HospitalInspections.org

Based on observation, staff interview and review of administrative records, policies and procedures, contracts, infection control and quality assurance documentation it was determined that the hospital failed to have an effective governing body responsible for the conduct of the hospital as evidenced by:

The governing body failed to consider the recommendations of the medical staff prior to appointing members to the medical staff, failed to enforce the medical staff bylaws (Refer to A-0046, A-0048, and A-0053). The governing body failed to ensure that the medical staff adhered to its bylaws (Refer to A-0340, A-0341, A-0353).

The governing body failed to ensure each patient's rights were protected and promoted, including that patients received care in a safe setting, to ensure that patients were provided with the phone number and address for lodging a grievance with the State agency, to ensure the operation of the grievance process, review grievances or delegate grievance responsibilities to a grievance committee, to establish a mechanism for timely referral of patient concerns of quality of care or pre-mature discharge to the Quality Improvement Organizations (QIO's), to have a process in place to notify patients' family and doctor of their admission (Refer to A-0115, A-0118, A-0119, A-0120, and A-0133).

The governing body failed to modify a patient's plan of care after the use of seclusion and/or restraints, to ensure safe implementation of restraints, to ensure that direct patient care staff were able to demonstrate competency in the application of restraints, and to require staff have education and training in recognizing and responding to distress, (Refer to A-0166, A-0194, A-0196, and A-0202).

The governing body failed to ensure that an ongoing, comprehensive quality assessment and performance improvement (QAPI) program was implemented and maintained, reflecting the complexity of the hospital services, focused on improving patient care and health outcome, such as Infection control, involving all departments, including those services furnished under contract or arrangement; the governing body failed to ensure that clear expectations for safety were established when patients were put at risk from the improper use of a glucometer, and unsafe living environment. The governing body failed to establish a QAPI program which reflected the complexity of the hospital's organization and services. (Refer to A-0263, A-0286, A-0308, and A-0309).

The governing body failed to ensure the physical environment was maintained to ensure the safety of the patients and due to the potential for harm an immediate jeopardy was called on 6/20/16 at 3:40 p.m. The IJ was abated on 6/20/16 at 4:45 p.m. (Refer to A-0700, A-0701, and A-0710).

The governing body failed to ensure a comprehensive on going, hospital wide infection control program and plan was developed and implemented to minimize infections and communicable diseases (Refer to A-0747), to ensure adequate infection control oversight (Refer A-0748), to ensure there was an effective, active system wide infection surveillance control program for prevention, control and investigation of infections (Refer to A-0749), and to provide oversight for the infection control program (Refer to A-0756). Additionally the governing body failed to ensure patients were free from risk of infection when a single patient glucometer was used on multiple patients and due to the potential for harm an immediate jeopardy was called on 6/20/16 at 3:40 p.m. The IJ was abated on 6/20/16 at 4:20 p.m. (Refer to A-0747).

The cumulative effect of these systemic problems resulted in the hospital's inability to provide quality patient care in a safe environment.

Based on interview with hospital staff and review of documents the hospital failed to ensure that the governing body appointed members of the medical staff after considering the recommendations of the existing members of the medical staff.

Findings:

Review of the current medical staff bylaws for the hospital revealed appointments to the medical staff were to be made by action of the governing board only after recommendations from the medical staff. In an interview on 6/22/16 starting at 10 a.m., the Medical Director stated there was no documentation that the Medical Practice Committee made recommendations to the governing body for appointments to the medical staff. Review of the meeting minutes of the Medical Practice Committee revealed no documentation of their recommendations. In an interview starting at 2:30 p.m. on 6/23/16 the Compliance Officer stated there was no documentation of governing body making appointments to the medical staff since 2013. The bylaws require reappointments to be made every two years.

Based on interview with hospital staff the hospital failed to ensure that the governing body approved and enforced medical staff bylaws and other medical staff rules and regulations.

Findings:

In an interview on 6/22/16 starting at 10 a.m., the Medical Director stated the credentials committee had not been meeting to review the credentials of all applicants and to make recommendations for membership in the medical staff. The Medical Director stated she continued to review information regarding the competence of medical staff members and make recommendations regarding reappointments without the credentials committee. However there was no documentation available of this activity.

Based on interview with hospital staff, the hospital failed to ensure that the governing body consulted directly with the individual assigned the responsibility for the organization and conduct of the hospital's medical staff, or his or her designee. At a minimum, this direct consultation must occur periodically throughout the fiscal or calendar year and include discussion of matters related to the quality of medical care provided to patients of the hospital.
Findings:
In an interview starting at 11 a.m. on 6/23/16, the hospital's CEO stated although she met regularly with the Medical Director there was no documentation of these meetings available.

Based on observation, interview and record review the hospital was not effective in promoting and protecting the rights of it's patient's when:

1. All the shower and bathroom emergency call systems went without repair rendering them unavailable for months and all showers in the unit (5/5) were noted to have shower heads that were not flush or slanted to tile background, posing as anchor points capable of sustaining the weight of a patient and potential for ligature access that could be used in a hanging attempt (Refer to A-0700).

2. The hospital failed to protect the patient's right to safe implementation of restraints when direct care staff was not trained for application of restraints (Refer to A-0194).

3. The hospital failed to ensure that direct patient care staff was able to demonstrate competency in the application of restraints (Refer to A-0196).

4.The hospital failed to require staff have education and training to recognize and respond to signs of physical or psychological distress, when patients are in restraints or seclusion (Refer to A-0202).

5. The hospital failed to notify patient's that they have a right to file a grievance directly with the State agency, and failed to provide the patient with a phone number or address for lodging a grievance with the State agency (Refer to A-0118).

6. The hospital failed to have the governing body approve and be responsible for the effective operation of the grievance process, review grievances or delegate grievance responsibilities to a grievance committee (Refer to A-0119).

7. The hospital failed to establish a mechanism for timely referral of patient concerns of quality of care or pre-mature discharge to the appropriate Quality Improvement Organizations (QIO's) (Refer to A-0120).

8. The hospital failed to have a process in place to have a patient's wish to notify their family and or doctor of their admission, at the time of admission (Refer to A0133).

9. The hospital failed to modify a patient's plan of care after the use of seclusion and or restraints for 5 of 9 closed sample records (Refer to A-0166).

The cumulative effect of these systemic problems resulted in the hospital's inability to protect and promote patient's rights, and to provide quality patient care in a safe environment.

Based on record and document review and interview the hospital failed to provide patients with the State agency phone number and address for lodging a grievance, in addition the hospital's grievance process policy and procedure explicitly indicated that patients grievances are not allowed to be filed with the State. This failure has the potential for not ensuring that patients are aware of their rights and receive a prompt resolution of grievances.

Findings:


Facility policy and procedure titled, "Beneficiary Problem Resolution Process,"dated 11/21/11, on page 2, number 3. (Document missing numbers 1 and 2) indicated "Beneficiaries must file grievances and appeals directly with the MHP (Mental Health Plan) and are not permitted to file directly with the state."


During an interview with ADM 2 (Administrative Staff) on 6/23/16, at 11 a.m., while concurrently reviewing policy and procedures, ADM 2 was asked if there were any other policies and procedures that were relevant to hospital patient's grievances, ADM 2 indicated that there were none.


During a review of hospital's document titled, "Each Patient, Resident or Client in this facility has the Following Rights," Number 18. Indicated, "To be informed of the provisions of law regarding complaints and of procedures for registering complaints confidentially, including but not limited to the address and telephone number of the Facility Standards Section, Department of Mental Health, having jurisdiction over this facility". There was a signature line for patient's to sign, there was no further information with details of addresses or phone number.


During an interview with ADM 1 on 6/22/16, at 8 a.m., ADM1 was asked if there were any postings on information for patients to access licensed agency (State), Adm1 stated, "I don't know." ADM1 was asked if there were postings where might they be located, ADM1 stated, "In the telephone room." During tour of the telephone room, accompanied by ADM1 a review of the postings revealed none of the postings gave information about or contact information of State agency to file grievances.


