HospitalInspections.org

Based on document review and interview, the governing body failed to:
A. protect patient rights.
Licensed and unlicensed staff were providing intubation to patients outside of their scope of practice, resulting in the death of 1 (#27) of 3 patients reviewed.
A patient signed consent for a procedure while receiving a medication that produced amnesia (loss of memory).
A patient was left unattended while receiving a Hemodialysis treatment.
Patients were placed in restraints without completed physicians orders, without assessment and monitoring while in restraints, without attempts of nursing intervention, and for staff convenience.
Refer to tags A0131, 0144, 0165, 0166, 0167, and 0168

B. ensure an ongoing and effective hospitalwide QAPI program.
Maintain, measure, analyze, and track quality indicators.
Collect data to identify opportunities for improvement.
Have an ongoing and effective patient safety program.
Have ongoing performance improvement projects, performance improvement was generated.
All departments of the hospital participated,.
Ensure adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital performance and reducing risk to patients.
Refer to tags A 0273, 0283, 0286, 0297, 0308, 0309 and 0315

C. 1. have a Director of Nurses (DON) to ensure appropriate operation of the nursing service.

2. ensure adequate staffing was available on 9 of 46 shifts reviewed.

3. ensure that the nursing staff developed, and kept current, a nursing care plan for 3(#12, 3, and 24) out of 3 (#12, 3, and 24) charts reviewed.

4. ensure nursing provided safe administration of blood by failing to:
a) accurately document the administration of blood,
b) consistently monitor and record vital signs (V/S) during the blood infusion process,
c) monitor and record vital signs one hour after the completion of blood infusion and
d) document which patient received 1 unit of blood that was documented as delivered to the nurses station, and 5) the facility failed to follow its established policies and procedures for blood administration.

5. supervise Paramedic staff #38, who performed an assessment on a patient and delayed reporting the change in the patient's health status to the patient's nurse. The patient was left without monitoring while the paramedic talked on the cell phone.
Refer to tags A0386, 0392, 0395, 0396, 0398 and 0409

D. have a current UR plan in effect.
Refer to tag A0652

E. provide evidence of an effective ongoing Infection Control program. Endoscopes and Bronchoscopes were used without proper disinfection.
Refer to tag A0756

F. implement all policies and protocols that address its organ procurement responsibilities.
Refer to A0885, A0886, A0888, A0889 and A0891

Based on observation, record review and interview, the facility failed to:


A. 1. provide continuous oversite of patient care during a Hemodialysis treatment.

2. ensure Hemodialysis patients who are susceptible to hepatitis B were offered Hepatitis B vaccine. Citing 5 of 5 hemodialysis patient records reviewed. (Patient's #1, 2, 3, 4 and 5).

3. supervise paramedics and respiratory personnel that were intubating patients.

4. provide RN supervision to paramedic and allowed staff #38 performed an assessment on a patient and delayed reporting the change in the patient's health status to the patient's nurse. The patient was left without monitoring while the paramedic talked on the cell phone.

5. properly assess patients and document the result of assessment, failed to document medication administration and effectiveness, and failed to clarify a new psychoactive medication ordered in 1(#3) of 3(#3,10, and 24) charts reviewed.

Refer to A0144


B. follow its own policy and procedures. The physician orders failed to specify the reason for restraint, the type of restraint, and the duration of restraint. The nursing documentation failed describe the behavior of patients to justify restraint application or usage. The medical record had minimal or no documentation of an individual patient assessment or revision of the plan of care in 3(#12, 24, and 25) of 3(#12, 24, and 25) identified patient charts that died in restraints or within 24 hours of restraint usage.

Refer to A0164


C. follow its own policy and procedures. The physician orders failed to specify the reason for restraint, the type of restraint, and the duration of restraint. The nursing documentation failed to document the behavior of patients to justify the restraint application or usage. Nursing failed to document less restrictive measures were tried or considered. The medical record had minimal or no documentation of an individual patient assessment or revision of the plan of care in 3(#12, 24, and 25) of 3(#12, 24, and 25) identified patient charts that died in restraints or within 24 hours of restraint usage. Failure to assess a patient in restraints can lead to potential injury or death.
Refer to A0165


D. follow its own policy and procedures. The medical record had minimal or no documentation of an individual patient assessment or revision of the plan of care in 3(#12, 24, and 25) of 3(#12, 24, and 25) identified patient charts that died in restraints or within 24 hours of restraint usage. Failure to assess a patient in restraints can lead to potential injury or death.
Refer to A0166

E. follow it own policy and procedures. Nursing failed to reassess the patients in restraint, or discontinue a restraint when the patient was no longer in danger of harm in 3(#10, 24, and 25) out of 3(#10, 24, and 25) patients reviewed.

Refer to A0167


F. follow its own policy and procedures. The physician orders failed to specify the reason for restraint, the type of restraint, and the duration of restraint. The nursing documentation failed to document behavior of patients to justify restraint application or usage. The medical record had minimal or no documentation of an individual patient assessment or revision of the plan of care in 3(#12, 24, and 25) of 3(#12, 24, and 25) identified patient charts that died in restraints or within 24 hours of restraint usage.
Refer to A0168




These deficient practices were determined to pose Immediate Jeopardy to patient health and safety and caused actual harm to patient #27 and placed all patients at risk of harm, injury, or subsequent death.

Review of the Quality Assurance Performance Improvement(QAPI) program and Patient Safety Program the facility failed to:

A. maintain, measure, analyze, and track quality indicators.
Refer to A0273

B. collect data to identify opportunities for improvement.
Refer to A0283

C. have a ongoing and effective patient safety program.
Refer to A0286

D. have ongoing performance improvement projects.
Refer to A0297

E. ensure QAPI activities were gathered, performance improvement was generated, and all departments of the hospital participated in the complexity of the facilities organization and services.
Refer to A0308

F. ensure QAPI activities reflected the complexity of the facility organization and services provided.
Refer to A0309


G. ensure adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital performance and reducing risk to patients.

Refer to A0315

Based on document review and interview the facility failed to:

A. The Medical Staff failed to provide supervision to Paramedics and to Respiratory Personnel that were intubating patients in the facility.

A review of the Governing Board Meeting Minutes dated March 10, 2015, revealed that each deficiency cited from the previous survey was discussed and the corrective action to be taken. Items already completed include the revision of the paramedic job description and their competency with intubation skills. Staff #2 added that it is recommended that a Pulmonologist be a sponsoring physician for the paramedics and approve them for intubation skills. This matter will be brought back to the Medical Executive Committee for approval.


An interview with The CEO revealed that the Medical Executive Committee has not had a meeting. The next meeting is scheduled for April 17, 2015. Staff #1 confirmed the Paramedics and Respiratory Techs continued to intubate patients in the facility.


A review of the document titled:
PARAMEDIC/MONITOR TECH. DEPARTMENT: LTACH


B. TECHNICAL COMPETENCIES.

1. Complies with operational standards as applicable to the LTACH Unit.

2. Follows implementation of operational standards as directed by Medical Director, and under supervision of the Nursing Supervisor/CNO, promotes the maintenance of patient rights and safety including, but not limited to:

a. Identifies cardiac rhythms and changes in vital signs as recorded by telemetry monitoring system and reports findings to the RN/Nursing supervisor and primary nurse.

b. Under the supervision of the Medical Director, performs insertion of LMA if unable to establish airway via endotracheal or nasotracheal intubation.

c. Under the supervision of the Medical Director, performs endotracheal or nasotracheal intubation to open airways and ventilate the patient in the event of a cardiac and/or respiratory arrest.

d. Under the supervision of the Nurse Supervisor, assists in obtaining and recording vital signs during an emergency when possible.

f. Under the supervision of the Nurse Supervisor, Assist in any emergencies that are needed but not limited to in-hospital setting ie: ER room, patient entering the facilities with emergencies needing to be stabilized.

g. Monitors patients on telemetry, identifying and documenting dysrhythmias, routine daily am and pm posting of EKG strips.

h. Maintain telemetry log.

i. Under the supervisor of the Nurse Supervisor, may assist in peripheral, external jugular IV insertion and blood draws.

j. Assist with patient care as needed e.g. turning and repositioning.

k. Run 12 lead EKG. Check crash cart, clean and keep track of telemetry boxes.


3. Maintain communication with the Nursing Supervisor, each nurse and other disciplines to promote a positive patient outcome.

a. Notifies nursing staff when leads are off patient or of incorrect lead placement as necessary.

b. Protect privacy of all patient information in accordance with privacy policies and procedures.

c. May access protected health information and other patient information only to the extent it is necessary to complete job duties.

4. Keep tardiness and absenteeism to a minimum and follows Hospital policy relating to attendance.

5. Demonstrates sound knowledge base in paramedic theory and its clinical applications in the LTACH care setting.

6. Demonstrates sound knowledge of paramedic techniques and procedures utilized in the areas of responsibility.

7. Demonstrates knowledge and skills necessary to provide care to patients and families served in relation to growth and development over their life span and identify their requirements relative to their age-specific needs.

a. Assist in adaptation of patient care standards to the needs of the adult and older adult in planning and providing care for patients admitted to the LTACH Unit.

b. Applies knowledge of physiological, psychological, and sociological changes in the older adult in planning and providing care.

8. Demonstrates thorough knowledge of the use of emergency equipment and its operation to provide direct care in a safe manner.


An interview on 3/23/15, with staff #5, respiratory personnel, revealed that she and other respiratory staff along with paramedics were intubating patients in the facility. Staff #5 stated she was practicing within her scope of practice.


A review of the document provided by the facility and titled Respiratory Care Scope of Practice revealed:


2.0 Scope of Practice: The practice of Respiratory Care encompasses activities in: diagnostic evaluation, therapy, and education of the patient, family and public.

2.1 Diagnostic activities include but are not limited to:
(1) obtaining and analyzing physiological specimens;
(2) interpreting physiological data;
(3) performing tests and studies of the cardiopulmonary system.

2.2 Therapy includes but is not limited to application and monitoring of:
(1)medical gases (excluding anesthetic gases)and environmental control systems;
(2) mechanical ventilator support;
(3) artificial airway care;
(4) bronchopulmonary hygiene;
(5) pharmacological agents related to respiratory care procedures:
(6) cardiopulmonary rehabilitation;
(7) hemodynamic cardiovascular support and
(8) coordinating patient discharge through discharge planning and appropriate home care companies.


A review of the employee files who were intubating patients in the facility revealed staff #15, #16, #17, #18 and staff #5 last updated their education for airway management in 2010.

During an interview with MD #20 on 3/24/15, at approximately 3:00PM, revealed that there was no program with Medical oversight that allowed for Paramedics and Respiratory personnel to intubate patients.

B. The Medical Staff failed to supervise respiratory personnel.
A review of patient #25's medical record revealed RT staff #5 wrote a telephone order to consult Harbor Hospice for this patient.
A review of the document provided by the facility and titled Respiratory Care Scope of Practice revealed:

Definition: "Respiratory Care" is defined as the healthcare discipline that specializes in the promotion of optimum cardiopulmonary function and health.

Respiratory Therapists apply scientific principles to prevent, identify, and treat acute or chronic dysfunction of the cardiopulmonary system. Knowledge of the scientific principles underlying cardiopulmonary physiology and pathophysiology, as well as biomedical engineering and technology, enable respiratory therapists to effectively assess, educate, and treat patients.

As a health care profession, Respiratory Care is practiced under medical direction across the health care continuum. Respiratory Care is specifically focused on the assessment, treatment, management, control, diagnostic evaluation, education, and care of patients with deficiencies and abnormalities of the cardiopulmonary system as well as on the prevention of the development of these deficiencies. Critical thinking, patient/environment assessment skills, and evidence-based clinical practice guidelines enable respiratory therapists to develop and implement effective care plans, patient driven protocols, disease-based clinical pathways, and disease management programs. A variety of venues serve as the practice site for this health care profession including, but not limited to: acute care hospitals, diagnostic laboratories, rehabilitation and skilled nursing facilities, patients' homes, patient transport systems, physician offices, convalescent and retirement centers, educational institutions, and wellness centers.

2.0 Scope of Practice: The practice of Respiratory Care encompasses activities in: diagnostic evaluation, therapy, and education of the patient, family and public.

2.1 Diagnostic activities include but are not limited to:
(1) obtaining and analyzing physiological specimens;
(2) interpreting physiological data;
(3) performing tests and studies of the cardiopulmonary system.

2.2 Therapy includes but is not limited to application and monitoring of:
(1)medical gases (excluding anesthetic gases)and environmental control systems;
(2) mechanical ventilator support;
(3) artificial airway care;
(4) bronchopulmonary hygiene;
(5) pharmacological agents related to respiratory care procedures:
(6) cardiopulmonary rehabilitation;
(7) hemodynamic cardiovascular support and
(8) coordinating patient discharge through discharge planning and appropriate home care companies.

The facility provided no evidence of patient driven protocols that would allow respiratory staff to take medical orders.



C. have an effective Medical Staff that met quarterly. The Medical Staff failed to participate in, and direct an Infection Control program and Quality Program.

A review of the document titled Bylaws of the Medical Staff revealed in Article XII, 12.2 d, the Medical Executive Committee meets as often as necessary to accomplish its duties, but no less than quarterly, and maintain a permanent record of its proceedings and actions.

A review of the Medical Executive Committee Minutes revealed the last meeting was 10/07/2014.

An interview with staff #1 confirmed the last meeting of the Medical Executive Committee was 10/07/2014.


These deficient practices were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk of harm, injury, or subsequent death.

Based on record review and interviews the facility failed to:

A. have a Director of Nurses (DON) to ensure appropriate operation of the nursing service and adequate staffing was available.

Refer to A0386


B. have adequate staffing according to the staffing grid in 10 out of 46 shifts scheduled.

Refer to A0392


C. supervise Paramedics. A paramedic performed an assessment on a patient and delayed reporting the change in the patient's health status to the patient's nurse. The patient was left without monitoring while the paramedic talked on the cell phone.
Refer to A0395

This deficient practice was determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk of harm, injury, or subsequent death.


D. ensure that the nursing staff develops, and keeps current, a nursing care plan for 3 (#12, 3, and 24 ) out of 3 (#12, 3, and 24) charts reviewed

Refer to A0396


E. have a Director of Nurses to ensure adequate supervision, evaluation, and clinical activities of non- employee agency nurses.

Refer to A0398


F. provide safe administration of blood by failing to:

1) accurately document the administration of blood ,

2) consistently monitor and record vital signs (V/S) during the blood infusion process,

3) monitor and record vital signs one hour after the completion of blood infusion and

4) document which patient received 1 unit of blood that was documented as delivered to the nurses station, and

5) the facility failed to follow its established policies and procedures for blood administration.

Refer to A0409

These deficient practices were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk of harm, injury, or subsequent death.

Based on interview and document review, the facility failed to provide evidence of medical staff approval of the contracted Radiology service and the contracted Radiologist who oversaw the services. There was no evidence the new service was integrated into the QAPI program.


On 3/25/2015, in the nurses station, staff nurse #34 indicated patient's were transported from the facility when a physician orderd an X-ray or other radiological procedure during normal business hours. He also indicated that he had transported a patient via wheel chair out of the building and across the back parking lot to another building in order to have the radiology test done. Staff #34 was asked if there was a covered hallway from the facility to the other building? He replied "No, he and the patient had gotten wet because it was raining".


On 3/25/2015, in the late morning, the contracted services were reviewed and found no contract for the service that was described. The radiology contract that was identified was for an after hours mobile radiology service.


