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Based on observation, staff interviews, medical record reviews, facility document review, and facility Policy and Procedure review, the hospital failed to protect and promote each Patients' rights, for a census of 124, when:

1. The notice of Patients' rights was not displayed in a prominent place in the lobby and was not displayed in any patient care areas. The one notice in the lobby was in English language only. Facility Policy and Procedures titled, "Patient Right's and Responsibilities" and "Patient Right's Advisement", dated 3/2013, did not identify how staff would determine a Patient's representative if there was a dispute (Refer to A-0117);

2. The grievance process was not explained to Patients when admitted, and there was no telephone number to the responsible State Agency available to Patient's or their representative (Refer to A-0118);

3. The Governing Body did not have oversight of the grievance process, and did not delegate that responsibility to a committee (Refer to A-0119);

4. Patients were uninformed on how to submit a grievance, either written or verbal (Refer to A-0121);

In addition, the facility failed to ensure:

1. Nine of 33 sampled Patients (Patients 6, 13, 14, 15, 16, 17, 18, 23, and 29) had an informed consent for psychotropic (mental health) medication (Refer to A-0131);

2. One of 33 sampled Patient's (Patient 6) was free from physical and verbal abuse; report the abuse to a State Agency; and have a Policy and Procedure for the investigation of abuse or neglect (refer to A-0145);

3. Three of three Patients reviewed for restraint or seclusion (R/S) episodes (Patients 26, 27 and 28) had an individualized plan of care for R/S which was individualized and indicated time limits for seclusion. (Refer to A-0166);

4. The implementation of appropriate R/S techniques, as determined by facility Policy and Procedure, for one of three Patients reviewed for R/S (Patient 27). There was no evidence the facility Policy and Procedure was in accordance with State law (Refer to A-0167);

5. A Physician's order was obtained within the specified time frames for R/S for two of three Patients reviewed for R/S
(Patient 26 and 28) (Refer to A-0168);

6. Three out of three Patients (Patients 26, 27 and 28) reviewed for R/S had appropriate monitoring of "Current Status" such as "Circulatory WNL [within normal limits], Pain or injury, or Patient is safe", vital signs (respiratory rate, blood pressure, temperature and heart rate) or "Current Behavior" such as "Cooperative, Uncooperative, Agitated, Yelling/Screaming, Other, and Ready for release: Yes or No". (Refer to A-0175)

7. A face to face evaluation was reviewed by an Attending Physician within 30 minutes of the evaluation for three out of three Patient records reviewed (Patients 26, 27 and 28) for R/S. (Refer to A-0182)

8. One out of three Patients (Patient 26) reviewed for R/S had a documented description of the behavior that precipitated the seclusion episode (refer to A-0185); and when

9. One out of three Patients (Patient 26) reviewed for R/S had a documented description of the condition or symptoms that warranted the use of seclusion. (Refer to A-0187).

These failures resulted in the potential for Patients not knowing their rights for grievance or informed consent processes for restraints, medication and general psychiatric care which could result in physical or mental harm. The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily mandated Condition of Participation for Patient's Rights.

Based on observation, staff interview, and facility Policy and Procedure review, the facility failed to ensure Patient's were informed of their rights, for a census of 124, when:

1. The notice of Patient's Rights was not displayed prominently in the hospital lobby or any patient care areas; and when

2. Facility Policy and Procedure did not explain how staff were to determine a Patient's representative if there was a dispute.

These failures had the potential for physical and mental harm due to the lack of knowledge regarding Patient's rights.

Findings:

1. During a concurrent observation and interview with the Chief Nurse Officer (CNO) in the hospital lobby on 4/21/16, at 11:20 a.m., there was one 8in. x 10in. brown framed notice of Patients Rights displayed in English only. No other languages were displayed. The CNO confirmed the observation.

During a concurrent observation and interview with the Security Officer/Plant Operations Director (SO/POD) of the entire facility on 4/21/16, at 2:50 p.m., there were no notices of Patient's Rights anywhere in the facilities' patient care areas. The SO/POD confirmed the observations.

Review of the facility Policy and Procedures titled, "Patient Right's and Responsibilities", dated 3/2013, indicated the following:
A. "Patient rights will be posted in the lobby and on each patient care unit".

2. Review of the facility Policy and Procedures titled, "Patient Right's and Responsibilities" and "Patient Right's Advisement", dated 3/2013, did not identify how staff would determine a Patient's representative if there was a dispute.

In an interview with the Assessment and Referral, Utilization Management Director (A&R/UMD) on 4/19/16, at 11:15 a.m., the A&R/UMD acknowledged the Policy did not address Patient's representatives and how to determine the correct representative, if there was a dispute.

Based on observation, staff interview, and facility Policy and Procedure review, the facility failed to ensure:

1. Patient's knew how to submit a grievance; and

2. The State agency telephone number was available to Patient's and/or their representatives' for complaints or grievances.

These failures had the potential for complaints or grievances to be unidentified or unresolved.

Findings:

1. During interviews on 4/20/16, at 3:30 p.m., with six random Patients on units, none of the Patients could identify how to submit a complaint or grievance. Some Patients did not know what a grievance was.

Review of the facility Policy and Procedure titled, "Complaint and Grievance Process", dated 10/15, indicated:
A. "Procedure: ...2. Means of explaining the Grievance Process to patient's: 2.1. At the time of admission, the ...clinician admitting the patient will explain this process to the patient; 2.2 At the time of admission, the ...clinician admitting the patient will provide the with literature explaining the Grievance process; 2.3 Signage will be displayed visibly throughout the hospital environment to inform patient's of their right to file a complaint or grievance; 2.4 Staff present at the time of a complaint, if unable to resolve the matter to the patient's satisfaction, will explain the grievance process to the patient."

2. During a concurrent observation and interview with the Security Officer/Plant Operations Director (SO/POD) of the entire facility on 4/21/16, at 2:50 p.m., there was no signage displayed to inform Patients of their right to file a complaint or grievance. The SO/POD confirmed the observations.

During review of the Admittance Package given to Patients regarding complaints or grievances, the package did not contain the telephone number of the State agency responsible for the investigation of complaints. The Department called every number listed for Patient's to call regarding a complaint or grievance, and none of the listed agencies actually took complaints or grievances from Patient's.

Review of the facility Policy and Procedure titled, "Complaint and Grievance Process", dated 10/15, indicated:
A. "Procedure: ...2.3 Signage will be displayed visibly throughout the hospital environment to inform patient's of their right to file a complaint or grievance".

During an Interview with the Risk Management/Performance Improvement Director (RM/PID) on 4/19/16, at 11:30 a.m., the RM/PID stated they handle grievances internally, not externally.

Based on staff interview, and facility Policy and Procedure review, the facility failed to ensure the Governing Body formed a grievance committee and had oversight of the committee's grievance process.

These failures had the potential for missed opportunities to resolve grievances to the satisfaction of the parties involved.

Findings:

In an interview with the Risk Management/Performance Improvement Director (RM/PID) on 4/19/16, at 11:30 a.m., the RM/PID stated the Governing Body approved the Grievance Policy, but had no oversight of the grievance process. RM/PID confirmed the facility had no grievance committee. The RM/PID stated a designee usually resolved all complaints or grievances.