During an interview with ADM 1, on 6/23/16, at 11:40 a.m., ADM 1 was asked if there is an address or telephone number given to patients who request the State agency information, ADM 1 stated, "No."


During an interview with Patient 12, on 6/27/16, at 2:45 p.m., Patient 12 was asked if he was aware how to file a complaint or grievance, Patient 12 stated, "You don't understand that won't make a difference here." Patient 12 was asked if he was aware how to file a grievance with the State, Patient 12 stated, "No." Asked if he was ever given any information at the time of admission, Patient 12 stated, "No, can I get that?"

Based on interview and record review the hospital failed to establish an effective operational process for grievances approved by the governing body. This failure created the potential of the governing body not being afforded the oversight and/or ability and responsibility to review, resolve and analyze grievances of patients.
Findings:
Facility policy and procedure titled, "Beneficiary Problem Resolution Process," dated 11/21/11, and facility policy and procedure titled, "Beneficiary Rights" dated 11/22/11, did not indicate any process or mechanism within the grievance process that involved oversight by the governing board or a grievance committee.
During an interview with ADM 2 (Administrative staff) on 6/23/16, at 11 a.m., while concurrently reviewing policy and procedures, ADM 2 was was unable to provide any further policies and procedures relevant to the facility's grievance process for patients.
During an interview with ADM 2, on 6/23/16, at 4 p.m., ADM 2 indicated there is no oversight by the governing board of grievances and there has been no written delegated authority from the governing board for responsibility of the grievance process to a grievance committee.

Based on interview and record review the hospital failed to establish a process of prompt resolution of patient's grievances when there was no mechanism for referring patient concerns regarding quality of care or premature discharge to the appropriate Quality Improvement Organization (QIO), this failure precluded patients from being aware of their right to lodge a complaint and to request a QIO review.

Findings:

Facility policy and procedure titled, "Beneficiary Problem Resolution Process," dated 11/21/11, and facility policy and procedure titled, "Beneficiary Rights" dated 11/22/11, did not indicate any process or mechanism within the grievance process that ensures a patient's concerns regarding quality of care or premature discharge are referred to a QIO.

During an interview with ADM 2 on 6/23/16, at 11 a.m., while concurrently reviewing policy and procedures, ADM 2 was asked if there were any other policies and procedures that were relevant to hospital patient's grievances, ADM 2 indicated that there were none.

During an interview with quality care coordinator (ADM 3), on 6/23/16, at 3 p.m., ADM 3 confirmed there is no process in place for referrals to QIO (Quality Improvement Organization).

Based on document review and interview the hospital failed to ask patients at the time of admission, whether the hospital should notify a family member or representative and the patients physician of their admission to the hospital. This failure has the potential of the patient's right for notification not occurring.

Findings:

On 6/21/16, at 1:33 P.M., during a concurrent interview with MD1 and RN1, they were asked if there was a policy and procedure for family and physician notification of patient's admissions. MD1 stated, "No." RN1 stated, "No we give the patient a telephone code and they (patients) can call on their own."

Based on interview, record review and document review the hospital failed to modify the patients plan of care after the use of restraint and or seclusion for 5 out of 9 closed sample records. This failure has the potential of the treatment plan not reflecting the restraint and or seclusion intervention, assessment and evaluation.

Findings:

During a review of the clinical record for Patient 3, the record indicated Patient 3 was placed in restraints on 12/3/16; there was no evidence that the treatment plan was updated to reflect a change in Patient 3's plan of care.

During a review of the clinical record for Patient 1, the record indicated Patient 1 was placed in restraints on 4/11/16, there was no evidence that the treatment plan was updated to reflect a change in the plan of care for Patient 1.

During a review of the clinical record for Patient 8, the record indicated Patient 8 was placed in seclusion on 2/10/16; there was no evidence that the treatment plan was updated to reflect a change in Patient 8's plan of care.

During a review of the clinical record for Patient 9, the record indicated Patient 9 was placed in seclusion on 9/10/15; there was no evidence that the treatment plan was updated to reflect a change in the patient's plan of care.

During a review of the clinical record for Patient 7, the record indicated Patient 7 was placed in seclusion on 3/13/16; there was no evidence that the treatment plan was updated to reflect a change in the plan of care for Patient 7.

The hospital policy and procedure titled, "Seclusion, Physical and Mechanical restraints", dated 4/7/14, indicated in part on page 5 of 7, Bullet 5. Additional documentation...Post each incident of seclusion or mechanical restraints within 24 hours physician will complete the face to face post seclusion or restraint evaluation with recommendations to the treatment plan for interdisciplinary team review.

During an interview and concurrent treatment plan review with LPT 1, on 6/20/16 at 3:35 p.m., LPT1 acknowledged that the medical records did not have treatment plans updated post restraints/seclusion.

Based on interview and record review the hospital failed to provide training on safe implementation of restraints, this failure has the potential to put patients and others at risk.

Findings:

The facility policy titled, "Seclusion, Physical and Mechanical Restraint," dated 4/7/14, indicated in part, "Part 2, Education and Training, Facility staff shall receive training in and demonstrate competency in the application of restraints and implementation of seclusion, monitoring, assessment, and providing care for a patient in seclusion or restraint... 2. Evidence of training must include the date the training was completed and the name of the trainer and demonstration of competency. 3. Only staff trained in the application of restraints, implementation of seclusion, monitoring, assessment and providing care for a patient in restraint or seclusion and nonphysical de-escalation techniques will be involved."

A sampled closed record review and review of the "Seclusion, restraint and emergency medications log" revealed;

Patient 10 was placed in restraints on 3/18/16, at 9 a.m.

Patient 3 was placed in restraints on 12/3/16, at 8:20 a.m.

Patient 9 was placed in restraints on 9/10/15, at 9:50 a.m.

Patient 11 was placed in restraints on 7/2/15, at 2:15 p.m.

Further record review of employees involved in restraint applications, RN4, RN5, RN6, RN7 and RA2 (Registered Nurse) all indicated that they had received "MABPRO" (management of assaultive behavior) training or "CPI" (crisis prevention intervention) during this time period. A review of the training skills competency forms filled out by the instructor did not include any training or competencies for the applications of restraints.

During an interview with LPT 1 (licensed psychiatric technician), on 6/27/16, at 9:30 a.m., LPT 1 revealed he is the instructor for CPI training and is familiar with the MABRO training. When asked about application of restraints in these trainings, LPT1 stated, "There is no demonstration of physical restraint applications, the training focuses on de-escalation, I am the instructor and we don't do restraint applications." LPT1 was questioned as to whether there was training for employees on the application of restraints for patients, LPT1 stated, "Not formally we just show them if they are on the floor when the restraint of a patient occurs, no competencies involved."

During an interview with MD1, on 6/27/16, at 10:30 a.m., MD1 acknowledged current training does not include demonstrated knowledge of restraint application, MD1 stated, "Our doctors receive the policies not sure about locums (a doctor who stands in temporarily), but I went through the training and I didn't actually get trained on restraint application."

Based on interview and record review the hospital failed to provide registry staff training on the safe implementation of restraints, this failure has the potential to put patients and others at risk.

Findings:

The facility policy titled, "Seclusion, Physical and Mechanical Restraint," dated 4/7/14, indicated in part, "Part 2, Education and Training, Facility staff shall receive training in and demonstrate competency in the application of restraints and implementation of seclusion, monitoring, assessment, and providing care for a patient in seclusion or restraint... 2. Evidence of training must include the date the training was completed and the name of the trainer and demonstration of competency. 3. Only staff trained in the application of restraints, implementation of seclusion, monitoring, assessment and providing care for a patient in restraint or seclusion and nonphysical de-escalation techniques will be involved."