On 3/25/2015, in the late morning, in the conference room, the Governing body/Medical staff meeting minutes were reviewed and found no mention of a radiology service separate from the after hours mobile radiology service. There was no documentation the new Radiologist overseeing the new service had been credentialed by the medical staff. There were no policies or procedures for the service.


On 3/25/2015, in the morning, an interview with staff #2 confirmed the new radiology service, it's Radiologist and new policies and procedures had not been approved by the Governing Body/Medical Staff because they had not had a meting since the new service began.

Based on reviewed documents and staff interviews, the facility failed to have a current UR plan in effect.

An interview on 3/23/2015, with staff #6, revealed that there had not been a UR meeting since October 2014.

A review of the UR Meeting Minutes dated October 7, 2014, revealed a "UR Plan for 2014-15" was presented to the committee for review. The minutes stated, "No additions or revisions suggested. Forward to Governing Board."

An interview on 3/24/2015, with staff #2 revealed the UR Plan for 2014-15 had not been presented or approved by the Governing Board.

A review of the "Bylaws of the Medical Staff", section 12.4 b 1, stated, "The Utilization Management Committee addresses overutilization, underutilization and inefficient scheduling of resources through a written plan approved by the Medical Staff, Administration and the Board."

Based on observation, interview, and document review:


A. the facility failed to provide a sanitary environment to prevent infection.

On 3/23/2015, at 8:30 a.m., in the conference room, the Administrator staff #1 confirmed no Director of nurses had been hired.


On 3/23/2015, at 8:35 a.m., in the conference room, an interview with the Infection Control nurse revealed she was also the Director of Quality Assessment and Performance Improvement nurse (QAPI), she was also filling in as the RN overseeing the nursing department until a full time Director of Nursing/Chief Nursing Officer (CNO) could be hired. She confirmed that there had not been a QAPI meeting or infection control meeting since since September 2014. She stated "I just haven't been able to get it all done. There isn't time to do all of it". In the absence of a CNO, the Chief Executive officer (Administrator) and Medical Staff failed to maintain the QAPI program and the infection control program. Evidence of this failed process is as follows:


On 3/23/2015, at 9:00 a.m., during a tour of the building that was provided by the administrator the following was observed:


1) The Central Supply stock room, laboratory, mechanical storage room, patient supply storage closet was observed to have supplies for patient use stored in shipping boxes too numerous to count (TNTC) stacked on wire racks and shelves.


2) The "Clean" equipment storage room was observed to contain three (3) bariatric reclining chairs with blue polyvinyl padded chair covers. The fabric of the chair covers were observed with numerous stained rings on the seat, back, and arms of the padded surface. The frame of the chair had tape residue and partial tape sticker on the top steering bars. The fabric foot covering the foot rest on all three chairs was torn making sanitation impossible. Two bed frames were observed with heavy dust and tape residue on them.


3) The clean equipment room was also observed to have nine (9) rolling poles used in patient rooms to support equipment. These poles were observed with rusted castors/bases, tape residue and dust on them. The poles were not covered to insure their sanitation after they had been thoroughly cleaned. The Administrator confirmed these pieces of equipment were cleaned and would be used if needed for patient care. These items were not cleaned completely and were unable to be sanitized in the condition they were stored.


4) The Storage room designated for scopes and respiratory emergency supply boxes revealed the following:

A tall narrow cabinet was observed with two (2) scopes stored in them. The scopes were identified as clean by the Administrator and Respiratory Therapy Director. Both scopes were observed with loops in the flexible tubing. Loops do not allow the fluid trapped in the interior lumen to drain out with gravity. Loops allow fluid to accumulate and harbor bacteria.


5) In front of the scope cabinet was three (3) large rolling utility storage boxes. The boxes were stacked with two on the bottom and one on the top. The box on the top, was identified as "Trach supply". The box was opened to reveal a top tray with a centrally located compartment. This compartment was observed with dried red flaked substance coating most of the compartment. When asked if that was blood the Respiratory Therapy Director replied, "No, it's Betadine. I can't keep the Betadine from leaking". Betadine is a dark brown high level sanitizing agent. A plastic bottle of Betadine was observed in the next compartment positioned on its side without leakage.


6) Disposable blood pressure cuffs were observed attached to rolling Dynamap machines (electronic device used to monitor blood pressure). The disposable blood pressure cuff should be left in the patient room and should be used for only one patient. These were identified in the first connecting hallway prior to the first nurses station.


7) Three (3) of three Dynamap rolling standards were observed soiled with lint, and dark colored dried spilled liquid. All floor surfaces outside the patient care areas were noticeably dusty with dried spills identified on the floors. On 3/24/2015, at 9:00 a.m., in an empty patient room, an interview with the Director of the contracted house keeping services confirmed his contract was to provide sanitation and housekeeping for the patient care area of the facility. He also confirmed that his staff did not clean equipment used by the nurses (blood pressure cuff, Dynamap, refrigerators) to support the care of the patients.


8) In the first nurses station was a small black specimen refrigerator. Found inside the refrigerator was a collection of lint and long hair curled in the front corner and a second collection of lint and long hair was identified in the door.


9) Clean linen storage was observed with white linen stored on top of one covered cart.


10) The medication preparation room across from the nurses station was observed with three large sharps containers. The one on the wall was full and had been closed but not removed from the wall. Two were positioned on the floor. One was full but remained open while the other was open and very near full.

Also observed in the med room was an air conditioning unit (AC). Positioned on the floor beneath the drain line was a patient wash basin to collect water that was dripping out of the AC unit. The basin was half full of water.

Stored on the floor across from the water basin was a refrigerator (frig) used to store patient medications requiring refrigeration. Observed in the top shelf of the small frig was an 8 inches ball of ice that encompassed part of the frame. In the door of the frig was a 2.5 CC (cubic centimeter) bottle of Prednisone Acetate ophthalmic solution. There was no label attached. There was no date opened or use by date found on the eye drops.


11) The following was found in the emergency treatment room.
24 gage (g) intravenous (IV) Bard brand catheter expired 11/2013, x 5
100 CC normal saline (NS) expired 10/2014
Suction catheter opened and left in cart.
18 g IV catheter needle Bard brand expired 12/2013, x 5
Laboratory blood collection tubes,
red tops, 4, expired 6/2013
yellow tops,4, expired 6/2013
Green tops, 4, expired 12/2013
Blue tops,4, expired 3/2013
sterile towel autoclaved 2016 (dark brown packaging)
22 g, 1.5 inch needle expired 2/2013
20 g, 1.5 inch aspiration needle expired 3/2013 x 2
Vicrile suture expired 1/15 x 3
Ethilon suture expired 7/2014 x 3
1000 cc lactated Ringer IV solution, Expired 12/2014. Found in Emergency treatment room crash cart.
500 cc NS IV solution, expired 11/2014. Found in Emergency treatment room rash cart.
Opened #9.0 Endotracheal tube
Foley catheter kit expired 12/2014


12) The following were found on the crash cart stored between the High observation unit and the medical surgical unit.
Vecurium Bromide 20 mg (milligrams) expired 7/2014 (this is a paralytic drug used in intubation and ventilator support)
Lidocain 20 mg/ml (milliliter) 2% expired 11/2014
Atropine Sulfate 1 mg/10 ml expired 10/2014

Staff #9 witnessed the findings and stated "Oh, we used this cart to intubate just yesterday".


13) During the tour, a small storage room was opened to reveal a rubber maid cabinet that contained the two (2) flexible diagnostic scopes. One scope was a bronchoscope and the other was gastroscopy scope. Both scopes were observed stored with the flexible tubing hung with a loop.


At approximately 10:00 a.m., after the completion of the tour, the Director of the Respiratory Department was interviewed. She revealed that she cleaned the scopes. The cleaning process described by the Respiratory Director included submerging the scope in disinfectant. It did not include flushing the internal lumen of the scope with the high level disinfectant liquid. The scope was submerged for 12 minutes in the high level disinfectant bath and flushed with clear water then 70% alcohol to help evaporate the water from the scope and then the scope was stored in the cabinet.


The Respiratory Director accompanied the surveyor back to the above mentioned storage cabinet. Both scopes were observed with a deep loop in the distal tubing. It was brought to her attention the scopes could not be stored with a loop in the tubing because residual solutions would collect in the loop and bacteria could grow in the medium. The residual solution, if left inside the distal tubing could cause damage to the patient during the next procedure.


The Respiratory Director uncoiled the loop. When the tubing was extended vertically, liquid ran out. The liquid ran onto the two towels that had been placed on the floor on the cabinet prior to this observation. Further conversation with the Respiratory Director revealed that her training on high level disinfection of the scopes had been given by the company representative, who sold the scopes. She indicated that she had never been told to flush the high level disinfectant through the internal lumen to disinfect the inside as well as the outside of the tube. A review of the scope use log revealed 87 patient's had one or more scope procedures in the year 2014. These 87 patient were exposed to cross contamination and were placed at risk of harm or death because of errant scope sanitation practices.


The company representative, at the time of training, had supplied the facility and the Respiratory Director with a digital video recording and a written hand book titled "Olympus Operational Manual Instructions"


On 3/25/2015, in the conference room the Olympus operation manual, for the facilities Olympus scopes GIF type Q160, was reviewed and revealed on page 61, under the bold caption

High-Level Disinfection the following instructions were identified:
2. Immerse all equipment in the disinfection solution.
3. While immersed, depress and releases the pistons of the valves and AW channel cleaning adapter.
4. Using a 30 milliliter syringe, flush the interior and recessed parts of them while they are immersed. Ensure the air bubbles are expelled.
5. Using the 30 ml syringe, flush the interior and recessed parts of the cap of the biopsy valve. Ensure that all air bubbles are expelled.
6. Attach the 30 ml syringe to the suction cleaning adapter and flush the tune with disinfectant solution. Ensure that all air bubbles are expelled.
7. Attach the 30 ml syringe to the luer port of the auxiliary water tube and flush the tube with disinfectant solution. Ensure that all air bubbles are expelled (for endoscope with auxiliary water feeding only)
8. Using a sterile, lint free cloth and/or 30 ml syringe, wipe down and/or flush all surfaces with the disinfectant solution to remove all air bubbles.
9. Rub the bristles of the cleaning brush to remove all air bubbles.
10. Soak all equipment for the amount of time and at the temperature recommended by the disinfectant manufacturer.


Rinsing after high-level disinfection:
After high-level disinfection, rinse all equipment according to the procedure below.
Use water of appropriate microbiologic quality. Once removed form disinfectant solution the instrument must be thoroughly rinsed with sterile water to remove any disinfectant residue.
If sterile water is not available, fresh potable tap water or water which has been process (filtered) to improve its microbiological quality may be used with 70% ethyl or isopropyl alcohol rinse


Storage and Disposal item number 5 found on page 67-68. Hang the endoscope in the storage cabinet with the distal end handing freely. Make sure that the insertion tube hangs vertically and as straight as possible.


On 3/24/2015, in the afternoon, interview with the Respiratory Therapy Director was interviewed and revealed the Infection Control nurse suggested she attend training at a major hospital for scope cleaning. The Infection Control nurse was not aware the facilities 2 scopes were manually cleaned and the major facility used an automatic scope washer to provide high level disinfection. This indicated the IC nurse had not questioned nor observed the scope cleaning process.


These deficient practices were determined to pose Immediate Jeopardy to patient's health and safety and placed patients at risk of harm, serious injury, and possibly subsequent death.



B. the Chief Executive Officer and Medical Staff, in the absence of a Director of Nursing, failed to maintain an Infection Control Program and incorporate it into the Quality Assessment Process Improvement program.

Refer to A 0756

Based on reviewed documents and staff interviews, the facility failed to:
A. implement all policies and protocols that address its organ procurement responsibilities.
Refer to A0885

B. implement all policies and protocols that address its organ procurement responsibilities under the OPO Agreement.
Refer to A0886

C. ensure that the family of each potential donor is informed of its options to donate organs, tissues, or eyes, or to decline to donate.
Refer to A0888

D. follow the Federal Regulation and their own policy ensuring that only a trained designated requestor or an organ procurement representative would initiate the request to the family for organ/tissue donation.
Refer to A0889

E. adequately educate appropriate hospital staff on donation policies, procedures and issues.
Refer to A0891

Based on review of the Governing Body(GB) minutes 2014-2015, Quality Assurance and Performance Improvement minutes for 2014, and contracted service agreements the facility failed to:


A. have a ongoing QAPI program that included rehabilitative services since October 2014.


Review of the Quality Assessment and Performance Improvement (QAPI) data and meeting minutes revealed the last meeting was in October 2014. There was no written data offered past October 2014.


An interview staff #2 on 3/23/2015, revealed the QAPI meetings and data had been put aside since the last Director of Nurses left the facility. Staff #2 reported feeling overwhelmed and stated, "I have just not been able to get to everything and I have let some stuff go." Staff #2 confirmed she has had no QAPI meetings or new data to add or provide since October of 2014.


B. have GB approved policy and procedures for physical therapy.

Refer to Tag; A01124

Based on review of the Governing Body(GB) minutes 2014-2015, Quality Assurance and Performance Improvement minutes for 2014, and contracted service agreements, the facility failed to have GB approved policy and procedures for physical therapy. Failure to have policy and procedures in place for patient care can lead to potential injury or even death. The facility also failed to insure the contracted linen provider transported clean and dirty linen in a safe and sanitary method.

Review of the policy and procedures offered by the administration for physical therapy revealed policies with the agency name on them. A contract was found on a service agreement for physical therapy in the facility.

An interview with staff #2 revealed that physical therapy was contracted through an outside agency. Staff #2 stated, "We don't have to have policy and procedures on physical therapy. They have their own."Staff #2 confirmed the facility had not adopted the physical therapy policy and procedures through Medical Staff or the GB. Staff #2 stated, "I didn't know we had to do that."

On 3/24/2015 at approximately 12:30 p.m. the contracted linen service was observed delivering clean linen and picking up soiled linen. The following was observed while still in the parking lot of the facility. A large paneled delivery truck arrived at the ambulance entrance. The back door of the truck was opened to expose both clean and soiled linen was transported in the same truck. Clean carts were identified by their outer cover. Each covered cart held clean linen. The clean linen carts were positioned at the front of the paneled truck and bags of soiled linen (5) were stacked at the back of the truck near the lift mechanism. In order to unload the clean linen carts, they had to be pulled past the dirty linen. One cart had bags of dirty linen propped against the clean cart cover. Three of the bags of soiled linen were open and/or the bag was ruptured. Soiled linen spilled out and the clean carts were exposed to the soiled linen. Two contracted, linen provider employees were observed removing clean linen carts from the delivery truck. Two of the carts were removed from the truck and pulled into the building. Conversation with the driver and delivery person concerning cross contamination of the clean and dirty linen revealed, "We just deliver it, you need to talk to our supervisor". Both carts were delivered to the nursing units as clean linen. Soiled linen was collected from the building and tossed into the truck. Two covered carts of "Clean linen" remained on the truck.

The above was confirmed by staff #2, the infection control nurse, who also witness the event.

Based on document review, the facility failed to get an informed consent prior to performing an invasive procedure on 1(patient #10) of 26 patients reviewed. (Informed consent is permission granted in the knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with full knowledge of the possible risks and benefits). Patient #10 was sedated when asked to sign consent for a procedure.


A review of patient #10's medical record revealed all of the hospital admission consents and procedure consent were signed by his wife. The record established the patient's wife was the person authorized to sign consents for the patient. The record revealed on 2/11/2015 patient #10 was intubated and placed on a ventilator. The patient was receiving Versed 1-2 mg IV every hour for sedation. Versed (Midazolam) is given to produce amnesia (loss of memory) so that the patient will not remember any discomfort or undesirable effects that may occur after a surgery or procedure. Staff #36 had the patient sign a consent for a PICC (peripherally inserted central catheter) line placement while sedated with the medication Versed.

