The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ANAHEIM GLOBAL MEDICAL CENTER 1025 S ANAHEIM BLVD ANAHEIM, CA 92805 Aug. 31, 2018
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation, interview, and record review, the hospital failed to ensure the patients received care in a safe setting, creating the increased risk of incidents or unsafe care for the patients.

Findings:

1. The hospital's facilities, supplies, and equipment were not adequately maintained to ensure the acceptable level of safety and quality. Cross reference to A724.

2. The hospital's P&Ps and professional standards were not implemented to assure the care was provided safely due to improper storage of sterilized packages, using a dehumidifier in the endoscopy room, not monitoring the temperature and humidity levels in the endoscopy room on the weekends, improper dilution of the enzymatic detergent, not maintaining a clean and sanitary environment, and improper hand hygiene and use of PPE. Cross reference to A749.

3. On 8/27/18 at 0955 hours, a tour of the seclusion room of the BHU Unit 3 was conducted with the Regional Director of BHU. A metal bolt-like object, approximately one inch long, was observed protruding from the center of the ceiling vent in the patient's bathroom. The Regional Director stated she had never seen this object before; however, it should not be there as it was unsafe in a patient care area of the BHU.

A work order for the BHU Unit 3 was provided by the Regional Director of BHU and reviewed on 8/30/18. The work order was placed on 8/28/18, showing a "mystery knob needs to be removed from ceiling vent" in the BHU Unit 3. The work order showed the job was completed by the facilities engineering on 8/30/18.

4. On 8/27/18 at 1300 hours, a tour of the BHU Unit 5 was conducted with the Regional Director of BHU. During an inspection of Room B, the call light was tested . When the call button in the room was pressed, the bell sounded at the nursing station; however, the light above Room B was not turned on. The Director acknowledged the light outside the room should turn on when the call button was pressed so staff who was not in the nursing station could be alerted.
VIOLATION: QAPI Tag No: A0263
Based on interview and record review, the hospital failed to ensure their QAPI program's quality processes were designed and implemented to ensure the quality and safety of patient care provided as evidenced by:

1. The hospital failed to ensure the QAPI program set priorities for its performance improvement activities in the high risk area in the BHU to identify opportunities for improvement and take actions using the data collected that affected health outcomes, patient safety, and quality of care for patients. Cross reference to A283.

2. The hospital failed to demonstrate an ongoing program to identify errors and adverse events, accurately analyze their causes and implement preventive actions and mechanisms that include learning feedback throughout the hospital. Cross Reference to A286.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide an efficient QAPI program and quality healthcare to the patients in the hospital.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure the QAPI program set priorities for its performance improvement activities in the high risk area in the BHU to identify opportunities for improvement and take actions using the data collected that affected health outcomes, patient safety, and quality of care for patients, creating the risk of persistent poor practice and substandard healthcare to the patients.

Findings:

Review of the Hospital Performance Improvement Plan 2018, showed the program is designed to integrate and coordinate all review activities relating to performance improvement, including performance assessment, medical staff peer review, infection control, and safety management.

Nine sampled patients (Patients 3, 4, 5, 6, 7, 8, 12, 14, and 15) from the BHU and seven sampled AHP staff's credential files (NPs 2, 3, 4, 5, 6 and 7, and PA 1) were randomly selected for review during the survey. The deficient practices were identified as follows:

* NP 5 had exercised clinical privileges or provided care to the patients when the NP was not granted clinical privileges as per the Medical Staff Bylaws. Cross reference to A339.

* The proctoring requirement or evaluation was not completed or initiated for six AHP Staff (NPs 2, 3, 4, 6, and 7, and PA 1) as per the hospital's Medical Staff Bylaws and P&P.

* The physicians did not date, sign or authenticate the NPs' entries in the medical records within 48 hours for six patients (Patients 4, 5, 6, 8, 14, and 15) from the BHU. Cross reference to A353, example #2.

* A comprehensive H&P examination was not completed and filed within 24 hours for six of nine sampled patients (Patients 3, 5, 6, 7, 8, and 12) from the BHU as per the hospital's General Rules and Regulation. Cross reference to A358.

* An individualized treatment plan was not developed or updated to address the care needs for four of nine sampled patients (Patients 4, 5, 6, and 8) from the BHU, creating the increased risk of not providing the necessary care and services to meet the care needs for the patients. Cross reference to A396.

* The nursing staff did not conduct an ongoing assessment when Patient 12 fell on [DATE] at 0748 hours, and the patient's BP decreased to 90/57 mmHg on 3/31/18 at 1655 hours. The patient fell again on 4/1/18 at 0505 hours. Cross reference to A395, example #1.

On 8/27/18 at 0900 hours, the QAPI plans and performance improvement projects including the QAPI meeting minutes were requested for review.

On 8/30/18, review of the incident reports for 2017 showed 638 incidents occurred in the BHU, 243 incidents occurrence in the Medical/Surgical unit, and 143 incidents occurred in the ED. Most incidents were related to security and safety (213 cases), care-related issues (171 cases), and falls (111 cases). The patient safety evaluation showed 18% improvement compared to 2016 with zero reportable falls and no sentinel event related to falls.

Review of the incident report log for six months (from 3/18/18 to 8/27/18) showed a total of 70 pages of incidents were reported, and 45% of these incidents occurred in the BHU.

The incidents for the months of April and August 2018 were randomly selected for review. In April 2018, there were 11 falls reported and 15 patients refused to stay in the hospital signing AMA. From August 1 to 27 of 2018, nine falls and nine AMAs were recorded.

Review of the Patient Falls report for the first quarter of 2018 showed there were 25 fall incidents including 22 fall incidents that occurred in the BHU. The Fall Report for the BHU showed Patient 12's fall incident was listed. The cause of fall was "due to physiological factor."

On 8/30/18, review of the QAPI meeting minutes was initiated.

* The QAPI meeting minutes dated 3/8/18, showed the collected hospital's satisfaction data/report was below the NRC average and CMS threshold. These reports included the hospital cleanliness, quietness, communication about medications, communication among staff and their responsiveness, discharge information, and rating of the hospital. However, review of the action plan only showed "The staff continues to work to improve ratings in all areas," without measurable improvement parameters.

* The QAPI meeting minutes dated 6/14/18, showed the patient satisfaction rating remained below the NRC average and CMS threshold. The documented action plan was unchanged and remained as "Staff continues to work to improve ratings in all areas."

There was no documented evidence the AMA events were analyzed. There was no documented evidence to show the above deficient practices were identified.

On 8/30/18 at 1400 hours, an interview was conducted with the CEO, CNO, and Manager of Performance Improvement/Quality/Risk. The CNO stated a fall incident would be debriefed, notified to the charge nurse and the physician, and reviewed for the improvement. The CNO was asked if any improvement was identified related to the fall incidents that occurred in March or April 2018 in the BHU. The CNO stated re-education of the BHU staff regarding fall assessment was provided in March and April 2018. The CNO also stated the power point presentation was presented to the staff. The CNO stated the former Director of BHU was asked to train the BHU staff on how to conduct rounding every 15 minutes.

The CNO was asked to provide the power point presentation related to the fall education and nursing assessment/reassessment after reviewing the fall incidents in March and April 2018. The CNO was also asked to provide documentation the fall incidents for the months of March and April 2018 were reviewed.

The Manager of Performance Improvement/Quality/Risk stated he "looked at all areas of the hospital" but acknowledged the BHU was not prioritized despite the high population, high prevalence, and problem-prone area. The CEO stated the pharmacy team looked at the fall incidents in the BHU and determined the medications were given late. There was a decrease in the amount of medications prescribed by the psychiatrists. The CEO stated there was a difficulty hiring a Director and Unit Manager for the BHU to manage and address the BHU issues.

On 8/31/18 at 1200 hours, during the exit conference, no further documentation was provided as requested.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on interview and record review, the hospital failed to demonstrate an ongoing program to identify errors and adverse events, accurately analyze their causes, and implement preventive actions and mechanisms that include feedback throughout the hospital. These failures created the risk of persistent poor practices and substandard healthcare.

Findings:

Review of the hospital's P&P titled Event/Incident notifications revised 08/17 showed the definition of unusual occurrences/incidents is the occurrences that is not consistent with the routine care and treatment, concerns or loss or damage to patient and hospital property. Reporting of unusual events provides essential information for use by the Quality/Risk Management. The information is used to identify problematic events and trend their frequency and severity, which in turn provides management with the information necessary to develop direct loss control and prevention programs. These programs protect the patients, employees, and the hospital. If an event occurs that results in death or significant bodily injury the employee must contact their Director/House Supervisor immediately, who must immediately contact the Administrator and/or Quality/Risk Management Director.

1. On 8/27/18, the incident report log for the last six months (from 3/18/18 to 8/27/18) was requested for review.

The incident reports for the months of April and August 2018 were randomly selected for review. The following was identified:

a. An incident was reported on 8/5/18, regarding an unsterilized package that was opened and used in a laparoscopic procedure by a new shared nurse from a sister hospital. Review of the RCA presented showed the timeline and personal testimonies of the staff involved.

During an interview and record review, the deficient practice was identified as RN 10 was not provided with adequate supervision when working independently in the OR area. The Director verified neither RN 10 nor ORT 1 checked the tray for sterilization indicators when opened or used for Patient 10's surgery. The Director stated the error was reported to her the next day (or on 8/6/18) by the SPD Tech after he began the cleaning process for the dirty instrument tray. The SPD Tech discovered the sterile indicator showed the laparoscopic tray had not gone through the sterilization process before it was used intraoperatively. Cross Reference to A944.

However, the RCA did not include analysis of possible causes to include the shared nurse had only one day of orientation, was on call for 22 days for the month of May alone, and was working independently with no preceptorship. The RCA did not include the signs and the separation of the carts containing sterile packs and the "transport cart containing clean trays." The RCA did not include verification of the indicator by the staff and the additional count of the added instrument when the tray was opened and added.

b. On 8/22/18 at 0915 hours, during an interview with the Medical Director BHU, the Medical Director stated an order was written to transfer a patient to the Medical-Surgical unit secondary to the increase of BUN and creatinine (the blood test to check for the kidney functions) suggesting dehydration. The request was declined by the Internal Medicine physician because the patient was admitted with a chronic condition. Hospice consultation was then sought by the psychiatrist without written approval from the patient's family members and without terminal diagnosis. However, the patient was not seen by the hospice team. The patient's oral intake was deprived with resulting decreased in vital signs. By the 5th day or on 8/12/18, rapid response team was called by the BHU staff because the patient was not responsive and had a low blood pressure, leading to Code Blue, and the patient died .

However, review of the submitted incident reports for the last six months (from 3/18 to 8/27/18) failed to show the incident that occurred on 8/12/18, in the BHU related to the death of the patient.

On 8/29/18 at 1400 hours, an interview was conducted with the CEO, CNO, and Manager of Performance Improvement/Quality/Risk. The CNO and the Manager verified they were notified of this incident on 8/13/18. The CNO and Manager stated the event was not classified as a sentinel or adverse event according to the hospital list. They acknowledged investigation remained unfinished by the Director of Medical/Surgical. There was no Director of BHU since the Regional Director of BHU left until the last week, when an Interim Director BHU was appointed. The CEO acknowledged the communication breakdown amongst the physicians involved. The Chief of Staff was informed and met with the Chair of the Department of Medicine and Behavioral Health on 8/22/18.

On 8/29/18 at 1630, the written plan of action regarding the physician's communication was submitted.

2. On 8/30/18 at 0930 hours, an interview and concurrent review of the Code Blue committee meeting minutes was conducted with the Director of ICU/ED.

Review of the Code Blue Committee meeting minutes dated 5/16/18, showed the committee sign-in list included the Respiratory Therapy Director, Director of Medical/Surgical, DOP, Director of ICU/ED, CNO, and Nursing Supervisor. Further review showed the following:

a. In February 2018, there were seven Code Blue incidents. The committee identified the primary RN failed to give the pertinent report regarding the patient; the Ambu bag (bag valve mask used for rescue breathing) had no mask attached; the pharmacy staff was delayed in responding to the Code; and the Code Blue form was incomplete.

The corrective action plan documented was to give a mock Code Blue to train the staff and fill up the form completely. However, there was no corrective plans from the DOP regarding the delayed pharmacy response, and from the Director of Respiratory Therapy regarding the Ambu bag without a mask.

b. In March 2018, there were eight Code Blue incidents. One of the Code Blue occurred in the ICU. The identified issues included the following:
- There was no crash cart at the bedside;
- The intubation tray had no stylus (a guide wire to stiffen up and mold the tube when inserting the life-saving device through patient's windpipe); and
- The bedside heart rate monitor did not correlate with the heart rate from the defibrillator.

The corrective action plan was to provide more training to the nursing staff. However, there was no corrective action plan related to the SPD who prepared the incomplete intubation tray and the Biomed staff who provided the necessary preventive maintenance of the medical equipment.

The Director of ICU/ED acknowledged the findings. She also acknowledged the Medical Director of ED services was not present during the meeting due to the change of position. The Director was not able to confirm the Code Blue meeting minutes were submitted to QAPI.
VIOLATION: MEDICAL STAFF Tag No: A0338
Based on interview and record review, the hospital failed to ensure the hospital's Medical Staff Bylaws were implemented to ensure the quality of medical care provided by the medical staff and AHP staff as evidenced by:

1. The hospital failed to ensure one of seven AHP staff (NP 5) had not exercised clinical privileges or provided care to the patient when the NP was not granted clinical privileges. Cross reference to A339.

2. The hospital failed to ensure the completion of evaluations or proctoring requirements for six of seven AHP staff (NPs 2, 3, 4, 6 and 7, and PA 1). Cross reference to A340.

3. The hospital failed to ensure the Medical Staff Bylaws, Rules, and Regulations were enforced for seven of nine patients in the BHU and one additional patient for the total of 15 sampled patients (Patients 1, 4, 5, 6, 8, 12, 14, and 15). Cross reference to A353.

4. The hospital failed to ensure a comprehensive H&P examination was completed and filed within 24 hours for six of nine sampled patients (Patients 3, 5, 6, 7, 8, and 12) from the BHU. Cross reference to A358.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare to the patients in a safe environment.
VIOLATION: COMPOSITION OF THE MEDICAL STAFF Tag No: A0339
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure one of seven AHP staff (NP 5) had not exercised clinical privileges or provided care to the patients when the NP was not granted the clinical privileges as per the Medical Staff Bylaws. This created the increased risk of substandard services provided to the patients.