Personnel file review of registry nurse RN 8 (Registered Nurse), indicated RN8 completed unit orientation on 8/4/15, the personnel file did not reveal any training or competencies for the application of restraints.

During an interview with LPT 1 (Licensed Psychiatric Technician), on 6/27/16, at 10:30 a.m., LPT 1 revealed he is the instructor for CPI (Crisis Prevention Intervention) training and is familiar with the MABRO (Management of Assaultive Behavior) training. When asked about application of restraints in these training's, LPT1 stated, "There is no demonstration of physical restraint applications, the training focuses on de-escalation, I am the instructor and we don't do restraint applications." Asked if the employees receive any training outside of CPI on restraint applications, LPT1 stated, "Not formally we just show them if they are on the floor when a restraint of a patient occurs, no competencies involved." LPT1 acknowledged that Registry staff receive the same training after assignment to the unit and are not required to have certification prior to assignment at the hospital.

During an interview with MD1, on 6/27/16, at 10:30 a.m., MD1 acknowledged current training does not include demonstrated knowledge of restraint application, MD1 stated, "Our doctors receive the policies not sure about locums (a doctor who stands in temporarily ), but I went through the training and I didn't actually get trained on restraint application."

Based on interview and record review the hospital failed to provide staff training on safe implementation of restraints, and training in how to recognize and respond to signs of physical and psychological distress this failure has the potential to put patients and others at risk.

Findings:

The facility policy titled, "Seclusion, Physical and Mechanical Restraint," dated 4/7/14, indicated in part, "Part 2, Education and Training, Facility staff shall receive training in and demonstrate competency in the application of restraints and implementation of seclusion, monitoring, assessment, and providing care for a patient in seclusion or restraint... 2. Evidence of training must include the date the training was completed and the name of the trainer and demonstration of competency. 3. Only staff trained in the application of restraints, implementation of seclusion, monitoring, assessment and providing care for a patient in restraint or seclusion and nonphysical de-escalation techniques will be involved."
During an interview with LPT 1 (Licensed Psychiatric Technician), on 6/27/16, at 10:45 a.m., LPT 1 revealed that he is the instructor for the CPI (Crisis Prevention Intervention) training and is familiar with the MABRO (Management of Assaultive Behavior) training. When asked about application of restraints in these trainings, LPT1 stated, "There is no demonstration of physical restraint applications, the training focuses on de-escalation, I am the instructor and we don't do restraint applications." Asked if the employees receive any training outside of CPI on restraint applications, LPT1 stated, "Not formally we just show them if they are on the floor when a restraint of a patient occurs, no competencies involved." When asked if the staff is trained to recognize and respond to signs of physical or psychological distress with patients in restraints, LPT1 stated, No, we don't do any training around restraint evaluation and monitoring."

Based on staff interview and review of administrative records, policies and procedures, contracts, infection control and quality assurance documentation, the hospital failed to develop, implement and maintain an effective, ongoing, data driven, hospital wide quality assessment and performance improvement (QAPI) program, that incorporated infection control issues, and that measured, analyzed and tracked quality indicators, including adverse patient events (Refer to A-0286).

The hospital's QAPI program failed to develop performance improvement activities that accurately reflected the scope and nature of the food and nutrition services and contracted food service (Cross reference A273 and A620) and pharmacy services (Cross Reference A283). The hospital's QAPI program failed to ensure that patients were free from risk of infection when a single patient glucometer was used on multiple patients. Since there was a potential for harm, an immediate jeopardy was called on 6/20/16 at 3 p.m. The IJ was abated on 6/20/16 at 5 p.m. (Refer to A-0747).

The hospital failed to have a QAPI program that included quality indicator data, focusing on high risk, high volume or problem prone areas. The hospital failed to ensure that results, summary's and trends of incident reports were shared with administrative hospital staff, and the facility failed to have a system in place to implement improvement actions, and track performances; the hospital failed to ensure that ongoing performance improvement projects were conducted (Refer to A-0308).

The hospital's QAPI program failed to identify and correct issues in the physical environment in order to ensure the safety of the patients and due to the potential for harm an immediate jeopardy was called on 6/20/16 at 3 p.m. The IJ was abated on 6/20/16 at 5 p.m. (Refer to A-0700, A-0701, and A-0710). The hospital failed to ensure that the QAPI program reflected the hospital's services, involved all departments and focused on indicators to improve health outcome and provide quality patient care and services (Refer to A-0309).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and document review the hospital failed to develop an ongoing hospital wide Quality Assessment and Performance Improvement Program that reflected the scope of the food and nutrition services that measured and analyzed quality indicators. This failure put 16/16 patient at risk of compromised medical and nutrition status.

Findings:

During an interview on 6/27/16 at 3:00 p.m., LPT 1 was requested to provide quality program material relevant to food service and clinical nutrition program. No documents were received.

During an interview on 6/27/16 at 2:30 p.m., Registered Dietitian (RD) stated there was a quality program that was currently in place to monitor the food temperatures when they arrived from the contracted food service and test tray one time per week. RD stated these monitors had been in place and were monitoring temperatures and not developed from identifying quality indicators. RD stated she did not know how to identify or develop quality program for the food service and patient nutrition care.

The hospital failed to collect data which could be used in the development and implementation of a quality assurance program to oversee all of the hospital's Pharmacy services.

Findings:

Review of the hospital's QAPI policy and procedure dated 4/6/11, entitled: "Quality Assurance and Program Improvement (QAPI)". The policy indicated: "The XXX Psychiatric Health Facility will have an effective, on-going, data-driven, hospital-wide quality assessment and performance quality improvement program which includes a hospital specific Quality Assurance Program ...The Committee will develop and maintain the QAPI Work Plan that provides QAPI Committee guidelines for monitoring of the hospital services including but not limited to: ...Review of hospital contracted services (Pharmacy, Dietary), Development and implementation of specific program improvement plans..."B. Data reports will be reviewed at the QAPI Committee a minimum of quarterly. Examples of data reports to be reviewed include, but are not limited to, the following: 1. Medical Errors/Adverse Patient Events...10. Program Improvement Projects... 13. Contracted Services... The QAPI Committee will track and analyze data quarterly with focused review and discussion on...problem-prone areas in order to analyze causes and implement preventative and/or corrective actions. E. The QAPI Committee will develop on-going Program Improvement Plans to address problem areas, identify causes and implement interventions to improve patient care..."

The hospital's QAPI Committee failed to collect data on the hospital's contracted Pharmacy services:

1) The hospital failed to collect data on the contracted Pharmacy's medication deliveries to the hospital. The hospital's Pharmacy contract indicated: "Provide, at no additional charge, scheduled delivery of pharmacy products to the PHF three (3) times daily Monday through Friday and twice (2) daily Saturday and Sunday with times to be determined by and or as mutually agreed by the parties;"

Interview with the hospital's ADM 1 on 6/22/16 at 3:55 pm revealed that the hospital had not created an addendum or changed the agreed number of Pharmacy deliveries. A review was conducted of the number of deliveries by the Pharmacy to the hospital for the month of May 2016. The number of Monday through Friday deliveries from the Pharmacy to the hospital were two (2), with only one (1) delivery on Monday May 30th and only one (1) delivery on Tuesday May 31st. The hospital failed to gather data and study the services provided by the hospital's Pharmacy.