Based on observation, record review and interview, the facility failed to:

A. provide continuous oversite of patient care during a Hemodialysis treatment.

Findings Include:

While touring the facility on 3/23/2015, at 9:30 am, the following was observed.

1. Patient #1 was receiving a Hemodialysis treatment. No staff member was in the room to provide direct care of the patient. The Registered Nurse (RN) providing care of the patient had gone to retrieve supplies down the hall in the supply room.

Review of facility Policy and Procedure 09.205 on 3/23/2015 revealed the following:

1. Subject: Patient Assessment- Pre and Post and Intradialytic

2. Policy: Providing continuous monitoring during the treatment of both patient and equipment will ensure safe and effective outcomes.

3. Responsibility: Registered Nurse

4. Procedure:

Pre-Dialysis

1. Pre dialysis assessment will include the following:
a. Weight, if available.
b. blood pressure, temperature, pulse, and respirations
c. Lung sounds
d. Edema
e. Mental status

2. Check patient's access for signs and symptoms of infection.

3. Assess Pain Level and document on the treatment sheet.

During Dialysis

1. Review /record blood pressure and pulse at least every 1/2 hour

2. Record blood pressure more frequently if patient shows signs of instability.

3. Check integrity of extra corporeal circuit every 1/2 hour and more often if necessary including:

a. Access site (maintain visibility) and BFR
b. Heparin pump (if applicable)
c. Pressure monitors
d. Alarm limits
e. Document all observations on treatment record at actual time done.

4. Monitor and document any/all response to pain management

Post Dialysis

1. Obtain a final blood pressure and pulse, prior to pulling the last needle or disconnecting the access. Hypotensive patients should rest and be given fluids.

2. Take temperature, blood pressure and pulse.

3. Obtain weight, if able, and compare to EDW

4. Record all findings on flow sheet.

5. Assess Pain Level and document on the treatment sheet.

6. Provide report to the floor RN assigned to the patient. Make a copy of the flow sheet for RVM records. Place the original flow sheet in the patient chart.

7. Complete any billing paperwork and submit to the appropriate person/department.


Interview with staff #2 on 3/23/2015 at 9:30 am confirmed the findings.

This deficient practice was determined to be an Immediate Jeopardy and put the patient at risk for harm, injury and subsequent death.



B. ensure Hemodialysis patients who are susceptible to hepatitis B were offered Hepatitis B vaccine. Citing 5 of 5 hemodialysis patient records reviewed. (Patient's #1, 2, 3, 4 and 5).


Findings Include:

Review of facility Hemodialysis Protocol on 3/23/2015 at 1:30 pm revealed the following:

Establish Hepatitis B Virus (HBV) status on admission and before starting hemodialysis on a patient.

All hemodialysis patient must have Hepatitis B surface antigen (HBsAg) obtained within one month before admission or at the time of admission to the facility Or, have known hepatitis B surface antigen antibody (anti-HBs) status of at least 10 milli-international units per milliliter no more that 12 months prior to admission. Place copy on chart.

*Hepatitis B surface antigen status must be obtained no later that 3 days from admission.
On admission and before starting new patient on dialysis, obtain the following labs (if not already done):
Hepatitis B surface antigen (HBsAg)
Hepatitis B surface antibody (HBsAb)
Hepatitis B Core AB (HBcSB or IGM)


Follow these steps below according to the lab values:

*Look at Hepatitis B Core AB (HBcAB or IGM) this lab result differtiates between acute and chronic infection. If positive notify attending MD and Nephrologist. If negative continue following steps according to lab values.

*If Hepatitis B surface antigen (HBsAg) is positive. Notify MD and Dialysis Staff. NO further labs or vaccination required at this time.

*If Hepatitis B surface antigen (HBsAg) is negative and Hepatitis B core AB/IGM is negative. Establish Straus of Hepatitis B Vaccination and Administer according to policy.
New Hemodialysis Patients will need a complete Hepatitis B vaccination series. Obtain consent before vaccination and give Hepatitis B Education sheet before administering the vaccination. The consent form and education must be signed/given with each injection of the series.

*Repeat Hepatitis B surface antigen every month if negative and until Hepatitis B surface antibody (HBsAb) is positive/reactive/10 mlU/ml.

*If Hepatitis B surface antibody (HBsAb) is positive/reactive (Consider Immune). Repeat Hepatitis B surface antibody (HBsAB) every 12 months from date of last Hepatitis B surface antibody (HBsAb).

*If Hepatitis B surface antibody (HBsAB) in one month. Follow steps based on lab results. Administer Hepatitis B Vaccination Education sheet before administering the vaccination. The consent form and education must be signed/given with each injection of the series.


While reviewing patient records on 3/23/2015 at 1:00 pm the following was noted:

1. Medical record for patient #1 revealed Hepatitis B results collected on 2/27/2015 revealed:
Hepatitis B Surface Antigen (HBsAB)- Negative
Hepatitis B Surface Antibody (HbsAB)- Negative

No documentation of Hepatitis B series initiation found, no patient care plan documentation found, and no follow-up Hepatitis B Surface Antigen (HBsAG) monthly labs found.


2. Medical record for patient #2 revealed Hepatitis B results collected on 3/1/2015 revealed:
Hepatitis B Surface Antigen (HBsAG)- Negative
Hepatitis B Surface Antibody (HBsAB)- Negative

No documentation of Hepatitis B series initiation found, no patient care plan documentation found, and no follow-up Hepatitis B Surface Antigen (HBsAG) monthly labs found.


3. Medical record for patient #3 revealed Hepatitis B results collected on 2/27/2015 revealed:
Hepatitis B Surface Antigen ( HbsAG)- Negative
Hepatitis B Surface Antibody (HbsAB)- Negative

No documentation of Hepatitis B series initiation found, no patient care plan documentation found, and no follow-up Hepatitis B Surface Antigen (HBsAG) monthly labs found.


4. Medical record for patient #4 revealed Hepatitis B results collected on 3/1/2015 revealed:
Hepatitis B Surface Antigen ( HbsAG)- Negative
Hepatitis B Surface Antibody (HbsAB)- Negative
No documentation of Hepatitis B series initiation found, no patient care plan documentation found, and no follow-up Hepatitis B Surface Antigen (HBsAG) monthly labs found.


5. Medical Record for patient #5 revealed Hepatitis B results collected on 2/27/2015 revealed:
Hepatitis B Surface Antigen ( HbsAG)- Negative
Hepatitis B Surface Antibody (HbsAB)- Negative

No documentation of Hepatitis B series initiation found, no patient care plan documentation found, and no follow-up Hepatitis B Surface Antigen (HBsAg) monthly labs found.

Interview with staff #9 on 3/23/2015 at 3:00 pm confirmed the findings.





29762


C. supervise paramedics and respiratory personnel that were intubating patients.
A review of the Governing Board Meeting Minutes dated March 10, 2015 revealed each deficiency cited from the previous survey was discussed and the corrective action to be taken. Items already completed include the revision of the paramedic job description and their competency with intubation skills. Staff #2 added that it is recommended that a Pulmonologist be a sponsoring physician for the paramedics and approve them for intubation skills. This matter will be brought back to the Medical Executive Committee for approval.

An interview with The CEO revealed the Medical Executive Committee has not had a meeting. The next meeting is scheduled for April 17, 2015. Staff #1 confirmed the Paramedics and Respiratory Techs continued to intubate patients in the facility.


A review of the document titled:
PARAMEDIC/MONITOR TECH. DEPARTMENT: LTACH

B. TECHNICAL COMPETENCIES.

1. Complies with operational standards as applicable to the LTACH Unit.

2. Follows implementation of operational standards as directed by Medical Director, and under supervision of the Nursing Supervisor/CNO, promotes the maintenance of patient rights and safety including, but not limited to:

a. Identifies cardiac rhythms and changes in vital signs as recorded by telemetry monitoring system and reports findings to the RN/Nursing supervisor and primary nurse.

b. Under the supervision of the Medical Director, performs insertion of LMA if unable to establish airway via endotracheal or nasotracheal intubation.

c. Under the supervision of the Medical Director, performs endotracheal or nasotracheal intubation to open airways and ventilate the patient in the event of a cardiac and/or respiratory arrest.

d. Under the supervision of the Nurse Supervisor, assists in obtaining and recording vital signs during an emergency when possible

f. Under the supervision of the Nurse Supervisor, Assist in any emergencies that are needed but not limited to in-hospital setting ie: ER room, patient entering the facilities with emergencies needing to be stabilized.

g. Monitors patients on telemetry, identifying and documenting dysrhythmias, routine daily am and pm posting of EKG strips.

h. Maintain telemetry log.

i. Under the supervisor of the Nurse Supervisor, may assist in peripheral, external jugular IV insertion and blood draws.

j. Assist with patient care as needed e.g. turning and repositioning.

k. Run 12 lead EKG. Check crash cart, clean and keep track of telemetry boxes.

3. Maintain communication with the Nursing Supervisor, each nurse and other disciplines to promote a positive patient outcome.

a. Notifies nursing staff when leads are off patient or of incorrect lead placement as necessary.

b. Protect privacy of all patient information in accordance with privacy policies and procedures.

c. May access protected health information and other patient information only to the extent it is necessary to complete job duties.

4. Keep tardiness and absenteeism to a minimum and follows Hospital policy relating to attendance.

5. Demonstrates sound knowledge base in paramedic theory and its clinical applications in the LTACH care setting.

6. Demonstrates sound knowledge of paramedic techniques and procedures utilized in the areas of responsibility.

7. Demonstrates knowledge and skills necessary to provide care to patients and families served in relation to growth and development over their life span and identify their requirements relative to their age-specific needs.

a. Assist in adaptation of patient care standards to the needs of the adult and older adult in planning and providing care for patients admitted to the LTACH Unit.

b. Applies knowledge of physiological, psychological, and sociological changes in the older adult in planning and providing care.

8. Demonstrates thorough knowledge of the use of emergency equipment and its operation to provide direct care in a safe manner.


An interview on 3/23/15, with staff #5, respiratory personnel, revealed that she and other respiratory staff along with paramedics was intubating patients in the facility. Staff #5 stated she was practicing within her scope of practice.


A review of the document provided by the facility and titled Respiratory Care Scope of Practice revealed:

2.0 Scope of Practice: The practice of Respiratory Care encompasses activities in: diagnostic evaluation, therapy, and education of the patient, family and public.

2.1 Diagnostic activities include but are not limited to:

(1) obtaining and analyzing physiological specimens;
(2) interpreting physiological data;
(3) performing tests and studies of the cardiopulmonary system.

2.2 Therapy includes but is not limited to application and monitoring of:
(1)medical gases (excluding anesthetic gases)and environmental control systems;
(2) mechanical ventilator support;
(3) artificial airway care;
(4) bronchopulmonary hygiene;
(5) pharmacological agents related to respiratory care procedures:
(6) cardiopulmonary rehabilitation;
(7) hemodynamic cardiovascular support and
(8) coordinating patient discharge through discharge planning and appropriate home care companies.

A review of the employee files that were intubating patients in the facility revealed staff #15, #16, #17, #18 and staff #5 last updated their education for airway management in the year of 2010.

During an interview with MD #20 on 3/24/15, at approximately 3:00PM, revealed there was not a program with Medical oversight that allowed for Paramedics and Respiratory personnel to intubate patients.

D. provide RN supervision to paramedic and allowed staff #38 performed an assessment on a patient and delayed reporting the change in the patient's health status to the patient's nurse. The patient was left without monitoring while the paramedic talked on the cell phone.

A review of a death chart revealed a Paramedic performed an assessment of a patient and delayed notifying a Registered Nurse of the change in patient #27's medical condition. Patient #27 became disconnected from the oxygen delivery device.

A review of a statement from Paramedic staff #38 revealed:

"On the morning of 09/16/14 at 0930 to be more precise 0936 I had come back to my assigned desk at Nurse STN #1 from using my personal cell phone outside. I sat down in front of the Monitors/ Computer where I usually sit and began preparing for MD #40 written orders. After the chart for room 114 was handed to me I began to attempt to Login to HIMS and start placing/registering the orders that were written I had to consult with Terry at Nurse STN #2 to get clarity on some of the orders written. around 09:55 the paramedic noticed the alarm went off on the monitor and the patient's heart rate was 46-48 beats per minute. I then got up and went into the patient's room and assessed patient's peripheral pulses and respiratory rate and quality and noticed patient's T-tube/oxygen had been disconnected from her trach tube. So I immediately reconnected the oxygen and repositioned her in the bed and reassessed. I stepped out of the patient's room to get patient's nurse LVN staff #39.

After I stepped out of Pt's Room, LVN staff #35 had noticed the Pt's Bradycardia on the Monitor as well and cam to Pt's Room 110 from Nurse Station 2 to provide assistance, shortly after Charge Nurse had come in and we were Ventilating Pt with a BVM and treating Pt's Symptomatic Bradycardia. Called Respiratory and they came in to give assistance as well. Pt's condition had declined and Pt would eventually go into Cardiac Arrest (Asystole) @ 1011. Pt had a DNR order that was honored and time of death was pronounced.

After the incident occurred, it was noticed that No Alarm from the Monitor never went off on the Patient in room #110 until Pt had already fallen into decompensated stage. Incident and concerns were reported to Supervisors."


A review of the document titled: PARAMEDIC/MONITOR TECH. DEPARTMENT: LTACH revealed: 2. a. Identifies cardiac rhythms and changes in vital signs as recorded by telemetry monitoring system and reports findings to the RN/Nursing supervisor and primary nurse.


During a tour of the facility, the telemetry alarms and monitors were unattended for 2 minutes while alert alarms were sounding. There was no staff observed at the monitor. The nurses walked by the sounding alarms and did not respond. On a separate tour of the facility, the surveyor observed the paramedic silencing telemetry alarms without checking on the patient.

An interview on 3/25/2015, at approximately 12:30 pm, with staff #2 confirmed the findings.



32143


E. failed to document medication administration and effectiveness, and failed to clarify a new psychoactive medication ordered in 1(#3) of 3(#3,10, and 24) charts reviewed. Failure to assess a patient after seizure activity, clarify medications, and document neurological assessments can cause harm to the patient and possible death.


Review of patient #3's primary nurses notes dated 3/20/2015, at 10:55 AM, stated, " H.D. nurse informed RN of possible seizure. Observed patient twitching of L neck and L shoulder lasted 10 minutes, O2 sat 100%. HD in progress."


Review of the Acute Dialysis Treatment Record dated 3/20/2015, revealed no documentation of the patient having seizure activity or report of seizure activity to the primary nurse. The patient #3 was in dialysis from 10:23 AM - 1:23 PM.


Review of patient #3's primary nurses notes dated 3/20/2015, at 11:00 AM, the physician was notified, 11:05 AM the nurse received new orders. The orders read, "Keppra 500mg IV x1 now." There was no documentation that the Keppra was given or if it was effective. There was no nursing assessment documented on neurological status or vital signs.


Review of patient #3's primary nurses notes dated 3/20/2015, at 11:25 AM, stated, "Family came out of room to Nurses station, stated that (patient #3) is doing it again. RN went into room, observed patient head and left neck twitching for 3 minutes witnessed activity stopped." There was no documentation of a patient assessment, neurological status, vital signs, or blood sugar taken. There was no documentation of HD nurse documenting any seizure activity. Nurse documented primary physician was at bedside at 11:50 AM.


