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Based on review of records and interview, the hospital failed to maintain and/or provide records necessary to determine staff qualifications such as current licensure, certification requirements, minimum qualifications; training and education requirements for 25 out of 25 staff personnel files requested (Staff #20, #21, #22, #23, #24, #37, #42, #47, #57, #58, #60, #63, #64, #65, #66, #67, #68, #69, #70, #71, #75, #82, #91, #96, and #97).


On 1-22-2018, five staff personnel records were requested from the hospital Human Resources (HR) Department for the dialysis staff (Staff #20, #21, #22, #23, and #24). Those records were incomplete. The contracted dialysis vendor was contacted and brought their copies of missing documents on 1-23-2018.


On the afternoon of 1-24-2018, 20 staff personnel files were requested for review. Six of the charts were brought to the conference room for review, but were incomplete. HR staff was given a list of missing documents that they were going to provide in the morning. The other 14 personnel files were not provided.


On the morning of 1-25-2018, the personnel files were requested again. At 2:00 p.m., Staff #25 brought files to be reviewed. Eight files were reviewed between 2:00 p.m. and 4:15 p.m. Those were missing documentation. Staff #25 was asked to bring the files back in the morning to complete the staff reviews. Staff #25 was asked to also bring copies of the documents that had been missing on the previous two review attempts.


Staff #25 was asked about the delay in getting files. Staff #25 advised that there were only 2 HR staff for all of the campuses and 1 was at another hospital, assisting with a survey at that facility. Staff #25 stated that part of the personnel charts had to be sent via computer from the Louisiana office; and there was a problem with the way the records had been loaded. This was preventing her from retrieving them.


On the morning of 1-26-2018, Staff #1 was advised of the problems with reviewing personnel files. Staff #1 stated he would look into where the requested files were. An hour later, Staff #55 was asked to find out when the files would be available. No information on file availability was provided. Files were not provided prior to exit conference.

Based on review of records, observation, and interview, the Governing Body failed to:

Patient Rights:

A. ensure 7 (#39, 40, 41, 53, 55, 56, and #60) of 9 (#52 and #54) patients were provided with the more commonly known complications (risks) associated with the procedure/surgery. The 7 of 9 informed consents were incomplete and did not contain the risks associated with the procedure/surgery.

B. enforce the policy titled "Informed Consent, GUIDELINES FOR OBTAINING CONSENT". Review of 7 of 9 patients consents revealed the consents were incomplete and did not contain the risks associated with the procedure/surgery.

C. ensure the powdered potassium chloride additive which was for altering concentration of the dialysate was stored in secure area.

D. ensure the security of the dialysis supplies and products in the acute dialysis unit.

E. ensure the safety of the dialysis patients in the acute unit if an emergency occurred.

F. ensure the pick-up tubes (wands) were fitting securely to the acid and bicarbonate jugs that were being used to dialyze the patients during a dialysis treatment to prevent nonbacterial contamination and evaporation.

G. ensure that 8 dialysis machines (#1, #3, #4, #5, #7, #8, #9, and #11) for the months of November and December 2017 were disinfected every 7 days and bleach clearance checked prior to the next patient use.

H. ensure dialysis staff were maintaining a clean and sanitary environment for the acute dialysis patient.

I. ensure that staff were qualified by education to perform invasive procedures for 1 (Staff #20) of 1 staff working on the acute hemodialysis unit.

J. follow its own policy and procedure to ensure alternatives were implemented before patients received chemical restraints or seclusion. There was no documentation of redirecting the patient's focus, employing verbal de-escalation, or other pertinent techniques in 3 (Patient #12, #22, and #23) out of 3 charts reviewed.

K. follow its own policy and procedure to have physician orders for the administration of a chemical behavioral restraint in 1(23) of 3 (12, 22, and 23) charts reviewed.

L. follow its own policy and procedure to conduct a comprehensive patient assessment to determine the need for other types of interventions before using a drug or medication as a restraint, perform a face to face before or within one hour of the administration of a chemical restraint, educate the patient or family on the restraint, assess the patient every 15 minutes after the restraint was given, ensure the patient was treated and monitored by competent staff. In 3 (Patient #12, #22, and #23) of 3 charts reviewed.

M. follow its own policy and procedures requiring Quality Assessment Performance Improvement (QAPI) to track data or implement monitors for any chemical restraints given in the Emergency Department (ED). QAPI failed to properly log, track, analyze, and execute a productive plan allowing hospital leadership to place into practice the actions necessary to make sure that chemical restraints were used only to assure the physical safety of the patient, staff, and others.

N. recognize a psychoactive medication given as a restriction to manage a patient's behavior as a chemical restraint in 3 (Patient #12, #22, and #23) of 3 patient charts reviewed.

O. follow its own policy and procedure to prevent patient restraints or seclusion to ever be used as a means of coercion, discipline, or convenience. Patient chart reviews and staff interviews revealed that less restrictive restraints were not applied before administering a psychoactive drug (chemical restraint). This was found to be due to a lack of knowledge concerning the definition of chemical restraints, a lack of appropriate patient assessments, administering chemical restraints without physician orders, and medical personnel administering chemical restraints without the knowledge of the medication or an understanding of why the patient was receiving the chemical restraint in 3 (Patient #12, #22, and #23) of 3 patient charts reviewed.

P. follow the facility policy and procedure for the physician to perform a face to face for a restraint and document that assessment in 3 (Patient #12, #22, and #23) of 3 patient charts reviewed. There was no documentation of a nursing assessment after chemical restraints were given. There was no documentation of patient behavior, effectiveness of the medication, or patient's physical status after the administration of the chemical restraint.

Q. have any Quality Assessment Performance Improvement (QAPI) data or monitors in place for chemical restraints in the facility. QAPI failed to properly log, track, analyze, and implement a productive plan to ensure the patients were safe before, during, and after a chemical restraint.


Nursing Service:

R. ensure the Chief Nursing Executive determined that staff were qualified by education to perform invasive procedures for 1(#20) of 1 staff working on the acute hemodialysis unit.

S. ensure adequate numbers of nursing staff on 4 of 10 units that were observed (4 South Nursing Unit and Emergency Department at Campus B, Cardiac Intensive Care Unit and Medical Intensive Care Unit at Campus A).

The facility failed to ensure adequate numbers of Registered Nurses (RN) to provide supervision of staff and patient care in critical patient care areas. Licensed vocational nurses were providing care without adequate RN supervision. The facility failed to ensure there was an adequate number of nurse's aides to assist with care in critical patient care areas.

T. ensure a Registered Nurse (RN) was assessing the patients care needs, health status, and responses to interventions. The Licensed Vocational Nurse (LVN), not an RN, was assessing the patient's changes in condition and administering intravenous medications without documented RN supervision in 1(#21) of 4(12, 21, 22, and 23) charts reviewed.

U. ensure staff #83 (RN) was qualified before assigning the staff member to care for a pediatric patient. Staff #83 provided Propofol to patient #39 in an Emergency Room setting. The facility could not provide evidence staff #83 had the required certification for Advance Life Support and Pediatric Advanced Life Support. This practice was not in the scope of practice for a Registered Nurse (RN) to give Propofol for conscious sedation.

V. to ensure they enforced their established policy. They allowed Registered Nurses (RNs) to give the medication Propofol and/or Ketamine to 6 of 6 (patient #12, 23, 39, 40, 41 and #61) patients reviewed which was not within their scope of practice.

W. ensure nurses had complete physician orders for blood and intravenous fluid administration, consents for blood administration, and nurses accurately documented blood was checked prior to administration in 5 of 6 patients reviewed for blood administration (Patient #'s 13, 17, 28, 42 and 48).

Patient #42 had sustained a hip fracture, was on medications that increased her risk of bleeding, had hip surgery and showed a decrease in her blood count. Patient #42 received blood transfusions over 24 hours after her lab results showed a decline.


Infection Control:

X. ensure a clean and sanitary environment and have an active program for preventing infections. This deficient practice was found in nine (9) of the hospital departments (4 South Nursing unit, Off Site Surgical center, Emergency Department Campus A, Critical Intensive Care Unit at Campus A, Critical Care Pharmacy, Labor and Delivery Unit Campus A, Dietary Campus A, and Dietary Campus B).

Y. ensure a sanitary environment for their nursing unit, main supply room, medication room, and emergency departments. This unit was found to have soiled suction canisters, rusted wheel casters, soiled shower drains, rusted supply carts, expired supplies. Medical supplies were stored in plastic bins that were soiled with spills and dust build-up, ceiling light covers full of dead bugs, rust on linen carts, rust on supply carts, mattresses were torn, matress and frames were soiled with dried blood..

Z. ensure off-site surgical center maintained tracheal tubes that were sterile and uncontaminated.

AA. ensure the Emergency Department at Campus A had a storage shelf for medical supplies with a protective barrier to protect supplies on the bottom shelf, maintain a clean and sanitary intravenous catheter caddy, and multi-dose vials of medication had expiration dates noted.

BB. ensure the Critical Intensive Care Unit at Campus A disposed of contaminated urinals, isolation carts were cleaned, and staff used proper infection control techniques when caring for patients in isolation.

CC. ensure the Medical Intensive unit at Campus A maintained a clean and uncontaminated isolation cart, used carts with no rusted wheel casters, and clean storage cabinets used for medications.

DD. ensure Critical Care Pharmacy Room staff used proper infection control techniques when mixing intravenous medications. The facility failed to maintain sanitary flooring in the pharmacy, maintain clean and unsoiled supply carts, used biohazard containers that closed properly, and discarded expired Intravenous solutions.

EE. ensure the Labor and Delivery unit at Campus A maintained incubators that were clean and free from spills and debris, used clean supply carts, and stored laryngoscope blades that were clean and free from contaminants and not expired.

FF. ensure the Dietary Department Campus A maintained clean floors under stationary work surfaces, clean surfaces on the frames of the heated food carts, and kept the clean storage area free from dented cooking pots, pans, and colanders.

GG. ensure Dietary on Campus B maintained a clean food preparation area free from oil and dust.

Refer to Tag A747 for further detail.



Surgical Services:

HH. ensure the surgical department sterilized implant trays and complete sets of instruments per the facility's sterilization policy or documented immediate use sterilization as an emergency. The facility's policy referenced the AORN, AAMI, and CDC guidelines. A review of the immediate use sterilization logs for the months of October, November, December 2017, and January 2018 revealed unwrapped implant trays and full sets of instruments trays were being flashed in the flash sterilizers. Also, the facility failed to follow their own policy for in hospital sterilization, the AORN (Association of perioperative Registered Nurses) standards, and the ANSI/AAMI (Association for the Advancement of Medical Instrumentation) standards and the CDC guidelines.

II. ensure that six (6) of six (6) sterilization records at Campus B were completed with the identification of the contents of the sterilizer load. Also, the facility failed to follow the AORN (Association of perioperative Registered Nurses) and the ANSI/AAMI (Association for the Advancement of Medical Instrumentation) standards.

JJ. change the cold disinfection solution (Rapicide) every 28 days per the manufacturer guidelines for the high level disinfecting of the endoscopy scopes.

KK. change the 1 Micron filter, .45 Micron filter, 0.2-Micron water filter, air filter, and the Carbon filter per the manufacturer guidelines for the Medivator scope reprocessor (washer). Also, the facility failed to change the water filter supplying water to the "Evotech ECR" endoscope washer monthly.

LL. ensure the surgical and obstetrical department provided a clean and sanitary environment.

MM. complete an update to the history and physical, to include changes in the patient's condition prior to the surgical procedure on 3 (#52, #53, and #54) of 5 (#52, #53, #54, #55, and #56) patient records reviewed. Also, the surgeon failed to follow the hospital policy titled, "History and Physical Requirement for Surgery".

OO. ensure that patient had a postoperative report immediately following the surgical procedure that was timed, name of the assistant, pre-operative and post-operative diagnosis, complications, anesthesia type, findings, and tissues removed on the chart on 2 (#46 and #47) of 6 surgical records. Also, the facility failed to follow their own medical staff rules and regulations.

Refer to Tag A0940 Surgical Services for further detail.



Anesthesia Services:

PP. ensure 2 (#39 and #41) of 3 patients (#39, #40, and #41) that received anesthesia services were provided care in a safe manner by qualified personnel. Two of three patients that received general anesthesia (Propofol) in the emergency department had a level of consciousness scored 0 (Not Responding), which indicates general anesthesia as defined per hospital policy "Anesthesia Services". These services were administered by personnel not credentialed to administer general anesthesia.

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

1.

A. ensure 7 (#39, 40, 41, 53, 55, 56, and #60) of 9 (#52 and #54) patients were provided with the more commonly known complications (risks) associated with the procedure/surgery. The 7 of 9 informed consents were incomplete and did not contain the risks associated with the procedure/surgery.

B. enforce the policy titled "Informed Consent, GUIDELINES FOR OBTAINING CONSENT".

The policy reads, "It is the physicians' responsibility to provide disclosure elements and answer questions for informed consent. The consent form should be completed at the time the explanation is given" ...

The facility's policy titled "Informed Consent, GUIDELINES FOR OBTAINING CONSENT", reads "To fill out the form, follow all the following steps:" The policy did not address the area of the consent containing the risks and hazards in connection with the procedure/ surgery.

A review of educational document and interviews confirmed the facility places the responsibility on the nurse to fill out the informed consent, place the risks associated with the procedure on the consent, and have it signed by the patient day of the procedure.

Refer to Tag A0131 for further detail.


2.

A. ensure the powdered potassium chloride additive which was for altering concentration of the dialysate was stored in secure area.


B. ensure the security of the dialysis supplies and products in the acute dialysis unit.


C. ensure the safety of the dialysis patients in the acute unit if an emergency occurred.


D. ensure the pick-up tubes (wands) were fitting securely to the acid and bicarbonate jugs that were being used to dialyze the patients during a dialysis treatment to prevent nonbacterial contamination and evaporation.


E. ensure that 8 dialysis machines (#1, #3, #4, #5, #7, #8, #9, and #11) for the months of November and December 2017 were disinfected every 7 days and bleach clearance checked prior to the next patient use.


F. ensure dialysis staff were maintaining a clean and sanitary environment for the acute dialysis patient.


G. and the Chief Nursing Executive failed to ensure that staff were qualified by education to perform invasive procedures for 1 (Staff #20) of 1 staff working on the acute hemodialysis unit.


Refer to Tag A 0386 for further detail.


It was determined that the deficient practices at the following Conditions of Participation for Patient's Rights for care in a safe setting for an Acute End-Stage Renal Disease unit posed an Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, impairment and/or subsequent death.



3.

A. follow its own policy and procedure to ensure alternatives were implemented before patients received chemical restraints or seclusion. There was no documentation of redirecting the patient's focus, employing verbal de-escalation, or other pertinent techniques in 3 (Patient #12, #22, and #23) out of 3 charts reviewed.

B. follow its own policy and procedure to have physician orders for the administration of a chemical behavioral restraint in 1 (Patient #23) of 3 (Patient #12, #22, and #23) charts reviewed.

C. follow its own policy and procedure to conduct a comprehensive patient assessment to determine the need for other types of interventions before using a drug or medication as a restraint, failed to perform a face to face before or within one hour of the administration of a chemical restraint, to educate the patient or family on the restraint, to assess the patient every 15 minutes after the restraint was given, to ensure the patient was treated and monitored by competent staff. In 3 (Patient #12, #22, and #23) of 3 charts reviewed.

D. follow its own policy and procedures requiring Quality Assessment Performance Improvement (QAPI) to track data or implement monitors for any chemical restraints given in the Emergency Department (ED). QAPI failed to properly log, track, analyze, and execute a productive plan allowing hospital leadership to place into practice the actions necessary to make sure that chemical restraints were used only to assure the physical safety of the patient, staff, and others.

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


Refer to Tag A 0154 for further detail.



4.

A. recognize a psychoactive medication given to manage a patient's behavior as a chemical restraint in 3 (Patient #12, #22, and #23) of 3 patient charts reviewed.

B. follow its own policy and procedure to prevent patient restraints or seclusion to ever be used as a means of coercion, discipline, or convenience. Patient chart reviews and staff interviews revealed that less restrictive restraints were not applied before administering a psychoactive drug (chemical restraint). This was found to be due to a lack of knowledge concerning the definition of chemical restraints, a lack of appropriate patient assessments, administering chemical restraints without physician orders, and medical personnel administering chemical restraints without the knowledge of the medication or an understanding of why the patient was receiving the chemical restraint in 3 (Patient #12, #22, and #23) of 3 patient charts reviewed.

C. follow the facility policy and procedure, for the physician to perform a face to face, for a restraint and document that assessment in 3 (Patient #12, #22, and #23) of 3 patient charts reviewed. There was no documentation of a nursing assessment after chemical restraints were given. There was no documentation of patient behavior, effectiveness of the medication, or patient's physical status after the administration of the chemical restraint.

D. have any Quality Assessment Performance Improvement (QAPI) data or monitors in place for chemical restraints in the facility. QAPI failed to properly log, track, analyze, and implement a productive plan to ensure the patients were safe before, during, and after a chemical restraint.

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

Refer to Tag A 0160 for further detail.

Based on document review and interview the facility failed to:

(A) ensure 7 (#39, 40, 41, 53, 55, 56, and #60) of 9 (#52 and #54) patients were provided with the more commonly known complications (risks) associated with the procedure/surgery. The 7 of 9 informed consents were incomplete and did not contain the risks associated with the procedure/surgery.

(B) Enforce the policy titled Informed Consent, GUIDELINES FOR OBTAINING CONSENT. The policy reads, "It is the physicians' responsibility to provide disclosure elements and answer questions for informed consent. The consent form should be completed at the time the explanation is given" ...

The facility's policy titled Informed Consent, GUIDELINES FOR OBTAINING CONSENT, reads "To fill out the form, follow all the following steps:" The police did not do not address the area of the consent containing the risks and hazards in connection with the procedure/ surgery.

A review of educational document and interviews confirmed the facility places the responsibility on the nurse to fill out the informed consent and place the risks associated with the procedure on the consent have it signed by the patient day of the procedure.


(A)
A review of the ED record for Patient #39 revealed a 13-year-old male presented to the Emergency Department on 1/9/2018 via EMS for left wrist injury and deformity post fall. Patient #39 was seen by Physician#94 at 8:31 P.M.

A review of the consent revealed it was incomplete. The risks and hazards of the procedure was not completed on the consent. There was not a witness signature on the consent.


A review of the ED record for patient #40 revealed she was a 62-year-old male patient who was brought to the on 12/23/2017 ER by EMS for possible hip dislocation. The patient was seen by Physician #94 at 1:34am.

A review of the consent revealed it was incomplete. The risks and hazards of the procedure was not completed on the consent. The consent revealed patient #40 was going to receive conscious sedation but there was no reason why the patient was receiving sedation.

A review of the document titled Pre-Procedure Assessment revealed "patient on monitor for procedure. General consent signed." No procedure was listed.

A review of the document titled Intra-Procedure revealed patient #40 received the anesthetic agent, Propofol but there was no reason why or procedure listed.


A review of the ED record for patient #41 revealed she was a 54-year-old female patient who was brought to the ER on 11/25/2017 by EMS for possible hip dislocation. The patient was seen by Physician #93 at 11:29pm.

A review of the consent revealed it was incomplete. The risks and hazards of the procedure was not completed on the consent.


A review of the surgical consent for patient #53, dated 11/1/2017 and timed 6:30am revealed it was incomplete. The patient was being consented for a Closed Reduction with Percutaneous Pinning of the left wrist with possible Distal Radius Osteotomy. The risks and hazards of the procedure was not completed on the consent.


A review of the surgical consent for patient #55, dated 11/30/2017 and timed 10:15am revealed it was incomplete. The patient was being consented for a Primary Repair of Umbilical Hernia. The risks and hazards of the procedure was not completed on the consent.


A review of the surgical consent for patient #56, dated 11/30/2017 and timed 9:40am revealed it was incomplete. The patient was being consented for a Primary Repair of Umbilical Hernia. The risks and hazards of the procedure was not completed on the consent.


A review of the surgical consent for patient #60, dated 1/10/2018 and timed 6:25am revealed it was incomplete. The patient was being consented for an esophageal dilation with General Anesthesia. The risks and hazards of the procedure was not completed on the consent.


A review of the facility Policy titled Informed Consent revealed in the section titled GUIDELINES FOR OBTAINING CONSENT: It is the physician's responsibility to provide disclosure elements and answer questions for informed consent. The consent form should be completed at the time the explanation is given ..... 7. Do not leave any lines blank.


An interview on 1/22/2018 at approximately 11:00am with staff #86 revealed patients are not to receive a procedure or be taken to surgery if the consent ins no completed.

An interview on 1/23/2018 at approximately 11:00am with staff #90 revealed patients are not to receive a procedure or be taken to surgery if the consent ins no completed.



(B)
A review of the facility Policy titled Informed Consent revealed in the section titled GUIDELINES FOR OBTAINING CONSENT: It is the physician's responsibility to provide disclosure elements and answer questions for informed consent. The consent form should be completed at the time the explanation is given .....

A review of the educational document provided by the facility was a copy of the Disclosure and Consent form that was completed in red. This document addresses how each line of the Consent is to be completed by the nurse. The paragraph of the Consent pertaining to risks and hazards revealed the comment in red, "This needs to be completed. If not already typed in on these lines, see attached List A, Items 1-19. Check what risk is applicable and have patient initial." (List A, procedures requiring full disclosure of specific risks and hazards,) Reference the Texas Administrative Code, Title 25, Part 7, Chapter 601


A review of the Texas Administrative Code, Title 25, Part 7, Chapter 601

601.1 General
(a) The purpose of this chapter is to implement the requirements of Texas Civil Practice and Remedies Code, Chapter 74, Medical Liability, Subchapter C, §74.102 (relating to Texas Medical Disclosure Panel).
(b) The treatments and procedures requiring full disclosure by a physician or health care provider to a patient or person authorized to consent for the patient are found in §601.2 of this title (relating to Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A) ...

601.4. Disclosure and Consent Form
(a) The Texas Medical Disclosure Panel adopts the following form which shall be used by a physician or health care provider to inform a patient or person authorized to consent for the patient of the possible risks and hazards involved in the medical treatments and surgical procedures named in the form.


A review of the document from The American College of Surgeons, titled II. Relation of the Surgeon to the Patient. Informed consent is more than a legal requirement. It is a standard of ethical surgical practice that enhances the surgeon/patient relationship and that may improve the patient's care and the treatment outcome. Surgeons must fully inform every patient about his or her illness and the proposed treatment ... The informed consent discussion conducted by the surgeon should include ... The more commonly known complications, which should be described and discussed. The patient should understand the risks as well as the benefits of the proposed operation ....


