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Based on medical record review, review of hospital policies and staff interviews, the hospital failed to ensure that it has an effectively functioning governing body that ensures hospital policies and procedures are followed, thoroughly investigates adverse events and analyzes collected data in order to determine cause and improve patient care and safety and ensures that medical staff responsible for patient care receive training and evaluation of patient care responsibilities. This occurred in 1 of 7 patients (Patient #1), in a total sample of 7 patients, and has the ability to affect the average daily PCS census of 32 patients.

Findings include:

1) The hospital's governing body failed to ensure that its policies were followed with regard to documentation of observations and care given to Patient #1. (Reference A166, A431 and A449)

2) The hospital's governing body failed to ensure that it's patient care policies for the care in medical emergencies were followed with Patient #1. (Reference A431 and A449)

3) The hospital's governing body failed to ensure that CMS death reporting policies were followed per the restraint/seclusion policy. (Reference A213)

4) The hospital's governing body failed to ensure that it had an effective QAPI system that could thoroughly analyze adverse event data for Patient #1 and document those events in an attempt to improve patient care and services provided in the PCS unit. (Reference A 286)

5) The hospital's governing body failed to ensure that medical staff were trained and demonstrated competency in their patient care responsibilities with regard to restraint /seclusion practices. (Reference A208)

These governing body failures led to systemic care failures that affected the care, treatment and services provided to Patient #1 on 12/20/13.

Based on medical record review and staff interview (C), the hospital failed to ensure that 7 of 7 patients (Patient #'s 1, 2, 3, 4, 5, 6 and 7) requiring physical restraint while in the PCS (Psychiatric Crisis Services) unit had care plans which documented the goals of the restraint intervention(s) used. This is in a total sample of 7 patients utilizing involuntary physical and/or chemical restraints in the PCS unit, and has the ability to affect the average daily PCS census of 32 patients.

Finding include:

The 1/6/14 record review of Patient #'s 1, 2, 3, 4, 5, 6, and 7's "MCBHD Assessment and Progress Record for Seclusion/Restraint-pages 1, 2 and 3" at approx. 4 p.m., reflects no documentation of care planned goals for the use of physical restraints used on these 7 patients.

During interview on 1/9/14 at 12:50 p.m., PCS Director C stated that no additional information could be identified.

Based on review of medical credentialing files and staff interview (N), the hospital failed to ensure that 5 of 5 physicians (Physician's F, M, O, P and Q) had documented evidence of restraint training competency in their employee files. This was in a total credentialing file review of 5 physicians who are credentialed to provide medical and psychiatrist services to hospital patients. This has the ability to affect the total average daily PCS census of 32 patients.

Findings include:

The 1/2/14 medical record review of Physician/ Psychiatrist credentialing files, at approx. 3 p.m., of F, M, O, P and Q, revealed no documented evidence of restraint /seclusion training competency either in orientation or periodic review.

The medical record review on 1/2/14 at approx. 3 p.m., documents Physician F, on 12/20/13 at 1:55 a.m., ordered 4 point restraints, brief manual hold and emergent involuntary medication (chemical restraint) for Patient #1. Physician F had no documented evidence in the credentialing file for Physician F or hospital files that restraint and seclusion training competencies were completed.

During interview on 1/2/14 at approximately 12:30 p.m., Medical Staff Services Director N could not identify that the training was completed by the above listed physician staff.

Based on medical record review, hospital policy and staff interview (C), the hospital failed to ensure that it reported restraint death in 1 of 1 patients (Patient #1), who was involuntarily medically and chemically restrained when becoming a pulseless non-breather while in involuntary physical restraints and was under the influence of involuntary chemical restraints. This occurred in a total sample of 7 patients, who were involuntarily medically and/or chemically restrained in the PCS unit. This has the ability to affect the PCS average daily census of 32 patients.

Findings include:

Medical record review of Patient #1's medical record, on 12/26/13 at approx. 2 p.m., did not show documentation that the hospital had contacted CMS to report patient death while in restraints occurring on 12/20/13. Patient #1 became a pulseless non-breather while in 4 point Velcro restraints at 2:17 a.m., after being given IM injections of 10 mg. of Haldol (antipsychotic), 2 mg. of Ativan and 1 mg. of Cogentin (drug to counteract involuntary movement effects caused by Haldol) at 2:03 a.m.