Review of the facility Policy and Procedure titled, "Complaint and Grievance Process", dated 10/15, there was no mention of Governing Body oversight, or a facility grievance committee which consisted of more than one person.

Based on staff interview and facility document review, the facility failed to ensure a clearly established procedure for the submission of complaints or grievances to the facility.

This failure had the potential for unresolved complaints or grievances.

Findings:

Review of the facility document titled "Compliment & Suggestion Form", given to Patient's on admission, the form was used to submit a complaint or grievance. Under the title in small letters was the statement: "request a Grievance Form if you have a concern that has not been addressed or resolved by other means".

Further review of the document indicated the following:
A. 2) I am writing this: To compliment the Hospital or Staff; or

B. 2) To make a suggestion for improvement (e.g., regarding safety, treatment, programming, etc.).

In an interview with the Risk Management/Performance Improvement Director (RM/PID) on 4/19/16, at 11:40 a.m., the RM/PID acknowledged the form titled, "Compliments and Suggestions" was the grievance form given to Patients on admission.

The title of the document, "Compliments & Suggestions Form", was misleading as it did not identify the document as one to be used to bring forth a grievance.

Based on staff interview, medical record review, and facility Policy and Procedure review, the facility failed to ensure nine of 33 sampled Patients (Patients 6, 13, 14, 15, 16, 17, 18, 23, and 29) had an informed consent for psychotropic (mental health) medication.

These failures had the potential for Patients or their representative to make uninformed decisions regarding the administration of medication for mental health conditions.

Findings:

Review of the medical record indicated nine of 33 sampled Patient's did not have informed consents for psychotropic medication. The informed consents lacked the following information:
1. Physician's signature for one of 12 consents reviewed: Patient 13;

2. Patient's signature for one of 12 consents reviewed: Patient 6;

3. Dated and timed by the Physician for one of 12 consents reviewed: Patient 16;

4. Dated and timed by the Patient for 10 of 12 consents reviewed: Patients 6, 14, 15, 16, 17, 18, 23 and 29;

5. Dosage, route of administration, frequency, and duration of psychotropic medication for twelve of twelve consents reviewed: Patients 6, 13, 14, 15, 16, 17, 18, 23 and 29;

6. An informed consent for a psychotropic medication, Lorazepam (anti anxiety medication) was missing: Patient 23;

7. Written information on medications was to be either "given to the patient by MD" or "requested by MD to be given by staff". Neither box had been checked for 11 of 12 consents reviewed: Patients 6, 13, 14, 15, 16, 17, 18 and 23; and when

8. A three way telephone consent did not include the physician or the patient for one of 12 consents reviewed. The consent was signed "three way consent with mother" under "patient/parent or guardian signature", with two nurses signatures under "witness signature": Patient 13.

Review of the facility Policy and Procedure titled, "Informed Consent for Psychotropic Medication", dated 1/16, indicated the following:
"All patients who are to be treated with psychotherapeutic medication... shall be given informed consent for such treatment...The type, range, frequency and amount [dosage] (including use of PRN, as needed, orders)...Method (oral, injection, ect.)...Duration of taking medications...Such consent shall be documented by the prescribing physician...Informed consent over the telephone. In such instances, a three way conversation should be set up between the physician, the patient, and the nurse".

In an interview with the Psychological Services Director (PSD) on 4/20/16, at 3:30 p.m., the PSD confirmed the Department's findings regarding the informed consents.

In an interview with the Chief Nurse Officer (CNO) on 4/21/16, at 10:45 a.m., the CNO stated an informed consent for psychotropic medication was not necessary if the medication was used as PRN [as needed] basis, such as lorazepam. The CNO further stated an informed consent for psychotropic medication did not need a dosage, just the name of the medication was "sufficient".

Based on observation, staff interview, facility document review, and facility Policy and Procedure review, the facility failed to:

1. Prevent staff physical and verbal abuse to one of 33 sampled Patients (Patient 6);

2. Report the abuse to a State Agency;

3. Have a Policy and Procedure for the investigation of abuse or neglect.

These failures led to Patient 6's abuse and subsequent transfer to an acute care hospital's Emergency Department (ED) with the diagnosis of "Acute Cervical Strain" (trauma to muscles and tendons of the neck from violent contraction or excessive or forcible stretch).

Findings:

1. During a concurrent observation and interview with Patient 6, and the Chief Nurse Officer (CNO) on 4/20/16, at 8:50 a.m., Patient 6 stated he had been "beaten up" and called bad names by a staff member on Saturday April 16, 2016, around 8 p.m. Patient 6 stated he had a bruise on his back. Upon observation, a red linear bruise was noted on Patient 6's mid back. Patient 6 stated he had been shoved against the wall by Mental Health Technician 1 (MHT 1), and his back hit a window sill. Patient 6 also stated he was put in a "head lock" and hit on the top of his head. There was a small lump felt on the right side of Patient 6's head.

Review of Registered Nurse 1's (RN 1) notes dated 4/16/16, at 9:50 p.m. indicated: "...Noted abrasion on mid back and a cut on the right [head] area approximately 4 [centimeters]. Patient is now [complaining of] pain on the bump side of his head, his neck, and his back, moderate pain... "

In an interview with the CNO on 4/20/16, at 9 a.m., the CNO stated she had Patient 6's grievance of alleged abuse written by him on a plain piece of paper, and not on the hospital's "grievance form."

Review of facility document titled "[Name of Hospital] Daily Staffing", dated 4/16/16, PM shift, indicated the census of the "B" unit was 20 patients. The document indicated five staff members were required for that shift. The document indicated there were four staff members present for this shift between 7-8 p.m.

At 8 p.m., an oncoming employee, MHT 1, was assigned to "B" unit.

During interviews with RN 2, RN 3 and MHT 3, on 4/20/16 from 4:30-5:30 p.m., all three employees indicated they were at "lunch" at 8 p.m. on 4/16/16. The staffing for "B" unit at 8 p.m. on 4/16/16 indicated MHT 2 and an oncoming MHT 1.

There was one staff member present, MHT 2, on the "B" unit for 20 patients, while the rest of the staff were at lunch. When MHT 1 arrived at 8 p.m., there were 2 MHT's for 20 patients.

Review of the facility document titled, "Meal and Rest Period Obligation Acknowledgment" indicated: "...I understand it is my obligation under the law and [name of hospital] policies to take a meal period at least 30 minutes...Because a violation of this rule constitutes a violation of the law and [name of hospital] policy, I understand that I may be subject to disciplinary action, up to and including immediate termination."

2. In an interview with the CNO on 4/20/16, at 9 a.m., the CNO stated they do not report abuse allegations to any State Agency.

3. In an interview with the CNO on 4/21/16 at 4 p.m., the CNO stated the facility did not have a Policy and Procedure related to either staff to patient or patient to patient abuse investigations. The CNO stated the abuse Policy and Procedure was used if Patient's stated there was abuse in the home. The CNO indicated the Policy and Procedure used to investigate abuse allegations was titled, "Corrective Action Process", and the Human resources staff conducted the investigation.

