mental status, ESRD (end stage renal disease), sepsis, seizures, GI bleeds, cardiogenic shock, hypovolemic shock, neurogenic shock, septic shock, These were only Verbalized policies, guidelines, standard of care and resources: anaphylactic shock, obstructive shock, hypo/hyperthermic patients, DIC, DKA, pediatric trauma, pregnant trauma patients, geriatric patients, and psychiatric patients.


Paramedic S#500, S#504, Paramedic S#505, Paramedic S#506

Verbalizes policies, guidelines, standard of care and resources; Plus demonstrates the skill safely, effectively and efficiently: Moderate sedation, care and disposition of clothing and valuables, Death Care, Transportation of the ICU patient, Transportation of the telemetry patient.


Paramedic S#500, Paramedic S#502, Paramedic #S503, Paramedic #S504, Paramedic #S505, Paramedic #S506

Verbalizes policies, guidelines, standard of care and resources; plus demonstrates the skill safely, effectively and efficiently: Notification of attending physician and documentation, Notification of primary RN and documentation, Shock Room throughput, Role of the Chief Resident, Role of the intern.


Paramedic #500, Paramedic#502, Paramedic #503,Paramedic #S504

Verbalize policies, guidelines, standard of care and resources: ACLS equipment, sterile trays, intubation tray/cart, chest tube bundle, medications/expiration dates, suction, oxygen transport tank, cardiac monitor/defibrillation supplies, pediatric crash cart, paramedic specific CBOT, Thoracotomy bundle, rapid response stretcher checklist, Shock room supply carts, Blue/intake/gold pod supply carts, Places work order, Stocks specialty supply carts (i.e. OB/GYN cart, supply cart, carts in 14), clean endoscope, cleans vaginal probe.


Paramedic S#500, S#502, Paramedic S#504, Paramedic S#505, Paramedic S#506

Demonstrates the skill safely, effectively and efficiently: sterile processing log/procedure, cardiac monitoring, manual blood pressure, basic cardiac rhythm recognition, advanced rhythm recognition.


Paramedic S#500; Paramedic S#501, Paramedic S#502, Paramedic S#503, Paramedic S#504, Paramedic S#505, Paramedic S#506

Demonstrates the skill safely, effectively and efficiently: phlebotomy, peripheral IV insertion, cervical spine alignment, blood cultures, EKG's, Manual ventilation with BVM (bag, valve, mask) and airway adjuncts, POC testing; cardiac monitoring;


Paramedic S#500

Verbalizes policies, guidelines, standard of care and resources: ventilator settings/troubleshooting, Internal paddles, external paddles, basic cardiac rhythm recognition, advanced rhythm recognition, synchronized cardioversion, transcutaneous/ transvenous pacing, hemodynamic setup and monitoring/arterial line set-up, fluid resuscitation/rapid infuser, massive blood transfusion procedure and set-up, Cricothyroidotomy set up; thoracotomy set up.


Paramedics S#502, Paramedic S#503, Paramedics S#504, Paramedic S#505, Paramedic S#506

Verbalizes policies, guidelines, standard of care and resources and demonstrated the competency/skill: ventilator settings/troubleshooting, Internal paddles, external paddles, basic cardiac rhythm recognition, advanced rhythm recognition, synchronized cardioversion, transcutaneous/transvenous pacing, hemodynamic setup and monitoring/arterial line set-up, fluid resuscitation/rapid infuser, massive blood transfusion procedure and set-up, Cricothyroidotomy set up; thoracotomy set up,
sterile processing log/procedure, phlebotomy, peripheral IV insertion, cervical spine alignment, blood cultures, EKG's, Manual ventilation with BVM (bag, valve, mask) and airway adjuncts, POC testing, cardiac monitoring, manual blood pressure, basic cardiac rhythm recognition, advanced rhythm recognition, ventilator settings/troubleshooting, cardiac monitoring, Internal paddles, external paddles, basic cardiac rhythm recognition, advanced rhythm recognition, synchronized cardioversion, hemodynamic setup and monitoring/arterial line set-up, fluid resuscitation/rapid infuser, massive blood transfusion procedure and set-up, thoracotomy set up, MVC (motor vehicle collision), gunshot wounds, stab wounds. Trauma management: head injuries


Paramedic S#502, Paramedic S#503, Paramedic S#504

Verbalized policies, guidelines, standard of care and resources Management of critical medical problems: ingestion, chest pain, CVA (cardiovascular accident), congestive heart failure (CHF), shortness of breath; altered mental status, seizures, GI bleeds, hypovolemic shock, neurogenic shock , septic shock, ESRD, anaphylactic shock, obstructive shock, hypo/hyperthermic patients, DIC, DKA, Pediatric trauma, pregnant trauma patients, sepsis, geriatric patients, psychiatric patients.


Paramedic S#500, Paramedic S#501, Paramedic S#504; Paramedic S#505, Paramedic S#506

Demonstrates the skill safely, effectively and efficiently: Trauma management: MVC (motor vehicle collision), gunshot wounds, stab wounds, head injuries.


Paramedic S#500, Paramedic S#501, Paramedic S#503

Verbalized policies, guidelines, standard of care and resources: spinal cord injuries, fall victims, aggravated assault, sexual assault, chest trauma, pelvic trauma, genitourinary trauma, extremity trauma, hanging/strangulation, drowning, burns and smoke inhalation.


Paramedic S#503

Verbalized policies, guidelines, standard of care and resources: Ingestion, chest pain, CVA (cardiovascular accident), congestive heart failure (CHF), shortness of breath, altered mental status, seizures, hypovolemic shock, septic shock, ESRD, anaphylactic shock, DKA, Pediatric trauma, pregnant trauma patients, sepsis, geriatric patients, psychiatric patients.


Paramedic S#500, Paramedic S#501, Paramedic S#505, Paramedic S#506

Management of critical medical problems: Demonstrates the skill safely, effectively and efficiently: Ingestion, chest pain, seizures, GI bleeds, hypovolemic shock, anaphylactic shock, obstructive shock, hypo/hyperthermic patients, DIC, DKA; Pediatric trauma, pregnant trauma patients, geriatric patients, psychiatric patients..


Paramedic S#503, Paramedic #504, Paramedic S#505, Paramedic S#506

Demonstrates the skill safely, effectively and efficiently: Ingestion, chest pain, CVA (cardiovascular accident), congestive heart failure (CHF),shortness of breath, altered mental status, ESRD, sepsis, spinal cord injuries, fall victims, aggravated assault, sexual assault, chest trauma, pelvic trauma, genitourinary trauma, extremity trauma, hanging/strangulation, drowning, burns and smoke inhalation, spinal cord injuries, fall victims, aggravated assault, sexual assault, chest trauma, pelvic trauma, genitourinary trauma, extremity trauma, hanging/strangulation, drowning, burns and smoke inhalation.


Paramedic S#504, Paramedic S#505, Paramedic S#506

Demonstrates the skill safely, effectively and efficiently: Chest tube set-up, Central line placement set-up, Tourniquet application, Stabilization of fractures, pelvic binder, traction splint. Trauma management: MVC (motor vehicle collision), gunshot wounds, stab wounds, amputation, crush injuries, head injuries, spinal cord injuries, fall victims, aggravated assault, sexual assault, facial/dental trauma, chest trauma, pelvic trauma, genitourinary trauma, extremity trauma, hanging/strangulation, drowning, burns and smoke inhalation. Management of critical medical problems: ingestion, chest pain, CVA (cardiovascular accident), congestive heart failure (CHF), seizures, GI bleeds, cardiogenic sock, hypovolemic shock, neurogenic shock , septic shock, ESRD, anaphylactic shock, obstructive shock, hypo/hyperthermic patients, DIC, DKA, Pediatric trauma, pregnant trauma patients, sepsis, geriatric patients, psychiatric patients. Bolus fluids under delegation.


Paramedic #S503

Verbalizes policies, guidelines, standard of care and resources: spinal cord injuries, fall victims, aggravated assault, sexual assault, chest trauma, pelvic trauma, genitourinary trauma, extremity trauma, hanging/strangulation, drowning, burns and smoke inhalation.



37322

Record review of the job description "Emergency Medical Technician Paramedic (EMTP) dated 09/01/2019 states:
Proficiently performs delegated technical functions including not limited to Phlebotomy, initiates intravenous lines


Record review of Hospital #2 of the scope of practice for the EMT-Intermediate/Paramedic Checklist revealed the following skills and tasks that must be completed with countersigning by the preceptor prior to being released from orientation revealed some of the task on the list that included:

o Peripheral IV insertion,

o Blood cultures,

o Defibrillation,

o Transcutaneous/Transvenous Pacing,

o Internal and external paddles (adults and pediatric patient),

o Fluid administration: bolus fluids under delegation.


Record review of the Patient Care Technicians competency, dated April 2019 revealed: No invasive task such as IV insertion, blood culture, fluid administration, pacing, or use of internal/external paddles noted on the competency.

Staff (ID # S719), Paramedic's checklist was completed on 07/02/2019.

Staff (ID # S720), Paramedic's checklist completed on 09/10/2019.


Interview on 09/24/2019, at 10:15 a.m., with RN Director, Staff (ID #S354) who stated, "Critical care used the EMT's, as techs (Patient Care Technicians). We are starting a critical care transport team, they are still in the training. We are a level III and Hospital (1) is a level ll. We will not have to depend on our vendors for our STEMI's and Stroke patients to transport these patients."


Interview on 09/24/2019, at 1:55 p.m., with a Paramedic Staff (ID# S719) stated, "I draw blood and IV (intravenous) and depends on where I am working or what the RN's need from us."


34839


Review of training records in the personnel file for Staff # S199, revealed last hemodialysis department checklist completed 11/11/13.

Review of Staff #S195, Hemodialysis RN Orientation checklist was completed on 10/11/11. No further Hemodialysis skills checklist completed.

Review of staff #S193, Hemodialysis RN orientation checklist completed on 10/04/17 no further training completed.

No water training or skills checklist identified for Staff #S193 and #S195, and both are responsible for daily water checks.

Interview with Staff #S191 stated, the department recognized the area for improvement in competency, skills, and water checklist and had Marcor in the facility on 9/17/2019 for a mandatory in-service, but did not complete a return back demonstration of competency on any of the participants.

1. Based on record reviews, interviews, and observation, an Immediate Jeopardy situation was called on September 25, 2019, at 10:30 a.m., at Hospital 2 Labor and Delivery Obstetric Care Unit. The hospital's Medical, Anesthesia, and Nursing staff failed to effectively communicate amongst themselves concerning a critical situation with one obstetric patient. The failure of the medical team to identify this critical event during the provision of care to this patient led to a negative outcome of Patient #429. This failed practice has the potential to affect obstetric patients receiving prenatal care, including labor and delivery in Hospital 2.


2. Based on record reviews, interviews, and observation, Hospital 2 Obstetric Care (Triage and Labor and Delivery Units) failed to follow the Association of Women's Health Obstetric and Neonatal Nurses (AWHONN) Staffing Needs Standards by not ensuring that they had the appropriate number of nurses to care for obstetric patients in those two units. This failed practice creates the likelihood for negative outcomes for mother and fetus/child. Hospital 2 adopted the AWHONN guidance as a hospital Policy for staffing the Obstetric Triage Unit, Labor and Delivery Unit, and Antepartum/Post-partum Unit.


3. Based on record reviews, interviews, and observations, Hospital 2 Obstetric Unit failed to have the required number of Intravenous pumps to provide quality care to two patients. Patient (A) with pre-eclampsia who needed Magnesium Sulfate and Patient (B) who needed a Pitocin induction due to non-reassurance fetal monitor heart rate. This failure placed mothers and fetuses at risk for fetal distress and created the likelihood of a patient developing seizures (pre-eclampsia) which can result in the death of mother or baby.


4. Pre-eclampsia: Hypertensive disorders of pregnant women complicate up to 10% of pregnancies worldwide, constituting one of the greatest causes of maternal and perinatal morbidity and mortality worldwide. As leaders in women's health care, ob-gyns play a leading role in the prevention, diagnosis, and treatment of hypertension in pregnancy and preeclampsia. Preeclampsia is a serious condition that typically starts after the 20th week of pregnancy, high blood pressure is a main contributing factor. The rate of preeclampsia in the US has increased 25% in the last two decades and is a leading cause of maternal and infant illness and death. The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine continue to support the short-term (usually less than 48 hours) use of magnesium sulfate in obstetric care for appropriate conditions and for appropriate durations of treatment, which includes the prevention and treatment of seizures in women with preeclampsia or eclampsia. (American College of Obstetrics & Gynecology ACOG, December 2018).

Labor can be induced via medications or other methods that stimulate uterine contractions so that a woman may attempt a vaginal birth. The ob-gyn may recommend induction if the pregnancy is post term or if the health of the mother or fetus is at risk. (ACOG, 2017)


5. Hospital #2's Obstetric Care (Triage and Labor and Delivery Units) failed to follow the AWHONN Staffing Needs standards by not ensuring that they had the appropriate number of nurses to care for the obstetric patient in those two units. This failed practice creates the likelihood for negative outcomes for mother and fetus/child.


6. Based on observation, interviews, and record review, Hospital 2 failed to follow AWHONN standards for management of patient with Pitocin drip. This failed practice can affect patients admitted to the Labor and Delivery Unit for Pitocin Induction or Pitocin Augmentation.


7. Based on review of documents and interview, the Governing Body failed to provide effective oversight of the Nursing Department. The Governing Body failed to ensure all policies, plans, reports requiring Governing Body review, and by-laws written and implemented by the Nursing Department were reviewed, approved, and/or adopted by the Governing Body.


8. Based on record review and interview, the Governing body failed to designate specific individuals as QMP (Qualified Medical Professional) that would be performing medical screening examinations in the emergency department.


9. Based on record review and interview, the governing body did not approve the QMP to complete Medical Screening Exam (MSE) in Hospital #2 in two of two medical personal assigned to the ED.


10. Based on record review and interview, the governing body failed to specify in the medical staff rules, regulations, and bylaws what the qualifications were for an individual to perform a medical screening examination. Furthermore, the governing body did not designate individuals who were qualified to perform a medical screening examination to patients presenting to the emergency center.


Findings:

Patient #429, Medical Record Review:

Patient #429 was a Gravida 2 Para 1 (Two pregnancy and one live child). During the hospital Obstetric Screening on 06/10/2019, the patient indicated that she was pregnant but did not know how many weeks of gestational age. During this appointment, the patient was given basic prenatal information. On 06/17/2019, Patient #429's History and Physical were completed. The provider indicated that the Estimated Date of Delivery was 09/26/2019. It was confirmed by ultrasound that the patient was at 22 weeks gestational age. The History and Physical revealed that the patient had a previous cesarean section. During the current pregnancy, she was diagnosed with Gestational Diabetes Mellitus (A1GDM).


During the prenatal visit on 06/10/2019, the patient revealed that she had a Cesarean Section in 2010. The provider who evaluated the patient wrote that the patient was unsure why or in what hospital the Cesarean Section was performed. She was 38 gestational weeks when labor was attempted. Provider indicated, she had a low transverse. The provider's notes during this visit indicated that the patient wanted a Trial of Labor and will continue to discuss.


Trial of labor after Cesarean Section) (TOLAC) is a planned or attempted vaginal birth after cesarean (VBAC). Sometimes, there is a need to change the plan, and a TOLAC results in cesarean birth after cesarean (CBAC). A birth is officially considered a VBAC once the TOLAC results in a vaginal delivery. (https://wwwuchicagomedicine.org)


A TOLAC is the attempt to have a VBAC. If it is successful, TOLAC results in a vaginal birth. If it is not successful, you will need another cesarean delivery. (The American College of Obstetrics & Gynecologist, FAQ070, December 2017)


The patient was also seen on 06/17/2019 and was diagnosed with Gestational Diabetes during this visit. She was placed on close monitoring with Finger Blood Sticks for glucose level five times a day. At this time, there were no indications that the provider asked details of the previous cesarean section but the plan for TOLAC continued.


During the prenatal visit of Patient #429, there were no indications that the obstetric provider attempted to speak to the patient concerning the reason(s) why she had a previous cesarean section during her first pregnancy and in what hospital it was performed. They proceeded with the Trial of Labor delivery plans.


On 9/12/2019, Patient #429 arrived at Hospital 2 at 4:41 am. Medical records revealed that the patient went to the Obstetric Triage Unit where she was evaluated by the nursing staff. The patient's pulse was taken and recorded as 141 beats/per minute. A pulse of 141 is indicative of tachycardia. Tachycardia, also called tachyarrhythmia, is a heart rate that exceeds the normal resting rate. In general, a resting heart rate over 100 beats per minute is accepted as tachycardia in adults. (https://en-wikipidia.org).


Maternal tachycardia is defined as a baseline heart rate greater than 100 bpm. Anxiety, a low-grade temperature elevation, fever, and chorioamnionitis have been associated with an MHR between 100 and 130 bpm (Yamashiro et al., 1988). This rare arrhythmia started and stopped spontaneously, could not be predictably induced or terminated, and increased the risk of tachycardia-induced congestive cardiomyopathy and heart failure (Kam, Lee, & Teo, 1994). When the tachycardic MHR baseline approaches 140 bpm, it may flatten, especially when a woman is diabetic and/or hemodynamically or metabolically unstable.


According to the Medical History recorded on 09/12/2019, at 4:43 am (during the patient's admission to Labor & Delivery), the Obstetric (OB) attending Physician #S714 indicated that the patient denied having Diabetes Mellitus during this pregnancy. However, record review showed that the patient had been diagnosed with Diabetes Mellitus since her 20th gestational week. The patient had been taking Metformin (an oral diabetes medicine that helps control blood sugar levels) with doses of 1,000 milligrams in the morning and 500 milligrams in the afternoon for the treatment of Gestational Diabetes Mellitus. During this medical encounter, the provider stated "There were no vitals taken for this visit". Vaginal examination at this time was C/C/0. (Cervix is completely dilated, complete effacement, and the baby's presenting part is at 0 station). Obstetric provider still recognized that the patient is a TOLAC. The OB Attending documented that the patient was not on pain management for labor.


During the admission, laboratory tests were ordered at 4:39 am for CBC ( complete blood count), Type and Screen, Hepatitis B, Rubella, and Urinalysis. Patient uterine contractions were from 1 to 2 per minutes. The patient was verbally consented by the OB provider for a TOLAC as she was having an intravenous access. Provider documented that the patient was in too much pain to sign the consent form. The provider also indicated that an interpreter was on the phone for the Spanish translation of the consent. During this encounter OB Resident S713 was present.


Record review indicated that at the time of admission the patient gestational age was 38 weeks. A cervical examination at 4:46 A.M. was C/C/0 (Cervix dilation complete, effacement complete, and fetus presenting part is at 0 station. The Patient was spontaneously pushing. At 3:00 am, the patient indicated that her amniotic sac ruptured. There was no mention of the color of the amniotic fluid in this provider's notes. The care of the patient at this time were provided by attending OB S714 and OB Resident #S713.


According to record review, at 4:29 am, the Spanish-speaking Labor and Delivery Nurse #S707 was trying to obtain verbal consent for delivery after an attempt to get this done over the phone failed. During this time, the patient was having contractions and Fetal Heart Tones were 150's. The record review of the Fetal Monitor strip showed the patient was contracting once every minute.


According to records, at 4:30 am, the patient stated, she wanted to push. Nurse #S710 and S708 were present as admitting Labor and Delivery Nurses. Record review of the Labor and Delivery progress notes indicated that at 4:30 am, the patient stated she had a history of Diabetes and Hypotension.


At 4:39 am, the patient was officially admitted to the Labor and Delivery unit for TOLAC.


At 4:41 am, patient's heart rate continued at 138 per minute. Fetal Heart Tones 143-155 per minute. Reactive fetal monitor strip. OB Resident #S713 documented, "Notified of increased maternal rate, and unable to obtain an initial blood pressure due to patient actively pushing".


At 4:43 am, maternal heart rate was 131 per minute. Glucose level out of range as 121 mg/dl (Range 74-106). The patient continued pushing and complaining of pain.


At 4:45 am, maternal heart rate dropped to 28 per minute and back up to 141. Fetal Heart Tones were 120 to 143 per minute. Positive variability. Mother continued pushing with no pain management.


The Patient was diagnosed to be positive for Group B strep (GBS) during her prenatal visit. The plan was to administer intravenous antibiotics during the second stage of labor to protect the new born. An order for Penicillin G potassium 4 million units was ordered to be infused at 4:45 am. Group B Streptococcus (GBS) is a type of bacterial infection that can be found in a pregnant woman's vagina or rectum. This bacteria is normally found in the vagina and/or rectum of about 25% of all healthy adult women. Women who test positive for GBS are said to be colonized. A mother can pass GBS to her baby during delivery. (https://americanpregnant.org).


At 4:46 am, maternal heart rate was 139 to 143 per minute and Oxygen Saturation was 99%. Fetal Heart Tone 140's.


At 4:49 am, maternal heart rate was 139 to 144 per minute. Fetal Heart Tones 120's with accelerations to 150 per minutes. Patient continued pushing with each contraction.


At 4:50 am, maternal heart rate was 125 to 131 per minute. Fetal Heart Tones 130's. Attending OB #S714 prompted the patient to push during the contractions and noted that there was minimal fetal head descend.


From 4:51 am to 4:53 am, the maternal heart rate was 140-145 per minute and Oxygen saturation was 98%. Fetal Heart Tones were 130's to 150's per minute.


At 4:56 am, maternal heart rate was 141-152 per minute. Fetal Heart Tones 120's-130 per minute.


At 4:58 am, maternal heart rate was 161 per minute. Fetal Heart Tone were 130's.


At 5:00 am, maternal heart rate was 162 per minute. The first note appeared assessing the uterine contractions by palpation. Nurse #S708 indicated that the uterine relaxation was soft. Contractions were moderate every 1 to 2 minutes. Duration of the contraction was from 50 to 90 seconds. At 5:00 am, a Nursing Assessment completed by Nurse #708 indicated that the cardiac assessment was WDL (Within Defined Limits). However, the patient had been in tachycardia since 4:41 am.


At 5:01 am, maternal heart rate was 159 per minute. Oxygen saturation 86%. If a pulse oxymeter measured a blood oxygen level (SpO2), a normal reading is typically between 95 and 100 percent. (https://www.healthline.com).


At 5:05 am, maternal heart rate was 159 per minute. Maternal Oxygen saturation dropped from 86% to 68%. Fetal Heart Tones were 120's on external monitoring. The laboratory blood collection that was ordered at 4:39 am for CBC, Type and screen, Hepatitis B, Rubella, and IgG (immunoglobulin) were collected at 5:05am. At this time maternal heart rate dropped to 70.


At 5:09 am, maternal heart rate was 143 to 146 per minute. Fetal Heart Tone base line dropped to 120, Fetal Heart Tones to 115-119.


At 5:11 am, maternal heart rate was 154 per minute. Fetal Heart Tone 119-120 per minute. Patient continued pushing with no progress.


At 5:15 am, maternal heart rate was between 60 for few seconds and rising to 144 per minute. Fetal Heart Tones from 90's to 115 per minute. Patient continued pushing.


At 5:17 am, maternal heart rate was 144-147 per minute. Medication was ordered for Butorphanol (Stadol) 2 milligrams injection, however, it was discontinued and not administered. This is an analgesic medication frequently used during active labor. From 5:18 am to 5:25 am, maternal heart rate was from 81 and fast rising to 164 per minute. Fetal Heart Tones from 115 to 120's on external monitor. Patient continued pushing with minimal descent noted. Attending MD #S714 indicated that there are some fetal Heart Tone decelerations.


At 5:27 am, maternal heart rate was 146 per minute. Fetal Heart Tones were 120's with decelerations to the 110's. Reactive. At this time the Certified Registered Nurse Anesthetist (CRNA) S715 was called to consent patient for anesthesia.


At 5:30 am, maternal heart rate was 152 per minute. At 5:31 am, OB Resident #713 was at bedside pushing with patient.
From 5:31 am to 5:34 am, maternal heart rate continued in tachycardia at a rate of 152-157 per minute. Fetal Heart Tones 115.


At 5:34 am, the laboratory results for the CBC were abnormal with WBC 13.3 K/uL (Range 4.5-11.0).


At 5:36 am, maternal heart rate was 176 and Oxygen saturation 84%.


At 5:38 am, maternal heart rate was 182. Fetal Heart Tones were 125 per minute with variable decelerations noted.


At 5:39 am, the attending OB (Attending S714) returned to patient's room and announced that a caesarian section needed to be performed due to failure to descend. The (Attending S714) did not discuss the patient has been in tachycardia for over an hour. The Attending MD documented for the first time that when patient ruptured at home, the amniotic fluid was clear. There is no medical documentation of the patient being tachycardia and Oxygen saturations had been as low as 68%.


At 5:41 am, the attending OB (MD S714) notified the CRNA (S715) that the patient's laboratory results were not back and gave the "OK" to proceed with the operating room.


Record review of the anesthesia assessment revealed that the patient had a history of hypertension. From the time of the patient's arrival, admission, treatment, and arrival at the operating room, there was no blood pressure or temperature documented as taken. There was not any type of consultation with other providers to identify the medical reason for the patient's persistent tachycardia. The patient had indicated that she had high blood pressure during admission to the Labor and Delivery Unit. The first time the patient's blood pressure was taken was in the operating room by the CRNA at 5:50 am. BP showed in the anesthesia report as 90's/40's and dropping to the 40's. Maternal heart rate remained above 130.


At 5:51 am, the patient went under anesthesia for a caesarian section. Baby was delivered at 5:55 am. Placenta was delivered at 5:56 am intact. According to the anesthesia records dated 9/12/2019, Patient #429 was administered Vasopressin at 6:15 am, 6:20 am, and 6:30 am by the CRNA. Anesthesiologist on duty was MD #S716. At 6:00 am, estimated blood loss was 1000 ML.


At 6:37 am, a Quick Note from MD #S716 indicated that there was an improvement in the patient's Blood Pressure (BP) after the second liter of fluids and no additional bleeding was noted and she no longer required vasopressors.


At 6:52 am, abnormal laboratory results for the patient were: Hemoglobin level 8.5 g/dl (Range 12-16), Hematocrit POC: 25.0% (Range 37.0-47.0). Low values for both which may indicate bleeding.


At 7:10 am, assessment completed by Nurse #708 indicated that the fundus was firm at the umbilicus.


At 7:20 am, patient's vital signs were recorded as BP 51/34, Pulse 144 per minute, and Temperature 97.3F. This is the first temperature recorded. No indication that the Obstetric Medical Team has been notified of the patient's BP or Pulse.


At 7:30 am, patient was taken by the anesthesia team to the OB Post Anesthesia Care Unit. Record review showed that the anesthesia team gave a verbal post-operative report to the OB Nurse #S708 who was responsible for the post anesthesia care and obstetric post-partum assessments.


At 7:35 am, patient's vital signs were: BP 64/44, Pulse 144, and Respiration 33 per minute. Within the normal limit for the post-partum checks with uterine fundus firm at the umbilicus, done by Nurse #S708. CRNA #S715 reported patient systolic BP of 78 and pulse of 135. The CRNA administered 500 ml intravenous bolus and 250 ml 5% albumin. Reported patient's heart rate as 122 with 90 systolic blood pressure. Also ordered a hematocrit and hemoglobin. At 7:50 am, patient's vital signs were: Pulse 135, Respirations 32, and BP 99/54.


At 7:38 am, medical order for pain with Toradol 30 mgs injectable. Patient rated her pain as an 8 (Scale from 0-10).


At 7:39 am, Anesthesia Care ended.


At 8:05 am, patient's vital signs were: Pulse was 146, Respirations 26, and BP 77/52. No indications that the RN notified the OB Medical team.


At 8:13 am, Toradol 30 mgs injectable was administered.


At 8:35 am, patient's vital signs were: Pulse was 160, Respirations 28, and BP 58/33. No indications that the RN notified the OB Medical Team. The patient continued in tachycardia and hypotension.


At 8:38 am, abnormal laboratory results: Hemoglobin 6.2 g/dl (Range 12-16.0) and Hematocrit 19.3% (Range 37.0-47.0) These results are lower than the ones from 6:52 am.


At 8:45 am, was the first time that the OB Medical Team came to assess the patient's condition. OB provider conducted a vaginal examination and a manual extraction of a large amount of bright red blood and clots.


At 8:46 am, Hemobate was administered. Hemobate or Carboprost is used to treat severe bleeding after childbirth (postpartum). (https://xrlist.com).


At 8:47 am, anesthesia at bed side. No one from the OB Medical Team or the anesthesia team evaluated the patient's tachycardia status that had been present since 4:41 am.


Medical Records reviewed revealed, that from 8:47 am through 10:00 am, the OB Medical team and Anesthesia Team continued providing different medical intervention. At 9:05 am, the patient received one unit of Pack Red Blood Cells. Massive Transfusion Protocol was activated. At 9:21 am, the OB Team and Anesthesia Team requested to take the patient to the operating room.
Blood work was ordered at 8:52 am, for PT/PTT/Fibrinogen/ABG's and at 10:00 am, the OB Medical Team inserted an intrauterine balloon in an attempt to control the vaginal bleeding. During the recovery care the balloon fell off.


At 10:23 am, the patient's vital signs were: Pulse was 175, Respirations 33, and BP 58/23. The OB Medical Team continued treating the patient's bleeding, however, there were no other medical services consulted to assist in stabilizing the hemodynamic status on this patient. Estimated blood loss of 3,000 ml.


At 10:20 am, laboratory test D-DIMER was collected. D-dimer (or D dimer) is a fibrin degradation product (or FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. It is so named because it contains two D fragments of the fibrin protein joined by a cross-link. (https://wikipedia.org). The blood work that was ordered at 8:52 am, was collected at 10:20 am.


At 10:23 am, the patient continued in critical condition with a BP of 58/23 and Pulse of 175. New order for Red Blood Cell transfusion.


At 10:44 am, a 12 lead EKG was ordered and a Chest X Ray. The patient was in persistent tachycardia and hypotension for over 6 hours. During the survey on 9/23/2019 and 9/24/2019, the OB staff was not able to show that the 12 lead EKG had been done on this patient as ordered.


At 10:52 am, Hemobate 250mcgs was ordered for the second time and Methergine 0.2 mgs. At 11:00 am, this order was discontinued. The uterotonic effect of Methergine is utilized after delivery to assist involution and decrease hemorrhage, shortening the third stage of labor. Methergine® (methylergonovine maleate) may be administered orally for a maximum of 1 week postpartum to control uterine bleeding.


At 11:03 am, the Full Code order was discontinued. At 11:23 am, patient was placed in mechanical ventilator. At 11: 25 am, the Massive Blood Transfusion Protocol was activated for the second time. At this time the patient's BP was 116/85 Pulse 115.


At 11:41 am, the results of the PT/PTT were abnormal: PT 19 seconds (Range 11.8-15) and PTT 39.6 seconds (Range 23.6-36.4). Fibrinogen: 82 mg/dl (low) (Range 200-500). A prolonged PT means that the blood is taking too long to form a clot. This may be caused by conditions such as liver disease, vitamin K deficiency, or a coagulation factor deficiency (e.g., factor VII deficiency). The PT result is often interpreted with that of the PTT in determining what condition may be present. (https://labtestonline.org). Low fibrinogen levels can also cause thrombosis due to an increase in coagulation activity. Acutely low levels are often related to conditions in which fibrinogen is used up more quickly than the body can produce it. This can occur with disseminated intravascular coagulation (DIC) and abnormal fibrinolysis, which occurs when the body is overactive in breaking down and clearing blood clots. (https://labtestonline.org March 2019.)


At 11:46 am, the patient's temperature dropped to 92.8 degrees Fahrenheit, BP 86/59, and Pulse 128. The thermometer is an internal device that is part of the Foley catheter. At 11:54 am, the patient's temperature continued at 92.8 degrees F, BP 74/44 and Pulse 155. Between the hours of 12:06 pm to 2:00 pm, the patient remained tachycardic, hypotensive, and on ventilator support. The OB Medical Team discussed with the patient's family the patient critical condition and the medical need for a hysterectomy.


The record indicated the Patient was taken to the operating room for a hysterectomy. At 2:43 pm, after the surgical procedure was completed, the patient went in cardiac arrest. Chest compressions were performed. The surgical field was re-inspected by the OB Medical team and there was not active bleeding. At this time the OB Team decided to call General Surgery to come in the operating room to evaluate the patient. The General Surgical Team noted a laceration of the right lobe of the liver and it was noted to be pulsatile bleeding. According to record review, even when General Surgical Team applied compression over the laceration the bleeding persisted. At 3:38 pm, the patient was pronounce dead.


Medical record review indicated that the patient post-operative diagnosis were: Prior cesarean section due to arrest to descend, non-reassurance Fetal Heart Tones, Gestational Diabetes Mellitus, Post-partum hemorrhage, hemorrhagic shock, and cardiac arrest.


On 9/25/2019, at 8:00 am, a group interview was conducted with 10 staff members who were present during Patient #429 critical event. Staff present during the interview were:

1. Director of Nursing #S706

2. Clinical Nurse Manager #S707

3. Nurse #S708

4. Administrator Director of Nursing #S709

5. Hospital 2 Chief Nursing Officer #S331

6. Nurse Clinician #S710

7. OB Resident #S713

8. Chief Nurse Executive #S712

9. Chief of Obstetrics and Gynecology #S711

10. Attending OB Physician #S714


During the interview, it was asked why the patient was offered a TOLAC without having a complete obstetric history. Staff S711 indicated that it was not clear why the patient did not want to give that information. The doctor stated that her OB Medical staff missed to bring the question during the patient's prenatal visits.


Nurse S708 who was present during the patient's initial assessment in the Triage Unit, stated that the temperature and blood pressure were not taken because the patient was uncomfortable. The Nurse indicated that when the patient was admitted to Labor and Delivery, they tried to do the blood pressure but every time the blood pressure machine would start the patient would have a contraction. When asked if the Triage Unit have a tympanic thermometer or any other type of thermometer, the Nurse stated, "no". When asked why a manual blood pressure was not taken, the Nurse stated, "I did not think about that". When asked if the OB Medical Team was notified of the patient's elevated heart rate, the Nurse stated, "no". Nurse #708 was asked if she notified the Attending OB physician on the patient's low blood pressure readings, the Nurse stated, "I thought anesthesia was taking care of that".


Staff S714 was the attending OB MD who admitted the patient to the Labor and Delivery Unit. She stated that she was in the operating room with another patient when she was notified by OB Resident MD S713 that the patient was complete and ready to push. Staff S714 stated that the OB Resident gave her the wrong information. The OB Resident #S713 communicated to Staff S714 that the patient had a cesarean section with the first child, a successful vaginal delivery, and would have been the second vaginal delivery. However, this patient was a TOLAC which means that this will be her first vaginal delivery. When the attending OB MD was asked if she had the correct information what she would have guided the OB Resident to do. The attending OB MD stated, based on her vaginal examination I would have probably given her something for pain until she completed the case she was working on the operating room. Nurse S708 stated that she did not mention to the OB MD S714 that the patient was in tachycardia. Staff S714 stated that she did not notice the patient's heart rate until CRNA #S715 mentioned to her before the surgery. The doctor stated she missed that critical element.


When asked if they noted that the patient was still tachycardia after delivery, Nurse S707 stated, "No, I was just doing the post-partum checks, I though the anesthesiology was keeping the OB doctors inform about the patient status". Staff S714 stated that she was unaware that the patient was unstable. She indicated that the anesthesia team did not communicate with her during the cesarean section surgery and that the patient was hypotensive and tachycardic during the surgery and during post anesthesia care. She was notified by the nurse that the patient was bleeding. That was the first time she became aware of the patient's hemodynamic status. Staff S714 stated, she did not know that during the cesarean section, the anesthesia team was administering medications to support the patient's blood pressure.


When asked if the order for the 12 lead EKG was carried out, Staff S714 stated, "I am not sure". When asked if a blood transfusion reaction was called and investigated, the MD stated, "no". When asked if another medical service such as Internal Medicine or Cardiology were consulted to assess the patient's hypotension and tachycardic status, the MD stated, "no".


During the interview, the Chief of Obstetrics and Gynecology S711 was asked what were the opportunities that were missed during this patient's management, the Chief stated, "There were many opportunities missed. The temperature and blood pressure during the admission, missed communication between the OB Resident and the attending physician, missed communication between anesthesia team during and after the surgery, missed communication between the nurses and the attending physician, we missed the opportunity to have another medical specialty evaluate the patient prolonged tachycardia". The Chief of Obstetrics and Gynecology stated that the entire team need to develop a plan to address the obstetric patient needs including cardiovascular needs. The Chief also stated that the hospital delivered about 300 patients a month and most of them are high risk OB patients due to diabetes, hypertension, drug addiction, and other conditions that are common on this population.


Interview and record review revealed Hospital 2 adopted the AWHONN guidance as a hospital Policy for staffing the Obstetric Triage Unit, Labor and Delivery Unit, and Antepartum/Post-partum Unit.


On 9/23/2019, at 9:30 am, a hospital tour was conducted of the Triage Obstetric Care Unit. The Triage Unit has 8 beds. Patients observed needed to be assessed to verify that they were in active labor and monitored on this unit, as well as patients scheduled for caesarian section. Any other obstetric patient needing medical assessment would also be evaluated in this unit. During the tour, only one Registered Nurse was observed monitoring the Triage Care Unit. RN #S708 was with one RN who was on orientation.


On 9/23/2019, at 10:00 am, RN #S708 was interviewed. She stated that the second RN went to the operating room with a patient needing a caesarian section. She stated that the Triage Unit is usually busy during the day and it slows down in the evenings. The RN indicated that there were always two RN's scheduled to work in the Triage Unit but during the day that does not always work.


PITOCIN ADMINISTRATION

On 09/24/2019, at 10:30 am, an observation was made in the Labor and Delivery. There were two nurses on duty, each was assigned to take care of two patient on Pitocin drip for induction/augmentation.


On 09/25/2019, at 21:10 am, an interview was conducted with Nurse Manager #S707. During the interview, the manager confirmed the nurses were managing two patients on Pitocin drip each. Manager S707 indicated that if the nurses needed help the OB management team will assist them. The manager stated they follow AWHONN schedule standards for the Obstetric Units.

On 09/24/2019, at approximately 1:50 pm, Nurse #S708 and Nurse #S710 were interviewed concerning the Pitocin drip. They stated that

(A) Based on observation, interview, and record review, the facility's direct care staff failed to follow the manufacturer's direction for use when testing water used for hemodialysis of patients for total chlorine in 1 of 1 observation. Failure to test water using the correct volume of water recommended by the manufacturer for the water treatment system has the potential of giving an incorrect result as to the presence of chlorine in the water which can potentially harm all patients receiving hemodialysis treatment in the facility.