A review of the document titled EXHIBIT B: PERIOPERATIVE EXPLICATIONS FOR THE ANA CODE OF ETHICS FOR NURSES revealed:
(The document is the American Nurses Association (ANA) Code of Ethics for Nurses
listed with the Association of periOperative Registered Nurse's (AORN) Explications.)
1.4 The right to self-determination
Respect for human dignity requires the recognition of specific patient rights, particularly the right of self-determination. Self-determination, also known as autonomy, is the philosophical basis for informed consent in health care ...


Perioperative explications
...The perioperative nurse provides care to each patient undergoing surgical intervention in a manner that preserves and protects patient autonomy, dignity, and human rights. The patient's autonomy in the decision-making process is acknowledged and supported by the perioperative nurse, who provides accurate, appropriate, and reasonable information to assist the patient in making an informed choice.8 The perioperative nurse elicits the patient's response regarding perception of the surgical procedure and the implications of decisions. The perioperative nurse ensures that the patient has access to additional and accurate information 9 ...


Perioperative examples
Provides information and explains the Patient Self-Determination Act (eg, informed consent, living will, power of attorney for health care, do-not-resuscitate order, organ procurement).10 Confirms that informed consent has been granted for planned procedure11; when possible, obtains surrogate's permission for emergency surgery.


References
8. "ANA code for nurses with interpretive statements-Explications for perioperative nursing," in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2002) 54.
9. Beyea, Perioperative Nursing Data Set, second ed, 178.
10. Ibid, 182.
11. Ibid, 183.


A review of the Texas Board of Nursing's position on the Nurse Practice Act (NPA) was as follows:
"In relation to nurses, the NPA section 301.002 "definition of professional nursing" states that professional nursing does not include "medical diagnosis or prescription of therapeutic or corrective measures." (i.e.: the RN may not engage in activities that require the use of independent medical judgement)."


An interview on 1/22/2018 at approximately 11:00am with staff #86 revealed the nurses fill out most of the consents. There are a few doctors that fill out the consent in their offices.

An interview on 1/23/2018 at approximately 11:00am with staff #90 revealed the nurses fill out most of the consents.

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

A. ensure the powdered potassium chloride additive which was for altering concentration of the dialysate was stored in secure area.


B. ensure the security of the dialysis supplies and products in the acute dialysis unit.


C. ensure the safety of the dialysis patients in the acute unit if an emergency occurred.


D. ensure the pick-up tubes (wands) were fitting securely to the acid and bicarbonate jugs that were being used to dialyze the patients during a dialysis treatment to prevent bacterial contamination and evaporation.


E. ensure that 8 dialysis machines (#1, #3, #4, #5, #7, #8, #9, and #11) for the months of November and December 2017 were disinfected every 7 days and bleach clearance checked prior to the next patient use.


F. ensure dialysis staff were maintaining a clean and sanitary environment for the acute dialysis patient.


G. and the Chief Nursing Executive failed to ensure that staff were qualified by education to perform invasive procedures for 1 (Staff #20) of 1 staff working on the acute hemodialysis unit.


Cross Refer to Tag A 0386



It was determined that the deficient practices at the Acute End-Stage Renal Disease unit posed an Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, impairment and/or subsequent death.


Findings include:


A. During a tour of the facility on 01/22/18 at 9:00 AM, it was observed that in the cabinets of the acute dialysis unit were 11.5 and 5.8 grams of powdered potassium chloride additive packages. Also, there were calcium chloride 5.7 and 11.3 grams of powdered packages. The cabinets had no locking mechanism. This allowed all employees to have access to the potassium chloride. This product was being used to spike the acid concentrate in the acid jugs.


An interview with hospital pharmacist #75 on 01/23/18 at 11:00 AM confirmed that the pharmacist had no knowledge that the powdered potassium chloride was available in the hospital. Staff #75 was asked does the hospital allow potassium chloride to be available to nursing staff for mixing higher concentrates. Staff#75 stated, "No." Pharmacist was asked if the company that makes the Acid and Bicarbonate solution allows additives and, if so, does the company stand behind the product once additives have been added. Pharmacist #75 stated, "I don't know I will have to check."


B. During a tour of the facility on 01/22/18 at 10:00 AM, observed the acute dialysis unit had three (3) doors and all 3 doors were unlocked. One of the doors was to the isolation room where an isolation patient was being dialyzed. The other door led directly to the dialysis supplies and products. The main door opened to the main unit. All these doors had key access which allowed Housekeeping or other department employees access to unit. During the survey, the surveyor was able to walk into any of the 3 entrances and never found a door locked for security. The nursing staff from the floor and housekeeping had access to the dialysis supplies and products. Observed different nursing staff entering and leaving the unit. Staff #19 was asked when does housekeeping enter the unit. Staff#19 stated, "At night when we are gone." Observed in the cabinets were the powdered potassium chloride additive. The cabinets had a locking mechanism, but the lock was broken. This allowed employees access to the potassium chloride. This deficient practice allowed access to the open jugs and allowing potassium chloride additives to be added to the open jugs or tampering with the open jugs.


An interview with Staff #19 and Hospital Pharmacist on 01/23/18 at 1:00 PM confirmed that potassium chloride should not be available for the nursing staff or other hospital employees.


C. During a tour of the Acute dialysis unit on 01/22/18 at 9:00 AM, observed there was no emergency call system at the patient's bedside. The staffing for the acute dialysis unit was 1-2 patients per 1 dialysis nurse. Staff #19 was asked was there an emergency call system. Staff #19 stated, "We have to go call from the phone." The acute unit had just experienced a code in the acute unit last week where the staff member had to go to the phone and call for help.


An interview with Staff #19 on 01/22/18 on the morning of the tour, it was confirmed there was no working emergency call system in the acute dialysis unit and the staffing in the acute dialysis unit was 1 nurse per 1-2 patients.


D. During a tour of the facility on 01/22/18 at 10:00 AM, observed a patient receiving a dialysis treatment and a patient in the isolation room. The pick-up tubes (wands) were hanging out of the acid and bicarbonate jugs. Also, observed a treatment being conducted in the intensive care unit where the pick-up tubes (wands) were hanging out of the acid and bicarbonate jugs. There was no secure connection from the pick-up tube to the opening of the acid or bicarbonate jug. This deficient practice allowed for cross contamination, acid spills, and bacterial growth in the bicarbonate jug. Acid concentrate is not susceptible to bacteria contamination, but every effort should be made to keep the system closed to prevent nonbacterial contamination and evaporation per the ANSI/AAMI standards.

An interview with Staff #27 on 01/22/18 at 4:00 PM confirmed the above findings.


E. A review of the disinfection logs for dialysis machines #1, #3, #4, #5, #7, #8, #9, and #11 for the months of November and December 2017 revealed the following:


1. Machine #1 in the month of November was not bleached every 7 days prior to use. The facility failed to bleach on 11/02/17, 11/09/17 and 11/30/17. Also, on the logs there were numerous write overs and mark outs making it difficult to determine the times the bleaching had occurred.


2. Machine #4 in the month of November was not bleached every 7 days prior to use. The facility failed to bleach on 11/30/17. Also, on the logs there were numerous write overs and mark outs making it difficult to determine the times the bleaching had occurred.


3. Machine #5 in the month of November was not bleached every 7 days prior to use. The facility failed to bleach on 11/02/17 and 11/23/17. Also, on the logs there were numerous write overs and mark outs making it difficult to determine the times the bleaching had occurred.


4. Machine #9 in the month of November was not bleached every 7 days prior to use. The facility failed to bleach on 11/30/17. Also, on the logs there were numerous write overs and mark outs making it difficult to determine the times the bleaching had occurred.


5. Machine #3 in the month of December was not bleached every 7 days prior to use. The facility failed to bleach on 12/07/17, and 12/14/17. Also, on the logs there were numerous write overs and mark outs making it difficult to determine the times the bleaching had occurred.


6. Machine #4 in the month of December was not bleached every 7 days prior to use. The facility failed to bleach on 12/07/17. Also, on the logs there were numerous write overs and mark outs making it difficult to determine the times the bleaching had occurred.


7. Machine #5 in the month of December was not bleached every 7 days prior to use. The facility failed to bleach on 12/07/17. Also, on the logs there were numerous write overs and mark outs making it difficult to determine the times the bleaching had occurred.


8. Machine #7 in the month of December was not bleached every 7 days prior to use. The facility failed to bleach on 12/07/17, and 12/14/17. Also, on the logs there were numerous write overs and mark outs making it difficult to determine the times the bleaching had occurred.


9. Machine #8 in the month of December was not bleached every 7 days prior to use. The facility failed to bleach on 12/07/17. Also, on the logs there were numerous write overs and mark outs making it difficult to determine the times the bleaching had occurred.


8. Machine #11 in the month of December was not bleached every 7 days prior to use. The facility failed to bleach on 12/07/17, and 12/14/17. Also, on the logs there were numerous write overs and mark outs making it difficult to determine the times the bleaching had occurred.



An interview with the Staff #19 on 01/22/18 at 4:00 PM confirmed the above findings.


F. During a tour of the acute dialysis unit on 01/22/18 in the morning and afternoon observed the following infection control issues:

1. On the linen cart in the acute unit observed several rust spots on the bottom shelf.


2. There was an electrical outlet behind one of the acute unit stations that had exposed wires showing.


4. There were two wooden cabinets holding the pharmacy refrigerator and a computer. Both cabinets had raw wood exposed. The cabinet had large chips Formica missing.


5. During the tour observed that the dialysis staff were sharing a storage area with the endoscopy staff. This storage area contained numerous jugs of potassium and bicarbonate jugs allowing any one to have access to the dialysis products and supplies.


6. During the tour observed the water room cabinet was not secured allowing any employee access to the water system.



An interview with Staff #19 on 01/22/18 in morning and afternoon confirmed the above findings during the tour of the facility.

Based on observation, interview, and record review, the facility failed to meet the Condition of Participation for Patient Rights "Use of Restraint and Seclusion" as evidence by:

The facility failed to follow its own policy and procedure to ensure alternatives were implemented before patients received chemical restraints or seclusion. There was no documentation of redirecting the patient's focus, employing verbal de-escalation, or other pertinent techniques in 3 (12, 22, and 23) out of 3 charts reviewed.

The facility failed to follow its own policy and procedure to have physician orders for the administration of a chemical behavioral restraint in 1(23) of 3 (12, 22, and 23) charts reviewed.

The facility failed to follow its own policy and procedure to conduct a comprehensive patient assessment to determine the need for other types of interventions before using a drug or medication as a restraint, failed to perform a face to face before the administration of a chemical restraint, to educate the patient or family on the restraint, to assess the patient every 15 minutes after the restraint was given, to ensure the patient was treated and monitored by competent staff. In 3 (12, 22, and 23) of 3 charts reviewed.

The facility failed to follow its own policy and procedures requiring Quality Assessment Performance Improvement (QAPI) to track data or monitors for any chemical restraints given in the Emergency Department (ED). QAPI failed to properly log, track, analyze, and implement a productive plan to ensure hospital leadership implemented actions to ensure that chemical restraints were used only to ensure the physical safety of the patient, staff and others.

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


Patient #12

Review of patient #12's medical record revealed that he was brought in by private car to the Emergency Department (ED) of facility "B" on 1/9/2018.

Review of the Nurses Notes dated 1/9/18 at 1918 (7:18PM) revealed the patient #12 "jumped from moving vehicle head first, according to witness, after argument with girlfriend."

Review of nursing triage note on 1/9/18 at 1917(7:17PM) revealed his blood pressure was 139/120, Pulse 115, respirations 22, and temperature 98.5.

1/9/18 at 1926 (7:26PM)- MD examined patient. 1927 (7:27PM) physician orders were put in for CT scan of the head and spine without contrast and CT of the Thorax and abdomen with contrast. Review of the physician notes revealed the patient was "uncooperative" but does not document what behaviors the patient was exhibiting. The physician documented a GCS score of 15 and stated he was "alert, CN's normal (2-12), motor normal, oriented x4, sensation normal, depressed mood/affect. Road rash noted to back and buttocks. All other systems reviewed and negative. Primary Impression: Motor vehicle accident with minor trauma Additional Impression: Suicide attempt, Medical clearance for psychiatric admission, abrasions of multiple sites."(The Glasgow Coma Scale (GCS) is the most common scoring system used to describe the level of consciousness in a person following a traumatic brain injury. Severe: GCS 3-8 You cannot score lower than a 3. Moderate: GCS 9-12 Mild: GCS 13-15.)

1/9/18 1930 (7:30PM)- Contrast was administered to patient #12 while in CT scan.
A hand written verbal physician order was found on the chart dated 1/9/18 at 1915 (7:15PM). The order read, "Ketamine (Ketalar) 100 mg IM x1 dose stat. vorb: Dr.______ (#35)/ ______ (#60).The order was not signed by the ordering physician. Review of the Patient Order Summary revealed the pharmacist edited the order for Ketalar (Ketamine) Inj.

On 1/9/18 at 1921 (7:21PM). The pharmacist changed the dosage to 500 mgs instead of 100 mgs. There was no documentation on the hand written order or electronic order that the physician was aware of the changes made to the medication dosage. There was no documentation by the physician or nurse on why the patient was ordered and given Ketamine (Ketamine 'Ketalar' is a dissociative general anesthetic).

Review of the medication administration record in the ED revealed on 1/9/18 the nurse documented that she gave patient #12 500mg of Ketamine IM at 1930 (7:30PM). There was no found documentation of what the drug was given for, if the patient was assessed after the administration of the drug, the effectiveness of the drug, or vital signs.

Review of the physician orders revealed patient #12 was ordered Ativan (lorazepam) 2 mg IM. There was no documentation on the orders, physician notes, or nursing notes on why this medication was ordered.

Review of the nurses notes dated 1/9/18 at 2044 (8:44PM) stated, " Patient continues to be inconsolable crying at this time stating, " I don't wanna die" and " tell me what to do Bro!" Patient sister at bedside at this time." There was no documentation if the nurse or physician spoke with the patient or if any de-escalation techniques were performed. There was no nursing assessment performed on the patients physical or neuro status at this time.

Review of the physician orders on 1/9/18 at 2040 (8:40PM) revealed an order was placed by the physician for "Haldol 10mg IM once." There was no reason documented for the medication, on the order form. The physician electronically signed the order at 2038(8:38PM).

Review of a patient Order Summary revealed the order for Haldol 10 mg's ordered by the physician was "edited" by the pharmacist at 2047 (8:47PM).The order was now changed to Haldol 5 mgs. There was no documentation found that the physician was notified and agreed on the medication change. Nurse #57 acknowledged the order at 2050 (8:50PM). .

The Medication Administration Record (MAR) revealed nurse #57 documented Haldol 5 mg was administered 1/9/18 at 2040 (8:40PM). intramuscularly (IM) to the right thigh 10 minutes before she acknowledged the change in the medication dosage electronically. There was no documentation of why the patient was receiving this medication and/or if the patient consented to the medication.

Review of patient #12's medical record revealed the patient was cleared medically and was ready for a mental health screening at 2105 (9:05PM).

Review of patient #12's medical record revealed the patient's vital signs were documented for the first time since the patient's admission (2 hours and 8 minutes later). The vital signs were documented 1/9/18 at 2125 "B/P 105/54, pulse 63, respiratory rate 20, pulse ox 100." There was no further written assessment documented.

Review of Nurses Notes on 1/9/18 at 2105 (9:05PM), "Nurse at this time notified Carlos with Sprint that patient is medically cleared for psych eval." 2215 (10:15PM)- "Sprint Team here at this time to evaluate patient." 12:05AM, " Dr. ____ (#35) informed nurse at this time that plan is to recall Sprint Assessor______ when patient becomes less drowsy from medication." There was no further documentation that the nurse evaluated the patient's physical or mental status at this time.

Review of Nurses Notes on 1/9/18 at 2:45AM, "______ (Sprint Team Assessor) at hospital at this time for eval. 4:11AM- Based upon assessment of Sprint Team Employee, patient did tell her that he jumped out of vehicle as a suicide attempt. At this time, he is not having any suicidal ideation's. Girlfriend and her mother in room at this time for support. 6:39AM- patient to be transferred to Fannin inpatient psych."

A phone interview was done on 1/23/18 with staff #57. Staff #57 was placed on speaker phone with her supervisor #48, Risk Manager #52 and surveyors. Staff #57 stated she did not remember all the details but she did receive an order for the patient to receive ketamine. Staff #57 stated that there was a lot of "drama" going on and it was very "confusing during that time." Staff #57 stated patient #12 was in the CT scan room and she went out of the ED over to CT and administered the Ketamine. Staff #57 was asked if the medication was given as a conscious sedation or for behavioral reasons. Staff #57 confirmed she did not know why she was administering this medication. Staff #57 stated, "I would think the doctor ordered that so he could get a good scan without artifacts." Staff #57 was asked if the patient was receiving Ketamine and Haldol for behavioral issues why was it not documented as a restraint. Staff #57 stated, "We don't do restraints anymore." Staff #57 was unaware that she was administering chemical restraints and was not documenting as such. Staff #57 stated, "To be honest I didn't even know that Haldol was a psychotropic medication." Staff #57 confirmed that patients have been placed in seclusion rooms and that Geodon and Haldol are used in the ED for behavioral issues. Staff #57 reported that she only had ACLS and BLS certifications. Staff #57 did not have advanced airway education or certifications. Staff #48 confirmed that the ED has not been documenting psychotropic medications as chemical restraints at facility B.

Review of the drug information for Ketamine on the FDA.com website revealed the following:

"Ketamine (Ketalar) is a general anesthetic. Adverse Effects >10% Emergence rxns, HTN, Increased cardiac output, Increased ICP, Tachycardia, Tonic-clonic movements, Visual hallucinations, Vivid dreams. Respiration: Although respiration is frequently stimulated, severe depression of respiration or apnea may occur following rapid intravenous administration of high doses of ketamine. Laryngospasms and other forms of airway obstruction have occurred during ketamine anesthesia.

Respiratory depression may occur with over dosage or too rapid a rate of administration of ketamine, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics.

Since it suppresses breathing much less than most other available anesthetics, ketamine is used in medicine as an anesthetic; however, due to the hallucinations it may cause, it is not typically used as a primary anesthetic, although it is the anesthetic of choice when reliable ventilation equipment is not available."

Intramuscular Route

"The initial dose of ketamine administered intramuscularly may range from 6.5 to 13 mg/kg. A dose of 10 mg/kg will usually produce 12 to 25 minutes of surgical anesthesia
Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia. However, it should be noted that purposeless and tonic-clonic movements of extremities may occur during the course of anesthesia. These movements do not imply a light plane and are not indicative of the need for additional doses of the anesthetic."


Review of the drug information for Haldol on the FDA.com website revealed the following:

"HALDOL (haloperidol) Haloperidol is the first of the butyrophenone series of major antipsychotics that is indicated for use in the treatment of schizophrenia. HALDOL is indicated for the control of tics and vocal utterances of Tourette's Disorder.

HALDOL (haloperidol) should be administered cautiously to patients: with severe cardiovascular disorders, because of the possibility of transient hypotension and/or precipitation of anginal pain. Should hypotension occur and a vasopressor be required, epinephrine should not be used since HALDOL may block its vasopressor activity and paradoxical further lowering of the blood pressure may occur. Instead, metaraminol, phenylephrine or norepinephrine should be used. When HALDOL is used to control mania in cyclic disorders, there may be a rapid mood swing to depression.

Monitor for development of neuroleptic malignant syndrome (fever, respiratory distress, tachycardia, seizures, diaphoresis, hypertension or hypotension, pallor, tiredness, severe muscle stiffness, loss of bladder control). Report symptoms immediately. May also cause leukocytosis, elevated liver function tests, elevated CPK"



Patient #22

Review of patient #22's chart revealed he was brought to facility A's ED. Patient was a 62 year old male brought to the ED by police in handcuffs. Patient had a diagnosis of psychosis.

Review of the physician orders dated 10/28/17 at 1925 stated, "Give Geodon INJ 10mg IM once." There was no reason given on the order for the administration of a psychotropic medication.

Review of the nurse's notes dated 10/28/17 at 1900 revealed RN documented, "While screener was at bedside pt became hostile and started yelling. Pt threw dinner tray against the wall." There was no documentation of de-escalation or any information on other diversions attempted.

10/28/17 1902 (7:02PM)- Report given to ______ RN( staff #82.)

10/28/17 2000- pt threw his food on the floor and abusive to staff. Respirations even and non-labored. No acute distress." From 10/28/17 at 10:00PM -10/29/17 7:23AM revealed nurse documentation of patient sleeping with no acute distress.

Review of the nursing MAR revealed patient #22 received an injection of Geodon INJ 10mg IM on 10/29/17 at 5:08AM. 11 hours after the original order was given by the physician. There was no documentation found why the medication was delayed for 11 hours, why the medication was administered during a period of time when the patient was described as sleeping with no acute distress, any documentation on behaviors, nursing assessments or de-escalation or alternative methods before a chemical restraint was given. There was no documentation of the effectiveness of the medication or anursing assessment after the administration of the medication. There was no additional paperwork of a chemical restraint applied.


Patient #23

Review of patient #23's chart revealed she was a 34 year old female brought to facility A's ED on 1/5/18 at 11:23AM. The patient was 5'5 and weighed 180lbs. The patient's chief complaint was "psych complaint."

Review of the physician notes dated 1/5/18 revealed initial comments written at 11:23AM, "Patient brought in by EMS after the patient was acting unusual and threatening family members. Patient on initial examination the emergency department does not cooperate with examination has no additional history patient's hitting the sink and walls on examination and will not allow the nurse to place the armband on patient."(SIC) Patient had a documented past medical history of Bipolar Disorder.

Review of the Nurses Notes dated 1/5/18 at 11:00AM revealed staff #47 documented, "Pt brought to ED per BPD. She tore up her mother's house. Patient unapproachable, uncooperative, screaming, threatening. There was no documentation of any de-escalation attempts made to calm the patient.

Review of the patients MAR revealed patient #23 had an order scheduled for Ativan 2 mg IM and Haldol 5mg IM on 1/5/18 at 11:25AM. The medications were not administered until 11:45AM (20 minute delay) There was no documentation on why the medication was delayed for 20 minutes. There was no written order found on the chart for those medications. There was no reason documented on the MAR or the nurse's notes on why the patient was receiving these medications.