Findings:

Review of the hospital's Medical Staff Bylaws revised 2/16 showed the following:

* No person shall exercise clinical privileges in the hospital unless and until that person applies for and obtained membership on the Medical Staff and is granted privileges as set forth in these Bylaws, or, with respect to AHP, had been granted a practice prerogatives or privileges under applicable Medical Staff policies.

* The CEO or designee may grant temporary privileges upon the recommendation of the Chair of Department which the privileges exercise, the Chief of Staff and upon one of the conditions including pendency of application, care of specific patients, locum tenens (generally refers to short-term assignments), and participate as a consultant on peer review matters. For pendency of application, the temporary privileges may be granted for an initial period not to exceed 30 days with three subsequent renewal of 30 days each, for a total of 120 days, not to exceed the pendency of the application.

Review of the hospital's P&P titled Nurse Practitioner (NP) Qualifications and Prerogatives-Standardized Procedure revised 7/16 showed the NP must have the qualification on the license as a Psychiatric/Mental Health NP if requesting practice within the inpatient BHU.

Review of Patient 8's medical record was initiated on 8/28/18. The patient was admitted on [DATE] at 0455 hours. MD 4 was the patient's attending physician. The Progress Note(s) dictated by NP 5 on 8/25/18 at 1426 hours and 8/26/18 at 1055 hours, showed the NP performed the face to face evaluation for Patient 8, reviewed the patient's chart, and discussed the plan with the staff. However, MD 4 had not signed or authenticated the NP's progress notes as required. Cross reference to A353, example #2d.

Review of NP 5's credential file was initiated on 8/29/18. The file contained the "Request for Practice Privileges Practice Prerogatives" signed by NP 5 on 11/15/17, to indicate the NP was requesting the core privileges in the specialty of Psychiatry. The form was signed by MD 4 on 11/16/17, showed the MD was the NP's Supervising Physician. However, there was no documented evidence to show NP 5 was granted the privileges.

Review of the Temporary Privileges for NP 5 provided by the Medical Staff Manager on 8/30/18 at 1130 hours, showed the temporary privileges was granted for NP 5 effective as of 2/23/18, to conduct a round in the BHU only and pending receipt of BRN psychiatric/mental health designation on the license. The form was signed by the Chair of the Department of Behavior Health and the CEO on 2/23/18. The section for the Chief of Staff showed the name of the Chief of Staff was typed and there was an initial written next to the date of 2/23/18.

On 8/29/18 at 1340 hours, an interview and concurrent review of NP 5's credential file was conducted with the Medical Staff Manager. The Medical Staff Manager stated NP 5 was requesting the privileges to the BHU; however, the requested privileges were not granted because the NP was not licensed or certificated as a Psychiatric/Mental Health NP, and the NP had not been appointed to the AHP Staff. The Manager stated NP 5 should not conduct a visit or provide care to the patients when the privileges had not been granted to the NP.

On 8/30/18 at 1020 and 1030 hours, an interview and concurrent review of Patient 8's medical record was conducted with the Chair of Department of Behavioral Health. The Chair of Department was informed and acknowledged NP 5 conducted a visit and provided care to the patients when the NP had not been appointed or granted privileges to the Department of Behavioral Health. The Chair of Department stated NP 5 would be stopped from seeing the patients in the BHU.

On 8/30/18 at 1235 hours, an interview and concurrent review of NP 5's Temporary Privileges was conducted with the Chief of Staff. The Chief of Staff stated the Chief of Staff did not recommend or approve the temporary privilege for NP 5.

On 8/30/18 at 1400 hours, an interview was conducted with the CEO, CNO, and Manager of Performance Improvement/Quality/Risk. When asked about the process of granting or approval of the temporary privileges for a NP, the CEO stated the Chair of Department and the CEO would sign to approve the temporary privileges for the NP. When asked if the temporary privilege should be signed or approved by the Chief of Staff, the CEO stated it was not needed to have the Chief of Staff to sign or approve the temporary privileges. Then, the CEO stated he was not sure if the Chief of Staff needed to sign for the approval of the temporary privileges for a NP.

On 8/31/18, NP 5's Credentialing Activity Reports Details was provided by the Medical Staff Manager. Review of the report showed NP 5 conducted 51 visits to the patients who were admitted to the inpatient and inpatient BHU with the admitted range from 3/5/18 to 7/13/18.
VIOLATION: MEDICAL STAFF PERIODIC APPRAISALS Tag No: A0340
Based on interview and record review, the hospital failed to ensure the evaluations or proctoring requirements were completed for six of seven AHP staff (NPs 2, 3, 4, 6, and 7, and PA 1) as per the hospital's Medical Staff Bylaws and P&P. This failure created the risk of substandard services provided by members of the AHP Staff.

Findings:

Review of the hospital's Medical Staff Bylaws revised 2/16 showed the following:

* The section of Article 5 - Allied Health Professionals showed an AHP shall be defined, appointed and governed by the Medical Staff Bylaws, Medical Staff Rules and Regulations, and Allied Rules and Regulations in accordance with the current and appropriate statutes, regulation, and/or licensure. All application shall be processed in a parallel manner to that provided in Article 6 for Medical Staff member, unless otherwise specific in the Medical Staff Rules and Regulation. Every two years, each AHP Staff must reapply for a renewed practice prerogatives or privileges.

* The section of Article 6 - Appointment and Reappointment showed the processing of reappointment includes:

- The applicant shall submit to the Medical Staff Office a completed reappointment application.

- The Medical Staff Office shall transmit the completed reappointment application and supporting materials to the appropriate Department Chair.

- The Department Chair shall review the reappointment application, supporting documentation and such other relevant information, and transmit to the Credentials Committee a written report and recommendations as to reappointment if reappointment is recommended.

- Upon receipt of the reappointment application and the Department Chair's written report and recommendations, the Credentials Committee shall review the application and supporting documentation, and transmit to the MEC a written report and recommendation as to the reappointment if reappointment is recommended.

- The MEC shall review the reports of the Credentials Committee and all other relevant information available, and shall forward to the GI, or the committee duly appointed by the GB.

Review the hospital's Department of Behavioral Health Rules and Regulation revised 2/16 showed any AHP in the field of Behavioral Medicine shall be under the direct supervision of the Chair of the Department of Behavioral Health. The members shall consist of healthcare professionals outlined in the Allied Health Rules and Regulation. The Chair will oversee whether the applicant had discharged all of the responsible AHP membership and whether the applicant had not exceed or abused the prerogative or privileges of the category for which the member is eligible. Class I is defined as the staff shall have completed the FPPE/proctoring requirement. Class IA is defined as the staff shall complete the FPPE/Proctoring requirement outlined on the clinical privilege request form.

Review of the hospital's P&P titled Nurse Practitioner (NP) Qualifications and Prerogatives - Standardized Procedure revised 7/16 showed the NP may only provide the medical services which he or she is competent to perform and which are consistent with the NP's education, training, and experience, and which are delegated in writing by the Supervising Physician who is responsible for the patient cared for by that NP. The NP must have the Qualification on the license as a Psychiatric/Mental Health NP if requesting practice within the inpatient BHU. The NP must have confirmation and documentation of a physician to serve as a Supervising Physician for the NP. The NP will be initially evaluated with a minimum of six cases and will be continuously evaluated with a minimum of two randomly selected charts every six months to assure that the NP is adequately supervised and does not exceed the scope of his/her practice. A written record of the review will be kept.

1. On 8/29/18 at 1340 hours, an interview and concurrent review of the credential files for NPs 7 and 4 was conducted with the Medical Staff Manager. The following was identified:

a. Review of NP 7's credential file showed the NP had been appointed to the Department of Behavioral Health with a Class IA Psychiatric/Mental Health Nurse Practitioner privileges effective as of 5/17/18. The Class IA required FPPE (proctoring) must be completed within two years of the appointment period.

The Request for Practice Privileges was signed by NP 7 on 2/26/18. The section of the Proctoring Requirement showed the NP would be initially evaluated with a minimum of six cases and will be continuously evaluated with a minimum of two randomly selected charts every six months. MD 4 signed the form on 2/26/18, as the NP's Supervising Physician.

However, there was no documented evidence to show whether the proctoring process or evaluation had been initiated for NP 7 as required.

b. Review of NP 4's credential file showed the NP had been appointed to the Department of Behavioral Health with a Class IA Psychiatric/Mental Health Nurse Practitioner privileges effective as of 2/22/18. The Class IA required FPPE (proctoring) must be completed within two years of the appointment period.

The Request for Practice Privileges was signed by NP 4 on 10/4/17. The section of the Proctoring Requirement showed the NP would be initially evaluated with a minimum of six cases and will be continuously evaluated with a minimum of two randomly selected charts every six months. MD 6 signed the form on 11/4/17, as the NP's Supervising Physician.

However, there was no documented evidence to show whether the proctoring process or evaluation had been initiated for NP 4 to ensure the quality of care provided to the patients in the BHU since the NP had not been appointed to the AHP staff until 2/22/18.

The Medical Staff Manager confirmed the above documentation. When asked how the NP was proctored, the Manger stated the physician would review and sign off for six randomly selected cases for the NP. When asked how soon the proctoring requirement would be initiated to assure the NP was adequately supervised and provided safe care to the patients, the Manager stated NPs 7 and 4 were newly appointed. The Manager stated the credentialing activity reports for NPs 7 and 4 had not been obtained to review whether the NPs had seen or provided care to the patients. When asked when the credentialing activity report would be obtained for the NP who was newly appointed, the Manager did not answer, but stated these NPs had not had any activities yet. The Manager was asked to provide the credentialing activity reports for NPs 7 and 4.

On 8/31/18 at 0815 hours, the Medical Staff Manager provided the Credentialing Activity Report Details for NPs 7 and 4.

Review of the Credentialing Activity Report Details for NP 7 showed the NP conducted 80 visits to the patients who were admitted to the inpatient BHU with the admitted range from 5/23/18 to 8/15/18.

Review of the Credentialing Activity Report Details for NP 4 showed the NP conducted 29 visits to the patient who were admitted to the inpatient BHU with the admitted range from 5/7/18 to 7/27/18.

The Medical Staff Manager confirmed the proctoring requirement was not initiated for NPs 7 and 4 when the NPs had conducted the visits or provided care to the patients in the BHU.

2. On 8/29/18 at 1340 hours, the Medical Staff Manager was asked how a NP would be evaluated for the quality of care before the reappointment. The Manager stated the physician would evaluate the NP by reviewing two charts every six months or eight charts within two years before the NP would be reappointed.

a. On 8/29/18 at 1340 hours, an interview and concurrent review of NP 3's credential file was conducted with the Medical Staff Manager.

NP 3's credential file showed the NP was initially appointed to the AHP Staff on 12/18/15, and had been reappointed to the Department of Behavioral Health with a Class IA Psychiatric/Mental Health Nurse Practitioner privileges effective as of 12/1/17.

The Request for Practice Privileges was signed by NP 3 on 9/15/17. The section of the Proctoring Requirement showed the NP would be initially evaluated with a minimum of six cases and continuously evaluated with a minimum of two randomly selected charts every six months. MD 4 signed the form on 9/20/18, as NP 3's Supervising Physician.

However, there was no documented evidence to show NP 3 was evaluated or proctored before the NP had been reappointed to the Department of Behavioral Health as required.

The Medical Staff Manager confirmed the finding.

b. On 8/30/18 at 0845 hours, an interview and concurrent review of NP 6's credential file was conducted with the Medical Staff Manager.

NP 6's credential file showed the NP was initially appointed to the AHP Staff on 5/26/16, and had been reappointed to the Department of Behavioral Health with Psychiatric/Mental Health Nurse Practitioner privileges effective as of 5/1/18.

The Request for Practice Privileges signed by NP 6 on 3/7/18, showed a Class IA Psychiatric/Mental Health Nurse Practitioner privileges was granted to the NP. The form also showed the section of the Proctoring Requirement showing the NP would be initially evaluated with a minimum of six cases and continuously evaluated with a minimum of two randomly selected charts every six months. MD 6 signed the form on 3/8/18, as NP 6's Supervising Physician.

Further review of NP 6's credential file showed the physician evaluated NP 6 once on 2/16/17, and twice on 9/15/17. There was no documented evidence to show the proctoring requirement or evaluation was completed for NP 6 before the NP had been reappointed as required.

The Medical Staff Manager confirmed the finding.

c. On 8/30/18 at 0845 hours, an interview and concurrent review of NP 2's credential file was conducted with the Medical Staff Manger.

NP 2's credential file showed the NP was initially appointed on 12/18/15, and had been reappointed as an AHP Staff to the Department of Medicine on 12/1/17.

The Request for Practice Privileges signed by NP 2 on 7/27/17, showed a Class IA Nurse Practitioner privileges was granted to the NP. The form also showed the section of the Proctoring Requirement showing the NP would be initially evaluated with a minimum of six cases and continuously evaluated with a minimum of two randomly selected charts every six months. MD 10 signed the form on 7/26/17, as NP 2's Supervising Physician.

Further review of NP 2's credential file showed the physician evaluated NP 2 once on 8/1/16, once on 2/2/17, and once on 9/1/17.

There was no documented evidence to show the proctoring requirement or evaluation was completed for NP 2 before the NP had been reappointed as required.

The Medical Staff Manager confirmed the finding.

d. On 8/30/18 at 0845 hours, an interview and concurrent review of PA 1's credential file was conducted with the Medical Staff Manager.

Review of PA 1's credential file showed the PA had been reappointed as an AHP Staff to the Department of Medicine with the PA privileges for a period from 10/1/16 to 9/30/18.

Review of the Request for Practice Privileges signed by PA 1 on 4/7/16, showed the PA requested core privileges and specific privileges. These requested privileges were granted as Class I for the PA. MD 9 signed the form on 5/5/16, to show the MD was one of the PA's Supervising Physician. The form also had the section of the Proctoring Requirement showing the PA would be initially evaluated with a minimum of six cases and continuously evaluated with a minimum of two randomly selected charts every six months.

Further review of PA 1's credential file showed MD 9 signed the AHP Ongoing Professional Practice Evaluation (OPPE) on 2/15/17. The section of "I recommend this individual continue with proctoring/FPPE" was checked. However, there was no documented evidence to show the proctoring requirement or evaluation was completed for the PA as required.

The Medical Staff Manager confirmed the above finding. The Manager stated the physician should evaluate PA 1 with two cases every six months

3. Review of the hospital's Medical Staff Bylaws revised 2/16 showed the primary responsibility delegated to each Department is to implement and conduct an ongoing specific review and evaluation activities that contribute to the preservation and improvement in performance, effectiveness, efficiency, and quality of patient care provided in the Department. The Department shall evaluate and make appropriate recommendations regarding the specific clinical privileges that each Medical Staff members or applicant may exercise in the Department, and the specific service that each individual AHP may provide. The Department shall monitor its members performance on an ongoing and concurrent basis for adherence to Medical Staff, Hospital, and Department Rules and regulations, and policies/procedure.