Review of the facility policy and procedure titled, "Employee Conduct and Work Rules", dated 11/18/14, indicated: "...The types of misconduct identified below are merely examples of the conduct that may lead to such corrective action...1. Verbal or physical abuse/threats, intimidating, swearing, disruptive, or coercing behavior directed toward (or in the presence of) a patient, visitor, or facility employee; 2. Fighting or striking another person on facility premises or during work hours..."

There was nothing in the Policy and Procedure which indicted how to investigate the allegation of abuse or who and when to report to a State Agency.

Based on staff interview, medical record review, and facility Policy and Procedure review, the facility failed to have a plan of care for restraint or seclusion (R/S) which was individualized and indicated time limits for seclusion for three of three Patients reviewed for R/S episodes (Patients 26, 27 and 28).

These failures had the potential for missed opportunities for behavior modification and possibly physical harm to patients restrained.

Findings:

1) Review of Patient 26's medical record indicated she was a 54 year old who was placed in seclusion four times on four different days according to documents titled Seclusion/Restraint Order dated 3/14/16, 3/19/16, 4/1/16, and 4/2/16.

Further review of Patient 26's medical record included a document titled
Emergency Interventions Treatment Plan which was dated as initiated on 3/16/16. The treatement plan contained no individualized interventions or updates for any of the above mentioned periods of care requiring R/S.

2) Review of Patient 27's medical record indicated he was a 17 year old patient, who was placed in seclusion four times within two days according to documents titled Seclusion/Restrain Order dated 4/3/16 and 4/4/16.

Further review of Patient 27's medical record included a document titled
Emergency Interventions Treatment Plan which was dated as initiated on 4/3/16. The treatement plan contained no individualized interventions or updates for any of the above mentioned periods of care requiring R/S.

3) Patient 28 was a 38 year old patient who was placed in seclusion/restraint once according to a document titled Seclusion/Restrain Order dated 4/1/16.

Further review of Patient 28's medical record included a document titled
Emergency Interventions Treatment Plan which was dated as initiated on 4/1/16. The treatement plan contained no individualized interventions or updates for any of the above mentioned periods of care requiring R/S.

Review of Patients' 26, 27 and 28's "Emergency Interventions Treatment Plan" revealed every "Short-Term Goals, Specific Interventions Focus, Treatment Modality, and Frequency/Duration" were the same for all three patients. There was no individualization, no update for discontinued R/S, and the specific time limit for R/S ordered by the Physician was not part of the Emergency Interventions Treatment Plan.

Review of the facility Policy and Procedure titled, "Seclusion/Restraint/Physical Hold" dated 1/16, indicated the following:
"Initiates/updates the Treatment Plan of Care within 24 hours to reflect current seclusion/restraint interventions and updates changes in treatment approach when indicated..."

In an interview with the Education Director (ED) on 4/21/16, at 11 a.m., the ED stated the staff are expected to follow the facility Policy and Procedure regarding R/S treatment plans.

In an interview with the Education Director (ED), on 4/21/16, at 11 a.m., the ED was shown all the seclusion documents. The ED stated she expected staff to document a RR every 15 minutes, even if the patient had refused vital signs, as you don't need permission to watch a patient breathe. The ED stated the expectation was for staff to fill out the boxes under the category of "Current Status and Current Behavior" every 15 minutes when vital signs are documented. The ED stated she expected staff to assess patients if they were yelling and screaming for over 1 hour, and any self injurious behavior, such as punching the wall or door of the seclusion room.

Based on staff interview, medical record review and facility Policy and Procedure review, the facility failed to implement safe restraint/seclusion techniques as determined by the facility Policy and Procedure for one of three Patients reviewed for restraint and seclusion (Patient 27). There was no evidence the facility Policy and Procedure was in accordance with State law.

The failure to implement appropriate restraint/seclusion techniques resulted in the potential for physical harm to patients while restrained or in seclusion.


Findings:

Review of Patient 27's documents titled Seclusion/Restraint Order in the medical record indicated he was a 17 year old patient, who was placed in seclusion four times within two days:

1a. Dated 4/3/16 at 7:21 p.m. for 64 minutes: Vital signs were not documented every 15 minutes, there was one documented vital sign at 9:10 p.m. There was a discrepancy in the documented time for ending seclusion and vital sign documentation, the seclusion was documented as ending at 8:25 p.m., the vital signs and documented "Current Status" was documented at 9:10 p.m. . There was no every 15 minute documentation of "Current Status" from 7:21 p.m. till 9:10 p.m. There was no evidence of every 15 minute documentation for "Current Behavior" for any time Patient 27 was in seclusion;

1b. Dated 4/3/16 at 9:48 p.m. for 2 hours: There was no evidence of every 15 minute documentation of vital signs, "Current Status", or "Current Behavior" for the time Patient 27 was in seclusion. At 10:01 p.m., a face to face assessment was completed with documented evidence Patient 27 was "Punching door" of the seclusion room. There was no documented evidence a RN assessed Patient 27 for self harm after he punched the door to the seclusion room;

1c. Dated 4/4/16 at 12:50 a.m. for 1 hour and 15 minutes: There was no evidence of every 15 minute documented vital signs. At 1:10 a.m., "Patient refused" was documented under vital signs, no RR was documented. At 1:10 a.m. there was documented evidence Patient 27 had an "injury or pain". There was no documented evidence a RN (Registered Nurse) assessed Patient 27's injury or pain. There was no evidence of every 15 minute documentation for "Current Status" or "Current Behavior" after 1:10 a.m.;

1d. Dated 4/4/16 at 3:52 a.m. for 2 hours: There was no evidence of every 15 minute vital sign documentation. "Patient refused" was documented at 4:10 a.m. There was no documented evidence "Current Status" or "Current Behavior" was assessed after 4:10 a.m. . There was evidence of self harm, as the documentation indicated, "Knuckles are swollen from hitting the walls of the quiet room".

There was no evidence a RN assessed Patient 27's behavior for mechanical restraints or his hands. There was no documented evidence a Physician was notified about the injury to Patient 27's hands. There was no documented evidence of 1:1 observations for the any of the times spent in seclusion.

Facility Policy and Procedure titled, "Seclusion/Restraint/Physical Hold" dated 1/16, indicated the following: "RN assigns a staff member, competent in CPR [cardiopulmonary resuscitation] and CPI [crisis prevention intervention], who has been trained and deemed competent in the usage and monitoring of seclusion and restraints, to conduct continuous in-person observation/monitoring for the duration of the seclusion/restraint episode; ...If patient engages in self harm behavior staff will open the door and RN will assess for release or mechanical restraint." There was no evidence the Policy and Procedure incorporated any State laws.

In an interview with the Education Director (ED), on 4/21/16, at 11 a.m., the ED was shown all the seclusion documents. The ED stated she expected staff to document a RR every 15 minutes, even if the patient had refused vital signs, as you don't need permission to watch a patient breathe. The ED stated the expectation was for staff to fill out the boxes under the category of "Current Status and Current Behavior" every 15 minutes when vital signs are documented. The ED stated she expected staff to assess patients if they were yelling and screaming for over 1 hour, and any self injurious behavior, such as punching the wall or door of the seclusion room.