(B) The facility failed to ensure hemodialysis machines in use in the facility for hemodialysis treatment of patients' dialysate solution had electrolyte analysis done by a laboratory when putting hemodialysis machine in service in 15 of 18 hemodialysis machines observed. Hemodialysis machine #s 5155, 5156, 5157, 5158, 5159, 5160, 5161, 5162, 5163, 5164, 5165, 5166, 5167, 5169, and 5170. Failed to conduct conductivity and PH of the dialysate solution at the of site of treatment.

Cross Reference A144


(C) The facility failed to provide evidence that 26 of 26 patients reviewed specifically for patient rights at facility #2 were informed of their rights in advance of furnishing patient care and prior to discharge affecting Patient's #s 135, 351, 374, 375, 376, 377, 378, 379, 380, 381, 382, 383, 384, 385, 386, 387, 388, 389, 390, 391, 392, 393, 394, 395, 396, and 397.

Specifically, patients' medical records did not contain a signed copy of their patient rights or evidence they were provided and explained their patient rights during the registration process in accordance with the facility's policy.

Cross Reference A117


(D) Hospital #1 failed to follow the process for resolution of patient grievance when the complaints required further investigation, were not resolved at the time of the complaints, and/or the patient requested a response from the hospital.

Cross reference A118


(E) The facility failed to ensure patients, or their legally authorized representatives (as allowed by State Law) the right to make informed decisions regarding their care and treatment. Specifically Patient's #379, #382, #391, #392, and #393 reviewed at Facility #2 were administered/injected with psychoactive medications that were not deemed a psychiatric emergency without providing informed written consent prior to the administration of the medications in accordance with the facility's policy for use of psychoactive medications.

Cross reference A131


(F) (a) The facility failed to take timely action to ensure patient care needs were not neglected (a form of abuse) at Hospital #2 after repeated reports of patients not receiving vital medications on time due to the Labor and Delivery Unit not having access to the required equipment for administration of medication. The facility was aware that Intravenous (IV) infusion equipment was not readily available to staff at times and neglected to investigate the process to identify problems associated with the timely distribution of IV infusion equipment. The facility neglected to take immediate actions to ensure vital IV infusion equipment was available for patient care. This failure to take action repeatedly left patients with delays in receiving vital medication.

(b) Failed to ensure patient rights to be free from all forms of abuse and neglect by failing to thoroughly investigate and/or respond to an allegation of neglect in accordance with their policies and procedures for 1 of 1 patients reviewed (Patient #383) with an allegation of neglect reported on his behalf at facility #2.

Cross reference A145


(G) The facility failed to ensure restraints were discontinued at the earliest possible time according to the physician orders and facility policy for 1 of 8 Patients (Patient #382) reviewed for restraints at facility #2. Specifically, Patient #382 remained in 4 point restraints while nursing documentation indicated he was resting and subdued during assessments on 6/7/19 at 00:15 until released from restraints at 08:06 AM (over 8 hours).

Cross reference A174


(H) The facility failed to have a physician or other licensed independent practitioner (LIP) see the patient face-to-face within 1-hour after the initiation of a restraint used for the management of violent or self-destructive behaviors for 4 of 8 patients (Patient's #379, #391, #394, and #395) reviewed for restraints at facility #2. Specifically,

(a) Patients were being administered psychotropic medications used to control violent behaviors and were not seen face-to-face within 1-hour after the adminsitration of the medications to evaluate the effect of the intervention, and

(b.) Patients had 4-point physical restraints implemented to control violent behaviors and were not seen face-to-face within 1-hour after the initiation of the 4-point restraints.

Cross Reference A 178

Based upon observation, record review, and interview, the facility failed to provide evidence that 26 of 26 patients reviewed specifically for patient rights at facility #2 were informed of their patient rights in advance of furnishing patient care and prior to discharge affecting Patient's #s 135, 351, 374, 375, 376, 377, 378, 379, 380, 381, 382, 383, 384, 385, 386, 387, 388, 389, 390, 391, 392, 393, 394, 395, 396, and 397. Specifically, patients medical records did not contain a signed copy of their patient rights or evidence they were provided and explained their patient rights during the registration process in accordance with the facility's policy.

Findings:

Review of the facility's policy titled Patient Rights and Responsibilities, last reviewed 8/30/19, revealed the following in part: Copies of the facility's Rights and Responsibilities will be made available to patients or the patient's Legal Representative in the following ways including, "a. Provided and explained to all inpatients and outpatients during the registration process by [the facility's] Patient Access Management staff with a signed and written acknowledgment obtained from the patient or the patient's Legal Representative on [the facility's] Form No. 283301."

Review of the Form No. 283301 titled, "Consents, Agreements, Authorizations, Acknowledgements and Irrevocable Assignments," last revised 8/19, documented the following for patient rights: "VII. Acknowledgement of receipt of patient Rights and Responsibilities" indicating "I have been informed and received a copy of [the facility's] Patient's Rights and Responsibilities." The patients signature is documented on page 2 for declaration that the patient read the document and understands the contents regarding the above initialed consents, agreements, authorizations, acknowledgments, and irrevocable assignments.

Review of the facility's Patient Rights and Responsibilities Form #284585 dated 12/17 indicated the patient or personal representative had the right to get information about the facility's patient rights when "you are admitted to the hospital or in advance of [the facility] providing or stopping the provision of care to you."

Observation conducted in Facility #2 on 9/17/19 at 12:35 PM, of the Emergency Center (EC), Room 33 revealed, Patient Access/Registration Clerk #S353 was completing the admission/registration process for Patient #377. There was not a discussion or explanation regarding Patient's rights. Staff #S353 verifies Patient #377's date of birth, social security number, address, and Gold card (insurance funding). Staff #S353 tells Patient #377, "I just need 2 forms signed today." Patient #377 asks, "What 2 forms?" Staff #S353 responds, "Consent to get treatment by the Doctor today and to verify insurance coverage." Patient #377 signs the electronic forms on the computer and then Staff #S353 offers her a welcome packet.

Review of the welcome packet revealed the patient rights and responsibilities was not part of the welcome packet. Review of the 2 forms signed in Patient #377's record revealed the above Form 283301 and the Insurance Verification Form No. 283825.

Observation conducted in Facility #2 on 9/24/19 at 2:13 PM, of Patient Access/Registration Clerk #S679 who was registering Patient #396 in the waiting area of the EC revealed, Staff #S679 asked Patient #396 to verify her address and demographics. Staff #S679 tells Patient #396 that he needed her signatures for "some forms; consent form" [Consents, Agreements, Authorizations, Acknowledgements and Irrevocable Assignments], "MAP for any type of prescription meds and PHI" [Medication Assistance Program Consent and Authorization for to Use and Disclose of Protected Health Information], and Insurance Verification." Patient #396 signs the electronic key pad for these specified forms. There was no discussion or explanation regarding Patient's rights. Staff #S679 then hands Patient #396 a welcome packet of forms.

Review of the welcome packet of forms revealed the patient rights and responsibilities was not part of the welcome packet.


Further observation on 9/24/19 at 2:45 PM consisted of another Patient Access/Registration Clerk #S 681 registering Patient #397 in the EC who was being admitted for observation status and surgery.

Staff #S681 verifies Patient #397's insurance coverage and provided the Important Message from Medicare. There was no discussion or explanation regarding Patient's rights for this patient that was being admitted for observation status and anticipation of surgery during the registration process.


Interview on 9/17/19 at 12:17 PM, with Patient Access Staff #S353 stated that during the registration process for patients she would verify the Patient's demographic information, insurance information, and have them sign the consents forms which included the insurance verification, medication assistance, PHI Health exchange, and consent for treatment. Staff #S353 then stated they would present the patient with a "welcome packet." After review of the welcome packet of forms revealed the patient rights and responsibilities was not part of the packet given to the patient. Further interview with Staff#S353 revealed no indication that she would review or explain to patients their rights or have them sign regarding their patient rights.


Interview on 9/24/19 at 2:00 PM, with Patient Access Staff #S679 stated when asked that patient's rights were reviewed with patients only "if they are admitted" to the hospital. Staff #S679 stated that if the patient is admitted, then the patient access/registration staff will follow up with the patient to review patient rights with the patient and give them a "pass code" for visitors.


Interview on 9/24/19 at 2:30 PM, with the Manager of Patient Access (PA) Staff #S 680 stated that patients are given a copy of the patient's rights and responsibilities form in their welcome packet.

Surveyor informed Staff #S680 after review of the welcome packets given to Patient's #377 and #396 during the registration process did not include the patient rights and responsibilities form.


Staff # S680 responded that she was currently making copies of the patient rights form "now and putting it in the packets now." Staff #S680 stated, "patients sign on the consent Form No. 283301 [Consents, Agreements, Authorizations, Acknowledgements and Irrevocable Assignments] that they have been informed of their rights. Staff #S680 confirmed patients do not sign an actual copy of the patient rights and responsibilities form and confirmed there is nothing specific that included documentation that the PA staff explained to all patients (inpatients and outpatients) during the registration process their patient rights except the acknowledgment obtained from the patient or the patient's Legal Representative on Form No. 283301.


Interview on 9/24/19 at 2:50 PM, Patient Access Staff #S681 was asked about patient rights and specifically when the patient was explained or informed of their patient rights. Staff #S681 indicated patient rights were "done in the consent form" [Form No. 283301] when they are initially registered.


Record review of 26 patients specifically reviewed for patient rights (Patients #' 135, 351, 374, 375, 376, 377, 378, 379, 380, 381, 382, 383, 384, 385, 386, 387, 388, 389, 390, 391, 392, 393, 394, 395, 396, and 397) which included a sample of medical records including inpatient, revealed no evidence or documentation that Patients signed a copy of their patient rights, were given a copy of the Patient Rights, or were informed of their Patient's Rights either orally and/or in writing. The medical records contained the above Form No. 283301 titled, Consents, Agreements, Authorizations, Acknowledgements, and Irrevocable Assignments signed by the patient and/or representative.

Based on interviews and record reviews, Hospital #1 failed to follow the process for resolution of patient grievance when the complaints required further investigation, were not resolved at the time of the complaints, and/or the patient requested a response from the hospital in 2 of 2 Patient's grievances filed.

Findings:

Review of complaint log for the most recent 3 months revealed the following:

- Patient #349 complaint on "Loss" reported on 8/27/19 and closed on 9/10/19.

- Patient #348 complaint on "Care/Treatment" reported on 7/1/19 and closed on 7/16/19.


Review of "Current Summary" report with eIRS# 153906 reflected Patient #349 contacted Patient Relations on 8/27/19 regarding his loss belongings (beige shoes with leather bottom, jeans, purple shirt, hat, bill fold with ID, debit/credit cards, and grey sweater) while visiting the Emergency Center on 8/24/19.

Follow up memo from Staff S601 on 8/28/19 at 11:36 a.m. to other personnel on the subject of "lost belongings" reflected (Patient #349) " ... wants to obtain information regarding the steps that were taken to look into his missing items." After internal investigations that involved multiple personnel, interviews, and camera footage reviews, a telephone follow-up was made to Patient #349 on 9/10/19 and the case was "closed."


Review of "Current Summary" report reflected Patient #348 contacted Patient Relations on 7/1/19 regarding complaints related to her care and treatment during "06/11/2019 IR (radiology) appointment" (multiple attempts initiating IV, pain, swollen hand). After internal investigations that involved other personnel, a telephone follow-up was made to Patient #348 on 7/16/19 and the case was "closed."


In an interview on 9/23/19 at 2:25 p.m., Staff# S531 examined these two complaint files and confirmed they should have been processed as grievances.


Review of policy titled Patient Complaints and Grievances, policy # 4200, with effective date of 03/30/06, reflected the following under Policy Elaborations: I. Definitions:

- "A. Complaint: A request or concern that is communicated verbally by a complainant regarding patient care or services that is resolved at the time of the Complaint by staff present."

- "C. Grievance: A formal or informal written or verbal Complaint that is made to the hospital by a patient, or the patient's representative, regarding ... patient's care (when the Complaint is not resolved at the time of the Complaint by staff present) ... when the patient requests a response from the hospital, the Complaint is considered a Grievance."

Based on records reviewed and interviews, the facility failed to ensure patients or their legally authorized representatives (as allowed by State Law) the right to make informed decisions regarding their care and treatment for 5 of 5 patient records reviewed for psychoactive medications that were not deemed a psychiatric emergency.

Specifically, Patients #s 379, #382, #391, #392, and #393 reviewed at Hospital (#2) were administered/injected with psychoactive medications that were not deemed a psychiatric emergency and without providing informed written consent prior to the administration of the medications in accordance with the facility's policy for use of psychoactive medications.

The facility failed to ensure that Disclosure and Consents for medical and surgical procedures are completed accordingly in 1 of 1 record reviewed.


Findings:

Review of the facility's policy titled "Consent to Treatment with Psychoactive Medication" effective 03/11, no revisions or reviews, indicated the following in part:

B. Before administering psychoactive medication to any patient, the attending physician or designee will explain to the patient and/or the patient legally authorized, the following in simple non-technical language in the person's primary language, if possible.

10. A written Consent for Treatment with Psychoactive Medications (HCHD) Form 281464 must be completed for each psychoactive medication administered.

D. Psychoactive medication will not be administered to psychiatric patient under voluntary, emergency, or Order of Protective Custody (OPC) provision without informed consent except in the case of an emergency situation.

Review of the facility's Form #281464 titled "Consent to Treatment with Psychoactive Medication" last revised 8/19, revealed it contained the specific requirements to obtain written informed consent in accordance with the policy.


Patient #379

Physician Order (PO) 7/5/19 at 20:12, Ativan 2 milligrams (mg) stat Intravenous (IV) push once.

Medication Administration Record (MAR) indicated administered at 20:05

PO 7/6/19 at 17:35, Ativan 2mg stat IV push once. MAR indicated administered at 17:00

PO 7/6/19 at 20:13, Ativan 2mg stat IV push once. MAR indicated administered at 20:30

Review of Patient #379's medical records revealed there was not an informed written consent prior to the administration of Ativan.


Patient #382

PO 6/6/19 at 19:32, Haloperidol lactate (Haldol) injection 1mg once. MAR - administered at 19:52

PO 6/7/19 at 08:47 AM, Risperidone 1mg tablet 2 times daily. MAR - administered on 6/7/19 at 08:45.

PO 6/7/19 at 08:50 AM, Risperidone (Risperdal) 1mg oral tablet every 6 hours PRN for agitation. Psychiatric emergency - No.

PO 6/7/19 at 11:11 AM, Lorazepam 2mg/ml injection, 2mg Intramuscular (IM) every 6 hours PRN for agitation, 2nd line, only if 1g risperidone is not sufficient. Psychiatric emergency - No.

PO 6/7/19 at 11:11 AM, Haloperidol lactate (Haldol) injection 5mg intramuscular every 6 hours PRN for agitation, 2nd line, only if 1g risperidone is not sufficient, not to exceed 20mg total in a day.

Review of Patient #382's medical records revealed there was not an informed written consent prior to the administration of Ativan (Lorazepam), Haldol, and Risperidone.


Patient #391

PO 8/28/19 at 04:30, Haldol 5mg IM once stat. MAR- administered at 04:31, psychiatric emergency - No.

During an interview on 9/24/19 at 11:30 AM, with the Quality Coordinator Staff (#S677) during review of Patient #391's medical records indicated there was not a reason stated on the order for Haldol. There also was not an identified mental illness indicated in the diagnosis area of his Provider notes. Staff #S677 confirmed Patient #391's EMR did not have written informed consent prior to the administration of Haldol.


Patient #393

PO 7/4/19 at 12:00, Haldol 1 mg IM in 2C (Med surg) every 8 hours PRN for agitation. Psychiatric Emergency - No. MAR- administered once 7/4/19 at 19:58

PO 7/3/19 at 03:47, Ativan 2mg IV push once. MAR- administered at 03:47. Psychiatric emergency - No. No reason indicated on physician order.

Review of Patient #393's medical records revealed there was not an informed written consent prior to the administration of Haldol and Ativan.


Patient #394

PO 9/4/19 at 07:46, Haldol 2.5mg IV. Psychiatric emergency - No. MAR- administered 07:54

PO 9/4/19 at 11:06, Zyprexa 5mg 2 times daily orally. Psychiatric emergency - No. The order did not have a diagnosis or reason for the order. MAR revealed Zyprexa administered 9/4/19 at 11:59 and at 19:55.

Review of Patient #394's medical records revealed there was not an informed written consent prior to the administration of Haldol and Zyprexa.


Interview with Staff #S671 on 9/26/19 at 09:50 AM, stated, the policy titled "Consent to Treatment with Psychoactive Medication" was "outdated." Staff #S671 further confirmed the facility was not obtaining informed written consent from the patient or the patient's LAR prior to administration of Psychoactive Medications; using Form 281464 in accordance with the facility's policy unless the patient was being treated at the Psychiatric inpatient unit of Facility #1.


41048


Hospital #2

Patient #436's records were reviewed and two of her consents did not have witness signatures, name, title, nor ID numbers. One consent was issued for the placement of a peripheral intravenous catheter and the other consent was for a blood transfusion.

Patient #436 was interviewed on the afternoon of 09/24/2019, and she explained that she did not remember anyone else signing the document. In addition, Patient #436 stated that she was not given a copy of the consent.

It was noted that the Patient is a Spanish speaker and used an interpreter at the time of signing her consent yet she was not given a copy of the document in Spanish to read or keep.

Based on observations, interviews, and record reviews, the facility's registration staff failed to ask about patient's current advance directives status in accordance with their policy, and/or provide the patients with accurate information concerning their rights on formulating advance directives for 3 of 3 patients (Patient's # 377, # 396, and #397) reviewed specifically for advance directives at Facility #2.


Findings:


Patient #377

Observation conducted in Hospital #2 on 9/17/19 at 12:35 PM, in Room 33 of the Emergency Center (EC) revealed, the Patient Access Management (PAM) staff #S353 was completing the admission/registration process for Patient #377. There was no discussion or explanation regarding Patient's rights. Staff #S 353 did not ask Patient #377 if she had advance directives or if she would like information on how to formulate advance directives. Staff #S353 verifies Patient #377's date of birth, social security number, address, and Gold card (insurance funding). Staff # S353 tells Patient #377, "I just need 2 forms signed today." Patient #377 asks, "What 2 forms?" Staff #S353 responds, "Consent to get treatment by the Doctor today and to verify insurance coverage." Patient #377 signs the electronic forms on the computer and then Staff #S353 offers her a welcome packet.

Review of the welcome packet revealed the patient rights and responsibilities were not part of the welcome packet. The welcome packet also did not have information regarding Advance Directives (Form # 283322).

Review of the 2 forms signed in Patient #377's record revealed the above Form 283301, and the Insurance Verification Form No. 283825.


Patient #396

Observation on 9/24/19 at 2:13 PM, of PAM staff #S679 who was registering Patient #396 in the waiting area of the EC (emergency center) revealed, Staff #S679 asked Patient #396 to verify her address and demographics. Staff #S679 tells Patient #396 that he needed her signatures for "some forms, consent form" [Consents, Agreements, Authorizations, Acknowledgements, and Irrevocable Assignments], "MAP for any type of prescription meds and PHI" [Medication Assistance Program Consent and Authorization for to Use and Disclose of Protected Health Information], and Insurance Verification. Patient #396 signs the electronic key pad for these specified forms. There was no discussion or explanation regarding Patient's rights. Staff #S679 did not ask Patient #396 if she had advance directives or if she would like information on how to formulate advance directives. Staff #S679 then hands Patient #396 a welcome packet of forms.

Review of the welcome packet of forms revealed the patient rights and responsibilities were not part of the welcome packet. The welcome packet also did not have information regarding Advance Directives (Form #283322).

Further observation on 9/24/19 at 2:45 PM consisted of another PAM staff #S681 registering Patient #397 in the EC who was being admitted for observation status and surgery.


Patient #397

Staff #S681 verifies Patient #397's insurance coverage and provided the Important message from Medicare. There was no discussion or explanation regarding Patient's rights for this patient that was being admitted for observation status and anticipation of surgery during the registration process.

Staff #S681 did not ask Patient #397 if she had advance directives or if she would like information on how to formulate advance directives.

Interview on 9/17/19 at 12:17 PM, with Patient Access Staff #S353 stated that during the registration process for patients she would verify the Patient's demographic information, insurance information, and have them sign the consent forms, which included the insurance verification, medication assistance, PHI Health exchange, and consent for treatment. Staff # S353 then stated, they would present the patient with a "welcome packet."

After review of the welcome packet of forms, revealed the patient rights and responsibilities were not part of the packet given to the patient or the information regarding Advance Directives (Form #283322).

Further interview with Staff #S353 revealed no indication that she would review or explain to patients their rights or have them sign regarding their patient rights. Staff #S353 stated that she was supposed to ask patients if they had advance directives and/or if the patient wanted information on how to formulate advance directives.

Interview on 9/24/19 at 2:00 PM, with Patient Access Staff #S679 stated when asked if patient's rights were reviewed with patients only, she stated, "if they are admitted" to the hospital. Staff #S679 stated that if the patient is admitted, then the patient access/registration staff will follow up with the patient to review patient rights with the patient and give them a "pass code" for visitors.

Further interview at 02:25 PM, with Staff #S679 confirmed he did not ask Patient #396 if she had advance directives because she had been asked before; and staff only have to ask if the patient is a "New Patient."

Staff #S679 showed the surveyor Patient #396's electronic record during the interview that already had documentation that Patient #396 did not have an advance directive. Staff #S679 confirmed, he did not provide Patient #396 with information regarding advance directives. Staff #S679 stated, the majority of patients have been at the facility before for care/treatment and their electronic medical record will already have documented from previous visits if they do or do not have advance directives.

Interview on 9/24/19 at 2:30 PM, with Staff #S680 stated that patients were supposed to be asked if they have advance directives during the registration process and that patients were given a copy of the patient's rights and responsibilities form in their welcome packet.

Surveyor informed Staff #S680 after review of the welcome packets given to Patient's #377 and #396 during the registration process; did not include the patient rights and responsibilities form or the form regarding Advance Directives.

Staff #S680 responded that she was currently making copies of the patient rights form "now and putting it in the packets now." Staff #S 680 further stated that the Advance Directive form #283322 is provided to patients if they want more information on formulating advance directives.

Staff #S680 indicated, patients sign on consent Form No. 283301 [Consents, Agreements, Authorizations, Acknowledgements, and Irrevocable Assignments] that they have been informed of their rights. Staff # S680 confirmed, patients do not sign an actual copy of the patient rights and responsibilities form and confirmed there is nothing specific that included documentation that the PAM staff explained to all patients (inpatients and outpatients) during the registration process their patient rights except the acknowledgment obtained from the patient or the patient's Legal Representative on Form No. 283301.

Staff #S680 also confirmed the Patients did not sign anything during the registration process specifically if they did or did not have advance directives. Staff #S 680 stated that patients' records will have the information if they have Advance Directives already populated in their electronic record from their previous visits.

Interview on 9/24/19 at 2:33 PM, with Patient #396 in the EC waiting area following her registration confirmed she had not been asked today if she had advanced directives during registration by PAM staff. Patient #396 further stated the staff "have asked in the past but not this time."


Review of the facility's policy titled, Advance Directives, last reviewed 8/29/19, indicated the following, in part;

"The facility shall ask all inpatient, emergency room patients, observation status patients, and day surgery patient, or the patient's Legal Representative if the patient has an Advance Directive and shall document the response in the patient's medical record."

Further review of the Appendix G, Advance Directive Emergency Center Process Flow indicated Advance Directives would be obtained by PAM staff during the verification of Demographic info while in the waiting area after triage; or during the bedside registration if patient was sent to a treatment room.


Review of the facility's Form #283322 dated 12/14 titled Advance Directives, given to patient's upon request of additional information regarding advance directives revealed the patient could obtain forms at:
http://www.dads.state.tx.us/news_info/publications/handbooks/advancedirectives.html


Review of this website provided in the facility's Form #283322 revealed, it was outdated and the current information for advance directives titled, "DIRECTIVE TO PHYSICIANS AND FAMILY OR SURROGATES," Advance Directives Act (see §166.033, Health and Safety Code) dated 12/2015 was at the following website (English):
https://hhs.texas.gov/sites/default/files/documents/laws-regulations/forms/LivingWill/LivingWill.pdf
(Spanish):
https://hhs.texas.gov/sites/default/files/documents/laws-regulations/forms/LivingWill/LivingWill-S.pdf


Review of the facility's policy titled Patient Rights and Responsibilities, last reviewed 8/30/19, revealed the following in part:
Attachment A (Form 284585) indicated the Patient's Rights to have an advance directive. The patient or personal representative had the right to receive notice of the facility's policy regarding Advance Directives prior to receiving treatment.


Review of the Form No. 283301 titled, "Consents, Agreements, Authorizations, Acknowledgements, and Irrevocable Assignments, last revised 8/19, revealed this form was signed by the patient during each registered visit to the facility. Further review of this form revealed, there was no information documented specifically as to whether the patient had an advance directive or did not have an advance directive.

Based on observation, interview, and record review:

(A) The facility's direct care staff failed to follow the manufacturer's direction for use when testing water used for hemodialysis of patients for total chlorine in 1 of 1 observation. Failure to test water using the correct volume of water recommended by the manufacturer for the water treatment system has the potential of giving an incorrect result as to the presence of chlorine in the water which can potentially harm all patients receiving hemodialysis treatment in the facility.


(B) The facility failed to ensure hemodialysis machines in use in the facility for hemodialysis treatment of patients' dialysate solution had electrolyte analysis done by a laboratory when putting hemodialysis machine in service in 15 of 18 hemodialysis machines observed. Hemodialysis machine #s 5155, 5156, 5157, 5158, 5159, 5160, 5161, 5162, 5163, 5164, 5165, 5166, 5167, 5169, and 5170. Failed to conduct conductivity and PH of the dialysate solution at the of site of treatment.


(C) The facility failed to ensure patients received care in a safe setting as a bathroom call light cord was inaccessible to a patient experiencing a fall. Sharp objects were accessible to patients on psychiatric unit.


(D) Failed to ensure patients received care in a safe setting in that 5 patients did not have the facility required allergy band to prevent the administration of contraindicated medications.


(E) The nursing staff failed to conduct the assessments and measurements of wounds, per the facility's policy, to determine if current treatments are effective. (Patients #122, 159, 160, 161, and 162). The nursing staff failed to clearly document wound care orders and failed to ensure recommended preventative measures were being followed for patients at risk for skin breakdown and to prevent further breakdown. (Patients #66 and 158).


(F) Hospital 1 failed to monitor humidity and failed to ensure end users were notified if temperatures were outside of acceptable ranges for 6 of 6 (station 15 area, Core D area, A Side Holding area, B Side holding area, Pod 7 area, and the CPU area) Emergency Department areas.


(G) Laboratory Issues: Hospital (2), failed to follow manufacturer recommended environmental specification for proper instrument testing conditions. The Facility's Emergency Care (EC) staff failed to follow Hospital (2's) policy for Quality Control for Refrigerator, Freezer, and Platelet Incubator.


Findings:

(A)
On 09/19/2019 at 9:30 a.m., Patient Care Technician #S42 and Registered Nurse #S43 were observed in the water treatment room of Hospital (1). Registered Nurse #S43 was observed testing the facility's water used for hemodialysis treatment of patients for total chlorine during the 4-hourly testing.

Observation of the facility's water treatment room at that time revealed a direct feed system in place without a holding tank, (CWP 100 series). Observation revealed the Registered Nurse collected 25 ml of product water in the specimen cup.

The Surveyor asked the Registered Nurse how much water was in the cup, he responded, "25 mls". The Surveyor and Registered Nurse verified the volume of water in the cup by looking at the gradation on the container. The Surveyor then asked Registered Nurse #S43 how much water was needed to test for total chlorine, he stated " 20 mls."

Registered Nurse #S43 then secured testing reagent strip from Hisense ultra 0.1 container and tested the 25 mls of water in the container for total chlorine. The Surveyor then notified Registered Nurse #S43 that he had used 25 mls of water instead of the recommended 20 by the manufacturer.

Registered Nurse #S43 stated "I will re-test it". He then proceeded to discard 5 mls of water from the specimen cup which held the 25 mls of water and proceeded to repeat the test using the existing water he had used for initial testing. The Surveyor notified him that the test result would be incorrect since he had already used a reagent strip in the water for the initial test.


Review of the manufacture's instruction on Serim Guardian Hisense Ultra 0.1 Test for Total Chlorine, directs user as follows:

"Fill the enclosed sample cup with water to be tested. Discard the contents and refill with 20 ml of water. Start the timer and immerse the indicator pad into the water sample. Vigorously swish test strips back and forth for a full thirty seconds. Remove strip and shake off excess water. Immediately compare color of the indicator pad to the color chart. Record the result and discard the test strip according to federal state and local regulation."


Review on 09/21/2019 of Registered Nurse #S43's Orientation Skills Assessment Checklist revealed documentation which indicated the most current hemodialysis skills check list on file was dated 01/04/13 - 2/9/13. There was no current skills assessment for competency for hemodialysis/testing for total chlorine in water used for hemodialysis of patients.


Review of a Learning and Resource Center Education History Report for Registered Nurse #S43, dated March 2018 - September 2019 revealed no evidence of skills assessment completed on the Registered Nurse.


During an interview on 09/20/2019 at 2:00 p.m., with the Vice President of Nursing for the hospital system, she said the facility did not have or implemented a skills assessment for hemodialysis.


(B) Electrolyte analysis

Review of the Manufacture's recommendation 2008T Manufacture's Operating Manual, P/N 490122 REV U, Page 18 directs users as follows:

"The machine must be labeled to indicate the type of concentrate for which it is configured. Check the composition (i.e. Na, Cl, K, Mg, HCO3) and pH of the dialysate solution after the machine is installed or after the machine is modified for different concentrate type. Verify the conductivity and pH of the dialysate solution through independent means before initiating treatment. Independent means could be by using an external conductivity meter, pH meter, pH paper, or using the machine's independent conductivity test. Improper conductivity or pH could result in Patient injury or death."


Observation on 09/16/2019 at 12:30 PM, of the facility's hemodialysis suite, located on the 6th floor of Hospital #1 revealed, there were 18 Fresenius 2008 T hemodialysis machines in place. Hemodialysis machine #s 5163 and 5169 were observed in use by patients.


The Surveyor requested documentation from the biomedical technician that verification of the electrolyte in the dialysis solutions were done by a laboratory. The Hemodialysis Unit's Biomedical Technician provided copies of electrolyte analysis completed on three hemodialysis machines #s 5154, 5168, and 5171. The record indicated the electrolyte analysis were completed on all three hemodialysis on 11/08/2018 and reported on 11/10/2018.


Review of Asset Detail Report provided by facility's staff revealed the following hemodialysis machines were put in service on the following days:

Hemodialysis machine # 5155 was put into service in the hospital on 11/16/2018.

Hemodialysis machine # 5157 was put into service in the hospital on 11/16/2018.

Hemodialysis machine # 5158 was put into service in the hospital on 11/16/2018.

Hemodialysis machine # 5159 was put into service in the hospital on 11/16/2018.

Hemodialysis machine #5160 was put into service in the hospital on 11/16/2018.

Hemodialysis machine # 5161 was put into service in the hospital on 11/16/2018.

Hemodialysis machine # 5162 was put into service in the hospital on 11/16/2018.

Hemodialysis machine # 5163 was put into service in the hospital on 12/07/2018.

Hemodialysis machine # 5164 was put into service in the hospital on 11/16/2018.

Hemodialysis machine # 5165 was put into service in the hospital on 11/16/2018.

Hemodialysis machine # 5166 was put into service in the hospital on 11/16/2018.

Hemodialysis machine # 5167 was put into service in the hospital on 11/16/2018.

Hemodialysis machine # 5168 was put into service in the hospital on 11/16/2018.

Hemodialysis machine # 5169 was put into service in the hospital on 11/16/2018.

Hemodialysis machine # 5170 was put into service in the hospital on 11/16/2018.


Review of the records revealed no documentation that verification of the electrolyte in the dialysis solutions were done by a laboratory.

Interview on 09/16/2019 12:30 PM, with Hospital (1) Biomedical Technician for the dialysis unit revealed, he had done electrolyte analysis on 3 of eighteen hemodialysis machine put in service in 2018.


Conductivity PH

Patient #193

On 09/23/2019 at 9:46 a.m., Patient # (193) was observed in room 6E of the medical intensive care unit of Hospital (1). The Patient was receiving hemodialysis utilizing 2008T hemodialysis machine # 5171. There was a portable Millennium XL reverse osmosis machine in use. The conductivity reading on the panel of the machine was 39.

During an interview on 09/23/2019 at 9:47 a.m., with Registered Nurse #S307 revealed, the conductivity and PH of the dialysate solution and safety check of the hemodialysis machine were done by Patient Care Technician #42 on the hemodialysis unit and then the prepared hemodialysis machine and reverse osmosis machines were taken to the medical intensive care unit. She said after this is done then she checks the total chlorine of the water at the patient's bedside.

Review of a dialysis machine system check and disinfection log revealed documentation of a conductivity of 14.0 mS/CM. Review of the Registered Nurse dialysis flow sheet revealed documentation of conductivity reading of 13.8. Conducting conductivity and PH of the dialysate solution and safety check of the dialysis machine in a different environment from where it is utilized can give incorrect reading which can harm the patient. The Ph should be verified to check that the right concentrate mixture is being used

Review on 09/20/2019 of Registered Nurse (S307) Orientation Skills Assessment checklist revealed documentation which indicated the most current hemodialysis skills check list was dated 05/25/07. Review of the record revealed no evidence of skills assessment completed on the Registered Nurse for hemodialysis


34839


3 out of 3 metal carts for the portable RO and dialysis machines observed, had rust and paint peeling off, therefore, not allowing for proper external disinfection.


28043


(C)
Bathroom Lights

A tour of Hospital(1) Unit 3A was conducted the morning of 9/17/19 accompanied by Staff #S62 and S145 and the following was observed:

In patient room 3A 1-1, a shared patient room, the call light cord in the patient bathroom was obstructed by a large trash can, which was placed in front of the call light cord, rendering it out of reach and ineffective for a patient experiencing a fall on the floor to summon help in an emergency. There appeared to be no other place for the large trash can in the bathroom; Staff #S148 draped the call light cord over the trash can in an attempt to make the cord accessible, which left the end of the cord too high and still out of reach for a patient on the floor.

The above findings were confirmed in an interview with Staff #S62 and S145 during the tour the morning of 9/16/19.


28141


Based on record review, observation, and interview, the hospital failed to ensure the rights of 2 of 13 patients (Patient #1 and Patient #228) on Hospital 1's mental health unit.

1) Patient #228, a patient with a history of severe sexual abuse, felt hopeless and anxious. She was on staff monitor for impaired insight and judgement. The patient had access to a staple with the potential for use in self-harm

The surveyor observed Patient #228 in bed on 09/20/19 at 1415. A two-page document was observed on the shelf next to the patient's bed. The document was stapled together. Staff #3 acknowledged the findings and removed the staple.

Patient #228's Initial Psychiatric Evaluation dated 09/18/19 reflected the patient was in a "down/depressed mood," felt hopeless, and had "flashbacks and nightmares pertaining to a situation that took place recently..." Patient #228 had a history of mental, sexual, and physical abuse and was noted with limited insight and judgement. Her initial diagnoses included Depressed Bipolar.

Nurse documentation dated 09/20/19 at 0114, reflected Patient #228 felt hopeless and helpless, and her anxiety prevented her from sleeping.

Nurse documentation dated 09/20/19 at 1546, reflected the patient was "seclusive to self or bed...remains on bizarre precaution monitoring..."

Physician Discharge Summary dated 09/23/19 at 1540, reflected the patient was a victim of sex trafficking.

Record review of the document titled Unit Specific Psychiatric Precautions, undated, defined "bizarre precautions" indicated for patients "with impaired insights and DSM diagnosis of Psychosis."


2) Patient #1 had been admitted with moderately severe depression and a history of eight prior suicide attempts. The patient made a self-harm attempt within two days of admission. During the survey, a sharp wire was found on the patient's unit. It was patient accessible and had the potential for patient self-harm. Observations on 09/20/19 at 1420, on the mental health inpatient unit's day room reflected an approximately three-inch two-pronged piece of wire with sharp edges and a small metal ring in front of a book case. Staff #S3 acknowledged the finding at that time.

Record review of the unit census dated 09/20/19 reflected Patient #1 was on suicide precautions.

Record review of Patient #1's Initial Psychiatric Evaluation dated 09/07/19 at 0758, reflected, the patient had been admitted with suicidal thoughts. The patient's PHQ-9 (Patient Health Questionnaire-9) reflected a total score of 18. The patient's past psychiatric history included "8 prior suicide attempts by various means ...[including] cutting wrists ..." Stanford University (2019) noted a score of 15 to 19 on the PHQ-9 reflected a moderately severe patient depression (http://med.stanford.edu/fastlab/research/imapp/msrs/_jcr_content/main/accordion/accordion_content3/download_256324296/file.res/PHQ9%20id%20date%2008.03.pdf).

Nursing documentation dated 09/10/19 at 0404, reflected the patient had a self-inflected superficial cut on his left wrist.

Daily Resident Physician Progress Note dated 09/10/19 at 0748, reflected Patient #1 wanted to hurt himself, had suicidal thoughts the night before and heard a voice telling him to hurt himself.



33326


(D) Allergy bands

A.) Review of the facility provided policy reflected the patient's allergy band was to be placed on the same arm as the identification band, to prevent the administration of medications a patient may be allergic to.

Observations on the morning of 9/24/29, on Hospital (1's) inpatient units, revealed the following:

6B room 4.1- Patient #225, had an allergy to Ibuprofen, the allergy band was on right wrist and the identification band was on the left wrist.

6D room 2.2- Patient #116, had an allergy to Codeine, the allergy band was on the right wrist and the identification band was on the foot.

5E room 9.0- Patient #221, had an allergy to Rocephin and Penicillin, the allergy band was on the left wrist and the identification band was on the right arm.

5G room 1.2- Patient #222, had an allergy to Marcaine, the patient did not have an allergy band on.

5G room 4.4- Patient #223, had an allergy to Penicillin, the allergy band was on the left wrist and the identification band was on the right wrist.

During an interview on the morning of 9/24/19, on the inpatient units, Staff #S303, Director of Nursing confirmed the findings.


(E) Wound Care

B.) Review of the facility provided policy #431 PRESSURE INJURY PREVENTION AND TREATMENT (dated 09/2018) reflected, "Upon admission, skin assessment shall be completed by nursing and documented in the patient's medical record and reassessed every shift and during transfer of care between health care providers .... E. The pressure injury (ulcer) prevention plan shall include interventions that minimize or eliminate friction and sheer, minimize pressure with off-loading, manage moisture, and maintain adequate nutrition and hydration ... D. Upon identification of a wound, a full wound assessment, including its location, size, and description of the tissue involved, shall be completed ..."