The number of deliveries for Saturday through Sunday were two (2), as outlined in the contract with the following exceptions: Saturday May 1st the hospital only had one delivery from the Pharmacy, Sunday May 8th the hospital only had one delivery from the Pharmacy, Saturday May 14th the hospital only had one (1) delivery from Pharmacy, Saturday May 21 and Sunday May 22 the hospital only had one (1) delivery from the Pharmacy on both days, and on Saturday May 28th and Sunday May 29th the hospital only had one (1) delivery from Pharmacy on both days. A second example of the hospital's Pharmacy failure to deliver medications timely included, the review of a closed record for Patient 4 on 6/23/16 at 3:55 pm. This review revealed the patient s physician had written an order on 5/12/16 at 6:00 pm, for Patient 4 to receive Keppra 250 mg by mouth twice a day. Keppra (Levetiracetam) is used to treat/prevent seizures. Despite the physician's order which was written on 5/12/16 at 6:00 pm for Patient 4 to start receiving this medication, the first dose of this medication did not arrive at the facility until 5/15/16 and was not administered to the patient until 9:00 am on 5/15/16. This patient missed 5 doses of this medication after the patient ' s physician had ordered this medication. Review of Patient 4 s Medication Administration Record (MAR) only indicated that this patient's Keppra was not available. Contrary to the contract between the hospital and the Pharmacy, under exhibit A-3, section Ai, which stated: "...Contractor shall: Provide Pharmacy products and services..." This failure to provide this patient's seizure medication timely could have adversely affected this patient's care.

The hospital's Pharmacy did not deliver this medication to the hospital in accordance with the current contract. The hospital's QAPI Committee's should have collected data which could have been used to analyze the contracted Pharmacy's delivery times.

2) The hospital's Pharmacy contract under Exhibit A-3 section xvi, revealed: "Perform monthly reviews of PHF's medication management policies and procedures including storage of medication, labeling, and protocols for reconciliation and counting of controlled medications, and procedures ...." Inspection of the hospital's Nursing station and the Drug Storage Room on 6/21/16 at 8:30 am revealed that the hospital did not have a copy of the current Pharmacy's policy and procedure manual in the hospital. Interview with the hospital's ADM 1 on 6/21/16 at 8:50 am revealed that even though the current Pharmacy had taken over providing Pharmaceutical Services to the Hospital late in March of 2016 the ADM 1 stated that she had never received a copy of a Pharmacy policy and procedure manual from the Pharmacy provider. As a result of the hospital not having a copy of the Pharmacy policy and procedure manual, there was no way for Pharmacy to perform a monthly review of the hospital's Pharmacy policies and procedures for medication management, storage of medications, labeling, and protocols for reconciliation and counting of controlled medications, and procedures for disposal, as outlined in the hospital's Pharmacy contract. The hospital's Pharmacy contract under Exhibit A-3 section xix, stated: "Maintain and distribute to County a Policy and Procedures manual is maintained in a current, complete, and timely manner reflecting actual practices... Both parties' appropriate personnel shall be trained on the contents and use of the Manual. Revisions shall be reviewed with both parties' appropriate personnel to ensure currency of training." Interview with the hospital ADM 1 on 6/21/16 at 8:50 am revealed that the hospital had never received a current and complete copy of a Pharmacy policy and procedure manual as outlined in the Pharmacy contract. Interview with LPT1 on 6/21/16 at 4:50 pm revealed that the current Pharmacy provider had not provided any training on a Pharmacy policy and procedure manual. Interview with LPT2 on 6/22/16 at 4:10 pm revealed that she had not had any direct contact with the Pharmacy since they had taken over and that she was not aware of any training that had been provided on the Pharmacy's policy and procedure manual. The hospital's QAPI committee failed to review and approve the hospital's proposed Pharmacy policy and procedure manual.

3) The hospital's Pharmacy contract under Exhibit A-3, section A xviii, revealed: "Attend Behavioral Wellness committee meetings as necessary, including but not limited to quarterly Pharmacy and Therapeutics and Infection Control meetings... " Review of the hospital's Infection Control meeting minutes on 6/27/16 at 12:55 pm revealed that the current Pharmacy had not participated in the hospital's last quarterly Infection Control meeting. The hospital's QAPI Committee should have gathered data on the Pharmacy's attendance in the hospital's Infection Control Meetings.

4) The hospital's QAPI Committee did not gather data on the hospital's use of their E-Kits. Inspection of one of the hospital's emergency drug supplies (E-Kits) on 6/21/16 at 2:10 pm revealed that this E-kit had been opened by hospital staff on 6/11/16 at 9:00 am for the drug Wellbutrin XL (an antidepressant) to be administer this medication to a patient. This E-Kit was continually used to administer multiple medications to multiple patients without replacement until 6/21/16 at 2:10 pm, (for more than 10 days without replacement). During a concurrent interview with the hospital's ADM 1, she stated that the hospital's policy was to have these E-Kits exchanged out by Pharmacy on the next scheduled daily Pharmacy delivery to the hospital. The ADM 1 indicated that these E-Kits do not stay in the hospital more than 24 hours after they are first opened. A second E-Kit was found on 6/22/16 at 10:05 am and it had also been opened on 6/15/16 at 8:00 am and not replaced since 6/22/16 at 10:05 am. This E-Kit had been opened for 7 days and continually used for several patients without replacement during the seven day period, contrary to the hospital's policy and procedure.

5) The hospital's QAPI failed to collect data and approve the use of the hospital's E-Kits. Interview with LPT 2 on 6/22/16 at 10:10 am revealed that the hospital's staff understanding was that the purpose for the E-Kits was for the administration of first doses, missing doses, delayed doses, or any other reason that a patient needed a dose of medication. Review of the hospital's "Emergency Medication Box" policy and procedure, dated May 2006 stated: "XXX (PHF) Nursing staff will follow these guidelines regarding the Emergency Medication Box. An Emergency Medication Box will be maintained in the PHF at all times which will contain a supply of emergency drugs. The Emergency Medication Box shall apply only for bonafide emergencies and shall not be used when medication can be obtained from the pharmacy ..." These E-Kits were being used by the hospital contrary to the hospital's established policy and procedure above.

On 6/19/16 at 11:50 pm, one of the hospital's staff had faxed an order over to the hospital's Pharmacy for Ativan (an antianxiety medication) 1 milligram (mg) by mouth every 4 hours as needed for anxiety for Patient 13. On 6/22/16 at 10:15 am, Patient 13 was administered the Ativan 1mg by LPT 2 from the hospital's E-Kit. When the surveyor asked LPT 2 why this medication was taken from the E-Kit, LPT 2 stated that Pharmacy had not sent this medication to the hospital yet. After verifying that the hospital had faxed this order over to the Pharmacy, LPT 2 went and found a fax confirmation in the hospital ' s fax log. LPT 2 called the Pharmacy on 6/22/16 at 10:45 am to confirm that Pharmacy had received this order for Ativan. After the Pharmacist pulled his records, he stated that the Pharmacy had indeed received this medication order from the hospital on 6/20/16 at 12:08 am, but somehow the Pharmacy had missed this order and never reviewed this order until LPT 2's call on 6/22/16 at 10:45 am (3 days later). This Ativan order was never reviewed by a Pharmacist for drug interactions, patient allergies, and general patient safety prior to this medication being administered by LPT 2 to Patient 13 on 6/22/16. This was an example of how the hospital was using the E-Kit to administer first doses, to their patients, contrary to the hospital's policy and procedure which stated that E-Kits were to be used for "bonafide emergencies" only.

6) Interview with the hospital's ADM 1 on 6/21/16 at 2:10 pm revealed that the hospital's Pharmaceutical Service Committee nor the hospital's Pharmacy and Therapeutics Committee had approved the current lists of drugs, which were inside the hospital's current E-Kits. Review of the hospital's "Emergency Medication Box" policy and procedure, dated May 2006 revealed: "The contents of the Emergency Box shall be determined by the pharmaceutical service committee and Therapeutics Committee or a committee consisting of the consulting pharmacist to the PHF and at least one licensed physician, shall sign the list of medications to be contained in the Emergency Box. Signed copies of the list shall be on file in the PHF." None of the items above were provided to the surveyor at the time of the survey. The hospital's QAPI committee failed to ensure that the pharmaceutical service committee approved the E-Kits contents.