Based on staff interview, medical record review, and facility Policy and Procedure review, the facility failed to obtain a Physician's order within the specified time frames for restraint or seclusion (R/S) for two of three patients reviewed for restraint or seclusion (Patient 26 and 28).

These failures may have led to patient harm due to unwarranted R/S.

Findings:

Review of Patient 26's R/S documentation indicated a Registered Nurse (RN) ordered seclusion on 4/1/16, at 8:04 a.m. The order was authenticated by the physician on 4/1/16 at 7:10 p.m.

Review of Patient 28's R/S documentation indicated a RN ordered R/S on 4/1/16, at 10:15 a.m. The order was authenticated by the physician on 4/1/16 at 3:15 p.m.

Facility Policy and Procedure titled, "Seclusion/Restraint/Physical Hold" dated 1/16, indicated the following: "In an emergency, the Nursing Supervisor/Charge Nurse may initiate a seclusion/restraint as a protective measure provided that a physician order is obtained as soon as possible, but no longer than 1 hour after initiation of the seclusion/restraint."

In an interview with the Education Director (ED) on 2/21/16, at 11 a.m., the ED stated she expected staff to follow facility Policy and Procedure regarding MD orders for R/S.

Based on staff interview, medical record review, and facility Policy and Procedure review, the facility failed to ensure three (3) out of three (3) Patients (Patients 26, 27 and 28) reviewed for restraint and seclusion (R/S) had monitoring of "Current Status" such as "Circulatory WNL [within normal limits], Pain or injury, or Patient is safe", vital signs (respiratory rate, blood pressure, temperature and heart rate) or "Current Behavior" such as "Cooperative, Uncooperative, Agitated, Yelling/Screaming, Other, and Ready for release: Yes or No".

This failure resulted in an injury to Patient 27's hands and had the potential to harm Patient's 26 and 28 while in seclusion.

Findings:

1. Review of Patient 26's medical record indicated she was a 54 year old who was placed in seclusion four (4) times, on four (4) different days:
1a. Dated 3/14/16 at 7:45 p.m. for 30 minutes: No vital signs were documented every 15 minutes. The seclusion record indicated Patient 26 "refused" vital signs. A respiratory rate (RR) was not documented;

1b. Dated 3/19/16 at 5:45 a.m. for approximately 2 hours and 45 minutes: There was no evidence vital signs or RR were documented every 15 minutes from 6 a.m. to 7 a.m. . There was no evidence of documentation for "Current Status" from 7:30 a.m. to 8:15 a.m. Documentation under "Current Behavior" indicated Patient 26 was "Yelling and Screaming" from 6 a.m. to 7:30 a.m., with no documented evidence a Registered Nurse (RN) assessed Patient 26's behavior of "Yelling and Screaming" for 1.5 hours;

1c. Dated 4/1/16 at 8:04 a.m. for 12 minutes: There were no documented vital signs, the seclusion record indicated, "Patient refused", no RR was documented;

1d. Dated 4/2/16 at 11:20 p.m. for 4 hours: There were no every 15 minute documented vital signs. The seclusion record indicated, "Refused" where vital signs were to be documented, there was no RR documented. The every 15 minute documentation under "Current Behavior", indicated Patient 26 was "Agitated" for 1.5 hours with no documented evidence a RN assessed Patient 26's agitation. There was no specific behavior documented to explain what "Agitated" meant. For 3 hours and 45 minutes Patient 26 was "Uncooperative", with no documentation as to what "Uncooperative" meant, and what type of behavior Patient 26 exhibited to be "Uncooperative". Patient 26 was released from seclusion when she fell asleep, 15 minutes after her behavior was documented as "Uncooperative".
There was no documented evidence of 1:1 observations for the any of the times spent in seclusion;

2. Review of Patient 27's medical record indicated he was a 17 year old patient, who was placed in seclusion four (4) times within two (2) days:

2a. Dated 4/3/16 at 7:21 p.m. for 64 minutes (documented), 1 hour and 40 minutes (possible): Vital signs were not documented every 15 minutes, there was one documented vital sign at 9:10 p.m. There is a discrepancy in the documented time for ending seclusion and vital sign documentation, the seclusion was documented as ending at 8:25 p.m., the vital signs and documented "Current Status" was documented at 9:10 p.m. . There was no every 15 minute documentation of "Current Status" from 7:21 p.m. till 9:10 p.m. . There was no evidence of every 15 minute documentation for "Current Behavior" for any time Patient 27 was in seclusion;

2b. Dated 4/3/16 at 9:48 p.m. for 2 hours: There was no evidence of every 15 minute documentation of vital signs, "Current Status", or "Current Behavior" for the time Patient 27 was in seclusion. At 10:01 p.m., a face to face assessment was completed with documented evidence Patient 27 was "Punching door" of the seclusion room. There was no documented evidence a RN assessed Patient 26 for self harm after he punched the door to the seclusion room;

2c. Dated 4/4/16 at 50 minutes after midnight for 1 hour and 15 minutes: There was no evidence of every 15 minute documented vital signs. At 1:10 a.m., "Patient refused" was documented under vital signs, no RR was documented. At 1:10 a.m. there was documented evidence Patient 27 had an "injury or pain". There was no documented evidence a RN assessed Patient 27's injury or pain. There was no evidence of every 15 minute documentation for "Current Status" or "Current Behavior" after 1:10 a.m.;

2d. Dated 4/4/16 at 3:52 a.m. for 2 hours: There was no evidence of every 15 minute vital sign documentation. "Patient refused" was documented at 4:10 a.m. . There was no documented evidence "Current Status" or "Current Behavior" was assessed after 4:10 a.m. . There was evidence of self harm, as the documentation indicated, "Knuckles are swollen from hitting the walls of the quiet room". There was no evidence a RN assessed Patient 27's behavior for mechanical restraints or his hands. There was no documented evidence a Physician was notified about the injury to Patient 27's hands.
There was no documented evidence of 1:1 observations for the any of the times spent in seclusion.


3. Patient 28 was a 38 year old patient who was placed in seclusion/restraint once:

3a. Dated 4/1/16 at 10:03 a.m. for 12 minutes physical restraint, and 1 hour and 32 minutes secluded: No monitoring sheet was provided by the facility. There was no documented evidence of 1:1 observations for the any of the time spent in seclusion.


Facility Policy and Procedure titled, "Seclusion/Restraint/Physical Hold" dated 1/16, indicated the following: "...RN assigns a staff member, competent in CPR [cardiopulmonary resuscitation] and CPI [crisis prevention intervention], who has been trained and deemed competent in the usage and monitoring of seclusion and restraints, to conduct continuous in-person observation/monitoring for the duration of the seclusion/restraint episode; ...If patient engages in self harm behavior staff will open the door and RN will assess for release or mechanical restraint...Assigned staff conducts 15-minute patient observations of the Seclusion/Restraint Hourly Flow Sheet that includes the following: Reviews for signs of injury related to restraint application; Evaluates behavior, staff interventions, and patient responses; Evaluates for breathing; Monitors for circulation and skin integrity;...Obtains vital signs; Notifies RN of any changes in physical or psychological status/comfort needs; Assesses patient every 15 minutes to determine if release criteria is met".