PATIENT #66 Hospital (1)

Review of Patient #66's medical records revealed a 62-year-old male presented on 7/10/19 to the facility's emergency department. The admission photos show the sacral skin is intact.

Review of the wound care nurse's notes reflected the following:

On 7/12/2019 at 12:26 am

Perianal: moisture related skin damage. Skin is moist, macerated, and erythematous. Periwound [sic]: clean, moist, intact.

Odor: mild.

Category 3 - the skin flap is completely absent. Partial thickness skin loss. Wound bed with 100% red tissue. Edges are irregular, open, attached to base. Periwound: C/D/I. No drainage noted. Braden Score: 14 Level of Risk: H.

ADDITIONAL RECOMMENDATIONS:

1. Turn pt. Q2hr, avoid supine (lying on the back) position/pressure to wound. Turn left or right side. Use foam wedge for optimal off loading. Provide cushion to hips or apply mepilex border dressing.

Review of the Wound Care Nurse's assessments of the Sacral wound revealed the following:

On 7/18/19 - Wounds are measured by Length X Width X Depth (LxWxD) in centimeters.

Sacrum: Pressure injury, DTI (deep tissue injury) Measurement: 6X4X unable to determine Intact skin with non-blanchable deep red, maroon, purple discoloration. Additional Recommendation: Turn pt. Q 2hrs, turn left or right side, and document. Avoid supine position/pressure to wound. Use foam wedge for optimal off loading.

On 8/1/19- Sacrum: Unstageable pressure injury. Measurements: 2X5.2X unable to determine. Wound bed obscured by 45% yellow slough, 5% dark red tissue, and 50% dark tan discoloration to skin. Additional Recommendation: Turn pt. Q 2hrs, turn left or right side and document: Avoid supine position/pressure to wound. Use foam wedge for optimal off loading.

On 8/8/19 - Sacrum: Unstageable pressure injury. Measurements: 2.5X4X unable to determine. Wound bed obscured by 90% white non-viable tissue and 10% dark red tissue. Additional Recommendation: Turn pt. Q 2hrs, turn left or right side and document: Avoid supine position/pressure to wound. Use foam wedge for optimal off loading.

On 8/11/19 at 7 PM, the nurse's documented an unstageable sacral wound with excoriation. The nursing documentation did not include measurements of the wounds.

On 8/12/19 - the wound care nurse assessed the wounds and wrote orders and recommendations to be followed.

On 8/23/19 - Sacrum: Unstageable pressure injury. Measurements: 3X3.8X unable to determine. Additional Recommendation: Turn pt. Q 2hrs, turn left or right side and document. Avoid supine position/pressure to wound. Use foam wedge for optimal off loading.

On 9/11/19 - Sacrum: unstageable pressure injury. Wound measures 6.0cmLx6.0cmWx2.0cmD. Undermining noted from 9 o'clock to 5 o'clock. Deepest point at 12 o'clock of 1.2cm. Wound base is 98% tan, tenacious nonviable tissue with 2% pale pink tissue. Edges are defined by not attached. Peri wound is denuded and macerated. Dressing that was removed was saturated with serosanguineous drainage. Additional Recommendation: Turn pt. Q 2hrs, Avoid supine position. Use foam wedge for optimal off loading.

On 9/13/19 at 11:47 am, the wound care nurse writes an order for dressing changes but does not describe the location or the area to be changed.

On 9/19/19 at 11:03 am, the wound care nurse writes an order for dressing changes but does not describe the location or the area to be changed.


Review of Patient #66's turning and repositioning documentation revealed the following:

7/12/19 at 2 am - Supine, 7 am- Supine, 11 am- Supine, from PM to 10 PM - no turning was documented.

7/13/19 at 8 am - Supine, 6 PM- Supine, 10 PM- Supine

7/14/19 at 2 am - Supine, from 6 PM to 6 am- no documented turning.

7/15/19 at 6 PM - Supine, 12 am- Supine, 4 am- Supine

7/17/19 at 8 am - Supine, 12 PM- Supine, 4 PM, no documented turning.

7/18/19 at 6 am till 7/20/19, the patient was no documented turned, Veniflex, do not turn.

7/21/19 at 6 PM - Supine, 8 PM- Supine

7/22/19 at 8 PM - Supine

7/23/19 at 8 PM - Supine, 2 am- Supine

7/24/19 at 9 am -Supine, from 10 PM to 7 am- no documented turning

7/26/19 at 2 PM - Supine, from 10 PM to 7/27/19 at 6 am- Supine

7/27/19 at 12 PM - Supine

7/29/19 at 10 PM - Supine

7/30/19 at 2 am - Supine, 8 PM - Supine

7/31/19 at 12 am- Supine, 10 PM - Supine

8/1/19 at 2 am - Supine, 12 PM - Supine, 3:40 PM - Supine, 6 PM - Supine, 8 PM - Supine, 10 PM - Supine, 10 PM - Supine

8/2/19 from 4 am to 6 PM - No documented turning

8/7/19 at 6 PM - Supine

8/9/19 at 12 am - No documented turning

8/15/19 from 11 am to 3 PM - no documented turning

8/16/19 at 11 am - no documented turning, from 7 PM 6:30 am - no documented turning

8/27/19 at 8:27 am - no documented turning, 12 PM - Supine, 8 PM - Supine

8/28/19 at 12 am - Supine, 4 am - Supine

8/31/19 at 2 PM - Supine

9/3/19 at 3 PM - Supine, 7:15 PM - Supine

9/5/19 from 9 PM to 1 am - no documented turning

9/6/19 at 4 PM to 7:15 PM - no documented turning

9/11/19 at 2 am - Supine

9/12/19 at 1 am - Supine, 2 am - Supine, 4 am - Supine, 5 am - Supine, 6 am - Supine, 7 PM - Supine, 9 PM - Supine, 10 PM - Supine

9/13/19 at 12 am - Supine


During an interview on the morning of 9/20/19, Staff #S401 confirmed the findings and stated Patient #66 was noncompliant and would place himself in the supine position. Staff #401 was unable to provide documentation of Patient #66's noncompliance or the staffs re-educating the patient when Patient #66 was found in the Supine position.

Review of Patient #66's treatment plan revealed the wound skin treatment plan was not added until 8/19/19 at 9:40 PM and was not updated to reflect Patient #66's continued non-compliance with lying supine and interventions to assist with compliance such as re-education and the use of wedges for positioning.


PATIENT #158

Review of Patient #158's medical records revealed an elderly patient admitted on 6/13/19.

On 6/17/19, the wound care nurse documented, Buttocks, scar tissue.

On 6/24/19, the wound care nurse documented, right/left only, 5cm X 7cm with 34% external dermal.

On 8/8/19, the wound care nurse documented, 9cm X 11.5cm with 90% and 10% pink base.

On 7/20/19, the nurse's note reflected a small skin tear to sacrum. The wound was not measured.

On 7/22/19, the nurse's note reflected (2) sacral wounds, the wounds were not measured.

On 7/29/19, the wound care nurse documented - 8.5cm X 11.5cm with 100% adherent black neurotic tissue.


Review of Patient #158's turning, and repositioning documentation revealed the following:

6/24/19 at 7 PM - Supine, 11:00 PM- Supine

6/26/19 at 1:00 am - Supine

6/28/19 at 2:30 PM - Supine

6/29/19 at 11:00 PM - Supine

6/30/19 at 3:00 am - Supine

7/6/19 at 9:00 am - Semi fowlers (reclining on back side), 9:00 PM - Semi fowlers

7/20/19 at 3:00 PM - Supine

7/23/19 at 7:00 am - Semi fowlers

7/24/19 at 7:00 am - Semi fowlers


Review of the facility provided policy #431 PRESSURE INJURY PREVENTION AND TREATMENT (dated 09/2018) reflected, "Purpose: To outline a comprehensive regimen designed to prevent, identify, and manage pressure injury (ulcer); to provide the guidelines for identifying at-risk patient, and the specific factors placing them at risk for the development of pressure injury (ulcer).

Policy Statement: All inpatient of Harris Health System shall be assessed for pressure injury (ulcer) and the risk of its development. Appropriate standardized assessment tools shall be used to identify at-risk patients and specific modalities shall be utilized to prevent and treat pressure injury (ulcer).

F. PRESSURE INJURY: A localized injury to the skin and/or underlying tissue usually over a bony prominence; the result of pressure or pressure in combination with shear and/ or friction."


Review of the facility provided policy #4001 Wound Care (dated 03/03/2019) reflected, "Purpose: to establish patient care guidelines to be used when a wound care referral is received by Harris Health System Physical Therapy ... Procedure for Inpatient Referrals: 1. WOCNURSE will assess all consults regarding pressure ulcers, moisture management ..."


C.) Review of the facility provided (Undated) staff training, "HARRIS HEALTH SKIN CARE MODULES Module 2: Pressure Injury Staging ... WOUND MEASUREMENTS: Wounds are measured by Length X Width X Depth (LxWxD). This is the diameter from edge to edge of wound. Any tunneling/undermining must be measured and identified.


PATIENT #161

Review of Patient # 161's medical records reflected a 72-year-old-female admitted on 7/14/19 with a diagnosis of NSTMI (non-ST elevation myocardial incident)

On 7/16/19, the nurse documented a skin tear to buttock. The nursing documentation did not include measurements of the wounds.

On 7/17/19, the wound care nurse recorded the following:

Lower back: Suggest pressure injury DTI (deep tissue injury)

Measurements (LXWXD) (cm) 4x3.5x unable to determine

Buttocks skin fold: Moisture related skin damage

Measurements (LXWXD) (cm) 3x0.3x0.23.5x unable to determine


On 7/17/19, a medial midline bruise. The nursing documentation did not include measurements of the wounds.

On 7/10/19, an excoriation below breast. The nursing documentation did not include measurements of the wounds.

On 7/22/19, fluid filled blister. The nursing documentation did not include measurements of the wounds.


During an interview on the morning of 9/25/19, in the facility conference room, Staff #S546, confirmed the findings and stated, "The measurements are not there..."


PATIENT #122

Review of Patient #122's medical records revealed a 45-year-old-female with an open wound to RLE s/p debridement's for necrotizing fasciitis.

The Physical Therapy Wound Care Evaluation dated 9/13/19 reflected the following:

1. Dressing change by nursing: Frequency daily. Clean the wound with gauze moistened with dermal wound cleanser ... Wound Size (cm): L: 25.0cm W: 10.5cm D: 0.8cm

Review of the nurses wound care and assessment notes dated 9/25/19, reflected the dressing was changed by the night shift; the nurse did not document the wounds size, width or depth.


Patient#162

Review of Patient #162's medical records revealed a 50-year-old-male admitted on 8/12/19 with Sezary Syndrome, a skin condition that places the skin at risk of developing rashes. Patient #162 developed 3 wounds to the scalp, due to the EEG monitor lead placements.

On 8/22/19, Patient #162 developed a wound to the left ear. The scalp wounds and the ear wound were not clearly described or measured.


PATIENT #159

Review of Patient #159's medical records reflected a 61-year-old-female admitted on 8/14/19 with a sacral decubitus ulcer and left foot gangrene.

On 8/16/19, the nurse documented a Stage 4 pressure wound; the nurse did not document the measurements or a description of the wound.

On 8/16/19, the wound care nurse documented the wound at 6.5cmX5cmX4cm.


PATIENT#160

Review of Patient #160's medical records reflected a 64-year-old-male admitted on 6/26/19 with End Stage Renal Disease.

On 6/26/19, the nurse documented- Skin intact.

On 7/8/19, the nurse documented- right elbow, red swollen.

On 7/10/19, the nurse documented- Left foot injury.

On 7/11/19, the nurse documented- Rectum Skin tear, moisture related.

On 7/11/19, the wound care nurse document, denuded, excoriated rectum.


During an interview on the morning of 9/20/19, when asked if the wounds should be measured, Staff #S150 stated, "Per policy, yes" and confirmed the findings.

During an interview on the morning of 9/25/19, in the facility conference room, Staff #S399 stated, "Once the wound is discovered the nurses are to remeasure the wound every Wednesday, if it hasn't improved by 0.2cm they have to put in a wound care nurse consult ... All wounds should be measured on admission by the nurses.


25846

(F)
Hospital 1

Based on a review of i-STAT Handheld and Precision Xceed Pro manufacturer's instructions, observation and confirmed in staff interview, hospital 1 failed to monitor humidity and failed to ensure end users were notified if temperatures were outside of acceptable ranges for 6 of 6 (station 15 area, Core D area, A Side Holding area, B Side holding area, Pod 7 area and the CPU area) Emergency Department areas.

1. A review of the i-STAT-1 System Manual, Art: 714336-000G, Rev. Date: 02-Sep-08, page 2-2 states under Specifications:
"Operating Temperature 16-30 °C (61-86 °F), Relative Humidity 90% (maximum) non-condensing"

2. A review of the Precision Xceed Pro, Blood Glucose Monitoring System operating manual, ART: 17026 Rev. B 03/09, page 12-1 states under Specifications: "Monitor Operating Temperature: 15-40 °C (59-104 °F), Humidity: From 10% to 90% noncondensing

3. During tour of the Emergency Department 09/20/2019, from 1110 to 1200 hours, it was observed that laboratory testing using the i-STAT Handheld and Precision Xceed Pro instruments was being performed in station 15 area, Core D area, A Side Holding area, B Side holding area, Pod 7 area and the CPU area.

4. During the tour of the Emergency Department areas, it was observed that there was no chart for recording the room temperature or humidity of 6 of 6 areas (station 15 area, Core D area, A Side Holding area, B Side holding area, Pod 7 area, and the CPU area) available for review.

5. A review of facilities management environmental monitoring records for the records for the Emergency Department area revealed no documentation of humidity, documentation of temperature but no documentation of an acceptable range.

6. In an interview of staff S112 on 9/27/2019, at 0858 hours, in the computer room, he stated that facilities management monitors sensors on the wall. They take reading every 10 minutes and use the Texas Regulations (25 TAC 1330169(c) for acceptable temperature range of 70-75 degrees F. In addition he stated there is no notification to the Emergency Department if the readings are outside temperature ranges.

7. In an interview of staff S112 on 9/27/2019 at 0903 hours in the computer room he stated that they did not monitor humidity.

Key:
i-STAT instrument - basic chemistry, blood gas and troponin testing
Precision Xceed Pro - glucose testing



30468

(G)
Laboratory Issues Hospital #2

1. Quick Reference Guide for the i-STAT Handheld, Art: 720660-00K, Rev. Date: October 11, 2017, page 51 states under Specifications: "Operating Temperature 16-30 °C (61-86 °F), Relative Humidity 90% (maximum) non-condensing"

2. Precision Xceed Pro, Blood Glucose Monitoring System operating manual, ART: 19306 Rev. A 12/09, page 12-1 states under Specifications: "Monitor Operating Temperature: 15-40 °C (59-104 °F), Humidity: From 10% to 90% noncondensing

3. During tour of the Emergency room on September 24, 2019, at 12:20 PM, it was observed that laboratory testing using the i-STAT Handheld and Precision Xceed Pro instruments was being performed on a counter near the "shock room" and in a small room marked "testing".

4. The "testing" room was observed to have a room temperature chart posted but the testing area near the "shock room" did not. Neither area had any documentation of humidity level monitoring.

5. Interview conducted in the laboratory on September 25, 2019, at 10:45 AM, S344, stated, "I don't think either instrument has any environmental specifications for humidity, so it has never been monitored".

Key:
i-STAT instrument - basic chemistry, blood gas and troponin testing
Precision Xceed Pro - glucose testing


1. Harris Health System Policy No: BBQ 5006.01/BBF 3015.03 titled Refrigerator, Freezer, and Platelet Quality Control states:

IF THE ALARM SOUNDS " ...5. For failure of blood bank refrigerator:

a. If the door is ajar, close it. Confirm proper temp.

b. If door was closed, check the probe bottle on the top shelf to ensure that the probe is placed far enough into the liquid to measure the temperature properly. Check the level of liquid in the bottle; it should be near the top. Refill the bottle as necessary with anti-freeze solution.

c. If there is a power failure and the alarm sounds, notify Engineering to restore the power.

d. If the alarm remains on and the interior temperature is out-of-limits, removes the blood units to an acceptable refrigerator

Based on review of documents and interview, the facility failed to ensure patient rights to be free from all forms of abuse and neglect by failing to:


A.) Take timely action to ensure patient care needs were not neglected (a form of abuse) at Hospital #2 after repeated reports of patients not receiving vital medications on time due to the Labor and Delivery Unit not having access to the required equipment for administration of medication. The facility was aware that Intravenous (IV) infusion equipment was not readily available to staff and neglected to identify problems associated with the timely distribution of IV infusion equipment. The facility neglected to take immediate actions to ensure vital IV infusion equipment was available for patient care. This neglect to take action repeatedly left patients with delays in receiving vital medication administration.


B.) Thoroughly investigate and/or respond to an allegation of neglect in accordance with their policies and procedures for 1 of 1 patients reviewed (Patient #383) with an allegation of neglect reported on his behalf at facility #2. On 8/9/19, it was alleged Patient #383 was neglected when staff failed to ensure one to one supervision for patient safety of suicidal ideation and in accordance with his physician orders. The facility did not have evidence this allegation of neglect was thoroughly investigated and/or reported to the Texas Department of State Health Services (DSHS) in accordance with their policy and procedures and State Law.

This deficient practice could compromise patient safety by failing to implement protections.


Findings:


A.) Review of incident reports for Labor and Delivery submitted in August 2019 was made. During the review, it was noted that on 8-13-2019, 8-17-2019, 8-23-2019, 8-28-2019, and 8-30-2019, patient care was delayed because staff could not get the necessary infusion pump to administer intravenous medications. Medications delayed included "time-critical antibiotic," Pitocin (medication necessary to augment labor), and IV fluids.


Interview was conducted with Hospital #2 CNO on the afternoon of 9-25-2019 regarding actions taken because of non-availability of pumps. The CNO was asked if the problem with patient care being delayed due to infusion pumps not available had been submitted to the Quality Department for evaluation of the problem and identification of the possible solutions since this was a quality of care issue. The CNO confirmed that it had not been reviewed by the Quality Department.


The CNO stated the hospital had enough IV pumps. He stated that he was aware that there was a delay in care as recent as the previous day on the Labor and Delivery unit due to no pump being available but insisted the problem wasn't with having enough pumps. The CNO explained that an inventory of pumps had been conducted and showed there were plenty of pumps available but there was shortage of IV poles that hold the pumps. The CNO confirmed that the plan to correct the problem was that IV poles had been placed on order. The CNO did not know how many poles had been ordered or when they would be in service. An inventory of IV pumps was provided the next day to show that the hospital had 801 Alaris IV pumps assigned to inventory. No inventory of IV poles was provided. No purchase order for IV poles was provided.


While the list provided showed that there was possibly an adequate number of pumps in the hospital's inventory, it did not indicate the availability of the pumps. The CNO confirmed that the problem had not been sent to Quality Assessment and Performance Improvement (QAPI), therefore, QAPI was not tracking the availability of those pumps, tracking delays in care, analyzing the process for distributing those pumps, or aggregating and analyzing data to ensure that the actual cause of delays in patient care had been identified. No evidence was provided that the facility had taken immediate action to put temporary processes in place to ensure that patient care was not neglected resulting in the likelihood for bad patient outcomes due to patients not receiving necessary IV medications in a timely manner.


21863


B.) Review of the facility's Policy and Regulation titled, Abuse, Neglect, and Exploitation of Patients occurring at the system facilities effective 4/2017 indicated the following in part: Post investigation- 2. The Accreditation and Regulatory Affairs Department shall make necessary notifications to regulatory agencies as required. There was not a specific named agency or phone number indicated.


The policy indicated the "types of abuse, neglect and exploitation requiring investigation" were on page 9 and 10 indicating physical abuse/assault, sexual assault, verbal or emotional abuse, exploitation, and sexual harassment. Neglect was not indicated as a type of abuse that needed an investigation. The policy did not define Neglect except for neglect of a Child and Elderly.


Review of the facility's Policy and Regulation titled, Mandatory Reporting Requirements and Notification Commitment last revised 7/12/19 indicated the following in part: Appendix A- Mandatory reporting indicated on page 6 that Abuse, Neglect, Exploitation, and/or Unprofessional/Unethical Conduct would be reported to the Texas Department of State Health Services [DSHS] (no other specific details were indicated). When to Report indicated to see Attachment D for time frames to report.


Review of Attachment D for reports of abuse, neglect, exploitation, unprofessional, or unethical conduct indicated the following:

a. Abuse/Neglect:

i. What to Report: [Facility] must report when it believes or knows information that would reasonable cause a person to believe that the physical or mental health or welfare of a patient who is receiving chemical dependency, mental health, or rehabilitation services has been, is, or will be, adversely affected by Abuse or Neglect caused by any person.

ii. Whom to Report to: The Texas Department of State Health Services, Patient Quality Care Unit, and Division for Regulatory Services. There was no phone number provided.

iii. When to Report: [Facility] must report this information "as soon as possible."

The policy did not define Neglect; except for neglect of a Child, Elderly, or a Person with a Disability.


Review of facility's Electronic Internal Reporting System (EIRS) File ID #151913 revealed an allegation reported 8/9/19 on behalf of Patient #383 by a nurse manager that alleged Neglect, Severity Level 1 - Unsafe condition when patient came to day surgery from Interventional Radiology (IR) and had suicidal ideations (SI). No report was received that the patient was on suicidal precautions. Patient had a physician order for one to one continuous supervision dated 8/4/19. The EIRS findings revealed the chart was reviewed. "No response from departmental leadership to date. Error on part of facility. Error reached patient. Error cause no harm. Level:3." Resolution/Outcome - Patient Safety Event Type: "Not applicable." File was closed on 9/6/19.


Further review of the EIRS internal reporting system revealed all allegations of abuse, neglect, and exploitation were coded as "assault." The system does not allow an option for Neglect. This specific EIRS File ID #151913 allegation of Neglect was coded as "diagnosis/treatment" in the reporting system.


Interview with Staff #S531 on 9/18/19 at 2:30 PM, was asked about reporting abuse and neglect allegations to a regulatory agency. Staff #S531 indicated the facility followed CMS [Centers for Medicare and Medicaid Services] guidelines. Staff #S531 stated she would "call in allegations of abuse that were substantiated" to the specified local (Houston) Zone Manager for the Patient Health Care Quality Unit, and indicated the local Zone Manager's phone number.


Further interview on 9/19/19 at 9:30 AM with the Staff #S531 indicated the last abuse neglect allegation reported to the DSHS was on 11/28/2015 for sexual assault that was substantiated. Staff #S531 stated when allegations are substantiated after investigation then they are reported to the state [DSHS]. Staff #S531 stated, if the allegations were inconclusive, they were referred to Patient Safety as a Grievance. Unsubstantiated allegations are not reported to the state.


Staff #S531 was interviewed on 9/19/19 at 10:00 AM regarding the EIRS File #151913 for Patient #383 and she indicated a report was entered in to the facility's EIRS because when the patient went to the IR suite the staff did not let the nurse know that he had one to one supervision for SI. Staff #S531 stated, there was a 20-minute delay (breach) of one to one supervision on 8/9/19 from 13:30 to 13:50 when the patient was in transition from IR to the Post-Anesthesia Care Unit (PACU). Staff #S531 stated the assigned one to one staff was responsible to complete 15 minute documented checks on the patient interventions flowsheet. Staff #S531 stated, this allegation (EIRS #151913) had not been reported to the state/DSHS because there had not been any response from the Radiology Department's Leadership and further stated, the Radiology Manager has left the position since this allegation. Staff #S531 confirmed there were not any statements available for review because this incident report was sent to the Radiology Manager for follow up and investigation. This EIRS incident was sent on 8/14/19 with a deadline of 8/21/19 to follow up and respond. Staff #S531 confirmed as of 9/19/19 there had not been any follow up from the department for this specific allegation. Staff #S531 confirmed this neglect allegation for Patient #383 was closed without a thorough/complete investigation or a determination if the allegation had been substantiated.


Review of Patient #383's medical record revealed the following: On 8/4/19 at 04:35 AM, the nursing flowsheet documented this Patient was suicidal with a plan to kill himself. Patient admitted to past suicidal attempts multiple times. Requested one to one sitter and Psychiatric consult, with suicide precautions.

Physician Order on 8/4/19 at 04:58 for a Patient Safety Assistant (PSA) continuous one to one supervision.


Review of Patient #383's Nursing flowsheets revealed breaches in documentation on 8/9/19 from 19:15 to 21:30 by the PSA for the one to one supervision. In addition, the Patient Flowsheet record allowed a blocked section for documentation of the one to one continuous observation; but this area was not used and does not have documentation for Patient #383.


CMS Guidelines define Neglect: for the purpose of this requirement, is considered a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness.

CMS Guidelines also suggest the hospital ensures a timely and thorough investigation of all allegations of abuse, neglect or mistreatment.

Based on review of documentation and interview, the facility failed to ensure restraints were discontinued at the earliest possible time according to the physician orders and facility policy for 1 of 8 Patients (Patient #382) reviewed for restraints at facility #2.

Specifically, Patient #382 remained in 4 point restraints while nursing documentation indicated he was resting and subdued during assessments on 6/7/19 at 00:15 until released from restraints at 08:06AM (over 8 hours).


Findings:

Review of the facility's Policy Titled Restraint and Seclusion, last reviewed 06/2019 indicated that restraint and seclusion episodes will always be discontinued as soon as possible for the safety and well-being of the patient, regardless of the scheduled expiration of the order.


Review of Patient # 382's records revealed the following restraint orders while Patient was in 2B Med/Surg Unit of Hospital #2:


Restraint order 6/6/19 at 07:27 PM: Continuous for 4 hours for 4 point soft (Right/Left (R/L) Wrist and R/L Ankle). Justification: Imminent risk of harm to self, others, or both. Discontinuation Criteria: Absence of Behavior that Required Restraint.


Restraint order 6/6/19 at 07:38 PM for Continuous for 4 hours for 4 point soft (R/L Wrist and R/L Ankle). Justification: Imminent risk of harm to self, others, or both. Discontinuation Criteria: Absence of Behavior that Required Restraint.


Restraint order 6/6/19 at 08:14 PM for Continuous for 4 hours for 4 point soft (R/L Wrist and R/L Ankle). Justification: Imminent risk of harm to self, others, or both. Discontinuation Criteria: Absence of Behavior that Required Restraint.


Restraint order renewal on 6/6/19 at 23:45 (11:45 PM) for Continuous for 4 hours for 4 point soft (R/L Wrist and R/L Ankle). Justification: Imminent risk of harm to self, others, or both. Discontinuation Criteria: Absence of Behavior that Required Restraint.


Restraint order 6/7/19 at 00:32 AM for Continuous X 4 hours for 4 point soft (R/L Wrist and R/L Ankle). Justification: Imminent risk of harm to self, others, or both. Discontinuation Criteria: Absence of Behavior that Required Restraint.


Restraint order 6/7/19 at 04:15 AM for Continuous X 4 hours for 4 point soft (R/L Wrist and R/L Ankle). Justification: Imminent risk of harm to self, others, or both. Discontinuation Criteria: Absence of Behavior that Required Restraint.


Restraint order 6/7/19 at 04:22 AM for Continuous X 4 hours for 4 point soft (R/L Wrist and R/L Ankle). Justification: Imminent risk of harm to self, others, or both. Discontinuation Criteria: Absence of Behavior that Required Restraint.


Restraint order 6/7/19 at 08:06 AM for Continuous X 4 hours for 4 point soft (R/L Wrist and R/L Ankle). Justification: Imminent risk of harm to self, others, or both. Discontinuation Criteria: Absence of Behavior that Required Restraint.


Restraint order 6/7/19 at 08:16 AM for Continuous X 4 hours for 4 point soft (R/L Wrist and R/L Ankle). Justification: Imminent risk of harm to self, others, or both. Discontinuation Criteria: Absence of Behavior that Required Restraint.


Review of the Nursing Flowsheet documentation for Patient # 382's restraints revealed the following documentation: 4-point Restraint implemented 6/6/19 at 7:27 PM and 4-point Restraint discontinued 6/7/19 at 08:06 AM


Condition impacting the need for restraint till present:

6/7/19 at 00:15 AM, Dr notified continue restraint 0-Other Patient resting; Subdued.

6/7/19 at 00:45 AM, Patient "Subdued."

6/7/19 at 01:00 AM, Patient resting; Subdued, restraint loosened.

6/7/19 at 01:23 AM, (Other) Patient resting, restraint loosed. 4 point restraints continued.

6/7/19 at 01:30 AM, Patient resting; Subdued, restraint loosened.

6/7/19 at 01:45 AM, Patient resting; Subdued, restraint loosened.

6/7/19 at 2:00 AM, Subdued. Restraint loosened. Position changed and range of motion.

6/7/19 at 05:38 AM, (Other) Patient resting, restraint loosened. 4 point restraints continued.

6/7/19 at 08:06 AM, Restraints Discontinued.


Patient #382 remained in a 4-point restraint from 6/6/19 at 7:27 AM until discontinued on 6/7/19 at 08:06 AM (over 12 hours). Nursing documentation indicated he was resting and subdued during checks on 6/7/19 at 00:15 until released from restraints at 08:06AM (over 8 hours).


The behavior requiring restraint was absent while Patient #383 was resting and subdued documented on 6/7/19 at 00:15, 00:45, 01:00, 01:23, 01:30, 01:45, 02:00, and 05:38.


Review of Nursing Flowsheet notes revealed the following:

6/7/19 at 4:00 AM, Patient is subdued but has periods of agitations and aggression, combative, fighting against restraints. Four point restraints on.

6/7/19 at 7:17 AM, Upon arrival, Patient is in 4 point restraints. Patient keeps saying how he wants to leave and randomly laughing. Patient talking to himself and keeps asking staff to let him go.


During an interview on 9/24/19 at 10:15 AM, Staff #S677 confirmed Patient # 382 should have been released from his 4 point restraints when it was documented that he had been resting and subdued since the behavior requiring restraint was absent and he met criteria for the release of the 4 point restraints; first documented on 6/7/19 at 00:15AM.


During an interview on 9/23/19 at 10:15, Staff #S360 stated violent restraints were to be removed from the patient when they were no longer exhibiting the behaviors. Staff #S360 stated the nurse can discontinue the restraints, remove, and if the patient becomes violent again, the nurse can get another restraint order to re-implement the restraint.

Based on record review of facility documentation and staff interviews, the facility failed to have a physician or other licensed independent practitioner (LIP) assess the patient face-to-face within 1-hour after the initiation of a restraint used for the management of violent or self-destructive behaviors for 4 of 8 patients (Patient's #379, #391, #394, and #395) reviewed for restraints at facility #2.


1.) Patients were being administered psychotropic emergency medications (also known as Chemical Restraints) used to control violent behaviors and was not assessed face-to-face within 1-hour after the initiation of the emergency medications to evaluate the intervention and,

2.) Patients had 4-point physical restraints implemented to control violent behaviors and was not assessed face-to-face within 1-hour after the initiation of the 4-point restraints.


Findings:

Patient #394

a.) Review of Patient #394's Physician Orders (PO) dated 9/3/19 at 23:57 revealed an order for violent restraint, 4 point due to imminent risk. Patient agitated, restless, verbally aggressive, and continues biting.

Review of the nursing flowsheet revealed this restraint was implemented at 23:58 and discontinued at 00:30 (32 minutes later).

Patient #394's record on 9/3/19 at 23:57 documented a face-to-face physician evaluation and a violent restraint provider note at the exact time of the PO. These physician assessments were documented before the implementation of Patient #394's 4-point restraint at 23:58 and not after the implementation to evaluate and assess the intervention.

Further review of Patient #394's record revealed there was not a face-to-face evaluation conducted within 1 hour after the initiation of the 4-point intervention on 9/3/19 at 23:58.


b.) Patient #394's record documented the following psychotropic medications administered due to a Psychiatric Emergency including violent behaviors.

PO 9/4/19 at 03:01 for Haldol 5 milligrams (mg) intramuscular (IM) one time stat now. Psychiatric emergency - yes. For aggression. Medication Administration Record (MAR) - Administered 02:30 without a verbal order (prior to the order placed in the record). There was no face-to-face evaluation documented within 1 hour after the initiation of emergency medication used for violent behaviors on 9/4/19 at 2:30 AM.

PO 9/4/19 at 09:19 Ativan 2mg Intravenous (IV) one-time push 1mg. Psychiatric Emergency - Yes. Emotional lability. Initiate this psychoactive medication for psychiatric stabilization, safety, and management of the patient's psychiatric crises. MAR- Administered at 09:25.
There was not a face-to-face evaluation conducted within 1 hour after the initiation of the emergency medication used for violent behaviors on 9/4/19 at 09:25 AM.


Patient #395

a.) PO on 9/3/19 at 17:52 for a violent restraint 4 point, imminent risk. Modification to a 3-point restraint: do not restraint left leg due to ortho boot. Nursing Flowsheet documented the 3-point Restraint implemented 9/3/19 at 18:00 due to aggressive behaviors, continues verbal threats, and lunging.

9/3/19 at 17:59 indicated a face to face physician evaluation for verbally threatening, observed patient, current order for restraints should be continued. Patient hitting, verbally threatening. This evaluation was completed just before the implementation of the 3-point restraint at 18:00.


b.) Emergency Medications administered:

PO 9/3/19 at 18:29, Benadryl 50mg/ml injection, 50 mg IM for aggression one time use only for psychiatric emergency. MAR - Administered at 18:08

PO 9/3/19 at 18:29 Versed (midazolam) one-time dose 5mg IM. MAR- Administered at 18:08


Patient #395's record there was not a documented face to face Physician evaluation conducted within 1 hour after the initiation of the emergency medications used for violent behaviors; Versed and Benadryl on 9/3/19 at 18:29.


Patient #379

a.) PO 7/6/19 at 17:21- Violent Restraint order 4-point Imminent risk. Release when absence of behavior. Nursing Flowsheet documented restraint implemented 17:15- Patient #379 was placed into a 4 point (2 right/left wrist, and 2 right/left ankle) physical restraint.

17:15- the Resident Medical Doctor (MD) documented a "Violent Restraints Provider Note" indicating the patient was violent and aggressive and required restraints in order to keep him and others safe. This note was as the exact time of the implementation of the 4-point restraint (17:15), and not after the implementation to evaluate the intervention. There was no face-to-face evaluation conducted within 1 hour after the initiation of this 4-point restraint used for violent behaviors on 7/6/19 at 17:15.


b.) PO 7/6/19 at 17:13 - Lorazepam 2mg IV stat once- Psychiatric Emergency- Yes. Justification for use: one time use only for psychiatric emergency. Initiate this psychoactive medication for psychiatric stabilization, safety, and management of patient's psychiatric crisis - Answer, aggression. The MAR indicated this medication Administered at 17:30. There was not a face-to-face evaluation conducted within 1 hour after the initiation of the emergency medication used for violent behaviors on 7/6/19 at 17:30.

Interview with the Quality Coordinator Staff #S677 on 9/24/19 at 10:00 AM, during the review of Patient #379's records stated the facility does not use Chemical Restraints. Staff #S677 stated the facility did not interpret the use of Emergency Medications administered in a Psychiatric Emergency as a Restraint, stating, it was a "gap in our quality." Staff #677 confirmed there was no physician or LIP one-hour face-to-face evaluation completed within one hour after the implementation of 4-point restraint and emergency medication on 7/6/19 for Patient #379.


Patient #391

Review of Patient #391's PO dated 8/28/19 at 04:26, revealed an order for a 4-point soft R/L wrist and r/l ankle imminent risk of harm to self, others, or both. The nursing flowsheet indicated restraint implemented at 04:26.

Review of the Physician's One-hour face-to-face evaluation on 8/28/19 at 04:26AM, was documented at the exact time of the implementation of the 4-point restraint and not after the implementation to evaluate the intervention.

Interview with the Quality Coordinator Staff #S677 on 9/24/19 at 11:30 AM, during the review of Patient #391's records indicated the physician is usually at the patient's bedside during the implementation of restraints and is putting in the orders into the patient's electronic medical record during the time of implementation. Staff #S677 confirmed there was no additional face-to-face evaluation completed in Patient #391's records after the implementation of the 4-point restraint at 4:26.


Interview with Staff #S671 on 9/26/19 at 09:50 AM, confirmed the facility had not identify the use of emergency psychotropic medications as a restraint and further stated, the Physicians were indicating the facility did not use "Chemical Restraints." Staff #S671 confirmed the facility had not ensured Patients that were being administered psychotropic emergency medications used to control violent behaviors (also known as Chemical Restraints) were assessed face-to-face within 1-hour after the initiation of the emergency medications because it had not been built into the electronic record platform to populate the face to face physician evaluation.


Facility Policies Reviewed:

Restraint and Seclusion last reviewed 06/2019, indicated the following in part,

A.) The policy defined Restraint to include "A drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition."

The policy defined Chemical Restraint as a medication used to restrict a patient's freedom of movement or manage a patient's behavior and is not a standard treatment or dosage for the patient's condition.

Types of Restraints included: c. Chemical Restraint: The use of a drug as a restraint requires two (2) fundamental criteria:

i. It is used to restrict the patient's behavior and freedom of movement; and

ii. It is not a standard treatment of dosage for the patient's condition.

iii. No patient shall be treated with a chemical restraint.


B.) In the area of Patient Monitoring and Documentation for Violent or Self-Destructive behavior revealed, the policy did not specify the requirement for a physician or LIP face-to-face evaluation requirement within 1 hour after the initiation of a restraint.


C.) In the area of patient Re-evaluation indicated, "Following the initial application of restraint/seclusion, the MD [Medical Doctor] conducts and in-person assessment at least every 4 hours." There was no indication of the one-hour face-to-face requirement after initiation of restraints.


D.) The policy indicated on page 12, Administering Emergency Medication:

1. Staff is to use the least restrictive method of administering the medication to avoid or reduce the use of force.

2. Physician orders for physically holding a patient to administer emergency medication is required prior to the application of the restraint (use of force).

3. A physical hold is terminated as soon as the medication is administered.

4. If physical holding for forced medication is necessary with a violent patient, the one (1) hour face-to-face evaluation requirement would also apply.


Further review of the entire policy revealed, there was no direction regarding the 1-hour face-to-face evaluation requirement by a physician or LIP except for the use of Administering Emergency Medication as specified above indicating, "If physical holding for forced medication is necessary with a violent patient, the one (1)-hour face-to-face evaluation requirement would also apply." There were no other procedures regarding the one-hour face-to-face.


In the area of Quality Monitoring for Restraints in the policy revealed restraints would be monitored and evaluated on a continual basis as part of the facility's Quality Management System which included "Evidence of face-to-face assessment by MD within one hour of restraint/seclusion application."