Review of physician orders dated 3/20/2015, at 11:45 AM, stated, "1 mg Ativan IVP x1." There was no nursing documentation from primary nurse or HD nurse of medication administration or effectiveness. There was no physical or neurological assessment documented.


Review of physician orders dated 3/20/2015, at 4:15 PM, revealed an order that read, "Geodon (psychotropic) 20 mg IV BID." There was no reason or diagnosis given for the administration of Geodon. There was no clarification order found. There was no evidence that Geodon was administered at any time.


Review of the policy and procedure "verbal/telephone orders" stated, "Documentation in the nurses notes of action taken to obtain or clarify physician's orders."


Review of the physician progress notes dated 3/20/2015, at 4:20 PM, revealed there was no documentation found of the patient seizure activity or new medications ordered.


Review of patient #3's primary nurses notes dated 3/20/2015, at 1:00 PM, revealed the patients metoprolol (beta blocker) was held due to blood pressure was, "86/40." HD nurse notes for 3/20/2015, at 1:09 PM, stated, blood pressure was 88/50. There was no documentation of medication held, patient neurological assessment, or medication effectiveness.


Review of the primary nurses notes on 3/20/2015, from 7:00 PM - 6:00 AM, revealed no documentation of seizure activity, medication effectiveness, or neurological assessment. Primary nurse documented at 7:00 PM, "pt seems obtunded; does not follow commands nor opens eyes when called."


These deficient practices were determined to pose Immediate Jeopardy to patient health and safety and caused actual harm to patient #27 and placed all patients at risk of harm, injury, or subsequent death.

Based on chart reviews, policy and procedures, and interviews, the facility failed to follow its own policy and procedures. The physician orders failed to specify the reason for restraint, the type of restraint, and the duration of restraint. The nursing documentation failed to justify the need for restraint application or usage. The medical record had minimal or no documentation of an individual patient assessment or revision of the plan of care in 3(#12, 24, and 25) of 3(#12, 24, and 25) identified patient charts that died in restraints or within 24 hours of restraint usage.

Review of Patient #24 chart revealed a restraint order sheet dated 2/13/15, at 2100 (9:00 PM). The "Restraint Order Sheet" stated, "Restrain Patient with: Soft wrist restraints, right arm, padded bed rail gap filler". Under the Interventions attempted the following interventions were checked with a response written as follows;
"A. 1:1 verbal intervention/reorientation/education Response: ongoing.
B. Assessment of irritants Response: ongoing.
C. Overdressing/ concealment of tubes Response: ineffective.
D. Diversional activities Response: ineffective
E. Companionship Response: ineffectiveness
F. Assessment of medications Response: ongoing
G. Assessment of medications Response: ongoing
H. Assessment of Lab and Physiologies Response: ongoing
I. Fall Precaution protocols Response: ongoing

Date restraints initially applied 2/13/15, at 2100 (9:00 PM). Clinical Justification (reason) for restraints: "Prevent pulling tubes and lines." This initial restraint order was written by a registered nurse. There is no documentation found that this order was a verbal order. Review of the physician signature on the "Restraint Order Sheet" revealed a date "2/14, 8 A." The date was incomplete by physician.

Review of the nurses notes dated 2/13/15, at 2105 (9:05 PM), stated, "Restraints: Patient attempting to pull ETT tube, on sedation, restraints initiated/ordered to prevent pulling of lines and tubes. " There was no further nursing documentation found of physician notification or order verification.

Review of the Nurses notes revealed a section that states, "Restraint Flowsheet." The flowsheet had two hour intervals where the nurse was to assess the patient of the following:

Assist with elimination every two hours, Offer/assist with nutrition/fluids every two hours, Release restraint every two hours x 10 min's & reposition, Check circulation, mobility & sensation every two hours, check skin integrity every 2 hours, reassess needs for restraints every 2 hours, assist with activity (rom, turning, etc) every 2 hours, respiratory effort unlabored, patient and family instructed of restraints, need for restraint is incorporated in plan of care."

Review of the Restraint flowsheet for patient #24 revealed the patient was only assessed at 2200 (10:00 PM) and 00 (12:00 AM). There was no documentation found of restraint assessment for 2:00 AM, 4:00 AM, or 6:00 AM.

Review of patient #24 chart revealed there was no order for a restraint on 2/14/15. Review of the Restraint Flowsheet dated 2/14/15 revealed the patient was assessed for needs at 8:00 AM only. There was no further documentation of restraint assessment until 2/14/15, at 2000 (8:00 PM). Review of the nurse's restraint flow sheet revealed the nurse checked the assessment boxes at 8:00 PM-12:00 AM. There was no further documentation for 2:00 AM, 4:00 AM, and 6:00 AM.

Review of the "Restraint Order Sheet" dated 2/15/15, at "2400" was incomplete. There was no type of restraint ordered, and there was no justification for a restraint. The physician signed the form "2/15" with no legible time documented. Review of the nursing notes for 2/15/15 at 0700 (7:00 AM) stated, "Bilat. Wrist Restraints remain in place."

Review of the "Restraint Order Sheet" dated 2/16/15, at 12:00 AM, revealed no order was found for type of restraint. Review of the Nurses notes dated 2/16/2015, at 7:00 AM, revealed the restraint flowsheet assessment boxes were checked at 8:00 AM and 10:00 AM. A note to the side stated, "11:30 restraints removed." Review of the Nursing notes dated 2/16/15, at 11:30 AM, stated, "Pt. extubated per R.T. Daughter here. AT 12:05 PM Resp/HR 0 respirations Bipap changed to 16/6 per RT. Pacemaker HR at 70. Physician notified by director of Respiratory Director. 12:25PM magnet to pacemaker to deactivate." No documentation of restraint removal in the nursing narrative notes found. No documentation found of condition after restraint removal found.

Review of patient #24 record revealed there was no documentation found of family notification or instruction of restraints.

Review of the facility's policy and procedures "Restraint Policy" stated, "Patient Restraint Procedure:

Orders for restraint must specify the reason (medical necessity and should indicate that restraint use is to improve the patients wellbeing) for the restraint, the type of restraint, the extremity or body parts to be restrained and the duration (time frame) for restraint application. As stated above, PRN or standing orders for patient restraints are not allowed by this organization or the medical staff.

Restraint orders shall be written periodically, not exceeding twenty four hours after face to face evaluation by the patient's attending physician.

The condition of the restrained patient must be continually assessed, monitored and re-evaluated.

Changing position and releasing soft restraints will be performed at a minimum of every two hours.

Patient /family will be notified, person, time of notification will be obtained. Explain to the patient and/or family the plan and rational for using restraints and the condition/behavior required for release of restraints."

Review of patient #12 chart revealed that she had an order for restraints on 3/19/2015 and 3/20/2015. The physician did not sign the order until 3/23/15. Policy and Procedures for restraints require the physician to sign the order within 24 hours. There was documentation of restraints on 3/21/2015, with no physician order found.

Review of patient patient #10 chart revealed an Initial restraint order dated 2/11/15. The order stated, "soft wrist restraints due to neurological impairment due to anesthesia/sedation, pulling out NG feeding tube, and medically unstable -interruption of medical treatment is life threatening." There was an RN signature for initiating the restraint and another RN signature that stated, "Second RN Evaluation Signature (within one hour of initiation).

A telephone interview with staff #26 on 3/26/2015, reported that two RN's were supposed to sign an initial restraint order. One RN signs when restraints were ordered and then a second RN an hour later. Staff #26 was not sure why she had to do that. Staff #26 stated, "I just go and sign the forms."

Review of patient #10 chart revealed the patient was in restraints on 2/16/15, 2/17/15, 2/18/15, and 2/22/15, with no physician orders for restraints. Review of the restraint orders for 2/11/15, had no justification for restraints. Order for restraints on patient #10 on 2/25/2015 had no physician date or time of signature.

During an interview with staff #24 on 3/25/15, at 2:00 PM, revealed that the staff nurses was to log the restraints in a log book. Review of this log book revealed there was one page of restraints logged for February 2015 and no restraints logged for March of 2015. Staff #24 reported there were patients on restraints currently but they have not been logged in the book. Staff #24 reported the logs are sent to the Risk Manager each month for review.

During an interview with staff #2 on 3/24/2015, revealed the restraint patient log had not been reviewed and updated. Staff #2 reported feeling overwhelmed and stated, "I have just not been able to get to everything and I have let some stuff go." Staff #2 confirmed that she had not been reviewing charts for restraints and has had no QAPI meetings or new data to add since October of 2014. Staff #2 and Staff #9 confirmed they were aware of the problems with restraints not being documented and failure to follow policy and procedures.

These deficient practices were determined to pose Immediate Jeopardy to patient health and safety and placed all patients for whom restraints were used at risk of harm, injury, or subsequent death.

Based on chart reviews, policy and procedures, and interviews, the facility failed to follow its own policy and procedures. The physician orders failed to specify the reason for restraint, the type of restraint, and the duration of restraint. The nursing documentation failed to justify the restraint application or usage. Nursing failed to document less restrictive measures were tried or considered. The medical record had minimal or no documentation of an individual patient assessment or revision of the plan of care in 3(#12, 24, and 10) of 3(#12, 24, and 10) identified patient charts that died in restraints or within 24 hours of restraint usage. Failure to assess a patient in restraints can lead to the likelihood of injury or death.

Review of Patient #24 chart revealed a restraint order sheet dated 2/13/15, at 2100 (9:00 PM). The "Restraint Order Sheet" stated, "Restrain Patient with: Soft wrist restraints, right arm, padded bed rail gap filler". Under the Interventions attempted the following interventions were checked with a response written as follows:
"A. 1:1 verbal intervention/reorientation/education Response: ongoing.
B. Assessment of irritants Response: ongoing.
C. Overdressing/ concealment of tubes Response: ineffective.
D. Diversional activities Response: ineffective
E. Companionship Response: ineffectiveness
F. Assessment of medications Response: ongoing
G. Assessment of medications Response: ongoing
H. Assessment of Lab and Physiologies Response: ongoing
I. Fall Precaution protocols Response: ongoing

Date restraints initially applied 2/13/15, at 2100 (9:00 PM). Clinical Justification (reason) for restraints: "Prevent pulling tubes and lines." This initial restraint order was written by a registered nurse. There is no documentation found that this order was a verbal order. Review of the physician signature on the "Restraint Order Sheet" revealed a date "2/14, 8 A." The date was incomplete by physician.

Review of the nurses notes dated 2/13/15, at 2105 (9:05 PM), stated, "Restraints: Patient attempting to pull ETT tube, on sedation, restraints initiated/ordered to prevent pulling of lines and tubes. " There was no further nursing documentation found of physician notification or order verification.

Review of the Nurses notes revealed a section that states, "Restraint Flowsheet" The flowsheet had two hour intervals where the nurse was to assess the patient of the following:

Assist with elimination every two hours, Offer/assist with nutrition/fluids every two hours, Release restraint every two hours x 10 min's & reposition, Check circulation, mobility & sensation every two hours, check skin integrity every 2 hours, reassess needs for restraints every 2 hours, assist with activity (rom, turning, etc) every 2 hours, respiratory effort unlabored, patient and family instructed of restraints, need for restraint is incorporated in plan of care."

Review of the Restraint flowsheet for patient #24 revealed that the patient was only assessed at 2200 (10:00 PM) and 00 (12:00 AM). There was no documentation found of restraint assessment for 2:00 AM, 4:00 AM, or 6:00 AM.

Review of patient #24 chart revealed there was no order for a restraint on 2/14/15. Review of the Restraint Flowsheet dated 2/14/15, revealed that the patient was assessed for needs at 8:00 AM only. There was no further documentation of restraint assessment until 2/14/15, at 2000 (8:00 PM). Review of the nurse's restraint flow sheet revealed the nurse checked the assessment boxes at 8:00 PM-12:00 AM. There was no further documentation for 2:00 AM, 4:00 AM, and 6:00 AM.

Review of the "Restraint Order Sheet" dated 2/15/15, at "2400" was incomplete. There was no type of restraint ordered, and there was no justification for a restraint. The physician signed the form "2/15" with no legible time documented. Review of the nursing notes for 2/15/15 at 0700 (7:00 AM) stated, "Bilat. Wrist Restraints remain in place."

Review of the "Restraint Order Sheet" dated 2/16/15, at 12:00 AM, revealed no order was found for type of restraint. Review of the Nurses notes dated 2/16/2015, at 7:00 AM, revealed the restraint flowsheet assessment boxes were checked at 8:00 AM and 10:00 AM. A note to the side stated, "11:30 restraints removed." Review of the Nursing notes dated 2/16/15, at 11:30 AM, stated, "Pt. extubated per R.T. Daughter here. AT 12:05 PM Resp/HR 0 respirations Bipap changed to 16/6 per RT. Pacemaker HR at 70. Physician notified by director of Respiratory Director. 12:25PM magnet to pacemaker to deactivate." No documentation of restraint removal in the nursing narrative notes found. No documentation found of condition after restraint removal found.

Review of patient #24 record revealed there was no documentation found of family notification or instruction of restraints.

Review of the facility's policy and procedures "Restraint Policy" stated, "Patient Restraint Procedure:

Orders for restraint must specify the reason (medical necessity and should indicate that restraint use is to improve the patients wellbeing) for the restraint, the type of restraint, the extremity or body parts to be restrained and the duration (time frame) for restraint application. As stated above, PRN or standing orders for patient restraints are not allowed by this organization or the medical staff.

Restraint orders shall be written periodically, not exceeding twenty four hours after face to face evaluation by the patient ' s attending physician.

The condition of the restrained patient must be continually assessed, monitored and re-evaluated.

Changing position and releasing soft restraints will be performed at a minimum of every two hours.

Patient /family will be notified, person, time of notification will be obtained. Explain to the patient and/or family the plan and rational for using restraints and the condition/behavior required for release of restraints."

Review of patient #12 chart revealed she had an order for restraints on 3/19/2015, and 3/20/2015. The physician did not sign the order until 3/23/15. Policy and Procedures for restraints require the physician to sign the order within 24 hours. There was documentation of restraints on 3/21/2015, with no physician order found.

Review of patient #10 chart revealed an Initial restraint order dated 2/11/15. The order stated, "soft wrist restraints due to neurological impairment due to anesthesia/sedation, pulling out NG feeding tube, and medically unstable -interruption of medical treatment is life threatening." There was an RN signature for initiating the restraint and another RN signature that stated, "Second RN Evaluation Signature (within one hour of initiation).

A telephone interview with staff #26 on 3/26/2015, reported that two RN's were supposed to sign an initial restraint order. One RN signs when restraints were ordered and then a second RN an hour later. Staff #26 was not sure why she had to do that. Staff #26 stated, "I just go and sign the forms."

Review of patient #10 chart revealed the patient was in restraints on 2/16/15, 2/17/15, 2/18/15, and 2/22/15, with no physician orders for restraints. Review of the restraint orders for 2/11/15 had no justification for restraints. Order for restraints on patient #10 on 2/25/2015 had no physician date or time of signature.

During an interview with staff #24 on 3/25/15, at 2:00 PM, revealed that the staff nurses was to log the restraints in a log book. Review of this log book revealed there was one page of restraints logged for February 2015 and no restraints logged for March of 2015. Staff #24 reported there were patients on restraints currently but they have not been logged in the book. Staff #24 reported the logs are sent to the Risk Manager each month for review.