Review of the nurse notes revealed staff #47 documented, "No effects noted to Haldol/Ativan. Pt remains unapproachable and uncooperative, intermittently threatening to nurse. There was no documentation of any de-escalation techniques or alternative restraint measures taken before a chemical restraint was used. There was no documentation if the patient agreed and was willing to take the medication or if a patient hold was required to administer the medication.

Review of the patient MAR revealed patient #23 had an order schedule for Geodon 10mg IM on 1/5/18 at 12:55PM. The medication was documented as given at 1:11PM.

Review of the nurses notes revealed on 1/5/18 staff #47 documented the following;
"1300 (1:00PM)- Pt pacing around room, has removed all of her clothes.
1310-(1:10PM)- pt lying in the floor tearing up the flooring and the baseboard in the room.
1313- (1:13PM)- VS taken- Systolic 135 diastolic 83, temperature 97.8 and Pulse oximetry 93 room air.
1329-(1:29PM)- Pt confrontational, not approachable, cursing at nurse, sitting on bed, then OOB walking around room, restless.
1335- (1:35PM)- pt offered and accepted sandwich and beverages. Drank readily.
1352-(1:52PM)- pt more pleasant, stated she would like some clothes to wear and something to drink. Both were provided for her.
1355- (1:55PM)- pt ambulatory to restroom; no specimen collected."

Review of the patients chart revealed the RN has changed and staff #99 documented on 1/5/18 that the patient was sleeping at 2:28PM and 3:28PM.

Staff #99 documented the following;

1846 (6:46PM)- - pt walked out of psych room yelling, cussing, and refusing to go back into her room. Pt walked into restroom after being told not to due to toilet overflowing. Security called. Pt walked out of restroom back into her room now standing in the middle of her bed and singing loudly waking other patients in room 7.

Review of the patient MAR revealed patient #23 had a scheduled medication of Ketamine 100mgs IM at 1845. The medication was administered at 1905 (20 minutes later). There was no physician order found on the chart. There was no reason on the MAR why the medication was administered.

Review of the nurses notes revealed on 1/5/18 staff #47 documented the following;
2000 (8:00PM)- - Pt ambulatory to restroom; no specimen collected.

2005(8:05PM)- - pt stated "I don't feel good" assessed. Gagging herself by sticking her finger down her throat. Small amt of emesis." VS Taken.

Review of the physician documentation revealed;

"MDM Differential Diagnosis
Patient requiring sedation in the emergency department patient given rounds of Geodon as well as Haldol and Ativan. Patient calm down to be amenable to blood work.(SIC) Patient was evaluated psychiatric team and found to be suitable for psychiatric admission. No additional medical problems."

Review of patient #23's nurses notes dated 1/6/18 at 1:17AM revealed the RN documented, "Pt standing at the door, pt was taking her clothes off and is standing. Pt advised to put her paper scrubs back on.

2:18AM pt still standing at the door, screaming, punching the door, stating let me out of here "I am going to fuck this place up. Pt is becoming increasingly agitated and violent. Dr. _____ (staff #35) notified. Medication orders received.

3:15AM- Pt ambulated to restroom without assistance."

Review of the patient MAR revealed the patient was scheduled Geodon 20 mg IM on 1/6/18 at 0135. The medication was administered on 1/6/18 at 2:52AM. There was no physician order found on the chart. There was no vital signs obtained on this patient from 1/6/18 2:52AM until 1/6/18 at 4:38AM (1 hr and 46 minutes).

Review of the policy and procedure "Standardized Use of Restraint and/or Seclusion" revealed " II. OBJECTIVE:
This policy standardizes the indications and methods for restraint and/or seclusion to comply with ethical, regulatory, and patient-focused considerations in order to promote safety and dignity of the restrained/secluded patient and prevent the use of restraint and/or seclusion whenever possible, with the goal of being restraint/seclusion-free.


POLICY STATEMENT:
A. Hospital leadership is responsible for creating a culture that supports a patient's right to be free from restraint or seclusion. Leadership must ensure that systems and processes are developed, implemented, and evaluated that support the patients' rights addressed in this standard, and that eliminate the inappropriate use of restraint or seclusion. Through their Quality Assurance Performance Improvement (QAPI) program, hospital leadership should:

1. Assess and monitor the use of restraint or seclusion in their facility;

2. Implement actions to ensure that restraint or seclusion is used only to ensure the physical safety of the patient, staff and others; and

3. Ensure that the hospital complies with the requirements set forth in this standard as well as those set forth by State law and hospital policy when the use of restraint or seclusion is necessary."


Review of the policy and procedure "Standardized Use of Restraint and/or Seclusion" revealed the facility's definition of restraints as, "DEFINITIONS:

A. Restraint: Any method (physical or chemical) of restricting a patient's freedom of movement (including seclusion), physical activity or normal access to his or her body that:

1. is not a usual and customary part of a medical diagnostic or treatment procedure to which the patient, or his or her legal representative, has consented;

2. is not indicated to treat the patient's medical condition or symptoms; or

3. does not promote the patient's independent functioning.

4. Cannot be intentionally easily removed by the patient in the same manner that it was applied.

a) Types of restraints:

(1) Non-Violent/Non-Self Destructive Restraint: Restraint use in any care setting for medical and post-surgical care which is used to promote medical treatment and healing, e.g. protection of airway, prevention of tube removal (IV lines, feeding tubes, endotracheal tubes, etc.). Documented clinical justification is required for such use.

(2) Violent/Self Destructive Restraint: Emergency restraint use in any care setting to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others.

(3) Chemical Restraint: The use of a sedating psychotropic drug to manage or control behavior or restrict a patient's freedom that is not a usual or customary standard of treatment for the patient's medical or psychiatric condition.

(a) Use of medication to modify behavior or induce normative sleep patterns that is standard treatment for the patient's condition is NOT considered a chemical restraint.

(b) Medication ordered on a PRN basis to address patient need for protection from anxiety, fatigue, and undue environmental stimulation associated with the standard of care for the patient's diagnosis is NOT considered a chemical restraint.

(c) CMS strictly prohibits the use of chemical restraints. (U) Refer to state standards and regulations on use of chemical restraints.


PROCESS:
B. A Registered Nurse with current demonstrated competency may initiate restraint use in an emergency, based on an appropriate assessment of the patient.

C. Restraint and/or seclusion are used only when less restrictive, alternative interventions are ineffective. See list of alternatives below:

F. Notification of Attending Physician: The attending physician responsible of the management and care of the patient shall be notified about the use of restraint as soon as possible if he/she is not the ordering physician.

G. If the face-to-face evaluation of a violent/psychiatric restrained or secluded patient is completed by a trained registered nurse or physician assistant, he/she must consult the attending physician or other licensed practitioner who is responsible for the care of the patient as soon as possible after the completion of the 1-hour face-to-face examination.

H. Notification of Family: Every effort will be made to promptly notify the patient's family concerning the need for, and application of, restraint if information to the family is not contraindicated.

I. Patient/Family Education: The physician or licensed nurse will educate the patient and family regarding restraints if information to the family is not contraindicated. This education will include alternatives attempted, need for restraint, criteria for removal of restraint, and patient safety issues. The family will be assured that the patient's safety, physical and emotional needs, dignity and privacy will be respected at all times.



Review of the restraint log revealed the log only had physical restraints documented. There was no chemical restraints in the log. An interview was conducted with staff # 2 on 1/23/18. Review of the QAPI revealed the facility was aware of and following physical restraints but not chemical. Staff #2 confirmed that Quality Assurance Performance Improvement (QAPI) department was not collecting any data or trending any possible complications concerning chemical restraints.

Staff #2 was asked about the facility's policy on chemical restraints. The hospital policy stated, "(c) CMS strictly prohibits the use of chemical restraints. (U) Refer to state standards and regulations on use of chemical restraints." However, CMS does recognize the use of chemical restraints. Staff #2 was not aware of the error in the facility's policy.

An interview with staff #47 was conducted on 1/23/18. Staff #47 stated that she was hired about six months ago to work as a psychiatric nurse/psychiatric nurse educator. Staff #47 stated the facility is on a rotation schedule with another large hospital in town. Every other week ambulance and law officers will bring the psychiatric patient to the facility to be seen in emergent situations. Staff #47 stated that she works as a nurse during that week taking care of the psychiatric patients and on the opposite week she is to be doing education.

Staff #47 was asked if a patient with a psychiatric emergency comes into the facility on the off week who takes care of them. Staff #47 stated that this does happen frequently and if she is here she does. If staff #47 is off then staff from the ED are assigned to that area.

Staff #47 was asked what education has been done with the staff concerning the psychiatric patient and when was it implemented. Staff #47 stated that they had rolled out a new physician order form that would be easier for the physicians on restraints. When the surveyors reviewed the form there was no order box for chemical restraints. Staff #47 was asked about chemical restraints. Staff #47 stated we don't do chemical restraints here. When staff #47 was told about the multiple chemical restraints given she stated, "Those were not chemical restraints they are medications to treat their condition." Staff #47 stated she "knows the regulations." When staff #47 was asked what the definition of chemical restraints was she was unable to give a clear answer. Staff #47 confirmed she did not understand that the chemical restraints being given in the ED were actually chemical restraints.

Staff #47 stated that the company had started a "Task Force" for mental health patients in the ED. However, the first meeting was "2 weeks ago" and there was no education or plans to be rolled out on care of this patient population.
An interview with staff #47 Director of ED Facility B and #50 Director of ED Facility A was conducted on 1/23/17. Both staff members confirmed that they were not aware that the psychotropic medications given in an emergent behavioral crisis were considered chemical restraints. Staff #47 and #50 confirmed that the staff had not been documenting or treating as such and would need to be addressed.

An interview with staff #34 ED Physician was conducted 1/24/18 at 3:50PM. Staff #34was asked why he would order Ketamine IM in the ED. Staff #34 stated that low doses were ordered for management of agitation. Staff #34 felt that the patients would need that when severely agitated to prevent Rhabdomyolysis (Rhabdomyolysis is a condition in which damaged skeletal muscle breaks down rapidly.) Staff #34 was asked about chemical restraints administered in the ED. Staff #34 stated he did not administer chemical restraints and psychotropic medications given in the ED were to treat the patients underlying problems. Staff #34 stated that he would not treat a psychiatric patient any differently than a medical patient. When asked about using a lesser restrictive restraint such as seclusion or physical restraints staff #34 stated, " That would just be cruel to tie a patient down that's already having hallucinations. I think that's very unfair to do to them." Staff #34 did not have a clear understanding of the CMS or State guidelines for mental health patients receiving chemical restraints for behavioral issues. Staff #34 did confirm that the documentation was lacking and there was an issue with the complicated computer system they are currently using. Staff #34 reported that the "system is difficult to manage and they have to decide if their time is spent documenting or treating the patient."

Based on observation, interview, and record review, the facility failed to meet the requirements for the "Use of Restraint and Seclusion" as evidence by;

Staff failed to recognize a psychoactive medication given to restrict a patient's behavior as a chemical restraint in 3(12, 22, and 23) of 3 patient charts reviewed.

The facility failed to follow its own policy and procedure to prevent patient restraints or seclusion to ever be used as a means of coercion, discipline, or convenience. Patient chart reviews and staff interviews revealed that less restrictive restraints were not applied before administering a psychoactive drug (chemical restraint), due to a lack of knowledge concerning the definition of chemical restraints, appropriate patient assessments, administering chemical restraints without physician orders, and medical personnel administering chemical restraints without the knowledge of the medication or an understanding of why the patient was receiving the chemical restraint in 3(12, 22, and 23) of 3 patient charts reviewed.

There was no documentation of a nursing assessment after chemical restraints were given. There was no documentation of patient behavior, effectiveness of the medication, or patient's physical status after the administration of the chemical restraint.

The facility failed to follow the facility policy and procedure for the physician to perform a face to face for a restraint and document that assessment in 3(12, 22, and 23) of 3 patient charts reviewed.

The facility failed to have any Quality Assessment Performance Improvement (QAPI) data or monitors in place for chemical restraints in the facility. QAPI failed to properly log, track, analyze, and implement a productive plan to ensure the patients were safe before, during, and after a chemical restraint.

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


Patient #12

Review of patient #12's medical record revealed the he was brought in by private car to the Emergency Department (ED) of facility "B" on 1/9/2018.

Review of the Nurses Notes dated 1/9/18 at 1918 (7:18PM) revealed the patient #12 "jumped from moving vehicle head first, according to witness, after argument with girlfriend."

Review of nursing triage note on 1/9/18 at 1917(7:17PM) revealed his blood pressure was 139/120, Pulse 115, respirations 22, and temperature 98.5.

1/9/18 at 1926 (7:26PM)- MD examined patient. 1927 (7:27PM) physician orders were put in for CT scan of the head and spine without contrast and CT of the Thorax and abdomen with contrast. Review of the physician notes revealed the patient was "uncooperative" but does not document on what behaviors the patient is exhibiting. The physician documented a GCS score of 15 and stated he was "alert, CN's normal (2-12), motor normal, oriented x4, sensation normal, depressed mood/affect. Road rash noted to back and buttocks. All other systems reviewed and negative. Primary Impression: Motor vehicle accident with minor trauma Additional Impression: Suicide attempt, Medical clearance for psychiatric admission, abrasions of multiple sites."(The Glasgow Coma Scale (GCS) is the most common scoring system used to describe the level of consciousness in a person following a traumatic brain injury. Severe: GCS 3-8 You cannot score lower than a 3. Moderate: GCS 9-12 Mild: GCS 13-15.)

1/9/18 1930 (7:30PM)- Contrast was administered to patient #12 while in CT scan. A hand written verbal physician order was found on the chart dated 1/9/18 at 1915 (7:15PM). The order read, "Ketamine (Ketalar) 100 mg IM x1 dose stat. vorb: Dr.______ (#35)/ ______ (#60).The order was not signed by the ordering physician. Review of the Patient Order Summary revealed the pharmacist edited the order for Ketalar (Ketamine) Inj.

On 1/9/18 at 1921 (7:21PM). The pharmacist changed the dosage to 500 mgs instead of 100 mgs. There was no documentation on the hand written order or electronic order that the physician was aware of the changes made to the medication dosage. There was no documentation by the physician or nurse on why the patient was ordered and given Ketamine (Ketamine 'Ketalar' is a dissociative general anesthetic).

Review of the medication administration record in the ED revealed on 1/9/18 the nurse documented that she gave patient #12 500mg of Ketamine IM at 1930 (7:30PM). There was no found documentation of what the drug was given for, if the patient was assessed after the administration of the drug, the effectiveness of the drug, or vital signs.

Review of the physician orders revealed patient #12 was ordered Ativan (lorazepam) 2 mg IM. There was no documentation on the orders, physician notes, or nursing notes on why this medication was ordered.

Review of the nurses notes dated 1/9/18 at 2044 (8:44PM) stated, " Patient continues to be inconsolable crying at this time stating, " I don't wanna die" and " tell me what to do Bro!" Patient sister at bedside at this time." There was no documentation if the nurse or physician spoke with the patient or if any de-escalation techniques were performed. There was no nursing assessment performed on the patients physical or neuro status at this time.

Review of the physician orders on 1/9/18 at 2040 (8:40PM) revealed an order was placed by the physician for "Haldol 10mg IM once." There was no reason documented for the medication, on the order form. The physician electronically signed the order at 2038(8:38PM).

Review of a patient Order Summary revealed the order for Haldol 10 mg's ordered by the physician was "edited" by the pharmacist at 2047 (8:47PM).The order was now changed to Haldol 5 mgs. There was no documentation found that the physician was notified and agreed on the medication change. Nurse #57 acknowledged the order at 2050 (8:50PM). .

The Medication Administration Record (MAR) revealed nurse #57 documented Haldol 5 mg was administered 1/9/18 at 2040 (8:40PM). intramuscularly (IM) to the right thigh 10 minutes before she acknowledged the change in the medication dosage electronically. There was no documentation of why the patient was receiving this medication and/or if the patient consented to the medication.

Review of patient #12's medical record revealed the patient was cleared medically and was ready for a mental health screening at 2105 (9:05PM).

Review of patient #12's medical record revealed the patient's vital signs were documented for the first time since the patient's admission (2 hours and 8 minutes later). The vital signs were documented 1/9/18 at 2125 "B/P 105/54, pulse 63, respiratory rate 20, pulse ox 100." There was no further written assessment documented.

Review of Nurses Notes on 1/9/18 at 2105 (9:05PM), "Nurse at this time notified Carlos with Sprint that patient is medically cleared for psych eval." 2215 (10:15PM)- "Sprint Team here at this time to evaluate patient." 12:05AM, " Dr. ____ (#35) informed nurse at this time that plan is to recall Sprint Assessor______ when patient becomes less drowsy from medication." There was no further documentation that the nurse evaluated the patient's physical or mental status at this time.

Review of Nurses Notes on 1/9/18 at 2:45AM, "______ (Sprint Team Assessor) at hospital at this time for eval. 4:11AM- Based upon assessment of Sprint Team Employee, patient did tell her that he jumped out of vehicle as a suicide attempt. At this time, he is not having any suicidal ideation's. Girlfriend and her mother in room at this time for support. 6:39AM- patient to be transferred to Fannin inpatient psych."

A phone interview was done on 1/23/18 with staff #57. Staff #57 was placed on speaker phone with her supervisor #48, Risk Manager #52 and surveyors. Staff #57 stated she did not remember all the details but she did receive an order for the patient to receive ketamine. Staff #57 stated that there was a lot of "drama" going on and it was very "confusing during that time." Staff #57 stated patient #12 was in the CT scan room and she went out of the ED over to CT and administered the Ketamine. Staff #57 was asked if the medication was given as a conscious sedation or for behavioral reasons. Staff #57 confirmed she did not know why she was administering this medication. Staff #57 stated, "I would think the doctor ordered that so he could get a good scan without artifacts." Staff #57 was asked if the patient was receiving Ketamine and Haldol for behavioral issues why was it not documented as a restraint. Staff #57 stated, "We don't do restraints anymore." Staff #57 was unaware that she was administering chemical restraints and was not documenting as such. Staff #57 stated, "To be honest I didn't even know that Haldol was a psychotropic medication." Staff #57 confirmed that patients have been placed in seclusion rooms and that Geodon and Haldol are used in the ED for behavioral issues. Staff #57 reported that she only had ACLS and BLS certifications. Staff #57 did not have advanced airway education or certifications. Staff #48 confirmed that the ED has not been documenting psychotropic medications as chemical restraints at facility B.

Review of the drug information for Ketamine on the FDA.com website revealed the following:

"Ketamine (Ketalar) is a general anesthetic. Adverse Effects >10% Emergence rxns, HTN, Increased cardiac output, Increased ICP, Tachycardia, Tonic-clonic movements, Visual hallucinations, Vivid dreams. Respiration: Although respiration is frequently stimulated, severe depression of respiration or apnea may occur following rapid intravenous administration of high doses of ketamine. Laryngospasms and other forms of airway obstruction have occurred during ketamine anesthesia.

Respiratory depression may occur with over dosage or too rapid a rate of administration of ketamine, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics.

Since it suppresses breathing much less than most other available anesthetics, ketamine is used in medicine as an anesthetic; however, due to the hallucinations it may cause, it is not typically used as a primary anesthetic, although it is the anesthetic of choice when reliable ventilation equipment is not available."

Intramuscular Route

"The initial dose of ketamine administered intramuscularly may range from 6.5 to 13 mg/kg. A dose of 10 mg/kg will usually produce 12 to 25 minutes of surgical anesthesia
Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia. However, it should be noted that purposeless and tonic-clonic movements of extremities may occur during the course of anesthesia. These movements do not imply a light plane and are not indicative of the need for additional doses of the anesthetic."


Review of the drug information for Haldol on the FDA.com website revealed the following:

"HALDOL (haloperidol) Haloperidol is the first of the butyrophenone series of major antipsychotics that is indicated for use in the treatment of schizophrenia. HALDOL is indicated for the control of tics and vocal utterances of Tourette's Disorder.

HALDOL (haloperidol) should be administered cautiously to patients: with severe cardiovascular disorders, because of the possibility of transient hypotension and/or precipitation of anginal pain. Should hypotension occur and a vasopressor be required, epinephrine should not be used since HALDOL may block its vasopressor activity and paradoxical further lowering of the blood pressure may occur. Instead, metaraminol, phenylephrine or norepinephrine should be used. When HALDOL is used to control mania in cyclic disorders, there may be a rapid mood swing to depression.

Monitor for development of neuroleptic malignant syndrome (fever, respiratory distress, tachycardia, seizures, diaphoresis, hypertension or hypotension, pallor, tiredness, severe muscle stiffness, loss of bladder control). Report symptoms immediately. May also cause leukocytosis, elevated liver function tests, elevated CPK"


Patient #22

Review of patient #22's chart revealed he was brought to facility A's ED. Patient was a 62 year old male brought to the ED by police in handcuffs. Patient had a diagnosis of psychosis.

Review of the physician orders dated 10/28/17 at 1925 stated, "Give Geodon INJ 10mg IM once." There was no reason given on the order for the administration of a psychotropic medication.

Review of the nurse's notes dated 10/28/17 at 1900 revealed RN documented, "While screener was at bedside pt became hostile and started yelling. Pt threw dinner tray against the wall." There was no documentation of de-escalation or any information on other diversions attempted.

10/28/17 1902 (7:02PM)- Report given to ______ RN( staff #82.)

10/28/17 2000- pt threw his food on the floor and abusive to staff. Respirations even and non-labored. No acute distress." From 10/28/17 at 10:00PM -10/29/17 7:23AM revealed nurse documentation of patient sleeping with no acute distress.

Review of the nursing MAR revealed patient #22 received an injection of Geodon INJ 10mg IM on 10/29/17 at 5:08AM. 11 hours after the original order was given by the physician. There was no documentation found why the medication was delayed for 11 hours, why the medication was administered during a period of time when the patient was described as sleeping with no acute distress, any documentation on behaviors, nursing assessments or de-escalation or alternative methods before a chemical restraint was given. There was no documentation of the effectiveness of the medication or anursing assessment after the administration of the medication. There was no additional paperwork of a chemical restraint applied.


Patient #23

Review of patient #23's chart revealed she was a 34 year old female brought to facility A's ED on 1/5/18 at 11:23AM. The patient was 5'5 and weighed 180lbs. The patient's chief complaint was "psych complaint."