Review of the facility's policy titled, "Consent to Treatment with Psychoactive Medication" effective 03/11, indicated the following, in part:

F. Administration of psychoactive medication in emergency situations:

1. The physician shall issue and order to administer psychoactive medication to a patient without the patient's consent. The physician will document in the clinical record:

a. The necessity of the order in specific medical and behavioral terms;

b. Other generally accepted less accepted less intrusive forms of treatment which the physician has evaluated, but rejected; and

c. The reasons those treatments were rejected.


Further review of the entire policy revealed there was no direction regarding the 1-hour face-to-face evaluation requirement by a physician or LIP after the initiation of psychoactive emergency medication without the patient's consent.


Interview with Staff #S671 on 9/23/19 at 11:00 AM, confirmed the facility did not have any additional policies regarding the use of Emergency Psychotropic medications administered to patients to control violent behaviors except for the guidelines for administering psychoactive medication in emergency situations in the policy titled Consent to Treatment with Psychoactive Medication, effective 3/11.

Based on review and interview, the hospital system failed to:

A. follow their own Quality Manual 2019 to assist the System Pavilions with oversight, support, or continual improvement of quality patient care, to ensure safe and efficient treatment in Hospital #1 and #2, and Outpatient Services (ACS) of 3 Pavilions.


B. the Facility's Quality Assessment Performance Improvement Committee failed to develop and implement a robust system which addressed all aspect of dialysis care and services in the facility (Hospital #1). Failed to ensure staff providing care and services to patients receiving hemodialysis treatment were assessed for competency.


C. take timely action to ensure patient care needs were not neglected (a form of abuse) at Hospital #2 after repeated reports of patients not receiving vital medications on time due to the Labor and Delivery Unit not having access to the required equipment for administration of medication. The facility was aware that Intravenous (IV) infusion equipment was not readily available to staff and neglected to investigate and identify problems associated with the timely distribution of IV infusion equipment. The facility neglected to take immediate actions to ensure vital IV infusion equipment was available for patient care. The failure to take action repeatedly left patients with delays in receiving vital medication administration.


D. ensure the laboratory services were integrated into the hospital-wide QAPI program and failed to implement strategies and monitor the effectiveness of corrective actions the laboratory implemented.

Refer to Tag A0283


E. to include contracted services in the Quality Assurance Performance Improvement (QAPI) process to ensure patient safety.

Refer to Tag A0308

Based on review of documents and interview, the facility failed to:

A. follow their own Quality Manual 2019 to assist the system Pavilions with oversight, support, or continual improvement of quality patient care to ensure safe and efficient treatment.


B. the Facility's Quality Assessment Performance Improvement committee failed to develop and implement a robust system which addressed all aspect of dialysis care and services in the facility (Hospital #1). Failed to ensure staff providing care and services to patients receiving hemodialysis treatment were assessed for competency.


C. Take timely action to ensure patient care needs were not neglected (a form of abuse) at Hospital #2 after repeated reports of patients not receiving vital medications on time due to the Labor and Delivery Unit not having access to the required equipment for administration of medication. The facility was aware that Intravenous (IV) infusion equipment was not readily available to staff and neglected to investigate to identify problems associated with the timely distribution of IV infusion equipment. The facility neglected to take immediate actions to ensure vital IV infusion equipment was available for patient care. The failure to take action repeatedly left patients with delays in receiving vital medication administration.


D. ensure the laboratory services were integrated into the hospital-wide QAPI program and failed to implement strategies and monitor the effectiveness of corrective actions the laboratory implemented.


Review of the facility Quality Manual 2019 revealed, the facility has a guide for the "Governance, Structure, and Leadership Responsibilities". The Manual revealed a community owned integrated system for the following Pavilions:

"1. Two (2) acute care hospitals

2. Sixteen (16) Community Health Centers,

3. Three (3) Pediatric and Adolescent Health Centers,

4. Nine (9) Homeless Shelter Sites,

5. Five (5) School Based Clinics,

6. Six (6) Mobile Health Clinics,

7. Two (2) Specialty Clinic Sites,

8. Five (5) Same-Day Clinics,

9. Dental Center,

10. Dialysis Center,

11. Contracted Outside Medical Services,

12. "Ask My Nurse" 24/7 Telephone Nurse Triage line,

13. Emergency Medical Services Fleet,

14. Ambulatory Surgery Center.


B. Process Interaction: The processes within ____ Health System Quality Management System are interrelated."

The listed Pavilions have been placed in three categories for quality reporting. Hospital #1, Hospital #2, and Out Patient Services (ACS). The Quality Manual 2019 instructed the reader on a hierarchy of reporting which started with the following,

Medical Staff Committees
Department/Service Committees/Councils
Physical Environment
System Level Committees
Medical Executive Board and pavilion Medical Executive Committee.


An interview was conducted with Staff #S738 on the morning of 9/24/19. Staff #S738 reported that if the individual departments had recognized a problem that could not be addressed and corrected in a timely manner then it should be brought to the director of the unit. Other options were to use the committees at the department level but was not necessary. The issues could be brought to the Pavilion Quality Review Council (QRC) that meets on a monthly basis.


Quality Review Council (QRC)

"The QRC provides oversight for the Quality Management System at the Pavilion level. Each Pavilion has its own QRC. The QRC has the responsibility and authority to determine the Quality Management System has been effectively implemented and maintained at the Pavilion. The QRC is responsible for measurement, monitoring and analysis of the National Integrated Accreditation for Healthcare Organizations (NIAHO) QM.7 Standard Requirements (SR).1-SR.18 quality of care metrics and other regulatory survey findings. The QRCs develop performance goals that are in alignment with the ____ Health System strategic objectives. In addition, all accredited/certified programs are required to routinely report (minimum of once year) outcomes and performance metrics, to QRC. The QRCs may also initiate performance improvement teams for issues that are unique to the departments within the pavilion."


Once the information has been addressed in the QRC at the Pavilion level, that information and data would be reported to the Quality Governance Council (QGC).


Quality Governance Council (QGC)

"3. Quality Governance Council (QGC) The QGC provides executive oversight for _____ Health Quality Management System to support and facilitate the continual improvement of quality health care. The QGC has the responsibility and authority to determine if the Quality Management System (QMS) has been effectively implemented and maintained. The QGC ensures conformance to the National Integrated Accreditation for Healthcare Organizations (NIAHO) standards and other statutory requirement as stipulated by State and Federal agencies ...."

"top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization. This review shall include assessing for risks, opportunities, and the need for changes to the quality management system, including the quality policy and quality objectives.

The review includes information on: a) The status of actions taken from previous management reviews, b) Changes in external and internal issues that are relevant to the quality management system, c) Information on the performance and effectiveness of the quality management system, including trends in: Customer satisfaction and feedback from relevant interested parties, the extent to which quality objectives have been met, process performance and conformity of products and services, nonconformities and corrective actions, monitoring and measurement results, audit results, the performance of external providers, d) The adequacy of resources, e) The effectiveness of action taken to address risks and opportunities, f) Opportunities for improvement.

The review also includes the decisions and actions related to: a) Opportunities for improvement, b) Any need for changes to the quality management system, c) Resource needs."


BOT Quality Committee

"This is a committee of the Board of Trustees that oversees the Quality Safety and Performance Improvement (PI) Programs of ____ Health System in order to maintain high quality service, patient and staff safety, and overall satisfaction within ____ Health System."


Governance
Board of Trustees

"Governance: Board of Trustees the ____ Health System Board of Trustees (BOT) is the governing body of ____ Health System. It has the ultimate authority and responsibility for the review, approval, and monitoring of ____ Health System's Quality Management System. The BOT ensures that an integrated plan is implemented throughout ____ Health System. The BOT designates the President/Chief Executive Officer as the executive agent who oversees the operation of the organization's Quality Management System. Refer to the Harris County Hospital District Board of Trustees Bylaws."


Rehabilitation Department Hospital #2

A tour was conducted in Hospital #2's inpatient Rehabilitation Department on 9/17/19. During a visit with the Physical therapy department staff, a daily patient census board for 9/17/19 revealed 96 patients would need a visit from the PT/OT department. Staff #733 confirmed, he did not have enough staff currently to cover that number of patients. Staff #733 stated, he had only 5 PT's.


An interview with Staff #S733 was conducted on 9/17/19 concerning the staffing issues in the therapy department of Hospital #2 and if the issues were being addressed through the Quality Assessment Performance Improvement (QAPI) process. Staff #733 reported that they have had two issues, inappropriate PT evaluations and staff shortage. Staff #733 stated that he had hired a PT this week, but she was in orientation. Staff #S733 reported that he has openings he was trying to fill. Staff #733 stated that he had recently gone to the UR committee meeting to meet with physicians concerning the inappropriate evaluation orders. Staff #733 provided the surveyor with a handout that he had discussed with the physicians in the Utilization Meeting for appropriate referrals. Staff #733 stated, he had not taken the issues to Quality Assessment Performance Improvement (QAPI) yet because they were working on the problem on the departmental level. Staff #733 confirmed that they had been working on the problems for two years. Staff #733 stated that he reported data to QAPI but did not have an active Performance Improvement (PI) process. Staff #733 stated that they would work out all the problems, implement the changes and then take it to QAPI. There was no discussion found in the meeting minutes for QAPI or the BOT to ensure the department had funding and support to hire additional staff to prevent missed visits. Review of the QRC calendar for reporting revealed the Rehabilitation Services were to report quarterly to QAPI. The department reported the 1st quarter but did not report in May 2019. Staff #116 confirmed on 9/18/19 that Rehabilitation Services missed reporting in May of 2019. There was no documentation found that QAPI was assisting the Rehabilitation Department of Hospital #2 with oversight, support, or continual improvement of quality patient care concerning the high volume of missed visits.

Patient charts reviewed on 9/18/19 revealed Hospital #2 failed to ensure adequate numbers of physical therapy (PT) staff were available to ensure timely evaluations, safe and efficient treatment, in 3 of 3 (432, 433, and 435) of 4 (432-435) patients.


Contracted Services

Review of the contracted services revealed, no contracted services were monitored through the QAPI process for any of the pavilions (Hospital #1, #2, or the ACS). Review of the Board of Trustee Minute Meetings from 9/18 -8/19 revealed, the contracted service contracts were approved during the meetings but there was no data that QAPI had assessed the services provided. There was no documented evidence provided that contracted services had reported to QAPI to ensure patient safety, improved quality of care, or improvement actions.


An interview was conducted with Staff #742 on 9/25/19 at 1:30 PM. Staff #743 confirmed that the contracted services are approved at the BOT level and are not going through the QAPI process.



10802

Review on 09/24/2019 of a sample of hemodialysis staffs' personnel and training records revealed no evidence that the Facility's Quality Assessment Performance Improvement Committee ensured staff providing care and services to patients receiving hemodialysis treatment were assessed for competency:


Patient Care Technician #S42
Review on 09/20/2019 of Patient Care Technician's #S42's Learning and Resource Center Education History Report, dated March 22, 2018, January 12th 2019 revealed he was hired to the facility on November 26, 2003. Review of the record revealed no evidence of current skills assessment completed on the Patient Care Technician for hemodialysis.


Registered Nurse #S41
Review on 09/20/2019 of Registered Nurse (S41's) Orientation Skills Assessment Checklist revealed documentation which indicated the most current hemodialysis skills check list was dated 08/27/08. Review of the record revealed no evidence of current skills assessment completed on the Registered Nurse for hemodialysis.


Patient Care Technician #S47
Review on 09/20/2019 of Patient Care Assistant #S47's Competency Based Clinical Orientation Tool dated 08/26/2019 revealed she was hired to the facility on 08/18/2012. Review of the record revealed the skills assessment was completed by the staff verbalizing the task. There was no demonstration of the tasks documented. Review of the record revealed no evidence of current skills assessment completed on the Patient Care Technician for hemodialysis.


Registered Nurse #S43
Review on 09/21/2019 of Registered Nurse #S43's Orientation Skills Assessment Checklist revealed documentation which indicated the most current hemodialysis skills checklist on file was dated 01/04/13 - 2/9/13. There was no current skills assessment competency for hemodialysis/testing for total chlorine in water used for hemodialysis of patients.

Review of a Learning and Resource Center Education History Report for Registered Nurse #S43, dated March 2018 - September 2019 revealed no evidence of skills assessment completed on the Registered Nurse.


During a review of the personnel records with facility's staff #S308, on 09/20/2019 at 9:00 a.m., who had provided the personnel record to the Surveyor, she stated the unit had no documentation that staff in the hemodialysis unit had conducted skills assessment for the hemodialysis direct care staff.


During an interview on 09/20/2019 at 2:00 p.m. with the Vice President of Nursing for the hospital system, she said the facility did not have or implemented a skills assessment for hemodialysis.


36827


Hospital 2

Review of incident reports for Labor and Delivery submitted in August 2019. During the review, it was noted that on 8-13-2019, 8-17-2019, 8-23-2019, 8-28-2019, and 8-30-2019 patient care was delayed because staff could not get the necessary infusion pump to administer intravenous medications. Medications delayed included, "time-critical antibiotic," Pitocin (medication necessary to augment labor), and IV fluids.


Interview was conducted with Hospital #2 CNO on the afternoon of 9-25-2019 regarding actions taken because of non-availability of pumps. The CNO was asked if the problem with patient care being delayed due to pumps not available had been submitted to the Quality Department for evaluation of the problem and identification of the possible solutions since this was a quality of care issue. The CNO confirmed that it had not been reviewed by the Quality Department.


The CNO stated the hospital had enough IV pumps. He stated that he was aware that there was a delay in care as recent as the previous day on the Labor and Delivery unit due to no pump being available but insisted that the problem wasn't with having enough pumps. The CNO explained that an inventory of pumps had been conducted and showed there were plenty of pumps available but there was shortage of IV poles that hold the pumps. The CNO confirmed that the plan to correct the problem was that IV poles had been placed on order. The CNO did not know how many poles had been ordered or when they would be in service. An inventory of IV pumps was provided the next day to show that the hospital had 801 Alaris IV pumps assigned to inventory. No inventory of IV poles was provided. No purchase order for IV poles was provided.


While the list provided showed that there may be an adequate number of pumps in the hospital's inventory, it did not indicate the availability of those pumps for patient use. The CNO confirmed that the problem had not been sent to Quality Assessment and Performance Improvement (QAPI), therefore, QAPI was not tracking the availability of those pumps, tracking delays in care, analyzing the process for distributing those pumps, or aggregating and analyzing data to ensure that the actual cause of delays in patient care had been identified. No evidence was provided that the facility had taken immediate action to put temporary processes in place to ensure that patient care was not neglected resulting in the likelihood for bad patient outcomes due to patients not receiving necessary IV medications in a timely manner.


25846


1. A review of the Laboratory 2019 Performance Improvement Departmental Semi-Annual Evaluation Executive Summary for Hospital 1 revealed for Microbiology a goal of 100% optimal fill volume of 8-10 ml for BD Bactec Plus Aerobic/F Culture Vials . The laboratory monitors fill volume for adult critical care and EC (Emergency Center).


2. Review of the Hospital #1 Microbiology Lab 2019 PI Summary Report Blood culture volume for Q1 2019 revealed that 68.1% (2421 of 3552 blood culture bottles that were monitored for correct fill volume) failed to meet the requirements for fill volume. Review of Q2 2019 blood culture fill volume revealed 68% (1657 of 2437 blood culture bottles) failed to meet the requirements for fill volume. For Q2 2019 June data was not included due to issues with Epic Beaker Reports.

a. Q1/2 2019 dropped to 31.91% of collected culture bottles containing the optimal volumes required by the manufacturer. This was a decrease of 16.39% from 2018.

b. A review of laboratory quality assurance records revealed they had been working on the problem of blood culture fill volumes since at least August of 2018.

c. A review of laboratory quality assurance records revealed the laboratory, at the department level, initiated a corrective action plan that involved communication with departments about optimal volume requirements, quick reference guides and manufacturer collection training materials to nurse leadership.

d. The August 2019 Corrective Action Plan root causes identified by the laboratory were:

(1) Microbiology Laboratory provided unit based summaries, Quick reference Guides and Manufacturer Training Guides to Nursing Leadership without receiving leadership's feedback.

(2) Lack of continuing education and competency assessments within the individual blood culture collection departments.

(3) Lack of Microbiology ability to provide detailed summaries to include collector's identity for the outliers in order for Nursing Leadership to follow up on... due to issues with EPIC Beaker reports

e. In August 2019 the Department of Pathology 2019 Q1/Q Performance Improvement Report Improvement Plan for fill volumes revealed the laboratory sent another request for a meeting with Quality Management and Patient Safety Department.


3. In an interview of the staff S751 on 09/26/2109, in the Galveston conference room, he confirmed the issue of blood culture fill volumes identified in 2018 was not brought to ERC until July 2019.


4. In an interview with staff S737 on 09/25/2019, in the Dallas conference room, she stated that Laboratory meet with quality twice a year in May and November.


B. The hospital failed to ensure the Hospital #1 transfusion of blood/blood components procedure included objectively defined transfusion reaction signs and symptoms to ensure transfusion reactions were promptly investigated.

Findings:

1. Review of the Facility policy, "Administration of Blood and Blood Components and Blood Derivatives" and "Appendix A Administration of Blood and Blood Components and Blood Derivatives" revealed, the policy failed to include objectively defined transfusion reaction symptoms to ensure transfusion reactions were promptly investigated.

II. Administration of Blood/Blood Components: ...

If signs/symptoms of transfusion reaction are noted at any time during the transfusion, immediately stop the transfusion and follow the Transfusion reaction protocol.


2. In an interview in Hospital (1) conference room at 1320 hours on 9/23/19, with Staff #S311 and after her review of the above policy, she confirmed that the "Administration of Blood and Blood Components and Blood Derivatives" policy did not define signs and symptoms of a transfusion reaction, such as back pain, chills, flushing, shortness of breath, itching, changes in temperature, blood pressure, pulse, or oxygen saturation, anaphylaxis, or cardiac arrest.


Code of Federal Regulations Part 493, 493.1271(e); Standard: Investigation of transfusion reactions

(e) Investigation of transfusion reactions.

(e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures.

(e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused.


C. The hospital failed to ensure the Hospital #1 Point of Care Testing policy and procedures (policy 4398) were approved by the laboratory director.

Findings:

1. Review the Hospital #1 nursing "Point of Care Testing" policy and procedures # 4398 revealed, the procedure was not reviewed and approved by the laboratory director of Point of Care.

a. A review of the Hospital #1 nursing "Point of Care Testing" policy 4398 revealed, it was approved by the administrative director of Pathology, not the laboratory director.

b. A review of laboratory Point of Care procedures on 09/27/2019 at 0912 hours revealed, the laboratory developed policies and procedures "i-STAT Procedure" #POC.PC.2.570.2.08.02 and "Precision XceedPro Glucometer" procedure #POC.PC.2.500.11.10.03 were approved by the laboratory director of Point of Care.


2. In an interview with staff #S311 at 0900 hours on 9/27/2019, she confirmed the administrative director was #S751, not the laboratory director of Point of Care.


3. In an interview of staff #S751 at 0915 hours on 9/27/2019, he confirmed the laboratory developed procedures for point of care testing approved by the laboratory director were located in Media Lab.


Code of Federal Regulations Part 493, 493.1251; Standard: Procedure Manual:"(d) Procedures and changes in procures must be approved, signed and dated by the current director before use."

Review of the contracted services revealed, no contracted services were monitored through the QAPI process for any of the pavilions (Hospital #1, #2, or the ACS). Review of the Board of Trustee Minute Meetings from 9/18 -8/19 revealed, the contracted service contracts were approved during the meetings but there was no data that QAPI had assessed the services provided. There was no documented evidence provided that contracted services had reported to QAPI to ensure patient safety, improved quality of care, or improvement actions.


An interview was conducted with Staff #S742 on 9/25/19 at 1:30 PM. Staff #743 confirmed that the contracted services are approved at the BOT level and are not going through the QAPI process.

Based on observation, interview, and record review, the facility failed to provide an organized nursing service:

A. The hospital failed to ensure that clear lines of authority had been established to show there was only one hospital-wide, unified nursing service. The organizational chart and job description for the Chief Nursing Officer (CNO) position showed that each campus location (Hospital 1 & 2) had a different CNO with lines of authority and designated responsibilities.


B. Nursing staff failed to clearly document wound care orders and implement preventative measures for patients at risk for skin breakdown and to prevent further skin breakdown for patients with wounds. (Patients #66 and 158)


C. Nursing staff failed to conduct assessments and measurements of wounds, per the facility's policy, to determine if current treatments were effective. (Patients #122, 159, 160, 161, and 162)


D. Nursing staff failed to prevent, identify, and assess avoidable pressure ulcers/injuries. (Patients # 306, 308, and 309)

Cross Refer to Tag A0386


Hospital # 2 failed to provide nursing staffing per policy for 1 of 21 hospital nursing units (Medical Intensive Care) for the time period of August 1-31,2019.

Cross Refer to tag A0392


Based on record review and interview, the facility failed to ensure training and competencies were current for nurses administering moderate sedation in 2 of 16 staff records reviewed (Staff # 102 and #276 ).

This deficient practice had the likelihood to cause harm in all patients receiving moderate sedation for procedures in Hospital 1 and 2.

Cross Refer to A0397


Nursing staff failed to administer drugs according to acceptable standards of practice and professional guidelines.

Registered Nursing staff at Hospital 1 and Hospital 2 failed to disinfect the rubber septum of medication vials prior to drawing up medication into a syringe.

This deficient practice could lead to the contamination of the medication and cause harm to the patients.

Cross Refer to: A-405


A. Nursing staff at Hospital 1 failed to ensure vital signs were assessed during and after blood transfusions in 3 of 9 (#120, 121, and 406) medical records reviewed for blood transfusions. Facility policy and nursing education for blood and blood product administration was incomplete with respect to vital signs monitoring during a potential or actual transfusion reaction and lacked definitions or parameters for monitoring reactions.


B. Nursing staff at Hospital 2 failed to titrate (adjust dosage based on patient response to medication) intravenous (IV) medications per physician orders in 1 (Patient #239) of three patients observed who were currently receiving titratable IV medications.


C. Hospital 2 failed to develop training material specific to objective indicators of blood transfusion reactions that the nursing staff should monitor for and report. Current training materials required nursing staff to use their own judgement as to whether or not a symptom was an indicator of blood transfusion reaction.

Cross Refer to A-0409


Based on observation, review of documentation, and interview, it was determined that nursing staff at Hospital 1 failed to ensure that patient home medications were secured.

Cross Refer to A-0413

Based on observation, interview, and record review, the facility failed to ensure a well-organized organized nursing service. The hospital failed to :

A. Ensure that clear lines of authority had been established to show there was only one hospital-wide, unified nursing service. The organizational chart and job description for the Chief Nursing Officer (CNO) position showed that each campus location had a different CNO with lines of authority and designated responsibilities establishing independent nursing services rather than a hospital-wide, unified nursing service. No documents were provided that reflected clear lines of authority to only one Registered Nurse (RN) directing all of nursing services.


B. Nursing staff failed to clearly document wound care orders and failed to ensure recommended preventative measures were being followed for patients at risk for skin breakdown and to prevent further skin breakdown for patients with wounds. (Patients #66 and 158).


C. Nursing staff failed to conduct assessments and measurements of wounds, per the facility's policy, to determine if current treatments were effective. (Patients #122, 159, 160, 161, and 162).


D. Nursing staff failed to prevent, identify, and assess avoidable pressure ulcers/injuries. (Patients # 306, 308, and 309)


Findings:

A. Unified Nursing Service: Hospital 1 and 2:

This hospital is a multi-campus hospital, here in referred to as Hospital #1 and Hospital #2, with a single license and Medicare participation agreement. As a single hospital, nursing services should have been structured as a single nursing service with clear lines of administrative authority.


Review of organizational charts and job descriptions showed that both campuses (Hospital #1 and Hospital #2) were operating with separate nursing services under the direction of an Associate Administrator/Chief Nursing Officer who reports directly to the hospital campus Executive Vice President/Administrator. The hospital campus EVP/Administrator reports directly to the hospital President/ Chief Executive Officer.


During a review of the organizational chart for Hospital #2 on 9-16-2019, Nursing Departments were observed to have direct lines of reporting to the Associate Administrator/Chief Nursing Officer. The Associate Administrator/Chief Nursing Officer had direct lines of reporting to the Executive Vice President/Hospital 2 Administrator.


An interview was conducted with Staff #S329 and Staff #S330 on 9-17-2019 at Hospital #2 during a review of the Associate Administrator/Chief Nursing Officer's personnel file with job description and the organization chart. Staff #S329 and #S330 both confirmed that the Associate Administrator/Chief Nursing Officer at Hospital #2 directly reported to the Executive Vice President/Hospital 2 Administrator. The Executive Vice President/Hospital 2 Administrator was responsible for evaluating the performance of the Chief Nursing Officer (CNO) as evidenced by the most recent Annual Performance Review completed on 5/20/2019. Review of the Job Summary also showed that the CNO had a direct reporting structure to the Executive Vice President/Hospital 2 Administrator.


An interview was conducted with the CNO of Hospital #2 on 9-17-2019 at 2:20 PM, to determine the lines of authority. The CNO confirmed that he did not report to Hospital #1 and Hospital #1 did not report to him. Each CNO reported to their respective Hospital Administrator. Each CNO acted independently with their nursing staff. The CNO reported that when things came up that affected the Hospital System, each CNO had a dotted-line reporting to the Senior Vice President/Chief Nursing Executive (CNE) and would take those issues to the System Nurse Executive Council which met regularly.


The CNO job description stated, "The Chief Nurse Officer (CNO) is the executive leader responsible for implementing nursing's philosophy, vision, and strategic direction within the organization. The CNO is accountable for operational leadership, human resource management, financial control, and quality improvement for the nursing within his/her defined areas of responsibility." "The CNO reports through a matrix and has a direct reporting relationship to the Hospital Administrator/Executive Vice President, and an additional reporting relationship to the Chief Nursing Executive."


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B. Documentation of wound care orders & implementation of skin breakdown preventative measures:


Hospital 1:

Review of the facility provided policy #431 PRESSURE INJURY PREVENTION AND TREATMENT (dated 09/2018) reflected, "Upon admission, skin assessment shall be completed by nursing and documented in the patient's medical record and reassessed every shift and during transfer of care between health care providers .... E. The pressure injury (ulcer) prevention plan shall include interventions that minimize or eliminate friction and sheer, minimize pressure with off-loading, manage moisture, and maintain adequate nutrition and hydration ... D. Upon identification of a wound, a full wound assessment, including its location, size, and description of the tissue involved, shall be completed ..."


PATIENT #66

Review of Patient #66's medical records revealed a 62-year-old male presented on 7/10/19 to the facility's emergency department. The admission photos show the sacral skin is intact.

Review of the wound care nurse's notes reflected the following:

On 7/12/2019 at 12:26 am

Perianal: moisture related skin damage. Skin is moist, macerated, and erythematous. Periwound [sic]: clean, moist, intact.

Odor: mild.

Category 3- the skin flap is completely absent. Partial thickness skin loss. Wound bed with 100% red tissue. Edges are irregular, open, attached to base. Periwound: C/D/I. No drainage noted.

Braden Score: 14 Level of Risk: H.

ADDITIONAL RECOMMENDATIONS:
1. Turn pt. Q2hr; avoid supine (lying on the back) position/pressure to wound. Turn left or right side. Use foam wedge for optimal offloading. Provide cushion to hips or apply mepilex border dressing.


Review of the Wound Care Nurse's assessments of the Sacral wound revealed the following:

On 7/18/19, Wounds are measured by Length X Width X Depth (LxWxD) in centimeters.

Sacrum: Pressure injury, DTI (deep tissue injury) Measurement: 6X4Xunable to determine, Intact skin with non-blanchable deep red, maroon, purple discoloration. Additional Recommendation. Turn pt. Q 2hrs, turn left or right side and document: Avoid supine position/pressure to wound. Use foam wedge for optimal offloading.

On 8/1/19, Sacrum: Unstageable pressure injury. Measurements: 2X5.2Xunable to determine. Wound bed obscured by 45% yellow slough, 5% dark red tissue, and 50% dark tan discoloration to skin. Additional Recommendation. Turn pt. Q 2hrs, turn left or right side and document: Avoid supine position/pressure to wound. Use foam wedge for optimal offloading.

On 8/8/19, Sacrum: Unstageable pressure injury. Measurements: 2.5X4Xunable to determine. Wound bed obscured by 90% white non-viable tissue and 10% dark red tissue. Additional Recommendation. Turn pt. Q 2hrs, turn left or right side and document: Avoid supine position/pressure to wound. Use foam wedge for optimal offloading.

On 8/11/19 at 7 PM, the nurse's documented an unstageable sacral wound with excoriation. The nursing documentation did not include measurements of the wounds.

On 8/12/19, the wound care nurse assessed the wounds and wrote orders and recommendations to be followed.

On 8/23/19, Sacrum: Unstageable pressure injury. Measurements: 3X3.8Xunable to determine. Additional Recommendation. Turn pt. Q 2hrs, turn left or right side and document: Avoid supine position/pressure to wound. Use foam wedge for optimal offloading.

On 9/11/19, Sacrum: unstageable pressure injury. Wound measures 6.0cmLx6.0cmWx2.0cmD. Undermining noted from 9 o'clock to 5 o'clock. Deepest point at 12 o'clock of 1.2 cm. Wound base is 98% tan, tenacious nonviable tissue with 2% pale pink tissue. Edges are defined by not attached. Peri wound is denuded and macerated. Dressing that was removed was saturated with serosanguineous drainage. Additional Recommendation. Turn pt. Q 2hrs, Avoid supine position. Use foam wedge for optimal offloading.

On 9/13/19 at 11:47 am, the wound care nurse writes an order for dressing changes but does not describe the location or the area to be changed.

On 9/19/19 at 11:03 am, the wound care nurse writes an order for dressing changes but does not describe the location or the area to be changed.


Review of Patient #66's turning and repositioning documentation revealed the following:

7/12/19 at 2 am- Supine, 7 am- Supine, 11 am- Supine, from PM to 10 PM- no turning was documented.

7/13/19 at 8 am- Supine, 6 PM- Supine, 10 PM- Supine

7/14/19 at 2 am- Supine, from 6 PM to 6 am- no documented turning.

7/15/19 at 6 PM- Supine, 12 am- Supine, 4 am- Supine

7/17/19 at 8 am- Supine, 12 PM- Supine, 4 PM, no documented turning.

7/18/19 at 6 am- till 7/20/19 the patient was no documented turned, Veniflex, do not turn.

7/21/19 at 6 PM- Supine, 8 PM- Supine

7/22/19 at 8 PM- Supine

7/23/19 at 8 PM- Supine, 2 am- Supine

7/24/19 at 9 am-Supine, from 10 PM to 7 am- no documented turning

7/26/19 at 2 PM- Supine, from 10 PM to 7/27/19 at 6 am- Supine

7/27/19 at 12 PM- Supine

7/29/19 at 10 PM- Supine

7/30/19 at 2 am- Supine, 8 PM- Supine

7/31/19 at 12 am- Supine, 10 PM- Supine

8/1/19 at 2 am- Supine, 12 PM- Supine, 3:40 PM- Supine, 6 PM- Supine, 8 PM- Supine, 10 PM- Supine, 10 PM- Supine

8/2/19 from 4 am to 6 PM- No documented turning

8/7/19 at 6 PM- Supine

8/9/19 at 12 am- No documented turning

8/15/19 from 11 am to 3 PM- no documented turning

8/16/19 at 11 am- no documented turning, from 7 PM 6:30 am- no documented turning

8/27/19 at 8:27 am- no documented turning, 12 PM- Supine, 8 PM- Supine

8/28/19 at 12 am- Supine, 4 am- Supine

8/31/19 at 2 PM- Supine

9/3/19 at 3 PM- Supine, 7:15 PM- Supine

9/5/19 from 9 PM to 1 am- no documented turning

9/6/19 at 4 PM to 7:15 PM- no documented turning

9/11/19 at 2 am- Supine

9/12/19 at 1 am- Supine, 2 am- Supine, 4 am- Supine, 5 am- Supine, 6 am- Supine, 7 PM- Supine, 9 PM- Supine, 10 PM- Supine

9/13/19 at 12 am- Supine


During an interview on the morning of 9/20/19, Staff #S401 confirmed the findings and stated Patient #66 was noncompliant and would place himself in the supine position. Staff #S401 was unable to provide documentation of Patient #66's noncompliance or the staffs re-educating the patient when Patient #66 was found in the Supine position.

Review of Patient #66's treatment plan revealed the wound skin treatment plan was not added until 8/19/19 at 9:40 PM and was not updated to reflect Patient #66's continued non-compliance with lying supine and interventions to assist with compliance such as re-education and the use of wedges for positioning.


PATIENT #158

Review of Patient #158's medical records revealed an elderly patient admitted on 6/13/19.

On 6/17/19, the wound care nurse documented, Buttocks, scar tissue.

On 6/24/19, the wound care nurse documented, right/left only; 5cmX7cm with 34% external dermal.

On 8/8/19, the wound care nurse documented, 9cmX11.5cm with 90% and 10% pink base.

On 7/20/19, the nurse's note reflected a small skin tear to sacrum. The wound was not measured.

On 7/22/19, the nurse's note reflected (2) sacral wounds, the wounds were not measured.

On 7/29/19, the wound care nurse documented- 8.5cmX11.5cm with 100% adherent black neurotic tissue.


Review of Patient #158's turning and repositioning documentation revealed the following:

6/24/19 at 7 PM- Supine, 11:00 PM- Supine

6/26/19 at 1:00 am- Supine

6/28/19 at 2:30 PM- Supine

6/29/19 at 11:00 PM- Supine

6/30/19 at 3:00 am- Supine

7/6/19 at 9:00 am- Semi fowlers (reclining on back side), 9:00 PM- Semi fowlers

7/20/19 at 3:00 9m- Supine

7/23/19 at 7:00 am- Semi fowlers

7/24/19 at 7:00 am- Semi fowlers


Review of the facility provided policy #431 PRESSURE INJURY PREVENTION AND TREATMENT (dated 09/2018) reflected, "Purpose: To outline a comprehensive regimen designed to prevent, identify, and manage pressure injury (ulcer); to provide the guidelines for identifying at-risk patient, and the specific factors placing them at risk for the development of pressure injury (ulcer).

Policy Statement: All inpatient of _____Health System shall be assessed for pressure injury (ulcer) and the risk of its development. Appropriate standardized assessment tools shall be used to identify at-risk patients and specific modalities shall be utilized to prevent and treat pressure injury (ulcer).

F. PRESSURE INJURY: A localized injury to the skin and/or underlying tissue usually over a bony prominence; the result of pressure or pressure in combination with shear and/ or friction."


Review of the facility policy #4001 Wound Care (dated 03/03/2019) reflected, "Purpose: to establish patient care guidelines to be used when a wound care referral is received by ______Health System Physical Therapy ... Procedure for Inpatient Referrals: 1. WOCNURSE will assess all consults regarding pressure ulcers, moisture management ..."


C) Assessments & measurements of wounds :


Review of the facility policy (Undated) staff training, "_______HEALTH SKIN CARE MODULES Module 2: Pressure Injury Staging ... WOUND MEASUREMENTS, Wounds are measured by Length X Width X Depth (LxWxD).
This is the diameter from edge to edge of wound. Any tunneling/undermining must be measured and identified.


PATIENT #161

Review of Patient # 161's medical records reflected a 72-year-old-female admitted on 7/14/19 with a diagnosis of NSTMI (non-ST elevation myocardial incident)

On 7/16/19, the nurse documented a skin tear to buttock. The nursing documentation did not include measurements of the wounds.

On 7/17/19, the wound care nurse recorded the following: Lower back: Suggest pressure injury DTI (deep tissue injury).
Measurements (LXWXD) (cm) 4x3.5x unable to determine. Buttocks skin fold: Moisture related skin damage. Measurements (LXWXD) (cm) 3x0.3x0.23.5x unable to determine

On 7/17/19, a medial midline bruise. The nursing documentation did not include measurements of the wounds.

On 7/10/19, an excoriation below breast. The nursing documentation did not include measurements of the wounds.

On 7/22/19, fluid filled blister. The nursing documentation did not include measurements of the wounds.


During an interview on the morning of 9/25/19, in the facility conference room, Staff #S546, confirmed the findings and stated, "The measurements are not there..."


PATIENT #122

Review of Patient #122's medical records revealed a 45-year-old-female with an open wound to RLE s/p debridement's for necrotizing fasciitis.

The Physical Therapy Wound Care Evaluation dated 9/13/19 reflected the following: Dressing change by nursing: Frequency daily. Clean the wound with gauze moistened with dermal wound cleanser ... Wound Size (cm): L: 25.0cm W: 10.5cm D: 0.8cm

Review of the nurses wound care and assessment notes dated 9/25/19, reflected the dressing was changed by the night shift, the nurse did not document the wounds size, width or depth.


Patient#162

Review of Patient #162's medical records revealed a 50-year-old-male admitted on 8/12/19 with Sezary Syndrome, a skin condition that places the skin at risk of developing rashes. Patient #162 developed 3 wounds to the scalp, due to the EEG monitor lead placements.

On 8/22/19, Patient #162 developed a wound to the left ear. The scalp wounds and the ear wound were not clearly described or measured.


PATIENT #159

Review of Patient #159's medical records reflected a 61-year-old-female admitted on 8/14/19 with a sacral decubitus ulcer and left foot gangrene.

On 8/16/19, the nurse documented a Stage 4 pressure wound; the nurse did not document the measurements or a description of the wound.

On 8/16/19, the wound care nurse documented the wound at 6.5cmX5cmX4cm.


PATIENT#160

Review of Patient #160's medical records reflected a 64-year-old-male admitted on 6/26/19 with End Stage Renal Disease.

On 6/26/19, the nurse documented- Skin intact.

On 7/8/19, the nurse documented- right elbow, red swollen.

On 7/10/19, the nurse documented- Left foot injury.

On 7/11/19, the nurse documented- Rectum Skin tear, moisture related.

On 7/11/19, the wound care nurse document, denuded, excoriated rectum.


During an interview on the morning of 9/20/19, when asked if the wounds should be measured, Staff #150 stated, "Per policy, yes" and confirmed the findings.


During an interview on the morning of 9/25/19, in the facility conference room, Staff #S399, "Once the wound is discovered the nurses are to remeasure the wound every Wednesday, if it hasn't improved by 0.2cm they have to put in a wound care nurse consult ... All wounds should be measured on admission by the nurses."