Nine sampled patients (Patients 3, 4, 5, 6, 7, 8, 12, 14, and 15) from the BHU and seven sampled AHP staff's credential files (NPs 2, 3, 4, 5, 6 and 7, and PA 1) were randomly selected for review during the survey. The deficient practices were identified as follows:

* NP 5 had exercised clinical privileges or provided care to the patient when the NP was not granted clinical privileges as per the Medical Staff Bylaws. Cross reference to A339.

* The proctoring requirements or evaluations were not completed or initiated for six AHP staff (NPs 2, 3, 4, 6 and 7, and PA 1) as per the hospital's Medical Staff Bylaws and P&P.

* The physicians did not date, sign or authenticate the NPs' entries in the medical records within 48 hours for six patients (Patients 4, 5, 6, 8, 14, and 15) from the BHU. Cross reference to A353, example #2.

* A comprehensive H&P examination was not completed and filed within 24 hours for six of nine sampled patients (Patients 3, 5, 6, 7, 8, and 12) from the BHU as per the hospital's General Rules and Regulation. Cross reference to A358.

Review of the Credential Approvals for the Behavioral Health Department from January to March 2018 showed NPs 3, 4, and 5 were recommended to be appointed as the AHP-Psych/Mental Health NP with Class IA AHP-Psych/Mental Health NP privileges. However, there was no documented evidence to show the above deficient practice was identified or discussed before recommending these NPs for reappointment or appointment.

On 8/30/18 at 1020 hours, an interview was conducted with the Chair of Department of Behavioral Health. The Chair of Department was asked how the AHP staff or a NP would be supervised to ensure the provision of safe patient care. The Chair of Department stated the physician would sign and date the NP's documentation within 48 hours. The Chair of Department was asked how to ensure the physician signed and dated the NP's documentation within 48 hours as required. The Chair of Department stated the Medical Record Staff would check for the completion of the requirement.

The Chair of Department of Behavioral Health was asked about the appointment and reappointment process for an AHP staff. The Chair of Department stated the Medical Staff Office would check for certification or required documentation; then the Chair of Department would sign off. When asked if the Chair of Department checked or reviewed the completion or accuracy of the required documentation, the Chair of Department stated no.

On 8/30/18 at 1235 hours, an interview was conducted with Chief of Staff. When asked about the appointment and reappointment process for the Medical Staff and AHP Staff, the Chief of Staff stated the Chair of Department and Credentials Committee had reviewed and made recommendations for the appointment or reappointment. All Chair of Department had met every other month as the MEC meeting. Credential report were discussed during the meeting. The Chief of Staff received the Department report from the Department Chair who assured the report was completed and accurate. After the MEC meeting, the Chief would present the MEC meeting minutes to the GB for the approval.

On 8/31/18 at 0910 hours, an interview and concurrent record review was conducted with the Medical Staff Manager. The Manager confirmed the proctoring requirement and OPPE for the AHP Staff or NP were not discussed during the meeting of the Department of Behavioral Health.
VIOLATION: MEDICAL STAFF BYLAWS Tag No: A0353
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure the Medical Staff Bylaws, Rules and Regulations were enforced for seven of nine patients in the BHU and one additional patient for the total of 15 sampled patients (Patients 1, 4, 5, 6, 8, 12, 14, and 15) as evidenced by:

1. There was no documented evidence to show the NP and physician had discussed with Patient 8 about the possible ill effects when the patient refused the medications and treatment. In addition, a Riese application and conservatorship for Patient 8 was not completed timely as per the hospital's P&P.

2. The physicians did not date, sign or authenticate the NPs' entries in the medical records within 48 hours for six patients (Patients 4, 5, 6, 8, 14, and 15).

3. The physician did not recapitulate two fall events in the discharge summary for Patient 12.

4. The physician did not sign the Mental Health Services Request for Voluntary Admission and Authorization for Treatment for Patient 6.

5. The telephone orders were not dated, signed or authenticated within 48 hours by the physician for five patients (Patients 4, 5, 8, 14, and 15).

6. There were no fluid restrictions ordered or obtained for Patient 1 when the patient had a weight gain. The patient had congestive heart failure from volume overload and end stage renal disease

These failures created the increased risk of poor health outcome for these patients.

Findings:

Review of the hospital's Medical Staff Bylaws revised 2/16 showed the ongoing responsibilities of each member of the medical staff shall include to provide patients with quality of care that meets the professional standards of the medical staff of the hospital; to abide by the Medical Staff Bylaws and Rules and Regulations and by all other lawful standards, and policies of the hospital; prepare and complete in a timely fashion the medical record for all the patients to whom the member provides care under the auspices of the hospital. The AHP shall be defined, appointed, and governed by the Medical Staff Bylaws, Medical Staff Rules and Regulations, and Allied Rules and Regulations in accordance with the current and appropriate statute, regulations, and/or licensure.

1. Review of the hospital's P&P titled Refusal of Treatment or Medications reviewed on 9/17 showed the physician should explain to the patient the reason for the required medication treatment or program and the possible ill effects if the patient refused. The physician shall enter a note describing the refusal and the outcome of the discussion. The note shall specifically document the potential consequences of the patient's declining to take the recommended course of action. Decisions about the continued treatment or alternative methods of treatment will have to be made individually by the physician based on the evaluation of the patient.

Review of the hospital's P&P titled Riese Hearings revised 6/15 showed a patient on 5250, 5250, 5260 or 5270 who refuses the ordered antipsychotic medication, may be subject to a medication capacity hearing. The attending designated psychiatrist will personally discuss with the patient the recommended/prescribed treatment with medication and make reasonable effort to obtain the consent of the patient to be treated with the medications. The designated attending psychiatrist will file a Riese application and complete the "Declaration of Physician Regarding Patient's Competency to Consent to Treatment by Psychotropic Medication Form."

Review of the hospital's P&P titled LPS Conservatorship (Initiation of Temporary Conservatorship, T-Con, 5353, and 5358) revised 6/15 showed the temporary LPS Conservatorship procedure includes the following:

* The charge nurse or designee shall serve the Notice of Proposed Appointment of Temporary Conservator on the proposed conservatee at least five days prior to the expiration of the 5250 hold.

* The staff person serving the Notice will complete the Proof of Personal Service.

* The designated psychiatrist involved in the patient's care will complete and sign the Declaration in Support of Appointment of Temporary Conservator for the patient who meet the criteria for gravely disable.

* The assigned social services employee will assist in completing the Application for LPS Conservatorship Investigation. Both documents, completed and signed, will be submitted to the Public Guardian's office by the 9th day of the 14 days hold (5250) along with a copy of the Notice and the completed Proof of Personal Services.

Review of Patient 8's medical record was initiated on 8/28/18. The patient was admitted on [DATE] at 0455 hours. The patient had a history of diabetes and high blood pressure. The physician ordered to place the patient on a 5150 hold on 8/5/18 at 0817 hours, on 5250 hold on 8/8/18 at 0153 hours, and on 5270 hold on 8/21/18 at 0933 hours.

The patient's medical record showed the patient refused the medications and treatment since the admission. Cross Reference to A395, example #2.

Review of the Progress Notes Report showed the following:

* On 8/5/18 at 1645 hours, a social worker documented Patient 8's family member requested the patient to be approved for conservatorship. The patient had a longstanding psychiatric history and refusal to take medications on occasion.

* On 8/10/18 at 0918 hours, a social worker documented the social worker informed the psychiatrist and left a voice message for NP 3 regarding the conservatorship for Patient 8.

* On 8/10/18 at 1539 hours, a social worker documented the social worker spoke to Patient 8's family member. The social worker left the second voice message for NP 3 regarding the patient's legal status and the request of conservatorship for the patient as per the patient's family member.

* On 8/17/18 at 0820 hours, a social worker documented the social worker left a note for the psychiatrist and NP to contact Patient 8's family member or to follow up with the social worker about the patient's status and treatment plan.

* On 8/17/18 at 1146 hours, a social worker documented the social worker spoke to the NP who agreed to and accepted the T-CON application. The NP will follow up with the assigned psychiatrist.

* On 8/19/18 at 0922 hours, NP 3 was notified Patient 8 was refusing the medications and treatments. The NP stated the plan was to conserve the patient.

* On 8/21/18 at 1318 hours, a social worker documented Patient 8 was informed the hospital initiated a conservatorship application for the patient.

Review of the Progress Note(s) dictated by NP 3 on 8/6/18 at 1817 hours, on 8/7/18 at 0757 hours, on 8/8/18 at 0554 hours, on 8/11/18 at 0815 hours, and on 8/23/18 at 1615 hours, showed Patient 8 refused medications. There was no documented evidence to show NP 3 or the physician discussed with Patient 8 the reason for the required medication treatment and the possible effects if the patient refused as per the hospital's P&P.

On 8/28/18 at 1000 hours, an interview and concurrent review of Patient 8's medical record was conducted with the Interim Director BHU. The Interim Director stated Patient 8 had refused to take the medications since the patient was admitted to the hospital. The Interim Director verified there was no documented evidence to show the NP or physician discussed with the patient about the refusal of medications and the possible effect if the patient refused as per the hospital's P&P.

When asked what should be done when the patient refused the medications and treatment, the Interim Director stated a Riese application should be filed and completed for the patient. When asked how soon the Riese application should be filed for the patient, the Interim Director stated the Riese application should be filed when the patient refused the medications for three days.

When asked whether the Riese application was completed for Patient 8, the Interim Director stated no. When asked about conservator application, the Interim Director stated the application for conservatorship was sent on 8/27/18. The Interim Director stated these applications should be filed or completed sooner when Patient 8 had refused the medications and treatment since the admission to the hospital. The Interim Director verified these applications were not completed timely for the patient.

2. Review of the hospital's P&P titled Nurse Practitioner (NP) Qualification and Prerogatives - Standardized Procedure revised 7/16 showed the NP may be responsible for the preparation of a complete medical record for each patient in accordance with the existing Medical Staff Bylaws, Rules and Regulations, and Policies. The Supervising Physician reviews, signs, and dates all entries in the medical record of every patient treated by the Nurse Practitioner within 48 hours of the treatment.

Review of the hospital's General Rules and Regulations revised 5/16 showed a PA or NP may record orders for his/her Supervising Physician as outlined in the Scope of Practice. All orders must be cosigned by the Supervising Physician within 48 hours from when the order was issued.

a. Review of Patient 4's medical record was initiated on 8/27/18. The patient was admitted on [DATE] at 0311 hours.

- The Progress Note(s) dictated by NP 4 on 7/14, 7/15, and 7/19/18, failed to show the Supervising Physician dated, signed or authenticated the progress notes within 48 hours as per the hospital's P&P.

The Progress Note dictated by NP 6 on 7/22 and 8/7/18, failed to show the Supervising Physician dated, signed or authenticated the progress notes within 48 hours as per the hospital's P&P.

- The physician's order dated 8/7/18 at 2225 hours, showed NP 6 ordered to give diphenhydramine (or Benadryl, an antihistamine medication) 50 mg now for severe agitation and olanzapine (or Zyprexa, an antipsychotic medication) 10 mg IM now for severe agitation. However, the Supervising Physician did not cosign the above orders within 48 hours as per the hospital's General Rules and Regulations.

On 8/30/18 at 1230 hours, an interview and concurrent review of Patient 4's medical record was conducted with the Regional Director of BHU. The Regional Director confirmed the findings.

b. Review of Patient 5's medical record was initiated on 8/27/18. The patient was admitted on [DATE].

The Progress Note-Internal Medicine electronically signed by NP 2 on 7/31/18 at 1732 hours, showed Patient 5 had a chronic back pain. The plan was to continue Naproxen (a pain medication); the patient was requesting an MRI (Magnetic Resonance Imaging, a medical imaging technique) that could be done as outpatient; and the plan had been explained to the patient. Further review showed the section for the Attending Physician Attestation was left blank. There was no documented evidence to show NP 2's Supervising Physician dated and signed the NP's entry within 48 hours as per the hospital's P&P.

On 8/27/18 at 1255 hours, during an interview and concurrent review of Patient 5's medical record with the Interim Director BHU, the Interim Director confirmed the finding.

c. Review of Patient 6's medical record was initiated on 8/27/18. The patient was admitted on [DATE] at 1718 hours.

The Progress Note dictated by NP 4 on 8/23/18 at 1109 hours, failed to show the Supervising Physician dated, signed or authenticated the progress note within 48 hours as per the hospital's P&P.

On 8/27/18 at 1255 hours, during an interview and concurrent review of Patient 6's medical record with the Interim Director BHU, the Interim Director confirmed the finding.

d. Review of Patient 8's medical record was initiated on 8/28/18. The patient was admitted on [DATE] at 0455 hours.

- The Progress Note(s) dictated by NP 3 on 8/6, 8/10, 8/11, 8/13, 8/14, 8/15, 8/16, 8/17, 8/18, 8/19, 8/20, 8/21, 8/22, 8/23, and 8/24/18, failed to show NP 3's Supervising Physician dated and signed the NP's entries within 48 hours as per the hospital's P&P.

The Progress Note dictated by NP 7 on 8/12/18, failed to show NP 7's Supervising Physician dated and signed the NP's entry within 48 hours as per the hospital's P&P.

The Progress Note(s) dictated by NP 5 on 8/25 and 8/26/18 failed to show NP 5's Supervising Physician dated and signed the NP's entries within 48 hours as per the hospital's P&P.

On 8/28/18 at 1000 hours, an interview and concurrent review of Patient 8's medical record was conducted with the Interim Director BHU. The Interim Director confirmed the above finding.

- Review of the physician's order signed by NP 3 on 8/5/18 at 0902 hours, showed the NP ordered to give Effexor (an antidepressant medication) 50 mg twice a day.

The physician's order signed by NP 3 on 8/5/18 at 0903 hours, showed the NP ordered to give Wellbutrin (an antidepressant medication) SR 150 mg daily.

The physician's order signed by NP 3 on 8/5/18 at 0904 hours, showed the NP ordered to give Seroquel (an antipsychotic medication) 400 mg at bedtime.

The physician's order signed by NP 3 on 8/5/18 at 0905 hours, showed the NP ordered to give Trileptal (an anticonvulsant medication) 300 mg twice a day.

The physician's order dated 8/21/18 at 0933 hours, showed the NP ordered the patient's legal status of 5270.