During an interview with staff #2 on 3/24/2015, revealed the restraint patient log had not been reviewed and updated. Staff #2 reported feeling overwhelmed and stated, "I have just not been able to get to everything and I have let some stuff go." Staff #2 confirmed she had not been reviewing charts for restraints and has had no QAPI meetings or new data to add since October of 2014. Staff #2 and Staff #9 confirmed they were aware of the problems with restraints not being documented and failure to follow policy and procedures.

These deficient practices were determined to pose Immediate Jeopardy to patient health and safety and placed all patients for whom restraints were used at risk of harm, injury, or subsequent death.

Based on chart reviews, policy and procedures, and interviews, the facility failed to follow its own policy and procedures. The medical record had minimal or no documentation of an individual patient assessment or revision of the plan of care in 3(#12, 24, and 25) of 3(#12, 24, and 25) identified patient charts that died in restraints or within 24 hours of restraint usage. Failure to assess a patient in restraints can lead to the likelihood of injury or death.

Review of Patient #24 chart revealed a restraint order sheet dated 2/13/15, at 2100 (9:00 PM). The "Restraint Order Sheet" stated, "Restrain Patient with: Soft wrist restraints, right arm, padded bed rail gap filler. Under the Interventions attempted the following interventions were checked with a response written as follows:
"A. 1:1 verbal intervention/reorientation/education Response: ongoing.
B. Assessment of irritants Response: ongoing.
C. Overdressing/ concealment of tubes Response: ineffective.
D. Diversional activities Response: ineffective
E. Companionship Response: ineffectiveness
F. Assessment of medications Response: ongoing
G. Assessment of medications Response: ongoing
H. Assessment of Lab and Physiologies Response: ongoing
I. Fall Precaution protocols Response: ongoing

Date restraints initially applied 2/13/15, at 2100 (9:00 PM). Clinical Justification (reason) for restraints: "Prevent pulling tubes and lines." This initial restraint order was written by a registered nurse. There is no documentation found that this order was a verbal order. Review of the physician signature on the "Restraint Order Sheet " revealed a date "2/14 8 A." The date was incomplete by physician.

Review of the nurses notes dated 2/13/15, at 2105 (9:05 PM), stated, "Restraints: Patient attempting to pull ETT tube on sedation, restraints initiated/ordered to prevent pulling of lines and tubes." There was no further nursing documentation that less restrictive measures were tried or considered, physician notification, or order verification.

Review of the Nurses notes revealed a section that states, "Restraint Flowsheet" The flowsheet has two hour intervals where the nurse is to assess the patient of the following:

"Assist with elimination every two hours, Offer/assist with nutrition/fluids every two hours, Release restraint every two hours x 10 min's & reposition, Check circulation, mobility & sensation every two hours, check skin integrity every 2 hours, reassess needs for restraints every 2 hours, assist with activity (rom, turning, ect) every 2 hours, respiratory effort unlabored, patient and family instructed of restraints, need for restraint is incorporated in plan of care."

Review of the Restraint flowsheet for patient #24 revealed that the patient was only assessed at 2200 (10:00 PM) and 00 (12:00 AM). There was no documentation found of restraint assessment for 2:00 AM, 4:00 AM, or 6:00 AM.

Review of patient patient #24 chart revealed there was no order for a restraint on 2/14/15. Review of the Restraint Flowsheet dated 2/14/15, revealed the patient was assessed for needs at 8:00 AM only. There was no further documentation of restraint assessment until 2/14/15 at 2000 (8:00 PM). Review of the nurse's restraint flow sheet revealed the nurse checked the assessment boxes at 8:00 PM-12:00 AM. There was no further documentation for 2:00 AM, 4:00 AM, and 6:00 AM.

Review of the "Restraint Order Sheet" dated 2/15/15, at "2400" was incomplete. There was no type of restraint ordered, and there was no justification for a restraint. The physician signed the form "2/15" with no legible time documented. Review of the nursing notes for 2/15/15 at 0700 (7:00 AM) stated, "Bilat. Wrist Restraints remain in place."

Review of the "Restraint Order Sheet" dated 2/16/15, at 12:00 AM, revealed no order was found for type of restraint. Review of the Nurses notes dated 2/16/2015 at 7:00 AM revealed the restraint flowsheet assessment boxes were checked at 8:00 AM and 10:00 AM. A note to the side stated, "11:30 restraints removed." Review of the Nursing notes dated 2/16/15, at 11:30 AM, stated, "Pt. extubated per R.T. Daughter here. AT 12:05 PM Resp/HR 0 respirations Bipap changed to 16/6 per RT. Pacemaker HR at 70. Physician notified by director of Respiratory Director. 12:25 PM magnet to pacemaker to deactivate." No documentation of restraint removal in the nursing narrative notes found. No documentation found of condition after restraint removal found.

Review of patient patient #24 record revealed there was no documentation found of family notification or instruction of restraints. There was no documentation of restraint care plan in the nursing care plan.

Review of the facility's policy and procedures "Restraint Policy" stated, "Patient Restraint Procedure:
*Orders for restraint must specify the reason (medical necessity and should indicate that restraint use is to improve the patients wellbeing) for the restraint, the type of restraint, the extremity or body parts to be restrained and the duration (time frame) for restraint application. As stated above, PRN or standing orders for patient restraints are not allowed by this organization or the medical staff.
* Restraint orders shall be written periodically, not exceeding twenty four hours after face to face evaluation by the patient's attending physician.
* The condition of the restrained patient must be continually assessed, monitored and re-evaluated.
*Changing position and releasing soft restraints will be performed at a minimum of every two hours.
*Patient /family will be notified, person, time of notification will be obtained. Explain to the patient and/or family the plan and rational for using restraints and the condition/behavior required for release of restraints."

Review of patient #12 chart revealed she had an order for restraints on 3/19/2015, and 3/20/2015. The physician did not sign the order until 3/23/15. Policy and Procedures for restraints require the physician to sign the order within 24 hours. There was documentation of restraints on 3/21/2015 with no physician order found.

Review of patient patient #10 chart revealed an Initial restraint order dated 2/11/15. The order stated, "soft wrist restraints due to neurological impairment due to anesthesia/sedation, pulling out NG feeding tube, and medically unstable -interruption of medical treatment is life threatening." There was an RN signature for initiating the restraint and another RN signature that stated, "Second RN Evaluation Signature (within one hour of initiation)."

A telephone interview with staff #26 on 3/26/2015, reported that two RN's were supposed to sign an initial restraint order. One RN signs when restraints were ordered and then a second RN an hour later. Staff #26 was not sure why she had to do that. Staff #26 stated, "I just go and sign the forms."

Review of patient #10 chart revealed the patient was in restraints on 2/16/15, 17, 18, and 22nd, with no physician orders for restraints. Review of the restraint orders for 2/11/15, had no justification for restraints. Order for restraints on patient #10 on 2/25/2015, had no physician date or time of signature. There was no documentation found of family notification or instruction of restraints. There was no documentation of restraint care plan in the nursing care plan.

During an interview with staff #24 on 3/25/15, at 2:00 PM, revealed the staff nurses were to log the restraints in a log book. Review of this log book revealed there were one page of restraints logged for February 2015 and no restraints logged for March 2015. Staff #24 reported there were patients on restraints at this time but they have not been logged in the book. Staff #24 reported the logs are sent to the Risk Manager each month for review.

During an interview with staff #2 on 3/24/2015, revealed the restraint patient log had not been reviewed and updated. Staff #2 reported feeling overwhelmed and stated, "I have just not been able to get to everything and I have let some stuff go." Staff #2 confirmed she had not been reviewing charts for restraints and has had no QAPI meetings or new data to add since October of 2014. Staff #2 and Staff #9 confirmed they were aware of the problems with restraints not being documented and failure to complete or initiate care plans.


These deficient practices were determined to pose Immediate Jeopardy to patient health and safety and placed all patients for whom restraints were used at risk of harm, injury, or subsequent death.

Based on chart reviews, policy and procedures, and interviews the facility failed to follow its own policy and procedures. Nursing staff failed to reassess the patients in restraint, or discontinue a restraint when the patient was no longer in danger of harm in 2 (#10, 24) out of 2 patients reviewed.


Review of the facility's policy and procedures "Restraint Policy" stated, "Patient Restraint Procedure:

*Orders for restraint must specify the reason (medical necessity and should indicate that restraint use is to improve the patients wellbeing) for the restraint, the type of restraint, the extremity or body parts to be restrained and the duration (time frame) for restraint application. As stated above, PRN or standing orders for patient restraints are not allowed by this organization or the medical staff.
* Restraint orders shall be written periodically, not exceeding twenty four hours after face to face evaluation by the patient's attending physician.
* The condition of the restrained patient must be continually assessed, monitored and re-evaluated.
*Changing position and releasing soft restraints will be performed at a minimum of every two hours.
*Patient /family will be notified, person, time of notification will be obtained. Explain to the patient and/or family the plan and rational for using restraints and the condition/behavior required for release of restraints.

Review of patient #10's nursing notes dated 3/1/2015, revealed a flow sheet the flow sheet revealed restraints were applied does not state what type of restraints. The flow sheet is marked "y" on the box that stated, "offer/assist with nutrition/fluids q 2 hours" at 8:00 PM, 10:00 PM, 12:00 PM, 2:00 AM, 4:00 AM and 6:00 AM review of the nurses notes revealed the patient is NPO (nothing by mouth) and is on a ventilator.


Review of the nurse's notes dated 3/1/2015, at 7:20 PM, stated, " report received from RN with walking rounds pt on bed awake,alert, nods to questions, follows simple commands, no distress. Appears comfortable. There was no documentation that patient #10 was reassessed for restraints at this time, if patient #10's restraints were necessary, or effective for the purpose it was ordered. If any trial release was performed.


Review of the nurse's notes dated 3/1/2015, at 2:00 AM, stated, "No acute changes in stay. asleep in bed. "At this point the patient was asleep and no longer in danger of hurting himself or others." The nurse did not discontinue the restraints.


Review of the nurse's notes dated 2/28/2015, at 8:00 PM, stated, "bilateral wrist restraints on secured to non-moveable section of the bed. At 10:00 PM Patient turned and repositioned in bed. Tolerated activity well. Restraints removed/resecured continue to monitor." There was no further documentation of the restraints, why the patient required the restraints to be reapplied, or any interventions applied.


Review of nurses notes for patient # 24 on 2/15/2015, revealed that the patient was in bilateral wrist restraints. The nurse documented at 7:00 AM "Bilat wrist restraints remain in place, 7:15 AM wrist restraints remain in place no acute distress, 12:00 PM Bilat wrist restraints in place no acute distress, 1:00 PM Bilat wrist restraints in place no acute distress." There was no documentation of the need for restraints or any interventions performed.


Staff #2 and Staff #9 confirmed they were aware of the problems with restraints not being documented and failure to follow policy and procedures.

These deficient practices were determined to pose Immediate Jeopardy to patient health and safety and placed all patients for whom restraints were used at risk of harm, injury, or subsequent death.

Based on chart reviews, policy and procedures, and interviews, the facility failed to follow its own policy and procedures. The physician orders failed to specify the reason for restraint, the type of restraint, and the duration of restraint. The nursing documentation failed to justify the restraint application or usage. The medical record had minimal or no documentation of an individual patient assessment or revision of the plan of care in 3 (#10, 12, and 24) of 3identified patient charts that died in restraints or within 24 hours of restraint usage.

Review of Patient #24 chart revealed a restraint order sheet dated 2/13/15, at 2100 (9:00 PM). The "Restraint Order Sheet" stated, "Restrain Patient with: Soft wrist restraints, right arm, padded bed rail gap filler". Under the Interventions attempted the following interventions were checked with a response written as follows:
"A. 1:1 verbal intervention/reorientation/education Response: ongoing.
B. Assessment of irritants Response: ongoing.
C. Overdressing/ concealment of tubes Response: ineffective.
D. Diversional activities Response: ineffective
E. Companionship Response: ineffectiveness
F. Assessment of medications Response: ongoing
G. Assessment of medications Response: ongoing
H. Assessment of Lab and Physiologies Response: ongoing
I. Fall Precaution protocols Response: ongoing

Date restraints initially applied 2/13/15, at 2100 (9:00 PM). Clinical Justification (reason) for restraints: "Prevent pulling tubes and lines." This initial restraint order was written by a registered nurse. There is no documentation found that this order was a verbal order. Review of the physician signature on the "Restraint Order Sheet" revealed a date "2/14, 8 A." The date was incomplete by physician.

Review of the nurses notes dated 2/13/15, at 2105 (9:05 PM), stated, "Restraints: Patient attempting to pull ETT tube, on sedation, restraints initiated/ordered to prevent pulling of lines and tubes. " There was no further nursing documentation found of physician notification or order verification.

Review of the Nurses notes revealed a section that states, "Restraint Flowsheet" The flowsheet had two hour intervals where the nurse was to assess the patient of the following:

"Assist with elimination every two hours, Offer/assist with nutrition/fluids every two hours, Release restraint every two hours x 10 min's & reposition, Check circulation, mobility & sensation every two hours, check skin integrity every 2 hours, reassess needs for restraints every 2 hours, assist with activity (rom, turning, etc) every 2 hours, respiratory effort unlabored, patient and family instructed of restraints, need for restraint is incorporated in plan of care."

Review of the Restraint flowsheet for patient #24 revealed the patient was only assessed at 2200 (10:00 PM) and 00 (12:00 AM). There was no documentation found of restraint assessment for 2:00 AM, 4:00 AM, or 6:00 AM.

Review of patient #24 chart revealed there was no order for a restraint on 2/14/15. Review of the Restraint Flowsheet dated 2/14/15, revealed the patient was assessed for needs at 8:00 AM only. There was no further documentation of restraint assessment until 2/14/15, at 2000 (8:00 PM). Review of the nurse's restraint flow sheet revealed the nurse checked the assessment boxes at 8:00 PM-12:00 AM. There was no further documentation for 2:00 AM, 4:00 AM, and 6:00 AM.

Review of the "Restraint Order Sheet" dated 2/15/15, at "2400" was incomplete. There was no type of restraint ordered, and there was no justification for a restraint. The physician signed the form "2/15" with no legible time documented. Review of the nursing notes for 2/15/15 at 0700 (7:00 AM) stated, "Bilat. Wrist Restraints remain in place."

Review of the "Restraint Order Sheet" dated 2/16/15, at 12:00 AM, revealed no order was found for type of restraint. Review of the Nurses notes dated 2/16/2015, at 7:00 AM, revealed that the restraint flowsheet assessment boxes were checked at 8:00 AM and 10:00 AM. A note to the side stated, "11:30 restraints removed." Review of the Nursing notes dated 2/16/15, at 11:30 AM, stated, "Pt. extubated per R.T. Daughter here. AT 12:05 PM Resp/HR 0 respirations Bipap changed to 16/6 per RT. Pacemaker HR at 70. Physician notified by director of Respiratory Director. 12:25PM magnet to pacemaker to deactivate." No documentation of restraint removal in the nursing narrative notes found. No documentation found of condition after restraint removal found.

Review of patient #24 record revealed there was no documentation found of family notification or instruction of restraints.

Review of the facility's policy and procedures "Restraint Policy" stated, "Patient Restraint Procedure:

Orders for restraint must specify the reason (medical necessity and should indicate that restraint use is to improve the patients wellbeing) for the restraint, the type of restraint, the extremity or body parts to be restrained and the duration (time frame) for restraint application. As stated above, PRN or standing orders for patient restraints are not allowed by this organization or the medical staff.

Restraint orders shall be written periodically, not exceeding twenty four hours after face to face evaluation by the patient ' s attending physician.

The condition of the restrained patient must be continually assessed, monitored and re-evaluated.