Review of the physician notes dated 1/5/18 revealed initial comments written at 11:23AM, "Patient brought in by EMS after the patient was acting unusual and threatening family members. Patient on initial examination the emergency department does not cooperate with examination has no additional history patient's hitting the sink and walls on examination and will not allow the nurse to place the armband on patient."(SIC) Patient had a documented past medical history of Bipolar Disorder.

Review of the Nurses Notes dated 1/5/18 at 11:00AM revealed staff #47 documented, "Pt brought to ED per BPD. She tore up her mother's house. Patient unapproachable, uncooperative, screaming, threatening. There was no documentation of any de-escalation attempts made to calm the patient.

Review of the patients MAR revealed patient #23 had an order scheduled for Ativan 2 mg IM and Haldol 5mg IM on 1/5/18 at 11:25AM. The medications were not administered until 11:45AM (20 minute delay) There was no documentation on why the medication was delayed for 20 minutes. There was no written order found on the chart for those medications. There was no reason documented on the MAR or the nurse's notes on why the patient was receiving these medications.

Review of the nurse notes revealed staff #47 documented, "No effects noted to Haldol/Ativan. Pt remains unapproachable and uncooperative, intermittently threatening to nurse. There was no documentation of any de-escalation techniques or alternative restraint measures taken before a chemical restraint was used. There was no documentation if the patient agreed and was willing to take the medication or if a patient hold was required to administer the medication.

Review of the patient MAR revealed patient #23 had an order schedule for Geodon 10mg IM on 1/5/18 at 12:55PM. The medication was documented as given at 1:11PM.

Review of the nurses notes revealed on 1/5/18 staff #47 documented the following;
"1300 (1:00PM)- Pt pacing around room, has removed all of her clothes.
1310-(1:10PM)- pt lying in the floor tearing up the flooring and the baseboard in the room.
1313- (1:13PM)- VS taken- Systolic 135 diastolic 83, temperature 97.8 and Pulse oximetry 93 room air.
1329-(1:29PM)- Pt confrontational, not approachable, cursing at nurse, sitting on bed, then OOB walking around room, restless.
1335- (1:35PM)- pt offered and accepted sandwich and beverages. Drank readily.
1352-(1:52PM)- pt more pleasant, stated she would like some clothes to wear and something to drink. Both were provided for her.
1355- (1:55PM)- pt ambulatory to restroom; no specimen collected."

Review of the patients chart revealed the RN has changed and staff #99 documented on 1/5/18 that the patient was sleeping at 2:28PM and 3:28PM.

Staff #99 documented the following;

1846 (6:46PM)- - pt walked out of psych room yelling, cussing, and refusing to go back into her room. Pt walked into restroom after being told not to due to toilet overflowing. Security called. Pt walked out of restroom back into her room now standing in the middle of her bed and singing loudly waking other patients in room 7.

Review of the patient MAR revealed patient #23 had a scheduled medication of Ketamine 100mgs IM at 1845. The medication was administered at 1905 (20 minutes later). There was no physician order found on the chart. There was no reason on the MAR why the medication was administered.

Review of the nurses notes revealed on 1/5/18 staff #47 documented the following;
2000 (8:00PM)- - Pt ambulatory to restroom; no specimen collected.

2005(8:05PM)- - pt stated "I don't feel good" assessed. Gagging herself by sticking her finger down her throat. Small amt of emesis." VS Taken.

Review of the physician documentation revealed;

"MDM Differential Diagnosis
Patient requiring sedation in the emergency department patient given rounds of Geodon as well as Haldol and Ativan. Patient calm down to be amenable to blood work.(SIC) Patient was evaluated psychiatric team and found to be suitable for psychiatric admission. No additional medical problems."

Review of patient #23's nurses notes dated 1/6/18 at 1:17AM revealed the RN documented, "Pt standing at the door, pt was taking her clothes off and is standing. Pt advised to put her paper scrubs back on.

2:18AM pt still standing at the door, screaming, punching the door, stating let me out of here "I am going to fuck this place up. Pt is becoming increasingly agitated and violent. Dr. _____ (staff #35) notified. Medication orders received.

3:15AM- Pt ambulated to restroom without assistance."

Review of the patient MAR revealed the patient was scheduled Geodon 20 mg IM on 1/6/18 at 0135. The medication was administered on 1/6/18 at 2:52AM. There was no physician order found on the chart. There was no vital signs obtained on this patient from 1/6/18 2:52AM until 1/6/18 at 4:38AM (1 hr and 46 minutes).

Review of the policy and procedure "Standardized Use of Restraint and/or Seclusion" revealed " II. OBJECTIVE:
This policy standardizes the indications and methods for restraint and/or seclusion to comply with ethical, regulatory, and patient-focused considerations in order to promote safety and dignity of the restrained/secluded patient and prevent the use of restraint and/or seclusion whenever possible, with the goal of being restraint/seclusion-free.

POLICY STATEMENT:

A. Hospital leadership is responsible for creating a culture that supports a patient's right to be free from restraint or seclusion. Leadership must ensure that systems and processes are developed, implemented, and evaluated that support the patients' rights addressed in this standard, and that eliminate the inappropriate use of restraint or seclusion. Through their Quality Assurance Performance Improvement (QAPI) program, hospital leadership should:

1. Assess and monitor the use of restraint or seclusion in their facility;

2. Implement actions to ensure that restraint or seclusion is used only to ensure the physical safety of the patient, staff and others; and

3. Ensure that the hospital complies with the requirements set forth in this standard as well as those set forth by State law and hospital policy when the use of restraint or seclusion is necessary."


Review of the policy and procedure "Standardized Use of Restraint and/or Seclusion" revealed the facility's definition of restraints as, "DEFINITIONS:

A. Restraint: Any method (physical or chemical) of restricting a patient's freedom of movement (including seclusion), physical activity or normal access to his or her body that:

1. is not a usual and customary part of a medical diagnostic or treatment procedure to which the patient, or his or her legal representative, has consented;

2. is not indicated to treat the patient's medical condition or symptoms; or

3. does not promote the patient's independent functioning.

4. Cannot be intentionally easily removed by the patient in the same manner that it was applied.

a) Types of restraints:

(1) Non-Violent/Non-Self Destructive Restraint: Restraint use in any care setting for medical and post-surgical care which is used to promote medical treatment and healing, e.g. protection of airway, prevention of tube removal (IV lines, feeding tubes, endotracheal tubes, etc.). Documented clinical justification is required for such use.

(2) Violent/Self Destructive Restraint: Emergency restraint use in any care setting to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others.

(3) Chemical Restraint: The use of a sedating psychotropic drug to manage or control behavior or restrict a patient's freedom that is not a usual or customary standard of treatment for the patient's medical or psychiatric condition.

(a) Use of medication to modify behavior or induce normative sleep patterns that is standard treatment for the patient's condition is NOT considered a chemical restraint.

(b) Medication ordered on a PRN basis to address patient need for protection from anxiety, fatigue, and undue environmental stimulation associated with the standard of care for the patient's diagnosis is NOT considered a chemical restraint.

(c) CMS strictly prohibits the use of chemical restraints. (U) Refer to state standards and regulations on use of chemical restraints.


PROCESS:

B. A Registered Nurse with current demonstrated competency may initiate restraint use in an emergency, based on an appropriate assessment of the patient.

C. Restraint and/or seclusion are used only when less restrictive, alternative interventions are ineffective. See list of alternatives below:

F. Notification of Attending Physician: The attending physician responsible of the management and care of the patient shall be notified about the use of restraint as soon as possible if he/she is not the ordering physician.

G. If the face-to-face evaluation of a violent/psychiatric restrained or secluded patient is completed by a trained registered nurse or physician assistant, he/she must consult the attending physician or other licensed practitioner who is responsible for the care of the patient as soon as possible after the completion of the 1-hour face-to-face examination.

H. Notification of Family: Every effort will be made to promptly notify the patient's family concerning the need for, and application of, restraint if information to the family is not contraindicated.

I. Patient/Family Education: The physician or licensed nurse will educate the patient and family regarding restraints if information to the family is not contraindicated. This education will include alternatives attempted, need for restraint, criteria for removal of restraint, and patient safety issues. The family will be assured that the patient's safety, physical and emotional needs, dignity and privacy will be respected at all times.



Review of the restraint log revealed the log only had physical restraints documented. There was no chemical restraints in the log. An interview was conducted with staff # 2 on 1/23/18. Review of the QAPI revealed the facility was aware of and following physical restraints but not chemical. Staff #2 confirmed that Quality Assurance Performance Improvement (QAPI) department was not collecting any data or trending any possible complications concerning chemical restraints.

Staff #2 was asked about the facility's policy on chemical restraints. The hospital policy stated, "(c) CMS strictly prohibits the use of chemical restraints. (U) Refer to state standards and regulations on use of chemical restraints." However, CMS does recognize the use of chemical restraints. Staff #2 was not aware of the error in the facility's policy.

An interview with staff #47 was conducted on 1/23/18. Staff #47 stated that she was hired about six months ago to work as a psychiatric nurse/psychiatric nurse educator. Staff #47 stated the facility is on a rotation schedule with another large hospital in town. Every other week ambulance and law officers will bring the psychiatric patient to the facility to be seen in emergent situations. Staff #47 stated that she works as a nurse during that week taking care of the psychiatric patients and on the opposite week she is to be doing education.

Staff #47 was asked if a patient with a psychiatric emergency comes into the facility on the off week who takes care of them. Staff #47 stated that this does happen frequently and if she is here she does. If staff #47 is off then staff from the ED are assigned to that area.

Staff #47 was asked what education has been done with the staff concerning the psychiatric patient and when was it implemented. Staff #47 stated that they had rolled out a new physician order form that would be easier for the physicians on restraints. When the surveyors reviewed the form there was no order box for chemical restraints. Staff #47 was asked about chemical restraints. Staff #47 stated we don't do chemical restraints here. When staff #47 was told about the multiple chemical restraints given she stated, "Those were not chemical restraints they are medications to treat their condition." Staff #47 stated she "knows the regulations." When staff #47 was asked what the definition of chemical restraints was she was unable to give a clear answer. Staff #47 confirmed she did not understand that the chemical restraints being given in the ED were actually chemical restraints.

Staff #47 stated that the company had started a "Task Force" for mental health patients in the ED. However, the first meeting was "2 weeks ago" and there was no education or plans to be rolled out on care of this patient population.

An interview with staff #47 Director of ED Facility B and #50 Director of ED Facility A was conducted on 1/23/17. Both staff members confirmed that they were not aware that the psychotropic medications given in an emergent behavioral crisis were considered chemical restraints. Staff #47 and #50 confirmed that the staff had not been documenting or treating as such and would need to be addressed.

An interview with staff #34 ED Physician was conducted 1/24/18 at 3:50PM. Staff #34was asked why he would order Ketamine IM in the ED. Staff #34 stated that low doses were ordered for management of agitation. Staff #34 felt that the patients would need that when severely agitated to prevent Rhabdomyolysis (Rhabdomyolysis is a condition in which damaged skeletal muscle breaks down rapidly.) Staff #34 was asked about chemical restraints administered in the ED. Staff #34 stated he did not administer chemical restraints and psychotropic medications given in the ED were to treat the patients underlying problems. Staff #34 stated that he would not treat a psychiatric patient any differently than a medical patient. When asked about using a lesser restrictive restraint such as seclusion or physical restraints staff #34 stated, " That would just be cruel to tie a patient down that's already having hallucinations. I think that's very unfair to do to them." Staff #34 did not have a clear understanding of the CMS or State guidelines for mental health patients receiving chemical restraints for behavioral issues. Staff #34 did confirm that the documentation was lacking and there was an issue with the complicated computer system they are currently using. Staff #34 reported that the "system is difficult to manage and they have to decide if their time is spent documenting or treating the patient."




28659


Pt #28:

On 1/20/2018 the medical record for (MR) patient #28 was reviewed and revealed this patient was an 81 year old male who was admitted after a fall at home. He had co-morbidities of Metastatic lung Cancer and anxiety. Pt #28 had no psychotic diagnosis at the time of admission. He was admitted through the Emergency Department (ED) on 12/1/2017. During his stay the nursing department followed the standardized electronic record assessments. At admission his medication included Ativan 0.5 mg. The admission order was for Ativan 0.5 mg every 4 hours as needed for anxiety, Duargesic patches were ordered every 72 hours for pain.

A review of the nurses notes from 12/1/2018 to the date of discharge on 12/11/2017 revealed no documentation of disruptive behavior until at the change of shift on 12/11/2017 the patient's daughter reported, He has been trying to get out of bed. Nurse Manager notified. Sitter approved". This was the only abnormal behavior entry documented into patient #28's MR. Each evaluation documented him as "alert and no distress noted".

However, on 12/6/2017 the physician ordered Seroquel 25 mg Immediate Release By mouth twice a day. The physician documented metabolic psychosis. This drug was discontinued the next day by the same physician.

On 12/7/2017 Gordon IM 10 mg (intramuscularly) "As needed" was administered after it was ordered by the physician. There was no supporting documentation for the use of Geodon. (Anti-psychotic medication)

On 12/7/2017 Geodon 20 mg IM was also ordered "as needed", and Resperdol 1 mg IM "as needed" was ordered but neither of these drugs were administered because the orders were incomplete and not sent from the pharmacy.

On 12/11/2017 Haldol IM 5 mg was administered as an IM injection on a "as needed " bases. Pt #28 already had Norco 5/325 mg for pain, Duragesis 50 mcg patch for pain, Ativan 0.5 mg for anxiety. Narcan was ordered IM 0.1 mg Every 2 minutes, but was not given. Pt #28 respiration decreased and was placed on conservative care and a "Do Not Resuscitate" order.

Pt #28 was discharge on hospice care with his family by his side. No documentation was found describing changes in his mental functions that would support the uses of anti psychotic drugs, especially Haldol which carries the black box warning for use in elderly patients.

From the makers of Haldol: Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses HALDOL Injection is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).

The warning for use of anti-psychotic drugs also includes both Resperdol and Geodon as not recommended for use in elderly patients who exhibit dementia related psychosis.

Based on review of record and interview, the hospital failed to effectively evaluate quality indicators provided by the contract agency to monitor the effectiveness and safety of services in 1 (contractor for environmental and building maintenance) of 5 contracts reviewed.

On 1-25-2018, an interview was conducted with Staff #2, Staff #6, and Staff #40. During the interview process, quality indicators for contracts were presented. The quality indicators for the environmental and building maintenance contractor were reviewed.

The Operational category of indicators for "Demand Work Order Completion" indicated that it was ">90% Completed per Schedule". Staff #2 was asked to explain this indicator and was not able to speak to it. Staff #2 was not able to state what the numerator and denominator for this measure were. Staff #2 was not able to identify or define what a "Schedule" was.

Staff #2 was asked how the contractor could be at >90% completed for "Schedule Demand Work Order Completion" when there were over 1,400 work orders outstanding with dates back to September 2017. Staff #2 stated that he did not know how that data had been calculated.

The Project Management category of indicators listed "On-Budget Performance" and "On-Time Completion Schedule Performance". Staff #2 was not able to explain what projects were being managed during the period of performance evaluation.

Staff #2 confirmed that he did not know what the indicators meant for this contracted service and was unable to explain them. He stated that the indicators were provided by the contractor to the corporate office and had to do with the contractor's financial reimbursement risk.

Staff #2 stated this contractor provided services for all of the corporate hospitals in Texas. Staff #2 was not able to tell if these numbers were the total for all corporate hospitals or only the hospital being surveyed.

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


A. ensure the Chief Nursing Executive ensured that staff were qualified by education to perform invasive procedures for 1 (Staff #20) of 1 staff working on the acute hemodialysis unit.

Refer to tag A386 for additional information.


B. ensure adequate numbers of nursing staff on 4 of 10 units that were observed (4 South Nursing unit and Emergency Department at Campus B, Cardiac Intensive Care Unit and Medical Intensive Care Unit at Campus A).

The facility failed to ensure adequate numbers of Registered Nurses (RN) to provide supervision of staff and patient care in critical patient care areas. Licensed Vocational Nurses (LVN) were providing care without adequate RN supervision. The facility failed to ensure there was an adequate number of nurse's aides to assist with care in critical patient care areas.

Refer to tag A392 for additional information.


C. ensure a Registered Nurse (RN) was assessing the patients care needs, health status, and responses to interventions. The Licensed Vocational Nurse (LVN), not an RN, was assessing the patients' changes in condition and administering Intravenous medications without documented RN supervision in 1 (Patient #21) of 4 (Patient #12, #21, #22, and #23) charts reviewed.

The facility failed to ensure adequate numbers of Registered Nurses (RN) to provide supervision of staff and patient care in critical patient care areas. Licensed Vocational Nurses (LVN) were providing care without adequate RN supervision on 2 of 2 units at Campus B (4 South Nursing unit and Emergency Department).

The facility failed to ensure an Emergency Department (ED) patient with a hip fracture, severe pain, and at risk for increased bleeding received timely assessment, accurate assessment, and treatment (Patient #42). Patient #42 received a triage assessment over 4 hours after presenting to the ED. Patient #42 was given an emergency severity index level of 3 (meaning urgent). Patient #42 was assessed as having severe pain (level 10) and was given an inaccurate emergency severity index.


Refer to tag A395 for additional information.


D. ensure staff #83 (RN) was qualified before assigning the staff member to care for a pediatric patient. Staff #83 provided Propofol to patient #39 in an Emergency Room setting. The facility could not provide evidence staff #83 had the required certification for Advance Cardiac Life Support and Pediatric Advanced Life Support. This practice was not in the scope of practice for a Registered Nurse (RN) to give Propofol for conscious sedation.

Refer to tag A397 for additional information.


E. to ensure they enforced their established policy. They allowed Registered Nurses (RNs) to give the medication Propofol and/or Ketamine to 6 of 6 (Patient #12, #23, #39, #40, #41 and #61) patients reviewed, which was not within their scope of practice.

Refer to tag A405 for additional information.


F. ensure nurses had complete physician orders for blood and intravenous fluid administration, consents for blood administration, and nurses accurately documented blood was checked prior to administration in 5 of 6 patients reviewed for blood administration (Patient #13, #17, #28, #42 and #48).

Patient #42 had sustained a hip fracture, was on medications that increased her risk of bleeding, had hip surgery and showed a decrease in her blood count. Patient #42 received blood transfusions over 24 hours later after her lab results showed a decline.

Refer to tag A409 for additional information.

Based on record review and interview, the Chief Nursing Executive failed to ensure that unlicensed technician staff were qualified by education to perform invasive procedures for 1 (Staff #20) of 1 staff working on the acute hemodialysis unit.


These findings had the likelihood to cause harm to all patients receiving care at the facility by failure to ensure unlicensed technician staff were competent to perform invasive procedures.

A review of Staff #20's personnel file revealed an unlicensed technician was allowed to cannulate AV (arteriovenous) Fistulas and AV Grafts; there was no evidence of training by the facility.

An interview with Staff #18 on 01/23/18 at 9:00 AM confirmed there was no policy approved by the Chief Nursing Executive and Governing Body of the Hospital to allow unlicensed technicians to cannulate AV (arteriovenous) Fistulas and AV Grafts accesses.

A review of the document titled, "Texas Administrative Code, Title 22 Examining Boards CHAPTER 224. DELEGATION OF NURSING TASKS BY REGISTERED PROFESSIONAL NURSES TO UNLICENSED PERSONNEL FOR CLIENTS WITH ACUTE CONDITIONS OR IN ACUTE CARE ENVIRONMENTS revealed the following:

"the following are nursing tasks that are not usually within the scope of sound professional nursing judgment to delegate and may be delegated only in accordance with, §224.6 of this title and paragraph
(1) of this subsection. These types of tasks include:

(A) sterile procedures--those procedures involving a wound or an anatomical site which could potentially become infected;

(B) non-sterile procedures, such as dressing or cleansing penetrating wounds and deep burns;

(C) invasive procedures--inserting tubes in a body cavity or instilling or inserting substances into an indwelling tube; and..."

Based on interview and record review, the facility failed to ensure adequate numbers of nursing staff on 4 of 10 units that were observed (4 South Nursing unit and Emergency Department at Campus B, Cardiac Intensive Care Unit and Medical Intensive Care Unit at Campus A).

The facility failed to ensure adequate numbers of Registered Nurses (RN) to provide supervision of staff and patient care in critical patient care areas. Licensed Vocational Nurses were providing care without adequate RN supervision. The facility failed to ensure there was an adequate number of nurse's aides to assist with care in critical patient care areas.


This deficient practice had the likelihood to cause harm to all patients who presented to these units.


Findings include:


4 South Nursing unit and Emergency Department at Campus B

Review of staffing sheets from 01/07-22/2018 revealed a Registered Nurse (RN) and Licensed Vocational Nurse (LVN) worked the unit on 01/08/2018, 01/15/2018, and 01/22/2018.

Review of the facility's staffing matrix dated 05/05/2017 that was being used on the unit revealed no documentation that LVNs could be staffed. The matrix called for 2 RN's for days and nights.



During interviews on 01/22/2018 after 10:54 AM the following was reported:

Staff #44 (LVN) reported there was generally 2 nurses on the floor. Sometimes they had three nurses and averaged 3-4 patients each. When the RNs take a lunch break, sometimes the manager was there and she covered the floor. There was no house supervisor to cover for the hospital.

Staff #42 reported they have 2 nurses sometimes and one of the nurses was a LVN (licensed vocational nurse). Staff #42 reported that the Emergency Department (ED) charge nurse served as the house supervisor. Sometimes the ED charge nurse would come up to help when they had a problem on the unit.

Staff #42 confirmed the days the LVN was working and the usage of the Matrix.

Staff #48 reported the charge nurses in the ED had to serve as charge nurse for the 4 South Nursing unit also. The ED charge nurse was also taking patients while in the ED. When the charge nurse left the ED unit that increased the patient load for the remaining nurses on the ED unit. Staff #48 reported they were not documenting when the ED charge was leaving to work 4 South unit.

Staff #41 provided another staffing matrix dated 05/15/2017 that allowed for usage of a LVN. Staff#41 reported she pulled the matrix off their computerized system and would train the nurses on usage of it.


Neither staffing matrix made mention of the shared RN from the ED. There was no way to ensure RN supervision over the LVN in the event of an emergency with one RN on the unit and depending on the ED charge RN to float between units.




Cardiac Intensive Care Unit at Campus A



Review of staffing assignment sheets, census sheets and staffing matrix from 01/14-24/2018 revealed the following:

01/24/2018 the unit was short one RN on the 7AM-7PM shift.