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D. Prevention, identification, and assessment of avoidable pressure ulcers/injuries:

Hospital 1:


Review of _____ Health System Pressure Injury Prevention and Treatment policy revised 08/2018 stated the following:

" ....Upon admission, skin assessment shall be completed by nursing and documented in the patient's medical record and reassessed every shift and during transfer of care between health care providers .... E. The pressure injury (ulcer) prevention plan shall include interventions that minimize or eliminate friction and sheer, minimize pressure with off-loading, manage moisture, and maintain adequate nutrition and hydration ... D. Upon identification of a wound, a full wound assessment, including its location, size, and description of the tissue involved, shall be completed ..."


Patient #306:

Patient 306 was admitted 05/22/2019 with diagnoses of spinal stenosis and complaints of weakness to lower extremities. The patient had a spinal fusion surgery during hospitalization. A head to toe skin assessment was completed by 2 Registered Nurses on 05/22/2019 and no pressure injuries were identified. The Braden Scale, which is used to predict pressure ulcer risk was completed and patient 306 was at moderate risk for developing a pressure ulcer/injury. There was no nursing or provider documentation of any skin impairment until 06/18/2019.

The first wound assessment for sacrum was documented 06/18/2019. Site assessment described wound as "Tinu\y crack on the mid of the sacrum) developed from an old scar {sic}"

The first wound assessment for left heel was documented 06/17/2019 by nursing. Site assessment described wound as a deep tissue injury and was not present on hospital admission. This was the only wound that was identified.

A WOCN consult was ordered 06/18/2019 by staff 743.

A WOCN consult was completed and documented 06/18/2019 by staff 744. An unstageable pressure injury to the sacrum was identified (full thickness tissue loss in which the base of the ulcer is covered by slough {dead tissue separating from the pressure ulcer} and/or eschar {dead tissue that sheds or falls off from healthy skin}. Until enough slough and/or eschar is removed to expose the base of the wound, the depth, and staging of ulcer cannot be established). And a deep tissue injury (a pressure related injury to subcutaneous tissues under unbroken skin) to the left heel was identified. Wound care recommendations were given and the patient's primary provider team was notified of wound care recommendations.

Records review showed there was no nursing care plan related to pressure ulcer/pressure injury prevention or care and there was little documentation of patient repositioning every two hours.


Patient # 309:

Patient 309 was admitted 05/26/2019 with diagnoses of left lower extremity gangrene, sepsis, and complaints of left foot pain. The patient underwent a left below the knee amputation 05/26/2019. A head to toe skin assessment was completed by 2 Registered Nurses on 05/22/2019 and no pressure injuries were identified. The Braden Scale, which is used to predict pressure ulcer risk, was completed and patient 309 was at a high risk for developing a pressure ulcer/injury. Skin assessments were ordered by Physician 747 on 05/26/2019.

There was no nursing or provider documentation of any skin impairment until 06/05/2019

The first wound assessment of buttock was completed 06/05/2019 by nursing. Site assessment described wound as "dark skin discoloration on left buttocks." A WOCN consult order was ordered 06/06/2019 by staff 745

A WOCN consult was completed and documented 06/07/2019. A deep tissue injury with some exposed dermal tissue was identified. Wound care recommendations were given and the patient's primary provider team was called by WOCN per records review.

On 06/12/2019 a WOCN assessment was completed. The buttock was staged as an unstageable with pink healthy tissue and yellow slough present. WOCN gave additional recommendations including repositioning every two hours, providing supplies to patient for discharge, and following up with a wound care clinic after discharge.

Nursing care plan included:

"Problem: Impaired Mobility ....Goal: The Maximum Level of Function Will Be Achieved And the Risk of Complications Reduced ....."Intervention: Monitor Skin Integrity",

"Problem: Impaired Skin Integrity ...Goal: The Skin Will Remain Intact" ....Intervention: Assess Skin Daily For Impaired Integrity: Irritated, Reddened, Dry, Cracked Areas, Excoriation or Complaints of Itching .....Intervention: Assess All Breakdowns for Color, Size, Drainage, And Odor .....Intervention: Administer Medication, Treatments And Therapies Related To Wound Management And Prevention"

All problems, goals, and interventions had a start date of 05/26/2019 and end date of 06/12/2019. Records review disclosed the patient was documented as a "self turn" and in a supine semi-fowlers position only.

Patient 309 was discharged with wound care and follow up with an outpatient clinic.


Patient # 308:

Patient 308 was admitted 05/29/2019 with diagnoses of left hip fracture, uncontrolled diabetes mellitus, neuropathy, and hypertension. Patient 308 had a left hip repair surgery during hospitalization. A head to toe skin assessment was completed by 1 Registered Nurse and 1 Patient Care Assistant on 05/29/2019. No pressure injuries was identified. The Braden Scale, which is used to predict pressure ulcer risk, was completed. Patient 308 was at a high risk for developing a pressure ulcer/pressure injury.

There was no nursing or provider documentation of any skin impairment until 06/03/2019.

The first wound assessment was documented on 06/03/2019 by nursing. Site assessment described the wound as a "Skin tear Coccyx DTI". Wound type was documented as a "skin tear", wound description was documented as a "DTI" or deep tissue injury.

A wound care consult was ordered 06/06/2019 by staff 746. A WOCN consult was completed and documented 06/07/2019 by staff 744. A deep tissue injury to the sacrum was identified. In addition, a deep tissue injury to the left hip was identified. Wound care recommendations were given and the patient's provider team was notified.


Nursing care plan included:

"Problem: Impaired Mobility .....Goal: The Maximum Level Of Function Will Be Achieved And Risk Of Complications Reduced ....Interventions: Monitor Skin Integrity....Intervention: Reposition As Needed ...."

"Problem: Impaired Skin Integrity .... Goal: The Skin Will Remain Intact ....Intervention: Assess Skin Daily For Impaired Integrity: Irritated, Reddened, Dry, Cracked Areas, Excoriation Or Complaints of Itching ....Intervention: Assess All Breakdowns For Color, Size, Drainage, And Odor .... Interventions: Administer Medications, Treatments, And Therapies Related To Wound Management And Prevention ...."

All problems, goals and interventions were active 05/30/2019- 06/08/2019. Records review revealed the patient was documented as a self-turn post-surgery and noted to have decreased functional independence.

Patient 308 was discharged to an acute rehabilitation facility.


During an interview on 09/25/19, Staff #S399, stated, "Once the wound is discovered the nurses are to remeasure the wound every Wednesday, if it hasn't improved by 0.2cm they have to put in a wound care nurse consult.

Based on interview, record review, and observation , Hospital 2 failed to provide adequate numbers of nurses to provide care for all patients.

Hospital # 2 failed to follow its staffing plan on 1 of 21 (Medical Intensive Care) hospital unit.


Findings:

Review of facility policy titled "Nurse Staffing" effective 10/29/09 and revised on 01/23/18 reflected ..."_____Health (system) shall: A. Implement and enforce a nurse staffing policy that ensures an adequate number and skill mix of nurses to meet the levels of care needed to provide safe quality patient care; B. Implement and enforce an official nurse-staffing plan that is based on the needs of each patient care unit and shift; and evidence relating to patient care needs ..."


Nursing staffing sheets for the 21 nursing units for the time period of August 1-31, 2019 were reviewed.


Record review of the Medical Intensive Care Unit (MICU) staffing sheets reflected:

On 08/08/19, on the day shift and the night shift there were 14 patients; 2 Nurses had a 3:1 patient load.

On 08/09/19 on the day shift there were 13 patients; 1 nurse was carrying a 3:1 patient load.

On 08/09/19 on the night shift there were 13 Patients; 1 nurse was carrying a 3:1 patient load. At 0430 1 nurse was pulled to another unit to sit with a psychiatric patient leaving 2 more nurses to carry a 3:1 patient load for the remainder of their shift.

On 08/11/19 on the day shift and the night shift there were 13 patients; 1 nurse was carrying a 3:1 patient load.

On 08/12/19 on the night shift there were 14 patients; 2 nurses were carrying a 3:1 patient load.

On 08/13/19 on the day shift there were 13 patients; 3 nurses were carrying a 3:1 patient load.

On 08/17/19 on the day shift there were 11 patients; 1 nurse was carrying a 3:1 patient load.


During a tour of the MICU on 09/17/19 at 1345, Staff RN #S95 stated, the staffing for the unit was 2 patients to 1 nurse.

Based on record review and interview, the facility failed to ensure that nursing staff who were administering moderate sedation to patients had training and current competencies to administer sedation medications in 2 of 16 Staff records reviewed (Staff #s S102 and S276 ).

This deficient practice had the likelihood to cause harm in all patients receiving moderate sedation for procedures in Hospital 1 and 2.


Findings:

Hospital #2 :

Staff #S276:

During a review of personnel records on September 25, 2019, after 1:00 PM, it was found that Staff #S276's moderate sedation training expired 4/2019, over 5 months ago. Human resources was asked to provide current competencies for Staff #S276. No current competencies and Human Resources confirmed Staff #S276's moderate sedation expired 4/2019.


A review of the document provided by Staff #S205 revealed, Staff #276 administered moderate sedation (Versed and Fentanyl) to 306 patients in GI Lab procedures since the moderate sedation training expired in 4/2019.


Review of the facility policy titled, "MODERATE SEDATION FOR ELECTIVE PROCEDURES, Policy No. 7.03" revealed the following:

" ...B. COMPETENCY REQUIREMENTS:

RN's working in areas where Moderate Sedation is administered must meet the annual Moderate Sedation competency requirement and have a current ACLS or equivalent certification ..."

Staff #S205 confirmed the above findings.


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Hospital 1 :

Staff #S102:

During a review of personnel records on September 26, 2019, after 9:00 a.m., it was found that Staff #S102's moderate sedation training expired 8/22/2019, over 1 month ago. Staff #S310 was asked to provide updated training. Staff #S310 later confirmed that Staff #S102 had not taken any moderate sedation training since 8/22/2018.

Review of medical records showed that Staff #S102 had given moderate sedation medications (Fentanyl and Versed) in cardiac catheterization procedures for 8 patients since the moderate sedation training expired.

Review of the facility document titled, "BT Cardiology Services: Cath Lab - 2019 required Nursing Education and Competency" revealed that Moderate sedation is listed as a required competency for all Cath Lab RN's.

Review of the facility policy titled, "Moderate Sedation for elective procedures" revealed the following:

"Competency requirements

RN's working in areas where Moderate Sedation is administered must meet the annual Moderate Sedation competency requirement and have a current ACLS or equivalent certification ..."

Based on observation, review of documentation, and interviews with facility staff, the facility failed to ensure drugs were administered according to acceptable standards of practice and professional guidelines.

Staff #S109 [Hospital 1] and Staff #S702 [Hospital 2] failed to disinfect the rubber septum of medication vials prior to drawing up medication into a syringe.

This deficient practice could cause the contamination of the medication. Facility policies provided did not specify how the injectable medication vial septum should be disinfected.


Findings:

Hospital 1:

During observation of a percutaneous nephrostomy tube placement in hospital #1 interventional radiology on 9/17/19 at approximately 10:15 am, Staff #S109 while drawing up fentanyl and versed removed the dust covers from the vials and did not disinfect the rubber septums of the vials before drawing up the medications into syringes.

In an interview with staff #S109 during the procedure on 9/17/19 at approximately 10:30 am, staff #S109 acknowledged these findings. In an interview with MRT supervisor, staff #S111 on 9/17/19 at approximately 11:30 am, the above finding was acknowledged.


Institute for Safe Medication Practices (ISMP) Safe Practice Guidelines for Adult IV Push Medications publication reflected in part, "the 'pop-off' vial caps from manufacturers are considered 'dust covers' and are not intended to maintain sterility of the vial diaphragm or access point. Thus, the diaphragm must always be disinfected after removing the cap of a new vial."


The facility policy entitled "Medication Administration" #565.00 dated 1/04 reflected in part, "Medication from each vial shall be administered using aseptic techniques." The facility document entitled "Procedural Support - Interventional Radiology: Registered Nurse: dated 1/13 reflected in part "Follows strict aseptic technique and standard precautions for all infusion procedures."


23032

Hospital # 2
Observation on 09-24-19 at 8:15 A.M. showed Staff #S702 prepared to administer medication to Patient # 403.

Review of physician order for Patient #403, dated 9-24-19, showed an order for Lasix 80 milligrams (mg) IVP (intravenous push) daily.

Continued observation showed staff #S702 removed two(2) vials of Lasix from her medication cart. Staff #S702 uncapped each vial and correctly withdrew a total of 8 milliliters (ml) into a single syringe. [Review of the Lasix medication label showed 1 ml=10 mg).]

Staff #S702 failed to disinfect the rubber septum of either of the vials of Lasix.

During an interview on 09-25-19 at 10 A.M. with Staff #S495 she stated the medication vials should be swabbed with alcohol after the cap was removed & prior to use.


Review of Centers for Disease Control (CDC) Guidelines for Injection Safety, June 2019, showed:"Parenteral medications should be accessed in an aseptic manner. This includes using a new sterile syringe and sterile needle to draw up medications while preventing contact between the injection materials and the non-sterile environment. Proper hand hygiene should be performed before handling medications and the rubber septum should be disinfected with alcohol prior to piercing it."

Based on observation, interview, and record review:

A. Hospital # 1 failed to ensure :

vital signs were assessed during and after blood transfusions in 3 of 9 (#120, 121, and 406) charts reviewed for blood transfusions. Facility policy and nursing education for blood and blood product administration was incomplete, without a requirement to monitor vital signs during a potential or actual transfusion reaction, definitions, or parameters for monitoring reactions. These deficient practices could potentially cause harm in all patients receiving blood products in the hospital.


B. Hospital #2 failed to ensure:

1. nursing staff who were titrating (adjusting dosages based on patient response to the medication given) Intravenous (IV) medications per physician orders to achieve the physician-ordered goal in 1 (Patient #239) of three patients observed who were currently receiving titratable IV medications;

2. training material was developed and nursing staff were educated on specific, objective indicators of blood transfusion reactions that the nursing staff should monitor for and report. Education material contained subjective indicators that required nursing staff to use their own judgement as to whether or not a symptom was an indicator of blood transfusion reaction.


Findings:

A. Hospital 1: blood transfusion issues - vital signs & policy/nursing training:

Facility policy, "Administration of Blood and Blood Components and Blood Derivatives," last reviewed 5/31/2019, was provided to the survey team. The policy stated in part, "Appendix A Administration of Blood and Blood Components and Blood Derivatives ...

II. Administration of Blood/Blood Components: ...

3. Measures and records baseline vital signs, within 15 mins prior to the procedure to include:

A. Temperature

B. Blood pressure

C. Pulse

D. Respirations ...

10. Observes patient closely during the first fifteen minutes. Obtain and document a set of vitals at the 15 minutes mark after the start of the infusion.

11. If signs/symptoms of transfusion reaction are noted at any time during the transfusion, immediately stop the transfusion and follow the Transfusion reaction protocol.

12. Measures and documents

a. Vitals prior to infusion

b. Vitals 15 minutes after the start of the infusion

c. Vital signs every hour until completion

d. Vital signs upon completion of administration ...


II. Transfusion Reaction Procedure:

If signs/symptoms of transfusion reaction are noted at any time during the transfusion, immediately stop the transfusion and

a. Notifies the physician and blood bank

b. Administer medications/treatments as ordered

c. Physician to order the Transfusion Reaction Protocol which includes

-a. Collect one pink top tube of patients' blood and a urine specimen which is the 1st post transfusion being started.

-b. Sends collected specimens and un-transfused portion of blood component with attached tubing and IV fluid to blood bank.

d. Leave the IV site intact or maintain IV"


In an interview conducted in Hospital (1) conference room at 1:20 PM on 9/23/19 with Staff #S311, the above policy was reviewed. Staff #S311 confirmed that the "Administration of Blood and Blood Components and Blood Derivatives" policy did not define signs and symptoms of a transfusion reaction, such as back pain, chills, flushing, shortness of breath, itching, changes in temperature, blood pressure, pulse, or oxygen saturation, anaphylaxis, or cardiac arrest. Staff #S311 also confirmed that the facility policy did not require monitoring of vital signs or indicate the frequency of monitoring vital signs if a transfusion reaction is suspected.


Review of the Nursing Education slide presentation document entitled, "Blood Administration (and Transfusion Reactions) updated August 2019, listed potential transfusion reaction signs and symptoms of fever, high fever, hypotension, severe hypotension, and sudden severe hypotension. However, fever, high fever, hypotension, severe hypotension, and sudden severe hypotension were not defined and parameters were not given. The training stated, "If a transfusion reaction is suspected, rapidly perform the following interventions ...Monitor the patients vital signs every 15 minutes or as indicated." Staff #S311 confirmed the above findings in the nursing education for blood administration and transfusion reactions.


Review of patients who received blood or blood components transfusion:

Patient #120

The record for Patient #120 was reviewed on 7/20/19 with Staff #S48 and #S148. Patient #120 had an order for 1 unit red blood cells on 8/15/19 at 11:00 am.

At 12:00 - Temperature 99 F, Blood pressure 135/89, Pulse 106, Respirations 25.

At 12:09 - Pretransfusion documentation completed.

At 12:11 - Transfusion initiated.

At 12:29 - Temperature 100 F, Blood pressure 135/83, Pulse 89, Respirations 18.

At 13:24 - Temperature 99.9 F, Blood pressure 148/74, Pulse 86, Respirations 18.

At 13:34 - transfusion stopped.

At 14:31 - Temperature 101.8 F, Blood pressure 140/84, Pulse 106, Respirations 20.

At 15:23 - Temperature 99.3 F, Blood pressure 121/77, Pulse 110, Respirations 17.


Vital signs were not monitored for 52 minutes after the last vital signs documented at 13:24 when the decision was made to stop the transfusion for a potential transfusion reaction with vital sign changes. The transfusion reaction protocol was initiated. There was no documentation of monitoring until the next vital signs were obtained at 14:31. This was confirmed during an interview while reviewing the patient record with Staff #S148.


Patient #121

The record for Patient #121 was reviewed on the afternoon of 9/20/19 in the conference room with Staff #S237 and #S303. Patient #121 had an order for 2 units of red blood cells on 7/17/19 at 5:46 PM. The patient experienced a transfusion reaction during the second unit on 7/18/19.

At 0005 - Temperature 98.7 F, Blood pressure 121/61, Pulse 96, Respirations 18

At 0008 - Transfusion started.

At 0025 - Temperature 98.7, Blood pressure 130/59, Pulse 98, Respiration 18

At 0050 - Temperature 98.6, Blood pressure 128/56, Pulse 98, Respirations 18

At 0120 - Temperature 101.5, Blood pressure 129/61, Pulse 102, Respirations 20 Transfusion stopped.

At 0205 - Temperature 99.6, Blood pressure 129/61, Pulse 102, Respirations 22

At 0300 - Temperature 99, Blood pressure 118/57, Pulse 98, Respirations 21


Vital signs were not monitored every 15 minutes after possible transfusion reaction with no documentation of indication for vital signs less than 15 minutes. This was confirmed in an interview with Staff #S237 and S303 while reviewing the medical record.


Another unit of red blood cells was started on 7/19/19 at 1237.

At 12:11 - Temperature 98.5, Blood pressure 118/64, Pulse 94, Respiration 16.

At 12:35 - Temperature 98.6. No blood pressure, pulse, or respirations documented.

At 12:39 - Transfusion started.

At 12:52 - Temperature 100 F, Blood pressure 106/53, Pulse 93, Respirations 16


A complete set of vital signs, including blood pressure, pulse, or respirations, was not obtained per policy within 15 minutes prior to starting the transfusion at 12:39 PM. This was confirmed in an interview with Staff #S237 and S303 while reviewing the medical record the afternoon of 9/20/19 in the conference room.


Patient #406

The record for Patient #406 was reviewed the afternoon of 9/23/19 in the facility conference room with Staff #S303. Patient #406 had an order for 1 unit of FFP (fresh frozen plasma) on 7/23/19 at 4:30 PM.

At 16:31 - Temperature 97.5, Blood pressure 123/65, Pulse 71, Respirations 16

At 16:43 - Temperature 98.1, Blood pressure 109/57, Pulse 69, Respirations 14. Transfusion started

At 1658 - Temperature 98.1, Blood pressure 110/58, Pulse 71, Respirations 14

At 1700 - Temperature 98.1, Pulse 70, Respirations 14. Blood pressure not documented.

At 1713 - Pulse 68, Respirations 14

At 1715 - Pulse 69, Respirations 14

At 1718 - Pulse 69, Respirations 14

At 1720 - Pulse 14

At 1730 - Pulse 68, Respirations 14

At 1743 - Temperature 98.1, Blood pressure 128/64, Pulse 69 Respirations 14

At 1745 - Pulse 68, Respirations 14

At 1758 - Temperature 97.7. Blood pressure, Pulse, Respirations not documented.

At 1800 - Temperature 97.5, Pulse 66, Respirations 14

At 1815 - Transfusion stopped Temperature 97.5, Pulse 67, Respirations 14 - Blood pressure not documented.

At 1830 - Pulse 65, Respirations 14

At 1845 - Pulse 68, Respirations 16. Blood pressure, Pulse, Respirations not documented.

At 1900 - Temperature 98.6, Pulse 65, Respirations 17. Blood pressure not documented.

At 1915 - Blood pressure 139/79, Pulse 100, Respirations 22


Vital signs for the transfusion were not taken per policy. A complete set of vital signs, including temperature, blood pressure, pulse, or respirations, was not obtained per policy within 15 minutes prior to starting the transfusion at 1643. After the transfusion was initiated, the vital signs were not taken per policy, including a complete set of vital signs every hour until completion and a set of vital signs upon completion of administration (there was no blood pressure documented on completion of the transfusion). There was no blood pressure documented between 1743 and 1915.


A "Hospital (1) Blood Bank Blood Pressure Infusion Record" form was provided to the surveyor for the above transfusion for Patient #406. Vital signs were documented for the patient on the blood bank form which were not documented in the medical record, including a complete set of vital signs at 17:13, 17:58, and 18:15. However, the form is not a part of the medical record.

The above findings were confirmed in an interview with Staff #S303 while reviewing the medical record the afternoon of 9/23/19 in Hospital (1) conference room.


36827


B. Hospital 2:

1. Incorrect titration of IV medication:

On the morning of 9-26-2019, a tour of the Medical Intensive Care Unit (MICU) at Hospital #2 was made. Staff #S705 was observed titrating norepinephrine (a medication used to increase blood pressure) for Patient #239. Staff #S705 explained that she was increasing the rate of infusion by 2 micrograms per minute (mcg/min) in order to achieve a MAP greater than 65 (mean arterial pressure - based off a calculation using blood pressure readings. MAP is used to help determine how well vital organs are receiving adequate blood flow). The MAP was being calculated and monitored for Patient #S239 through an arterial line (ART line), which was a thin catheter inserted into an artery.


Review of literature on the National Institute of Health website, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4355573/, explained the following about the MAP, "Prolonged hypotension, defined as a MAP of less than 60 to 65 mm Hg, is associated with poor outcome".


Review of documentation in the electronic patient record showed that the medication was started at 1 mcg/min at 9:10 AM on 9-26-2019 per physician order. Between 9:10 AM and 9:20 AM, the medication had been titrated up to 8 mcg/min with a blood pressure of 77/45 and a MAP of 56 at 9:20 AM. The next increase of medication was made 40 minutes later, at 10:00 AM. Review of the ART line readings showed that the MAP had never achieved the ordered target of greater than 65 between the time it was started and the time the increases began again at 10:00 AM. Nineteen (19) potential rate changes necessary to achieve the ordered MAP of greater than 65 were missed during that 40-minute time period.


An interview was conducted with Staff #S705 was conducted at the patient's bedside on 9-26-2019 after 11:00 AM. Staff #S705 confirmed that she was assigned two patients and had been providing patient care to her second patient during the 40-minute time gap.


An interview was conducted on 9-26-2019 after 11:00 AM with Staff #S94. Staff #S94 stated, she was on the other end of the unit and didn't know that Staff #S705 needed assistance with her patient. Staff #S94 confirmed that there is not an automatic process to place a patient on a 1:1 (one patient to one nurse) when they had critical and frequent medication titration changes necessary, until the desired goal was achieved and the patient acuity returned to a level that 1 nurse could then manage 2 patients again.


Because there was not an automatic process, this placed the burden on the nurse who was assigned two patients and trying to manage one with frequent medication changes to ask other nursing staff for assistance. This process could create a situation where the nurse may not be able to locate other staff in her area because they are caring for their assigned patients, forcing her to leave the patient needing frequent titrations to tend to her other patient assigned or delay care to her other assigned patient.


2. Non-specific policy & education related to blood transfusion reaction /patient monitoring:

On 9-25-2019 at 10:00 AM, personnel files for nursing staff were reviewed at Hospital #2. The staff were found to have specialized training in blood transfusion. The module content for blood transfusion reaction training was requested for review. Review of the content showed that symptoms to be monitored for were listed in vague, subjective terms. Terms included: fever, high fever, hypotension, severe hypotension, sudden severe hypotension, severe nausea and vomiting, severe chills, and hypertension. No parameters or definitions of these terms were listed. Without clear parameters and definitions to define these terms, nurses had to make their own decision of what the parameters would be, such as what qualified as severe and if a patient's normal blood pressure qualified as the medical definition of hypertension or hypotension, when should it be identified as a reportable transfusion reaction and when does it become severe.


Review of Policy Number 4170 Administration of Blood Components and Blood Derivatives did not explain what the parameters or definitions for transfusion reaction signs and symptoms were.


Staff #S415 at Hospital #2 Outpatient Infusion Center was asked about the terms, how they were defined and when they would be reported. Staff #S415 stated it would depend on the patient and what was going on with them. Staff #S415 was not able to explain an objective process for qualifying the subjective terms used to describe a transfusion reaction.

Without objectively defined transfusion reaction signs and symptoms, the nursing staff was relying on their own judgement and could potentially miss a life-threatening blood transfusion reaction.

Based on observation, review of documentation, and interview, it was determined that Hospital 1 failed to ensure that patient's home medications were secured.

Findings:

Hospital 1:

Patient home medications were not secured. During a tour of Hospital 1, 5F nursing unit on the afternoon of 9/17/2019, the surveyor observed that in room 7 there were unsecured patient's home medications. When the surveyor entered the patient's room, accompanied by staff member #S64 and staff member #S132, the patient was not in the room.

On the window ledge there was a small, shaving kit type bag that was open and it was observed to contain unsecured pill bottles. The pill bottles were taken to the nurse's station by the nurse manager and an examination of them revealed that there were 4 separate bottles all labeled with the name of patient #125. One of the bottles was labeled Tramadol 50 milligram (mg) mg and was observed to contain one tablet. Another bottle was labeled Lisinopril/HCTZ 20/25 mg and was observed to contain approximately 7 tablets. Another bottle was labeled Promethanzine 25 mg and was observed to contain approximately 7 tablets. The last bottle was labeled Lisinopril/HCTZ 20/25 mg and was observed to contain approximately 20 tablets (note: staff member #S132 confirmed that there were approximately 20 tablets in the pill bottle).

The surveyor asked staff member #S64 if there was a physician's order for this patient to have home medications at the bedside. Staff member #S64 checked the electronic medical record and confirmed that there was no such order. Additionally, staff member #S64 checked the electronic medical record and informed the surveyor that the patient was not on any of these unsecured medications.

Staff member #S64 also informed the surveyor that the medications that were found in the patient's room should not be at the bedside. Staff member #S64 added that these medications had just been brought in today by a friend of the patient.


Review of hospital policy #521.00, entitled "Patient Medications Brought From Home" with a last revised date of 04/09/2019 stated, "To assure patient safety in the handling of medication(s) or remedy(ies) brought from home by or for a patient admitted to a ______Health System facility for an inpatient stay."

The policy also stated: "____Health System shall safely handle and monitor use of medication(s) or remedy(ies) brought from home by or for a patient admitted as an inpatient to a Harris Health System facility."


Review of hospital policy #565.00, entitled "Medication Administration" with an effective date of 101/2004 stated, "To establish the guidelines for the safe and accurate administration of medications within approved areas of ____Health System facilities." The Policy stated, "It is the policy of _____Health System, through the implementation of the measures outlined, to enhance accuracy during medication administration and enhance patient safety."

In the definitions section of the policy: "C. Bedside Medications: Medications stored within the patient's immediate vicinity for which the patient has ready access for use while hospitalized."

"L. Qualified Licensed Personnel (QLP): Any individual permitted by law and by Harris Health to provide care and services, without relevant direction or supervision with the scope of the individual's license and consistent with individually granted clinical privileges."

"P. Security of Medications: For the purposes of this policy, security of the storage area for medications is defined as "under the constant surveillance of authorized users or secured within a locked device, cabinet, or room where only authorized personnel have access."

Page 10 of the policy stated under: "VIII. Bedside Medications: A. Orders for medications to be stored at the bedside shall be written by QLP. The order shall contain all necessary components of a medication order as well as a statement specifying that the medication shall be stored at the bedside."

"E. Medications left at the bedside shall be maintained in a secure area."

"G. Medications left at the bedside shall follow general labeling guidelines (Medication Use Safety Policy 564.40 Medication Storage, Labeling and Disposal) and be limited to as needed (PRN) medication is the following categories: 1. Hemorroidal preparations (e.g. witch hazel pads, hydrocortisone creams or ointments); 2. Topical lotions, creams or ointments used as a comfort measure and not treatment; 3. Oral care regimens; 4. Lubricant eye drops; and/or 5. Saline nasal drops or sprays."

(A) Based on observation, review of documentation, and staff interviews, the pharmacy failed to provide training for safe handling of hazardous medications. Staff #S405 was observed handling chemotherapy medications in a manner that did not promote patient safety, worker safety, or environmental protection.

(B) Based on observation, interview, and policy review, hospital #2 failed ensure that pharmaceutical services were provided in accordance with accepted standards bags of IV fluids were stored next to a partially filled bottle of drinking water in a supply warehouse where temperature and humidity were not monitored. In addition, a medication Pyxis machine had dried drippage with debris and cleaning of the Pyxis was not addressed in pharmacy policy.


Findings:

During a tour of the pharmacy warehouse at hospital #2 on the morning of 9/23/19 accompanied by staff #S404, staff #S405 was observed unpacking a box of chemotherapy drugs. Staff #S405 was not wearing gloves or any protective equipment. The chemotherapy medications were place in a gray plastic bin, the plastic bin was place on a metal shelf; there were medical supplies observed on the shelves below. After unpacking other pharmacy supplies, staff #S405 placed the gray plastic bin on a metal cart. The plastic bin containing the chemotherapy medications was uncovered. Staff #S405 rolled the cart from the pharmacy warehouse to central pharmacy located a significant distance from the warehouse, exposing the chemotherapy medications to the public environment. A chemotherapy spill kit was not available for possible spillage. The cart was rolled into the negative pressure room where medications were stored in central pharmacy. Staff #S405 placed the chemotherapy medications in the refrigerator in the negative pressure room.


An interview was conducted with staff #S405 on 9/23/19 at 12:57 PM, in the pharmacy warehouse. The surveyor asked staff #405 if he had training for handling chemotherapy medications. Staff #S405 said no.


Review of policy 594.0, last review date 11/13/2018, stated, "All hazardous drugs shall be handled by competent trained personnel in a manner that reduces risks to human health, the environment, and/or property. D. Closed system drug-transfer device (CSTD): A drug-transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of HD or vapor concentrations outside the system. II. Departments with employees who handle GD, on a regular basis must: Document employee competency to handle HD. 6. Ensure that appropriate personal protective equipment is available and worn by employees. A. HD's shall be handled under conditions that promote patient safety, worker safety and environmental protection."


In an interview on 9/23/19 with staff #S404 the findings were confirmed.


34617



During a tour of the clean supply warehouse at hospital #2 on 09/19/19 beginning at 11:10 a.m., accompanied by Staff #S222, Staff #S225, and Staff #S228, observations revealed the following in part:

A partially filled bottle of drinking water lying horizontal next to 1000 cc bags of 5% Dextrose in 0.45% Saline IV fluids - on the bottom of a cart with a cardboard box lying on top of one bag of the IV fluids and a plastic bin lying on top of 500 cc bag of 0.9% Sodium Chloride IV fluids.

The above findings were confirmed with Staff #S228 in an interview on 09/19/19 at 11:32 a.m., in the clean supply warehouse at hospital #2.


During an interview of Staff #S77 and Staff #S230 on 09/19/19 at 11:50 a.m., in the clean supply warehouse at hospital #2, both confirmed that neither temperature or humidity were being monitored in the warehouse at the time of the survey.


During an inspection of the Pyxis cabinet for the storage of medications in the sterile corridor of the operating suite at hospital #2 on 09/23/19 at 11:28 a.m. in the presence of Staff #S205, observation revealed dried drippage on the inside and outside of the clear plexi-glass door of the bottom shelf and areas of black debris to the lower shelf that could be removed from both areas by wiping them with an Oxivir wipe.


In an interview on 09/23/19 at 11:28 a.m., in front of the Pyxis cabinet in the sterile corridor of the operating suite at hospital #2, Staff #S205 confirmed the above findings.


The hospital policy no. 550.00 entitled "Automated Dispensing Cabinets," with an effective date of "4/08," and a last review date of "08/27/2019," was reviewed on 09/24/19 at 1:58 p.m., in a conference room at hospital #2 and stated the following in part, "POLICY STATEMENT: The Automated Dispensing Cabinets (ADC) shall be used to increase patient safety, expedite medication administration, and ensure proper documentation of medication actions." The policy did not address the cleaning of the Pyxis.


In an interview on 09/24/19 at 1:59 p.m., in a conference room at hospital #2, Staff #S495 confirmed that the policy did not address cleaning of the Pyxis and that hospital does not have a policy on cleaning of the Pyxis.


In an interview on 09/24/19 at 9:33 a.m., in an administrative office at hospital #2, Staff #498 confirmed that the hospital has nothing in a policy that addresses cleaning of the Pyxis machine for medication but stated, "Techs are encouraged on a daily basis to clean the Pyxis when they are delivering meds," "It's an expectation," and "Staff do monthly audits to check for expired meds. That is an opportunity to clean the Pyxis."


41048


On 9/19/19 at 11:10 am, a tour of the clean supply warehouse at hospital #2 was performed. The observations noted during this tour are as follow:

A. Several opened supply blue crates were seen opened with the contents exposed. Several of these crates had IV fluids such as Normal Saline, Lactated ringers and 0.45% saline in various volumes.

B. Several IV fluid bags and opened crates with IV fluids were noted to be stored with items such as wheel chairs, metal pallets, and trash.

C. Oral Contrast solution drinks left in an opened box exposed to environment.

These observations were made in the presence and confirmed by staff #S222. The warehouse was described as a clean environment by staff #S222.

Based on review of documentation and interviews with facility staff, the facility failed to develop accountability procedures to ensure controlled medications that were dispensed as a continuous intravenous (IV) infusion were not diverted by unauthorized persons. This unsafe condition placed patients at risk of not receiving the actual amount of prescribed medications and potentially being cared for by an impaired staff member in 4 of 4 random observations Patient #s 163, 164, 239, and 705


Findings:

During the tour of 4E Intensive Care Unit (ICU) in Hospital #1 on the morning of 9/23/19 with Staff #S400 it was observed:

Patient #163 was receiving a continuous IV infusion of Fentanyl, a narcotic drug, through a standard infusion pump that could be used for all types of medications. The tubing used to connect the bag to the infusion pump and connect the infusion pump to the patient's IV site was observed to be standard IV tubing. This tubing was observed to have multiple luer-lock ports where a syringe could be used to withdraw or add medications between the medication bag and the pump. This unsecured set-up has the likelihood for unauthorized persons to access and withdraw narcotics without detection.


Patient #164 was receiving a continuous IV infusion of Fentanyl, a narcotic drug, through a standard infusion pump that could be used for all types of medications. The tubing used to connect the bag to the infusion pump and connect the infusion pump to the patient's IV site was observed to be standard IV tubing. This tubing was observed to have multiple luer-lock ports where a syringe could be used to withdraw or add medications between the medication bag and the pump. This unsecured set-up has the likelihood for unauthorized persons to access and withdraw narcotics without detection.


In an interview, Staff #S425 was asked, "What would prevent anyone from drawing Fentanyl out of the proximal port closest to the Fentanyl IV bag and replacing it with something like saline?" Staff #S425 replied, "I guess nothing." The surveyor further asked, "Do you have any IV tubing that goes with this Alaris pump that has no extra luer-lock ports?" Staff #S425 replied, "Yes, we have the low sorbing tubing set that has no extra ports." Staff #S425 provided the surveyor a brand new IV tubing set without additional ports, the package was labeled, "BD Alaris Pump Infusion Set Low Sorbing Tubing."


In an interview on the afternoon of 9/23/19, Staff #S129 acknowledged the findings above.


36827


On 9-26-2019 at 10:57 AM, a tour was made of the Medical Intensive Care Unit at Hospital #2. Staff #94 reported that two Fentanyl continuous infusions were currently being used. One was in ICU room 11 and the other was in ICU room 16. Both infusions were observed to be through a standard infusion pump that could be used for all types of medications. The tubing used to connect the bag to the infusion pump and connect the infusion pump to the patient's IV site was observed to be standard IV tubing. This tubing was observed to have multiple ports where a syringe could be used to withdraw or add medications between the medication bag and the pump. This unsecured set-up has the likelihood for unauthorized persons to access and withdraw narcotics without detection.


Staff #S705 was caring for Patient #239 in ICU room 16. Staff #S705 was interviewed and asked what would prevent someone from removing the narcotic from the access port on the tubing and replacing it with a compatible fluid like normal saline. Staff #S705 replied, "Nothing".

Based on observation, review of documentation, and staff interviews, the facility failed to store controlled substances in a secure manner. Controlled substances were observed unsecured on a pallet in the pharmacy warehouse in 1 of 2 hospital pharmacies toured. Hospital #2


Findings:

During a tour of the pharmacy warehouse at hospital #2, on the 9/23/19 at 11:20 am, accompanied by staff #S404, 4 boxes of controlled substances (CS) were observed on a pallet. Staff #S404 said, the CS are delivered with the medications and supplies. The CS medications remain on the pallet in the warehouse until the pharmacy technician delivers it to central pharmacy.

Review of sign in and out form reveal the vendor delivered the CS at 9:02 am. Staff #S408 was observed loading the CS into a metal cart with combination lock at 11:35 am.

Review of Management and Accountability of controlled substances policy no. 582.00, last review date 09/23/2019, stated, " III. Storage and Security. A. Only authorized personnel shall have access to CS. C. Security of CS in areas that do not have ADC. 1. CS in non-ADC areas will be stored and secured in a locked cabinet or secured medication room.

In an interview during the tour staff #S404 agreed with the findings.

Based on observation, review of documentation, and interview, it was determined that the hospital failed to ensure that expired medications were removed from stock. Expired medications were not removed from pharmacy stock and available to be dispensed in 2 of 28 centers pharmacy monitored.