Changing position and releasing soft restraints will be performed at a minimum of every two hours.

Patient /family will be notified, person, time of notification will be obtained. Explain to the patient and/or family the plan and rational for using restraints and the condition/behavior required for release of restraints."

Review of patient #12 chart revealed she had an order for restraints on 3/19/2015, and 3/20/2015. The physician did not sign the order until 3/23/15. Policy and Procedures for restraints require the physician to sign the order within 24 hours. There was documentation of restraints on 3/21/2015, with no physician order found.

Review of patient patient #10 chart revealed an Initial restraint order dated 2/11/15. The order stated, "soft wrist restraints due to neurological impairment due to anesthesia/sedation, pulling out NG feeding tube, and medically unstable -interruption of medical treatment is life threatening." There was an RN signature for initiating the restraint and another RN signature that stated, "Second RN Evaluation Signature (within one hour of initiation).

A telephone interview with staff #26 on 3/26/2015, reported that two RN's were supposed to sign an initial restraint order. One RN signs when restraints were ordered and then a second RN an hour later. Staff #26 was not sure why she had to do that. Staff #26 stated, "I just go and sign the forms."

Review of patient #10 chart revealed the patient was in restraints on 2/16/15, 2/17/15, 2/18/15, and 2/22/15, with no physician orders for restraints. Review of the restraint orders for 2/11/15 had no justification for restraints. Order for restraints on patient #10 on 2/25/2015 had no physician date or time of signature.

During an interview with staff #24 on 3/25/15, at 2:00 PM, revealed the staff nurses was to log the restraints in a log book. Review of this log book revealed there was one page of restraints logged for February 2015 and no restraints logged for March 2015. Staff #24 reported there were patients on restraints currently but they have not been logged in the book. Staff #24 reported the logs are sent to the Risk Manager each month for review.

During an interview with staff #2 on 3/24/2015, revealed the restraint patient log had not been reviewed and updated. Staff #2 reported feeling overwhelmed and stated, "I have just not been able to get to everything and I have let some stuff go." Staff #2 confirmed she had not been reviewing charts for restraints and has had no QAPI meetings or new data to add since October of 2014. Staff #2 and Staff #9 confirmed they were aware of the problems with restraints not being documented and failure to follow policy and procedures.

These deficient practices were determined to pose Immediate Jeopardy to patient health and safety and placed all patients for whom restraints were used at risk of harm, injury, or subsequent death.

Based on reviews of quality data and interviews, the facility failed to maintain, measure, analyze, and track quality indicators.


Review of the Quality Assessment and Performance Improvement (QAPI) data and meeting minutes revealed the last meeting was in October 2014. There was no written data offered past October 2014.


An interview staff #2 on 3/23/2015, revealed that the QAPI meetings and data had been put aside since the last Director of Nurses left the facility. Staff #2 reported feeling overwhelmed and stated, "I have just not been able to get to everything and I have let some stuff go." Staff #2 confirmed she has had no QAPI meetings or new data to add or provide since October 2014.

Based on reviews of quality data and interviews, the facility failed to collect data to identify opportunities for improvement.


Review of the Quality Assessment and Performance Improvement (QAPI) data and meeting minutes revealed the last meeting was in October 2014. There was no written data offered past October 2014.

An interview staff #2 on 3/23/2015, revealed that the QAPI meetings and data had been put aside since the last Director of Nurses left the facility. Staff #2 reported feeling overwhelmed and stated, "I have just not been able to get to everything and I have let some stuff go." Staff #2 confirmed she has had no QAPI meetings or new data to add or provide since October 2014.

Based on review of quality indicators, performance improvement documents, occurance reports and interviews, the facility failed to have a ongoing and effective patient safety program.



Review of the Quality Assessment and Performance Improvement (QAPI) data and meeting minutes revealed the last meeting was in October 2014. There was no data for reduction of medical errors sine October 2014.


An interview staff #2 on 3/23/2015, revealed that the QAPI meetings and data had been put aside since the last Director of Nurses left the facility. Staff #2 reported feeling overwhelmed and stated, "I have just not been able to get to everything and I have let some stuff go." Staff #2 confirmed she has had no QAPI meetings or new data to add or provide since October 2014.

Based on Quality Assurance and Performance Improvement(QAPI) review and interviews, the facility failed to have ongoing performance improvement projects.


Review of the QAPI meeting minutes the facility failed to have a QAPI meeting or current data since October 2014.


An interview staff #2 on 3/23/2015, revealed that the QAPI meetings and data had been put aside since the last Director of Nurses left the facility. Staff #2 reported feeling overwhelmed and stated, "I have just not been able to get to everything and I have let some stuff go." Staff #2 confirmed she has had no QAPI meetings or new data to add or provide since October 2014.

Based on reviews of Quality Assessment and Performance Improvement (QAPI) data, meeting minutes, and interviews, the governing body failed to ensure QAPI activities were being gathered, performance improvement was generated, all departments of the hospital participated, and the activities reflected the complexity of the facilities organization and services provided.

Review of the QAPI data and meeting minutes revealed the last meeting was in October 2014. There was no written data offered past October 2014.


An interview staff #2 on 3/23/2015, revealed that the QAPI meetings and data had been put aside since the last Director of Nurses left the facility. Staff #2 reported feeling overwhelmed and stated, "I have just not been able to get to everything and I have let some stuff go." Staff #2 confirmed she has had no QAPI meetings or new data to add or provide since October 2014.

Based on reviews of Quality Assessment and Performance Improvement (QAPI) data, meeting minutes, and interviews, the governing body and medical staff failed to ensure QAPI activites were being gathered, performance improvement was generated, and all departments of the hospital participated.


Review of the QAPI data and meeting minutes revealed the last meeting was in October 2014. There was no written data offered past October 2014.

An interview with staff #2 on 3/23/2015, revealed that the QAPI meetings and data had been put aside since the last Director of Nurses left the facility. Staff #2 reported feeling overwhelmed and stated, "I have just not been able to get to everything and I have let some stuff go." Staff #2 confirmed she has had no QAPI meetings or new data to add or provide since October 2014.

Based on reviews of Quality Assessment and Performance Improvement (QAPI) data, meeting minutes, and interviews, the governing body failed to ensure adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital performance and reducing risk to patients.


Review of the QAPI data and meeting minutes revealed the last meeting was in October 2014. There was no written data offered past October 2014.

An interview staff #2 on 3/23/2015, revealed that the QAPI meetings and data had been put aside since the last Director of Nurses left the facility. Staff #2 reported feeling overwhelmed and stated, "I asked for help to do this job and I was told they just couldn't do that right now due to financial reasons. It has become so hard to keep up."

Based on reviews of Governing Board minutes, employee files, organizational charts, and interviews, the facility failed to have a Director of Nurses (DON) to ensure appropriate operation of the nursing service and adequate staffing was available.


Review of the Governing Board minutes dated 3/10/2015, revealed no mention of a DON or an interim DON.


An interview was conducted with staff #1 on 3/23/2015. Staff #1 stated staff #12 was his interim DON. Review of staff #12's employee file revealed that she was hired as a nurse practitioner and was functioning as a member of the medical staff but no mention of DON position.


An interview with staff #12 on 3/23/2015, revealed that she was trying to help out as a interim DON but had never signed a job description or application for the DON position.



29762


Based on document review and interview, the facility failed to follow the established administrative authority provided for the director of nurses. The Administrator continued to determine Nurse staffing as evidenced by the Staffing Committee Meeting Minutes. The meeting minutes revealed the Administrator conducted the Staffing Committee Meeting. The Administrator was not a registered nurse and was not qualified to determine the types and numbers of nursing personnel and staff necessary to provide nursing care to the patients seeking care in the facility.


A review of the Staffing Committee's Meeting Minutes dated February 6, 2015, revealed that the Administrator determined Nurse staffing as part of the Staffing Committee Meeting. The meeting minutes revealed that the Administrator conducted the Staffing Committee Meeting. The Administrator was not a registered nurse and was not qualified to determine the types and numbers of nursing personnel and staff necessary to provide nursing care to the patients seeking care in the facility.


The State Nursing Practice Act required that nurses working in a hospital may refuse to work mandatory overtime and refusing to work overtime "does not constitute patient abandonment." State law also requires that the governing body of a hospital adopt, implement, and enforce a written official nurse services staffing policy that ensures that an adequate number and skill mix of nurses are available to meet the level of patient care needed.

State law requires hospitals to establish nurse staffing committees as standing committees of the hospital. These committees must meet at least on a quarterly basis. The nurse staffing committee is required to develop and recommend a nurse staffing plan to the hospital's governing body. The requirements for committee membership are specific and require the various types of nursing services provided by the hospital to be adequately represented on the committee. The Chief Nursing Officer (CNO) is a voting member of the committee and 60% of the committee must be RNs who spend at least 50% of their work time in direct patient care. RNs serving on the committee must be elected by their peers who provide direct patient care at least 50% of their work time. Committees are to meet during working hours and nurses are to be relieved of other duties in order to attend the meetings. Nurse staffing plans should be used as a component of the nurse staffing budget and nurses are encouraged to provide input to the nurse staffing committee without fearing retaliation from their employer.


An interview with staff #2 and staff #9 revealed that the Administrator perticipated in the Nurse Staffing Committee.


It was determined that these deficient practices created the likelihood of harm, serious injury, and subsequent death to patients. The patients' level of nursing skill needed or the level of the skilled nurses was not being considered when deciding the level of staffing.

Based on review of the staffing schedules, staffing grid, and policy and procedures, the facility failed to have adequate staffing according to the staffing grid in 9 out of 46 shifts scheduled.


Review of the policy and procedure "Nurse Staffing Policy" revealed, "It is the policy of the governing board of Harbor Hospital of Southeast Texas to comply with Texas laws and rules reguarding nurse staffing. Harbor Hospital shall adopt, implement and enforce a nurse staffing policy that complies with rules adopted by the Texas Health and Human Services Commision or its agencies and ensures an adequate number and skill mix of nurses to meet the levels of care needed at Harbor Hospital."


Review of the working schedules from 3/1/ 2015-3/23/2015 revealed 5 shifts were short a Registered Nurse (RN). Review of the unlicensed staff revealed 4 shifts were short unlicensed personnel.


An interview with staff # 9 and staff #1 on 3/24/15, confirmed there were nurse job openings and they are unable to cover some shifts. Staff #1 confirmed that agency nurses are being called when needed but there have been times shifts were left without full RN coverage.

Based on document review and interview, the facility failed to supervise Paramedic. Staff #38, who performed an assessment on a patient and delayed reporting the change in the patient's health status to the patient's nurse. The patient was left without monitoring while the paramedic talked on the cell phone.

A review of a death chart revealed that a Paramedic performed an assessment of a patient and delayed notifying a Registered Nurse of the change in patient #27's medical condition. Patient #27 became disconnected from the oxygen delivery device.

A review of a statement from Paramedic staff #38 revealed:

"On the morning of 09/16/14 at 0930 to be more precise 0936 I had come back to my assigned desk at Nurse STN #1 from using my personal cell phone outside. I sat down in front of the Monitors/ Computer where I usually sit and began preparing for MD #40 written orders. After the chart for room 114 was handed to me I began to attempt to Login to HIMS and start placing/ registering the orders that were written I had to consult with Terry at Nurse STN #2 to get clarity on some of the orders written. around 09:55 the paramedic noticed the alarm went off on the monitor and the patient's heart rate was 46-48 beats per minute. I then got up and went into the patient's room and assessed patient's peripheral pulses and respiratory rate and quality and noticed patient's T-tube/oxygen had been disconnected from her trach tube. So I immediately reconnected the oxygen and repositioned her in the bed and reassessed. I stepped out of the patient's room to get patient's nurse LVN staff #39.

After I stepped out of Pt's Room, LVN staff #35 had noticed the Pt's Bradycardia on the Monitor as well and cam to Pt's Room 110 from Nurse Station 2 to provide assistance, shortly after Charge Nurse had come in and we were Ventilating Pt with a BVM and treating Pt's Symptomatic Bradycardia. Called Respiratory and they came in to give assistance as well. Pt's condition had declined and Pt would eventually go into Cardiac Arrest (Asystole) @ 1011. Pt had a DNR order that was honored and time of death was pronounced.

After the incident occurred, it was noticed that No Alarm from the Monitor never went off on the Patient in room #110 until Pt had already fallen into decompensated stage. Incident and concerns were reported to Supervisors".


A review of the document titled: PARAMEDIC/MONITOR TECH. DEPARTMENT: LTACH revealed:

2. a. Identifies cardiac rhythms and changes in vital signs as recorded by telemetry monitoring system and reports findings to the RN/Nursing supervisor and primary nurse.


During a tour of the facility, the telemetry alarms and monitors were unattended for 2 minutes while alert alarms were sounding. There was no staff observed at the monitor. The nurses walked by the sounding alarms and did not respond. On a separate tour of the facility the surveyor observed paramedic, staff #33, silencing telemetry alarms without checking on the patient.


An interview on 3/25/2015, at approximately 12:30 pm with staff #2 confirmed the findings.

Based on chart reviews, policy and procedures, and interviews, the facility failed to ensure that the nursing staff develops, and keeps current, a nursing care plan for 3 (#12, 3, and 24 ) out of 3 (#12, 3, and 24) charts reviewed.


Review of patient #12's chart revealed a care plan was initiated on 3/18/2015. Patient #12 was admitted with respiratory failure, non insulin dependent diabetes(NIDDM), and abdominal symptoms. The patient was put on four litters of oxygen(O2), nothing by mouth(NPO), blood work and fall precautions. The careplan was found to be incomplete, no evidence of individualized nursing reassessment of the patient care needs, or response to nursing interventions as evidenced by the following:


1. The section for family identified goals and family participation was left blank.

2. The care plan was addressed on 3/18/2015, with the patient marked as NPO. Patient #12 was placed on total parenteral nutrition (TPN) on 3/19/2015. No documentation was found of TPN administration. There are no goals or outcomes listed for nutrition as of 3/23/15.

3. Patient had a careplan for respiratory when placed on a ventilator 3/19/2015. Patient was put on a trial CPAP on 3/21/2015, with no update of careplan.

4. Patient was started on IV antibiotics for a surgical procedure. The patient had a gastric tube placement 3/23/15. There is no careplan or documentation found for gastric status or medication changes.

5. Patient #12 was sedated on 3/19/2015. The Neurological/ Psychological section of the careplan was blank.

6. The pain management section of the care plan was blank.


Review of patient # 3's chart revealed no care plan found.


Review of patient #24's chart revealed that she was admitted 2/7/2015, with Respiratory Failure, Bradycardia, Hypertension, Morbid Obesity, CVA, Non- Insulin Diabetes, Urinary Tract Infection, and Pulmonary Edema. Patient #24 expired on 2/16/15.


Review of patient #24's careplan revealed the following:

1. The admission and discharge portion of the care plan was blank.

2. Patient #24 had a urinary tract infection and the Genitourinary part of the care plan was blank.

3. Patient #24 was high risk for skin breakdown due to bed confinment, obesity, and NPO status. The Integumentary part of the care plan was blank.

4. The psychological, pain management, and safety sections of the care plan were also blank.


An interview with staff #2 and #9 on 3/24/2015, confirmed the care plans were incomplete. Staff #2 stated, "Yes, I know they are not working on them. I would have to say they are not good."

Based on review of manuals, employee files, nursing schedules, and interviews, the facility failed to have a Director of Nurses to ensure adequate supervision and evaluation of clinical activities of non- employee agency nurses.