The physician's order dated 8/21/18 at 1820 hours, signed by NP 2 on 8/23/18 at 1041 hours, showed the NP ordered to give K-dur (potassium supplement) extended release tablet 40 mEq ( milliequivalent, a weight measurement) once.

However, the Supervising Physicians for the above NPs did not date, sign or authenticate the above orders within 48 hours as per the hospital's General Rules and Regulations.

On 8/30/18 at 1230 hours, an interview and concurrent review of Patient 8's medical record was conducted with the Regional Director of BHU. The Regional Director confirmed the physician did not sign or authenticate the above orders as required.

e. Review of Patient 15's medical record was initiated on 8/30/18. The medical record showed the progress notes were dictated by a NP on 8/11, 8/12, and 8/14/18. However, the physician had not authenticated these progress notes within 48 hours as per the hospital's P&P.

f. Review of Patient 14's medical record was initiated on 8/30/18. The medical record showed progress notes dated 7/21, 8/7, and 8/11/18, had been written by a NP. However, the physician had not authenticated these progress notes within 48 hours as per the hospital's P&P.

On 8/30/18 at 1240 hours, an interview and concurrent review of Patients 14 and 15's medical record was conducted with the Regional Director of BHU. The Regional Director confirmed the physicians did not authenticate the above telephone orders as required.

3. Review of the hospital's General Rules and Regulations revised 5/16 showed the discharge summary shall recapitulate the significant findings and events of the patient's hospitalization to include the reasons for hospitalization , procedures performed, care, treatment and services provided, the disposition and condition of the patient at discharge, information provided to the patient and family, provisions for follow-up care, and the final diagnosis.

Review of Patient 12's medical record was initiated on 8/28/18. The patient was admitted on [DATE] at 2101 hours, and was discharged on [DATE] at 1735 hours.

Review of the Progress Note Inquiry from 3/30/18 at 1246 hours to 4/2/18 at 1813 hours, showed the following:

* On 3/31/18 at 0748 hours, Patient 12 fell at the hallway and had a BP reading of 65/49 mmHg.

* On 4/1/18 at 0505 hours, Patient 12 was found lying on the floor in the bathroom and had a BP reading of 64/46 mmHg.

Review of the Discharge Summary Note signed by MD 1 on 4/2/18 at 1059 hours, failed to show the above two fall events were recapitulated by the MD as per the hospital's General Rules and Regulations.

On 8/30/18 at 0830 hours, during an interview and concurrent review of Patient 12's medical record with Regional Director of BHU, the Regional Director confirmed the finding.

4. Review of Patient 6's medical record was initiated on 8/27/18. The patient was admitted on [DATE] at 1718 hours.

Review of the physician's telephone order dated 8/25/18 at 1320 hours, showed MD 6 ordered "legal status voluntary."

Review of the Mental Health Services Request for Voluntary Admission and Authorization for Treatment showed Patient 6 signed the form on 8/25/18 at 1330 hours. However, the section titled "CERTIFICATE OF ATTENDING PHYSICIAN" was not signed, dated, and timed by the physician.

On 8/27/18 at 1455 hours, during an interview and concurrent review of Patient 6's medical record with the Interim Director BHU, the Interim Director confirmed the above document.

5. Review of the hospital's General Rules and Regulations revised 5/16, showed all verbal/telephone orders must be authenticated with the date, time, and signature within 48 hours by the ordering practitioner or another practitioner who is responsible for the care of the patient and authorized to write orders.

a. Review of Patient 8's medical record was initiated on 8/28/18. The patient was admitted on [DATE] at 0455 hours.

The physician's telephone order dated 8/5/18 at 0817 hours, showed to check Patient 8's vital signs every shift.

The physician's telephone dated 8/5/18 at 0817 hours, showed MD 4 ordered to admit Patient 8 to the inpatient BHU and the patient's legal status of 5150 hold.

The physician's telephone order dated 8/5/18 at 0817 hours, showed MD 4 ordered to check the hemoglobin A1C, lipid level, TSH, and RPR Qualitative.

The physician's telephone order dated 8/8/18 at 0153 hours, showed MD 4 ordered the patient's legal status of 5250 hold.

However, the above physician's telephone orders were not dated, timed, signed, or authenticated within 48 hours by the physician as per the hospital's General Rules and Regulations.

b. Review of Patient 4's medical record was initiated on 8/27/18. The patient was admitted on [DATE] at 0311 hours.

The physician's telephone order dated 7/22/18 at 1300 hours, showed MD 6 ordered to administer diphehydramine 50 mg IM now for severe agitation, and olanzapine 10 mg IM now for severe agitation.

However, the telephone order was not dated, timed, signed, or authenticated within 48 hours by the physician as per the hospital's General Rules and Regulations.

c. Review of Patient 5's medical record was initiated on 8/27/18. The patient was admitted on [DATE] at 1220 hours.

The physician's telephone orders dated 8/23/18 at 1313 hours, showed to give diphenhydramine 50 mg IM and chlorpromazine (an antipsychotic medication) 100 mg IM now for severe agitation.

However, the telephone order was not dated, timed, signed, or authenticated within 48 hours by the physician as per the hospital's General Rules and Regulations.

On 8/30/18 at 1230 hours, during an interview and concurrent review of Patients 4, 5, and 8's medical records with the Regional Director of BHU, the Regional Director confirmed the physicians did not authenticate the above telephone orders as required.

d. Review of Patient 15's medical record was initiated on 8/30/18. The medical record showed the physician's telephone order was received from MD 6 to change the patient's legal status to 5250 as of 8/29/18. However, the physician had not authenticated this telephone order.

e. Review of Patient 14's medical record was initiated on 8/30/18. The medical record showed 17 physician's telephone orders including medications, physical therapy, laboratory testing, and the patient's admission to BHU, were received on 7/2, 7/3, and 8/3/18. However, the physician had not authenticated these telephone orders.

On 8/30/18 at 1240 hours, during an interview and concurrent review of medical records of Patients 14 and 15 with the Regional Director of BHU, the Regional Director confirmed the physicians did not authenticate the above telephone orders as required.





6. According to the Core Curriculum for Nephrology Nurses, Sixth Edition, the recommended weight gains should not exceed 1 kg between dialysis treatments during the week and 1.5 to 2 kg during the weekend. Generally recommended individual fluid allowances should be the total of four 8-ounce glasses of fluids (or 960 ml) plus the patient's urinary output volume.

On 8/28/18, review of Patient 1's medical record was initiated. The patient was admitted on [DATE].

Review of the H&P examination dated 8/24/18, showed Patient 1 had chest pain, shortness of breath, "congestive heart failure (chronic condition that affects the pumping power of the heart)" from volume overload, hypertension (high blood pressure), and end stage renal disease (the final stage of chronic kidney disease). Further review showed the patient had a dialysis treatment prior to coming to the hospital. The patient's weight documented in the ED records was 84 kg.

Further review of Patient 1's medical record showed the following:

* On 8/25/18, the physician had assessed Patient 1 as having significant volume overload as manifested by hypertension and shortness of breath. A dialysis treatment was ordered for 8/25/18, to remove an additional 2.5 kg of fluid as tolerated.

Review of the dialysis treatment record dated 8/25/18, showed Patient 1 had a pre-treatment weight of 87.5 kg, which was 3.5 kg greater than the patient's admission weight of 84 kg. The patient's post-treatment weight was 86.5 kg, a removal of 1 kg of fluid.

* On 8/27/18, the physician saw Patient 1 and ordered another hemodialysis treatment to remove 2 to 3 kg of fluid as tolerated.

Review of the dialysis treatment record dated 8/27/18, showed Patient 1 had a pre-treatment weight of 88 kg, which was 4 kg greater than the patient's admission weight of 84 kg or 1.5 kg greater than the previous post-treatment weight. The patient's post-treatment weight was 85 kg, which was 1 kg greater than the patient's admission weight.

However, there were no fluid restrictions ordered or obtained for Patient 1.

On 8/28/18 at 0840 hours, an interview and concurrent review of Patient 1's medical record was conducted with Charge RN 1. The Charge RN confirmed there were no orders for fluid restrictions for the patient.

On 8/29/18 at 1105 hours, during a telephone interview with MD 5 regarding Patient 1's admission weight and pre/post dialysis treatment weights, the MD was informed and acknowledged that the patient should have been on fluid restriction.
VIOLATION: MEDICAL STAFF RESPONSIBILITIES Tag No: A0358
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure the comprehensive H&P examinations were completed and filed within 24 hours for six of nine sampled patients (Patients 3, 5, 6, 7, 8, and 12) from the BHU as per the hospital's General Rules and Regulation, creating the increased risk of substandard healthcare outcomes for the patients.

Findings:

Review of the hospital's General Rules and Regulations revised 5/16 showed the following:

* The H&P examination must be dictated or handwritten and placed on the patient's medical record within 24 hours of the patient's admission, unless a previous H&P examination performed within 30 days of admission is on record, in which case that H&P examination will be updated by the practitioner within 24 hours of admission.

* The H&P examination shall be authenticated by the responsible practitioner as soon as feasible, but no later than 14 days after the patient's discharge. When the H&P examination or update note is performed by a NP or PA, the practitioner's Supervising Physician shall review and countersign the H&P examination and update note prior to surgery or within 24 hours of admission, whichever occurs first.

* The content of the H&P examination should be sufficiently detailed to provide a database for the professional staff providing care to the patient. All H&P examination shall include chief complaints/reason admitted ; details of present illness; past medical and surgical history; present medications; pertinent laboratory and Xray findings; the admitting diagnosis and any co-morbidity or diagnostic impression; and the plan of treatment.

* Behavior Health Unit patient's medical records must indicate the psychiatric components of the record, including history of findings and treatment provided for the psychiatric condition for which the patient was admitted . A physical and psychiatric history and evaluation must be dictated/written and authenticated by the attending psychiatrist within 24 hours of admission.

1. Review of Patient 12's medical record was initiated on 8/28/18. The patient was admitted on [DATE] at 2101 hours.

Review of the H&P examination dictated by NP 1 on 3/30/18 at 0942 hours, showed NP 1 authenticated this form on 4/19/18 at 1309 hours, and MD 2 authenticated this form on 4/9/18 at 1427 hours. The H&P examination was not countersigned by the physician within 24 hours of admission as per the hospital's General Rules and Regulations.

On 8/28/18 at 1335 hours, an interview and concurrent review of Patient 12's medical record was conducted with the Interim Director BHU and IT 1. The Interim Director and the IT confirmed the finding.

2. Review of Patient 7's medical record was initiated on 8/28/18. The patient was admitted on [DATE] at 1614 hours.

Review of the H&P examination dictated by NP 2 on 8/27/18 at 1814 hours, failed to show NP 2's Supervising Physician countersigned the H&P examination within 24 hours of admission as per the hospital's General Rules and Regulations.

On 8/30/18 at 1230 hours, an interview and concurrent review of Patient 7's medical record was conducted with the Regional Director of BHU. The Regional Director confirmed the H&P examination was not authenticated or completed as required.

3. Review of Patient 8's medical record was initiated on 8/28/18. The patient was admitted on [DATE] at 0455 hours.

* Review of the H&P examination dictated by PA 1 on 8/5/18 at 1404 hours, showed the form was electronically authenticated by PA 1 on 8/7/18 at 1126 hours and by MD 7 on 8/9/18 at 1334 hours. The physician did not countersign the H&P examination within 24 hours of admission as per the hospital's General Rules and Regulations.

* Review of the Initial Psychiatric Evaluation dictated by NP 3 on 8/5/18 at 0918 hours, showed the form was electronically authenticated by NP 3 on 8/6/18 at 0950 hours and by MD 4 on 8/8/18 at 1156 hours. The physician did not authenticate the psychiatric evaluation within 24 hours of admission as per the hospital's General Rules and Regulations.

On 8/30/18 at 1230 hours, during an interview and concurrent review of Patient 8's medical record with the Regional Director of BHU, the Regional Director confirmed the physician did not countersign or authenticate the H&P examination and Initial Psychiatric Evaluation as required.

4. Review of Patient 6's medical record was initiated on 8/27/18. The patient was admitted on [DATE] at 1718 hours.

Review of the Psychiatric Evaluation dictated by MD 6 on 8/9/18 at 2031 hours, failed to show this form was authenticated by the MD. The Psychiatric Evaluation was not authenticated by the attending psychiatrist within 24 hours of admission as per the hospital's General Rules and Regulations.

On 8/30/18 at 1230 hours, during an interview and concurrent review of Patient 6's medical record with the Regional Director of BHU, the Regional Director confirmed the finding.

5. Review of Patient 5's medical record was initiated on 8/27/18. The patient was admitted on [DATE] at 1220 hours.

Review of the Psychiatric Evaluation signed by MD 8 on 3/11/18 at 1156 hours, showed Patient 5 had a history of [DIAGNOSES REDACTED].

Review of the Patient Profile-Audit History showed Patient 5 had a history of taking levothyroxine (medication used to treat [DIAGNOSES REDACTED]) 75 mcg daily.

Review of the laboratory result for the TSH level collected on 3/13/18 at 0600 hours and released on 3/13/18, showed the TSH level was 6.37 IU/ml (normal level: 0.34 to 5.6 IU/ml).

Review of the H&P examination dictated by NP 2 on 3/13/18 at 1059 hours, showed the form was electronically authenticated by NP 2 on 3/19/18 at 1006 hours and by MD 9 on 3/22/18 at 0330 hours.

However, the H&P examination did not contain information regarding Patient 5's history of [DIAGNOSES REDACTED] or had the TSH level of 6.37 IU/ml. In addition, the physician did not countersign the H&P examination within 24 hours of admission as per the hospital's General Rules and Regulations.

On 8/27/18 at 1255 hours, an interview and concurrent review of Patient 5's medical record was conducted with the Interim Director BHU. The Interim Director confirmed the finding.





6. On 8/27/18, Patient 3's medical record was reviewed. The patient was admitted on [DATE].

The H&P was completed by the attending psychiatrist on 8/26/18; however, the H&P examination was not completed by the medicine physician within 24 hours as required.

On 8/27/18 at 1430 hours, the Regional Director of BHU verified the medicine physician must complete the H&P examination within 24 hours when the patient was admitted to the BHU.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on interview and record review, the hospital failed to ensure an effective and organized nursing service to provide quality care to the patients as evidenced by:

1. The hospital failed to ensure the supervision of personnel performance and nursing care in the BHU and ORs. Cross reference to A392.

2. The hospital failed to ensure the nursing care was provided to meet the needs of two of nine sampled patients (Patients 12 and 8) from the BHU. Cross reference to A395.