Findings:


During a tour of out patient clinic (#3) on the late morning of 9/25/2019, observation in the pharmacy revealed that stored among other medications on a shelf was one 200 ml bottle of Acyclovair 200 mg/5 ml oral suspension. The labeling on the bottle listed the "written date" as 7/25/2018. The "filled date" as 7/30/2018, and the "Expires beyond use date" as 7/30/2019.


Review of pharmacy policy entitled "Expired/Beyond Use Date Medication Preparation Removal," stated, "In an effort to ensure patient safety and meet regulatory requirements regarding outdated product removal, the Department of Pharmacy (DOP) has outlined a procedure for flagging and removing expired/beyond use medications to prevent them from being dispensed to Harris Health System patients." Page two stated under the procedure section, "A. All medication areas shall be inspected routinely for cleanliness, expiration dates, and beyond use dates." "D. The medication areas shall be inspected, and documentation completed by the 25th of each month." "E. Expired/beyond use medications shall be removed from stock and placed in the designated expired medication section (quarantined from medication areas) within the pharmacies."


In an interview with staff member #S527 the above finding was confirmed.


38015


Observation on 9/16/19 at 2:00 PM, of Hospital 2'sTeen Clinic located on the first floor revealed the following: in the pharmacy clinic, located inside and used exclusively for the Teen Clinic, were five full bottles of the antibiotic Amoxicillin (with 60 capsules in each) that expired on 8/19.


In an interview on 9/16/19 at 2:00 PM, with Family Nurse Practitioner Staff #S379, she stated that the expired medications should have been discarded and not available for patient use. She then promptly discarded all five bottles of the Amoxicillin.

Based on review of laboratory quality assurance records, hospital procedures, laboratory procedures, and staff interview, it was determined that:

A. Hospital # 1 failed to ensure the laboratory services were integrated into the hospital-wide QAPI program and failed to implement strategies and monitor the effectiveness of corrective actions the laboratory implemented.

B. The hospital failed to ensure the Hospital #1 transfusion of blood/blood components procedure included objectively defined transfusion reaction signs and symptoms to ensure transfusion reactions were promptly investigated.

C. The hospital failed to ensure the Hospital #1 Point of Care Testing policy and procedures (policy 4398) were approved by the laboratory director.

The cumulative effect of these system failures resulted in the failure to have an effective process to provide safe delivery of laboratory services to patients.

D. The hospital failed to ensure the laboratory services were integrated into the hospital-wide QAPI program and failed to implement strategies and monitor the effectiveness of corrective actions the laboratory implemented.


Findings:

1. A review of the Laboratory 2019 Performance Improvement Departmental Semi-Annual Evaluation Executive Summary for Hospital 1 revealed for Microbiology a goal of 100% optimal fill volume of 8-10 ml for BD Bactec Plus Aerobic/F Culture Vials. The laboratory monitors fill volume for adult critical care and EC (Emergency Center)


2. Review of the Hospital #1 Microbiology Lab 2019 PI Summary Report Blood culture volume for Q1 2019 revealed that 68.1% (2421 of 3552 blood culture bottles that were monitored for correct fill volume) failed to meet the requirements for fill volume. Review of Q2 2019 blood culture fill volume revealed 68% (1657 of 2437 blood culture bottles) failed to meet the requirements for fill volume. For Q2 2019 June data was not included due to issues with Epic Beaker Reports.

a. Q1/2 2019 dropped to 31.91% of collected culture bottles containing the optimal volumes required by the manufacturer. This was a decrease of 16.39% from 2018.

b. A review of laboratory quality assurance records revealed they had been working on the problem of blood culture fill volumes since at least August of 2018.

c. A review of laboratory quality assurance records revealed the laboratory, at the department level, initiated a corrective action plan that involved communication with departments about optimal volume requirements, quick reference guides and manufacturer collection training materials to nurse leadership.

d. The August 2019 Corrective Action Plan root causes identified by the laboratory were:

(1) Microbiology Laboratory provided unit based summaries, Quick reference Guides and Manufacturer Training Guides to Nursing Leadership without receiving leadership's feedback.

(2) Lack of continuing education and competency assessments within the individual blood culture collection departments.

(3) Lack of Microbiology ability to provide detailed summaries to include collector's identity for the outliers in order for Nursing Leadership to follow up on... due to issues with EPIC Beaker reports

e. In August 2019 the Department of Pathology 2019 Q1/Q Performance Improvement Report Improvement Plan for fill volumes revealed the laboratory sent another request for a meeting with Quality Management and Patient Safety Department.


3. In an interview of the staff S751 on 09/26/2109, in the Galveston conference room, he confirmed the issue of blood culture fill volumes identified in 2018 was not brought to ERC until July 2019.


4. In an interview with staff S737 on 09/25/2019, in the Dallas conference room, she stated that Laboratory meet with quality twice a year in May and November.


E. The hospital failed to ensure the Hospital #1 transfusion of blood/blood components procedure included objectively defined transfusion reaction signs and symptoms to ensure transfusion reactions were promptly investigated.

Findings:

1. Review of the Facility policy, "Administration of Blood and Blood Components and Blood Derivatives" and "Appendix A Administration of Blood and Blood Components and Blood Derivatives" revealed, the policy failed to include objectively defined transfusion reaction symptoms to ensure transfusion reactions were promptly investigated.

II. Administration of Blood/Blood Components: ...

If signs/symptoms of transfusion reaction are noted at any time during the transfusion, immediately stop the transfusion and follow the Transfusion reaction protocol.


2. In an interview in Hospital 1 conference room at 1320 hours on 9/23/19, with Staff #S311 and after her review of the above policy, she confirmed that the "Administration of Blood and Blood Components and Blood Derivatives" policy did not define signs and symptoms of a transfusion reaction, such as back pain, chills, flushing, shortness of breath, itching, changes in temperature, blood pressure, pulse, or oxygen saturation, anaphylaxis, or cardiac arrest.


Code of Federal Regulations Part 493, 493.1271(e) Standard: Investigation of transfusion reactions

(e) Investigation of transfusion reactions.

(e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures.

(e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused.


F. The hospital failed to ensure the Hospital #1 Point of Care Testing policy and procedures (policy 4398) were approved by the laboratory director.

Findings:

1. Review the Hospital 1 nursing "Point of Care Testing" policy and procedures # 4398 revealed, the procedure was not reviewed and approved by the laboratory director of Point of Care.

a. A review of the Hospital 1 nursing "Point of Care Testing" policy 4398 revealed, it was approved by the administrative director of Pathology, not the laboratory director.

b. A review of laboratory Point of Care procedures on 09/27/2019 at 0912 hours, revealed, the laboratory developed policies and procedures "i-STAT Procedure" #POC.PC.2.570.2.08.02 and "Precision XceedPro Glucometer" procedure #POC.PC.2.500.11.10.03 were approved by the laboratory director of Point of Care.


2. In an interview with staff #S311 at 0900 hours on 9/27/2019, she confirmed the administrative director was #S751, not the laboratory director of Point of Care.


3. In an interview of staff #S751 at 0915 hours on 9/27/2019, he confirmed the laboratory developed procedures for point of care testing approved by the laboratory director were located in Media Lab.


Code of Federal Regulations Part 493, 493.1251; Standard: Procedure Manual:"(d) Procedures and changes in procures must be approved, signed and dated by the current director before use."

Based on observation, interview, and record review, the facility failed to provide an organized, clean, and sanitary dietary department for Hospital 1, in 1 of 2 hospital dietary departments toured.


Findings:


Observations during a tour of Hospital 1's kitchen on 9/16/19 and 9/17/19, accompanied by Staff #S50 and Staff #S52 revealed the following:

- Staffs #s S50, S165, and S164, in the food production areas with exposed beards and moustaches.

- A large food storage bin with a plastic scoop's handle sitting on the dry beans.

- (2) chef's knives with dried food debris stored in the knife holder readily available for use.

- The large meat slicer with dried food debris around the cutting blade readily available for use.

- The manual tomato slicer had dried food debris on the cutting blades available for use.

- (2) Cutting boards with a dark substance left in the deep cuts on the boards.

- A dark brown and yellow slime growth in the mop drain, located in the dish room.

- (2) mops being stored in dirty water.

- (2) full containers of individual patient's butter, to be used for the patient's lunch tray assembly, sitting out on a counter at room temperature. The butter's packaging reflected the item required refrigeration.


Further observation on 9/17/19 revealed, a reach-in refrigerator with a digital external temperature of 44 degrees Fahrenheit. The reach-in refrigerator did not have an internal thermometer.


During interviews on the morning of 9/16/19 and 9/17/19, Staff #S166 confirmed the findings. Staff #S166 stated the digital thermometer's temperature probe is placed in the middle of the refrigerators. Staff #S166 was unable to provide a policy or procedure for the checking of the internal product temperatures for the products at the warmest part of the refrigerators, by the door.


Review of the facility policy #6.10 Food and Nutrition Services Dress Code (dated 10/16/2018) reflected, "A. All hair shall be covered at all times while working in the production area and cafeteria, F. Facial hair must be well groomed and trimmed or it must be covered with a beard restraint to protect exposed food, clean equipment, utensils and linens."


Review of the TFER (Texas Food Establishment Rules) October 2015 reflected the following:

228.186(f) Drying mops
(f) Drying mops. After use, mops shall be placed in a position that allows them to air-dry without soiling walls, equipment, or supplies.

228.111(b) Cutting surfaces.
(b) Cutting surfaces. Surfaces such as cutting blocks and boards that are subject to scratching and scoring shall be resurfaced if they can no longer be effectively cleaned and sanitized or discarded if they are not capable of being resurfaced.

228.114(a)(5)(A)
Surfaces of utensils and equipment contacting food that is not time/temperature control for safety shall be cleaned at any time when contamination may have occurred.

228.68(b)(1)
In-use utensils, between-use storage. During pauses in food preparation or dispensing, food preparation and dispensing utensils shall be stored except as specified under subsection (a) of this section, in the food with their handles above the top of the food and the container.

228.43(a)Hair Restraints
(a) Except as provided in subsection (b) of this section, food employees shall wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair, that are designed and worn to effectively keep their hair from contacting exposed food; clean equipment, utensils, and linens, and unwrapped single-service and single-use articles.

228.106(k)(1) Food thermometers provided and accessible
Temperature measuring devices.
(1) In a mechanically refrigerated or hot food storage unit, the sensor of a temperature measuring device shall be located to measure the air temperature or a simulated product temperature in the warmest part of a mechanically refrigerated unit and in the coolest part of a hot food storage unit.

(2) Except as specified in paragraph (3) of this subsection, cold or hot holding equipment used for time/temperature controlled for safety (TCS) food shall be designed to include and shall be equipped with at least one integral or permanently affixed temperature measuring device that is located to allow easy viewing of the device's temperature display.

Based on observation, review of documentation, and interview, it was determined that Hospital 1, Hospital 2, and Clinic 3 administrative staff failed to ensure that the physical environment was maintained to protect the safety and well being of the patients:

*Hospital 1: automatic external defibrillator (AED) not working, patient bathroom emergency call light pulls absent or wrapped around grab bars ( 8 +), numerous wall-mounted fluorescent lights not working, leaking pipe in basement with exposed electrical wire nearby, eye wash station absent in area where chemicals stored, and dust on ice machines and other areas.

*Hospital 2: improper storage of potentially hazardous dialysis solution, stained ceiling tiles noted in multiple departments, torn vinyl on numerous chairs in patient /family waiting areas. Dialysis solution stored in environment not temperature controlled.

Clinic 3 : leaking chemicals in chemical storage cabinet, numerous wall-mounted fluorescent lights not working, dirty floor drain.


Findings:

Hospital 1:

Tour of the hospital 1 basement on the morning of 9/16/2019:

In corridor 81 of the basement, there were five overhead ceiling mounted fluorescent light fixtures containing what appeared to be dead insects. In an interview with staff member #S112 at time of observation, the finding was confirmed.

Visible light was observed under the exterior door to the loading dock, this provided the potential for a point of entry for insects and rodents. In an interview with staff member #S126 at time of observation,the finding was confirmed.

Room B-MM81 003ab, dirty equipment (2 each IV poles) was found stored with clean and covered equipment (bedside commodes). Additionally, it was observed that there was visible dust on the paper towel dispenser in the room. In an interview with staff member #S116 at time of interview, the findings were confirmed.


Tour of the Emergency Department on the afternoon of 9/16/2019:

In the "sort room," one of three ceiling mounted fluorescent light fixtures was not working.

In the Emergency Department waiting room, there was a 3-person bench which was found to have multiple cracks in vinyl covering on the seating area on two of the seats.

In the janitor closet located in room 1 -EC 60 003, the ceiling mounted fluorescent light fixture was dirty in appearance.

In room 1 ED 70 001 the EM Research Lab, one of the ceiling mounted fluorescent light fixture was not working.

In the bulk storage room, 2 of 4 ceiling mounted fluorescent light fixtures were not working.

In storage room F10, one of the ceiling mounted fluorescent light fixtures was not working.

In the Pediatric triage room 1 PE 51 008, the ceiling light fixture had what appeared to be dead cockroach in it.

In room 1 FC 43-003 the core supply room, the top of the DCP 1-10 panel had visible dust on it.

The ice machine located in Core D had visible dust on top of the ice machine.

In an interview on the afternoon of 9/16/19 during the time of observations with staff member #S118, the findings from the emergency department were confirmed.


Tour of the hospital on 9/17/2019:

Hospital 1:

Observation in the Central Sterile processing hallway at approximately 10:55 a.m. The AED (automatic external defibrillator) located in the central sterile processing hallway (located adjacent to the men's locker room 2937) did not work.

During a tour of the central sterile processing area on the morning of 9/17/2019, the surveyor asked staff member #S58 if the AED worked. Staff member #S58 attempted to determine if the AED was operable but was unable to make the AED function. In an interview with staff members #S58, #S132, and #S133 it was confirmed that the AED did not function.

Nursing unit 5C tub room, the emergency pull cord was observed wrapped on one of the stainless-steel grab bars. This was confirmed in interview with staff member #S132.

Biohazard room on 5C had one of the ceiling mounted fluorescent light tubes not working. This was confirmed in interview with staff member #S134.

Linen room on 5C had one of the ceiling mounted fluorescent light tubes not working. This was confirmed in interview with staff member #S132.


Tour of the hospital on 9/18/2019:

Hospital 1:

Nursing Units

Soiled Utility room #61C81014, was observed to contain a black plastic linen cart, inside the cart was a sign which stated, "No trash (any) in linen cart inside the 6E Soiled Utility Room (such gowns, gloves, paper towels)." Observation inside the cart revealed approximately 6 blue disposable examination gloves in the bottom of the cart. This was confirmed in an interview with staff members #S314.

Ice machine in patient nourishment room 61C82-001, visible dust was observed on top of the ice machine. This was confirmed in interview with staff member#S321.

On the fourth floor GYN unit in the tower building, patient restroom 424, was observed to have the emergency pull cord wrapped around the stainless-steel grab/assist handle. On the fourth floor OB unit in the tower building, patient restroom 486 was observed to have the emergency pull cord wrapped about around the stainless-steel grab/assist handle. This was confirmed in interview with staff member #S132.


Tour of the hospital's water softener storage area on the afternoon of 9/24/2019:

Hospital 1:

Water hardness testing reagents were expired. During a tour of the "salt room" on the afternoon of 9/24/2019, it was observed in a wall mounted cabinet that there were 6, 60 ml bottles of Hardness #7 testing reagent. The expiration dates on these bottles were 6/2015, 8/2016, 11/2016 (missing screw on top), 8/2019 x 2, and 2/2019. Also found was a container of Oxivir Tb wipes which had an expiration date of 12/2018.

The interior of the cabinet in which the above was stored was dirty in appearance and there was a 500 ml Nalgene bottle which was approximately 2/3 full labeled "Feed Water" no date was found on this container as to when it was prepared.

Observation of the brine tank revealed that it was partially uncovered exposing the interior content of the tank to the atmosphere.
When the surveyor looked in the tank there were small pieces of visible debris observed floating on the water in the tank. There was also a valve above the brine tank which was dripping into the tank.

Interview with staff member #S316 and staff #S525 at the time of observations the above findings were confirmed.

In a follow-up interview on the morning of 9/25/2019 with staff member #S113, the survey team was informed that the brine tank should be covered.


Tour of hospital outpatient location (Clinic #3) on the morning of 9/25/2019:

Clinic 3:

Clean Storage room in the Laboratory, contained ceiling mounted fluorescent light fixture which had two light tubes that were not working.

Exterior doors from the electrical room and mechanical room had visible light observed at the threshold. This provided the potential for a point of entry for insects and rodents.

Electrical room had eight ceiling mounted fluorescent light fixture tubes which were not working.

The floor drain in the sterile instrument room was dirty in appearance with visible debris in the drain.

An examination on the yellow flammable chemicals cabinet located in the mechanical room revealed that the upper shelf was wet in appearance as if one of the containers was leaking and lower shelf was also wet in appearance. The above findings for outpatient clinic #3 were confirmed during the observations in an interview with staff member #S526.

Storage closet in the central supply room had one ceiling mounted fluorescent light tube not working. This was confirmed during the observation in an interview with staff member #S528.


Review of hospital policy number 7507.01 entitled "Maintenance of Equipment" stated, "This policy assigns responsibility, establishes requirements, and provide procedures for the efficient and timely user and support maintenance of facilities, medical, and dental equipment at ----- Health System activities."


Review of hospital policy number 7200 entitled, "Environmental Services Cleaning Guidelines" stated in the Purpose section: "To reduce the risk of hospital acquired infections from transmission between patients, personnel, in an overall healthcare environment; To ensure standardized cleaning protocols that enhance our patient experience by providing a high level service to produces a clean, safe and healthy environment; and To foster collaboration between the hospital's Infection Prevention Program and Environmental Services."


36834


Hospital #1:

1. Leaking water pipes were observed at the facility Mechanical area on the basement floor. Next to one of the leaking pipe was uncovered junction box with visible exposed wires.

2. Some patient bathrooms had no emergency pull cord alarms installed.

3. Emergency eye wash at the mechanical area on the basement floor where facility stored hazardous/corrosive chemicals had been removed.

4. The stairwells at the facility car garage appeared grossly filthy and had visible debris, dirt, brown stains, and offensive odor.


During the tour of hospital (#1) mechanical area on the basement floor on 09/16/19 at 10:15 a.m., two leaking water pipes was observed dripping water to the floor. Next to one of the leaking pipe was uncovered junction box with visible wires in it. These findings were confirmed by staff member #S112.


Further observation revealed an emergency eye wash had been removed from the mechanical area of the basement floor. Hazardous and corrosive chemicals labeled CL2840 and unlabeled 5 gal black gas cylinder were stored in the basement. Interview with staff member #S112 revealed, there was no emergency shower or eye wash available. He said it had been removed since "thought we didn't need it."


Observation of the hospital #1 Emergency Center on 09/16/19 at 12:10 p.m., revealed, patient bathroom 1-EC 70 005 had no emergency pull cord installed. This was confirmed by staff member # S 370.


Observation on hospital #1 level 3 C- High Risk antepartum on 09/17/19 at 10:12 a.m., revealed, patients bathroom 3-C 51 027 had no emergency pull cord installed. This was confirmed by staff member # S 383.


Observation on hospital #1 level 6 F- GI Lab on 09/18/19 at 10:25 a.m., revealed, patients bathroom 6-GI 70 005 had no emergency pull cord installed. This was confirmed by staff member #S57.

Interview with staff member #S57 at the time of observations revealed that patients on GI and critical care patients used the 6-GI 70 005 restroom.


Policy on emergency pull cords requested, the hospital had no policy in place.


Observation of the hospital #1 garage stairwells on 09/24/19 revealed ,they were grossly filthy with visible debris, dirt, brown stains and offensive odor. This was confirmed by staff member #S113 who reported they were "in the process of cleaning them."


Review of facility policy # 7507.01 titled "Maintenance of Equipment" with last review date of 08/30/2019, reflected the following purpose, " ...provide procedures for the efficient and timely user and support maintenance services of facilities."


Review of facility policy # 7200 titled "Environmental Services cleaning guidelines" with a last reviewed date 09/11/2019, reflected the following purpose, "To ensure standardized cleaning protocols that enhance our patient experience by providing a high-level service to produce a clean, safe and healthy environment."


35028

Hospital 2:

Unsafe storage of dialysis solution:

Observation of the Hospital #2 warehouse on 9/25/2019 at 10:10 AM showed six (6) one-gallon containers of Minncare Cold Sterilant used in dialysis, not in their original shipping boxes. Batteries and oxygen tanks were stored in the same area as the solutions.


In an interview with Staff #S227 (Materials Management Supervisor) in the Hospital #2 warehouse on 9/25/2019 at 10:10 AM, he stated that the containers of Minncare Cold Sterilant and Renal Pure should have been in boxes. He stated, he did not know the hazards identification of the two solutions. He concluded by saying the warehouse gets very hot during the summer, the temperature is not monitored, and the solutions should not be stored in a hot warehouse.


In an interview with Staff #S470 (Manager of Safety and Environmental Health) at Hospital #2 on 9/25/2019 at 10:20 AM, he stated he did not know the hazards identification of the two solutions. He concluded by saying, the warehouse gets very hot during the summer.


Record review of Safety Data Sheet for Minncare Cold Sterilant (product code: 3029765, 3029764, 3029817), revised 2/19/2015, showed: " ... Oxidizing liquid ... May cause fire or explosion ... Causes severe skin burns and eye damage. Harmful if inhaled. May cause respiratory irritation ... Keep ... in a cool, well-ventilated place. Store away from other materials ... Store at temperatures not exceeding 75 degrees Fahrenheit ... Store locked up."


38015

Hospital 2:

Observation on the morning of 9/16/19 at Hospital 2 revealed there were four heavily stained ceiling tiles in facility's main Service Hallway. In an interview with Facility's Director Staff #S229 at time of findings, he stated, the stained ceiling tiles should not have been there.


Observation on the morning of 9/17/19 of Hospital 2's Emergency Center's Patient Waiting Room showed there were three heavily stained ceiling tiles. In an interview with Facility's Director Staff #S229 at that time, he stated, the stained ceiling tiles should not have been present.


Observation on the morning of 9/16/19 of Hospital 2's Outpatient pharmacy waiting room showed, there were three chairs that had their vinyl armrests torn, exposing the foam padding from underneath.


Observation on the morning of 9/17/19 of Hospital 2's NICU (neonatal intensive care unit) waiting room showed, there were two chairs with torn vinyl armrests, exposing the foam padding underneath.


Observation on the morning of 9/18/19 of Hospital 2's Radiology waiting room showed, there were eight chairs with torn vinyl armrests, exposing the foam padding underneath.


Observation on the morning of 9/19/19 of Hospital 2's third floor ICU waiting room showed, there were two chairs with torn vinyl armrests, exposing the foam padding underneath.


Observation on the afternoon of 9/19/19 of Hospital 2's Day Surgery waiting room showed, there were three chairs with torn vinyl armrests, exposing the foam padding underneath.


In interviews on 9/16/19, 9/17/19/, 9/18/19, and 9/19/19, at the times of observations of the torn chairs with Staff #S374, he stated the chairs should not have been available for patient use and he had called facility maintenance to replace them each time they were identified.

Based on observation, review of documentation, and interviews with facility staff, the facility failed to properly maintain patient care equipment and supplies in Hospitals 1 and 2, and Clinic # 6.


Hospital 1 :

A. Biomedical inspections were not completed for patient care equipment in radiology and emergency departments.

B. X-ray machine in radiology and equipment in rehabilitation was not maintained in a sanitary manner.

C. Patient equipment was not stored appropriately.

D. Trash and dirty linen were not disposed of in a sanitary & safe manner.

E. Housekeeping cart was left unattended and unlocked providing public access to hazardous cleaning chemicals.


Hospital 2:

F. Emergency crash carts were not maintained and inspected in a manner that ensured the safety and quality of supplies and equipment in the carts.

G. Environmental issues were observed to include : unsafe storage of equipment and supplies; unsanitary conditions related to a cracked countertop and Pyxis medication storage; and improper disposal of trash.


Clinic 8 : glucometer lacked a biomedical inspection per policy.


Findings:

Hospital 1:

A. Biomedical equipment inspection:

Radiology:

During a tour of hospital #1 interventional radiology department 9/17/19 at approximately 9:00 am, two Vortex Genie 2 shakers used to mix Onyx liquid embolic material (liquid embolic agent for the treatment of intracranial aneurysms) were observed in the Biplane-Neuro Room that had no biomedical inspection tags of any kind affixed. In an interview during the tour at approximately 9:00 am, staff #111 acknowledged there was no evidence of biomedical inspection of the Vortex Genie shakers.

The facility policy titled "Maintenance of Equipment" #7507.01, review date 8/19, reflected in part, "C. The Pavilion Director(s), Facility and Biomedical Engineering Services will ...3. Implement a maintenance program for the repair, preventative maintenance, safety testing and CVC (Calibration/Verification/Certification) of equipment located at _____Health Facilities."


36834

Hospital 1:

A. Biomedical equipment inspection :

Emergency Center [and at the offsite Clinic #6] :

During the tour of the hospital #1 Emergency center on 09/16/19 at 12:15 p.m., one glucometer machine was noted not to have a preventive Maintenance (PM) sticker on it. This was confirmed by staff member #S370. She reported that, "I didn't know it had no PM sticker. It's supposed to have one."

Tour of Offsite clinic #6 on 0909/23/19 at 09:23 a.m., revealed, a glucometer machine with no inspection sticker in it. This was confirmed by staff member # S316.


B. X-ray machine in radiology and equipment in rehabilitation not maintained in a sanitary manner:

During a tour of the hospital #1 Radiology department on 09/16/19, in the company of staff member #S120, revealed a digital portable X ray machine was dusty and had white stains on it. This was confirmed by staff member# S120.

During a tour of the hospital #1 Rehab service area on 09/17/19 at 09:56 a.m., in the company of staff member #S121, revealed, the Tilt table and cad chair was observed to be dusty. The Tilt table and cad chair on Hospital #1 level 2- rehab services department were observed to be dusty. Dirty towels were observed thrown in a trash can. Used tweezers and spoons were observed disposed in dirty linen bin.


C. Patient equipment was not stored appropriately:

During a tour of the hospital#1 Rehab service area on 09/17/19 at 09:56 a.m., in the company of staff member #S121, revealed, patient commodes and shower chairs were observed inappropriately stored and crammed in a bathroom used by staff members.


D. Trash and dirty linen were not disposed of in a sanitary and safe manner:

Continued observation in hospital 1 rehab area on 09/17/19, showed dirty wash towels thrown in a trash can. Used tweezers and spoons were observed disposed in a dirty linen bin. Patient commodes and shower chairs were observed crammed in a bathroom used by staff members. These findings were confirmed by staff member # S121.

A tour of the hospital #13 B - Texas Health Steps on 09/17/19 at 10:15 a.m., revealed, a draining sink at the janitor's room 3NO 32 023 appeared grossly dirty and had visible brown stains. The floor had visible brown stains. Staff member #S123 confirmed these findings. She reported "I rarely come here. It's supposed to be cleaned after use."


Review of facility policy # 7507.01 titled "Maintenance of Equipment," with last review date of 08/30/2019, reflected the following purpose, " ...provide procedures for the efficient and timely user and support maintenance services of facilities, medical and dental equipment." It stated, "the Director of each clinical activity or department will implement an equipment operator PM program that ensures equipment operator monitoring and maintenance before, during, and after use of each piece of equipment."


Review of facility policy # 7200 titled "Environmental Services cleaning guidelines," with a last reviewed date 09/11/2019, reflected the following purpose: "To ensure standardized cleaning protocols that enhance our patient experience by providing a high-level service to produce a clean, safe and healthy environment."


18956

Hospital 1:

E. Housekeeping cart was left unattended and unlocked providing public access to hazardous cleaning chemicals.

Findings:

On 9/20/2019 at 1:40 PM, during a tour of the Medical Surgical Unit hall, it was noted that a housekeeping cleaning cart was open to public view and the environmental/housekeeping staff was not present. There were several bottles of Oxivir disinfectant in the housekeeping cart.

On 9/20/2019 at 2:00 PM, an environmental/housekeeper was interviewed. The environmental worker #S724 stated that she can stay away from her cleaning cart for long periods of time. When asked if the cart had a locked compartment where she can keep the disinfectant safe from the public, the worker stated, "No, the managers are trying to put locks on these carts but the one I am using today has no lock. I could have closed the drawers".

On 9/20/2019 at 2:15 PM, a tour of Medical Surgical Unit 5E was conducted. It was noted that the housekeeping cart was unattended, open and in full public view. In the cart were Oxivir bottles and large Ecolab soap containers. It was noted that an environmental/housekeeper was inside a patient's room. Three minutes later the housekeeper came back to the cart.

On 9/20/2019 at 2:03 PM, environmental/housekeeper #S725 came out of a patient's room. When asked if the cleaning cart had a lock she stated, "No". The worker stated that she forgot to close the cart drawers.


Record review of the Competency Check List for environmental/housekeeper #S724. The Last competency check list was signed and dated on 3/28/2017. Under "Can you leave your cart unattended" the reply was "Never". According to this document the employee failed this competency. The employee failed because according to management the answer was "For 30 minutes".


Record review of the Competency Check List for environmental/housekeeper #S725. The last competency check list was signed on 4/19/2017. Under "Can you leave your cart unattended" the reply was "Never". According to the document, the employee failed this competency. The employee failed because according to management the answer was "For 30 minutes".


Record review for both employees Competency Assessment EVS (Environmental Service Technician 1) showed that both employees were retrained on 9/22/2019, two days after this finding.


On 9/26/2019 at 8:30 am, Staff #S726 and #S727 and were interviewed. During the interview, the Staff stated that they try to have the Competency Check List completed for every environmental service staff member every year. They indicated that all the employees had to complete the hospital training requirements annually. However, it did not cover the duties and responsibilities of the environmental service staff. Staff #S726 stated that they follow the Life Safety Code standards in which the housekeeping cart can be left unattended and in public view for 30 minutes. When it was mentioned that this is a health survey and not a Life Safety Code survey, the Staff stated that it is the hospital policy that the environmental staff can leave the cleaning carts unattended and in public view for 30 minutes.


On 9/26/2019 at 9:00 am, Staff #726 came back to the interview room and stated, he was wrong, that there is no hospital policy allowing the environmental/housekeeper staff to leave the cart open and unattended for 30 minutes. His expectation is that all the cleaning carts and cleaning supplies be locked away for safety reasons. The Staff stated that they were in the process of installing locks on those cleaning carts.


36827

Hospital 2:

F. Emergency crash carts were not maintained and inspected in a manner that ensured the safety and quality of supplies and equipment in the carts.

Findings:

During a tour of Unit 3A at Hospital #2 on 9-16-2019, an emergency Crash Cart was opened and inspected. The cart drawers were observed to be locked with plastic locking tags of various colors that were numbered. When a drawer was opened, the lock tag had to be broken off. The purpose of the tags was to alert staff if the drawer had been opened or tampered with, ensuring that the necessary supplies were available in an emergency.

Crash Carts were required to be checked daily and documented on a review log. Review of the log for the Crash Cart showed that the staff were to inspect that the lock was intact. However, there was not a spot to record the number on the lock tag.

A search of internet sites showed that the lock tags being used, Health Care Logistics Heavy Duty are sequentially numbered lock tags. Since the serial numbers were not logged and verified at each check, it was possible for unauthorized persons to open the cart, remove equipment and supplies including emergency medications stored in the cart, and reseal the drawer with another locking tag. This could result in emergency supplies and equipment being unavailable to an emergency response team.

Once open, the sterile equipment inside drawers was found to be stored in a manner that compromised sterility of the packaging. Packages of sterile instruments and supplies were bundled together with rubber bands that had been tightly placed, tearing and puncturing the sterile wrapping. Nonsterile packaging of supplies was observed to be placed under and inside the outer wrapping of the sterile chest-tube tray used to emergently insert a chest tube into the lung cavity of patients. By placing non-sterile packaging under the wrapper, the sterility of the surgical instruments inside the sterile tray was compromised.

Staff #S91 was present during the tour. Interview with Staff #S91 confirmed that serial numbers were not being recorded and checked to ensure they had not been tampered with. Staff #91 confirmed that packaging of sterile items in the cart had been compromised due to method of storage in the cart.


34617

Hospital 2

G. Environmental issues were observed to include unsafe storage of equipment and supplies, unsanitary conditions related to a cracked countertop and Pyxis medication storage, and improper disposal of trash.

Findings:

During a tour of the Post Anesthesia Care Unit at hospital #2 on 09/16/19 beginning at 1:30 p.m., accompanied by Staff #S205, Staff #S204, and Staff #S200, observations revealed an ice machine used for patients was sitting on a countertop with a crack to the back right side such that the countertop could not be properly cleaned.

The above findings were confirmed during an interview of Staff #S200 in the PACU at hospital #2 on 09/16/19 at 2:00 p.m.


During a tour of the clean supply warehouse at hospital #2 on 09/19/19 beginning at 11:10 a.m., accompanied by Staff #S222, Staff #S225, and Staff #S228, observations revealed the following:

1. A #20 fr foley catheter with a 5 cc balloon in a wrapper with black smudges draped over a dirty corrugated box and the finding was confirmed at the time of the observation by Staff #S225 and Staff #S222.

2. A pair of used exam gloves lying in a wire rack on a stored rolling cart used for patient care.

3. A pair of used exam gloves lying in a box with an item identified as a "CPR cable awaiting repair."

4. A "Let's Do This" orange bucket with multiple dirty blue rags with an orange peel on top of the rags.

5. A partially filled bottle of drinking water lying horizontal next to 1000 cc bags of 5% Dextrose in 0.45% Saline IV fluids - on the bottom of a cart with a cardboard box lying on top of one bag of the IV fluids and a plastic bin lying on 500 cc bag of 0.9% Sodium Chloride IV fluids.

The above findings were confirmed with Staff #S228 in an interview on 09/19/19 at 11:32 a.m., in the clean supply warehouse at hospital #2.


In an interview of Staff #S77 and Staff #S230 on 09/19/19 at 11:50 a.m., in the clean supply warehouse at hospital #2, both confirmed that neither temperature or humidity were being monitored in the warehouse at the time of the survey.


During an inspection of the Pyxis cabinet for the storage of medications in the sterile corridor of the operating suite at hospital #2 on 09/23/19 at 11:28 a.m., in the presence of Staff #S205, observation revealed dried drippage on the inside and outside of the clear plexi-glass door of the bottom shelf and areas of black debris to the lower shelf that could be removed from both areas by wiping them with an Oxivir wipe.

In an interview on 09/23/19 at 11:28 a.m., in front of the Pyxis cabinet in the sterile corridor of the operating suite at hospital #2, Staff #S205 confirmed the above findings.


The hospital policy no. 550.00 entitled, "Automated Dispensing Cabinets," with an effective date of "4/08," and a last review date of "08/27/2019," was reviewed on 09/24/19 at 1:58 p.m., in a conference room at hospital #2 and stated the following in part, "POLICY STATEMENT: The Automated Dispensing Cabinets (ADC) shall be used to increase patient safety, expedite medication administration, and ensure proper documentation of medication actions." The policy did not address the cleaning of the Pyxis.


In an interview on 09/24/19 at 1:59 p.m., in a conference room at hospital #2, the Program Manager Accreditation, Regulatory Affairs, confirmed that the policy did not address cleaning of the Pyxis and that hospital does not have a policy on cleaning of the Pyxis.


In an interview on 09/24/19 at 9:33 a.m. ,in an administrative office at hospital #2, Staff #S498 confirmed that the hospital has nothing in a policy that addresses cleaning of the Pyxis machine for medication but stated, "Techs are encouraged on a daily basis to clean the Pyxis when they are delivering meds," "It's an expectation," and "Staff do monthly audits to check for expired meds. That is an opportunity to clean the Pyxis."

Based on review, observation, and interviews the facility failed to ensure the following:

A. Hospital #2 failed to ensure patient equipment (IV poles and IV pumps) was properly labeled, transported, inspected, and stored in a safe manner.

B. Hospital #2 failed to identify and label patient equipment used in isolation rooms and contaminated areas. Failed to ensure appropriate cleaning methods were performed to all soiled and contaminated patient equipment.

C. Hospital #2 failed to follow the facility's policy and procedures to prevent the spread of infections and provide a proper decontamination area to cleanse, sanitize, and store patient equipment.

D. The Infection Control Preventionist (ICP) failed to monitor the appropriate use of disinfectant in the decontamination area, warehouse, telemonitor room, shared room, training, and oversight to the Central Supply Technicians and Environmental services for proper cleaning, sanitation, and storage of patient equipment. Hospital #2 failed to provide the technicians with proper personal protective equipment (PPE), adequate ventilation, Material Safety Data Sheet (MSDS) information, eye wash station, and hot water to cleanse the cleaning area and for proper hand hygiene.

E. Hospital #2 failed to ensure that temperature and humidity were monitored in a clean supply warehouse where bags of IV fluids were stored.

F. Hospital #2 failed to ensure that sterile and clean patient medical supplies were stored in a clean and sanitary environment in a temperature and humidity-controlled room in 3 (Supply warehouse, Central Supply, and Physical Therapy Department) of 3 areas observed.

The condition and deficient practices were identified were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.

G. Hospital #2 failed to maintain a sanitary environment in the kitchen.

H. Hospital #1 and #2 failed to maintain a sanitary environment in the physical therapy department. Hospital #2 Failed to properly sanitize the Fluid therapy machine between patients and no cleaning process was implemented. Hospital #1 failed to have documentation of the Hydroculator temperatures and failed to have clean linen available for patient use in the outpatient specialty clinic #4.

I. Hospital #1 failed to provide a clean and sanitary environment for patient areas 5G, 5F, and 3A.

J. Hospital #1 and #2 failed to properly isolate patients with infectious diseases by co-mingling patients in the same patient rooms.

K. Hospital #1 and #2 failed to ensure that tuberculosis skin tests (TST) given to employees as part of the infection control program were recorded with all information necessary to ensure that test results were accurate and/or correct.

L. Hospital #2 failed to keep separate clean items from dirty contaminated items including clean containers from soiled linens, to separate cleans beds from dirty beds, to keep clean patient supplies from touching the floors and/or being exposed to potentially dirty mops, and to ensure there was no blood or body fluids from being on the floor in a patient's room.

M. Hospital #1 failed to ensure a clean and sanitary environment in the occupational therapy room and 5 (4.214, 216,218,220, and 222) out 5 patient bathrooms in the mental health inpatient unit.

N. Hospital #2's Nursing staff failed to demonstrate appropriate hand hygiene and personal protective equipment (PPE) use when providing wound care to Patient # 405, and failed to demonstrate appropriate hand hygiene and proper disinfection of patient equipment when administering medication to Patient # 403.