Review of the nursing schedule from 3/1/2015- 3/23/2015, revealed 18 out of 46 shifts were filled with Agency nurses. The facility did not have a Director of Nurses (DON) during this time frame.


Interview with staff #9 confirmed that there has not been a DON supervising the agency nurses. Staff #9 reported that she has been responsible for the schedule and orientation of agency nurses. Staff #9 reported that the agency nurse gets a copy of the employee orientation book and staff #9 takes them around to the units. When staff #9 was asked, "How long is the orientation of an agency nurse?" Staff #9 reported it takes about 30 minutes. It just depended on how experienced the nurse was. Failure to properly orient and supervise non-employee nursing personnel can cause potential for patient harm and possible death.

Based on document review, the Respiratory Therapist was performing the duties of a licensed nurse by taking and placing medical orders in the patient's medical record. The respiratory personnel took an order from a physician and placed the order in the medical record to place a patient on Hospice Care. It is not in the Scope of Practice for a Respiratory Therapist or Respiratory Technicians to take physician orders that would change the patient's Plan of Care.


A review of the document provided by the facility and titled Respiratory Care Scope of Practice revealed:


Definition: "Respiratory Care" is defined as the healthcare discipline that specializes in the promotion of optimum cardiopulmonary function and health.

Respiratory Therapists apply scientific principles to prevent, identify, and treat acute or chronic dysfunction of the cardiopulmonary system. Knowledge of the scientific principles underlying cardiopulmonary physiology and pathophysiology, as well as biomedical engineering and technology, enable respiratory therapists to effectively assess, educate, and treat patients.

As a health care profession, Respiratory Care is practiced under medical direction across the health care continuum. Respiratory Care is specifically focused on the assessment, treatment, management, control, diagnostic evaluation, education, and care of patients with deficiencies and abnormalities of the cardiopulmonary system as well as on the prevention of the development of these deficiencies. Critical thinking, patient/environment assessment skills, and evidence-based clinical practice guidelines enable respiratory therapists to develop and implement effective care plans, patient driven protocols, disease-based clinical pathways, and disease management programs. A variety of venues serve as the practice site for this health care profession including, but not limited to: acute care hospitals, diagnostic laboratories, rehabilitation and skilled nursing facilities, patients ' homes, patient transport systems, physician offices, convalescent and retirement centers, educational institutions, and wellness centers.

2.0 Scope of Practice: The practice of Respiratory Care encompasses activities in: diagnostic evaluation, therapy, and education of the patient, family and public.

2.1 Diagnostic activities include but are not limited to:
(1) obtaining and analyzing physiological specimens;
(2) interpreting physiological data;
(3) performing tests and studies of the cardiopulmonary system.

2.2 Therapy includes but is not limited to application and monitoring of:
(1)medical gases (excluding anesthetic gases)and environmental control systems;
(2) mechanical ventilator support;
(3) artificial airway care;
(4) bronchopulmonary hygiene;
(5) pharmacological agents related to respiratory care procedures:
(6) cardiopulmonary rehabilitation;
(7) hemodynamic cardiovascular support and
(8) coordinating patient discharge through discharge planning and appropriate home care companies.



The facility provided no evidence of patient driven protocols that would allow respiratory staff to take medical orders.

A review of patient #25 ' s medical record revealed RT staff #5 wrote a telephone order to consult Harbor Hospice for this patient.

Based on interview and document review, the facility failed to provide safe administration of blood by failing to:
1) accurately document the administration of blood ,
2) consistently monitor and record vital signs (V/S) during the blood infusion process,
3) monitor and record vital signs one hour after the completion of blood infusion and
4) document which patient received 1 unit of blood that was documented as delivered to the nurses station, and
5) the facility failed to follow its established policies and procedures for blood administration.
This pattern was evident for all patients who received blood transfusions at the facility.

On 3/24/2015, review of the "Blood and Blood Products Receipt log" revealed the following; of 14 units of blood recorded for 8 patients no corresponding patient identifiers were recorded 9 of 9 patients on the blood receipt log (#1, #2, #9, #26, #27, #28, #29, #30, and #31).

1.) Review of facility documentation and the Medical Record (MR) for patient (Pt/pt.) #1 revealed the following:
The Blood and Blood Products Receipt Log Identified three (3) units of blood were received on two (2) separate days. On 3/6/2015, 1 of 2 units of blood were recorded as received. One identifying number is recorded, W036515184912. Each unit of blood is tagged with a different identifying number. There is no follow-up documentation on the receipt log that identified the second unit of blood. Nursing documentation does not clarify if the second unit was received or if the physician discontinued the order.
Review of pt. #1's Blood and Blood Component Flow Sheet indicated on 3/6/2015, a single unit of blood was started at 2356 (11:56 p.m.) The blood unit was identified as W036515207055. V/S were recorded five minutes apart for 4 sets. Then at 30 minutes after the last set, then 1 hour later and the final V/S were recorded when the unit was completely infused at 0230. This unit was not recorded on the Blood and Blood Products Receipt Log.
Further review of pt. #1's MR revealed on 3/16/2015, revealed that he received a hemodialysis (HD) treatment where two (2) units of blood were infused. The first unit was identified as W036515204465. HD was documented as started at 1715 and the first unit of blood was started 1745(5:45 p.m.). The second unit was identified as W036515204442. It was documented as started at 1900 (7:00 p.m..) Pt #1's HD treatment concluded at 2045, (8:45 p.m.).
Further review revealed that prior to pt. #1 receiving HD and two (2) units of blood, documentation reflected the following; on 3/16/2015, at 1515 (3:15), Blood unit W036515184912 was started and not completed until 1830. Pt #1 was in HD on 3/16/2015, from 1715 until 2045. The staff nurse documented the unit of blood she administered ended 15 minutes after the HD nurse administered the first unit during the HD treatment. Review of the nurses documentation on the 12 hour nurses notes dated March 16, 2015, found no mention of a blood transfusion on the shift prior to HD. Documentation mentioned only 2 units of blood given during the HD treatment. Finally, the identification number W036515184912 was documented on the receipt log on 3/6/2015, ten days before it was administered.

2.) Review of patient # 9 revealed that he received blood transfused over 6 hours. Two (2) sets of vital signs (VS) were documented. At the initiation of the blood transfusion, initial vital signs included a temperature, pulse, respiration and blood pressure. There were no other V/S's documented until the transfusion was complete. On 3/24/2015, in the afternoon staff Registered Nurse (RN) #9 confirmed this finding.

3.) Review of MR for patients #1, #2, #26, #27, #28, #29, #30 and #31 revealed that the facility's Blood Administration form, found in each patient's record, did not identify a location to document vital signs 1 hour after the blood transfusion was completed, therefore, the Registered Nursing staff documented vital signs when they completed the infusion of the blood. There was no further documentation of patient V/S's for blood transfusion reaction. On 3/24/2015, in the afternoon interview with the Infection Control /Quality Assessment Process Improvement Nurse confirmed vital signs were not being documented 1 hour post transfusion.

4.) Review of the Blood and Blood Products Receipt Log revealed on 2/17/2015, Employee # 33's printed name appeared on the log in the "Blood Transporter's Name" column. This indicated a blood product was transported into the facility from the blood bank. No other data appeared on the line. There was no patient name, no time that indicated the unit was received, no time the unit was hung, no number of units received, no temperature of the blood, no condition of the blood, no blood identification sticker, no nurse who received the blood and no indication the blood was returned to the blood bank.

5.) Review of the following policies:
a. Blood and Blood Products Pick up and Receipt Documentation Policy. Only Staff members who have been trained on the transportation and handling of blood and blood products will be allowed to pick up and transport blood between the contracted lab and the facility. On 3/24/2015, in the a.m., interview with nursing staff #31 and #31 indicated when the physician ordered blood whoever was available would go get it. There was no one in particular who was designated to retrieve the blood and bring it to the facility from the contracted blood bank.
Further review of the policy revealed the following data will be documented on the Blood and blood Products Receipt Form. "Name of patient whom the blood is for, date and time of receipt, number of units, temperature of unit, Unit number, name of person transporting the blood, name of person receiving blood, Integrity of the unit (compromised or intact), time transfusion began, date and time unused blood returned (if applicable)." The facility failed to follow its policy and consistently record the required data.

b. Blood and Blood Products Transfusion Policy. Found under Procedure:
e). Infuse (blood) slowly for first 50 cc (cubic centimeter), observe the patient for signs and symptoms of an adverse reaction.
f). VS (are) to be taken, after the first 50 cc, then every hour until complete and 1 hour post completion.
Nursing documentation on the Blood and Blood Component Flow Sheet did not indicate the first 50 cc as slowly infused or that VS were taken after the first 50 cc were infused. The dates and times simply indicate when the transfusion began and when it ended. The nursing staff also failed to document 1 hour post VS. The facility failed to document VS as part of the safety protocol for administration of blood products to patients.

On 3/24/2015, at 9:00 a.m., in the Infection Control (IC)/Quality Assessment Process Improvement (QAPI) nurse's office the IC/QAPI nurse indicated a local hospital held the outside lab contract which included the blood bank.

At 2/24/2015, at 10:00 a.m., at the nurse's station, an interview with staff RN (Registered Nurse) #30 revealed the process for blood administration as he understood it. The nurse received the order to draw blood form the patient for a type and cross match. The blood would be transported to the contracted hospital lab. Once the type and cross match (t/c) was completed and the blood was available, either the security officer from the contract service would transport the blood to the facility or whoever was available from the facility would go retrieve the blood from the contracted hospital. Once the blood was brought into the building, a book was signed that indicated the blood had arrived and who had transported it.

Once the blood was available, the nurse would start the blood and vital signs (VS) would be taken. Staff RN #30 indicated the V/S would be taken every 15 minutes times 2, every 30 minutes times 2 and every hour thereafter until complete. When staff #30 was questioned about post transfusion V/S's, he replied "yes post V/S would be taken too." When he was asked about assessment, he replied we check V/S, output and breathing. Pt #9's chart was reviewed and staff #30 was asked to locate the 1 hour post V/S's. He indicated that the last final V/S's must be the 1 hour post transfusion V/S's because "every nurse knows you must take them." Continued review revealed the transfusion ended when the last VS was documented. No 1 hour post transfusion VS were recorded.

Although staff was aware of the industry standard for 1 hour post blood transfusion V/S, no nurse was assessing and documenting the 1 hour required V/S. Nursing staff were unaware of the facilities policy for V/S. They were also unaware of the facilities policies for Receipt of Blood and Blood components and administration of blood and blood components.

Based on reviewed documents and staff interviews, the facility failed to follow its own policy and procedures for discharge planning. The facility failed to document any discussion of the results of the discharge evaluation with the patient or individual acting on his or her behalf in 5(#7, 8, 13, 14, and 15) of 5(#7, 8, 13, 14, and 15) charts reviewed.

A review of the facility's "Policy and Procedure Title: 3300.430 Discharge Planning" revealed the facility's policy for documentation procedure states, "The discharge planning and social services provided are documented in the designated area of the patient's medical record following each contact with or on behalf of the patient. Documentation should be brief and concise and should include dates of services, source of referral, plan of service and outcome. Each contact with patient or family should be noted. If contacts are very extensive they may be summarized periodically. If for some reason a requested service cannot be; provided, this should be indicated. The discharge plan itself will be documented and will include an evaluation of the availability of appropriate services to meet the patient's identified needs. Discharge documentation should include discharge date, discharge destination and arrangements made."

An interview conducted on 3/23/2015, with staff #6, revealed that the Case Manager of the facility was the only staff conducting discharge planning duties and the facility does not have a social worker on staff. Staff #6 reported contact with or, on behalf of the patient, in regard to discharge planning, was not being documented in the medical record. Staff #6 presented a form she developed to use for discharge planning documentation but, reported she has not been able to get Administrative approval to use the form.

A review of patient #7, #8, #13, #14, and #15 charts revealed there was no documentation following each contact with or on behalf of the patient in regard to discharge plans.

Based on reviewed documents and staff interviews, the facility failed to follow its own policy and procedures. The facility failed to document in the medical record following each contact with or on behalf of the patient. The facility failed to include a discharge planning evaluation in the patient's medical record in 5(#7, 8, 13, 14, and 15) of 5(#7, 8, 13, 14, and 15) charts reviewed.

A review of the facility's "Policy and Procedure Title: 3300.430 Discharge Planning "revealed the facility's policy for documentation procedure states, "The discharge planning and social services provided are documented in the designated area of the patient's medical record following each contact with or on behalf of the patient. Documentation should be brief and concise and should include dates of services, source of referral, plan of service and outcome. Each contact with patient or family should be noted. If contacts are very extensive they may be summarized periodically. If for some reason a requested service cannot be; provided, this should be indicated. The discharge plan itself will be documented and will include an evaluation of the availability of appropriate services to meet the patient's identified needs. Discharge documentation should include discharge date, discharge destination and arrangements made."

An interview conducted on 3/23/2015, with staff #6, revealed the Case Manager of the facility was the only staff conducting discharge planning duties and the facility does not have a social worker on staff. Staff #6 reported contact with or, on behalf of the patient, in regard to discharge planning, was not being documented in the medical record. Staff #6 presented a form that she developed to use for discharge planning documentation but, reported she has not been able to get Administrative approval to use the form.

Based on reviewed documents and staff interviews, the facility failed to implement their own policies and protocols that address its organ procurement responsibilities as revealed in 4 (#23, 24, 25, and 26) of 4 (#23, 24, 25, and 26) charts reviewed.

Review of the facility's "Policy & Procedure Title: 3300:085" revealed the following statements: "Harbor Hospital in collaboration with STA (Southwest Transplant Alliance) shall ensure that the family of each potential donor is informed of their option to donate organs, tissue or eyes. The individuals designated by the hospital to initiate the request to the family must be an organ procurement representative or a designated requestor." The policy states, "'Designated Requestor' is an individual who has completed a course offered or approved by the Organ Procurement Organization (OPO) and designed in conjunction with the tissue and eye bank community in the methodology for potential donor families and requesting organ or tissue donation. "

An interview with staff #9 on 3/24/2015, revealed that the charge nurse was not aware of the hospital's policy that only an organ procurement representative or a "designated requestor" may initiate contact with the family for donation. When asked who normally approached a patient's family to initiate the organ/tissue donation process/conversation, staff #9 stated, "the nurses usually ask the family about donation." Staff #9 stated, "I have asked families many times if they were interested in donation."

Review of the facility's "Policy & Procedure Title: 3300:085" revealed the following statement: "Harbor Hospital endorses organ and tissue donations for transplantation and encourages the utilization of its resources and efforts by its employees and medical staff to ensure that the Southwest Transplant Alliance (STA) is notified in a timely manner of all individuals whose death is imminent or who have died in the hospital." The policy further states, "Referrals for potential organ donation will occur in a timely manner, at or near the time of death regardless of age or medical history. Timely manner for organ donation referral is defined as:
a. At or before pronouncement of brain death
b. When Glasgow Coma Scale is less than or equal to 4
c. Documentation of at least three (3) absent brain stem reflexes and no spontaneous breathing (the patient must be maintained by continuous mechanical ventilation)."
"Referrals for potential tissue only donation will occur at or near the time of cessation of cardiopulmonary function, regardless of age or medical history by calling STA referral line at 1-800-201-0527."