7) The hospital's QAPI failed to collect data to ensure that separate records of use were being created for the hospital's E-Kits as outlined by the hospital's policy and procedures. Interview with the hospital's LPT2 on 6/22/16 at 10:05 am revealed that the only record of the medications which had been taken from the E-Kits, were the slips of paper which the hospital staff placed back inside the E-Kits and returned to the hospital's Pharmacy. The hospital maintained no documentation of what had been removed or used in regards to the medications which had been administered from the E-Kits. Review of the hospital's "Emergency Medication Box" policy and procedure, dated May 2006 revealed: "7. Separate records of use shall be maintained for drugs administered from the supply. Such records shall include the name and dose of the drug administered, name of the patient, the date and time of administration and the signature of the person administering the dose."

8) The hospital's QAPI failed to collect data from the Drug Room's controlled drugs. Inspection of the hospital's drug storage room on 6/27/16 at 11:00 am revealed that the hospital had Klonopin (Clonazepam a controlled narcotic) 1 mg, fourteen tablets for Patient 14 inside of a controlled drug drawer. Patient 14 had been discharged from the hospital back in April of 2016, but these drugs were still filed inside this drawer. The Pharmacy's contract under Exhibit A-3, section H ii, revealed: "Dispose, of all medications not used by the PHF, on a monthly basis, ..." These medications were still in the hospital's controlled drug drawer two months after the patient had been discharged from the hospital contrary to the hospital's Pharmacy contract.

Interview with the hospital's ADM 1 and the hospital's Medical Director on 6/23/16 at 3:35 pm revealed that the hospital did not have an approved policy and procedure for the destruction of its controlled drugs. During the interview, ADM 1 indicated that the hospital had been working on a "Draft" policy and procedure, which had not entered into the hospital's approval process at this point. ADM 1 was aware that the facility was in need of a policy and procedure for the destruction/disposition of controlled and non-controlled drugs, but she stated that this procedure was still in the development stages.

Inspection of the hospital's Drug storage room on 6/27/16 at 11:00 am revealed that the following controlled drugs were locked inside the hospital's controlled drug drawer:

Patient 1 had a clear plastic bag of Ativan (Lorazepam, which is a controlled narcotic) 1 mg a total of 28 tablets of this drug. This medication had been sent over to the hospital by the hospital's Pharmacy on 6/3/16. There was no record or log in the hospital or in the drug room that this medication had currently been stored inside the drug room. Had someone taken this plastic bag from the controlled drug drawer, the hospital had no record that this drug had even been stored inside this drawer, so no one would have known that this controlled narcotic had been taken or removed for this drawer.

Patient 14 also had a clear plastic bag of Klonopin (Clonazepam, which is a controlled narcotic) 1mg a total of 14 tablets of this drug. This medication had been sent over to the hospital by the hospital's Pharmacy on 4/16/16. There was no record or log in the hospital or in the drug room that this medication had been stored inside the drug room. Had someone taken this plastic bag from the controlled drug drawer, the hospital had no record that this drug had ever been stored inside this drawer, so no one would have known that this controlled narcotic had been taken or removed from this drawer.

Patient 15 also had a clear plastic bag with Xanax (Alprazolam, a controlled narcotic) 1mg a total of 30 tablets of this drug and Hydrocodone (Vicodin, a controlled narcotic) a total of 4 tablets of this drug. These medications had been sent over to the hospital by the hospital's Pharmacy on 6/3/16. There was no record or log in the hospital or in the drug room that these medications had been stored inside the drug room's controlled drug drawer. Had someone taken this plastic bag from the controlled drug drawer, the hospital had no record to indicate that these controlled narcotics had been taken or removed.

Review of the hospital's policy and procedure on 6/27/16 at 11:30 am, entitled: "Controlled Substances" dated: 5/2/12 revealed: "When a controlled medication is delivered from the pharmacy and signed in by the Med Nurse and Team Leader, a copy of the signed pharmacy delivery sheet will be put in the NARCOTIC Control book and kept with the Controlled Substance Delivery Log." Review of the hospital's NARCOTIC Control book revealed that none of these controlled drugs had been entered into the hospital's NARCOTIC Control book for accounting and control. The hospital's policy and procedure entitled: "Controlled Substance Delivery Log", dated 3/14/12 was reviewed concurrently. This policy read: "...When a controlled medication is delivered from the pharmacy and signed in by the Med Nurse, a copy of the signed delivery sheet will be put in the NARCOTIC Control book, which contains all narcotics-related documents... During each Narcotic count the controlled substance delivery log will be referred to for verification of the number of cassettes on hand. Current sheets (the Narcotic Control Form) will continue to be used to verify amount in each cassette. Once the cassette is empty... The Pharmacy Delivery sheet with the corresponding RX number is to be attached to the completed Narcotic Control Form and filed together in the Completed Narcotic Binder. In addition, a daily check will be made by the Med Nurse verifying the medications listed on the Controlled Substance Delivery Log are in the lock box." Inventory reviewed "Will be indicated on the signature page with the med nurse signature." No part of the hospital's policy and procedure above was followed for the medications above with the exception that these medications had been locked inside of the controlled drug cabinet/drawer inside the drug room.

Review of the hospital's policy and procedure on 6/27/16 at 11:30 am, entitled: "Controlled Substances" dated: 5/2/12 revealed: "At each shift change, a physical inventory of controlled medications, as defined by state regulation, is conducted by two licensed clinicians and is documented on audit record".

Inspection of the hospital's "Controlled Drug Count Sheet", revealed several examples where there was no evidence of who the second person was who performed the count at the end or the beginning of a shift. For example, on 6/16/16 there was no signature on the document as to who the second person was who completed the shift count with the other LPT at 7:00 pm. Review of the audit document for April 2016 revealed that on 4/25/16 at change of shift (7:00 pm) there was no second signature on the hospital's audit record. Again on 4/27/16 and 4/30/16 there was no second signature at 7:00pm, as outlined in the hospital's policy and procedure. For 3/10/16 and 3/20/16, there was no second signature for the controlled drug shift count. On 3/10/16 and 3/13/16 at 7:00 am, there was no documentation of who the second person who performed the shift count for the controlled medications as outlined in the hospital's policy and procedure above. The hospital's QAPI Committee did gather any data on the Drug Room's controlled drug storage.

Based on interview with hospital staff, the hospital's governing body failed to be responsible and accountable for ensuring that clear expectations for safety were established.

Findings:

In an interview on 6/23/16 starting at 11 a.m., the hospital's CEO stated she did not believe any of the hospital's patients were put at risk for developing a blood-borne infection from the hospital's practice of using a single patient glucometer on multiple patients despite warnings from the Centers for Disease Control and Prevention (CDC) about outbreaks of hepatitis resulting from such usage.

Based on interview with hospital staff and review of records, the governing body failed to ensure that the quality assurance and performance improvement (QAPI) program reflected the complexity of the hospital's organization and services and involved all hospital departments and services (including those services furnished under contract or arrangement).

Findings:

Review of the documentation of the hospital's QAPI program revealed it did not reflect all of the hospital's services. The hospital conducted only one study each year rather than studies that focused on high-risk, high-volume, or problem-prone areas. In an interview on 6/23/16 starting at 11 a.m., the hospital's CEO stated there was no need for additional QAPI studies.

Based on interview with hospital staff and review of records, the governing body failed to ensure that an ongoing program for quality improvement and patient safety, including the reduction of medical errors, was defined, implemented, and maintained.

Findings:

Review of the documentation of the hospital's quality assurance and performance improvement (QAPI) program revealed no ongoing program addressing patient safety and reduction of medical errors had been implemented. In an interview on 6/21/16 at 11 a.m. the DON stated there was no documentation available of the QAPI program in the governing body meeting minutes.

Based on interview with hospital staff and review of records the governing body failed to ensure that the medical staff periodically conducted appraisals of its members.