01/23/2018 the unit was short one RN on the 7AM-7PM shift and one RN and one nurse's aide on the 7:00 PM-7:00 AM shift.

01/22/2018 the unit was short one RN on the 7AM-7PM shift and one RN and one nurse's aide on the 7:00 PM-7:00 AM shift.

01/21/2018 the unit was short one RN on the 7AM-7PM shift and one RN and one nurse's aide on the 7:00 PM-7:00 AM shift.

01/20/2018 the unit was short two RNs on the 7AM-7PM shift and one nurse's aide on the 7:00 PM-7:00 AM shift.

01/19/2018 the unit was short one RN on the 7AM-7PM shift and one RN and one nurse's aide on the 7:00 PM-7:00 AM shift.

01/18/2018 the unit was short one nurse's aide on the 7:00 PM-7:00 AM shift.

01/16/2018 the unit was short one RN and one nurse's aide on the 7:00 PM-7:00 AM shift.

01/15/2018 the unit was short one RN and one nurse's aide on the 7:00 PM-7:00 AM shift.

01/14/2018 the unit was short two RNs on the 7AM-7PM shift and one RN and one nurse's aide on the 7:00 PM-7:00 AM shift.

There was documentation that at times some nurses were taking 3 patients each. Some shifts, nurses would take 2 patients each and share the care on another patient.

Staff #9 confirmed the staffing numbers.



Medical Intensive Care Unit at Campus A



Review of staffing assignment sheets, census sheets and staffing matrix from 01/15-24/2018 revealed the following:

01/23/2018 on the 7:00 AM - 7:00 PM shift the unit had a total of 9 RNs which included the charge nurse. The charge nurse did not take patients, one nurse had a 1:1 patient and 7 nurses were left to take care of 15 patients. Two of the nurses shared the care on a patient making their load 3 patients.

01/22/2018 on the 7:00 AM - 7:00 PM shift the unit had a total of 9 RNs which included the charge nurse. The charge nurse did not take patients, one nurse had a 1:1 patient and 7 nurses were left to take care of 15 patients. Two of the nurses shared the care on a patient making their load 3 patients.

01/21/2018 on the 7:00 AM - 7:00 PM shift the unit had a total of 8 RN's which included the charge nurse. The charge nurse did not take patients, one nurse had a 1:1 patient and 6 nurses were left to take care of 13 patients. Two of the nurses shared the care on a patient making their load 3 patients.

01/19/2018 on the 7:00 AM - 7:00 PM shift the unit had a total of 8 RN's which included the charge nurse. The charge nurse took one patient, one nurse had a 1:1 patient, and one nurse took 3 patients. There were 5 nurses left to take care of 11 patients. Two of the nurses shared the care on a patient making their load 3 patients.

01/18/2018 on the 7:00 AM - 7:00 PM shift the unit had a total of 8 RN's which included the charge nurse. The charge nurse did not take patients and there were 7 nurses left to take care of 16 patients. Two of the nurses took 3 patients a piece.

01/16/2018 on the 7:00 AM - 7:00 PM shift the unit had a total of 8 RN's which included the charge nurse. The charge nurse did not take patients and there were 7 nurses left to take care of 15 patients. One of the nurses took 3 patients. On the 7:00 PM-7:00 AM shift the unit had a total of 7 RNs to start the shift with 14 patients. The charge nurse did not take patients which left 6 RN's to take care of 14 patients. Three of the nurses took 3 patients a piece.

Staff #9 confirmed the staffing numbers.





During confidential interviews on 01/24/2018 after 9:30 AM, the following was stated about staffing:


"There are 16 beds and ideal staffing ratio is 2:1, but today (01/24/2018) there are only 7 nurses." "The charge nurses have to take patients."

"We're a little short of staff. A couple of people left on 7:00 AM-7:00 PM shift. There are supposed to be 9 nurses."

"Nine nurses would be optimal so the charge nurse could be free floating"

"Nurse morale is low"


During an interview on 01/25/2018 AM, after 9:30 AM, Staff #18 (Chief executive nursing officer) confirmed having staffing issues in the ED and ICU areas. They were going to hire new graduates and bring in agency staff in February 2018. The new graduates had to go through 12 weeks of training and the agency staff were not coming in until February 5th and the 19th.

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

A. ensure a Registered Nurse (RN) was assessing the patients' care needs, health status, and responses to interventions. The Licensed Vocational Nurse (LVN), not an RN, was assessing the patients' changes in condition and administering Intravenous medications without documented RN supervision in 1 (Patient #21) of 4 (Patient #12, #21, #22, and #23) charts reviewed.

B. ensure adequate numbers of Registered Nurses (RN) to provide supervision of staff and patient care in critical patient care areas. Licensed Vocational Nurses were providing care without adequate RN supervision on 2 of 2 units at Campus B (4 South Nursing unit and Emergency Department).

C. ensure an Emergency Department (ED) patient with a hip fracture, severe pain and at risk for increased bleeding received timely assessment, accurate assessment and treatment (Patient #42). Patient #42 received a triage assessment over 4 hours after presenting to the ED. Patient #42 was given an emergency severity index level of 3 (meaning urgent). Patient #42's was assessed as having severe pain (level 10) and was given an inaccurate emergency severity index.



This deficient practice had the likelihood to cause harm to all patients.

Findings include:

A.

Review of patient #21's chart revealed she was brought to Campus B's ED on 12/3/17 at 3:45 PM.
Review of the RN triage notes dated 12/3/17 at 3:45 PM stated reason for visit, "Patient smoked synthetic marijuana at Bj's liquor store, fell asleep by the front door, ambulance was called. ______ (EMS) responded, patient became combative and EMS administered 340 mg ketamine. Patient has obstructed airway, Donna, RT suctioning."

There was no further RN documentation noted on this patient until shift change 12/3/17 at 7:10 PM (3 hours and 25 minutes.) Review of the Emergency Medical Services (EMS) report revealed the patient received 320 mg of Ketamine IM not 340 mg as RN documented.

Emergency Medical Services Report

Review of the EMS "Prehospital Care Report Summary" revealed the patient was a 35-year-old female that had breast cancer and had a double mastectomy. She also had a history of substance abuse and psychiatric problems.

" History of present illness:

Pt was walking around store smoking synthetic Marijuana. Pt laid down on the ground in front of door and went to sleep. After about 15 minutes the owner of the store called 911 when pt refused to get up and leave. When we arrived, pt is still on the floor, not responding, when we lifted patient up off ground and were getting her to stretcher, she roused up but then laid back down." Pt was documented as unresponsive, pupils dilated, and clear BBSx4.

"Transport:

Pt assisted to stretcher, secured x 3 straps, 2 rails, harness, psyche strap. Pt placed in unit. Once I attached leads and B/P cuff, I went to check patient's pupils. She came awake yelling, throwing her arms and legs around. Pt is taking seat belts off and highly combative. If you try to go by pt. or touch her she tries to hit, kick, bite, spit on you. I had fire and partner hold patient down. The 4 of them were struggling, we could not get to hip/buttocks. I gave first injection of ketamine in R upper arm. Pt still resisting but to a manageable level. Pt keeps trying to get out of straps .Pt is becoming more agitated and aggressive, 2nd injection of Katamine (sic) given R hip/buttocks area. ED contacted.

Evaluation:

Upon arrival to the facility, pt placed in room 6. While we were waiting for room assignment, pt was unable to maintain airway without suctioning. I told staff several times pt needed to be suctioned but was never given a room assignment. When finally a room assignment was given, I asked nurse to get me suction and now. I was able to clear most of mucus. Nurse came in and started suctioning through nose causing bleeding and saying she had some type of resistance. The other nurse told her to suction through the mouth and leave the nose alone. Pt was moved to another room. Pt care and report given to staff w/o incident. On our departure pt is yelling and awake.

EMS documented "Ketamine 120 mg given IM at 1510 (3:10 PM). Second dose 200 mg IM 1520 (3:20 PM)."

Patient #21's Medical Chart

Review of Patient #21's ED chart, under Nurses Notes and Primary Assessment, Staff #58 Licensed Vocational Nurse (LVN) documented the following;

12/3/17 @ 1547 (3:47 PM) - Pt unresponsive, ems at bedside suctioning pt. pt. moved from room 13 to room 12. Placed on cardiac monitor o2 78% ra. Placed on nrb@15.

1550 (3:50 PM) -"Evaluation Method Telemetry; Heart rate 114; EKG Rhythm Sinus Tachycardia. Ems stated that katimin (sic) was given im x2 pta.

1555 (3:55 PM) - pt. appears to be posturing at this time. Dr Gingrich called back to bedside. v.o. given for Ativan 1 mg ivp rbvo."

1618 (4:18 PM) - Respiratory at bedside."

Review of the MAR revealed Staff #58 LVN administered Ativan 1 mg IV push on 12/3/17 at 4:00 PM. Vital signs were taken at 3:51 PM, 4:00 PM, 4:56 PM, and 6:11 PM by Staff #58. There was no further RN or LVN nursing documentation found of patient's assessment/effectiveness after the administration of IV Ativan. No RN or LVN assessment of the patients physical or neurological status after the medication was given.

Review of the physician notes on 12/3/17 at 4:11 PM stated, "Patient observed smoking synthetic marijuana, given ketamine for aggressive behavior. While here the patient just had a brief tonic-clonic seizure. Will continue to monitor patient, she is protecting her airway although she has lots of secretions that need to be suctioning. Patient is maintaining her vital signs, normal saturation, tachycardia due to drug abuse. No signs of trauma and no history of trauma."

Review of Patient #21's chart revealed an RN took vital signs at 7:00 PM. Blood pressure was "102/67, pulse 93, resp rate 27, pulse ox 100%, and 98.5 temp." There was no physical or neurological assessment documented.

Review of the physician orders on 12/3/17 at 7:03 PM revealed an order for "Geodon (psychotropic medication) 20mg was ordered IM one time dose." There was no reason on the order for the administration of this drug.

Review of the Nursing MAR revealed Geodon 20 mg injection stated, "No administrations were electronically documented for this order." There was no documentation from the MD or Nursing notes on why the medications were ordered or why the order was not given. There is no documentation found on why the medication order was canceled.


Medication Information:

Ketamine (Ketalar)

According to the FDA Ketamine (Ketalar) is a general anesthetic. Adverse Effects >10% Emergence rxns, HTN, Increased cardiac output, Increased ICP, Tachycardia, Tonic-clonic movements, Visual hallucinations, Vivid dreams. Respiration: Although respiration is frequently stimulated, severe depression of respiration or apnea may occur following rapid intravenous administration of high doses of ketamine. Laryngospasms and other forms of airway obstruction have occurred during ketamine anesthesia.

Respiratory depression may occur with over dosage or too rapid a rate of administration of ketamine, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics.

Since it suppresses breathing much less than most other available anesthetics, ketamine is used in medicine as an anesthetic; however, due to the hallucinations it may cause, it is not typically used as a primary anesthetic, although it is the anesthetic of choice when reliable ventilation equipment is not available.

Intramuscular Route

The initial dose of ketamine administered intramuscularly may range from 6.5 to 13 mg/kg. A dose of 10 mg/kg will usually produce 12 to 25 minutes of surgical anesthesia. Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia. However, it should be noted that purposeless and tonic-clonic movements of extremities may occur during the course of anesthesia. These movements do not imply a light plane and are not indicative of the need for additional doses of the anesthetic.


Ativan (Lorazepam)

Lorazepam, sold under the brand name Ativan among others, is a benzodiazepine medication. It is used to treat anxiety disorders, trouble sleeping, active seizures including status epilepticus, alcohol withdrawal, and chemotherapy induced nausea and vomiting, as well as for surgery to interfere with memory formation and to sedate those who are being mechanically ventilated.

Common side effects include weakness, sleepiness, low blood pressure, and a decreased effort to breathe. When given intravenously the person should be closely monitored. Among those who are depressed there may be an increased risk of suicide.


B.

An interview was conducted with Staff # 42 concerning staffing on 1/22/18. Staff #42 confirmed he would be paired with an LVN on many shifts. Staff #42 stated that he would be the only RN most of the time. Staff #42 confirmed that he would call another supervisor or someone from the ED if he needed a break. Staff #42 stated that he had to clock out when he went to lunch but he would bring something to eat so he could stay on the floor. Staff #42 confirmed that he was not aware of any written evidence if a staff member clocked in to relieve him at lunch. Staff #42 confirmed there was not always someone that could come up from the ED on weekends or if they were shorthanded.

An interview was conducted with Staff #43 concerning staffing on 1/22/18. Staff #43 stated that she was filling in today as the supervisor at St. Mary's for the floor. Staff #43 was asked about staffing when only an RN and LVN are working together. Staff #43 was asked how the RN took a break without leaving the LVN alone, if no RN is available to cover. Staff #43 stated that the staff bring their lunch and eat on the floor. Staff #43 was asked if the nurses have to clock out during lunch. Staff #43 confirmed the staff do clock out for lunch "but they are always nearby if they are needed." Staff #43 confirmed that if the staff clock out they are expected to still be available when needed. Staff #43 confirmed there was no documentation, or a "clock in", from a relief RN to prove there was a RN supervising the LVN during breaks.





10135

4 South Nursing unit and Emergency Department at Campus B

Review of staffing sheets from 01/07-22/2018 revealed a Registered Nurse (RN) and Licensed vocational nurse (LVN) worked the unit on 01/08/2018, 01/15/2018, and 01/22/2018.

Review of the facility's staffing matrix dated 05/05/2017 that was being used on the unit revealed no documentation that LVNs could be staffed. The matrix called for 2 RNs for days and nights.



During interviews on 01/22/2018 after 10:54 AM the following was reported:

Staff #44 (LVN) reported there was generally 2 nurses on the floor. Sometimes they had three nurses and averaged 3-4 patients each. When the RNs take a lunch break, sometimes the manager was there and she covered the floor. There was no house supervisor to cover for the hospital.

Staff #42 reported they have 2 nurses sometimes and one of the nurses was a LVN (licensed vocational nurse). Staff #42 reported that the Emergency Department (ED) charge nurse served as the house supervisor. Sometimes the ED charge nurse would come up to help when they had a problem on the unit.

Staff #42 confirmed the days the LVN was working and the usage of the Matrix.

Staff #48 reported the charge nurses in the ED had to serve as charge nurse for the 4 South Nursing unit also. The ED charge nurse was also taking patients while in the ED. When the charge nurse left the ED unit that increased the patient load for the remaining nurses on the ED unit. Staff #48 reported they were not documenting when the ED charge was leaving to work 4 South unit.

Staff #41 provided another staffing matrix dated 05/15/2017 that allowed for usage of a LVN. Staff#41 reported she pulled the matrix off their computerized system and would train the nurses on usage of it.


Neither staffing matrix made mention of the shared RN from the ED. There was no way to ensure RN supervision over the LVN in the event of an emergency with one RN on the unit and depending on the ED charge RN to float between units.



C.


Review of the Emergency Department (ED) record on Patient #42 revealed she was an 89-year-old female who presented on 01/22/2018 at 01:03 AM with complaints of a "HIP FRACTURE" and a "fall".

Review of a physician order dated 01/22/2018 at 4:52 AM (over 3 hours after presenting) revealed an order for an x-ray of the hip. The report at 4:49 AM revealed Patient #42 had a mild to moderate displaced left proximal femoral fracture.

Review of the record revealed Patient #42 received a triage assessment at 5:15 AM (over 4 hours after presenting). Patient #42 was given an emergency severity index level of 3 (meaning urgent). Patient #42's blood pressure was 192/83, pulse 94, and respirations of 20 and temperature of 98.1. Patient #42 was assessed as having a pain level of 10 (0 meaning no pain and 10 meaning severe pain).

Review of the medication administration record revealed that Patient #42 was administered the pain medication Morphine 6 milligrams intravenously for a pain level of 10 at 5:50 AM (over 4 hours after presenting).

Review of documentation revealed Patient #42 was seen by the physician at 6:43 AM (over 5 hours after presenting). There was documentation that Patient #42 was currently on Aspirin and Plavix (blood thinners). Both medications increased the risk of bleeding


The next documentation of vital signs being taken were at 6:58 AM and the blood pressure was 150/69, pulse 94 and respirations of 20. There was no documentation of a temperature being taken.


Review of lab results dated 01/22/2018 and collected at 5:20 AM and resulted at 7:24 AM revealed the following:

Red blood count was low at 3.02 (reference ranges being 3.8-5.1);
Hemoglobin count was low at 10.0 (reference ranges being 12.0-15.2);
Hematocrit count was low at 30.3 (reference ranges being 34.0-45.5).


Review of lab results dated 01/22/2018 collected at 7:20 AM and resulted at 7:44 AM revealed the following decrease:

Red blood count was low at 2.07 (reference ranges being 3.8-5.1);
Hemoglobin count was low at 8.3 (reference ranges being 12.0-15.2);
Hematocrit count was low at 25.3 (reference ranges being 34.0-45.5).

Patient #42 was admitted as an inpatient and left the ED at 9:31 AM.

Review of surgical notes revealed that Patient #42 with into the operating room on 01/22/2018 at 3:39 PM for an open reduction internal fixation of the left proximal femur.

Review of nurse's notes and blood transfusion records dated 01/23/2018 (the next day) revealed Patient #42 received two units of blood.


During an interview on 01/25/2018 after 10:50 AM, Staff #78 and Staff #100 confirmed the time of presentation to the ED, pain medication administration, lab results, and the time the blood was administered, and physician orders.



Review of the facility's policy named "Five-level Triage" dated 03/2017 revealed the following:




" ...Level 1 (Emergent):

These patients have an immediate problem with primary survey components are in need of life saving intervention. They present with compromise in either, Airway, breathing, circulation, homodynamic instability or, are responsive. Reassessment is continuous. Immediate lifesaving interventions required.

Level 2 (Semi-Emergent):
Condition requires expeditious treatment. These patients have potential threat of loss of life, organ, limb or vision should be seen as soon as possible in the Emergency Department or any other appropriate safe environment. Examples of these patients are those with high-risk chief situation) .... severe pain /distress reported as seven or greater on a 1-10 scale in the context or organ or limb risk ...."

Based on document review and interview, the facility failed to ensure Staff #83 (RN) was qualified before assigning the staff member to care for a pediatric patient. Staff #83 provided Propofol to Patient #39 in an Emergency Room setting. The facility could not provide evidence Staff #83 had the required certification for Advanced Cardiac Life Support and Pediatric Advanced Life Support. It is not in the scope of practice for a Registered Nurse (RN) to give Propofol for conscious sedation.

Review of the ED record for Patient #39 revealed a 13-year-old male presented to the Emergency Department via EMS for left wrist injury and deformity post fall. Patient #39 was seen by Physician #94 at 20:31 (8:31 PM)

A review of "Sedation Record" for Patient #39 revealed one "INTRA-PROCEDURE" record.

The sedation record for Patient #39 showed multiple doses of Propofol was given by Staff #83 (Registered Nurse) for the purpose of conscious sedation. The doses given were:
Propofol 100 mg at 21:56 (9:56 PM)
Propofol 40mg at 21:58 (9:58 PM)
Propofol 20 mg at 21:59 (9:59 PM)
Propofol 20 mg at 21:59 (9:59 PM)
Propofol 20 mg at 22:01 (10:01 PM)

Review of employee file for Staff #83 showed no current competencies in Advanced Cardiac Life Support (ACLS) or Pediatric Advanced Life Support (PALS). Staff #83 administered Propofol to a pediatric patient #39.

An interview with Staff #26 on 1/25/2018 at approximately 1:00 PM confirmed the required ACLS and PALS certification was not in Staff #83's personnel file.

Based on document review and interview, the facility failed to enforce the established policy and allowed Registered Nurses (RNs) to give the medication Propofol and/or Ketamine to 6 of 6 (Patient #12, #23, #39, #40, #41 and #61) patients reviewed. The policy specifically refers to the Texas Board of Nurses Positon Statement:

"Excerpt: Therefore, it is the position of the Board that the administration of anesthetic agents (e.g. Propofol, methohexital, ketamine, and etomidate) is outside the scope of practice for RNs and non-CRNA advanced practice registered nurses except in the following situations:

o when assisting in the physical presence of a CRNA or anesthesiologist (the CRNA or anesthesiologist may direct the RN to administer anesthetic agents in conjunction with the CRNA or anesthesiologist intubating or otherwise managing the patients airway)

o when administering these medications as part of a clinical experience within an advanced educational program of study that prepares the individual for licensure as a nurse anesthetist (i.e. when functioning as a student nurse anesthetist)

o when administering these medications to patients who are intubated and mechanically ventilated in critical care settings."

There were none of the above exceptions present when the RNs gave Propofol to Patient #39, #40 and #41.


Review of the ED record for Patient #39 revealed a 13-year-old male presented to the Emergency Department via EMS for left wrist injury and deformity post fall. Patient #39 was seen by Physician #94 at 20:31 (8:31 P.M.)

A review of "Sedation Record "for Patient #39 revealed one "INTRA-PROCEDURE" record.

The sedation record for Patient #39 showed multiple doses of Propofol was given by Staff #83 (Registered Nurse) for the purpose of conscious sedation. The doses given were:
Propofol 100 mg at 21:56 (9:56 PM)
Propofol 40mg at 21:58 (9:58 PM)
Propofol 20 mg at 21:59 (9:59 PM)
Propofol 20 mg at 21:59 (9:59 PM)
Propofol 20 mg at 22:01 (10:01PM)

A review of the ED record for Patient #40 revealed she was a 62-year-old female patient who was brought to the ER by EMS for possible hip dislocation. The patient was seen by Physician #94 at 1:34am.

A review of "Sedation Record" for Patient #40 revealed record timed at 11:51 PM showed multiple doses of Propofol were given by Staff #82 (Registered Nurse) for the purpose of conscious sedation. The doses given were:

Propofol 75 mg at 4:05 AM
Propofol 50mg mg at 4:07 AM

A review of the ED record for Patient #41 revealed she was a 54-year-old female patient who was brought to the ER by EMS for possible hip dislocation. The patient was seen by Physician #93 at 2329 (11:29 PM).
A Review of "Sedation Record" for Patient #41 revealed 2 INTRA-PROCEDURE records:

The first sedation record timed at 11:51 PM for Patient #41 showed multiple doses of Propofol were given by Staff #84 (Registered Nurse) for the purpose of conscious sedation. The doses given were:
Propofol 40 mg at 11:52 PM
Propofol 30 mg at 11:53 PM
Propofol 30 mg at 11:54 PM
Propofol 30 mg at 11:57 PM
Propofol 40 mg at 12:01 AM

The second sedation record timed at 12:47 AM for Patient #41 showed Propofol 70 mg was given by Staff #84 (Registered Nurse) for the purpose of conscious sedation.