The Procedure section of the Policy & Procedure Title: "3300:085" states,
"1. The nursing staff will be responsible for calling the STA referral line for all potential donors. General information concerning the potential donor's health history will be reviewed with the primary nurse. The STA referral line contact person will then determine if the potential donor is a medically suitable candidate for donation or is to be ruled out as a donor.
2. If the potential donor is ruled out, the nurse is required to list the reason, time and the name of the STA contact person in the Final Disposition of the Body Form. The family is not approached about donation.
3. If the STA contact person determines that the potential donor is a medically suitable candidate, a designated requestor for organ and or tissue donation will then be notified by the STA contact person. The designated requestor will then call the nursing unit for additional information regarding the potential donor and may contact the family for donation. Rule out must be recorded in the Final Disposition of the Body Form."

Review of patient #23's chart and the "DEATH REPORT AND AUTHORIZATION FOR RELEASE" form revealed the patient died on 1/26/2015 at 11:20 a.m. and Southwest Transplant Alliance (STA) was notified of the patient's death on 1/26/2015 at 11:40 a.m. The form documentation stated the following: "Medically Nonviable for Tissue Donation: Deferred for organ donation à #413619" .

Review of patient #23's chart and "ANATOMICAL GIFT WORKSHEET (Organ and Tissue)," form dated 1/26/2015, revealed documentation that Southwest Transplant Alliance was notified at 11:40 a.m. with the case referral number #413619 and the name "Tammie" along with the statement, "deferred for organ donation" were written next to the referral number. The referral was made 20 minutes after the patient's death and could be considered a "timely notification." There was no documentation found in the patient's chart stating the reason that the patient was ruled out as a potential donor.

Review of patient #24's chart and the "DEATH REPORT AND AUTHORIZATION FOR RELEASE" form revealed the patient died on 2/16/2015 at 12:35 p.m. The form documentation does not address organ donation or referral to Southwest Transplant Alliance.

Review of patient #24's chart and "ANATOMICAL GIFT WORKSHEET (Organ and Tissue)," form dated 2/16/2015 revealed documentation that Southwest Transplant Alliance was notified at 3:20 p.m. with the case referral number #417024 and the statement, "R/O due to age & eyes also denied" written next to the referral number. The referral was made 2 hours and 45 minutes after the patient's death and would NOT be considered a "timely notification." There was no further documentation found in the patient's chart stating any other reason that the patient was ruled out as a potential donor.

Review of patient #25's chart and the "DEATH REPORT AND AUTHORIZATION FOR RELEASE" form revealed the patient died on 1/28/2015 at 7:50 a.m. and Southwest Transplant Alliance was notified of the patient's death on 1/28/2015 at 9:15 a.m. The form documentation stated the following: "Medically Nonviable for Tissue Donation: declined - referral #413894".

Review of patient #25's chart and "ANATOMICAL GIFT WORKSHEET (Organ and Tissue)," form dated 1/28/2015 revealed documentation that Southwest Transplant Alliance was notified at 9:15 a.m. with the case referral number #413894 and the name "Wayne" along with the statement, "Ruled out àDeclined" were written next to the referral number. The referral was made 1 hour and 25 minutes after the patient's death and would NOT be considered a "timely notification." There was no documentation found in the patient's chart stating the reason that the patient was declined or ruled out as a potential donor.

Review of patient #26's chart and the "DEATH REPORT AND AUTHORIZATION FOR RELEASE" form revealed the patient died on 1/12/2015 at 10:37 p.m. The form documentation does not address organ donation or referral to Southwest Transplant Alliance.

Review of patient #26's chart and "ANATOMICAL GIFT WORKSHEET (Organ and Tissue)," form dated 1/12/2015 revealed documentation that Southwest Transplant Alliance was notified at 11:22 p.m. with the case referral number #411331 along with the marked check box that stated, "Patient determined unsuitable by Procurement Coordinator, no approach necessary." The referral was made 45 minutes after the patient's death and could be considered a "timely notification." There was no further documentation found in the patient's chart that stated the reason that the patient was determined unsuitable as a potential donor.

Based on review of the facility's written agreement with the Organ Procurement Organization (OPO), reviewed documents and staff interviews, the facility failed to implement their own policies and protocols that address its organ procurement responsibilities under the OPO Agreement as revealed in 4 (#23, 24, 25, and 26) of 4 (#23, 24, 25, and 26) records reviewed.

Review of the facility's "Policy & Procedure Title: 3300:085" revealed the following statements: "Harbor Hospital in collaboration with STA shall ensure that the family of each potential donor is informed of their option to donate organs, tissue or eyes. The individuals designated by the hospital to initiate the request to the family must be an organ procurement representative or a designated requestor." The policy states, "Designated Requestor" is an individual who has completed a course offered or approved by the Organ Procurement Organization (OPO) and designed in conjunction with the tissue and eye bank community in the methodology for potential donor families and requesting organ or tissue donation."

An interview with staff #9 on 3/24/2015, revealed that the charge nurse was not aware of the hospital's policy that only an organ procurement representative or a "designated requestor" may initiate contact with the family for donation. When asked who normally approached a patient's family to initiate the organ/tissue donation process/conversation, staff #9 stated, "the nurses usually ask the family about donation." Staff #9 stated, "I have asked families many times if they were interested in donation."

Review of the facility's "Policy & Procedure Title: 3300:085" revealed the following statement: "Harbor Hospital endorses organ and tissue donations for transplantation and encourages the utilization of its resources and efforts by its employees and medical staff to ensure that the Southwest Transplant Alliance (STA) is notified in a timely manner of all individuals whose death is imminent or who have died in the hospital." The policy further states, "Referrals for potential organ donation will occur in a timely manner, at or near the time of death regardless of age or medical history. Timely manner for organ donation referral is defined as:
a. At or before pronouncement of brain death
b. When Glasgow Coma Scale is less than or equal to 4
c. Documentation of at least three (3) absent brain stem reflexes and no spontaneous breathing (the patient must be maintained by continuous mechanical ventilation)."
"Referrals for potential tissue only donation will occur at or near the time of cessation of cardiopulmonary function, regardless of age or medical history by calling STA referral line at 1-800-201-0527."

The "Procedure:" section of the "Policy & Procedure Title: 3300:085" states,
"1. The nursing staff will be responsible for calling the STA referral line for all potential donors. General information concerning the potential donor's health history will be reviewed with the primary nurse. The STA referral line contact person will be then determine if the potential donor is a medically suitable candidate for donation or is to be ruled out as a donor.
2. If the potential donor is ruled out, the nurse is required to list the reason, time and the name of the STA contact person in the Final Disposition of the Body Form. The family is not approached about donation.
3. If the STA contact person determines that the potential donor is a medically suitable candidate, a designated requestor for organ and or tissue donation will then be notified by the STA contact person. The designated requestor will then call the nursing unit for additional information regarding the potential donor may contact the family for donation. Rule out must be recorded in the Final Disposition of the Body Form."

Review of patient #23's chart and the "DEATH REPORT AND AUTHORIZATION FOR RELEASE" form revealed the patient died on 1/26/2015 at 11:20 a.m. and Southwest Transplant Alliance (STA) was notified of the patient's death on 1/26/2015 at 11:40 a.m. The form documentation stated the following: "Medically Nonviable for Tissue Donation: Deferred for organ donation à #413619".

Review of patient #23's chart and "ANATOMICAL GIFT WORKSHEET (Organ and Tissue)," form dated 1/26/2015 revealed documentation that Southwest Transplant Alliance was notified at 11:40 a.m. with the case referral number #413619 and the name "Tammie" along with the statement, "deferred for organ donation" were written next to the referral number. The referral was made 20 minutes after the patient's death and would be considered a "timely notification." There was no documentation found in the patient's chart stating the reason that the patient was ruled out as a potential donor.

Review of patient #24's chart and the "DEATH REPORT AND AUTHORIZATION FOR RELEASE" form revealed the patient died on 2/16/2015 at 12:35 p.m. The form documentation does not address organ donation or referral to Southwest Transplant Alliance.

Review of patient #24's chart and "ANATOMICAL GIFT WORKSHEET (Organ and Tissue)," form dated 2/16/2015 revealed documentation that Southwest Transplant Alliance was notified at 3:20 p.m. with the case referral number #417024 and the statement, "R/O due to age & eyes also denied" written next to the referral number. The referral was made 2 hours and 45 minutes after the patient's death and would NOT be considered a "timely notification." There was no further documentation found in the patient's chart stating any other reason that the patient was ruled out as a potential donor.

Review of patient #25's chart and the "DEATH REPORT AND AUTHORIZATION FOR RELEASE" form revealed the patient died on 1/28/2015 at 7:50 a.m. and Southwest Transplant Alliance was notified of the patient's death on 1/28/2015 at 9:15 a.m. The form documentation stated the following: "Medically Nonviable for Tissue Donation: declined - referral #413894".

Review of patient #25's chart and "ANATOMICAL GIFT WORKSHEET (Organ and Tissue)," form dated 1/28/2015 revealed documentation that Southwest Transplant Alliance was notified at 9:15 a.m. with the case referral number #413894 and the name "Wayne" along with the statement, "Ruled out àDeclined" were written next to the referral number. The referral was made 1 hour and 25 minutes after the patient's death and would NOT be considered a "timely notification." There was no documentation found in the patient's chart stating the reason that the patient was declined or ruled out as a potential donor.

Review of patient #26's chart and the "DEATH REPORT AND AUTHORIZATION FOR RELEASE" form revealed the patient died on 1/12/2015 at 10:37 p.m. The form documentation does not address organ donation or referral to Southwest Transplant Alliance.

Review of patient #26's chart and "ANATOMICAL GIFT WORKSHEET (Organ and Tissue)," form dated 1/12/2015 revealed documentation that Southwest Transplant Alliance was notified at 11:22 p.m. with the case referral number #411331 along with the marked check box that stated, "Patient determined unsuitable by Procurement Coordinator, no approach necessary." The referral was made 45 minutes after the patient's death and could be considered a "timely notification." There was no further documentation found in the patient's chart that stated the reason that the patient was determined unsuitable as a potential donor.

Based on reviewed records and staff interviews, the facility failed to ensure that the family of each potential donor was informed of its options to donate organs, tissues, or eyes, or to decline to donate.

An interview conducted on 3/24/2015, with staff #2, revealed that the facility did not have Quality Assurance Performance Improvement mechanisms in place to ensure that the families of all potential donors are informed of their options to donate organs, tissues, or eyes, or to decline to donate. Staff #2 stated, "I just haven't had time to get anything set up to track organ donation."

Based on reviewed records and staff interviews, the facility failed to follow the Federal Regulation and their own policy ensuring that only a trained designated requestor or an organ procurement representative would initiate the request to the family for organ/tissue donation.

Review of the facility's "Policy & Procedure Title: 3300:085" revealed the following statements: "Harbor Hospital in collaboration with STA shall ensure that the family of each potential donor is informed of their option to donate organs, tissue or eyes. The individuals designated by the hospital to initiate the request to the family must be an organ procurement representative or a designated requestor." The policy states, "Designated Requestor" is an individual who has completed a course offered or approved by the Organ Procurement Organization (OPO) and designed in conjunction with the tissue and eye bank community in the methodology for potential donor families and requesting organ or tissue donation."

An interview with staff #9 on 3/24/2015, revealed that the charge nurse was not aware of the hospital's policy that only an organ procurement representative or a "designated requestor" may initiate contact with the family for donation. When asked who normally approached a patient's family to initiate the organ/tissue donation process/conversation, staff #9 stated, "the nurses usually ask the family about donation." Staff #9 stated, "I have asked families many times if they were interested in donation."

When asked what employee training had been given by the facility on the topic of organ/tissue donation, staff #9 stated, "we watched a video about it." Staff #9 denied being offered any other training related to organ/tissue donation.

Based on reviewed documents and staff interviews, the facility failed to adequately educate appropriate hospital staff on donation policies, procedures and issues.

An interview with staff #9 on 3/24/2015, revealed that the charge nurse was not aware of the hospital's policy that only an organ procurement representative or a "designated requestor" may initiate contact with the family for donation. When asked who normally approached a patient's family to initiate the organ/tissue donation process/conversation, staff #9 stated, "the nurses usually ask the family about donation." Staff #9 stated, "I have asked families many times if they were interested in donation."

When asked what employee training had been given by the facility on the topic of organ/tissue donation, staff #9 stated, "we watched a video about it." Staff #9 denied being offered any other training related to organ/tissue donation.

Based on review of the Governing Body(GB) minutes 2014-2015, Quality Assurance and Performance Improvement minutes for 2014, and contracted service agreements, the facility failed to have GB approved policy and procedures for physical therapy. Failure to have policy and procedures in place for patient care can lead to potential injury or even death.


Review of the policy and procedures offered by the administration for physical therapy revealed policies with the agency name on them. A contract was found on a service agreement for physical therapy in the facility.


An interview with staff #2 revealed the physical therapy was contracted through an outside agency. Staff #2 stated, "We don't have to have policy and procedures on physical therapy. They have their own." Staff #2 confirmed the facility had not adopted the physical therapy policy and procedures through Medical Staff or the GB. Staff #2 stated, "I didn't know we had to do that."

Based on observation, interview, and document review, the Chief Executive Officer and Medical Staff, failed to maintain an Infection Control Program and incorporate it into the Quality Assessment Process Improvement program.


On 3/24/2015, at 10:30 a.m., and interview with the Infection Control nurse (IC) confirmed no IC meetings had been conducted since September 2014. She stated "I have not had time to focus in IC because I'm trying to do all this Director of Nurses (DON) stuff until we can hire a DON".


On 3/25/2015, at 10:30 a.m., review of the IC meeting minutes confirmed data stopped September 2015. The IC control nurse was asked to provide the IC pan for the facility. She provided a document titled, "Policy and Procedure (P&P) Titled 4400.081 Infection Prevention and Control Plan" and stated "If this is not what you want I have all this". The IC nurse pointed toward a file cabinet which contained bits and pieces of infection control data. The data had been collected from random hospital departments but had not been reviewed or incorporated into the facilities' IC plan or IC committee.


Review of the Policy and Procedure (P&P) Titled 4400.081 Infection Prevention and Control Plan" Procedure revealed the following:

"The program will institute an active and effective infection prevention and control program through"

* Problem identification, data collection and analysis, interventions through policy and practice changes and on-going data collection to monitor success.

* Managing critical data and information through identification and description of the problem, selection of appropriate methods of measurements, data sources, preparation and distribution of reports.

* Compliance with regulations and guidelines from the CDC.(Centers for Disease Control)

*Intervention to prevent transmission of infectious diseases through review of microbiology records regularly to identify unusual clusters of a greater than usual incidence of certain species of strains and maintain regular contact with clinical, medical and nursing staff to ascertain the occurrence of disease clusters or outbreaks to assist in maintenance and monitoring of infection control procedures and to provided consultation as necessary.

* Outbreak investigation and control.

* Education and training of staff.

* Monitoring of the Infection Control Program through a multidisciplinary committee".


A review of the data presented revealed no problems had been identified in 6 months (September 2014-March 2015) and no data collected or analyzed had been identified for review. CDC guidance had not been reviewed or implemented. There had been no multidisciplinary team meeting for 6 months.


Based on the failure of the process to sanitize the flexible scopes, the infection control program had failed to identify this breach in process of high level sanitation for the bronchoscope and the gastroscopy scope.


The IC program had not implemented a plan that identified actual or potential problems. The departments had not identified how data would be collected. An interview with Lab, Dietary, Pharmacy, and Respiratory Therapy services revealed they chose their problem identifiers without input from the medical staff, IC committee or interaction with the IC nurse.


There was no evidence of infection control meetings for the medical staff to review.


An interview with the Chief Executive Officer confirmed the facility had not reviewed the infection control program or data since September 2014.


On 3/24/2015, at approximately 11:00 a.m., an interview with Staff #2 confirmed the above findings.