Findings:

Review of the medical staff bylaws revealed the medical staff was to conduct appraisals of its members through the means of the bylaws and the credentials committee. In an interview on 6/22/16 starting at 10 a.m., the Medical Director stated the medical staff bylaws were not being followed regarding appraisals and re-appraisals of its members.

Based on interview with hospital staff and review of records, the governing body failed to ensure that the medical staff examined the credentials of all eligible candidates for medical staff membership and made recommendations to the governing body on the appointment of the candidates in accordance with State law, including scope-of-practice laws, and the medical staff bylaws, rules, and regulations.

Findings:

Review of the medical staff bylaws revealed the members of the medical staff were to examine the credentials of applicants to the medical staff and make recommendations through the means of the credentials committee. In an interview on 6/22/16 starting at 10 a.m. , the Medical Director stated the medical staff bylaws were not being followed regarding recommendations to the governing body.

Based on interview with hospital staff and review of records, the governing body failed to ensure that the medical staff adopted and enforced bylaws to carry out its responsibilities.

Findings:

In an interview on 6/22/16 starting at 10 a.m. the Medical Director stated the medical staff bylaws were not being followed regarding committee meetings. There were no minutes of the credentials committee available and the medical executive committee had not met yet in 2016.

Based on staff interview, record and document review the facility failed to ensure medications were obtained and administered per physician order and the facility policy and procedures for three of 16 patients (Patient 7, Patient 11 and Patient 4), as evidenced by: Failure to follow medication administration policy has the potential of resulting in a negative outcome to patient's health due to the potential for administering incorrect medication's per orders of the physician.

Findings:

The facility policy and procedure titled, "Medication Administration," with no effective date and unsigned, indicated in part, "2. Definitions, 2.2 As needed (PRN)- Medication ordered without specific administration times and given on an as needed basis with parameters per physician's order..." "4. Medication orders, 4.2 Orders for PRN medications must include specific indications for when the medication is to be administered (and must be documented in the nurse's notes in addition to the (Medication Administration Record-MAR)..."

1. A review of the clinical record for Patient 7 indicated a physician's order dated 6/16/16 for two Tylenol (medication to relieve pain) 325 mg (milligram) every four hours as needed for pain. On 6/18/16 an order was written for ibuprofen 400 mg. every six hours as needed for pain. Review of Patient 7's medication administration record (MAR) reflected the patient was administered doses for "pain/left arm pain." On 6/19/16 documentation in the MAR indicated Tylenol 650 mg. was given at 3 a.m. and ibuprofen was given at 3 a.m., both for left arm pain.

Further record review indicated Patient 7's physician orders dated 6/18/16 for Ativan (an antianxiety medication) 2 mg. by mouth every four hours as needed agitation and Haldol 10 mg. (a major antipsychotic medication) by mouth every four hours as needed for severe agitation. Review of the patients MAR indicated on 6/18/16 at 9 p.m. Patient 7 received both the Ativan and Haldol for "¿ (increased) agitation " and on 6/19/16 the patient received both medications for increased agitation at 3 a.m., 7 a.m., and 10 p.m. On 6/20/16 Patient 7 received both Ativan and Haldol for the same indication of agitation at 2 p.m. and again at 6 p.m.

2. A review of the clinical record for Patient 11, indicated that Patient 11's physician prescribed on 5/31/16, at 11:05 A.M., "Tylenol (a pain reliever medication) 650 milligrams (mg) BID PRN pain (twice a day as needed)." On the same date and same time Patient 11's physician prescribed "Ibuprofen (an anti-inflammatory to treat pain) 400 mg PRN pain daily." Review of Patient 11's PRN medication administration record from 6/1/16 through 6/4/16, indicated Patient 11 received multiple doses of both Tylenol and Ibuprofen all for complaints of pain. Further review of Resident 11's clinical record revealed Resident 11 was prescribed by her physician on 6/3/16 Ativan (a drug used to treat anxiety) 0.5 mg every 6 hours PRN anxiety, 6/6/16, Vistaril (an antihistamine medication used to treat among other conditions, anxiety) 25 mg every 4 hours PRN anxiety. On 6/9/16, Patient 11's physician prescribed Ativan 0.5 mg every 6 hours PRN anxiety/agitation. On 6/10/16, Patient 11's physician prescribed Ativan 0.5 mg every 12 hours PRN anxiety." Review of Patient 11's PRN medication administration record from 6/3/16 through 6/14/16, indicated Patient 11 received multiple doses of both Ativan and Vistaril all for "anxiety."During an interview with Adm1 on 6/22/16 at 4p.m. while concurrently reviewing Patient 11 s Vistaril and Ativan order ADM 1 (Administrative Staff) stated, "This order should have been questioned as to a quantifier of anxiety". While reviewing Patient's 11 Tylenol and Ibuprofen medication ordered for pain, ADM 1 stated, "This too should have been questioned because there is no pain level for each medication." Referencing the Tylenol BID order, Adm 1 stated, "This is wrong, the doctor should have declared hours not BID." Adm1 was asked if the nursing staff have been trained on PRN orders, Adm1 stated, "Yes, they have been trained many times." Adm1 acknowledged the nursing staff should have questioned the orders as the orders didn't follow hospital policy.




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3. Review of the closed record for Patient 4 on 6/23/16 at 3:55 pm revealed that the patient's physician ordered on 5/12/16 at 6:00 pm, Keppra 250mg by mouth twice a day for this patient. Keppra (Levetiracetam) is used to treat/prevent seizures in patients. The physician's order which had been written on 5/12/16 at 6:00 pm for Patient 4, the first dose of this medication did not arrive into the hospital until 5/15/16 and the medication was not administered to the patient until 9:00 am. This patient missed 5 doses of this medication after the patient's physician had ordered it on 5/12/16. Review of Patient 4's Medication Administration Record (MAR) indicated that this patient's Keppra was not available. Contrary to the contract between the hospital and the Pharmacy, under exhibit A-3, section Ai, which stated: "...Contractor shall: Provide Pharmacy products and services..."

Inspection of the hospital's drug room, interview with LPT 2 (Licensed Psychiatric Technician), and inspection of patient 12's current medications (1 out of 16 patients), the hospital failed to develop and implement policies and procedures to ensure that medications which were brought into the hospital (by the patient or a family member), were inspected and verified prior to the administration of these medications to the patient. This failure could have resulted in the patient receiving the wrong medications.

Findings:

Inspection of the hospital's drug storage room on 6/27/16 at 9:00 am, revealed one amber drug container with a child-proof lid of Depakote (a seizure medication) ER (extended release) 500 mg along with a white bottle of Abilify (an antipsychotic medication) 15 mg . Patient 12 brought both of these medications into the hospital with him on 5/19/16. Both medications had been filled by an outside Pharmacy on 5/17/16. The Depakote ER 500 mg container had originally been filled with 90 tablets and the container now only had 19 tablets. The Abilify 15 mg bottle had been filled with 30 tablets of this medication, but this bottle now only contained 21 tablets. Both medications had been administered to patient 12, during his stay in the hospital and this was confirmed in a concurrent interview with LPT 2. On 5/19/16 at 3:00 pm, the patient's physician wrote an order for both of these home medications to be taken by the patient while in the hospital. Examination of the bottles and interview with LPT 2 on 6/27/16 at 9:00 am, revealed that the hospital had no system in place to have medications which had been brought into the hospital by a patient or their family, to be checked and verified by an individual (who was qualified to do so within their scope of practice). LPT 2 went on during this interview and stated that this hospital had not developed a system to validate that the medications inside these containers, were indeed the same medications which were labeled on the container and the bottle. Further inspection of the outside of these containers revealed that they had no information on them indicating that these medications had been verified by anyone at the hospital. This practice could have led to medication administration errors by hospital staff.