In an interview with the Education Director (ED), on 4/21/16, at 11 a.m., the ED was shown all the seclusion documents. The ED stated she expected staff to document a RR every 15 minutes, even if the patient had refused vital signs, as you don't need permission to watch a patient breathe. The ED stated the expectation was for staff to fill out the boxes under the category of "Current Status and Current Behavior" every 15 minutes when vital signs are documented. The ED stated she expected staff to assess patients if they were yelling and screaming for over 1 hour, and any self injurious behavior, such as punching the wall or door of the seclusion room.

Based on staff interview, medical record review, and facility Policy and Procedure review, the facility failed to ensure a face to face evaluation was reviewed by an Attending Physician within 30 minutes of the evaluation for three of three Patient records reviewed (Patients 26, 27 and 28) for restraint/seclusion (R/S).

These failures had the potential for patient harm related to R/S used without cause.

Findings:

1. Review of Patient 26's medical record indicated she was a 54 year old who was placed in seclusion four times on four different days:

1a. Dated 4/1/16: The face to face evaluation was completed at 8:10 a.m., and the evaluation was reviewed with the Attending Physician at 10 a.m.;

1b. Dated 4/2/16: The face to face evaluation was completed at 11:40 p.m., and the documented evaluation by the Attending Physician was noted 5 minutes before the face to face was performed, at 11:35 p.m.;

1c. Dated 3/19/16: The face to face evaluation was completed at 6:45 a.m., and the evaluation was reviewed with the Attending Physician the next day, 3/20/16. No time was documented.

2. Review of Patient 27's medical record indicated he was a 17 year old patient, who was placed in seclusion four times within two days:

2a. Dated 4/3/16: The face to face evaluation was completed at 10:01 p.m., and the evaluation was reviewed with the Attending Physician 21 minutes before it was completed, at 9:40 p.m.;

2b. Dated 4/4/16: The face to face evaluation was completed at 12:55 a.m., and the evaluation was reviewed with the Attending Physician at 2:45 p.m.;

2c. Dated 4/4/16: the face to face evaluation was completed at 4:35 a.m., and the evaluation was reviewed with the Attending Physician at 2:45 p.m.

3. Patient 28 was a 38 year old patient who was placed in seclusion/restraint once:

3a. Dated:4/1/16: the face to face evaluation was completed at 10:20 a.m., and the evaluation was reviewed by the Attending Physician at 11a.m.

Facility Policy and Procedure review indicated the following:
1. "Procedure:...Contacts the Attending Physician or designee to discuss the evaluation of the patient, the need for other interventions or treatments and the need to continue or discontinue the R/S. This needs to be done as soon as possible after completing the One Hour Face to Face Medical & Behavioral Evaluation but no longer than 30 minutes after the evaluation is completed.

In an interview with the Education Director (ED) on 4/21/16, at 11 a.m., the ED stated she expected staff to follow the facility Policy and Procedure for the one hour face to face evaluation review with the Attending Physician.

Based on staff interview, medical record review, and facility Policy and Procedure review, the facility failed to ensure one of three Patients (Patient 26) reviewed for restraint and seclusion (R/S) had a documented description of the behavior that precipitated the seclusion episode.

This failure had the potential for harm to Patient 26 as a result of being placed in seclusion.

Findings:

Review of Patient 26's seclusion documentation on 4/1/16, at 7:45 p.m., did not indicate the specific behavior that warranted placement in seclusion.

Facility Policy and Procedure indicated the following:
1. "Procedure: The physician's orders specify the reason for restraint and seclusion usage... ."

In an interview with the Education Director (ED) on 2/21/16, at 11 a.m., the ED stated she expected staff to follow facility Policy and Procedure regarding documentation of behaviors which lead to R/S.

Based on staff interview, medical record review, and facility Policy and Procedure review, the facility failed to ensure one (1) out of three (3) Patients (Patient 26) reviewed for restraint and seclusion (R/S) had a documented description of the condition or symptoms that warranted the use of seclusion.

This failure had the potential for harm to Patient 26 due to being placed in seclusion.

Findings:

Review of Patient 26's seclusion documentation on 4/1/16, at 7:45 p.m., did not indicate the specific condition or symptoms that warranted placement in seclusion.

Facility Policy and Procedure indicated the following:
1. "Procedure: The physician's orders specify the reason for restraint and seclusion usage... ."

In an interview with the Education Director (ED) on 2/21/16, at 11 a.m., the ED stated she expected staff to follow facility Policy and Procedure regarding specific behaviors which led to R/S.

Based on observations, staff interviews, medical record and facility document review, the facility failed to ensure:

1. An adequate number of staff was available each shift to provide direct patient care; and

2. Training of staff for new equipment, an ECG machine (machine used to determine heart rhythms) was completed;


These failures led to inadequate staffing and training which had the the potential for accidents, injuries, patient neglect, and death.

Findings:

1. The Chief Nurse Officer (CNO), Director of Nursing (DON) in an interview on 4/20/16 at 1:48 p.m., produced a staffing document for nursing staff assigned and scheduled for the previous week. She said the nurse staffing was assigned according to the "grid" and the "hospital patient acuity form" which was concurrently reviewed with the CNO/DON during the interview. She said the "staffing coordinator makes the staffing assignments", and that she oversees her work.

In an interview with the Staffing Coordinator, (SC) on 4/22/16 at 10:00 a.m., when asked if the CNO/DON approves the assignments on the daily schedules before they go out to the hospital units she said, no, she may come by and glance at it but we do not have a process for her to approve the assignments. Therefore there was no evidence a licensed nurse had reviewed and approved schedules or assignments prior to the shift.
Review of the job description for the Staffing Coordinator revealed, "The staffing Coordinator is responsible for the centralized scheduling of Nursing Services staff. This requires a thorough knowledge of policies related to scheduling as well as a general knowledge of human resources...Primary Responsibilities...Implements established procedures for reallocation of staff to meet daily needs...Projects staffing needs for each shift on acuity and special patient procedures..."
During interviews with RN 2, RN 3 and MT 3, on 4/20/16 from 4:30-5:30 p.m., all three (3) employees indicated they were at "lunch" at 8 p.m. on 4/16/16. The staffing for "B" unit at 8 p.m. on 4/16/16 indicated MT 2 and an oncoming MT 1.

During a Tour of Unit E on 4/22/16 at 11:40 a.m., an interview was conducted with a Mental Health Technician (MHT 6), who stated there were concerns regarding staffing. The MHT 6 said, some of the patients had not been out of bed yet today. "Sometimes patients are unable to leave the unit for gym activities or groups due to not enough staff, this happens once or twice a month and the patients complain about not getting their therapy time." MHT 6 said, "When I've worked on C and D unit at times I have been the only MHT and I did not feel very comfortable."

In an interview with LN 6 on 4/22/16 at 11:52 a.m., he said "I can't do my job right now because I need to observe the patients because we do not have enough staff".

In an interview with RN 7 on 4/21/16 at 3:24 p.m. she stated, "Every couple of weeks we don't have enough staff."