O. Hospital #1 staff failed to perform hand hygiene before performing a interventional radiology procedure.

P. Hospital #1 failed to implement infection control practices of cleaning and disinfecting contaminated equipments. Failed to clean and disinfect Hansen connectors, wands, and all surfaces of contaminated hemodialysis machine in 2 of 2 hemodialysis machines observed terminally cleaned. Failed to wash/sanitize contaminated hands during central venous catheter care in 2 of 3 patients observed during termination of hemodialysis treatment. Patient #S16 and 15.

Q. Hospital #2's warehouse failed to ensure dialysis solutions were stored in a clean and temperature-controlled area.

R. Hospital #1 failed to ensure that manufacturer's directions regarding probe covers (sterile sheaths) were followed for use of endocavity transducers in the obstetrics clinic. Also, the facility failed to store the transvaginal probes per the manufacture guidelines.

Refer to Tag A0749

Based on review, observation, and interviews the facility failed to ensure the following:

A. Hospital #2 failed to ensure patient equipment (IV poles and IV pumps) were properly labeled, transported, inspected, and stored in a safe manner.

B. Hospital #2 failed to identify and label patient equipment used in isolation rooms and contaminated areas. Failed to ensure appropriate cleaning methods and proper disinfectants were performed to all soiled and contaminated patient equipment.

C. Hospital #2 failed to follow the facility's policy and procedures to prevent the spread of infections and provide a proper decontamination area to cleanse, sanitize, and store patient equipment.

D. The Infection Control Preventionist (ICP) failed to monitor the appropriate use of disinfectant in the decontamination area, warehouse, telemonitor room, shared room, training, and oversight of the Central Supply Technicians and Environmental services for proper cleaning, sanitation, and storage of patient equipment. Hospital #2 failed to provide the technicians with proper personal protective equipment (PPE), adequate ventilation, Material Safety Data Sheet (MSDS) information, eye wash station, and hot water to cleanse the cleaning area and for proper hand hygiene.

E. Hospital #2 failed to provide a sanitary environment because temperature and humidity were not monitored in a clean supply warehouse where bags of IV fluids were stored next to a partially filled bottle of drinking water, a Foley catheter was draped over a dirty corrugated box, a bucket held dirty rags and orange peels, and used exam gloves had not been disposed of properly.

F. Hospital #2 failed to provide a clean and sanitary environment to mitigate the risks of possible hospital acquired infections and ensure sterile and clean patient medical supplies were stored in a clean and sanitary environment in a temperature and humidity-controlled room in 3 (Supply warehouse, Central Supply, and Physical Therapy Department) of 3 areas observed.

The condition and deficient practices were identified were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.

G. Hospital #2 failed to maintain a sanitary environment in the kitchen.

H. Hospital #1 and #2 failed to maintain a sanitary environment in the physical therapy department. Hospital #2 failed to properly sanitize the Fluid therapy machine between patients and no cleaning process was implemented. Hospital #1 failed to have documentation of the Hydroculator temperatures and failed to have clean linen available for patient use in the outpatient specialty clinic #4.

I. Hospital #1 failed to provide a clean and sanitary environment for patient areas 5G, 5F, and 3A.

J. Hospital #1 and #2 failed to properly isolate patients with infectious diseases by co-mingling patients in the same patient rooms.

K. Hospital #1 and #2 failed to ensure that tuberculosis skin tests (TST) given to employees as part of the infection control program were recorded with all information necessary to ensure that test results were accurate and/or correct.

L. Hospital #2 failed to keep separate clean items from dirty contaminated items including clean containers from soiled linens, to separate cleans beds from dirty beds, to keep clean patient supplies from touching the floors and/or being exposed to potentially dirty mops, and to ensure there was no blood or body fluids from being on the floor in a patient's room.

M. Hospital #1 failed to ensure a clean and sanitary environment in the occupational therapy room and 5 (4.214, 216,218,220, and 222) out 5 patient bathrooms in the mental health inpatient unit.

N. Hospital #2's Nursing staff failed to demonstrate appropriate hand hygiene and personal protective equipment (PPE) use when providing wound care to Patient # 405; failed to demonstrate appropriate hand hygiene and proper disinfection of patient equipment when administering medication to Patient # 403.

O. Hospital #1 failed to perform hand hygiene before performing a interventional radiology procedure.

P. Hospital #1 failed to implement infection control practices of cleaning and disinfecting contaminated equipment. Failed to clean and disinfect Hansen connectors, wands, and all surfaces of contaminated hemodialysis machine in 2 of 2 hemodialysis machines observed terminally cleaned. Failed to wash/sanitize contaminated hands during central venous catheter care in 2 of 3 patients observed during termination of hemodialysis treatment. Patient #S16 and 15.

Q. Hospital #2's warehouse failed to ensure dialysis solutions were stored in a clean and temperature-controlled area.

R. Hospital #1 failed to ensure that manufacturer's directions regarding probe covers (sterile sheaths) were followed for use of endocavity transducers in the obstetrics clinic. Also, the facility failed to store the transvaginal probes per the manufacture guidelines.


Decontamination Room Hospital #2

A tour of the Decontamination Room was conducted on the morning of 09/19/2019, with Staff #S272. The Decontamination room was approximately 12 ft by 10 ft and had 7 cracked visibly soiled tiles on the floor with an elongated rectangular drain in the middle of the room that was rusted, making it impossible to clean. A dirty crash cart was located in the room with an employee's jacket laying on top of it. A shelf located on the back wall of the room housed a visibly soiled sterile package containing an infant chest tube from 2003.

15 dirty IV poles were present with rust on the base of each pole. Staff #S272 reported, the IV poles had been placed there "sometime last week". One of the IV pumps had a clear plastic bag partially wrapped around it. Staff #S272 reports that IV pumps wrapped in plastic bags are from patient isolation room. However, the technician was unable to identify what type of isolation room or infectious disease the IV pump had come in contact with, making proper sanitation of the equipment impossible.

A dirty crash cart was in the room with a jacket laying on top of it. A shelf located on the back wall of the room housed a visibly soiled sterile package containing an infant chest tube from 2003.

The room contained a place for gloves, but no other Personal Protective Equipment was available for staff use.

The decontamination process was conducted on a stainless-steel surface next to a sink. The sink did not have hot water and had hardwater build up around the faucet. Once the contaminated patient equipment was clean it was placed back on the dirty surface area. The equipment was then wrapped and placed on a dirty linen basket.

Staff #S272 reported that she has never received infection control training that pertains to the disinfection of patient equipment.

Staff #S322 confirms the findings in an interview when she states, "I would use the new decontamination room myself. I had never seen the old room".


Warehouse Hospital #2

A tour was conducted of the facility's warehouse with Staff #S222 and Staff #S227 on 9/17/19 at approximately 12:45 PM. The warehouse had multiple loading and unloading areas. The warehouse was entered from a door that was unlocked. On one wall of the warehouse, there was three garage doors with 2 doors that were currently opened.

The following observations were found:

The concrete floors were heavily soiled with clumps of dirt, dust, paper trash, bird feathers, and insects.

Heavily soiled cardboard boxes and plastic tubs of patient medical supplies were sitting on soiled metal carts ready to be transported to the hospital uncovered. Two of the heavily soiled metal carts had staff food sitting on them.

There was no dirty to clean areas marked out in the warehouse.

Patient sterile and clean medical supplies were found uncovered sitting next to shipping boxes, sitting on the floor on wooden pallets, and heavily soiled metal cart with heavy dust and dirt around the supplies. Sterile and clean medical supplies were also seen lying on the floor of the warehouse. Some of the sterile items observed throughout the Warehouse exposed to environmental contaminants included:
*Paracentesis kit
*Urinary Catheter kit
*Dry Suction Water Seal Chest Drain kit
*1 box of Chloraprep- preoperative skin preparation

Multiple types of opened and exposed patient supplies were sitting on dusty and dirty pallets. Multiple patient IV bags were sitting in an opened soiled storage containers, also sitting on heavily soiled metal carts.

Patient exercise equipment was seen in the warehouse with heavily soiled moving blankets placed on top of the equipment. A dirty patient treadmill with trash, soiled cords, and an orange cone sitting on top of it was sitting in the warehouse uncovered.

50 + unmarked patient beds were being stored in the Warehouse. Staff #S227 was unable to verify if the beds were broken. There were no signs indicating if the beds were clean or dirty.

An interview with Staff #S222 was conducted on the morning of 9/17/19. Staff #S222 reported that the doors to the warehouse could be open for long lengths of time. The warehouse stored laboratory equipment and surgical supplies that were required to be in temperature and humidity-controlled areas. Staff #S222 confirmed, there had been no tracking of temperatures or humidity within the warehouse area. Staff #S222 was asked if he had ever had any infection control training and he replied, "no, I have not."


Telemonitor Room Hospital #2

A tour of Hospital #2's Telemonitor Room was conducted on the morning of 09/26/2019. Along the entrance wall the room housed a table for decontamination of individual telemonitors. Staff #S755 demonstrated the process for sanitizing telemonitors. The table contained a box of dirty monitors that sat next to a "Huck" or waterproof barrier. One type of disinfecting wipes was sitting on the waterproof barrier next to the dirty monitor, exposing the wipes to contaminants. There were no other types of disinfectants available. Clean monitor storage was on the same table next to the waterproof barrier and dirty telemonitors. The staff member was unable to identify what type of isolation room or infectious disease the telemonitor had been exposed to, the use of appropriate disinfectant to sanitize patient's telemonitors was not known.

There was one box of gloves on the table sitting a waterproof barrier. There was no other personal protective equipment available for staff use and the room did not contain a place for staff members to wash their hands. There was a red biohazard trash can on the floor.

The decontamination process was conducted on the waterproof barrier. The stored dirty equipment was sitting next to the cleaning area in a plastic tub. The visibly soiled and contaminated telemonitors were placed on the waterproof barrier and once it was cleaned, the now clean telemonitors was placed back on the same dirty surface area and allowed to dry. The telemonitor sitting on the contaminated waterproof barrier is then placed in storage bins on the same table or in plastic Ziploc bags to be sent to the unit for patient use. The technician was unaware that she had just placed a clean item on the contaminated waterproof barrier. The patient telemonitors were now potentially exposed to infectious organism and contaminated, the telemonitor would be sent to the units for patient use.


The facility-based policy "Centralized Telemetry Monitoring" reviewed on 9/26/2019 stated in part, "C. Telemetry Box Removal: ... 3. The nurse or PCA cleans the telemetry box and cardiac leads and places the telemetry box and cardiac leads in a Ziploc bag and return to the Central Telemetry Monitoring Center. 4. The telemetry-monitoring technician documents the return of the telemetry box and cardiac leads. 5. The telemetry-monitoring technician cleans the telemetry box and cardiac leads with recommended bactericidal solution for future use ..."


Shared-Patient Rooms Hospital #2

A review of clinical records for unit 3A was conducted on the afternoon of 9/17/2019 with Staff #S265 and revealed the following:

*Patient #81 with a wound on the left thigh that had a confirmed diagnosis of penicillin resistant Staph Aureus was placed in a shared room with Patient #82 being treated for an asthma exacerbation.


A tour was conducted with Staff #322 on Unit 4C to observe patients #85 and #86 who were in a shared room on the morning of 9/18/19. There was hair on the shower floor and unidentified wet substance visible on the bathroom ground. The bathroom shower had cracked tiles with missing grout, making it impossible to disinfect and prevent the spread of infectious diseases.

In an interview with Staff #S322, she reported that patients who have a known infectious disease may share a room with other patients as long is the infectious disease is "contained." Staff #S322 further explained by stating, "patients who have a wound that is covered or a urinary infectious disease with a catheter would be considered contained." When asked where the catheter is disposed of she stated, "in the patient's (shared) bathroom." Staff #S322 further reported, there is no policy or procedure instructing unit staff to clean the bathroom between patient use or disposal of bodily fluids containing infectious disease in the shared bathroom exposing patients to possible infectious diseases.


34617

Hospital #2

During a tour of the clean supply warehouse at Hospital #2 on 09/19/19 beginning at 11:10 a.m., accompanied by Staff #S222, Staff #S225, and Staff #S228, observations revealed the following:

1. A #20 fr Foley catheter with a 5 cc balloon in a wrapper with black smudges draped over a dirty corrugated box and the finding was confirmed at the time of the observation by Staff #S225 and Staff #S222.

2. A pair of used exam gloves lying in a wire rack on a stored rolling cart used for patient care.

3. A pair of used exam gloves lying in a box with an item identified as a "CPR cable awaiting repair."

4. A "Let's Do This" orange bucket with multiple dirty blue rags with an orange peel on top of the rags.

5. A partially filled bottle of drinking water lying horizontal next to 1000 cc bags of 5% Dextrose in 0.45% Saline IV fluids - on the bottom of a cart with a cardboard box lying on top of one bag of the IV fluids and a plastic bin lying on top of a 500 cc bag of 0.9% Sodium Chloride IV fluids.

The above findings were confirmed with Staff #S228 in an interview on 09/19/19 at 11:32 a.m. in the clean supply warehouse at Hospital #2.

In an interview of Staff #S77 and Staff #S230 on 09/19/19 at 11:50 a.m., in the clean supply warehouse at hospital #2, both confirmed that neither temperature or humidity were being monitored in the warehouse at the time of the survey.


40989



Hospital #2

1. An observation tour was conducted on 9/19/2019 after 11:00 AM, with Staff #S205, #S227, #S224 in the supply warehouse. This is a large warehouse where most all supplies for Harris Health are delivered. There are two large doors to the left that roll up and down for deliveries. To the right was rows of shelves and pallets covered with shipping boxes and blue shipping bins. Upon inspection of these boxes and bins, the following were found:

A. A sterile Cross-Cut Carb Bur, (a rotary cutting tool used in surgical procedures) was found in an open shipping box.

B. A blue shipping bin with sterile surgical gowns, sterile gloves, and sterile infant catheters that was left open and exposed to unmonitored temperatures and humidity's.

C. Lying on a pallet was a sterile Dry Suction Water Seal Chest Drainage System that was heavily soiled with dirt and dust.

D. Next to the sterile water seal chest drainage system were several half opened boxes of Similac Neosure (a formula used to feed preterm infants) exposed to unmonitored temperatures.

E. A blue shipping bin with two sterile tracheostomy care set trays and a sterile surgical gown. The blue bin was visibly dirt with dust and dirt and open to the temperature of the room.

D. Two sterile Pericardiocentesis Kits we found on top of two blue shipping bins. One sterile kit was found to have a hole in the outer plastic exposing the sterile items to dirt, dust, and debris.

E. Two opened shipping boxes containing approximately 12 bottles of 1 inch sterile packing strip (sterile packing used for wounds) were covered with dust and dirt.

F. The floor near the loading dock was visibly wet due to rain, and delivered boxes were sitting on the wet concrete.


An interview was conducted on 9/19/2019 after 11:00 AM, with Staff #S227. S227 was asked if all the boxes were delivered today. Staff #S227 replied, "No they were not all delivered today. The ones over there on the pallets could have been here several days and just not delivered to the department yet. We will go and stock the departments ourselves mostly, but we do not stock the OR department. We take their stuff up on the service elevator to the 4th floor and they come and unbox it and stock it themselves."


A review of the document titled, "PRE-CLEANNING, STERILIZATION, HIGH AND LOW LEVEL DISINFECTION, AND STORAGE OF PROCESSED PATIENT DEVICES, APPENDIX N STERILE ITEMS, Policy No: 1301 effective Date: 12/16" revealed:

"...A. Sterile items should be stored in manner that will reduce the potential for contamination:

1. Room temperature should be approximately 24 Degrees C (75 degrees F)

2. The room (s) should have at least for (4) air exchanges per hour, and

3. Humidity should be controlled so that it does not exceed seventy percent (70%).


G. Outside shipping containers, (corrugated cardboard cartons) should not be used as containers in sterile storage areas..."

Staff #S227 confirmed the above findings.


2. An observation tour was conducted in the Central Supply on 9/19/2019 after 10:00 am, with Staff #S205, #S227, and #S227. This room was used to store clean patient equipment and supplies to restock the crash-carts (a multi drawer cart that stores patient supplies readily available for use in an emergency) within the hospital. Upon entering the room, there were multiple carts, open shelves storing sterile and non-sterile supplies, closed cabinets storing patient supplies, and clean equipment placed along the wall.


An interview was conducted with Staff #S227 on 9/19/2019 after 10:00 AM. Staff #S227 was asked what all was stored in this room. Staff #S227 stated, "It is supplies to replace crash cart items and take-home supplies for the patients if they need them." Inside the Central Supply room there were multiple carts with dirty biohazard bins (red bins used to discard needles and sharp objects) attached to the sides. Down the left side of the room were several closed cabinets. Inside the closed cabinets were patient supplies with corrugated boxes just lying on top of the supplies.

In the first cabinet, there was a corrugated box stored on top of Aquacel Extra (an antimicrobial used in the treatment of wounds on patients). Inside the cabinet labeled "Cabinet-8" was dirty corrugated shipping boxes next to a sterile instrument set wrapped in plastic. Staff #S227 was asked why the sterile instrument set was sitting on the bottom shelf next to a soiled external shipping box. Staff #S227 replied, "That's an old set of instruments in a large tray that we don't put on the crash carts any more. We should have sent that to sterile processing because now they are wrapped and stored different."

Inside the cabinet labeled "Cabinet-6 were multiple blue bins used to store anti-embolism stockings. The blue bins were heavily soiled with dirt, dust, and debris. Inside Cabinet-7 was multiple boxes of Aquacel Extra stored on a shelf that had missing paint and chipped surface exposing the porous wood underneath. The porous surface cannot be sanitized to mitigate the risk of hospital acquired infections. On top of the Aquacel Extra boxes were 2 corrugated boxes that were covered with dirt and dust.

Along the back wall were 4 IV poles with IV pumps attached. These were being charged through an electrical outlet along the wall. The bottom of the IV poles were rusted, chipped, and missing paint. Rusted surfaces cannot be properly sanitized. A metal shelf was seen storing corrugated and external shipping boxes heavily covered with dust and dirt.

Staff #S227 and #S224 confirmed the above findings.



A review of ANSI/AAMI ST79:2017 revealed the following:

"11.1 Sterile Storage

Sterile items should be stored under environmentally controlled condition that reduces the potential for contamination ...

Supplies should be removed from external and web-edged shipping container before transport to any restricted area ..."


3. A tour of the Physical Therapy Department was conducted on 9/17/2019 after 1:30 PM, with Staff #S205. Upon entering the department, the surveyor saw a patient stretcher parked in the hall way next to the wall. Upon further inspection it was noted that the sign on the door read two doctor's names. The door was open and four patient stretchers were stored. Staff #S205 was asked why the stretchers were stored in this room and if they were cleaned prior to being placed here. Staff #S205 stated, "We don't have any storage place to keep them and we will just come and get one if we need it. No, I do not know if they are clean or not."

There were two additional rooms labeled with doctor's names with patient stretchers. There was a total of 12 stretchers stored in three rooms that were unclean. Staff #S205 was asked why the stretchers were being stored in a room that was not identified as a supply room. As she began to remove the signs she stated, "Because they are behind on making signs for doors. These stretchers are not only for the OR, they are also stretchers used in the emergency room, and labor and delivery. So, they bring them here too." Staff #SS205 was again asked if the stretchers were cleaned before they were brought to this department for storage. Staff #S205 stated, "I do not know if they are clean or not. I cannot say for sure that they are clean."

Staff #S205 confirmed the above findings.


32143



A tour was conducted of the kitchen at Hospital #2, in the morning of 9/16/19, with staff #S73, S74, S76, and S77.

Hospital #2 - Kitchen

The retail refrigerated shelving unit was found to have rusted areas where food is stored and sold.

The main ice machine in the kitchen area was found to have mold and mildew on the inside lid. #S73 reported the ice machine was on a cleaning schedule but confirmed the findings of the mildew, and confirmed it was not cleaned properly.

The dish washing area had missing and broken floor tiles. Food particles were found down in the broken tiles making it difficult to keep clean.

Two of the door jams and threshold in the kitchen were soiled, missing paint, and dirty.

The dishwasher was dirty and caked up with grime in the door facing area.

9 plastic cases with snap lids were found stacked on a metal cart. The cases were full of condiments for patient use. The cases were soiled and sticky on the inside and condiments had spilled on the contents inside.

The ice cream freezer was soiled on the inside with trash and dried food particles. The sides of the freezer had significant ice buildup. The freezer was unable to be wiped down and cleaned properly due to the ice buildup.

Grout was missing between multiple tiles in the kitchen food prep areas. Food particles and debris was found in the missing grout areas. The floor could not be properly cleaned.

5 large packages of ground meet were found on 9/16/19 in the refrigerator section. The meat had a received date of 9/13/19. There was no date on the meat on when it was to expire. The kitchen staff was unable to provide any guidelines or information on how long the meat could be refrigerated before use. The kitchen staff was unable to guarantee safety of the meat. #S77 had the meat discarded.

2 plastic containers were found on a shelf in the cooler. #S73 confirmed they were used to place food in. The lids were removed, and the plastic cooler was soiled on the inside with dirt.

a container holding sugar was found to have a soiled scooper sitting inside the bin. The scooper was soiled with spilled dried reddish orange liquid.

A plastic three-tiered food cart was observed sitting in the kitchen next to the food prep area. The cart had lettuce in a container sitting on the cart. The cart was soiled with trash, dried spilled liquids, and dried food particles.

A six-layer metal cart was found in the cooler with a plastic bag over it. Inside the cart was trays of homemade pizzas. There were multiple stickers on the cart with different dates of when the pizzas were made. One of the stickers said 9/13/19, another stated 9/16/19 and 9/14/19. The spinach on the pizza was dried out and crunchy. The staff could not guarantee when the pizzas were made or when they should expire. The pizzas had to be discarded.

The dish warmer was found sitting next to the serving line. It was full of dishes to use for patient trays. The inside and rim of the dish warmer was soiled with dried food particles and dried liquids.

24 cups were found ready for use stacked on a shelf. The cups were wet and trash was found under the cups.

A large stack of patient food trays was stacked and placed on the line for food. 10 trays were pulled from the stack. All the trays were wet and dripping water. The trays had not been allowed to properly dry before stacking.

3 cooking sheets were found wet, ready for use with heavy carbon build up around the bottom and sides. The sheets are not able to be cleaned properly and the surveyor was able to remove the carbon residue off with a finger.

4 large cooking pans were found stacked wet and ready for use.

12 medium and small metal pans were found stacked wet and ready for use.

Stacking wet dishes, pots, or pans without completely drying first, provides a moist, warm environment which provides good conditions for bacterial growth. This is called wet nesting. The FDA 2017 specifies that all dishes should be air-dried before being stacked and stored. The code states, "Items must be allowed to drain and to air-dry before being stacked or stored. Stacking wet items such as pans prevents them from drying and may allow an environment where microorganisms can begin to grow."

An interview with #S73 was conducted on 9/16/19. #S73 confirmed there was inadequate drying area for the size of the kitchen and the staff were stacking wet dishes when they needed more room.



A tour was conducted of the Physical Therapy (PT) Department at Hospital #2, in the morning of 9/17/19, with the director of therapy services for Hospital #2.


Hospital #2- Physical Therapy

The wall behind a hand washing sink and paper towel holder had been patched but had not painted or sealed. The sheet rock was still porous and unable to be cleaned from splattered water from the sink.

A door leading out to the patio and playground was missing molding. Sheet rock was chipped and missing around the threshold.

A wooden stand up mirror was found to be worn on the legs. The wood was now porous and unable to be cleaned appropriately.

A small freezer used for cold packs was found to have excess ice buildup on the inside. Two blue plastic cups were found in the freezer and were found to be soiled with unidentifiable substance. The freezer was unable to be cleaned properly due to ice buildup.

The paraffin wax machine is used for patients to dip their hands in. The inside bottom of the wax was soiled. There was no Preventative Maintenance (PM) sticker on the outside yet this was an item that must be plugged in and can cause injury to a patient if it is not working properly.

The splint form tray was soiled with mineral build up and rusted areas.

A Fluidotherapy machine was not included in the cleaning schedules for infection prevention. The PT director confirmed the machine was not being cleaned and did not have any information available in how the machine should be cleaned. Fluidotherapy is a medical treatment using a Fluidotherapy unit that creates a dry thermal heated air streaming and flowing through and over finely granulated Cellex particles in a chamber. The patient places their hands and arms down into the unit.


Hospital #2 - Executive Nursing Area

During chart reviews on 9/18/19, room #250 had rain dripping from the ceiling and around the windows. The sheet rock had opened and mold and mildew were found in the ceiling.



A tour was conducted of the Central Supply Room #1, #2, and warehouse on the morning of 9/19/19 at 10:10 AM.

Hospital #2 - Central Supply Room

The central supply room was found to have opened patient medical supplies stored with dirty shipping boxes, dirty crash carts, and soiled hospital equipment.

Opened patient medical supplies were found stored with dirty shipping boxes, dirty crash carts, and soiled hospital equipment.

Soiled crash carts were found with sharps containers attached. The sharps containers had dirty syringes and tubing inside.

Multiple surgical instruments were found in boxes laying open.

Rusted patient IV poles and pumps were found sitting next to clean patient medical supplies.


Hospital #2 - Clean Supply Room #2

A clean patient supply room was found behind the main central supply area. The room had opened medical supplies sitting on metal racks. Dirty Oxygen bottles were sitting in heavily soiled and rusted racks.

A bin of surgical tape was found covered in a gritty rusted particles and dirt. Shipping boxes were mixed in with the open supplies.


Hospital #2 - Warehouse

A warehouse was found with two bay doors open during a heavy rain storm. There was no distinction or areas marked off to determine what areas were considered dirty, clean, and ready to go out to patients. The warehouse serves both Hospitals #1 and #2, and out patients areas.

An interview with #S227 confirmed there was no dirty, to clean, to patient process in the warehouse. #S227 stated, "All of the warehouse is considered clean."

Rain was blowing into the warehouse getting packages soiled with rain water. The concrete floor was wet and patient supplies were sitting on the wet floor.

Blue bins that come from a supplier with patient supplies in them. When they are emptied the boxes go back for more supplies. The boxes were heavily soiled and sitting in soiled areas. There was no information on how these boxes are cleaned.

#S227 reported that he was not sure how the blue bins were cleaned when they left his facility. #S227 stated, "I used to work for them before I came to work here. We used to just wash them out with a water hose, but I don't know what they do now."

The blue boxes had mix matched supplies in them with no indication what was in the boxes. The boxes were stacked all over the warehouse with no clear process to unload and deliver where needed.

Over 50 cardboard shipping boxes were found on the ground opened with patient supplies inside. Some of the boxes were found on the ground or on wooden pallets. The boxes were dusty and dirty along with the supplies inside.

Multiple beds were stored in the warehouse and had plastic over them. The beds were supposed to be clean. The beds were stored in a heavily soiled and dirty warehouse. No cleaning instructions were found or offered.

A refrigerated area was found in the soiled warehouse. Inside was laboratory agents. The inside of the refrigerated unit was heavily soiled with dirt and the door gasket was broken and soiled with mildew.

A box of surgical CloraPreps (a sterile product) was found wet, sitting on a pallet, opened and exposed to elements and dirt.

10 of the blue boxes were found open with multiple supplies in the boxes. Patient IV fluids were found in the boxes along with sterile suture remover sets, bandages and syringes. The bags of D5 IV fluids were found with dust and dirt on them.

7 Foley catheter trays were found unboxed sitting on top of other soiled shipping boxes. The trays were dirty.

A sterile surgical pack was found sitting on a dirty wooden pallet. The covering of the pack was ripped and dirty. Inside the pack was surgical drapes and equipment.

The floors of the warehouse were littered with trash, dirt, hair, and wood chips. The concrete flooring had large cracks and holes making it difficult to properly clean.

A box of 24 liquid contrast bottles, that is consumed by the patient, was found sitting in an opened box and on t

Based on observation, interview, and record review, the facility failed to:

A. ensure the Transesophageal Echocardiogram Endoscope (TEE) and the transvaginal probes were stored in a manner that would protect them from damage or contamination and that was consistent with national guidelines and manufacturers' recommendations such as hanging vertically in a cabinet and storing in a clean environment. Also, that the facility followed their own policy on "Pre-Cleaning, Sterilization, High and Low-level disinfection, and Storage of the processed patient care devices. Further review revealed, the facility failed to monitor the temperature and humidity of the storage room where TEE probes were stored.

It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients having a transesophageal echo, vaginal ultrasound, surgical procedure, and Cardiac Cath Lab procedure in the facility at risk for the likelihood of harm, serious injury, and possibly subsequently death.


B. ensure the temperature in the Operating room (OR) was within acceptable standards to inhibit microbial growth, reduce the risk of infection, promote patient comfort, and assure the physical safety of all patients. The temperature and Humidity was out of range for 33 of 33 days reviewed from August 18, 2019, to September 19, 2019. There was no documentation on the log after a follow up that indicated corrective action had been taken regarding the out of range temperatures. The operating room staff was not knowledgeable of the temperature requirements prior to opening sterile cases in the Operating Room. The was no continuous monitoring of temperature and humidity in the Cath Lab #1, Cath Lab #2, and Cath lab storage room where sterile wrapped pacemaker trays were stored.

It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients having a transesophageal echo, vaginal ultrasound, surgical procedure, and Cardiac Cath Lab procedure in the facility at risk for the likelihood of harm, serious injury, and possibly subsequently death.


C. ensure documentation in the surgical chart that the time out was accurately completed and included all elements of a complete Time Out.


D. ensure a sanitary environment for the provision of surgical services and patient care for 25 (Cath Lab #1, Cath Lab #2, Cath Lab Sterile Storage Room, Bronchoscopy scope processing room, bronchoscopy supply storage room, sterile processing clean preparation area, sterile processing autoclaves, sterile processing instrument storage room, Floor 3 - OR 14, OR 15, OR 6, Anesthesia supply room, Supply core next to charting area, Labor & Delivery (L&D) storage room, Probe storage room (OG-10), GI Lab #3, GI scope processing room, Main OR Floor 4 - OR 7, OR 11, Core area outside OR 3, anesthesia workroom, Core outside anesthesia workroom, sub-sterile room between OR 11&12, Sterile Core area) of 25 areas observed.


E. Based on observation, record review, and interview, the facility failed to ensure that the patient was provided all information necessary to make an informed decision on their care in 8 (Patient #'s 41, 42, 44, 203, 204, 206, 207, and 208) of 8 surgical charts reviewed.


HOSPITAL #2

Based on observation interview and record review, the facility failed to:

A. ensure the temperature in the Operating room (OR) was within acceptable standards to inhibit microbial growth, reduce the risk of infection, promote patient comfort and assure the physical safety of all patients in 10 (OR's #1, #2, #3, #4, #5, #6, #11, #12, #13, and #14) of 11 areas observed. The temperature was out of range for 30 of 30 days reviewed. There was no documentation on the log to indicate corrective action taken or the temperature upon follow up after corrective action was completed. Further review revealed the facility failed to monitor the temperature and humidity of the storage room where the TEE probes were stored.


B. maintain a clean and sanitary environment to ensure patients' health and safety in 9 (Post Anesthesia Care Unit, Cardiology Department, GI Lab, Sterile Core, Sterile Processing Department, Anesthesia Storage Room, Operating Suite 3rd floor, Pre-operative Holding area, and Storage Room 4th floor) of 9 areas observed.


(C) . maintain a clean and sanitary environment to ensure patients' health and safety in in 9 (Post Anesthesia Care Unit, Cardiology Department, GI Lab, Sterile Core, Sterile Processing Department, Anesthesia Storage Room, Operating Suite 3rd floor, Pre-operative Holding area, and Storage Room 4th floor) of 9 areas observed.


Hospital #2 failed to ensure a sanitary environment in that an ice machine was sitting on a cracked countertop such that the countertop could not be properly cleaned, instruments were found in peel pouches with tears, unwrapped oral airways were available for patient use, disposable scalpels were tucked between the layers of a wrapped crash cart kit, instruments were found in discolored peel pouches, hinged instruments in closed positions were packaged in peel pouches, instruments with unprotected tips were packaged in peel pouches that could breech the integrity such that sterility of the instruments could not be assured, chipped floor tiles were observed in front of steam sterilizers such that the floor could not be properly cleaned, a transesophageal echo probe (TEE) available for patient use was being stored horizontally in a hard plastic transparent transport case in a room where temperature and humidity were not monitored and not stored appropriately in a hanging or vertical position, paper sacks were used to store sterile supplies, paper sacks and staplers were stored next to sterile supplies, a medication Pyxis machine had dried dripping with debris, and re-usable bougies in peel pouches that had no reprocessing information regarding disinfection/sterilization were available for patient use.


Findings:

Hospital 1
B. TEMPERATURE AND HUMIDITY

During a tour on September 18, 2019, after 1:00 p.m., the following observations were made:

In OR #6, there was no temperature and humidity monitor in the room. Staff #382 was asked how the OR personnel monitored temperature and humidity prior to opening sterile cases and during surgical procedures. Staff #S382 stated, "Facilities Engineering department monitors those and will notify the OR if it is out of range." Staff #S382 was asked how the staff would know if Facilities Engineering department did not call. Staff #S382 stated, "We just monitor by feel. If it is too cold or hot or if there is condensation on surfaces, then we know." Staff #S382 was asked to call Facilities Engineering department and get a temperature and humidity for all the OR's on the third floor at that time.

At 2:49 Staff # 386 called and reported the following readings:

OG 7 - 64 degrees and 64.2% humidity
OG 15 - 64.8 degrees and 55% humidity
OG 14 - 63.4 degrees and 59% humidity


The temperature was out of range in all three rooms reported. The humidity was out of range in one room reported. Staff #S124 and #S55 were asked if Facilities Engineering department had notified the OR of the levels that were out of range. Staff #S124 and #S55 confirmed they had not.


A request was made for Facilities Engineering department to come do a recheck on OR 7, as a sterile procedure was being done in that room and the humidity was out of range. At 3:03 p.m., Staff #S385 did a manual recheck of OG 7. The reading was 67.1 and 59%. Staff #S385 was asked why there was an almost 5% difference in the recheck of the humidity. Staff #S385 explained that temperature and humidity was not monitored in each individual room. Staff #S385 stated, "We do average temperature and humidity in the OR. For example, if there are two air handlers in one area that provide air-conditioning to the OR's then we would average the temperature and humidity readings from both.


Staff #S385 was asked if Facilities Engineering department continuously monitors the temperature and humidity for the OR's. Staff #S385 stated, "yes, we do". Staff #385 was asked why Facilities Engineering department had not made any notification to the OR's about the ranges out of range as reported earlier on the phone. Staff #S385 then stated, "Well we usually only call at the 5 a.m. check." Staff #S385 was asked to clarify that if the ranges for temperature and humidity were out of range outside of the 5 a.m. check that there was no notification to the OR. Staff #S385 stated, "Yes, mam, usually that's the case."


Review of the facility temperature and humidity logs for August 18 to September 19, 2019 revealed the following:

FLOOR 3

OG 10
The temperature was documented out of range 11 of 33 days reviewed.

OG 12 (OR 13)
The temperature was documented out of range 3 of 33 days reviewed.

OG 8
The temperature was documented out of range 9 of 33 days reviewed.

OG 14
The temperature was documented out of range 18 of 33 days reviewed.

OG 15
The temperature was documented out of range 8 of 33 days reviewed.

OG 7
The temperature was documented out of range 33 of 33 days reviewed.
The humidity was documented out of range 13 of 33 days reviewed.

OG 6
The temperature was documented out of range 33 of 33 days reviewed.
The humidity was documented out of range 6 of 33 days reviewed.


FLOOR 4

OR 1
The temperature was documented out of range 11 of 33 days reviewed.

OR 2
The temperature was documented out of range 13 of 33 days reviewed.

OR 3
The temperature was documented out of range 31 of 33 days reviewed.
The humidity was documented out of range 31 of 33 days reviewed.

OR 4
The temperature was documented out of range 33 of 33 days reviewed.

OR 5
The temperature was documented out of range 14 of 33 days reviewed.

OR 6
The temperature was documented out of range 12 of 33 days reviewed.

OR 7
The temperature was documented out of range 8 of 33 days reviewed.

OR 8
The temperature was documented out of range 31 of 33 days reviewed.
The humidity was documented out of range 1 of 33 days reviewed.

OR 9
The temperature was documented out of range 12 of 33 days reviewed.

OR 10
The temperature was documented out of range 13 of 33 days reviewed.
The humidity was documented out of range 2 of 33 days reviewed.

OR 11
The temperature was documented out of range 8 of 33 days reviewed.

OR 12
The temperature was documented out of range 14 of 33 days reviewed.


CATH LAB
Review of documents provided by Facilities Engineering department show that temperature and humidity was not being continuously being monitored in Cath Lab 1 and 2. There was no monitoring at all in the sterile storage room that housed sterile pacemaker instruments trays.

Staff #S385 confirmed findings regarding on the temperature and humidity ranges in the operating rooms.


During an interview on September 26, 2019, after 9:00 a.m. with Staff #S385 the following was confirmed:

Staff #S385 confirmed the temperature and humidity was monitored quarterly in Cath Lab 1 and 2 but not continuously. Staff S#385 confirmed there was no monitoring of temperature or humidity in the Cath Lab sterile storage areas that housed sterile pacemaker instrument trays.


Review of the AORN Perioperative Standards and Recommended Practices, revealed,

"Temperature should be maintained between 68 degrees F to 75 degrees Fahrenheit (20 degrees to 23 C) within the operating room suite. General work areas in sterile processing should be maintained between 68 degrees to 73 degrees F.

Relative humidity should be maintained between 20% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas; should be maintained below 60% in sterile storage areas.


Review of the facility document titled, "--- Health System - Hospital 1 Hospital, Facility Engineering, Standard Operating Procedure Manual" with an original date of September 2018 revealed the following:

"Guideline
---- Health System hospital 1 ensures HVAC systems in critical areas are installed and maintained in a manner that results in the appropriate temperature and relative humidity ranges for the clinical areas they serve.

Purpose:
The Engineering Department monitors and control both space temperature and humidity levels in healthcare occupancies within ranges specified TDSHS, CMS, ASHRAE. The building are equipped with controls and instrumentation that automatically adjust the HVAC systems with a goal of maintaining the correct parameters in operating/C-Section rooms, sterile supply locations, and other locations by the hospital ....

The temperature and humidity ranges are as specified in ANSI, ASHRAE standard 170-2013 however, to ensure compliance with national standards and best practices, the acceptable humidity range for ---Health System Hospital 1 facility is expanded to include from 20% to 60% RH for all locations."