Based on observation, interview, and document review, the hospital failed to ensure that the pharmaceutical services met the needs of all 16 of 16 patients as evidenced by their failure to:

1) Administer Keppra (a seizure medication) as ordered by the patient's physician. (Refer to A-405)

2) Develop and implement policies and procedures to ensure that medications which were brought in by the patient and/or their families were verified before their administration to the hospital's patients. (Refer to A-413)

3) Monitor the contracted Pharmacy's deliveries, ensure that the facility had an established drug recall system, that the hospital had an approved Pharmacy policy and procedure manual, that the hospital maintained a current copy of any Pharmacy policy and procedure manual on designated work stations, as well as ensure that the contracted Pharmacy participated in the hospital's Infection Control Committee meetings. (Refer to A-491)

4) Develop a policy and procedure for the destruction of controlled drugs. The hospital failed to develop and implement a system for accounting for controlled narcotic drugs, and follow the hospital's policies and procedures. (Refer to A-494)

5) Stock only emergency medications which did not require specialized training along with specialized equipment for patient administration of these medication, ensure that emergency supplies were approved, restocked, supplied, and used in accordance with the hospital's policy and procedures, ensure that records of drugs used from emergency supplies were maintained, as well as ensure that medications were ordered with patient safety precautions as a part of the order. (Refer to A-500)

6) Ensure that only authorized personnel have access to the hospital's drug room. (Refer to A-504)

7) Ensure that outdated and unusable drugs were not available for patient administration. (Refer to A-505)

8) Ensure that medication error data is collected and analyzed to improve patient care. (Refer to A-508)

9) Develop a drug formulary with criteria for the indication for use, effectiveness, risks of each drug, along with the costs of each drug. (Refer to A-511)

The cumulative effect of these systemic problems resulted in the inability of the hospital's pharmaceutical services to direct staff in such a manner to meet the pharmaceutical needs of the hospital's patients in accordance with the hospital's policies and procedures, drug references and acceptable standards of practice.

Review of the Pharmacy contract/agreement between the hospital and their contracted Pharmacy revealed that the contracted Pharmacy had not provided the hospital with all of the agreed services which had been identified in Pharmacy's contract. Potentially exposing the hospital's patients to missing medications and delayed treatments.

Findings:

Review of the hospital's agreement/contract with the current contracted Pharmacy provider, which began in late March of 2016 for the Fiscal Year (FY) from 2015 to 2018 revealed the following: "The Contractor shall":

1) "Provide, at no additional charge, scheduled delivery of pharmacy products to the PHF three (3) times daily Monday through Friday and twice (2) daily Saturday and Sunday with times to be determined by and or as mutually agreed by the parties;"

Interview with the hospital's ADM 1 (administrative staff) on 6/22/16 at 3:55 pm revealed that the hospital had not created an addendum or changed the agreed number of Pharmacy deliveries. A review was conducted of the number of deliveries by the Pharmacy to the hospital for the month of May 2016. The number of Monday through Friday deliveries from the Pharmacy to the hospital were two (2), with only one (1) delivery on Monday May 30th and only one (1) delivery on Tuesday May 31st.

The number of deliveries for Saturday through Sunday were two (2), as outlined in the contract with the following exceptions: Saturday May 1st the facility only had one delivery from the Pharmacy, Sunday May 8th the hospital only had one delivery from the Pharmacy, Saturday May 14th the hospital only had one (1) delivery from Pharmacy, Saturday May 21 and Sunday May 22 the hospital only had one (1) delivery from the Pharmacy on both days, and on Saturday May 28th and Sunday May 29th the hospital only had one (1) delivery from Pharmacy on both days. The hospital ' s Pharmacy was not delivering medications to the hospital as agreed in accordance with the current contract.

2) The hospital's Pharmacy contract under Exhibit A-3, revealed: "provide daily medication recalls via email", yet during an interview with the hospital's ADM 1 and Medical Director on 6/23/16 at 2:00 pm the hospital stated that it had no current system for handling drug recalls. The hospital did not have any records showing that the hospital had been receiving daily recall emails from the pharmacy.

3) The hospital's Pharmacy contract under Exhibit A-3 section xvi, reveale3d: "Perform monthly reviews of PHF's medication management policies and procedures including storage of medication, labeling, and protocols for reconciliation and counting of controlled medications, and procedures..." Inspection of the hospital's Nursing station and the Drug Storage Room on 6/21/16 at 8:30 am revealed that the hospital did not have a current copy of the Pharmacy' s policy and procedure manual in the hospital. Interview with the hospital's ADM 1 on 6/21/16 at 8:50 am revealed that even though the current Pharmacy had taken over providing Pharmaceutical Services to the Hospital late in March of 2016, the ADM 1 stated that she had never received a copy of a Pharmacy policy and procedure manual from the Pharmacy provider. As a result of the hospital not having a copy of the Pharmacy policy and procedure manual, there was no way for Pharmacy to perform a monthly review of the hospital's Pharmacy policies and procedures for medication management, storage of medications, labeling, and protocols for reconciliation and counting of controlled medications, and procedures for disposal, as outlined in the hospital's Pharmacy contract. The hospital's Pharmacy contract under Exhibit A-3 section xix, states: "Maintain and distribute to County a Policy and Procedures manual is maintained in a current, complete, and timely manner reflecting actual practices...Both parties' appropriate personnel shall be trained on the contents and use of the Manual. Revisions shall be reviewed with both parties' appropriate personnel to ensure currency of training." Interview with the hospital's Nursing Supervisor on 6/21/16 at 8:50 am revealed that the hospital had never received a current and complete copy of the Pharmacy policy and procedure manual as outlined in the Pharmacy contract. Interview with LPT 1 on 6/21/16 at 4:50 pm revealed that the current Pharmacy provider had not provided any training on a Pharmacy policy and procedure manual. Interview with LPT 2 on 6/22/16 at 4:10 pm revealed that she had not had any direct contact with the Pharmacy since they had taken over and that she was not aware of any training that had been provided on the Pharmacy's policy and procedure manual.

4) The hospital's Pharmacy contract under Exhibit A-3, section C i, revealed: "PHF shall: Implement Contractor's (Pharmacy's) policies and procedures;" Again the hospital was unable to implement the Pharmacy's policy and procedure manual as it did not have a current and complete copy of the Pharmacy's policy and procedure manual. A Pharmacy policy and procedure manual had not been approved by the hospital's Pharmacy and Therapeutics (P&T) Committee, Medical Executive Committee, or the hospital's Governing Body, based on an interview conducted on 6/21/16 at 8:50 am with ADM 1 (administrative staff). Inspection of the hospital's Nursing Station and the hospital's Drug Room on 6/21/16 at 8:30 am revealed that a copy of the Pharmacy's policy and procedure manual was not present that morning.

5) The hospital's Pharmacy contract under Exhibit A-3, section A xviii, revealed: "Attend Behavioral Wellness committee meetings as necessary, including but not limited to quarterly Pharmacy and Therapeutics and Infection Control meetings..." Review of the hospital's Infection Control meeting minutes on 6/27/16 at 12:55 pm revealed that the current Pharmacy had not participated in the hospital's last quarterly Infection Control meeting.

Inspection of the hospital's drug room, interview with LPT 2 (Licensed Psychiatric technician) and interview with ADM 1 (Administrative Staff) along with the Medical Director revealed that the hospital had no policy and procedure for the disposal/destruction of controlled drugs (a drug which has abuse and dependence potential) and the hospital had controlled drugs from April 2016, which were still waiting for destruction. The hospital had no documentation that controlled medications were waiting for destruction for 3 of 16 sampled patients (patients 1,14, and 15). The hospital's Pharmacy contract also states that the Pharmacy will dispose of all medications not used by the hospital on a monthly basis. The hospital also failed to ensure that controlled drug counts (which were to be performed by the staff every shift), were documented on the hospital's controlled drug count sheet as outlined in the hospital's policy and procedures. These failures could resulted in the facility having drug abuse concerns with their controlled drug accountability.