3. The hospital failed to ensure the individualized treatment plan was developed or updated to address the care needs for four of nine sampled patients (Patients 4, 5, 6, and 8) from the BHU. Cross reference to A396.

4. The hospital failed to ensure the nursing staff administered the insulin (a medication used to treat high blood sugar) as per the physician's order for one of 15 sampled patients (Patient 12). Cross reference to A405.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare in a safe environment to the patients.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observation, interview, and record review, the GB failed to assume responsibility for determining, implementing, and monitoring policies governing the hospital's total functions to ensure compliance with the following CoPs: 482.21 (QAPI), 482.22 (Medical Staff), 482.23 (Nursing Services), and 482.42 (Infection Control).

Findings:

1. The hospital failed to ensure their QAPI program's quality processes were designed and implemented to ensure the quality and safety of care provided to the patients. Cross reference to A263.

2. The hospital failed to ensure the hospital's Medical Staff Bylaws were implemented to ensure the quality of medical care provided by the medical staff and AHP staff. Cross reference to A338.

3. The hospital failed to have an effective, organized nursing service to provide quality care to the patients. Cross reference to A385.

4. The hospital failed to ensure the patients received care in a safe setting. Cross reference to A144.

5. The hospital failed to ensure the active IC program was developed and implemented to prevent the spread of infections in accordance with the hospital's P&Ps and nationally recognized infection control practices and guidelines. Cross reference to A747.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare to the patients in a safe environment.
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based on interview and record review, the hospital failed to ensure the supervision of personnel performance and nursing care in the BHU and ORs was provided as evidenced by:

1. The hospital failed to ensure there was supervision of nursing care provided in the BHU when the hospital did not have a qualified Director of the BHU. This failure placed all patients in the BHU at risk for substandard care and poor health outcomes.

2. The hospital failed to provide adequate orientation, supervision, and evaluation of a shared employee (RN 10) before the RN worked independently as the circulator nurse in the OR area. This failure resulted to the use of a non-sterile instrument tray during a surgical procedure for a patient (Patient 10), and created the increased risk for a post-operative infection for the patient.

Findings:

1. Review of the hospital's job description for the Director of BHU (undated) showed in part:

* Professional and Technical Skills:

- Ensures staff is informed, involved, and supported in implementing department goals.

- Ensures staff participates in performance improvement by collecting, reviewing data results for opportunities for improvement and action plan development to meet the established benchmarks.

- Ensures department staffing is balanced and the work schedule is completed based upon the needs of the department. Addresses attendance and punctuality with staff.

- Performs department rounds to assist patients, physicians, and staff.

- Ensures staff credentials and competencies are current.

- Addresses and implements appropriate action for quality of care concerns, staff concerns, patient/physician complaints, and department concerns.

- Holds staff accountable for their respective job responsibilities.

* Position Qualifications:

- Minimum Education: Bachelor's degree required. Master's degree in nursing or related field or other appropriate postgraduate degree or written plan to obtain these qualifications.

- Minimum Experience: Five years mental health inpatient experience and 5 years supervisory experience required.

On 8/22/18 at 1135 hours, the Regional Director of BHU and CNO were interviewed. The Regional Director stated she had not been the Director of the hospital's BHU since 5/28/18. The CNO confirmed the statement. When asked, the CNO stated the Director of Medical/Surgical was the Interim Director of the BHU since 5/28/18. When asked regarding qualifications, the CNO acknowledged the Director of Medical/Surgical did not have the qualifications necessary to be the Interim Director of the BHU as required.

On 8/22/18 at 1330 hours, the Director of Medical/Surgical was interviewed. The Director stated he has been covering the BHU since 5/28/18, and acknowledged he did not have recent psychiatric nursing experience which was required to be the Director of BHU. When asked what his responsibilities were as the Interim Director of the BHU, he stated the Regional Director of the BHU was still in charge; however, she was not onsite, so he communicated with her as needed via phone or email.

During a follow up interview with the CNO, the CNO stated the Director of BHU's last date at the hospital was 5/31/18. The CNO confirmed there was no Director of BHU since 6/1/18, until an Interim Director BHU was appointed.





2. The hospital failed to ensure RN 10 was provided with the adequate orientation, supervision, and evaluation before working independently in the OR area. Cross reference to A944.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure nursing care was provided to meet the needs of two of nine sampled patients (Patients 12 and 8) in the BHU as evidenced by:

1. The nursing staff did not conduct an ongoing assessment for Patient 12's BP when the patient's BP reading was 90/57 mmHg on 3/31/18 at 1655 hours after a fall. In addition, the nursing staff failed to notify the physician when the patient had a suicidal ideation prior to the patient's discharge on 4/2/18.

2. The nursing staff did not ensure the blood test was obtained for one patient (Patient 8) as per the physician's order. In addition, the nursing staff failed to ensure the hospital's P&Ps related to Refusal of Treatment or Medications, Riese hearing, and LPS Conservatorship were implemented when Patient 8 refused medications and treatment.

These failures created the increased risk of substandard care provided to the patients.

Findings:

Review of the Nursing section of the hospital's P&P titled Patient Assessment/Reassessment reviewed 9/17 showed the following:

* Reassessment is completed by the RN or LVN each shift on inpatient care areas and more frequently as indicated by the patient's condition or unit specific parameters. The RN provides oversight and reviews the assessment and care provided by the LVN. Documentation is done in the medical record. The care plan will be reviewed by the RN and updated daily. Reassessment is performed at least every shift and includes physiological, psychosocial, activity, patient care needs, response to treatment, nutritional status, and functional status.

* For the Behavioral Health Unit, components of assessment include precipitating crisis/psychiatric history, medications/allergies/substance abuse; impairments and severity, mental status indicators, and appropriate level of care/5150 criteria. The patient will be reassessed at least once a shift for compliance to treatment plan, participation in program, and changes in behavior/medical condition.

1. Review of Patient 12's medical record was initiated on 8/28/18. The patient was admitted on [DATE] at 2101 hours, and was discharged on [DATE] at 1735 hours.

Review of the Psychiatric Initial Examination signed by MD 1 on 3/30/18 at 0905 hours, showed Patient 12 had a history of hypertension, was admitted to the hospital for a safe and secure environment after threatening to kill people and herself.

a. Review of the hospital's P&P titled Falls Prevention Protocol reviewed 9/17 showed the post fall management includes to assess for any injury, obtain vital signs, assess for change in range of motion, monitor patient as condition warrants, document the event details and interventions taken in the medical record, and modify the interdisciplinary plan of care as the patient's conditions warrants.

Review of the physician's order dated 3/29/18, showed to check the vital signs every shift for Patient 12.

Review of the Vitals Inquiry showed the following:

* On 3/29/18, Patient 12's BP was 97/56 mmHg at 1708 hours, 132/70 mmHg at 2000 hours, and 97/61 mmHg at 2256 hours. The patient's HR was 117 bpm at 1708 hours, 102 bpm at 2000 hours, and 106 bpm at 2256 hours.

* On 3/30/18, Patient 12 refused the vital signs to be checked at 0524 and 1559 hours.

* On 3/31/18 at 0745 hours, Patient 12's BP was 109/68 mmHg.

Review of the Progress Note Inquiry dated 3/31/18 at 1445 hours, showed an addendum at 0815 hours showing Patient 12 fell at the hallway and bumped her head at 0748 hours. At 0758 hours, the patient's BP was 65/48 mmHg and the HR was 114 bpm. The nursing staff called and spoke to PA 1. The PA told the nursing staff to observe the patient and call back if the patient complained of increased pain and had abnormal vital signs.

However, there was no documented evidence to show the nursing staff had rechecked Patient 12's BP and HR or provided interventions after the patient's fall until 3/31/18 at 1655 hours. At this time, Patient 12 had a BP reading of 90/57 mmHg and a heart rate of 102 bpm. In addition, a care plan was not developed to address the patient's risk for further falls until 4/1/18 at 0510 hours, when a care plan was initiated to address the patient's risk for injury. The care plan showed Patient 12 would remain free from injury. The interventions included to assess the patient for fall risk each shift, strategies for reducing fall, and environmental strategies for preventing falls.

Review of the Progress Note Inquiry showed an entry dated 4/1/18 at 0555 hours, indicating Patient 12's bed alarm sounded at 0505 hours, and followed by a thumping noise. Documentation showed the patient was found lying on the floor in the bathroom and claimed of hitting the head. The patient complained of aching pain with the pain level of four out of 10 (on the pain scale of one to 10 with one indicating no pain and 10 indicating the worst pain). Immediately after the fall, the patient's BP reading was 64/46 mmHg and the heart rate was 105 bpm. Ten minutes later, the patient's BP went up to 123/69 mmHg and the HR was 101 bpm. The physician was notified and ordered one to one observation and fall precautions.

There was no documented evidence to show the nursing staff had assessed the patients' BP and HR for 12 hours, from 3/31/18 at 1655 hours to 4/1/18 at 0505 hours.

On 8/28/18 at 1335 hours, an interview and concurrent review of Patient 12's medical record was conducted with the Interim Director BHU and IT 1. The Interim Director and the IT confirmed the above documentation. The Interim Director stated there were three shifts in the BHU with eight hours per shift. The morning shift was from 0700 hours to 1500 hours; the evening shift was from 1500 hours to 2300 hours; and the night shift was from 2300 hours to 0700 hours. The Interim Director stated the nursing staff should reassess Patient 12's vital signs and provide interventions such as encourage fluid intake when the patient's BP dropped to 90/57 mmHg on 3/31/18 at 1655 hours. The Interim Director stated the nursing staff should assess the patient's vital signs when the shift changed on 3/31/18 at 2300 hours.

b. Review of the Suicide section of the Daily Assessment Inquiry dated 3/30/18 at 1620 hours, showed Patient 12 had a suicidal ideation, homicidal ideation, suicidal plan, and persistent suicidal thought.

Review of the Discharge Summary Note signed by MD 1 on 4/2/18 at 1059 hours, showed Patient 12 denied suicidal ideation and homicidal ideation. On 4/2/18, the patient was discharged when the patient no longer met the criteria for acute inpatient hospitalization .

Review of the physician's order dated 4/2/18 at 1057 hours, showed to discharge Patient 12 to a shelter and follow up with the outpatient psychiatrist.

Review of the Suicide section of the Daily Assessment Inquiry dated 4/2/18 at 1144 hours, showed Patient 12 had a suicidal ideation but no homicidal ideation, suicide plan, and persistent suicidal thought. There was no documented evidence to show the nursing staff notified the physician when the patient was assessed as having the suicidal ideation on 4/2/18 at 1144 hours.

Review of the Discharge Assessment Inquiry dated 4/2/18 at 1640 hours, showed Patient 12's behavior was appropriate.

Review of the Progress Note Inquiry showed an entry dated 4/2/18 at 1813 hours, showing Patient 12 denied suicidal ideation and homicidal ideation. The patient was cooperative and receptive to the discharge plan. The patient was stable for discharge as per the physician.

On 8/28/18 at 1335 hours, an interview and concurrent review of Patient 12's medical record was conducted with the Interim Director BHU and IT 1. The IT stated Patient 12 was discharged on [DATE] at 1735 hours. The Interim Director BHU stated the nursing staff assessed the patient as having suicidal ideation on 4/2/18 at 1144 hours, after the physician assessed and ordered to discharge the patient on 4/2/18 at 1057 hours. The Interim Director stated the nursing staff should notify the physician when the patient had the suicidal ideation prior to discharge. When asked, the Interim Director and IT 1 was unable to find documented evidence to show the nursing staff notified the physician when the patient was assessed as having a suicidal ideation on 4/2/18 at 1144 hours and prior to the patient's discharge.

2. Review of the hospital's P&P titled Refusal of Treatment or Medications reviewed 9/17 showed to contact the physician whenever the patient refuses medications, treatment or program ordered by the physician.

Review of the hospital's P&P titled Rise (or Riese) Hearings revised 6/15 showed a patient on 5150, 5250, 5260 or 5270 who refuses the ordered antipsychotic medication, may be subject to a medication capacity hearing. The designated attending psychiatrist will file a Riese application and complete the "Declaration of Physician Regarding Patient's Competency to Consent to Treatment by Psychotropic Medication Form." The nursing staff will call the county counsel's office requesting for a Riese hearing.

Review of the hospital's P&P titled LPS Conservatorship (Initiation of Temporary Conservatorship, T-Con, 5353, and 5358) revised 6/15 showed the temporary LPS Conservatorship procedure includes the following:

* The charge nurse or designee shall serve the Notice of Proposed Appointment of Temporary Conservator on the proposed conservatee at least five days prior to the expiration of the 5250 hold.

* The staff person serving the Notice will complete the Proof of Personal Service.

* The designated psychiatrist involved in the patient's care will complete and sign the Declaration in Support of Appointment of Temporary Conservator for the patient who meet the criteria for gravely disable.

* The assigned social services employee will assist in completing the Application for LPS Conservatorship Investigation. Both documents, completed and signed, will be submitted to the Public Guardian's office by the 9th day of the 14 days hold (5250) along with a copy of the Notice and the completed Proof of Personal Services.

Review of Patient 8's medical record was initiated on 8/28/18. The patient was admitted on [DATE] at 0455 hours. The patient had a history of diabetes and high blood pressure. The physician ordered to place the patient on a 5150 hold on 8/5/18 at 0817 hours, on 5250 hold on 8/8/18 at 0153 hours, and on 5270 hold on 8/21/18 at 0933 hours.

a. Review of the physician's telephone orders dated 8/5/18 at 0817 hours, showed to check the Hemoglobin A1C, lipid coronary, TSH, and RPR Qualitative.

Review of the physician's orders dated 8/20/18 at 1935 hours, showed to check Patient 8's CBC and BMP.

Further review of Patient 8's medical records showed the CBC and BMP were collected for Patient 8 on 8/21/18 at 0610 hours. However, there was no documented evidence to show the Hemoglobin A1C, lipid panel, TSH, and RPR Qualitative were completed for Patient 8 as ordered. There was no documented evidence to show the nursing staff notified the physician when the Hemoglobin A1C, lipid panel, TSH, and RPR Qualitative were not completed for the patient.