A review of the policy titled "Moderate Sedation" revealed:

APPENDIX A: Texas Board of Nursing Position Statement - 15.8 Role of the Nurse in Moderate Sedation:

Excerpt: Therefore, it is the position of the Board that the administration of anesthetic agents (e.g. Propofol, methohexital, ketamine, and etomidate) is outside the scope of practice for RNs and non-CRNA advanced practice registered nurses except in the following situations:

o when assisting in the physical presence of a CRNA or anesthesiologist (the CRNA or anesthesiologist may direct the RN to administer anesthetic agents in conjunction with the CRNA or anesthesiologist intubating or otherwise managing the patients airway)

o when administering these medications as part of a clinical experience within an advanced educational program of study that prepares the individual for licensure as a nurse anesthetist (i.e. when functioning as a student nurse anesthetist)

o when administering these medications to patients who are intubated and mechanically ventilated in critical care settings

o when assisting an individual with current competence in advanced airway management, including emergency intubation procedures

o when utilizing a US FDA approved Computer-Assisted Personalized Sedation System in accordance with the US FDA approval requirements, where appropriate safety requirements are met (such as immediate availability of anesthesia providers) after completing appropriate training.


During an interview with Staff #78 on January 22, 2018 after 2:30 PM, Staff #78 was asked if nurses administer Propofol. Staff #78 stated, "I don't know about St. Mary's hospital for sure, but nurses in the ER at St. Elizabeth administer Propofol a lot. With it being a trauma center, they do high number of procedures in the ER and use Propofol to do it."


32143


Ketamine (Ketalar) Administrations

Patient #12

Review of Patient #12's medical record revealed the he was brought in by private car to the Emergency Department (ED) of Campus "B" on 1/9/2018.

Review of the Nurses Notes dated 1/9/18 at 1918 (7:18 PM) revealed the Patient #12 "jumped from moving vehicle head first, according to witness, after argument with girlfriend."

Review of nursing triage note on 1/9/18 at 1917 (7:17 PM) revealed his blood pressure was 139/120, Pulse 115, respirations 22, and temperature 98.5. There was no documentation that the physician was aware of abnormal blood pressure. Review of the nurse's notes revealed the patient was placed on a cardiac monitor at 1920 (7:20PM).

1/9/18 at 1926 (7:26 PM)- MD examined patient. 1927 (7:27 PM)- physician orders were put in for CT scan of the head and spine without contrast and CT of the Thorax and abdomen with contrast. Review of the physician notes revealed the patient was "uncooperative" but does not document on what behaviors the patient is exhibiting. The physician documented a GCS score of 15 and stated he was "alert, CN's normal (2-12), motor normal, oriented x4, sensation normal, depressed mood/affect. Road rash noted to back and buttocks. All other systems reviewed and negative. Primary Impression: Motor vehicle accident with minor trauma Additional Impression: Suicide attempt, Medical clearance for psychiatric admission, abrasions of multiple sites."

1/9/18 1930 (7:30PM)- - Contrast was administered to Patient #12 while in CT scan.

A hand written verbal physician order was found on the chart dated 1/9/18 at 1915 (7:15 PM) . The order read, "Ketamine (Ketalar) 100mg IM x1 dose stat. vorb: Dr.______ (#35)/ ______ (#60)." The order was not signed by the ordering physician.

Review of the Patient Order Summary revealed the pharmacist edited the order for Ketalar (Ketamine) Inj. On 1/9/18 at 1921(7:21 PM) . The pharmacist changed the dosage to 500 mgs instead of 100 mgs. There was no documentation on the hand written order or electronic order that the physician was aware of the changes made to the medication dosage. There was no documentation by the physician or nurse on why the patient was ordered and given Ketamine (Ketamine 'Ketalar' is a dissociative general anesthetic).

Review of the medication administration record in the Emergency Department (ED) revealed on 1/9/18 the nurse documented that she gave Patient #12 500 mgs of Ketamine IM at 1930 (7:30 PM). There was no found documentation of what the drug was given for, if the patient was assessed after the administration of the drug, the effectiveness of the drug, or vital signs.



Patient #23

Review of Patient #23's chart revealed she was a 34 year old female brought to Campus A's ED on 1/5/18 at 11:23 AM. The patient was 5'5 and weighed 180lbs. The patient's chief complaint was "psych complaint."

Review of the patient MAR revealed Patient #23 had a scheduled medication of Ketamine 100 mgs IM at 1845 (6:45 PM). The medication was administered at 1905 (7:05 PM) (20 minutes later). There was no physician order found on the chart. There was no reason on the MAR why the medication was administered.

A phone interview was done on 1/23/18 with staff #57. Staff #57 was placed on speaker phone with her supervisor #48, Risk Manager #52 and surveyors. Staff #57 stated she did not remember all the details but she did receive an order for the patient to receive Ketamine. Staff #57 stated that there was a lot of "drama" going on and it was very "confusing during that time."

Staff #57 stated Patient #12 was in the CT scan room and she went out of the ED over to CT and administered the Ketamine. Staff #57 was asked if the medication was given as a conscious sedation or for behavioral reasons. Staff #57 confirmed she did not know why she was administering this medication. Staff #57 stated, "I would think the doctor ordered that so he could get a good scan without artifacts." Staff #57 reported that she only had Advanced Cardiac Life Support (ACLS) and Basic Life Support (BLS) certifications. Staff #57 did not have advanced airway management education or certifications.


Patient # 61

Patient #61 was brought to Campus A's ED on 1/23/18 at 11:04 AM for vomiting.

Review of the physician notes dated 1/23/18 at 11:14 AM stated, " Patient comes in with repeated episodes of nausea and vomiting. She has had 5 visits in the last week at multiple ER's including Jasper and here. She comes in today with nausea vomiting abdominal pain. No reports of fever diarrhea per "(sic).

Review of the physician order dated 1/23/18 at 11:41 AM stated, " Ketalar INJ 27mg IV once."

Review of the patient Medication Administration Record (MAR) revealed Patient #61 was administered Ketamine INJ 27 mg per Intravenous (IV) push in right hand on 1/23/18 at 1:31PM. (2 hours and 50 minutes later). There was no documentation on why the medication was delayed. There was no documented nursing assessment until 2:06 PM. (35 minutes after the general anesthetic was administered by IV. There was no documented evidence of a physician or anesthesiologist present when the RN administered the Ketamine.

Ketamine Information

Review of the Drug Information obtained from FDA.com regarding Ketamine injectable revealed the following:

"Ketamine (Ketalar) is a general anesthetic. Adverse Effects >10% Emergence rxns, HTN, Increased cardiac output, Increased ICP, Tachycardia, Tonic-clonic movements, Visual hallucinations, Vivid dreams. Respiration: Although respiration is frequently stimulated, severe depression of respiration or apnea may occur following rapid intravenous administration of high doses of ketamine. Laryngospasms and other forms of airway obstruction have occurred during ketamine anesthesia.

Respiratory depression may occur with over dosage or too rapid a rate of administration of ketamine, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics.

Since it suppresses breathing much less than most other available anesthetics, ketamine is used in medicine as an anesthetic; however, due to the hallucinations it may cause, it is not typically used as a primary anesthetic, although it is the anesthetic of choice when reliable ventilation equipment is not available.

Intramuscular Route

The initial dose of ketamine administered intramuscularly may range from 6.5 to 13 mg/kg. A dose of 10 mg/kg will usually produce 12 to 25 minutes of surgical anesthesia. Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia. However, it should be noted that purposeless and tonic-clonic movements of extremities may occur during the course of anesthesia. These movements do not imply a light plane and are not indicative of the need for additional doses of the anesthetic."

Based on interview and record review, the facility failed to ensure nurses had complete physician orders for blood and intravenous fluid administration, consents for blood administration, and nurses accurately documented blood was checked prior to administration in 5 of 6 patients reviewed for blood administration (Patient #'s 13, 17, 36, 42 and 48).

Patient #42 had sustained a hip fracture, was on medications that increased her risk of bleeding, had hip surgery and showed a decreased in her blood count. Patient #42 received blood transfusions over 24 later after her lab results showed a decline.

This deficient practice had the likelihood to cause harm to all patients who received blood.


Findings include:


Review of the clinical record on Patient #17 revealed he was a 79-year-old male who presented on 11/19/2017 at 11:03 PM with complaints of weakness.


Review of lab reports on Patient #17 revealed the following at 11:59 PM:

Red blood count was low at 2.02 with reference ranges being 4.4-11.5;
Hemoglobin count was critically low at 6.3 with reference ranges being 13.0-17.5;
Hematocrit count was critically low at 18.6 with reference ranges being 39.0- 52.5.

Review of the nurses notes on 11/20/2017 at 1208 AM, revealed the physician was notified about the hemoglobin and hematocrit. A verbal order was received to administer 2 units of packed red blood cells.

Review of physician's orders revealed an order dated 11/20/2017 to "Transfuse Blood" and the quantity was for "2". The order did not include the timeframe on how fast to infuse the blood.

There was also a physician's order for "Intravenous Fluids" and the volume was "250ml". There was no documentation of what type of fluid to use nor an infusion rate.

Review of transfusion records revealed Patient #17 received ¼ of the first unit before the IV (intravenous) infiltrated. Patient #17 was given 30cc of the second unit of blood before being transferred out to another hospital. The transfusion record did not include the time that nursing staff performed checks on the blood before administration.

Review of the record on Patient #17 revealed no consent to administer blood.

During an interview on 01/22/2018 after 3:45 PM, Staff #48 confirmed the physician's orders, transfusion records and consent.






Review of the clinical record of Patient #43 revealed he was an 83-year-old male who was admitted into the facility on 01/15/2018 with a diagnosis which included a hip fracture.

Review of a physician's order dated 01/17/2018 at 8:53 AM, revealed an order for "Fresh Frozen Plasma (FFP)" "Stat" and the quantity "1"

The order was incomplete and did not include the rate at which to infuse the blood product.

Review of the transfusion notes revealed blood being administered on 01/17/2018 from 11:10 AM - 1:12 PM

Review of the record revealed no consent for the FFP. A consent was found for hip surgery which made mention of blood and blood products, but it was signed 01/17/2018 at 2:15 PM (after the transfusion). This consent was not signed off by the physician.

During an interview on 01/25/2018 after 10:50 AM, Staff #78 physician orders and missing blood consent.






Review of the Emergency Department (ED) record on Patient #42 revealed she was an 89-year-old female who presented on 01/22/2018 at 01:03 AM with complaints of a "HIP FRACTURE" and a "fall".

Review of lab results dated 01/22/2018 and collected at 5:20 AM and resulted at 7:24 AM revealed the following:

Red blood count was low at 3.02 (reference ranges being 3.8-5.1);
Hemoglobin count was low at 10.0(reference ranges being 12.0-15.2);
Hematocrit count was low at 30.3 (reference ranges being 34.0-45.5).


Review of a physician's screening dated 01/22/2018 at 6:43 AM, revealed documentation that Patient #42 was currently on Aspirin and Plavix (blood thinners). Both medications increased the risk of bleeding.

Review of lab results dated 01/22/2018 collected at 7:20 AM and resulted at 7:44 AM revealed the following decrease:
Red blood count was low at 2.07 (reference ranges being 3.8-5.1);
Hemoglobin count was low at 8.3 (reference ranges being 12.0-15.2);
Hematocrit count was low at 25.3 (reference ranges being 34.0-45.5).


Review of the ED record revealed Patient #42 was admitted as an inpatient and left the ED at 9:31 AM.

Review of surgical notes revealed that Patient #42 went into the operating room on 01/22/2018 at 3:39 PM for an open reduction internal fixation of the left proximal femur.

Review of a physician's order dated 01/23/2018 at 10:12 AM (the next day), revealed Patient #42 had a verbal order to "Transfuse Blood-ADULT" and the quantity was "2". There was also a physician's order "Intravenous Fluids" and the volume was "250ml". There was no documentation of what type of fluid to use nor a rate.

Review of nurse's notes and blood transfusion records dated 01/23/2018 revealed Patient #42 received two units of blood.
Review of the record revealed no blood consent that was signed by the physician nor physician notes indicating risks and benefits were explained to the patient.

During an interview on 01/25/2018 after 10:50 AM, Staff #78 reported that the first unit of blood was picked up from the lab at 11:10 AM. Staff #78 confirmed the lab results, the time the blood was administered, physician orders and blood consents.

Review of the facility's policy named "ADMINISTRATION OF BLOOD AND BLOOD PRODUCTS" dated 10/2015 revealed the following:

...1. Blood and blood products will be administered according to physician order. Obtain consent prior to administration (with exception of emergency situations (life/death) ..."

"...6. Use only normal saline to infuse with blood..."




28659

Review of the clinical record on Patient #13 revealed he was a 59-year-old male who presented on 06/01/2017 with complaints of pancreatic cancer.


Review of physician's orders revealed an order dated 6/1/20017 to "type and cross match 2 units packed red cells (PRC), 10 ml, normal saline (NS) and 50 units heparin for flush". Procedure, Blood Transfusion-2 units PRC. Lasix 20 mg IVP before first unit" NS did not include the timeframe on how fast to infuse the blood. NS KVO (keep vein open)" dated 6/1/2017 at 8:30 AM.


Review of the record on Patient #13 revealed the consent was signed by the patient and nurse. The physician did not sign the consent. There was no physician's signature identified on the consent and no evidence the physician had explained the need for or consequences of a blood or blood product transfusion.


A review of patient #36 was a 62-year-old female patient with a chief complaint of "shortness of breath. She was admitted 12/3/2017. Found to be anemic and the physician ordered type and cross match for a blood transfusion.

The consent was filled out as follows, "Transfusion of blood and/or blood products" at 03:44 AM on 12/4/2017. The consent was signed by the patient. The signature identified as the witness was not legible. There was no physician's signature identified on the consent and no evidence the physician had explained the need for or consequences of a blood or blood product transfusion.

Based on observation, interview, and record review, the facility failed to ensure the security of patient medical records in 3 of 3 locations.(Off-site medical record storage facility for an unknown length of time, the off-site surgical center, and the neo-natal unit of campus A. for an unknown length of time.)


This deficient practice had the likelihood to effect all patients of the hospital.


Findings included:


On 1/24/2018, a tour of the off-site storage building for medical records identified patient medical records for the year 2016 and 2017 stored on the lower floor of the main storage and supply warehouse for the hospital. The records were stored at the back of the building, secured on pallets.

The large front loading bay door was observed open at the time of arrival. The warehouse stored general, nonperishable patient-use supplies. Two warehouse staff were observed moving about the warehouse. Older medical records were stored in a second floor room with one door and one key entry.

Interview with the warehouse staff confirmed there was not storage space available on the second floor and therefore the medical records were stored at ground level. Both warehouse staff and pick-up and delivery personnel potentially had access to the unsecured medical records and the personal identifying information that was contained within each record.

On 1/25/2018 an interview with the Director of the Health Information Management Department agreed the 2016 and 2017 medical records were not stored in a manner that protected them from the possibility of patient privacy being violated.


10135

Off-site surgical center


During an observation on 01/23/2018 after 9:23 AM, pages of patient information was found stored in unlocked drawers at a nurse's station. The information included the patient's names, date of birth, age, phone numbers, insurance information, appointment information and lab test that needed to be rechecked.

Staff #85 confirmed the observation and reported the information was supposed to be locked in the cabinet at the nurse's station.



32143

During an observation on 01/24/2018, in the Neonatal Unit of Campus A, multiple pages of meconium lab sheets were found stacked in an unlocked drawer. The sheets had patient information on them.

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

A. ensure the immediate environment and equipment in the pharmacy was kept up in manner to prevent contamination and drug diversion in 2 of 3 pharmacy areas (Critical Care and Labor and Delivery Unit).

The facility failed to ensure medications were compounded in a manner to ensure patient safety. They failed to ensure staff properly sanitized medications used during compounding before placing them in the mixing hood. The facility failed to ensure staff had sanitary means for handwashing prior to mixing medications.

The facility failed to ensure the immediate environment and equipment in the pharmacy was kept up in a manner to prevent contamination and drug diversion in 2 of 3 pharmacy areas (Critical Care and Labor and Delivery Unit).

B. ensure intravenous fluids were stored in their protective overwrap.

C. ensure medications in an anesthesia cart were inventoried.

This deficient practice had the likelihood to affect all patients who were admitted to these units.

Findings include:



Critical Care Pharmacy Room Campus A

Staff #76 was observed on 01/24/2018, after 10:30 AM, to exit the pharmacy to go and wash her hands. Staff #76 came back and was observed getting medications off the shelf needed for compounding and placed them inside a panel on the mixing hood. Staff #76 did not sanitize the items before mixing the solution.

Staff #76 confirmed she washed her hands at the nurse's station because the sink broke yesterday.

Some of the baseboard on the wall behind the mixing hood was missing. The area could not be properly sanitized.

A stainless steel cart was next to the mixing hood; and it was soiled with dried spills. Packages of syringes were stored in plastic bins on the cart and the bins were soiled with old tape and spills. A basin of supplies was on the cart. Inside the basin was bottles of saline on top of other supplies and a soiled glove was in the basin. There was an open bottle of alcohol, open packet of cleaning sponges and a bottle of sterile water (1/4 of solution already used) sitting on the soiled cart. The supplies used to sanitize the area were open and not dated and stored on the soiled cart. Supplies had fallen off and could be seen on the floor underneath the cart. The tile flooring in the area had gaps and some were chipped where the subfloor underneath could be seen. There was no way the flooring could be properly sanitized in the area.

There was another shelf next to mixing hood that had plastic bins containing medications. A soiled glove was draped across the vials.

A biohazard container which was almost full of empty vials and syringes with needles sticking out of them was next to the mixing hood and there was no top on it.

Staff #76 confirmed the observation.

There was a bag on intravenous fluid stored on a shelf out of the overwrap.

Staff #80 confirmed the observation and reported the bag was only good out of the overwrap for 30 days.


Review of a facility's policy named "Aseptic Technique and Drug Compounding" dated 02/2017 revealed the following:

Aseptic technique refers to carrying out a procedure under controlled conditions in a manner that will minimize the change of contamination. Because contaminants may be introduced from the environment, equipment and supplies, or personnel, it is essential to control these different sources of contamination at the time aseptic technique is carried out.



Labor and Delivery Unit at Campus A

During an observation on 01/24/2018, after 2:00 PM, the following was found:


An anesthesia cart was stored in the medication room on the labor and delivery unit. The cart had some of the following medications stored in it:

Xylocaine and Bupivacaine (anesthetic agents);
Atropine (involuntary nervous system blocker);
Epinephrine and Phenylephrine (vasoconstrictors);
And Esmolol (a cardiac agent).

There were other medications and supplies in the cart. There was no inventory sheet being kept on the cart.

Staff #77 confirmed there was no inventory sheet being kept.

Based on observation, interview, and record review, the facility failed to provide a clean and sanitary environment and have an active program for preventing infections. This deficient practice was found in nine (9) of the hospital departments (4 South Nursing unit, Off Site Surgical center, Emergency Department Campus A, Critical Intensive Care Unit at Campus A, Critical Care Pharmacy, Labor and Delivery Unit Campus A, Dietary Campus A, and Dietary Campus B.). The facility failed to:


A. ensure a sanitary environment for their nursing unit, main supply room, medication room, and emergency departments. This unit was found to have soiled suction canisters, rusted wheel casters, soiled shower drains, rusted supply carts, expired supplies. Medical supplies were stored in plastic bins that were soiled with spills and dust build-up, ceiling light covers full of dead bugs, rust on linen carts, rust on supply carts, mattresses were torn, matress and frames were soiled with dried blood..


B. ensure Off-site surgical center maintained tracheal tubes that were sterile and uncontaminated.


C. ensure the Emergency Department at Campus A had a storage shelf for medical supplies with a protective barrier to protect supplies on the bottom shelf, maintain a clean and sanitary intravenous catheter caddy, and multi-dose vials of medication had expiration dates noted.



D. ensure the Critical Intensive Care Unit at Campus A disposed of contaminated urinals, isolation carts were cleaned, and staff used proper infection control techniques when caring for patients in isolation.



E. ensure the Medical Intensive unit at Campus A maintained a clean and uncontaminated isolation cart, used carts with no rusted wheel casters, and clean storage cabinets used for medications.



F. ensure Critical Care Pharmacy Room staff used proper infection control techniques when mixing intravenous medications. The facility failed to maintain sanitary flooring in the pharmacy, maintain clean and unsoiled supply carts, used biohazard containers that closed properly, and discarded expired Intravenous solutions.



G. ensure the Labor and Delivery unit at Campus A maintained incubators that were clean and free from spills and debris, used clean supply carts, and stored laryngoscope blades that were clean and free from contaminants and not expired.


H. ensure the Dietary Department Campus A maintained clean floors in sanitary work surfaces and on the frames of the heated food carts, kept the clean storage area free from dented cooking pots, pans, and colanders.



I. ensure Dietary on Campus B maintained a clean food preparation area free from oil and dust.


Refer to Tag A749 for additional information.

Based on observation, interview, and record review, the facility failed to provide a clean and sanitary environment and have an active program for preventing infections. This deficient practice was found in nine (9) of the hospital departments (4 South Nursing unit, Off Site Surgical center, Emergency Department Campus A, Critical Intensive Care Unit at Campus A, Critical Care Pharmacy, Labor and Delivery Unit Campus A, Dietary Campus A, and Dietary Campus B.)

This deficient practice had the likelihood to cause harm in all patients.

Findings include:




10135

During an observation on 01/22/2018 starting at 9:52 AM. the following was found:

4 South nursing unit at Campus (Nursing unit)

Room #4063

There was a suction canister on the wall which was soiled. The shower floor had a build-up of black substance and the shower drain had a build-up of black substance.


Room #4065

There was a patient chair that had wheel casters which were rusted. The suction canister on the wall was soiled and there was old tape left on the canisters with pen marks on it. A shower chair was found to be rusted underneath the seat.


Room #4068

There was a shower drain with a build-up of black substance. The soap tray was soiled with black substance.