The 1/6/14 at approx. 2 p.m. review of hospital policy states: "MS 3.1.6.1-Seclusion, Physical Restraint and/or Involuntary Medication: Emergent Use, date reviewed/revised on 09/12" states under "XIII....The death must be reported no later that the close of business day following knowledge of the death and staff must document in the patient's medical record the date and time the state and federal notification occurred."

During telephone interview on 1/9/14 at 10:05 a.m., PCS Director C stated that the state agency had been contacted and thought that the state agency had the responsibility to contact CMS about Patient #1's restraint death. Director C stated that the death had not been reported to CMS.

Based on review of third quarter 2013 QAPI documents and staff interview (A, C), the hospital failed to ensure that 1 of 1 deaths in restraints reviewed (Patient #1) was fully analyzed in order to provide feedback and learning opportunities throughout the hospital. This occurred in a total of 1 restraint deaths reported by the hospital, in a total sample of seven patients utilizing restraints in the PCS unit. The hospital failed to use collected QAPI data on PCS unit restraint usage to set threshold goals for restraint use and analyze restraint care issues. This occurred in a total review of 7 patients, who required use of involuntary chemical and/or physical restraint in the PCS unit. This has the ability to affect the average daily PCS census of 32 patients.

Findings include:

1) Director of Quality A stated in interview on 12/26/13 at approx. 11 a.m., the hospital had looked at all the circumstances surrounding the death of Patient #1 while in restraints and could find nothing that needed improvement. Director of Quality A stated that they had no case review documentation of what was reviewed, other than the witness statements and Patient #1's medical record.

PCS Director C stated in interview on 1/2/14 at approx. 3 p.m. that the hospital held a meeting, but there were no notes of the discussion or what was reviewed in the hospital meeting that was held due to the death of Patient #1 while in restraints. Director C further stated that a timeline of events was put together but that it had not been formally submitted in the meeting. There is no documented evidence of a root cause analysis to analyze possible causes of Patient #1's death and determine if care was given in a safe and effective manner, and according to hospital policy.

The hospital failed to follow its policies regarding the documentation of patient treatment, care and services rendered for Patient #1 on 12/20/13. The PCS unit staff was not compliant with hospital policy or federal regulatory standards for delivery of services documentation. (Reference A395 and A449)

2) The 2013 review of the PCS QAPI documentation on 1/6/14 at approx. 3 p.m. shows there was information to show that the hospital was tracking restraint incidents in the PCS unit in 2013 through the third quarter year. Data collected documented a 2% use increase in restraints from 2012 to present. Review of the data collection revealed no QAPI plan with a stated goal for restraint usage, and had no interventional performance improvement plans to track restraint care processes.

During interview on 1/2/14 at approx. 3 p.m., Director of PCS C stated that PCS unit QAPI documents were reviewed. Director C further stated the restraint data collected had no QAPI threshold goals or interventional planning in an attempt to improve patient care.

Based on medical record review, Code 4 forms, hospital policy review and staff interviews (A, F), the hospital failed to ensure that PCS (Patient Crisis Services) nursing staff treated 1 of 7 sampled patients (Patient #1) as directed by hospital's Code 4 policy during cardiopulmonary resuscitative efforts; and failed to ensure that PCS nursing staff assessed 1 of 7 sampled patients (Patient#1) for signs and symptoms of unstable conditions after a significant change in behavior requiring restraint intervention. This occurred in 1 of 7 patients, in a total sample of 7 patients who required use of involuntary chemical and/or physical restraint in the PCS unit; and has the ability to affect the average daily PCS census of 32 patients.