During an observation of unit E on 4/22/16, at 12:01 p.m. it was revealed there was only one MHT working on unit E. In a concurrent interview with a Property Clerk (PC), (a non nursing staff member), she stated she had been sent to the unit to help out as needed for the 22 admitted patients. The PC said she had previously presented staffing concerns to the DON/CNO in the past. When asked, what was the outcome of that meeting she said "nothing changed."

Review of "Daily Staffing Schedules" for all the units for the period of 4/11 to 4/17/16, indicated many of the hospital units were understaffed. Upon review of their staffing Patient Acuity Form (a form used to determine the correct number of staff per acuity for each unit) it was noted the facility did not follow their acuity requirements for staffing. Based on facility provided acuity form the following additional staffing should be provided: "Acuity: for Q-5 minute checks (add 1 staff for 2-4 patients)...Acuity: for 1:1 (add 1 staff)."


For seven of seven days reviewed, the hospital units were not in compliance with their staffing requirements:

1. Monday, 4/11/16: Day shift for Units E Census 23
Core Reg: 5
# of Q5:1
# of 1:1: 1
Staff need: 6
Actual staff: 5.5
Additional Staff needed: .5

Unit F Census 22

Core Reg: 5
# of Q5: 3
# of 1:1: 1
Staff need: 7
Actual: 6.5
Additional Staff needed: .5

P.M. shift for Unit B Census 19

Core Reg: 5
# of Q5: 1
# of 1:1:0
Staff need: 5
Actual: 4.5
Additional Staff needed: .5

Unit E Census 21+2

Core Reg: 5.5
# of Q5: 1
# of 1:1: 1
Staff need: 6.5
Acutal: 6
Additional Staff needed: .5


Unit F Census: 23

Core Reg: 5.5
# of Q5: 3
# of 1:1: 1
Staff need: 7.5
Actual: 7
Additional Staff needed: .5

Night Shift for Unit E Census 23

Core Reg: 3
# of Q5: 2
# of 1:1: 1
Staff need: 5
Actual: 4
Additional Staff needed: 1

Unit F Census 21

Core Reg: 3
# of Q5: 3
# of 1:1: 1
Staff need: 5
Actual: 4
Additional Staff needed:1

2. Tuesday, 4/12/16: Day shift Units B Census 18

Core: 4.5
# of Q5: 1
# of 1:1: 0
Staff need: 4.5
Actual:4
Additional Staff needed: .5

Unit F Census 23

Core: 5
# of Q5: 3
# of 1:1: 1
Staff need: 7
Actual: 6.5
Additional Staff needed: .5

P.M. shift Unit F Census 21

Core: 5
# of Q5: 3
# of 1:1: 1
Staff need: 7
Actual: 6.5
Additional Staff needed: .5

Night Shift Unit E Census 21

Core: 3
# of Q5: 2
# of 1:1: 1
Staff need: 5
Actual: 4
Additional Staff needed:1

3. Wednesday, 4/13/16: Day shift Unit F Census 22

Core: 5
# of Q5: 2
# of 1:1: 1
Staff need: 7
Actual: 6.5
Additional Staff needed: .5

4. Thursday, 4/14/16: Day shift Units E Census 18

Core: 5
# of Q5: 2
# of 1:1: 0
Staff need: 6
Actual: 5.5
Additional Staff needed: .5

Unit F Census 23

Core: 5.5
# of Q5: 1
# of 1:1: 1
Staff need: 6.5
Actual: 6
Additional Staff needed: .5


5. Friday, 4/15/16: Day shift Unit F Census 23

Core: 5.5
# of Q5: 1
# of 1:1: 1
Staff need: 6.5
Actual: 6
Additional Staff needed: .5


6. Saturday, 4/16/16: Day shift: Unit B Census 19

Core: 4.5
# of Q5: 1
# of 1:1: 1
Staff need: 4.5
Actual: 4
Additional Staff needed: .5

7. Saturday, 4/16/16: Day shift Unit F Census 23

Core: 5.5
# of Q5: 1
# of 1:1: 1
Staff need: 6.5
Actual: 5
Additional Staff needed: 1

8. Saturday, 4/16/16: Evening Shift Unit A Census 13

Core: 3.5
# of Q5: 1
# of 1:1: 1
Staff need: 5
Actual: 4
Additional Staff needed: 1

9. Saturday, 4/16/16: Evening Shift Unit F Census 23

Core: 5.5
# of Q5: 1
# of 1:1: 1
Staff need: 6.5
Actual: 6
Additional Staff needed: .5

10. Sunday, 4/17/16: Day shift Unit F Census 23

Core: 5.5
# of Q5: 1
# of 1:1: 1
Staff need: 5.5
Actual: 5
Additional Staff needed: .5

In a record review of the hospitals "Meal and Rest Period Obligation Acknowledgement form" provided to the hospital employees requiring Employee Signature and date, it stated, "I understand that state law requires that I take a meal period of no less than 30 minutes whenever I exceed five hours in a work day...Because a violation of this rule constitues a violation of the law and ...policy,.. I understand that I may be subject to disciplinary action, up to and including immediate termination... I also understand that I am entitled to a rest period at a rate of 10 minutes for every four hours of work...and that no Supervisor, Manager, or Director may ask or require me to give up my rest period...I also understand that it is my responsibility to take my 10 minute rest period." In a concurrent record review of the hospital staffing schedules from 4/11/16 to 4/17/16, there was no indication of break relief coverage for any day during any shift for these hospital mandated meal and rest periods.
In review of a list of hospital scheduled therapy groups for the month of March/2016, it was noted that on 3/23/16 there were 3 therapy groups canceled due to "0 Staffing" which was verified by the Psychological Services Director, (PSD).
2. In an interview with the Safety Officer, Plant Operations Director (SO/POD) on 4/22/16, at 11 a.m., the SO/POD stated the facility received a new ECG machine [used to assess heart rate and patterns] on 3/25/16. The SO/POD stated he was told by nursing staff the machine was not working on 4/8/16, and needed calibration. The SO/POD stated he had the ECG machine checked, and it was working fine.
Review of Patient 3's medical record indicated a Physician's order dated 4/7/16, at 8:30 a.m. indicated "EKG-[history] of abnormal study".
Review of Patient 3's "Medication Administration Record" (MAR), dated 4/7/16, indicated the EKG was not done because, "Attempted [times two (2)], machine needs calibration".
In an interview with Registered Nurse 3 (RN 3) on 4/13/16, at 1 p.m., RN 3 stated staff did not know how to run the ECG machine, because it was new, and staff had no training prior to the ECG machine being delivered to the unit on 3/25/16.
In an interview with the Education Director on 4/21/16, at 11 a.m., the ED stated she did not know there was a new ECG machine in the facility. The ED confirmed no training had been completed for staff on how to use the new ECG machine.

Based on staff interviews, medical record reviews and facility Policy and Procedure review, the facility failed to ensure Physician's orders for drugs and biologicals were signed, dated, and timed by a Physician authorized to write orders by hospital Policy and in accordance with State and Federal laws.

These failures had the potential of causing medication errors to patients and may subsequently cause harm.

Findings:

During a concurrent medical record review and interview, with the Psychological Services Director (PSD) on 4/20/16 at 8:45 a.m., 8 of 33 sampled patient's medical records revealed Physician's orders that were not signed, dated and timed within 48 hours of the date written (between 3/16/16 and 4/18/16). These errors were verified with the PSD.