4 South nursing unit at Campus (Main supply room)

There was an oxygen caddy that was covered in rust stored in the room.
Patient medical supplies were stored in plastic bins that were soiled with spills and dust build-up.
There was 5 Tegaderm dressings found on the shelf that expired October 2017.


4 South nursing unit at Campus B (Medication room)

There was a plastic bin of Microtainer lancets used for taking blood sugars which had been removed from their original box. There was no way to tell when the lancets expired. Lab supplies were stored in a plastic container which was soiled with dust and debris. The floor in the medication room was soiled with a buildup of dirt, rust and wax.


4 South nursing unit at Campus B (Emergency Department)

Clean linen was stored in the hallway on a cart. The bottom shelf of the cart had no protective barrier and the floor under the cart was soiled with spills and dust.

At the front entry way of the Emergency Department the ceiling light cover was noted to be full of dead bugs.

Exam Room #5 had a mattress on the stretcher which was torn with the inside cushion exposed. There was no way the mattress could be sanitized. The mattress was stained with a dried red substance which had the appearance of blood. The frame of the bed had a buildup of dirt and rust in the joints. An intravenous (IV) pole in the room was missing paint and the wheel casters were rusted. The linen bag holder in the room was heavily rusted. The equipment could not be sanitized with the rust on it.

Trauma room #2 had a linen bag holder in the room that was heavily rusted. The top of a crash cart was soiled with glue from old stickers. An intravenous (IV) pole in the room was missing paint and the wheel casters were rusted. Patient supplies were stored in plastic bins and drawers that were soiled spills, dust and hair. The cabinets underneath the sink were rusted and soiled with a buildup of black metal looking substance. The bedframe of the patient's stretcher was stained with a dried red substance which had the appearance of blood.

Staff #41 and #48 confirmed the observations.




During an observation on 01/23/2018 after 9:00 AM, the following was found:

Off-site surgical center

The outside base of the crash cart was rusted. Packets of tracheal tubes were taken from the crash cart. One sterile tracheal tube packet was torn exposing the tube to contaminants. Three more sterile tracheal tube packets were soiled with brown stains.

Review of the instructions on the packets read "Sterile unless package has been opened or damaged."

Staff #'s 85 and 103 confirmed the observations.




During an observation on 01/23/2018 after 1:00 PM, the following was found:


Emergency department at Campus A

Rapid Mid-level Assessment Room #6 had a shelf which had medical supplies stored on it. The bottom shelf was exposed and did not have a protective barrier. Bottles of saline and packets of dressing were stored on the bottom shelf.

An open box which contained 2x 2 dressings and alcohol pads was found in the intravenous caddy. The inside of the box was stained with a dry red substance which had the appearance of blood.

An open vial of Lidocaine was found in a cabinet and it did not have an open date logged on it.

Review of an undated policy posted in the pharmacy named "Beyond-Use Dating (BUD) Vials and Sterilization Products" revealed that "Multi-Dose Vials (MDV) now have specific maximum Beyond use date of 28 days."


In the main supply room medical supplies were stored in plastic bins which had a build-up of dust. The supplies included respiratory supplies which were not contained in bags. A basin was found with a bag of supplies used to draw blue. A blood tube was found in the basin which had a patient label on it and it was dated 05/11/2017.


Two sharps containers were found stored in the medication room. The outside of the containers were heavily soiled with dry spills and dust.

Staff #50 confirmed the observations.



During an observation on 01/24/2018 after 9:00 AM, the following was found:

Critical Intensive Care Unit at Campus A

Room #2202

There was a urinal which contained urine sitting on the floor near the door at the entrance to the room.


Room #2203

There was a pair of used gloves on the top of a cart which was outside the room. The patient in the room was in contact isolation according to a sign that was posted. Staff nurse #74 could be seen with her personal protective gear on and hanging a tube feeding. Staff nurse #74 exited the room with her gown and gloves on to come and remove the pair of gloves off the cart in the hallway.



Medical Intensive Care unit at Campus A

Room #2221

There was an isolation cart sitting outside the room. The inside drawers of the cart had a build-up of brown substance. The wheel casters were rusted and the top covering of the cart was cracked. The cart could not be properly sanitized with the cracked surface and rusted wheel casters.

At the nurses station was six cabinets which were used for storage of patient medications. The cabinets were soiled with dust. Three of the cabinets had patient medications stored in them. One drawer had intravenous fluid stored in it.

At the same nurses station was locked drawers used for storage of patient medications. The inside of the drawers original color was white. The drawers were soiled with red, brown and black spills, debris and dust. Patient medications were stored in the soiled drawers.


Critical Care Pharmacy Room

Staff #76 was observed on 01/24/2018, after 10:30 AM, to exit the pharmacy to go and wash her hands. Staff #76 came back and was observed getting medications off the shelf needed for compounding and placed them inside a panel on the mixing hood. Staff #76 did not sanitize the items before mixing the solution.

Staff #76 confirmed she washed her hands at the nurse's station because the sink broke on yesterday.

Some of the baseboard on the wall behind the mixing hood was missing. The area could not be properly sanitized.

A stainless steel cart was next to the mixing hood and it was soiled with dried spills. Packages of syringes were stored in plastic bins on the cart and the bins were soiled with old tape and spills. A basin of supplies was on the cart. Inside the basin was bottles of saline on top of other supplies and a soiled glove was in the basin. There was an open bottle of alcohol, open packet of cleaning sponges and a bottle of sterile water (1/4 of solution already used) sitting on the soiled cart. The supplies used to sanitize the area were open and not dated and stored on the soiled cart. Supplies had fallen off and could be seen on the floor underneath the cart. The tile flooring in the area had gaps and some were chipped where the subfloor underneath could be seen. There was no way the flooring could be properly sanitized in the area.

There was another shelf next to mixing hood that had plastic bins containing medications. A soiled glove was draped across the vials.

A biohazard container which was almost full of empty vials and syringes with needles sticking out of them was next to the mixing hood and there was no top on it.

Staff #76 confirmed the observation.


There was a bag on intravenous fluid stored on a shelf out of the overwrap.

Staff #80 confirmed the observation and reported the bag was only good out of the overwrap for 30 days.


Review of a facility's policy named "Aseptic Technique and Drug Compounding" dated 02/2017 revealed the following:

Aseptic technique refers to carrying out a procedure under controlled conditions in a manner that will minimize the change of contamination. Because contaminants may be introduced from the environment, equipment and supplies, or personnel, it is essential to control these different sources of contamination at the time aseptic technique is carried out.



Labor and Delivery unit at Campus A

During an observation on 01/24/2018 after 2:00 PM the following was found:
Eighteen plus infant cribs and incubators were found stored in a room on the unit. They were wrapped in plastic bags indicating they were clean and ready for patient use. Some of the wheels on the beds were rusted and had hair wrapped around the wheels. Some of the drawers were soiled with paper. One of the incubator had a front panel that was soiled with a build-up of brown substance.

Medical equipment was stored on a cart in the room and were covered with a plastic bag to indicate they were ready for use. The cart they were stored on was soiled with spills and debris.

An anesthesia cart was stored in the medication room on the labor and delivery room unit. A peel packet containing a laryngoscope blade was found in the cart. The packet was soiled with a dried red substance which had the appearance of blood. A sticker on the packet indicated it was sterilized September 22, 2003 (15 years ago).

Staff #'s 41 and 77 confirmed the observation.


Review of the facility's undated "INSTRUCTIONS FOR USE Heat-sealing Pouch: flat & gusseted" by Medical Action Industries Inc..revealed the following:

7. Storage
1. Store in cool, dry and clean place ...
3. Expiration date is printed on all product packers. This is three years from manufacture date. Product integrity has only been validated for this stated shelf life ..."



32143

During an observation on 01/22/2018 starting at 9:52 AM the following was found:

Campus B

Patient Room 4058 (terminally cleaned room.)
(A terminally cleaned room is a cleaning procedures implemented in the room or immediate physical environment after the patient has been discharged to eliminate possible transmission to a patient newly occupying the room.)

There were multiple holes in the sheet rock on the wall behind the bed and on the wall facing the bed. The walls were not sealed and cannot be cleaned properly.

The nurse's workstation on wheels (WOW) was dusty and soiled with old tape residue and hair in a terminally cleaned room.

The bed linen had holes in the bottom sheet and hair on the top sheet.

The wall above the patient trash can was stained with a dry liquid. The trash can still had trash in it.

The outside of the patient trash can was dirty and soiled with unknown substance. The trash can had pealing tape and residue that was soiled with dust and hair.

The bed frame was rusted under the mattress in multiple spots.

The lounge chair was soiled with dust, dirt, old dried food crumbs and hair. The lounge chair had a tear and the wooden arms were worn exposing the wood leaving a porous area.

The veneer from the top of the wardrobe was missing, exposing particle board.

The toilet seat was cracked and the bowl was dirty from sediment and needed to be cleaned.

The second patient trash can under the sink had trash in it.

In the clean utility room the cart was soiled with dust, dirt, and hair.

The patient medical supplies were in dirty containers sitting on the shelves. The containers were soiled with dust and hair.


The nourishment room on the 4th floor short stay of Campus B

Found to have a dirty cabinet with dust, hair, dirty spoon and water stained shelves.

There was a soiled small refrigerator sitting on the floor. The top of the door, and inside door was soiled with dried liquids, particles, dirt, and dust. The Freezer was iced over. The freezer could not be wiped down due to the heavy buildup of ice.

Condiments and paper goods were sitting on the counter in soiled bins. The bins were soiled with dust and dried food particles.


The Emergency Department of Campus B

Found to have patient medical supplies sitting on a counter in bins. The clear plastic doors on some of the bins were cracked and broken. The bins were soiled with dust and particles. There was heavy tape residue. The open tan colored bins were found to be heavily soiled with unknown dried substances, dust, and hair.

A drawer was opened and found to have an opened bag of cotton balls spilled out into the drawer. There was packages of blood culture supplies in the drawer. The staff was using the cotton balls on patients to remove IV's and perform finger sticks for blood glucose checks.

The medication cabinet was found to have plastic containers holding medications. A plastic container holding IV solutions was broken and soiled with dust and hair. The bottom of the unit was soiled with dust.
The medication refrigerator was found to have medications sitting on the bottom of the unit. The bottom of the unit was soiled with dust and hair.

The freezer part of the patient medication refrigerator was frozen with ice and could not be wiped down properly.


Trauma Room 4 of Campus B

The stainless steel door handle was found to be broken. The doors under the sink were able to be opened.

The wooden chairs were worn and wood was exposed. The vent return in the room was dusty and soiled.

The resting holder for the ophthalmoscope and otoscope was heavily soiled around the on and off switch. The unit was soiled with a dried, brown crusty material.

The Stretcher and mattress were found wet and had multiple tears. The stretcher frame was soiled with dust, tape residue, rust and hair.


Off Site Surgical Center

Exam Room #2

Found to have a patient exam table. The table had tears at the bottom of the vinyl covering and was soiled with a white dried substance.


Patient Room #3

Had a vinyl covered lounge chair that was ripped and soiled with dust and hair.


Clean Medical Supply Room

Found to have bins of patient medical supplies. The bins were heavily soiled in dust and hair.
1000 ml bottle of Normal saline was found open with no date.


During an observation on 01/24/2018 starting at 10:00 AM a.m. the following was found:

Campus A

Intensive Care Unit (ICU)

Room 2215 of the Intensive care Unit had a patient that was on contact Isolation. Anyone who enters the room is required to put on a gown before entering the room. The supply cart was empty of gowns. The nurse stated that they had run out and had not filled the cart.

In the patient medication cabinet (Pyxis), on the bottom shelf, a large container of Propofol bottles were found sitting in a soiled container of dust and dirt. On a shelf, a container of Potassium Chloride was found torn and sitting in a wet and crystallized solution.

The clean patient medical supplies in ICU was sitting in open soiled bins and on top of dirty carts. The bins had multi layered stickers and sticky residue that collected dust and hair.

Next to employee sink at the nurses station a plastic splash guard was found. The guard was cracked and broken. The guard was heavily soiled with dirt and rust.

Drawers in the nursing station was found to have patient supplies in them. The supplies were stored in plastic containers that were soiled with debris, dust, and hair.


Pharmacy (next to medical ICU)

In the middle of the pharmacy work area, an open cup was found, found filled with a soft drink.

Sitting next to stored patient medications was a large trash can filled with trash and drinking cups.

A red step stool was found on the floor next to patient medications. The stool was heavily soiled with caked on dust, dirt, and hair.

IV bags were sitting on a bottom shelf very close to the floor. The shelves were soiled with dust and hair. Tape residue was found very soiled.

Sitting on the floor next to open bins of patient medications a dirty broom and filled dust pan was found.

Open bins of patient IV bags of D5W was found sitting in dust and dirt. The outside of the bins were heavily covered with torn labels and multiple layers of tape.

An employee refrigerator was found in the middle of the pharmacy. The refrigerator was full of food. The refrigerator was sitting under a work area of the pharmacy.

The sink in the Pharmacy was broken. The sink would not drain properly. The maintenance man came into the pharmacy with a work cart that had been pushed through the halls of the hospital next to medications and preparation areas.


Labor and Delivery Unit (L&D)

The patient medication refrigerator freezer was found to be layered in frost and ice.

Room 313 L&D

Sheet rock was missing from the wall by the closet.

The wheels on the headboard part of the bed were broken and torn.

The leg extenders on the bed are covered in a vinyl material. The material was found torn in several areas.
The lights were burned out in the bathroom.

The bathtub was dirty and had brown water standing in the bottom of the tub.

In the circumcision room a plastic mold to lay the infant in was found soiled with betadine and stacked under the procedure bed.

15 packages of sterile Mogen clamps were found sterilized with the hinges closed.

Orthopedic Floor

The Pyxis on the orthopedic floor was soiled on the inside with dust and hair. Medication bins were found to be soiled.
Patient medical supplies were found sitting on rusted carts.



Patient Room 605 (a terminally cleaned room.)

The cloth couch was stained and dirty. Behind the couch was dusty and the back of the couch was torn.

The bed was found to be heavily rusted under the mattress.

The plastic facing on the IV pump was broken.


5th Floor Medical

Patient Room 5105

Was a terminally cleaned room. The couch in the room was torn on the arm rest.

The couch cushion was removed and the couch was dirty with food particles, an ink pen, dust, dirt and hair.

The lounger was heavily soiled with dust, dirt, hair a spilled sticky substance running down the inside of the chair.
The bedside table was missing pieces of wood exposing bare wood.

The bathroom shower was missing safety strips and the shoe molding had pulled back from the shower leaving a gapping area to trap hair, and water.

The shower had dirt and a dark brown substance smeared in the bottom of the shower floor.

The shower chair was dirty and had hair on the seat.

Underneath the shower chair was mildewed.


Kitchen

The kitchen floor area behind the grill was found to be soiled with grease build up and food particles. The warmer was heavily soiled on the glass door with spilled liquids and food particles.

In the food preparation area of the kitchen grill a dirty broom and filled dust pan were found sitting next to a food preparation area.

The soda machine in the kitchen area was soiled with a white mildew substance on the bottom of the fluid tray.

Next to the coffee machine in the kitchen area four bottles of syrup were found sitting in a plastic tray holder. The bottles had vanilla, hazelnut and sugar free vanilla syrup in them. The bottles were either half full or almost empty. There was no dates on the bottles on when they were opened. The pumps on the bottles and the plastic holder was soiled with brown sticky substance and dust.

Upon review of a bottle of vanilla flavored syrup a white mildew was found growing on the pump of the bottle.









28659

Dietary Department Campus A.

On 1/24/2018 during a morning tour of the dietary department, the tile floor beneath stationary work surfaces was observed with visible debris and the appearance of an oily surface. The Dietary Supervisor confirmed an automated floor cleaning machine was used to clean the kitchen floor, however the machine could clean only the floor in areas free of stationary work surfaces.

Further observations of failed sanitation was noticed on the outside frame of heated food carts where a build up of brown debris was observed 1/2 inch deep in the corner of the frame.


Multiple dented cooking pots, pans and colanders were observed in the clean storage area. The Dietary Supervisor confirmed they were heavily dented and a routine replacement order had been scheduled. The purchase order was not provided as evidence of the intended replacement of the dented food preparation equipment.





Dietary Department Campus B.

On 1/22/2018 in the morning a tour of the facilities dietary department revealed a food preparation area that exhibited lower level surfaces with a oily dusty surface. The dietary manager confirmed the lower level tables surfaces were not wiped clean.

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

A. ensure the surgical department sterilized implant trays and complete sets of instruments per the facility's sterilization policy or documented immediate use sterilization as an emergency. The facility's policy referenced the AORN, AAMI, and CDC guidelines. A review of the immediate use sterilization logs for the months of October, November, December 2017, and January 2018 revealed unwrapped implant trays and full sets of instruments trays were being flashed in the flash sterilizers. Also, the facility failed to follow their own policy for in hospital sterilization, the AORN (Association of perioperative Registered Nurses) standards, and the ANSI/AAMI (Association for the Advancement of Medical Instrumentation) standards and the CDC guidelines.

B. ensure that six (6) of six (6) sterilization records at Campus B were completed with the identification of the contents of the sterilizer load. Also, the facility failed to follow the AORN (Association of perioperative Registered Nurses) and the ANSI/AAMI (Association for the Advancement of Medical Instrumentation) standards.


C. change the cold disinfection solution (Rapicide) every 28 days per the manufacturer guidelines for the high level disinfecting of the endoscopy scopes.


D. change the 1 Micron filter, .45 Micron filter, 0.2-Micron water filter, air filter, and the Carbon filter per the manufacturer guidelines for the Medivator scope reprocessor (washer). Also, the facility failed to change the water filter supplying water to the "Evotech ECR" endoscope washer monthly.


E. ensure the surgical and obstetrical department provided a clean and sanitary environment.



F. complete an update to the history and physical, to include changes in the patient's condition prior to the surgical procedure on 3 (#52, #53, and #54) of 5 (#52, #53, #54, #55, and #56) patient records reviewed. Also, the surgeon failed to follow the hospital policy titled, "History and Physical Requirement for Surgery".

Refer to Tag: A 0952 for additional information



G. ensure that patient had a postoperative report immediately following the surgical procedure that was timed, name of the assistant, pre-operative and post-operative diagnosis, complications, anesthesia type, findings, and tissues removed on the chart on 2 (#46 and #47) of 6 surgical records. Also, the facility failed to follow their own medical staff rules and regulations.


Refer to Tag: A 0959 for additional information



Findings included:


A. A review of the immediate use sterilization logs for the months of October, November, December 2017 and January 2018 revealed unwrapped implant trays and full sets of instruments trays were being flashed in the flash sterilizers. Also, the facility failed to follow their own policy for Immediate Use Steam Sterilization, the AORN (Association of perioperative Registered Nurses) standards, and the ANSI/AAMI (Association for the Advancement of Medical Instrumentation) standards.


A review of the IUSS (Immediate Use Steam Sterilization) sterilization log for the month of October 2017 for the flash sterilizers, there were 8 individual instruments and/or tray sets flashed. There were two (2) instruments dropped or contaminated, four (4) not sterile/not ready, and two (2) with a hole in the wrapper. The IUSS system for the October log was used 6 times for single instruments and 2 times for sets of instruments.


A review of the IUSS sterilization log for the month of November 2017 for the flash sterilizers, there were 14 individual instruments and/or tray sets flashed. There was one (1) instrument dropped or contaminated, ten (10) not sterile/not ready, one (1) not a facility instrument, and two (2) with a hole in the wrapper. The IUSS system for the November log was used 8 times for sets of instruments. There were 6 single instruments documented on the log as being flashed.


A review of the IUSS sterilization log for the month of December 2017 for the flash sterilizers, there were 12 individual instruments and/or tray sets flashed. There were four (4) instruments dropped or contaminated, seven (7) not sterile/not ready, and one (1) with a hole in the wrapper. The IUSS system for the December log was used 6 times for sets of instruments and 6 times for single instruments.


A review of the IUSS sterilization log for the month of January 2018 noted in the first week for the flash sterilizers that there were 3 individual instruments and/or tray sets flashed. There was one (1) instrument dropped or contaminated, and (2) with a hole in the wrapper. The IUSS system for the January log was used 2 times for sets of instruments and 1 time for a single instrument.

A review of the immediate use sterilization log indicated there were numerous times instruments were not ready and that immediate use sterilization was used due to hole in the wrappers.

A review of the Board of Directors Quality Committee of the Board dated November 2017 revealed no documentation about the high usage of IUSS (immediate use steam sterilization) process. There was no drill down to track or analyze the issues causing the immediate use sterilization to have such a high usage in the facility. There was no written plan or process to address the high usage of immediate sterilization.

A review of the surgical clinical indicators that was reported to the quality department from the surgery department revealed no indication that the immediate use sterilizations was a quality issue that needed to be addressed.


A review of the facility's policy titled, "Steam Sterilization/Infection Control" revealed the following:

"PURPOSE: To perform guidelines for performing sterilization of instruments, supplies, and equipment utilizing event related criteria.

7. Flash sterilization: for nonporous, metal, no lumens will be flashed for 3 minute at 270F. For porous, items with lumens, and more than 10 metal instruments, a 10 min run at 270 will be used. Flash sterilization this may vary according to instruction provided by the manufacturer."

The facility's policy does not address the Immediate use steam sterilization (IUSS) should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner. The facility's policy still addresses the term "Flash"; the term "flash sterilization" no longer serves to describe the various steam sterilization cycles and processes that are used to process items that are not intended to be stored for later use. For this reason, the more appropriate term is IUSS per the AORN recommended practices.


A review of the perioperative standards and recommended practices "Association of Perioperative Registered Nurses" revealed the following:

"Recommendation VII

Immediate use steam sterilization (IUSS) should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner.

Immediate use steam sterilization may be associated with increased risk of infection to patients. Time constraints may result in pressure on personnel to eliminate or modify one or more steps in the cleaning and sterilization process. The term flash sterilization has historically been used to describe steam sterilization of unwrapped items intended to be used immediately. Flash sterilization cycles have traditionally been either 3 or 10 minutes of exposure, depending on the nature of the device being sterilized or the type of cycle indicated, minimal or no dry time, and no cooldown, thereby making the entire cycle time shorter than the cycle times for wrapped or terminally sterilized items. However, current manufacturer's instructions for use may require a variety of cycle times and the use of single wrappers or flash containers as opposed to sterilizing unwrapped items. The term "flash sterilization" no longer serves to describe the various steam sterilization cycles and processes that are used to process items that are not intended to be stored for later use. For this reason, the more appropriate term is IUSS.