Findings include:

1) The 12/27/13 at 11 a.m. review of hospital "Policy MS# 6.2.1. -Code 4 -Medical and Nursing Care of the Patient with a Medical or Life-threatening Emergency, date reviewed/revised 09/12" documents: "...IV. The nurse will ensure that emergency equipment is brought to the room or area of emergency.
V. The nurse will initiate as clinically indicated or as directed:
A. Monitor vital signs a minimum of every 5 minutes
B. Suction the patient
C. Administer oxygen p to 10 liters per minute without a physician's order in a patient with spontaneous respiration
D. Administer oxygen at 15 liters for a patient who is receiving ventilation per Ambu bag pending physician arrival/further notice
E. Administer only non-IV medications at physician's direction
F. Monitor oxygen saturation
G. Obtain blood sugar/fingerstick
H. Implement other appropriate basic care measures
VI. The physician and nurse will assess and record interventions and patient responses on the Physician and Nursing Code 4 Progress Records."...".

Medical record review on 12/26/13 approx. 2 p.m. documents that Patient #1 was admitted into the PCS unit on 12/20/13, and became aggressive leading to the use of involuntary physical and chemical restraint (Haldol 10 mg., Ativan 2 mg. and Cogentin 1 mg. given IM at 2:03 a.m.). Patient #1, while in physical restraints and under the influence of chemical restraint, was identified by RN D to be pulseless and not breathing at approx. 2:15 a.m. RN D was documented as initiating Code 4 protocols (emergency resuscitation) for Patient #1 at 2:17 a.m.

The 12/27/13 at approx. 1:30 p.m. review of 3 of the 3 Code 4 forms: the "MCMHC Code 4 Nursing Progress Record", the "MCMHC Code 4 Medical Progress Record" and the "MC QI Post Code 4 Evaluation form" for Patient #1 documents no written evidence that emergency equipment was used, that vital signs were taken during the code after protocol initiation, that oxygen was given or Ambu bag was used, that monitoring of oxygen saturation or blood sugar was obtained.

During interview on 12/27/13 at approx. 1:30 p.m., Director of Quality A stated that written staff witness statements show that CPR, AED directed CPR and oxygen was administered during the Code 4, but statements do not document liters per minute. Director A further stated that documentation is lacking on Nursing and Medical and QI Code sheet forms, and in Patient #1's medical record.


2) Medical record review was conducted on 12/26/13 at approximately 11:30 a.m. Patient #1 arrived in PCS crisis intake on 12/20/13 at approximately 1:47 a.m. under police hold. Review of the medical record showed no evidence of aggression on PCS arrival until after Patient #1 was taken to the hospital restroom per patient request at approximately 1:49 a.m. After toileting self, Patient #1 charged out of bathroom towards staff in an aggressive physical manner, and required manual hold restraint from police and hospital staff.

Medical record review of Patient #1's previous PCS hospital visits on 12/13/14 and 12/17/13 reflects that patient is Diabetic with Hypertension (chronic health condition).

Medical record review of the 12/20/13 hospital visit reflects that there is no documented evidence that a fingerstick blood sugar was obtained by hospital staff to ensure that Patient #1 was not suffering from medical delirium due to Diabetes. This patient was manually held for an undocumented period of time, and transferred into 4 point Velcro restraints. At approximately 2:17 a.m., Patient #1 was found to be pulseless and not breathing.

In interview with Psychiatrist F on 1/6/14 at approximately 2 p.m., F states that hospital staff did not perform blood sugar test on Patient #1.

Based on medical record review, hospital policy review and staff interview (A, H), the hospital failed to maintain a complete and accurate medical record for 1 of 1 patients (Patient #1), who was evaluated and treated in the PCS unit. This occurred in 1 of 7 patients (Patient #1), in a total sample of 7 patients, who required use of involuntary chemical and/or physical restraint in the PCS unit; and has the ability to affect the average daily PCS census of 32 patients.

Findings include:

1) The hospital failed to ensure that PCS hospital staff documented a time line of events when Patient #1 entered the hospital's PCS unit on 12/20/13 per hospital documentation policy. (Reference A166, A449)

The hospital failed to ensure PCS staff documented admission time and time patient was taken to bathroom in Patient #1's medical record.

The hospital failed to ensure that PCS hospital staff documented a timeline for significant change in behavioral condition, in Patient #1's medical record, which led to chemical and physical restraint use for Patient #1.