The list below indicated which patients medical records were out of compliance:
A. Patient 26: 4 Physician's orders
B. Patient 12: 2 Physician's orders
C. Patient 18: 1 Physician's orders
D. Patient 17: 2 Physician's orders
E. Patient 27: 20 Physician's orders
F. Patient 16: 2 Physician's orders
G. Patient 11: 7 Physician's orders
H. Patient 6: 6 Physician's orders

Facility Policy and Procedure titled, "Integrity of all Medical Records, dated 4/15, indicated:
A. "...Physician Orders...All the orders must be legible and signed and dated by the provider within 48 hours."

Based on interviews and record review, the hospital failed to ensure medication orders were timed, and the order authentication had a date and time, for 1 of 34 sampled patients. Three written orders for Patient 34 were without a time, and five of her telephone/verbal order authentication had no date and time. It could not be determined if the prescribers authenticated the prescribed orders in a timely manner in accordance with the hospital policy and procedure.

Findings:

On 4/21/15 at 11:45 a.m., a review of Patient 34's medical record with the director of pharmacy (DOP) revealed three of the written medication orders had the signature and the date but had no time of being written.

Further review reflected five telephone/verbal orders, dated from 3/25/16 to 4/16/16, were countersigned (authenticated) by the prescriber. However, one could not tell when the prescriber did so, as the authentication did not include a date and time. The DOP verified the finding.

The hospital's policy and procedure entitled "Integrity of All Medical Records," indicated, "All the orders must be... signed and dated by the provider within 48 hours."

Based on observation, interview, and document review, the hospital failed to ensure the provision of safe and effective system for medication storage when:

a. Thermometers for medication refrigerators were not recalibrated on a yearly basis as per manufacturer's recommendation to ensure accurate reading of the temperature;

b. The audible alarm on the thermometers was not turned on and set up correctly to alert the staff when the temperature was out of range; and

c. Policy and procedure did not address the responsibility of the personnel responsible for the maintenance of the thermometers.

The failures resulted in four of five medication refrigerators not being recalibrated at least since 2014, and one refrigerator had inaccurate temperature reading resulting its medications being removed.

Findings:

During a visit to the pharmacy on 4/19/16 at 10:45 a.m., the main medication refrigerator was identified. It contained many refrigerated medications including various types of vaccines and insulins. Attached on the outside of the refrigerator was a digital thermometer, which had a display showing the current temperature and the maximum and minimum temperature values. The alarm on this thermometer was in the "off" position. The director of pharmacy (DOP) stated she did not know when the thermometer was last recalibrated, and could not explain why the alarm was turned off. The chief nursing officer (CNO), who was present, said Plant Operations was responsible for recalibrating them. A small sticker on the back of the thermometer indicated the recalibration was "due 12/29/14."

The same type of digital thermometer was being utilized in the medication refrigerators in Nursing Units A&B, C&D, and E. The temperature logs for the pharmacy and the nursing units showed twice daily (a.m. and p.m.) temperature reading and recording by the pharmacy technician (PT).

The medication refrigerator in Unit A&B was inspected on 4/19/16 at 12 p.m. The thermometer was found inside the refrigerator. Its alarm was in the "off" position. The refrigerator contained 6 vials of various insulins and multiple injectable vials of lorazepam (to treat anxiety or agitation). There was no information as to when the recalibration was due.

On 4/19/16 at 1:30 p.m., the medication refrigerator in Unit E was inspected with the CNO and DOP. The alarm on the digital thermometer was also in the "off" position. The refrigerator contained 3 vials of lorazepam, 6 vials of insulin, and 1 PPD (purified protein derivative- to test for tuberculosis). The small sticker on the back of the thermometer indicated the recalibration was "due 12/26/14."

On 4/19/16 at 1:46 p.m., the medication refrigerator in Unit C&D was examined with the CNO and DOP. The refrigerator contained 6 vials of lorazepam, 6 vials of various insulins, and 1 vial of tetanus toxoid (to prevent tetanus). The thermometer alarm was also turned off. There no information as to when the recalibration was due. DOP said she did not know when the thermometers were last recalibrated, and the pharmacy had not been doing the recalibration.

On 4/19/16 at 2:20 p.m. in the presence of the CNO and DOP, the Safety Officer/Plant Operations Director (SO/POD) said he had not recalibrated any thermometers for the medication refrigerators and did not know how often they should be recalibrated.

On 4/19/16 at 3:20 p.m., the SO/POD provided the online information for the digital thermometers in use in the refrigerators. It indicated recalibration was the responsibility of the hospital and "annual recalibration is recommended." The SO/POD said he did not know whether it was his responsibility for maintaining and recalibration of those thermometers; the hospital policy did not address either his department or the pharmacy was responsible.

On 4/20/16 at 10:20 a.m., the thermometer alarm on the medication refrigerator in the pharmacy was still turned off. At this time, the PT reviewed the User Manual and followed the direction to set up the Alarm Mode so it would alert (by an audible sound) staff when the temperature was out of range. The PT and DOP verified that the pharmacy did not correctly configure the alarm setting for each thermometer in use, which explained why the alarm was turned off. The DOP acknowledged that because the alarm setting was not correctly set up and the alarm turned off, any out-of-range temperature in between the morning and afternoon checking would not have been identified, and actions taken.

On 4/20/16 starting at 10:35 a.m., a new thermometer, provided by Plant Operations, was placed in each of the four identified refrigerators to test the accuracy of each thermometer in use. The medication refrigerator in Unit E did not have an accurate reading after being tested at two different times. Its reading was 9 to 10 degrees Fahrenheit higher than that of new thermometer. At 12:15 p.m., the DOP removed all its current medications. They were 3 vials of lorazepam, 6 vials of various insulins, and 1 vial of PPD.

A review of the hospital's "Refrigeration, Freezing and Warming" policy and procedure, dated 5/2015, indicated, "The thermometer accuracy will be verified against known standard and documented per hospital policy." This policy did not delineate the process how the accuracy would be verified, and who would be responsible for the maintenance and recalibration of the thermometers.

Based on observation, interview, and record review, the hospital failed to ensure the provision of safe and effective medication use, in accordance with applicable standards of practice, when its policy and procedure for the automated dispensing cabinet (ADC) override (when an authorized user obtains medications before the pharmacist review) did not delineate the process for overrides and did not establish criteria for and medications designated for override functionality. The failure resulted in non-emergent medication, such as fentanyl patches (a potent long-acting narcotic applied to the skin), being available for override before the pharmacist review for appropriateness; and may result in inconsistent practice among its staff members.

Findings:

Fentanyl transdermal patch is a potent narcotic applied to the skin, to treat moderate to severe pain. It was designed to release the drug in a slow, steady manner over 72 hours. The full prescribing information for fentanyl patch indicates it was contraindicated for use in non-opioid tolerant patients (those who had not used opioids previously in sufficient quantities to develop a tolerance to opioid effects). The warnings for its use included "serious, life-threatening, or fatal respiratory depression [a condition of having a breathing rate that becomes too low to ventilate the lung] may occur with use... even when used as recommended."