VII. a. Immediate use steam sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. Immediate use steam sterilization should not be used as a substitute for sufficient instrument inventory."


An interview with Staff #63 on 01/24/2018 at 3:00 PM confirmed the facility's surgical department follows the AORN standards and ANSI/AAMI.


Upon a review of the 2011 "Association for the Advancement of Medical Instrumentation" ANSI/AAMI ST79:2010, the guidelines revealed the following:

"10.6.3 Release criteria for implants
As with all cycles, an experienced, knowledgeable person should review the sterilizer chart or printout at the end of the sterilization cycle, as well as the results of other indicators that have been used to monitor the sterilization process. The load should be quarantined until the results of the SI testing are available (CDC, 2008).
Releasing implants before the SI results are known is unacceptable and should be the exception, not the rule.
When documented medical exceptions dictate (e.g., the need for trauma-related orthopedic screw-plate sets), it could be necessary to release an implantable device before the SI results are known. In this case, the release of the device before the SI results are known should be documented; the SI result obtained later should also be documented. (See Annex L for examples of an implant log and an exception form.) It is critical that this documentation be fully traceable to the patient. Emergency situations should be defined in written guidance developed in consultation with infection prevention and control, the surgeon, and risk management. Steps should be taken to reduce the frequency of emergency release of implantable items. For example, ongoing periodic reviews of the exception forms and implant logs could reveal consistent patterns of events that are causing emergency release and that could be corrected.
NOTE-See Section 12 (New product evaluation) for general guidelines on how to assess the specific label claims of new products that become commercially available.
Rationale: Patient safety could be adversely affected by the implantation of a nonsterile device. The sterilization of implantable should be closely monitored and each load containing implants should be quarantined until it is verified that SI testing has yielded negative results. In defined emergency situations in which the quarantine of implants cannot be maintained, breaking of the quarantine is allowed for documented medical exceptions in accordance with facility policies and procedures. See also the rationale for 10.6.1."

An interview with Staff #63 on 01/24/2017 at 3:00 PM confirmed the surgical department was flashing instruments and instrument trays on a routine basis and not just for emergencies.


B. ensure that six (6) of six (6) sterilization records at facility B were completed with the identification of the contents of the sterilizer load. Also, the facility failed to follow the AORN (Association of perioperative Registered Nurses) and the ANSI/AAMI (Association for the Advancement of Medical Instrumentation) standards.


Review of facility document titled, "STERISCAN Reusable Test Pack - Record Keeping Log" revealed the following:


1. On 1/16/2018 in sterilizer one (1), load 011604 showed contents of 3-P and 2-W.
There was no way to identify contents of the sterilized load.


2. On 1/16/2018 in sterilizer one (1), load 011605 showed contents of 3-P and 1-W. There was no way to identify contents of the sterilized load.

3. On 1/16/2018 in sterilizer one (1), load 011606 showed contents of 9-P and 2-W.
There was no way to identify contents of the sterilized load.

4. On 1/16/2018 in sterilizer one (1), load 011607 showed contents of 4-P and 1-W.
There was no way to identify contents of the sterilized load.

5. On 1/23/2018 in sterilizer one (1), load 012305 showed contents of eye instruments and peel pouches 3. There was no way to identify contents of the sterilized load.


A review of the perioperative standards and recommended practices "Association of perioperative Registered Nurses" revealed the following:

"Recommendation XVIII
Documentation should reflect activities related to sterilization

Documentation demonstrates compliance with regulatory and accrediting agency requirements and identifies trends and quality improvement opportunities.

XVIII.a. Sterilization records should be maintained for the amount of time specified in the health care organization's policies and should be in compliance with professional standards and local, state, and federal regulations.
162646 [2: Moderate Evidence]
Accurate and complete records are required for process verification and are used in sterilizer function analysis.

XVIII.b. Every sterilization cycle and modality, including steam (eg, gravity-displacement, dynamic air-removal), ethylene oxide, hydrogen peroxide gas plasma, hydrogen peroxide vapor, ozone, and dry heat should be documented.

Documentation should include contents of each load:
load identification;
exposure parameters;
the operator's name or initials;
and results of physical, chemical, and biological monitors."

Upon a review of the 2017 "Association for the Advancement of Medical Instrumentation" ANSI/AAMI ST79:2017, the guidelines revealed the following:

"ANSI/AAMI ST79:2017 -- Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

13 Process monitoring, testing, and quality control

13.3 Product identification and traceability

13.3.1 General considerations

Each item or package intended for use as a sterile product should be labeled with a lot control identifier to allow full traceability of that item to the patient; alternately, an instrument tracking system may be used. Each load should have a load control record that includes a detailed content list, including specific identification of sets and the contents of sealable pouches.

13.3.2 Package labeling and expiration dating, if applicable
Each item or package intended for use as a sterile product should be labeled with a lot control Identifier prior to sterilization. The lot control identifier should identify:

a) the sterilizer identification number or code;
b) a detailed list of the contents (e.g., identification of multiple sets and the contents of paper-plastic pouches);
c) the person who assembled the package;
d) the date of sterilization;
e) the cycle number (cycle run of the sterilizer); and
f) the patient, if applicable, Items processed for immediate use should include a patient identifier."



In an interview on 1/23/2018 after 9:00 AM with OR Director #86, confirmed the findings. Staff #86 was asked what the process for recording load contents was at facility B. Staff #86 stated, "We know we have to do that. We normally do in our main sterilization. I don't know why they didn't on these loads but we will correct this."


C. During a tour of the Endoscopy Lab on the afternoon of 01/23/2018, review of logs revealed the following:

A review of the document titled, "DSD Filter Change Log" from January 2016 through December 2017 revealed the following:

1. In May 2016 the cold disinfection (Rapicide) solution was not changed. The solution was changed on 04/12/16 and was not documented as changed again until 06/07/16, which was 56 days late.

2. In July 2016 the cold disinfection (Rapicide) solution should have been changed on 07/28/16. The solution was changed on 07/01/16 and was not documented as changed again until 08/29/16, which was 58 days late.

3. In December 2016 the cold disinfection (Rapicide) solution was not changed. The solution was changed on 11/25/16 and was not documented as changed again until 04/28/17, which was 4 months late.

3. The log documentation revealed no cold disinfection solution was changed in the months of January, February, and March 2017.

4. In May 2017 the cold disinfection (Rapicide) solution should have been changed on 05/26/17. The solution was changed on 04/28/17 and was not documented as changed again until 05/31/17, which was 5 days late.

A review of the manufacture guideline revealed the high level disinfectant (Rapicide) only has up to 28-day reuse life.

An interview with Staff #98 on 01/23/18 at 3:00 PM confirmed the above findings.


D. During a tour of the Endoscopy Lab on the afternoon of 01/23/2018 observed the following:

A review of the document titled, "DSD Filter Change Log" from January 2016 through December 2017 revealed the following:

In the Endoscope Reprocessing room there were three (3) "Medivator" washers.

Each Medivator reprocessor had a 1-Micron Filter, .45-Micron Filter, and 0.2 Micron. A review of the "DSD Filter Change Log" revealed the last date that filters were changed was 02/13/17. The filters should have been changed in August 2017. The filters were 4 and half months past their date to be changed. Also, on each Medivator machine that was a carbon filter that was to be changed every 6 months. A review of the "DSD Filter Change Log" revealed that the carbon filter had never been changed.


The Endoscope Reprocessor Instruction and Service manual states, "The 1, .45, 0.2 micron filters must be replaced, at a minimum of once every six months. The air filter must be replaced every 3 months. The carbon filter was to be change every 6 months."

An interview with Staff #98 on 01/23/18 at 3:00 PM confirmed the above findings.


During a tour of the surgical department on 01/24/18 at 10:00 AM observed "Evotech ECR" (endoscope cleaning reprocessor). Staff #68 was asked when were filters changed on the "Evotech". Staff #68 stated, "Let me check and get the invoices, I think monthly."

A review of the invoices revealed the filter was changed monthly from 01/31/17 through 08/23/17. The filter was for purification of removing undesirable chemicals, biological contaminants, suspended solids and gases from water before entering the "Evotech ECR". The filter had not been changed for 5 months.

An interview with Staff #55 on 01/24/18 at 2:00 PM confirmed the above findings.


E. During a tour of the surgery area in the main Operating room (OR) on 1/24/2017 after 9:00 AM the following infection control issues were found:

1. In OR room #5, the anesthesia chair had rust on the castings for the wheels.

2. In OR room #5, the anesthesia machine had a conduit on the back of the anesthesia machine that was cracked and had exposed wire.

3. In OR room #6, the anesthesia machines had chipped and peeling paint on the edge of the top base of the machine and on the drawers of the anesthesia machine.

4. In OR room #16, the laundry hamper had chipped paint on it. There were eight Peel packs (packages that hold instruments once sterilized) that were past expiration date. One expired in 2013, six expired in 2015, and one in 2016.

5. In OR room #17, there was an opaque splattered substance on the glass front of the cabinets in the room.

6. In the C-Arm (Portable X-Ray machine) storage room there was a hole in the plaster, approximately 4x12 inches, located above the floor trim molding.

7. On the Stryker supply cart located in the main hallway, a cannulated screw (4x55) sterile package was found open and laying on a shelf inside the cart.

8. On the Stryker supply cart located in the main hallway, a non-sterile instrument (distal stem removal) was found stored on the shelf with sterile implants.

9. On the Stryker supply cart located in the main hallway, one box of Hydro Set (a sterile supply) was found stored on shelf with sterile implants and showed expiration date 10-11-2017.
An interview on 01/24/18 with Staff #55, #63, and #90 and #95 confirmed the above findings.

During a tour of the pre-holding obstetrics area on 1/25/2017 after 9:00 AM the following infection control issues were observed:

1. In the neonatal cart, a clear package was found to contain three laryngoscope blades together and one laryngoscope handle. The blades and handles were being stored together in one bag.

An interview on 01/24/18 during the tour with Staff #55 and #63 confirmed the above findings.

Based on record review and interview, the surgeon failed to complete an update to the history and physical, to include changes in the Patient's condition prior to the surgical procedure on 3 (#52, #53, and #54) of 5 (#52,#53,#54,#55, and #56) patient reviewed. The surgeon failed to follow the hospital policy on "History and Physical requirement for surgery".

A review of Patient #52's record revealed there was no history and physical update documented from the surgeon prior to the patient having a surgical procedure on 10/4//2017. A review of the history and physical did not indicate a medical emergency.

A review of Patient #53's record revealed there was no history and physical update documented from the surgeon prior to the patient having a surgical procedure on 11/1/2017. A review of the history and physical did not indicate a medical emergency.

A review of Patient #54's record revealed there was no history and physical update documented from the surgeon prior to the patient having a surgical procedure on 12/1/2017. A review of the history and physical did not indicate a medical emergency.

Review of hospital policy "History and Physical requirement for surgery" revealed the following:
" ...3. Outpatient Procedures:

a. All patients admitted for outpatient procedures that involve anesthesia services
require a current History and Physical (within 30 days). Additionally on the day of admission and prior to surgery, the surgeon or a licensed qualified professional involved on the case, will write an update note, addressing the patient's current medical status or interval changes, utilizing the Update History & Physical Form ..."

An interview with Staff #78 on 1/22/2018 after 1:00 PM confirmed the above findings and that the facility's policy was not followed.

Based on record review and interview, the facility failed to ensure that patient had a postoperative report immediately following the surgical procedure that was timed, name of the assistant, pre-operative and post-operative diagnosis, complications, anesthesia type, findings, and tissues removed on the chart on 2 (#46 and #47) of 6 surgical records. Also, the facility failed to follow their own medical staff rules and regulations.

A review of Patient #46's surgical record revealed the Patient had a "Colonoscopy" on 10/5/2017. There was no documented time, assistant, pre-operative and post-operative diagnosis, complications, anesthesia type, findings, and tissues removed on the postoperative procedure note. Nurse practitioner #101 signed the postoperative note and was not listed as an assistant.

A review of Patient #47's surgical record revealed the Patient had an "Exam under anesthesia, arthroscopy, partial right meniscectomy, debridement of synovium, and lateral femoral condyle" on 11-3-2017. There was no post-operative note immediately available following the surgical procedure. A post-operative note was transcribed at 12:38 PM. Patient #47 was transferred to another unit at 12:15 PM with no postoperative note on the surgical record.


Review of hospital document titled "RULES AND REGULATIONS, MEDICAL STAFF" revealed the following:

"An operative progress note is required in the medical record immediately after the procedure,
when the full operative report or other high risk procedure report cannot be entered into the
record immediately after the operation or procedure. Immediately after surgery is defined as
"upon completion of surgery, before the patient is transferred to the next level of care." This is to
ensure that pertinent information is available to the next caregiver. In addition, if the surgeon
accompanies the patient from the operating room to the next unit or area of care, the operative
note or progress note can be written in that unit or area of care. The operative progress note
should include sufficient information that the patient can be cared for until the operative report is
placed on the chart.

9.1. Operative reports dictated or written immediately after a procedure should record the
name of the primary surgeon and assistants, findings, procedures performed and
description of the procedure, estimated blood loss, as indicated, specimens removed,
and postoperative diagnosis. The completed operative report shall be authenticated by the surgeon and filed in the medical record as soon as possible after surgery."

An interview with Staff #78 on 1/22/2018 after 1:00 PM confirmed the above findings and that the facility's medical staff rules and regulations were not followed.

Based on chart reviews and interview, the hospital failed to ensure 2 (#39 and #41) of 3 patients (#39, #40, and #41) that received anesthesia services were provided care in a safe manner by qualified personnel. Two of three patients that received general anesthesia (propofol) in the emergency department had a level of consciousness scored 0 (Not Responding), which indicates general anesthesia as defined per hospital policy "Anesthesia Services". These services were administered by personnel not credentialed to administer general anesthesia.

It was determined that the deficient practice posed an Immediate Jeopardy to patient health and safety and placed all patients receiving propofol in the emergency department (ED) at risk for the likelihood of harm, serious injury, and possibly subsequently death.

Refer to tag A1002 for additional information.

Based on chart reviews and interview, the hospital failed to ensure 2 (#39 and #41) of 3 patients (#39, #40, and #41) that received anesthesia services were provided care in a safe manner by qualified personnel. Two of three patients that received general anesthesia (propofol) in the emergency department had a level of consciousness scored 0 (Not Responding), which indicates general anesthesia as defined per hospital policy "Anesthesia Services". These services were administered by personnel not credentialed to administer general anesthesia.

It was determined that the deficient practice posed an Immediate Jeopardy to patient health and safety and placed all patients receiving propofol in the emergency department (ED) at risk for the likelihood of harm, serious injury, and possibly subsequently death.


Findings Include:

Review of the ED record for Patient #39 revealed a 13 year old male presented to the Emergency Department via EMS for left wrist injury and deformity post fall. Patient #39 was seen by Physician #94 at 20:31 (8:31 P.M.)

A review of "Sedation Record" for Patient #39 revealed one "INTRA-PROCEDURE" record;

The sedation record at 2155 (9:55 PM) for Patient #39 showed the following medications given by Staff #83 (Registered Nurse):

"Propofol 100 mg at 21:56
Propofol 40mg at 21:58
Propofol 20 mg at 21:59
Propofol 20 mg at 21:59
Propofol 20 mg at 22:01"

Review of Aldrete Score System, (Aldrete score is a method used to determine if a patient is ready to be discharged to a less-intensive area of the hospital after recovery from anesthesia) on ED record for Patient #39 revealed, Patient #39 had consciousness level of 0, Not Responding, and oxygenation level of 0, unable to maintain saturation greater than 90% even with supplement.

Review of "General Disclosure & Consent Medical and Surgical Procedures" revealed a consent signed by Patient #39's mother for "Conscious sedation with a closed reduction of left wrist".

Review of the "Sedation Record" showed that Patient #39 received general anesthesia (propofol), as indicated with a consciousness level of 0, Not Responding.


Review of the Emergency Room record for Patient #41 revealed a 54 year old female patient who was brought to the ED by EMS (Emergency Medical System) ground for possible hip dislocation. The patient was seen by Physician #93 at 2329 (11:29 P.M.).

A Review of "Sedation Record" for Patient #41 revealed two "INTRA-PROCEDURE" records:

The first sedation record at 2351 (11:51 P.M.) for Patient #41 revealed the following medications given by Staff #84 (Registered Nurse):

"Propofol 40 mg at 23:52
Propofol 30 mg at 23:53
Propofol 30 mg at 23:54
Propofol 30 mg at 23:57
Propofol 40 mg at 0:01"

Review of Aldrete Score System for Patient #41 revealed a consciousness level of 1, arousable on calling, on first sedation record.


The second sedation record at 0047 (12:47 A.M.) for Patient #41 showed the following medications given by Staff #83(Registered Nurse):
"Propofol 70 mg at 0047"

Review of Aldrete Score System for Patient #41 revealed a consciousness level of 0, Not Responding.

Review of "General Disclosure & Consent Medical and Surgical Procedures" revealed a consent signed by Patient #41 for "Conscious sedation for reduction of right hip".

Review of the "Sedation Record" showed the Patient #41 received general anesthesia (propofol), as indicated with a consciousness level of 0, Not Responding.





D. Review of hospital policy, "Guidelines for Anesthesia Services" dated 6/2017 revealed the following:
"I. KEY WORDS: Anesthesia, analgesia, sedation

II. OBJECTIVE/S: To provide guidelines to meet the CMS conditions of participation requirements for anesthesia services and to establish clinical situations that involve anesthesia versus analgesia.

Ill. POLICY STATEMENT: CHRISTUS Health wants to ensure a safe environment for all patients who are administered various types of anesthetic and analgesic services as part of the course of treatment.


IV. DEFINITIONS:

A. Anesthesia: Anesthesia involves the administration of a medication to produce a blunting or loss of pain, voluntary and involuntary movement, autonomic function and memory and/or consciousness.
B. General Anesthesia: A drug-induced loss of consciousness during which patients are not
arousable, even by painful stimulation. The ability to independently maintain ventilator support is often impaired. Patients often require assistance in maintaining a patent airway and cardiovascular function.
C. Regional Anesthesia: The delivery of anesthetic medication at a specific level of the spinal cord and/or to peripheral nerves. (Epidural, Spinal, Neuraxial block) Used when loss of consciousness is not desired by sufficient analgesia and loss of voluntary and involuntary movement is required.
D. Monitored Anesthesia Care (MAC): Anesthesia care that includes the monitoring of the patient by a practitioner who is qualified to administer anesthesia. Deep sedation analgesia is included in MAC.
E. Deep sedation/analgesia: A drug-induced depression of consciousness during which patients cannot be easily aroused, but respond purposefully following repeated or painful stimulation.
F. Moderate sedation/analgesia (conscious sedation): A drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway and spontaneous ventilation is adequate.
G. Minimal sedation: A drug-induced state during which patients respond normally to verbal commands.
H. Topical or local anesthesia: The application or injection of a drug, or combination of drugs, to stop or prevent a painful sensation to a circumscribed area of the body where a painful procedure is to be performed ...

V. PROCESS:
A. Rescue Capacity: It is not always possible to predict how an individual patient will respond to anesthesia services. Hospitals are required to ensure that procedures are in place to rescue patients whose level of sedation becomes deeper than initially intended. Rescue requires intervention by a practitioner with expertise in airway management and advanced life support ...


D. The Medical Staff bylaws, or rules and regulations, must include criteria for determining the anesthesia service privileges to be granted to an individual practitioner and a procedure for applying the criteria to individuals requesting privileges for any type of anesthesia services, including those not subject to the anesthesia administration requirements (sedation). The type and complexity of procedures for which the practitioner may administer anesthesia must be specified in the privileges granted to the individual practitioner. When a hospital permits operating practitioners to supervise a CRNA administering anesthesia, the Medical Staff bylaws, or rules and regulations, must specify for each category of operating practitioner the type and complexity of procedures that category of practitioner may supervise. However, individual operating practitioners do not need to be granted specific privileges to supervise a CRNA.

E. Compliance: The following items must be established in each facility's policies and procedures:

1. Definition of what privileges are required for each level of anesthesia services (see definition section above), including sedation and MAC ..."


Review of insert For "Propofol Injectable Emulsion, USP, for INTRAVENOUS ADMINISTRATION" revealed the following:

"WARNINGS
Use of propofol injectable emulsion has been associated with both fatal and life-threatening anaphylactic and anaphylactoid reactions. For general anesthesia or monitored anesthesia care (MAC) sedation, propofol injectable emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Sedated patients should be continuously monitored, and the facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available. Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. These cardiorespiratory effects are more likely to occur following rapid bolus administration, especially in the elderly, debilitated, or ASA PSIII or IV patients ..."


Review of the credentialing file document, "CORE PRIVILGES, EMERGENCY MEDICINE, MINOR AMBULATORY CARE, AND OFF CAMPUS ED" revealed that there were no general anesthesia privileges for Physicians #93 and #94.

Review of employee file for (Registered Nurse) #83 revealed no current competencies in Advanced Cardiac Life Support (ACLS) or Pediatric Advanced Life Support (PALS) Registered Nurse (#83) who administered general anesthesia (propofol) to a pediatric patient #39.

During an interview with Staff #78 on January 22, 2018 after 2:30 P.M., Staff #78 was asked if nurses administer propofol. Staff #78 stated, "I don't know about facility B hospital for sure, but nurses in the ER at facility A administer propofol a lot. With it being a trauma center, they do high number of procedures in the ER and use propofol to do it."

During an interview with Staff # 51 on January 24, 2018 after 08:30 A.M., Staff # 51 was asked if nurses are allowed to administer propofol intravenously. Staff # 51 stated, "Yes they are allowed to push propofol if the physician is in the room."

During an interview with Chief Nursing Executive #18 on January 24, 2018 after 08:30 A.M., Staff #18 was asked if he was aware that nurses are allowed to administer propofol by intravenous push. Staff #18 stated, "I was not aware of this practice."

During an interview with Staff #87 (Anesthesiologist) on January 25, 2018 after 11 A.M., Staff #87 stated, "If a patient loses consciousness during administration of propofol, it is then considered a general anesthesia."

Patient #39 and Patient #41 were given general anesthesia (propofol) by a Registered Nurse. Patient #39 and #41 had a level 0 of consciousness during the procedure. Registered Nurse #83 gave general anesthesia (propofol) to a pediatric patient with no current competencies in ACLS or PALS.

Physician #93 and #94 did not have credentialing privileges for general anesthesia.