Review of the "Table 7.1 Design Parameters ANSI/ASHRAE/ASHE standard 170-2013 provided by the facility revealed the following:

"Operating Room -
Design temperature - 68 degrees to 75 degrees
Design Humidity - 20-60%"


C. TIME OUT

During record reviews at the facility from September 23 to September 26, 2019, the following was revealed:

The documentation in the surgical chart for the time out did not include all elements of a complete Time Out. Chart reviews completed for Patient #'s 42, 43, 44, 203, 204, 205, and 206, show documentation of the patient identity, correct procedure and site, team members present and in agreement of procedure. There was no documentation in the record that all the activity stopped prior to and during the time out.

During an interview with Staff #S695 on September 24, 2019, after 12:00 p.m., Staff #S695 confirmed the documentation was not in the patient medical record.


Review of the facility document titled, "Procedural Safety Guide" revealed the following:

"Timeout
Prior to any invasive action done on patient by the procedure team. All activity stops, music silenced."


Review of the facility policy titled, "Universal Protocol - Appendix C - Time Out Process" with an effective date of 5/31/2007 revealed the following:

"C. During the Time out, other activities are suspended, to the extent possible without compromising patient safety, so that all members of the team are focused on the active confirmation of the correct patient, procedure, site/side, and other critical elements.


D. SANITARY ENVIRONMENT

During a tour on September 16, 2019, after 1:00 p.m. the following observations were made:

CATH LAB #2

There was a build-up of dust, dirt, and debris on the linoleum in the corners of the room. There were seams in the linoleum flooring that had disintegrated exposing cracks that would harbor bacteria. Several areas in the linoleum flooring had tears, cracks and had separated from the wall.

The door and door frame had missing pieces of the frame exposing the wood. There was no way to properly disinfect the frame. The door frame had scrapes and missing paint on the frame. The rubber fatigue mat on the floor was covered in dust, dirt, and debris.

There was rust, dirt, hair, and debris around the base of the Cath lab table. The base of the Cath lab table had missing scrapes and chips of paint. There was rust on the surgical metal table wheel casters. There were scrapes and chips of plaster missing on the walls. There was no way to properly disinfect the walls. There was rust on the frame and wheel casters of the linen hamper.

There was a rolling step stool that had three steps. The steps were covered in a rubber slip mat. The mat was peeling up and covered in dust, dirt, and debris. The edge of the step outside of the rubber mat was covered rust, dirt, and debris.

The Cath Lab table was made with disposable sheets. There was no way to determine if the sheets were clean or dirty. Surveyor lifted the sheets to look under and the mattress had spots of a shiny substance that appeared to be contrast medium. There was a yellow and black spill containment platform. The inside base of the platform was covered in black build up and dust.

The supply bins that stored sterile patient supplies were coated in dust, dirt, and debris. There was a vinyl covered lead radiation flap hanging from the Cath Lab table that a tear in the vinyl.

There was a sterile patient supply (Mynx vascular closure device) stored in the cabinet that had been opened. The supply was in the cabinet ready for patient use. There was a package of electrodes stored in the cabinet in an open package. Review of the manufacturer precautions on the packaged revealed, "Pre-cautions, do not open package until immediately prior to use."

There were three expired Impulse FL4 Angio catheters used in coronary angiograms that expired 6-19, over 3 months ago.

The cabinet door had a metal handle that was loose and had been taped to the door to secure the handle. The cabinet stored a mixture of sterile supplies (needles, IV tubing, Micro-puncture kits, radial art lines, suction catheters, sutures) stored with non-sterile supplies (Suction canisters, emesis bags, and oxygen tubing).

There was a cabinet that had sterile Angio catheters used in coronary angiograms. The catheters were stored in a manner that allowed the bottom of the catheters to touch the base of the cabinet and hang out of the cabinet when the door was open. The base of the cabinet was coated in dust, dirt, and debris. There was a bin containing sterile IV tubing. There was a bin on top that had fallen into the bin of sterile IV tubing and was sitting on top of the sterile supplies.

There was a drawer that contained a syringe out of the manufacturer package and was laying in the drawer. The drawer contained lab supplies (blood collection tubes and vacutainers) and was stored with boxes of batteries.

There was a Hemochron machine that tested ACT (Activated Clotting Time). The lab test is used to monitor high doses of unfractionated (standard) therapy which slows the ability of the blood to clot. Sitting next to the Hemochron machine on the cabinet was a plastic quality check probe. The probe was used daily to check the accuracy of the Hemochron machine. The probe was broken and taped together on the back. Underneath the tape there was a build-up of dirt and debris.


During a patient tracer on September 17, 2019, after 11:00 a.m. the following observations were made:

Staff #S391 was observed completing a prep. Staff #S391 used a Chloraprep to prep the chest area for a pacemaker procedure. Staff #S391 went back and forth from the surgical site to the periphery several times while prepping.

Review of the manufacturer IFU for Chloraprep revealed the following:

"Once the solution is visible on the skin, completely wet the treatment area with the antiseptic using gentle back and forth strokes. Progress from incision site to the periphery of the surgical field ..."

After the patient had been prepped and draped, Staff#S102 raised the drape and went under the drape to check the IV site on the opposite side of the bed. Staff #S102 caused the drape to tent, and the hemostats and suction tubing already attached to the drape where flapping risking contamination to the field.

Observed IV tubing on the floor. Staff #102 stepped on the IV tubing and then proceeded to wipe it off with a Sani-wipe.


CATH LAB SUPPLY ROOM

There was a storage rack with boxes of corrugated boxes that had sterile Micro-puncture kits stored in them. The boxes were sitting next to sterile Swan-Ganz kits (a sterile catheter used to monitor the heart's function and blood flow). There were unsterile supplies (patient urinal) stored next to the Swan-Ganz kits. The shelves on the storage racks were coated in tape residue.

There was a bin observed on a shelf that had sterile instruments in it. The bin had sterile peel packs (surgical sterilization pouches) in the bottom of the bin. There were sterilized wrapped items sitting on stop of the peel packs. The peel packs that were stored were crushed, bent and wrinkled. There was no way to ensure the sterility of the item. The bin contained multiple peel packs that had water stains on the package. There was a "Vis-U-All Self Seal Cath Lab Connector" in a sterile peel pack that had water stains and was sterilized in 1998, over 20 years ago. There was a "Interrogator Pacemaker cable" stored in a sterile peel pack that was crushed, wrinkled and had water stains on it. The pacemaker was sterilized in 2011, over 8 years ago. There was a sterile Medtronic pacemaker cable that expired 6-26-2011, over 8 years ago. The base of the bin was coated in dust, dirt, and debris. The base of the bin also had a dead bug in it.

The bins on the shelves containing sterile and non-sterile supplies were coated in dust, dirt, and debris. There was corrugated cardboard boxes that had sterile patient supplies (Micro-Introducer Kits) stored in them. There was a dolly stored in the room that was coated in rust.


Review of ANSI/AAMI S179:2017 - Comprehensive guide to steam sterilization and sterility assurance in health care Facilities Engineering department revealed the following:

"11 Storage and transportation

11.1 Sterile storage
11.1.l Storage Facilities (Engineering department)

Sterile items should be stored under environmentally controlled conditions in a manner that reduces the potential for contamination.

Sterile storage areas should be kept clean and dry.

Sterile items should be
1) stored far enough away from the floor, the ceiling, and outside walls to allow for adequate air circulation, ease of cleaning, and compliance with local fire codes;

2) stored at least 8 to 10 inches above the floor, at least 18 inches below the ceiling or the level of the sprinkler heads, and at least 2 inches from outside walls;

3) stored in such a way that wrapped packages are not stored beneath rigid sterilization containers on the same shelf; and

4) positioned so that packaging is not crushed, bent, compressed, or punctured and so that their sterility is not otherwise compromised."


Review of the AORN (Association of perioperative Registered Nurses) 2019 Perioperative Standards and Recommended Practices, Guidelines for Sterilization, revealed the following:

" ...Recommendation IV.c. Supplies and equipment should be removed from external shipping containers and open-edged corrugated cardboard boxes before transfer to the sterile storage area or point of use.

External shipping containers and open-edged cardboard boxes may collect dust, debris, and insects during shipment and may carry contaminants into the surgical suite ..."


Review of ANSI/AAMI ST79:2017 revealed the following:

"11.1 Sterile Storage

Sterile items should be stored under environmentally controlled condition that reduces the potential for contamination ...

Supplies should be removed from external and web-edged shipping container before transport to any restricted area ..."


CATH LAB FAMILY WAITING ROOM

The chairs in the family room had crevices that were full of food crumbs, dirt, dust, and debris. There was food underneath the chairs that appeared to be an old French fry. There was scrapes and chips of paint missing that exposed the plastic on the walls. There was rust on the metal ceiling frames. The window seal had water stains and a circular brown stain that appeared to be from a soda can.

Staff ##310 confirmed the findings on the Cath lab.


STERILE PROCESSING CLEAN PREPARATION AREA

During a tour on September 17, 2019, after 1:00 p.m. the following observations were made:

Staff #S392 was observed putting an instrument set from the oral clinic together. Observed rust on instruments (stringer 1 & 2 tooth extractors). The set was ready for packaging and sterilization and Staff #S392 did not recognize the rust on the instruments.

There were several metal carts in the preparation room. Staff #S58 stated that some of the carts were made available for outside vendor reps to stock and store instruments and implants for the sets that were stored at the facility. Also, some of the carts contained surgical supplies and instruments. The carts observed were as follows:

RED CART
The red cart contained unsterilized Synthes implants used to restock the surgical trays. The cart had a rubber top covered in dust and debris. There was a drill bit in the crevice on the top of the cart.

BLUE CART #1
The cart contained glass medicine cups, stringer instrument holder, dust covers, and misc. supplies. The top of the cart had a plastic covering that was broken, and pieces of the plastic were missing on the corners. There was no way to properly disinfect the covering. Inside the cart, the base of the drawer was covered in rust, dust, dirt, and debris. The metal drawer glides that hold the drawer in place were covered in rust. The base frame of the cart had scrapes of paint missing and was covered in rust. The was no way to properly disinfect the cart.

RED ZIMMER CART
The cart contained eye instruments. There were bins that contained metal surgical pins. The base of the bins was covered in dust and debris. The top of the cart had a plastic covering that was broken and pieces of the plastic were missing on the corners. There was no way to properly disinfect the covering.

BLUE CART #2
The cart contained Biomet, Zimmer, Synthes, and Smith &Nephew instruments and supplies. The base of the cart was covered in rust.

The floor in front of the autoclaves and next to the metal carts storing extra surgical instruments had chips of cement missing. There were several holes in the cement floor that exposed the subfloor.


STERILE PROCESSING INSTRUMENT STORAGE ROOM

There was a metal rack in the storage room that stored Neurological instruments. The bottom shelf had two splash guards pieced together. There were several gaps in areas that would allow contamination and splashing of the instruments when the floor was mopped.

There were several instrument sets (Plastic Tram Extras, GU XLARGE Male Urethral sounds, and Synthes Loaner trauma ortho) that had a faded external chemical indicator on the set. The external chemical indicator was faded and there was no way externally to determine if the items had been exposed to the sterilization process.

There was a Depuy loaner instrument. The peel pack had a total of three peel packs, two on the inside and one external. There was a radial head instrument sterilized inside a double peel pack. The inside peel pack was folded in on several corners. There was a Biomet Screw removal instrument sterilized inside a double peel pack. The inside peel pack was folded in several places. The external package had several stains on the outside of the package that appeared to be water stains.

The sterilization packaging was not done in a manner that would allow sterilization of the contents.


Review of the AORN (Association of perioperative Registered Nurses) 2019 guidelines revealed the following:

"V. Chemical indicators specific to the sterilization method selected should be used with each package.
Chemical indicators are used to verify that one or more of the conditions necessary for sterilization have been achieved within each package. External and internal CIs do not verify sterility of the contents.

V.a A CI should be placed on the outside and inside of every package to be processed unless the internal indicator is readable through the package material. External CIs are used to verify that the package has been exposed to the sterilization process. External indicators are intended to differentiate processed packages from unprocessed packages. Internal CIs are used to verify that the sterilant has reached the contents of the package and that critical variables of the sterilization process have been met. The number of critical process variables that are monitored with an internal indicator is dependent on the specific type of internal indicator that is used.

V.a.1. A class I CI (i.e., process indicator) should be placed externally. Examples of process indicators are indicator tape and indicator labels."


Review of AORN 2019 guidelines for packaging revealed the following:

"VII.d.
Unless otherwise specified in the manufacturer's IFU, when double pouching is used,
the inner pouch should fit within the outer pouch without folding, and
the inner pouch should face in the same direction as the outer pouch (i.e., plastic or Mylar faces plastic or Mylar, and paper or Tyvek faces paper or Tyvek).

Folding the inner pouch may entrap air and inhibit sterilant contact.

The plastic side of the pouch is impervious to sterilant penetration. The paper side of the pouch permits sterilant penetration. Facing the inner pouch in the same direction as the outer pouch results in paper-to-paper contact through which the sterilant can penetrate. If the paper side of the inner pouch is in contact with the plastic side of the outer pouch, penetration of the sterilant through the paper side of the inner pouch is prevented."

Staff #S58 confirmed the above findings in the sterile processing department.


FLOOR 3 - SURGERY

HALLWAY

During a tour on September 18, 2019, after 1:00 p.m. the following observations were made:

There was a cleaning cart in the hallway next to the epidural cart cove. There was a scoop used to pick up debris in the Operating Room (OR). The scoop had not been cleaned and was stored on the cart covered in dirt and debris. On the shelves of the cart there was a corrugated cardboard box that had plastic trash bags in it. On the bottom shelf, there was suction canisters and tubing to restock in the surgical rooms. The base of the shelf was covered in dust and debris. The top of the cart had a cushioned matt covering. The covering had tears in it. There was no way to properly disinfect the covering.

There was a cove next to the charting area that had scrapes and missing chips of paint exposing the plaster. The outside corner had missing plaster on the wall.


OR 15

There was a cooler that contained blood products sitting on the floor. Staff #S383 was asked if the room had been cleaned. Staff #383 stated, "Yes, it has." Staff #S383 was asked how long the blood products had been in the room and what case the products were from. Staff #383 stated she would check. Staff #384 was called to the room. Staff #384 was asked what case the blood products were from. Staff #384 stated "The blood products were from a previous case this morning." Staff #S383 was asked what time the case completed. Staff #383 stated, "11:24 am." The blood was found in a cooler on the OR floor almost two hours after the case completed. Staff #S384 was asked what the protocol was for returning unused blood products to the lab. Staff #S384 stated that blood products should be kept with the patient they were issued for or returned to the lab when the case was completed if they were no longer needed. Staff #S383 confirmed, the blood products were left in the OR room unattended for almost 2 hours and housekeeping had cleaned the room with the cooler of blood sitting on the floor.

The suction canisters in the room had splashes of red substance that appeared to be blood. There was rust on the wheel casters of the linen cart. The linen cart had scrapes and missing chips of paint. There was no way to properly disinfect the cart. The wall tiles had cracks and chips of tile missing. The fluid warmer had rust in the basin. The base of the fluid warmer pole had missing areas of the top protective covering. The IV pole for the Hot Line warmer had rust on the base.

The OR table mattresses where pulled back for observation. The mattress had been placed back on the table and covered in sheets while the underneath of the mattress was wet. The mattress was still wet during observation.

The anesthesia cart had sterile esophageal stethoscopes and urethral catheters stored on the side of the cart in front of the black medication wastage container. There was no way to prevent contamination of the sterile supplies from splashes to the medication wastage container. The anesthesia cart had sterile intubating stylet supplies with a rubber band tightly woven around them. Physical damage to the package, such as holes and tears can be caused by compression of the package.

The main door to the OR had broken and chips of the door missing that exposed the wood. There was no way to properly clean the door with exposed wood.


L&D (LABOR AND DELIVERY) STORAGE ROOM

There were c

HOSPITAL #1

Based on observation, record review, and interview, the facility failed to ensure that the patient was provided all information necessary to make an informed decision on their care in 9 (Patient #'s 41, 42, 44, 203, 204, 205, 206, 207, and 208) of 9 surgical charts reviewed. Also, the facility failed to ensure that an informed telephone consent had two witnesses as required per facility policy for 1 (#205) of 1 surgical patients in 2 of 2 hospitals. Hospital #s 1 and 2

Hospital 1

(A) Based on observation, record review, and interview, the facility failed to ensure that the patient was provided all information necessary to make an informed decision on their care in 4 (Patient #398, #399, #400, and #401) of 4 surgical charts reviewed.

(B) the facility failed to ensure a properly executed informed consent was obtained prior to Patient # 404 undergoing a bronchoscopy under moderate sedation.

(C) hospital #2 failed to ensure a properly executed consent for 4 (Patient #233, #234, #235, and #237) of 6 patients whose medical records were reviewed because the surgeon who performed the surgery was not listed on the operative consent and the hospital failed to follow it's own policy on informed consents.


Findings:

Hospital 1

The facility failed to:

A. ensure that all practitioners who were performing surgery were listed on the informed consent. There was no way to ensure the patient was fully informed what practitioner would be performing their surgery.

B. ensure that the informed consent was dated and timed by the patient and witness. There was no way to ensure that the informed consent was done prior to the start of the procedure.

C. ensure that an informed telephone consent had two witnesses as required per facility policy for surgical patients.


An interview with Staff #S309 on September 25, 2019, after 9:00 a.m. revealed the following:

Staff #S309 stated, "On the informed consent it states the patient requests my physician, and such associates, technical assistants and other health care providers as they deem necessary, to treat my condition." Staff #S309 stated, "The facility does not list all residents and fellows. This above statement covers anyone that performs the surgery. Staff #S309 stated, "The physicians know and acknowledge they are fully responsible for any resident/fellow that works under them." Staff #S309 was asked if the patient was given information prior to the surgery regarding who would be performing their surgery. Staff #S309 stated, "Well that it is the facility's expectation."


Review of the facility policy and procedure titled, "Consent for Medical Treatment and Identification of a Surrogate Decision Maker" with an effective date of 12/2006 revealed the following:

"B. Informed Consent

3.a. The form shall be signed and dated by the patient or the patient's LAR, a competent witness, and the healthcare provider administering the treatment or performing the procedure...

4. The Informed Consent form shall contain the name of the responsible Healthcare provider who is performing the procedure or administering the medical treatment ..."


29191


Hospital #1

C. Telephone Consent

Patient #205 was a 50-year-old male admitted to hospital on 8/22/2019 with history of roux-en-y gastric bypass and depression. Also, has history of encephalopathy, anorexia, and significant weight loss. Patient was scheduled for surgery on 9/18/2019 for open versus laparoscopic gastrotomy tube and possible jejunostomy tube. The patient was evaluated by the primary team and psychiatry that the patient lacks the capacity to decline Peg placement. The family was involved in the decision making.

Review of the facility document titled, "Disclosure and Consent, Medical and Surgical Procedures" revealed the consent was a telephone consent given by the mother of the patient. The consent signature was only witnessed by one staff registered nurse. There was only one witness and the signature of the witness had no time or date on the consent.

The surgical procedure was performed on 9/23/2019.


A review of the facility's policy titled, "CONSENT FOR MEDICAL TREATMENT AND IDENTIFICATION OF A SURROGATE DECISION-MAKER" revealed the following:

"Purpose: To provide guidelines for obtaining and documenting consent for nonemergency medical care and treatment and surgical and diagnostic procedures, including the identification of a surrogate decision-maker, when appropriate.

H. INFORMED CONSENT: Permission given by a patient or patient's legally authorized representative to perform a medical treatment or surgical procedure after the patient has been advised of the risks or hazards that could influence a reasonable person in deciding whether or not to give permission. In order for the patient to make an informed decision about whether to give his or her permission, the patient needs information about the treatment or procedure, the Practitioner(s) or Healthcare Provider(s) who will actually provide the treatment or perform the procedure, and the risks and hazards associated with it that could influence a reasonable person to make a decision to give or withhold consent."

An interview with Staff #S429 on 9/23/2019 at 2:30 PM confirmed there was only one signature on the telephone consent form. The facility failed to follow its own Disclosure and Consent policy.


40989


Hospital #2

A review of Patient #398's medical record revealed that all practitioners who performed the procedure were not listed on the informed consent. There was no way to ensure the patient was fully informed what practitioner would be performing their surgery. During observation on 9/17/2019 of the procedure, it was noted the provider on the informed consent was not the provider who performed the procedure.


A review of Patient #399's medical record revealed that all practitioners who performed the surgical procedure were not listed on the informed consent. There was no way to ensure the patient was fully informed what practitioner would be performing their surgery. A post procedure note was written by a provider that was not listed on the consent. The primary surgeon listed additional staff assisting in the surgical procedure on the postoperative note.


A review of Patient #400's medical record revealed that all practitioners who performed the surgical procedure were not listed on the informed consent. There was no way to ensure the patient was fully informed what practitioner would be performing their surgery. The postoperative note was written and revealed an additional Resident MD performed much of the surgical procedure but was not listed on the informed consent.


A review of Patient #401's medical record revealed that all practitioners who performed the surgical procedure were not listed on the informed consent. There was no way to ensure the patient was fully informed what practitioner would be performing their surgery. A review of the postoperative note was written by Resident MD that performed/assisted with the surgical procedure. The Resident MD was not listed on the informed consent.


A review of the facility policy and procedure titled, "Consent for Medical Treatment and Identification of a Surrogate Decision Maker" with an effective date of 12/2006 revealed the following:

" ...B. Informed Consent

3.a. The form shall be signed and dated by the patient or the patient's LAR, a competent witness, and the healthcare provider administering the treatment or performing the procedure...

4. The Informed Consent form shall contain the name of the responsible Healthcare provider who is performing the procedure or administering the medical treatment ..."


An interview was conducted with Staff #S202 on 9/17/2019 after 10:00 AM. Staff #S202 was asked if they list the residents on the informed consents. Staff #S202 replied, "Only fellows can do procedures in the GI Lab. We do not list them on the consent, only the attending is on the consent." Staff #S202 was asked if the patient was informed that someone other than the attending would be performing the procedure. Staff #S202 stated, "The attending or the fellow does the consent and I'm sure the patient is aware of that."

Staff #S202 confirmed the above findings.


34617


Hospital #2

During a medical record review for Patient #233, #234, #235, #236, #237, and #238 with Staff #S205 at hospital #2 on 09/26/19 at 10:10 a.m. in an administrative office the findings revealed the following:

The faculty surgeon listed on the operative consent signed by the patient was not the surgeon identified in the operative report who actually performed the surgery for patient #233, #234, #235, and #237.

1. Patient #233 - the resident was listed as the surgeon on the op note.

2. Patient #234 - the resident completed the op note that stated, "I began the procedure on the right side" and "Dr ...was present and scrubbed for the entirety of the procedure" which was the name of the faculty surgeon on the consent.

3. Patient #235 - the resident was listed as the surgeon on the op note.

4. Patient #237 - the teaching physician that noted he performed the procedure with the resident was not the faculty surgeon listed on the operative consent.

The above findings were confirmed with Staff #S205 in an interview on 09/26/19 at the time of the medical record reviews at hospital #2. In addition, Staff #S205 stated, "We can't list multiple surgeons. It has to be a single name and has to be a faculty surgeon. We don't list the residents because they do the consent in the clinic before the surgery date and the resident may change because they rotate. The resident may have moved on to another hospital."

The hospital policy no. 4215 entitled, "Consent for Medical Treatment and Identification of a Surrogate Decision Maker," with an effective date of "12/2006," was reviewed on 09/26/19 at 11:45 p.m. with Staff #S205 in an administrative office at hospital #2 and stated the following in part:

IV. OBTAINING AND DOCUMENTING CONSENT:

B. Informed Consent

3. The patient's medical record shall contain a properly executed Informed Consent form, ...Disclosure and Consent for Medical and Surgical Procedures, ...or Disclosure and Consent for Dental and Surgical Procedures ...prior to conducting any procedure or other type of treatment that requires Informed Consent, except in emergencies ...

4. The Informed Consent form shall contain the name of the responsible Healthcare Provider(s) who is performing the procedure or administering the medical treatment: ...


23032


Hospital 2

Review of facility's policy tilted " Consent for Medical Treatments and Identification of a Surrogate Decision-Maker,"dated 12/2006, showed "... IV. B 3. The patient's medical record shall contain a properly executed Informed Consent...prior to conducting any procedure or other type of treatment that requires informed consent except in emergencies...B.4. the Informed Consent form shall contain the name of the responsible Healthcare provider(s) who is performing the procedure..."


Observation on 09-24-19 at 9:15 A.M., showed Patient # 404 undergoing a bronchoscopy procedure. [*A bronchoscopy is a procedure that allows a doctor to examine the inside of the lungs, including the bronchi, which are the main pathways into the lungs. During a bronchoscopy, a doctor inserts a thin tube containing a light and camera into the lungs through the nose or mouth.]

Staff #S731, the attending MD , was in the room during the procedure, however, Staff #S732, the fellow, actually performed the entire procedure.

Review of the "Disclosure & Consent For Medical & Surgical Procedures", listed the following procedures: bronchoscopy, airway exam, endobronchial biopsy, moderate sedation, aragon plasma coagulation, and bronchioalveolar lavage."

The physician listed as performing the procedure was Staff #S731, the attending physician. The fellow, Staff# S732 who actually performed the bronchoscopy was not listed anywhere on the consent form. This was verified by Staff RN #S748 .

Based on observation and staff interviews, the facility failed to monitor and implement a sanitary environment. Six (6) surgical instruments were observed rusty in plastic pouches available for patient use.

Findings:

During a tour on 9/17/19 at hospital #2 nuclear medicine department accompanied by staff #S90 and #S238, a pair of rusty hemostats in plastic pouch were observed in the emergency cart available for patient use. Staff #S238 agreed with the findings.

During a tour 9/19/19 at 11:40 am at Outpatient clinic # 6 in central supply, five (5) rusty surgical instruments were observed in plastic pouches available for patient use.

The findings were confirmed by staff #S258 during the tour.

Based on record review and interview, the facility failed to ensure that policies and procedures that included pre and post anesthesia evaluation responsibilities were developed and implemented.

This deficient practice had the likelihood to cause harm in all patients receiving anesthesia services at the facility in 2 of 2 hospital anesthesia services reviewed Hospital 1 and 2.


Findings:

Hospital (1)

A request was made on September 16, 2019, after entrance for the anesthesia policy and procedure table of contents. On September 23, 2019, review of the table of contents for anesthesia revealed three policies; Moderate Sedation, Universal protocol, Consent for Treatment and Surrogate Decision Maker. There was no policy specific to anesthesia that included pre and post anesthesia evaluation listed.

An interview with Staff #S309 on September 25, 2019, after 9:00 a.m. confirmed that the facility did not have any anesthesia policies and procedures.


Review of the facility document titled, "-- Health System Medical Staff Rules & Regulations" revealed the following:

"H. Anesthesia
A Pre-anesthesia and post-anesthesia note must be documented for each patient anesthesia."

There were no criteria included on who could perform the evaluations, what information should be included in the evaluations, and when if any time frames on when the evaluations should be performed.


40989

Hospital #2

An interview was conducted with Staff #S671 on 9/23/2019 after 10:00 AM. Staff #S671 was asked to provide the anesthesia policies and procedures regarding pre and post-op evaluations by anesthesia. Staff #S671 said there are no specific anesthesia policies they will be addressed in the --- Health System Medical Staff Rules & Regulations.


A review of the document titled, "STATEMENT ON ANESTHESIA SERVICES AT Hospital 2 " was as follows:

" ...The anesthesia service at Hospital 2 will follow the American Society of Anesthesiology guidelines, the ---- Health Bylaws and Rules and Regulations, the Harris Health credentialing requirements for the administration of anesthesia, and the CMS Conditions of Participation ..."

No documentation was perceived or provided by Staff #S671 regarding the Governing Body's approval of the anesthesia services statement or approval of the guidelines to ensure patient safety.


Review of the facility document titled, "---Health System Medical Staff Rules & Regulations" revealed the following:
" ...H. Anesthesia
A Pre-anesthesia and post-anesthesia note must be documented for each patient anesthesia."

There was no criteria including who could perform the evaluations, what information should be included in the evaluations, and when if any time frames on when the evaluations should be performed.
Staff #S671 confirmed the above findings.

Based on observations, interviews, and record review, the outpatient services provided by the facility failed to meet the needs of the patients in accordance with acceptable standards of practice regarding the sterilization of instruments ( citing outpatient clincis 7, 8, and 9).

Findings:

Facility policy No. 1303 entitled "PRE-CLEANING, STERILIZATION, HIGH AND LOW LEVEL DISINFECTION, AND STORAGE OF PROCESSED PATIENT CARE DEVICES" stated in part,

"III. CLEANING AND DECONTAMINATION: ...

D. Instruments must be disassembled and with hinges opened and sprayed with enzymatic solution ...

APPENDIX H
TABLE-TOP STEAM STERILIZERS
I. GENERAL CONSIDERATIONS: ...

C. Table-top steam sterilizers must have recording devices to monitor and provide a read out for time, temperature and pressures during the time that a sterilizer is in operation, i.e. sterilizing a load ...

G. Temperature 75°F.

H. Humidity thirty percent (30%)- sixty percent (60%) ...


III. BIOLOGICAL INDICATORS (BI): ...

G. After the sterilizer cycle, incubate the BI test and control vials (Note: the control vial must be from the same lot # as the processed BI). Label the control for the BI with a "C" and date. Read and record the results.

H. Record the results for the BI ...

L. Load documentation: label each item or pack with a "lot control identifier" to be used in the event of a recall, to trace problems such as wet packs to their source and to facilitate proper stock rotation:

1. The "lot control identifier" should include the sterilizer number, the cycle number and the date of sterilization;

2. Records on cycle parameters must be kept for each sterilization cycle;

3. Lot number;

4. Contents of load;

5. Exposure time and temperature if not on a recording chart;

6. Operator signature;

7. Results of BI testing;

8. Results of CI and the BI challenge test pack; ...


APPENDIX I
STERILIZATION PROCESS MONITORING
I. GENERAL REQUIREMENTS: ...

A. Every load should:

1. Be physically-monitored for time, temperature, and pressure. Before items are removed from the sterilizer, check printout to verify that all cycle parameters were met and sign the printout; ...

VI. LOAD DOCUMENTATION:

For each sterilization cycle, the following information should be recorded and maintained: ...

B. Contents of load;

C. Exposure time and temperature if not on a recording chart;

D. Operator signature;

E. Results of BI testing, if applicable;

F. Results of CI and the BI challenge test pack; ...


APPENDIX K
GUIDELINES FOR HIGH-LEVEL DISINFECTION ...

G. Prior to placement of instruments into the disinfectant solution, they must be thoroughly cleaned with a suitable detergent by brushing the surfaces to remove all blood, body fluids, tissue and any other foreign matter. Hinged instruments must be opened to permit thorough removal of all organic material. Lumens in instruments must be thoroughly brushed and irrigated until clean ...


APPENDIX N
STERILE ITEMS

Sterile items should be stored in a manner that will reduce the potential for contamination:

1. Room temperature should be approximately 24°C (75°F);

2. The room(s) should have at least four (4) air exchanges per hour; and

3. Humidity should be controlled so that it does not exceed seventy percent (70%)."


During tours of the outpatient sites, the following observations were made regarding sterilization.

On 09/18/19, Outpatient clinic #6 same day clinic dental sterilization area was toured and the following findings were noted:

* It was observed that 13 instruments with a locking mechanism were with the locking mechanism in a closed and clamped position. The locking mechanism is a series of interlocking teeth on each handle that clamps and holds the instrument handles in place with tension. When instruments are closed, the sterilizing agent cannot penetrate all surfaces to ensure complete sterilization of all surfaces of the instruments.

The above was confirmed in interview with staff member S647, who performs instrument sterilization at this location.


Per the Centers for Disease Control and Prevention (CDC) article, GUIDELINE FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES, 2008, by William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC), found at: http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf, states on page 74 that hinged instruments and instruments that close should be opened during the process of sterilization.


During the tour of outpatient clinic # 6 same day clinic dental sterilization area on 09/18/19, it was noted that the sterilization log did not contain the temperature, time, or duration of the sterilization process. The logs for September 2019 only included the items sterilized, machine used, and the operator identification.

In an interview, staff #S647 stated that they did not have the ability to print out the record of time, temperature, and duration from the autoclave machine. The staff member verbalized the machine maintained a temperature of over 270 degrees Fahrenheit for at least 30 minutes, but there was no documentation to reflect that. Per policy and standard practice, the temperature, time, and duration need to documented when sterilizing instruments.


On 09/24/19, the Outpatient health center #7 sterilization area was toured and the following finding was noted:

* Review of the biological indicator log for 2019 revealed that the test results of the control vial were not documented consistently. The following dates did not have results of the control vial documented: from 04/07/19 through 05/08/19, and 08/08/19 through 08/29/19.

In an interview, staff member #S651 confirmed that the control vial results of the biological indicators were not consistently documented. Staff member #S651 performs instrument sterilization at this location.


On 09/25/19, the outpatient Home Health Center #9 dental sterilization area was toured and the following finding was noted:

* According to the temperature and humidity log, the humidity in the room had been out of range throughout September. The acceptable range according to the form was 30%-60%. The range was too high on the following dates: 9/4 - 63%, 9/6 - 62%, 9/9 - 63%, 9/10 - 62%, 9/11- 63%, 9/12- 65%, 9/13 - 61%, 9/17 - 62%, 9/18 - 62%, and 9/24 - 61%.


In an interview, staff member #S662, who performs instrument sterilization at this location, stated that the out of range humidity readings had not been reported to maintenance or adjusted. According to facility policy, the humidity in the sterilization area is not to exceed 70%, however, the form used at his location indicated the humidity should be maintained under 60%. Staff member S661 verified that the humidity over 60% should have reported to maintenance and a work order entered to adjust the humidity in the room.


Based on the above findings, the facility failed to ensure that sterilization of instruments at various outpatient locations was consistent with acceptable standards of practice and facility policy as evidence by failing to appropriately log the temperature, time, and exposure duration of instruments in the sterilizer, failing to document the required test control vial results for biological indicators, and failing to maintain appropriate humidity in the sterilization area. The above findings were confirmed on 09/26/19 in an interview with staff members #S613 and #S631.

Based on record review and interviews, the facility failed to:

a. ensure adequate numbers of physical therapy (PT) staff available to ensure timely evaluations, safe, and efficient treatment, in 3 (432, 433, and 435) of 4 (432 - 435) patient charts reviewed.

b. ensure the rehabilitation services be integrated into the hospital-wide Quality Assessment Performance Improvement (QAPI) program.

c. ensure policy and procedures were properly updated and reviewed.

Findings:

Hospital #2

Patient #432

Review of Patient #432's chart revealed, she was a 3-month-old female. Patient #432 was born on 6/12/19 and a patient at the NICU ( neonatal intensive care unit). Review of the physician's orders revealed a physical therapy evaluation was ordered on 6/13/19 at 8:22 am.

Review of Staff #S734 note dated 6/14/19 at 7:55 AM stated, "PT consult received and reviewed. Chart reviewed. Pt currently intubated. Will await improved respiratory status (at least on CPAP) prior to performing PT evaluation. Will continue to monitor weekly. Please call with any questions. Thank you." The Physical Therapist did not write a note that the physician was contacted nor was an order written to discontinue the order until the patient was a candidate for therapy. The therapist continued to re-evaluate the patient on the following dates:

6/14/19
6/17/19
6/24/19
7/15/19
7/22/19
8/5/19
9/3/19

On 9/4/19, the therapist performed the initial evaluation. There was no documentation that the physician was aware of the 3-month delay in the physician orders and delay of physical therapy. The PT evaluation was for 3 to 5x per week for therapy sessions. Review of the chart revealed the following: Week of 9/4/19 only one visit performed. A scheduled visit on 9/5/19 was missed.

Week of 9/9/19: Patient received a visit on 9/9/19 and 9/10/19. A visit on 9/11/19 was missed. No further visits were scheduled.

An interview with Physician #S735 was conducted on 9/18/19 in the afternoon. Physician #735 stated that she was aware that patients had not received their initial PT evaluations but had not documented it. Physician #735 reported that it was just a verbal understanding and confirmed it needs to be documented.

An interview was conducted with Staff #S734 on 9/18/19 concerning the missed visits from 6/14/19 to 9/3/19, for Patient #432. Staff #S734 stated that she attended the interdisciplinary meetings in the NICU but confirmed she never documented that the physician was aware. Staff #S734 stated, when the babies were being seen by another discipline or had family she would not have time to go back to make up those visits. Staff #S734 confirmed, there was not enough staff to see all the patients each day.


Patient # 433

Review of Patient #433's chart revealed she was born on 8/11/19. An order was placed for a PT evaluation on 8/12/19. A note from PT stated the patient had an umbilical line in place and was not a candidate for PT. There was no note that the physician was notified or an order to discontinue. An order was found to discontinue PT on 8/16/19. Another physician order was found on 8/20/19 to perform a PT evaluation. The PT evaluation stated the patient was to be seen 1-3 x per week. The patient had missed visits on the following dates:

8/22/19
8/29/19
8/29/19
9/4/19.


Patient #435

Review of Patient #435's chart revealed the patient had a physician's order for Occupational Therapy (OT) evaluation. The patient's initial evaluation was performed on 8/29/19 with a frequency of 3-5 x per week for 2 weeks. The visits were as followed:

Initial was performed on 8/29/19.

Week 9/2/19 had missed visits on 9/3/19 and 9/5/19. The patient had a change in condition on 9/6/19 and was moved to ICU. The patient had no visits from OT and no order was found to discontinue treatment. There was no re-evaluation done on the patient for a change in condition. Patient #435 was seen and treated by the OT on 9/12/19 and 9/13/19 but still short a visit for the week of 9/9/18.


Review of the assignment board for 9/17/19 revealed there was 96 patients on the board for the day and only 5 PT's to do regular visits, initial evaluations, re-assessments, and discharges.


An interview with Staff #S733 was conducted on 9/17/19 concerning the staffing issues in the therapy department of Hospital #2. Staff #S733 reported that they have had two issues one being inappropriate PT evaluations and staff shortage. Staff #S733 stated that he had hired a PT this week, but she was in orientation. Staff #S733 reported that he has openings he was trying to fill. Staff #S733 stated that he had recently gone to the UR committee meeting to meet with physicians concerning the inappropriate evaluation orders. Staff #S733 stated, he had not taken the issues to Quality Assessment Performance Improvement (QAPI) yet because they were working on the problem on the departmental level. Staff #S733 confirmed that they had been working on the problems for two years. Staff #733 stated that he reported data to QAPI but did not have an active Performance Improvement (PI) process.


Review of the policy and procedures for therapy services for Hospital #2 revealed they had not been updated. Staff #S733 reported that he had been in the director position for three years but had not updated all of the policy and procedures.