The hospital failed to ensure that PCS hospital staff documented a timeline of the manual physical restraint hold given to Patient #1 by police and contracted hospital security staff in the patient's medical record.

2) The hospital failed to ensure that PCS hospital staff documented a timeline of care and treatment given to Patient #1, when patient became pulseless and breathless per Code 4 (emergency treatment) policy, in the patient's medical record. (Reference A166, A449)

The hospital failed to ensure that PCS hospital staff documented Code 4 events on the required hospital forms in Patient #1's medical record.

The hospital failed to ensure that PCS medical staff documented a medical assessment and documented any medical or pharmacological treatment given to Patient #1 in the medical record.

These systemic documentation failures prevents the hospital from providing a medical record service that maintains complete and accurate medical record documentation for all patients. (Reference A166, A449)

Based on medical record review, hospital policy review and staff interviews (A, H), the hospital failed to ensure that 1 of 7 medical records (Patient #1) documented a complete timeline of patient care events, and treatment and services provided. This occurred in 1 of 7 patients (Patient #1), in a total sample of 7 patients, who required use of involuntary chemical and/or physical restraint in the PCS unit; and has the ability to affect the average daily PCS census of 32 patients.

Findings include:

1) The 12/27/13 review of hospital "Policy (no policy number) -Psychiatric Crisis Service (PCS) Policy and Procedure, date reviewed/revised 5/30/13" documents: "...D. 6.... the RN will monitor and document patient observation and treatment regularly and as clinically indicated...".

Medical record review on 12/26/13 at approx. 12 p.m. reflects Patient #1 arrival in PCS crisis intake on 12/20/13 under police hold. Review of the medical record shows no evidence of aggression on PCS arrival until after Patient #1 was taken to the hospital restroom per patient request. After toileting self, Patient #1 charged out of bathroom towards staff in an aggressive physical manner and required manual hold restraint from police and hospital staff.

There is no documentation of the time that the following events occurred:
(1) no admission or entry time for the 12/20/13 PCS unit visit, (2) no documentation of time patient was escorted to bathroom after PCS
entry, (3) no documentation of the time that Patient #1 became aggressive, (4) the timeframe that the manual hold was applied was not documented, (5) there is no documentation to the patient's response to the manual hold, and (6) there is no documentation in the medical record to determine when the patient was first seen by the physician/psychiatrist.

During interview on 12/27/13 at approx. 1:30 p.m., Director of Quality A stated documentation is lacking.

2) Medical record review on 12/26/13 at approx. 12 p.m. documents that Patient #1 was admitted to the PCS crisis unit, and became aggressive leading to the use of involuntary chemical and physical restraint. Patient #1, while in physical restraints and under the influence of chemical restraint, was identified by RN D to be pulseless and not breathing at approx. 2:15 a.m. RN D was documented as initiating Code 4 protocols for Patient #1 at 2:17 a.m.

The 12/27/13 at 1:30 p.m. review of 3 of the 3 Code 4 forms: the "MCMHC Code 4 Nursing Progress Record", the "MCMHC Code 4 Medical Progress Record" and the "MC QI Post Code 4 Evaluation form" documents no written evidence emergency protocols were followed. (Reference A 395)

During interview on 12/27/13 at approx. 1:30 p.m., Director of Quality A stated that written staff witness statements show that CPR, AED directed CPR and oxygen was administered during the Code 4. Director A further stated that documentation in the patient's medical record is lacking.

3) The 12/27/13 at 11 a.m. review of hospital "Policy MS# 6.2.1. -Code 4 -Medical and Nursing Care of the Patient with a Medical or Life-threatening Emergency, date reviewed/revised 09/12" documents: "II. The physician will perform a medical assessment and render medical and pharmacological treatment and basic life support."

There was no documentation of a medical assessment or treatment given per hospital policy after Physician F, the patient's primary PCS physician/psychiatrist was called into Patient #1's restraint room due to loss of pulse and respirations.

During interview with Medical Director H on 1/2/14 at approximately 4 p.m. verified lack of medical documentation.
(Reference A 431, A449)