On 8/28/18 at 1000 hours, an interview and concurrent review of Patient 8's medical record was conducted with the Interim Director BHU. The Interim Director confirmed the above documentation. The Interim Director stated Patient 8 refused to be checked for the Hemoglobin A1C, lipid panel, TSH, and RPR Qualitative tests. The Interim Director was informed and acknowledged the above finding.

b. The physician's telephone order dated 8/5/18 at 0455 hours, showed to check Patient 8's blood sugar before meals and at bedtime and give regular insulin (a medication used to treat high blood sugar) via sliding scale; and to administer Tradjenta (a medication used to treat high blood sugar) 5 mg daily, Cardizem (a medication used for high blood pressure) 120 mg daily and hold if the patient's SBP was less than 110 mmHg, atorvastatin (a medication used for high cholesterol) 10 mg at bed time; prazosin (a medication used for high blood pressure) one capsule at bed time; and clonidine (a medication used for high blood pressure) 0.1 mg every six hours as needed for SBP greater than 160 mmHg and for DPB greater than 100 mmHg.

The physician's order dated 8/5/18 at 0902 hours, showed to give Effexor (antidepressant medication) 50 mg twice a day.

The physician's order dated 8/5/18 at 0903 hours, showed to give Wellbutrin SR (antidepressant medication) 150 mg daily.

The physician's order dated 8/5/18 at 0904 hours, showed to give Seroquel (antipsychotic medication) 400 mg at bedtime.

The physician's order dated 8/5/18 at 0905 hours, showed to give Trileptal (antiseizure medication also used for bipolar disorder) 300 mg twice a day.

Review of the Medication Administration History Report from 8/1/18 to 8/28/18, showed Patient 8 refused the above medications as follows:

* Patient 8 refused to take the atorvastatin from 8/5 to 8/24/18, a total of 10 days.

* Patient 8 refused to take the Wellbutrin and Cardizem from 8/5 to 8/25/18, and on 8/27 and 8/28/18, a total of 23 days.

* Patient 8 refused to take the Tripletal from 8/5 to 8/20/18, and on 8/23 and 8/24/18, a total of 18 days.

* Patient 8 refused to take the prazosin from 8/5 to 8/18/18, and on 8/20, 8/22, 8/23, and 8/24/18, a total of 18 days.

* Patient 8 refused to take Seroquel from 8/5 to 8/18/18, and on 8/20, 8/22, and 8/23/18, a total of 17 days.

* Patient 8 refused to take Effexor from 8/5 to 8/18/18, and on 8/20, 8/22, 8/23, and 8/24/18, a total of 18 days.

* Patient 8 refused to be checked for blood sugar before breakfast for 19 days (from 8/5 to 8/15/18; from 8/17 to 8/20/18; and on 8/23, 8/24, 8/27 and 8/28/18), before lunch for 22 days (from 8/5 to 8/15/18; from 8/17 to 8/24/18; and on 8/27 and 8/28), before dinner for 18 days (from 8/5 to 8/7/18; from 8/9 to 8/22/18; and on 8/27/18), at bed time for 20 days (from 8/5 to 8/25/18 and on 8/27/18).

The Medication Administration History Report showed the nursing staff documented the physician and charge nurse were aware Patient 8 refused all medications on 8/27/18 at 0812 hours.

Review of the Progress Note Report showed an entry dated 8/19/18 at 0922 hours, showing NP 3 was notified of Patient 8 refusing the medications and treatments; the NP stated the plan was to conserve the patient.

There was no documented evidence to show the nursing staff notified the physician when the patient refused the medications until 8/19/18 (or 13 days later). This was not in accordance with the hospital's P&P.

There was no documented evidence to show an application for the Riese hearing and conservatorship were completed timely for Patient 8. Cross reference to A353, example #1.

On 8/28/18 at 1000 hours, an interview and concurrent review of Patient 8's medical record was conducted with the Interim Director BHU. The Interim Director confirmed the above finding. The Interim Director was asked what action should be taken when a patient refused the medications or treatments. The Interim Director stated a Riese application would be filed and completed for the patient who refused medications. When asked how soon the Riese application would be filed for the patient, the Interim Director stated the Riese application would be filed when the patient refused medications for three days. When asked whether the Riese application was complete for Patient 8, the Interim Director stated no. The Interim Director BHU stated the conservatorship application was sent out for Patient 8 on 8/27/18. The Interim Director stated the applications should be sent out sooner for Patient 8.
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure an individualized treatment plan was developed or updated to address the care needs for four of nine sampled patients (Patients 4, 5, 6, and 8) from the BHU, creating the increased risk of not providing the necessary care and services to meet the care needs for these patients.

Findings:

Review of the Behavior Health Assessment section of the hospital's P&P titled Patient Assessment/Reassessment reviewed 9/17 showed under the Nursing section, the Interdisciplinary Team Conferences are to review/update the care plan for each patient weekly.

Review of the hospital's P&P titled Documentation; Interdisciplinary Plan of Care revised 9/17 showed all members of the interdisciplinary health care team involved in the care of the patient are responsible for contributing to the Interdisciplinary Plan of Care. The Interdisciplinary Plan of Care will be individualized, based upon the identified actual or potential patient problems, in collaboration with the patient/family if possible. The written plan of care is based on the patient's goals and the timeframes, settings, and services required to meet those goals. Expected outcomes (goals) will be realistic and measurable.

On 8/27/18 at 1455 hours and on 8/28/18 at 0810 hours, an interview was conducted with the Interim Director BHU. The Interim Director stated the interdisciplinary team had met every week to discuss and update the treatment plan for the patients who were admitted to the BHU; the interdisciplinary team would include the physician or NP, RN, SW, Activity Staff, and Pharmacy Staff. During the meeting, the interdisciplinary team discussed the patient's behavior, medication, discharge plan, and events that occurred during the previous week. The IDT would also update the treatment plan during the meeting.

1. Review of Patient 8's medical record was initiated on 8/28/18. The patient was admitted on [DATE] at 0455 hours.

Patient 8's medical record showed the following:

* Patient 8 refused the medications and treatment. Cross reference to A395, example #2.

* There was no documented evidence to show the applications for Riese hearing and conservatorship were completed timely for Patient 8 as per the hospital's P&P. Cross reference to A353, example #1.

Review of the Progress Notes Reports from 8/4/18 and 8/30/18, showed Patient 8 continued to stay isolated in the room and did not participate in the group activities multiple times.

Review of the Behavioral Health Interdisciplinary Treatment Plans dated 8/5, 8/9, 8/16, and 8/13/18, showed the following:

* The Behavioral Health Interdisciplinary Treatment Plan dated 8/5/16, showed three identified problems were discharge planning, symptom stabilization, and medication management. The form showed to continue interventions. However, the sections for admitting diagnosis, admitted , change in diagnosis, medication adjustment, and IM's required were left blank. There were no signatures from the nursing staff and activity staff to show the nursing and activity staff attended the meeting. The form did not show the expected outcome or goals including short term and long term goals for the patient.

* The Behavioral Health Interdisciplinary Treatment Plan dated 8/9/16, showed three identified problems were alternation in thought process, hypertension, and discharge. The form showed the section for "psychiatrist," "nursing," "social worker," and "activity therapy" were signed to indicate these disciplines attended the meeting.

* The Behavioral Health Interdisciplinary Treatment Plan dated 8/16/18, showed six identified problems were alteration in thought process, hypertension, spiritual distress, suboptimal oral nutrient intake related to poor appetite, need for follow up care post discharge and discharge plan. The form showed the section for "psychiatrist," "nursing," "social worker," and "activity therapy" were signed to indicate these disciplines attended the meeting.

* The Behavioral Health Interdisciplinary Treatment Plan dated 8/23/18, showed eight identified problems were alternative of thought process, hypertension, spiritual distress, decrease nutrients, discharge planning, knowledge deficit, self-care deficit, and ineffective coping. The form showed the section for "psychiatrist," "nursing," "social worker," and "activity therapy" were signed to indicate these disciplines attended the meeting.

However, the above Behavioral Health Interdisciplinary Treatment Plan(s) did not address Patient 8's refusal to take medications, treatments or activities. There was no documented evidence to show interventions or actions should be taken to address the refusal of medications and treatments. The treatment plans did not contain the short term or long term goals for Patient 8 as required.

On 8/28/18 at 1000 hours, an interview and concurrent review of Patient 8's medical record was conducted with the Interim Director BHU. The Interim Director confirmed the above findings.

On 8/29/18 at 1055 hours, during an interview with the Director Activity BHU, the Director stated the Director conducted an initial activity assessment when the patient was admitted to the unit; then the activity aides engaged the patient into group activities or provide one to one session if the patient did not want to attend the group activities. When asked about Patient 8's activities, the Director stated the patient did not want to participate in any activity. When asked if the patient's activity plan was reevaluated or updated, the Director stated the treatment plan meetings were conducted weekly for each patient, and the team discussed and updated the treatment plan during the meeting. The Director was informed and acknowledged Patient 8's treatment plan was not updated to address Patient 8's refusal to participate in any group activities.

2. Review of Patient 6's medical record was initiated on 8/27/18. The patient was admitted on [DATE] at 1718 hours.

Review of the Progress Note Inquiry from 8/8/18 to 8/27/18, showed Patient 6 received Zyprexa (antipsychotic medication) IM on 8/10, 8/11, and 8/16/18; and received Benadryl (antiallergy medication) 50 mg IM on 8/10 and 8/11/16 for aggressive behavior.

Review of the Behavioral Health Interdisciplinary Treatment Plans dated 8/9, 8/16, and 8/13/18 showed the following:

* The Behavioral Health Interdisciplinary Treatment Plan dated 8/16/18, showed one identified problem was discharge planning. The sections for IM medications and continued behavioral symptoms were left blank. There was no signature in the "nursing" section to show the nursing staff attended the meeting. The Treatment Plan did not address Patient 6's behavior or the administration of the IM medications when the patient received the Zyprexa and Benadryl for aggressive behavior.

* The Behavioral Health Interdisciplinary Treatment Plan dated 8/23/18, showed the patient's problem included alteration thought process and risk of violence towards others. However, there was no signature in the "nursing" section to show the nursing staff attended the meeting.

The above Behavioral Health Interdisciplinary Treatment Plan did not contain the short term or long term goals for Patient 6 as required.

On 8/27/18 at 1455 hours, an interview and concurrent review of Patient 6's medical record was conducted with the Interim Director BHU. The Interim Director confirmed the finding.

3. Review of Patient 4's medical record was initiated on 8/27/18. The patient was admitted on [DATE] at 0311 hours.

a. Review of the Psychiatric Evaluation dictated on 5/4/18 by MD 6, showed Patient 4 had a long standing history of possible dementia. It was unclear if the patient had ever had history of schizophrenia.

Review of the Behavioral Health Interdisciplinary Treatment Plan dated 5/4/18, showed the identified problem was discharge planning. The section for the admitting diagnosis showed "Schiz." (or schizophrenia). The sections for the "continued behavioral symptoms," "prior living situation," "is patient able to returns to prior living arrangements," "discharge plan," and "aftercare Plan referral" were left blank.

b. Review of the Progress Note Inquiry dated 7/15/18, showed Patient 4 received Zyprexa 10 mg IM and Benadryl 50 mg IM at 0749 hours; and Thorazine (antipsychotic medication) 100 mg and Benadryl 50 mg IM at 0838 hours.

Review of the Behavioral Health Interdisciplinary Treatment Plans dated 7/19/18, showed the sections for "IM's required" was checked as "No." There was no signature in the "nursing" section to show the nursing staff attended the meeting. There was no documented evidence to show the treatment plan was updated to address the administration of Zyprexa, Benadryl, and Thorazine to the patient.

c. Review of the Progress Note Inquiry dated 7/22/18, showed Patient 4 received Zyprexa 10 mg and Benadryl 50 mg IM at 1339 hours.

Review of the Behavioral Health Interdisciplinary Treatment Plans dated 7/26/18, showed the sections for "IM's required" and "continued behavioral symptoms" were left blank. There was no signature in the "nursing" section to show the nursing staff attended the meeting. There was no documented evidence to show the treatment plan was updated to address the use of the IM medications for the patients.

d. Review of the Progress Note Inquiry showed Patient 4 received Zyprexa 10 mg and Benadryl 50 mg IM on 8/7/18 at 2231 hours; Zyprexa 10 mg IM on 8/8/18 at 1745 hours; and Thorazine 100 mg, Benadryl 100 mg, and Ativan (antianxiety medication) 2 mg IM on 8/9/18 at 2012 hours,

Review of the Behavioral Health Interdisciplinary Treatment Plans dated 8/9 and 8/16/18, showed the sections for "IM's required" and "continued behavioral symptoms" were left blank. There was no signature in the "nursing" section to show the nursing staff attended the meeting. There was no documented evidence to show the treatment plan was updated to address the use of the IM medications for the patients.

The above Behavioral Health Interdisciplinary Treatment Plan(s) did not contain the short term or long term goals for Patient 4 as required.

On 8/28/18 at 0810 hours, an interview and concurrent review of Patient 4's medical record was conducted with the Interim Director BHU. The Interim Director confirmed Patient 4's treatment plans were not completed or updated for Patient 4 in accordance to the patient's conditions.

4. Review of Patient 5's medical record was initiated on 8/27/18. The patient was admitted on [DATE] at 1220 hours.

Review of the Behavioral Health Interdisciplinary Treatment Plan dated 8/16/18, showed one identified problem was alteration in comfort and pain. However, there was no documented evidence to show the short and long term goal for the patient's pain. There was no documented evidence to show intervention would be provided to the patient when the patient complained of pain.

Review of the Progress Note Inquiry showed Patient 5 received Norco (a narcotic, or pain medication) for back pain on 8/19/18 at 0854 hours, Norco for tooth pain on 8/20/18 at 0019 and 1900 hours, Norco for mouth pain on 8/21/18 at 1845 hours, Norco for tooth and mouth pain on 8/22/18 at 0721 and 1900 hours, Motrin (a pain medication) for mouth pain on 8/23/18 at 1800 hours, Norco for mouth pain on 8/23/18 at 1915 hours, and Norco for mouth pain on 8/25/18 at 1747 hours.

Review of the Behavioral Health Interdisciplinary Treatment Plan dated 8/23/18, failed to show the interdisciplinary team had identified pain management as the problem when Patient 5 received pain medications during the previous week. There was no documented evidence to show the treatment plan was updated to address pain management for the patient.

On 8/27/18 at 1455 hours, an interview and concurrent review of Patient 5's medical record was conducted with the Interim Director BHU. The Interim Director confirmed the treatment plan was not updated in accordance to Patient 5's needs.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure the nursing staff administered insulin as per the physician's order for one of 15 sampled patients (Patient 12), creating the increased risk of poor health outcomes for the patient.

Finding:

Review of Patient 12's medical record was initiated on 8/28/18. The patient was admitted on [DATE] at 2101 hours, and was discharged on [DATE] at 1735 hours. The patient had a history of diabetes.