During a visit to Nursing Unit A&B on 4/19/16 at 12 p.m., the director of pharmacy (DOP) stated the fentanyl patches were not override-able. Licensed nurse 1 (LN 1) and Registered Nurse 3 (RN 3) explained the process of override required a staff nurse and a nurse supervisor to sign into the ADC and obtain (via the override function) the medication(s) together. They were asked to override a fentanyl patch for a patient who did not have an order for it, and were able to do so without any difficulty.

On 4/19/16 at 4 p.m., the DOP provided the hospital's "Med Dispense: Overrides" policy and procedure, dated 9/2015, which revealed it did not delineate a process for overrides, such as defining the urgent clinical situations (e.g., pain, nausea & vomiting, extreme agitation, etc.) that warrant override, who could override, which medications could, or could not, be overridden. The policy only indicated that one medication, warfarin (a blood thinner), not to be included on the override list. The DOP verified this fact.

During an interview on 4/20/16 at 10:10 a.m., RN 3 was unable to describe any contraindications related to the fentanyl patch. She said she would override the fentanyl patch for patients if there was an order for it.

In the 2010 "ASHP [American Society of Health-System Pharmacists] Guidelines on the Safe Use of Automated Dispensing Devices," it indicated, "[O]rganizational policies and criteria for system overrides should be developed that limit access to medications before orders have been reviewed and approved by a pharmacist. Override access to medications should be limited to cases in which the drug product has been approved by a multidisciplinary committee of physicians, pharmacists, and nurses as having a clinically urgent need for the medication that outweighs the potential risk of medication error."

Based on observation, interview, and document review, the pharmacy failed to ensure a re-packaged (a process where oral drug products are being packaged in single-unit or unit-dose blister packages from a large stock bottle) medication was given the beyond-use-date (BUD or expiration date) consistent with the pharmacy policy and procedure. A repackaged controlled medication was given one year and seven month expiration date instead of one year.

The failure may affect the safe and effective use of medications as repackaged medications may not be stable after one year (after being subject to the repackaging process).

Findings:

During a visit to the inpatient pharmacy on 4/19/16 at 10:40 a.m., a vault containing controlled substance medications was examined with the director of pharmacy (DOP). Random inspection of the medications identified 26 unit-dose tablets of repackaged Oxycontin (a potent narcotic medication for pain) 40 milligrams (unit of measurement). Each Oxycontin unit dose had a BUD of 12/31/17 (one year and 6 months from survey date). DOP stated repackaged medications should have a BUD of one year from the day it was re-packaged or the manufacturer's expiration date, whichever was shorter. In other words, the BUD should not, in any case, exceed one year.

A review of the repackaging log with the DOP revealed the pharmacy repackaged the Oxycontin tablets on 3/13/16 and should have assigned a one-year BUD of 3/13/17 (not 12/31/17). The DOP acknowledged the pharmacy technician mislabeled the repackaged Oxycontin tablets, and the pharmacist, who verified the repackaging for correctness, missed it.

The pharmacy's "Dispensing: Prepackaging" policy and procedure, dated 9/2014, indicated,
"Assignment of beyond-use date shall meet the requirements of the pharmacy's beyond-use dating policy... [T]he USP [United States Pharmacopeia] <1146> standard of one year, or the manufacturer's expiration date, whichever is shorter will be followed..."

Based on observation, interview, and document review, the hospital failed to ensure lorazepam (a controlled substance medication - to treat anxiety and agitation) injection vials, in five of five medication refrigerators, was stored in a manner to prevent loss or diversion.

Findings:

On 4/19/16 at 12 p.m., in the company of the chief nursing officer (CNO) and the director of pharmacy (DOP), a medication refrigerator was identified inside the medication room in Unit A&B. The refrigerator, which was not locked, contained a clear lock box with a keyed lock, about 5 inch H x 10 inch W x 6 inch D in size. The lock box contained multiple 1-milliliter (ml) injectable vials of lorazepam 2 milligram/ml (unit of concentration), and was not secured or mounted to an immovable part of the refrigerator, so it could be removed from the refrigerator. The CNO and DOP stated the medication nurses had access to the medication room.

On 4/19/16 at 1:35 p.m. with the CNO and DOP present, the unlocked medication refrigerator was identified inside the medication room in Unit E. Inside the refrigerator was the unsecured, clear lock box, which contained 3 vials of lorazepam.

Unit C&D was currently under construction, so it was unmanned. On 4/19/16 at 1:46 p.m., the contents of the unlocked medication refrigerator, inside the medication room, was examined in the presence of the CNO and DOP. The refrigerator contained 6 vials of lorazepam inside the unsecured lock box. Per the CNO and DOP, nursing staff members from the other units had access to this medication room.

The same set up was observed on 4/19/16 at 2 p.m. in Unit G with the CNO and DOP. The unlocked medication refrigerator had 8 vials of lorazepam inside the clear lock box. Both the CNO and DOP acknowledged the lock box could be removed by any nursing staff member who had the intention of removing them. The CNO stated the staff did not check the inventory (or the presence of) the lorazepam vials in the refrigerator during shift change unless it had been used during their shift.

On 4/20/16 at 11:10 a.m. with the DOP present, the inspection of the medication refrigerator in Unit F also identified an unsecured lock box inside. It contained 10 vials of lorazepam.

The hospital's "Controlled Drugs: Distribution and Accountability" policy and procedure, dated 9/2015, indicated all controlled drugs will be stored in a manner to prevent diversion.

Based on observation and staff interviews, the facility failed to maintain a safe environment when two (2) bathrooms in the lobby were not equipped to prevent accidents.

This failure could have allowed an emotionally unstable person to intentionally hurt themselves.

Findings:

While touring the front lobby of the facility, on 4/21/16 at 3 p.m., both the men and woman's bathrooms of the lobby were inspected. Both bathrooms were observed to be kept locked. And, in order to utilize the bathroom, one would need to first obtain the key from the front Receptionist.

In a subsequent interview with the front receptionist, he indicated that the bathrooms in the lobby could be used by patients, family and visitors. When the front receptionist was asked what he would do in case a patient was taking a little too long in the bathroom, he said that, "If they are in there too long, I would go and check-in on them."

When entering the bathroom, the fixtures in the stalls were observed. The water pipes and fixtures coming from the wall and connecting to the toilet were noted to cause a ligature point (a point where a cord or rope can be tied) in a way that anyone could use it to deliberately harm themselves.

During an interview with the Safety Officer/Plant Operations Director on 4/22/16 at 11 a.m., he acknowledged that these are the only two bathrooms that have not yet been brought up to their required standards. He added that Corporate Risk Management has been made aware of the fixtures and ligature points.

Based on observation and staff interview, the hospital failed to have an arrangement for emergency gas.

The failure to have the availability of gas in an emergency could result in physical or mental harm to patients who resided in the facility.

Findings:

During the initial tour of the facility conducted on 4/19/16 at 9 a.m., the facility's emergency gas and water supply was observed.

In an interview with the hospital's Safety Officer/Plant Operations Director, he reported that, in case of disruption of services during an emergency, the hospital did not have a plan in place, or an arrangement made with an outside source for emergency gas supply.