Review of the physician's orders dated 3/31/18 at 1733 hours, for the medium dose correctional insulin showed to administer insulin "AC" as follows:

* If the patient's BS was between 131 mg/dL to 150 mg/dL, give the patient 2 units of insulin
* If the patient's BS was between 151 mg/dL to 200 mg/dL, give the patient "2 units" of insulin
* If the patient's BS was between 201 mg/dL to 250 mg/dL, give the patient 4 units of insulin
* If the patient's BS was between 251 mg/dL to 300 mg/dL, give the patient 6 units of insulin
* If the patient's BS was between 301 mg/dL to 350 mg/dL, give the patient 8 units of insulin
* If the patient's BS was between 351 mg/dL to 400 mg/dL, give the patient 10 units of insulin
* If the patient's BS was greater than 400 mg/dL, give the patient 12 units of insulin. If the patient's BS was over 200 mg/dl twice, go to high algorithm or the high dose correctional insulin.

Review of the physician's order for the high dose correctional insulin dated 4/1/18 at 1730 hours, showed to administer insulin "AC" as follows:

* If the patient's BS was between 131 mg/dL to 150 mg/dL, give the patient 2 units of insulin
* If the patient's BS was between 151 mg/dL to 200 mg/dL, give the patient 3 units of insulin
* If the patient's BS was between 201 mg/dL to 250 mg/dL, give the patient 6 units of insulin
* If the patient's BS was between 251 mg/dL to 300 mg/dL, give the patient 9 units of insulin
* If the patient's BS was between 301 mg/dL to 350 mg/dL, give the patient 12 units of insulin
* If the patient's BS was between 351 mg/dL to 400 mg/dL, give the patient 15 units of insulin
* If the patient's BS was greater than 400 mg/dL, give the patient 18 units insulin.

Review of the Measurements Inquiry showed the following:

* On 3/31/18 at 1730 hours, Patient 12's BS was 449 mg/dL and 12 units of insulin was administered to the patient.

* On 3/31/18 at 2123 hours, Patient 12's BS was 319 mg/dL and four units of insulin was administered to the patient. According to the physician's order dated 3/31/18 at 1733 hours, eight units of insulin should be administered to the patient instead of four units of insulin.

* On 4/1/18 at 0659 hours, Patient 12's BS was 231 mg/dL and 4 units of insulin was administered to the patient. According to the physician's order dated 3/31/18 at 1733 hours, the nursing staff should clarify with the physician to ensure the administration of insulin as per the high dose correctional insulin when the patient's BS was over 200 mg/dL twice (on 3/31/18 at 1730 and 2123 hours).

* On 4/1/18 at 1145 hours, Patient 12's BS was 362 mg/dL.

On 8/28/18 at 1335 hours, an interview and concurrent review of Patient 12's medical record was conducted with the Interim Director BHU and IT 1. The Interim Director and the IT confirmed the nursing staff did not administer the insulin as per the physician's order.
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the hospital failed to ensure the pharmacy staff provided adequate supervision of the medication storage area in the CVOR and PACU. This failure had the potential for the unsafe and inappropriate use of medications.

Findings:

Review of the hospital's P&P titled Storage of Chemicals and Drugs revised 9/17 showed all medications shall be stored under conditions that ensure their stability and maintain their effectiveness. Drugs and chemicals shall be stored under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and safety. Drugs and chemicals shall not be kept in stock after the expiration date on the label and no contaminated or deteriorated drugs shall be accessible for use. The DOP or qualified designee shall conduct at least monthly inspections of all areas where drugs and chemicals are stored, administered, prepared, or dispensed to ensure compliance and removal of outdated medication. All expired, damaged, and/or contaminated drugs shall be segregated until they are removed from the hospital.

Review of the manufacturer's instructions for the use of sevoflurance (an anesthetic medication used to put patients to sleep before surgery) showed it is indicated for induction and maintenance of general anesthesia. Sevoflurance should be administered only by persons trained in the administration of general anesthesia. The manufacturer does not make recommendation regarding the stability of the sevoflurance once the original bottle has been opened.

On 8/27/18 at 0930 hours, the initial tour of the CVOR and PACU areas was conducted accompanied by the Director of the Perioperative and Director of MCH. The following was identified:

a. In the CVOR, a rusty blue cart was identified as belonging to the perfusionist. The cart contained two vials of Lasix (a diuretic medication) that had expired on [DATE], and an opened bottle of isoflurane (an inhalation anesthetic used for general anesthesia) that was 3/4 full. The opened bottle of isoflurane was not dated as to when it was opened. The Directors were unable to tell how long this bottle had been in the cart. The Directors was unable to explain why the bottle of inhalation anesthetic was in the perfusionist's cart and was not in the anesthesia cart.

b. In the PACU, inspection of the medication storage area showed a vial of atropine sulfate (medication to treat slow heart rate and drooling) had expired on ,d+[DATE]. A half-full bottle of sevoflurance was found not dated as to when it was opened.

The PACU RNs were unable to tell how long the bottle of sevoflurance had been stored in the drug storage area. The Director of the Perioperative and Director of MCH acknowledged the findings.

On 8/29/18 at 0930 hours, an interview was conducted with the DOP, Pharmacy Staff, and Pharmacy Clinical Coordinator. The DOP stated the hospital's pharmacy dispensed the unit doses for most medications. The DOP stated if a medication vial was used, it would be intended for "one time" use only and then discarded; and if a multidose vial will be used the vial would be dated in the pharmacy by the dispensing pharmacist to last for 28 days. When asked about the method of storing and how long the inhalation anesthetics could be kept, the DOP was not able to confirm the anesthetic shelf life and stability after the bottles were opened. The DOP also stated the perfusionist was not listed among the hospital staff who could administer medications. The DOP acknowledged more pharmacy rounds should be made in the perioperative areas to be able to monitor and maintain the drug storage.

On 8/30/18 at 1235 hours, during an interview with the Chief of Staff, the Chief of Staff stated the perfusionist used the anesthetic gases to adjust the patient's BP during the surgery.
VIOLATION: CONTROLLED DRUGS KEPT LOCKED Tag No: A0503
Based on observation, interview, and record review, the hospital failed to ensure methadone (a pain medication also used to treat narcotic drug addiction) was wasted as per the hospital's P&P. This failure posed the risk for narcotic diversion by the staff and medication errors for the patients receiving medications in the BHU Unit 3.

Finding:

The hospital's P&P titled Storage of Chemicals and Drugs dated 9/17 showed in part:

- All medications shall remain securely stored until time of administration...Unused doses shall be immediately destroyed or returned to the pharmacy, Pyxis return bin, or a secured designated area...

- Controlled substances shall be securely stored in such a manner as to prevent theft or diversion. This may include storage limited to authorized access in a Pyxis, or in a double-locked cabinet, drawer, or receptacle with appropriate documentation to ensure accountability of each dose.

The hospital's P&P titled Inspections of Medication Storage Areas dated 9/17 showed scheduled medications are stored in a double-locked cabinet or drawer. Wastage is documented and countersigned by a witness.

On 8/27/18 at 1000 hours, a tour of the medication room in the BHU Unit 3 was conducted with the Regional Director of BHU. A Silent Knight pill crusher was observed on the counter. Inspection of the pill crusher showed a one-half tablet of methadone tablet in an opened pill packet observed inside the base of the pill crusher. The methadone tablet was located outside of a locked cabinet or drawer. When asked, the Director stated the methadone tablet should have been wasted in the sharps container as per the hospital's P&P.

On 8/29/18 at 0940 hours, an interview was conducted with the DOP. The DOP was informed of the above observation. The DOP stated if a controlled substance was cut in half, the other half must be wasted and witnessed.
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation and interview, the hospital failed to ensure the hospital's facilities, supplies, and equipment were adequately maintained to ensure an acceptable level of safety and quality. This failure could result in substandard health outcomes and unsafe patient environment.

Findings:

1. On 8/27/18 at 0930 hours, the initial tour of the OR area was conducted with the Director of Perioperative Services and Director of MCH. The following was identified:

* In the OR scrub area, four out of eight faucets were not operational. One knee faucet control in the scrub area across the CVOR was about to fall off.

* In the CVOR, a Xenon light source was observed with no PM sticker. A rusty blue cart was observed containing a blue test tube that expired on [DATE].

The Director of Perioperative Services confirmed the above observations.

2. On 8/28/18 at 0900 hours, inspection of the ICU area was conducted with the Director of ED/ICU and Director of MCH. The following was identified:

* The window blinds in ICU Rooms 3 and 4 had loose latches and were about to fall off.

* The Bair Hugger machine (a warming machine) had no PM sticker.

* Twelve IV pumps were not plugged in. Observation of a posted instruction on the wall of the ICU dirty utility room showed the IV pumps should be plugged in to maintain reliability and availability.

3. On 8/28/18 at 0930 hours, a tour of the ED was conducted with the CEO and Medical Director of ED Services. The following was identified:

* Three overhead light fixtures in the four-bed ED room were not operational.

* Two drawers that contained patients' personal items were about to fall off.

* Bed 1's overhead light fixture was uneven and had no bulb cover.

The CEO and Medical Director of ED Services acknowledged the above observations. They also acknowledged the patient could remove and use the exposed bulb as a weapon.

4. On 8/30/18 at 1100 hours, a tour of the BHU Unit 6 was conducted with the Interim Director BHU and Director of MCH. The following was identified:

* The shower control knobs in the shower room were protruded from the walls where the patients could hurt/hang themselves.

* The video surveillance for the seclusion room had limited coverage by a huge blind spot where the glass-covered window was not being shown.

* The grout in the activity room's floor tiles had huge amount of black substance.

* The activity room storage area was observed with old game boards. These game boards were not organized. Cockroaches were observed on the walls.

* In the outdoor activity area, the rain gutter was held by loose screws which could serve as a potential weapon for patients in the BHU.

The Interim Director BHU and Director of MCH acknowledged the findings.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, interview, and record review, the hospital failed to ensure the active IC program was developed and implemented to prevent the spread of infections in accordance with the hospital's P&Ps and nationally recognized infection control practices and guidelines as evidenced by:

* The hospital failed to ensure their hospital-wide infection control prevention program was in place to include the processes of evaluation, implementation, surveillance, prevention, and control of infections. Cross reference to A749.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare to the patients in a safe environment.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, interview, and record review, the hospital failed to ensure their hospital-wide infection control prevention program was in place to include the processes of evaluation, implementation, surveillance, prevention, and control of infections as evidenced by:

1. Failure to ensure the sterilized packages were labeled as per the hospital's P&P. In addition, the hospital failed to ensure the compromised sterility of sterilized packages were not available in the patient care area and failed to ensure the P&P related to shelf life of sterilized items was developed in accordance with the AORN's guidelines.

2. Failure to ensure a dehumidifier machine was not used in the endoscopy room of the OR as per the AORN's guidelines.

3. Failure to ensure the temperature and humidity levels were monitored on the weekends as per the hospital's P&P.

4. Failure to use the enzymatic solution properly.

5. Failure to maintain a clean and sanitary physical environment.

6. Failure to ensure the contracted dialysis staff performed hand hygiene and used the PPE as per the dialysis company's P&P.

These failures created the risk of the spread of infections to the patients and staff in the hospital, which could result in substandard health outcomes and unsafe patient care.

Findings:

1. The AORN's Guidelines for Perioperative Practice, Guideline for Sterilization published online 2018, recommended the health care organization should establish a process for determining the shelf life of sterilized items. The shelf life should be event-related unless otherwise specified by the packaging label's expiration date. The shelf life is dependent on the packaging material, storage conditions (sterile items should be stored under controlled conditions that reduce the risk of contamination), transport, and handling.

Review of the AORN's Guidelines for Perioperative Practice, Guideline for Packaging Systems, publish online 2018, showed packages should be labeled before sterilization. Package labels should include the sterilizer number or unique identifier if more than one sterilizer is used; the cycle or load number; the date of sterilization; description of the contents; and identification of the assembler. The P&P regarding selection and use of packaging systems should include labeling, storage requirements pre- and post- sterilization, and shelf life.

Review of the facility's P&P titled Sterilization Processes and Practices revised 6/15 showed all items used within a sterile field must be rendered sterile either by use of steam/gravity or prevac sterilization, gas plasma sterilization, and chemical sterilization. Instrument sets and instruments for surgery are double wrapped in approved wrappers with sterilization process indicators inside the package or tray, as well as on the outside, using steam tape. A label with the sterilizer number, load number, and date of sterilization will be on the outside of every package sterilized.

Review of the facility's P&P titled Sterilization-Packaging Systems, Selection and Use revised 6/15 showed all items sterilized will be labeled with the date, sterilizer number, and load number.

a. On 8/27/18 at 1000 hours, a tour of the OR area was conducted with the Director of Perioperative Services. Nine urology tips contained in a discolored, yellowed tinged packaging were observed in the sterile supply storage area. The discolored, yellowed tinged packaging was labeled with the date of 12/97.

The Director of Perioperative Services verified the above observation. The Director stated she thought the item was sterile unless the package was opened.

b. On 8/27/18 at 1030 hours, an observation of the equipment storage room was conducted with the Director of Perioperative Services and SPD Tech. A brochoscopy cart was observed with the following:

* The drawers contained sterile trays, two individually wrapped packages of bronchoscopes dated 7/16/14, and individually wrapped packages of metal bronchoscopy instruments including suction tips, long forceps, forceps, and scissors dated 8/5/14.

* Drawer #2 contained a pediatric tracheal tube and suction catheter with discolored packaging dated 12/98.

* A mediastinoscopy drawer contained instruments in single processed packages with no date of sterilization, load number or expiration date.

The Director of Perioperative Services verified the above findings.

The SPD Tech stated the dates on the packages were the dates the scopes and instruments were sterilized. The SPD Tech stated the instruments were considered sterile for four years from the sterilization date. The Director of Perioperative Services stated she did not have a P&P that showed the sterile wrapped trays or instruments were good for four years.

2. Review of the AORN's Guidelines for Perioperative Practice, Guideline for Perioperative Practice: Design and Maintenance published online 2018, showed free-standing fans, portable humidifiers, air conditioners, and humidifiers should not be used. Humidifiers and dehumidifiers contain standing water that may be a source for Legionella (bacteria).

On 8/27/18 at 1300 hours, an observation of the endoscopy room was conducted with the Director of Perioperative Services, Biomedical Engineer, and GI Tech 1. A dehumidifier machine with water in the reservoir was observed in the endoscopy room.

The Director of Perioperative Services, Biomedical Engineer, and GI Tech 1 confirmed the observation. GI Tech 1 stated the water reservoir was not needed to be emptied until it was full. The Biomedical Engineer stated the dehumidifier machine would be shut down when the reservoir was full of water, then it had to be emptied. The GI Tech stated the last time she used the dehumidifier was when the humidity readings were high; she turned it on and ran it during the endoscopy procedures for the whole day.

On 8/27/18 at 1530 hours, an interview was conducted with the Director Infection Prevention. The Director stated a dehumidifier machine should not be used in the surgical services department or ORs for humidity control.

3. Review of the facility's P&P titled Temperature and Humidity Monitoring revised 6/15 showed the humidity and temperature of each OR will be monitored daily and recorded on the humidity and temperature logs for each OR room, by a designated person.

On 8/30/18 at 1130 hours, an interview and concurrent record review was conducted with the Director of Perioperative Service. The Director stated the temperature and humidity levels were not checked or recorded if there were no cases on the weekend. The Director stated there was no staff working to monitor the temperature and humidity levels during the weekend. When asked about the P&P for monitoring the temperature and humidity levels for the OR, the Director verified the hospital's P&P was not implemented.





4. On 8/28/18 at 1425 hours, a tour of the Endoscopy Cleaning Room was conducted with the Director of MCH and Director Perioperative Services. A wall poster was observed showing the directions for use of the enzymatic cleaning of the different scopes (bronchoscopes, upper and lower GI scopes).

Review of the directions for use of the enzymatic cleaning solution showed the ratio was to add an ounce of the enzymatic solution to a gallon of warm water. The scope equipment should be submerged completely for two minutes and suctioned through channels of flexible instruments. The exterior would then be washed with the enzymatic sponge and all channels of the equipment would be brushed until clear. Then rinsed thoroughly.

On 8/28/18 at 1425 hours, GI Tech 1 was observed cleaning and processing a GI scope. The GI Tech was observed adding three ounces of the enzymatic solution to a gallon of water instead of adding one ounce of enzymatic solution to a gallon of warm water. The GI Tech did not follow the directions for the use of the enzymatic solution.

The Director of MCH and Director Perioperative Services acknowledged the findings.

5a. On 8/27/18 at 0930 hours, the initial tour of the CVOR areas was conducted accompanied by the Director of Perioperative Services and Director of MCH. A rusty blue cart was observed in the CVOR.

b. On 8/28/18 at 0900 hours, the inspection of the ICU was conducted accompanied by the Director of ICU/ED and Director of MCH. The following was observed:

* In ICU 6, an Ambu bag (bag-valve mask used for emergency rescue breathing) was observed on top of the used bedpan and urinal.

* In ICU 5, a food tray was found on top of the dirty linen cart.

* An ambulance transferring board was stored in clean linen room.

* The sides of the Formica counter at the nurses station were peeling off making it difficult to disinfect.

The Director of ICU/ED and Director of MCH confirmed the finding.

c. On 8/30/18 at 1100 hours, a tour of the BHU Unit 6 was conducted accompanied by the Interim Director BHU and Director of MCH. The following was identified:

* The grout of the floor tile in the activity room had a huge amount of black substance.

* The activity room storage area was observed with old game boards. These game boards were not organized. Cockroaches were observed on the walls.

The Interim Director BHU and Director of MCH acknowledged the findings.





d. The hospital's P&P titled Inspections of Medication Storage Areas dated 9/17 showed the medication storage and preparation areas are neat, clean, and in good appearance.

On 8/27/18 at 1000 hours, a tour of the medication room in BHU Unit 3 was conducted with the Regional Director of BHU. The following was identified:

- Two docks for the blood glucose monitors had a heavy buildup of dust.

- A large pill crusher had a heavy buildup of dust and grime.

- A sharps container had a heavy buildup of dust and grime.

- Multiple hairs, dust, and trash including empty pill packaging, a plastic cup, and a used tissue were observed on the floor.

- A black substance was observed on the floor in several spots where the baseboard met the wall.

- The linoleum floor tile behind the door and against the wall was stained reddish-brown.

- The surface of the cabinet doors near the floor was not intact, exposing the inner material.

- A used oxygen tank was stored in the medication room.

The Regional Director of BHU verified the above findings. The Director stated the nurses were responsible for cleaning the blood glucose monitors and docks, and the pill crusher. The Director stated the oxygen tank should not be stored in the medication room. The Director acknowledged if the floor or cabinet surface was not intact, it could not be disinfected properly. When asked about the environmental inspection, the Director stated the charge nurse did environment of care (EOC) rounds in BHU Unit 3 including the medication room every shift to ensure the medication room was being cleaned properly.

On 8/27/18 at 1130 hours, the RN Environment of Care Handoff Rounds Form dated 8/26/18 for the morning was reviewed with the Regional Director of BHU. The form showed a check mark in the box marked "yes" for the medication room indicating it was clean and free of dust. The Director acknowledged the documentation on the form did not accurately reflect the condition of the medication room in BHU Unit 3.

On 8/30/18 at 0945 hours, an interview was conducted with the Director Infection Prevention. When asked, the Director stated the Infection Prevention (IP) team conducted rounds in the medication rooms to look for infection control issues including expired medications and to see if the pill crushers were being cleaned. The Director was informed and acknowledged of the findings in the medication room in BHU Unit 3. The Director stated moving forward, the IP team would work more closely with the EVS Manager to ensure the environment was maintained in a sanitary manner.

e. On 8/27/18 from 0945 to 1345 hours, a tour of the BHU Unit 3 and BHU Unit 5 was conducted with the Regional Director of BHU.

* The soiled utility room in the BHU Unit 3 was observed as follows:

- The floor had a heavy buildup of dirt and grime along the baseboards.

- Trash and hair was observed on the floor.

- The lids on the soiled linen bins had a recessed edge with a heavy buildup of dirt and grime.

* A heavy buildup of dust and grime was observed on the floor and along the baseboards in the BHU Unit 3 exam room.

* A heavy buildup of dirt and grime was observed on the floor and along the baseboards in the BHU Unit 3 seclusion room.

* Water stains, chipped and peeling paint, and a detached baseboard were observed in the bathroom of Room A.

* A chair in the BHU Unit 5 shower room was dirty, had standing water in the seat, and was not an appropriate chair to be used in a shower.

* A dirty toilet tank, bowl, and base with an exposed rusty bolt was observed in Room B.

The Regional Director of BHU verified each of the above findings. The Director stated there was one EVS staff member assigned to each BHU unit during the day, and the EVS staff could be paged to come to a unit at night if needed. When asked about the metal chair being used as a shower chair, the Director stated there was a standard shower chair available for use, and the metal chair was not appropriate to be used in the shower room. The Director confirmed Room B was supposed to be a clean room ready for a patient admission; however, the bathroom in Room B was not sanitary. The Director further stated she expected a patient room to be cleaned and disinfected properly.

On 8/30/18 at 0945 hours, during an interview with the Director of Facilities/Safety/Biomed, The Director acknowledged the issues with the detached baseboards in BHU and stated the "cove base" would be eliminated from the BHU because items could be hidden behind it. The hospital would be changing to paint instead for patient safety.





f. On 8/27/18 at 0945 hours, a tour of the Medical/Surgical unit was conducted with the Director of Medical/Surgical. The following was identified:

* In the medication room, there was a black buildup between the back of the sink and the wall, and between the counter and wall on the right side of the sink. The outer surface of the counter was worn off on the left side of the sink exposing the porous surface which could affect the disinfection of the counter.

* The edges of the doors and the doorframes of the patient rooms had chipped/gouged areas exposing the porous wood underneath.

* The door hinges on several room doors were rusted.

* The nurses station and the computer area next to the station had missing areas of the plastic overlay which exposed the porous wood underneath.

* There were cracked flooring tiles with a black buildup around the edges of the tiles and in the cracked areas.

* There was the black buildup around the base of the nurse station and the legs on the computer desk.

* The isolation carts had areas where the paint had been chipped off. The metal area underneath of the isolations carts had rusty-colored areas.

* The paint and the outer surface of the wallboard around a light switch in a patient room were missing, exposing the porous material underneath.

The Director of Medical/Surgical verified the above observations.

g. On 8/27/18 at 1400 hours, an observation of of the dialysis equipment storage room was conducted with the Director of Medical/Surgical. The following was identified:

* There was a black buildup approximately three feet by three feet on the light gray tile floor.

* One hemodialysis machine had dirt buildup on the frame of the attached RO system. There were some rusted areas along the bottom edges of the dialysis machine. A white cloth was found between the IV pole and the side of the machine.

The Director of Medical/Surgical verified the above observations.

6. Review of the dialysis company's P&P titled Hand Hygiene revised 4/13 showed hands should be washed prior to gloving and after the removal of gloves.

Review of the company's P&P titled Infection Control In the Hospital Dialysis Setting revised 4/18 showed gloves should be changed when going from a "dirty" area or task to a "clean" area or task.

a. On 8/27/18 at 1300 hours, during a tour of the Medical/Surgical unit with the Director of Medical/Surgical, an observation of a dialysis treatment by the hospital's contracted dialysis service for Patient 1 was conducted. The following was identified:

* The dialysis machine was placed on the right side of Patient 1's bed. The patient's dialysis catheter was located on the patient's left chest.

* RN 6 was observed leaning across Patient 1's bed, performing Patient 1's pre-dialysis catheter care leaning across the bed. After the catheter care was completed, the RN removed the gloves, performed hand hygiene, and put on new pair of gloves. Then the RN went around to the opposite side of the patient's bed, checked the patient's dialysis catheter dressing, and made some adjustments to the dressing and dialysis catheter limbs. After making the adjustments, RN 6 applied hand sanitizer to the gloves the RN was wearing, went to the dialysis machine and removed a new bag of normal saline from its outer wrapper to replace the empty normal saline bag on the dialysis machine prior to initiating the patient's treatment. The RN did not change gloves and perform hand hygiene between tasks as per the P&P.

On 8/29/18 at 1040 hours, a telephone interview was conducted with the ESRD RN Manager of the contracted dialysis company. The Manager was informed of the finding. The Manager stated it was not the company's policy to use hand sanitizer to clean the used gloves.

b. Review of the dialysis company's P&P titled Priming a Non-ETO Sterilized Single Use Dialyzer (undated) showed to perform hand hygiene and put on PPE (which includes gloves, gown, and eye protection) prior to priming the machine; to inspect the dialyzer package to verify that is intact; and after removal from the packaging to place the dialyzer into the dialyzer holder on the machine. Materials required to prime the dialyzer and the dialysis delivery system included a one liter bag of normal saline.

On 8/28/18 at 1500 hours, the preparation of a dialysis machine for Patient 11's dialysis treatment was observed with the Director Infection Prevention and Director of Medical/Surgical. The following was observed:

* RN 7 was observed wearing only gloves while preparing the dialysis machine for the patient's dialysis treatment. The RN did not wear the gown and eye protection during the preparation of the machine as per the P&P.

* RN 7 did not perform hand hygiene after removing the gloves as per the P&P.

* RN 7 opened a sterile dialyzer package and placed the sterile dialyzer on top of the machine. The RN did not place the dialyzer into the dialyzer holder as per the P&P.

* RN 7 placed two bags of normal saline on top of the dialysis machine. The RN removed the outer wrapper from one normal saline bag and hung it on the IV pole. The RN then removed the outer wrapper from the second bag of normal saline and hung it on the IV pole with the first bag of normal saline. The number of saline bags placed on the machine was not as per P&P.

The Director Infection Prevention was asked if the IC team performed the observations of the contracted dialysis staff for possible infection control issues. The Director stated they observed the contracted dialysis staff, but the Director was not familiar with dialysis care and would not be able to identify any infection control issues.

On 8/29/18 at 1040 hours, a telephone interview was conducted with the ESRD RN Manager of the contracted dialysis company. The Manager confirmed only one liter bag of normal saline should have been opened and placed on the machine; the sterile dialyzer should have been placed directly in the dialyzer holder after it was opened and should not be placed on top of the dialysis machine; the RN should be wearing PPE when preparing the dialysis machine, and perform hand hygiene after removing the gloves.
VIOLATION: OPERATING ROOM CIRCULATING NURSES Tag No: A0944
Based on interview and record review, the hospital failed to ensure the adequate orientation, supervision, and evaluation were provided to a shared employee (RN 10) working in the OR area. This failure resulted to RN 10 not receiving the complete orientation to perform her job duties properly and competently.

Findings:

Review of the hospital's P&P titled Orientation, Hospital, and Departmental revised 1/16 showed the orientation of new employees is the responsibility of the Human Resources Department and Department Director of the area to which the new hire is assigned. The Department Directors will be responsible for ensuring the new staff are provided with a departmental orientation with a preceptor.

Review of the hospital's P&P titled Competency Assessment and Verification revised 6/15 showed a staff member's competency is the responsibility of the charge nurse, departmental supervisors, managers, and/or directors, in conjunction with the Human Resources and Education Department. All new hires are required to attend the New Employee Orientation and pass an orientation posttest; and each department director or educator will determine the format and content of the department specific checklists for department knowledge, skills, and competencies.

Review of the hospital's P&P titled Sterilization Processes and Practices revised 6/15 showed all items used within a sterile field must be rendered sterile either by use of steam/gravity and prevac sterilization gas plasma sterilization, and chemical sterilization. Articles to be steamed will have an autoclave-sensitive tape used on all wrapped items and a sterilization indicator will be placed on the inside of each item.

Review of a memorandum from ORT 1 dated 8/8/18, showed on 8/5/18, a circulating nurse (RN 10) brought in a laparoscopic tray to OR 6 and unwrapped it next to the sterile surgical field. The memorandum showed ORT 1 stated RN 10 took out "what appeared to be sterile instruments" from the tray and used them intraoperatively for Patient 10.

On 8/21/18 at 1400 hours, an interview with RN 10 was conducted. RN 10 stated on 8/5/18, she circulated an emergency surgical case in OR 6. During the case the surgeon requested a surgical instrument which was kept on the laparoscopic trays. The RN stated she found a laparoscopic tray on a covered cart in the hallway, next to the other sterile instrument carts. RN 10 stated she took the tray into OR 6, placed it on a ring stand, and opened the wrap. The RN stated the room was dark so she did not check the outside sterilization tape for confirmation that the tray had gone through the sterilization process. When asked if the instruments on the unsterilized tray were counted before they were used, RN 10 stated the count was done at the end of the case.

On 8/21/18 at 1410 hours, an interview was conducted with the Director of Perioperative Services. The Director stated RN 10 was a shared employee from a sister hospital. When asked about orientation and training, the Director stated the RN received one day of orientation to the OR and would receive the hospital orientation on 9/2/18, the RN's official date of hire. The Director verified the RN was provided with a preceptor.