Findings:

During observation and inspection of the hospital's drug storage room on 6/27/16 at 11:00 am revealed that the hospital had Klonopin (Clonazepam a controlled narcotic) 1 mg, fourteen tablets for Patient 14 inside of a controlled drug drawer. Patient 14 had been discharged from the hospital in April of 2016, and these controlled drugs remained inside the hospital's drug storage room for two months after this patient had been discharged. The Pharmacy's contract under Exhibit A-3, section H ii, revealed: "Dispose, of all medications not used by the Psychiatric Hospital (PHF), on a monthly basis,....".

Interview with the hospital's ADM 1 (administrative staff) and the hospital's Medical Director on 6/23/16 at 3:35 pm revealed that the hospital did not have an approved policy and procedure for the destruction of its controlled drugs. During the interview, ADM 1 indicated that the hospital had been working on a "Draft" policy and procedure, which had not entered into the hospital's approval process at this point. ADM 1 was aware that the facility was in need of a policy and procedure for the destruction/disposition of controlled and non-controlled drugs, but she stated that this procedure was still in the development stages.

Inspection of the hospital's Drug storage room on 6/27/16 at 11:00 am revealed that the following controlled drugs were locked inside the hospital's controlled drug drawer:

Patient 1 had a clear plastic bag of Ativan (Lorazepam, which is a controlled narcotic) 1 mg a total of 28 tablets of this drug. This medication had been sent over to the hospital by the hospital's Pharmacy on 6/3/16. There was no record or log in the hospital or in the drug room that this medication had currently been stored inside the drug room. The hospital had no supporting documentation to account for these controlled drugs in the event that someone had taken this plastic bag from the pharmacy's controlled drug drawer.No one would have known that this controlled narcotic had been missing from this drawer.

Patient 14 also had a clear plastic bag of Klonopin (Clonazepam, which is a controlled narcotic) 1mg a total of 14 tablets of this drug. This medication had been sent over to the hospital by the hospital's Pharmacy on 4/16/16. There was no record or log in the hospital or in the drug room that this medication had been stored inside the drug room. Had someone taken this plastic bag from the controlled drug drawer, the hospital had no record that this drug had ever been stored inside this drawer, so no one would have known that this controlled narcotic had been taken from this drawer.

Patient 15 also had a clear plastic bag with Xanax (Alprazolam, a controlled narcotic) 1mg a total of 30 tablets of this drug and Hydrocodone (Vicodin, a controlled narcotic) a total of 4 tablets of this drug. These medications had been sent over to the hospital by the hospital's Pharmacy on 6/3/16. There was no record or log in the hospital or in the drug room that these medications had been stored inside the drug room's controlled drug drawer. Had someone taken this plastic bag from the controlled drug drawer, the hospital had no record to indicate that these controlled narcotics had been taken or removed.

Review of the hospital's policy and procedure on 6/27/16 at 11:30 am, entitled: "Controlled Substances" dated: 5/2/12 states: "When a controlled medication is delivered from the pharmacy and signed in by the Med Nurse and Team Leader, a copy of the signed pharmacy delivery sheet will be put in the NARCOTIC Control book and kept with the Controlled Substance Delivery Log." Review of the hospital's NARCOTIC Control book revealed that none of these controlled drugs had been entered into the hospital's NARCOTIC Control book for accounting and control. The hospital's policy and procedure entitled: "Controlled Substance Delivery Log", dated 3/14/12 was reviewed concurrently. This policy read: "...When a controlled medication is delivered from the pharmacy and signed in by the Med Nurse, a copy of the signed delivery sheet will be put in the NARCOTIC Control book, which contains all narcotics-related documents...During each Narcotic count the controlled substance delivery log will be referred to for verification of the number of cassettes on hand. Current sheets (the Narcotic Control Form) will continue to be used to verify amount in each cassette. Once the cassette is empty...The Pharmacy Delivery sheet with the corresponding RX number is to be attached to the completed Narcotic Control Form and filed together in the Completed Narcotic Binder. In addition, a daily check will be made by the Med Nurse verifying the medications listed on the Controlled Substance Delivery Log are in the lock box. "Inventory reviewed" will be indicated on the signature page with the med nurse signature." No part of the hospital's policy and procedure above was followed for the medications above with the exception that these medications had been locked inside of the controlled drug cabinet/drawer inside the drug room.

Review of the hospital's policy and procedure on 6/27/16 at 11:30 am, entitled: "Controlled Substances" dated: 5/2/12 revealed: "At each shift change, a physical inventory of controlled medications, as defined by state regulation, is conducted by two licensed clinicians and is documented on audit record".

Inspection of the hospital's "Controlled Drug Count Sheet", revealed several examples where there was no evidence of who the second person was who performed the count at the end or the beginning of a shift. For example, on 6/16/16 there was no signature on the document as to who the second person was who completed the shift count with the other LPT at 7:00 pm. Review of the audit document for April 2016 revealed that on 4/25/16 at change of shift (7:00 pm) there was no second signature on the hospital's audit record. Again on 4/27/16 and 4/30/16 there was no second signature at 7:00pm, as outlined in the hospital's policy and procedure. For 3/10/16 and 3/20/16, there was no second signature for the controlled drug shift count. On 3/10/16 and 3/13/16 at 7:00 am, there was no documentation of who the second person who performed the shift count for the controlled medications as outlined in the hospital's policy and procedure above.

Observation and inspection of the hospital's emergency drug supply revealed that the hospital failed to:

1) Ensure that the E-Kit (Emergency Drug Kit) did not contain medications which would require additional training and require monitoring with an Electro Cardiograph (ECG) a machine which records the electrical pulse of the heart.

2) Ensure that emergency medications kits, which had been opened were been sent back to the Pharmacy for replacement in accordance with the hospital's policy and procedures.

3) Ensure that all medications from these E-kits had been administered, as outlined by the hospital's policy and procedure.

4) Ensure that the E-kit contents had been approved in the Pharmaceutical Service Committee minutes and the Pharmacy and Therapeutics Committee minutes.

5) To maintain separate records of use for the drugs which were being used from the hospital's E-kits.

6) Ensure that the number of emergency drugs stored inside their E-Kit matched the hospital's E-Kit policy and procedure.

7) To implement and follow their policies and procedures.

8) Ensure that all physician orders contained standardized patient safety elements for all patients who could receive insulin sliding scale orders. These failures by the hospital could have resulted in death or injury for 16 out of 16 patients.

Findings:

1) Inspection of the hospital's emergency drug supplies (E-Kits) on 6/21/16 at 2:00 pm revealed that these E-Kits contained drugs like: Sodium Bicarbonate 8.4 % Auto Injector (to balance the acid in a patient during an emergency situation), Lidocaine 2% Auto Injector (used to reverse a patient's irregular heart rhythm) , and Epinephrine 1 mg/ml (also used to modify a patient's heart rhythm). The administration of these medications by injections require both specialized training (such as Advanced Cardiovascular Life Support (ACLS)), as well as the equipment to monitor the heart's electrical activity, such as an electrocardiogram (EKG or ECG). An electrocardiogram (EKG or ECG) is a test which checks for problems with the electrical activity of your heart. An EKG shows the heart's electrical activity as line tracings on paper. The spikes and dips in the tracings are called waves. During the course of the survey, various Licensed Psychiatric Technicians (LPT), Registered Nurses (RNs), and Physicians were interviewed and none of them had received any specialized training or possessed ACLS training certificates, which might have allowed them to administer these drugs as long as they had the right equipment. Based on interview with ADM1 (administrative staff) on 6/21/16 at 2:00 pm, the hospital does not own or have access to an ECG or an EKG machine. By definition, Basic Life Support (BLS) relies on Cardio Pulmonary Resuscitation (CPR) an emergency procedure which is done when someone's heart or breathing stops and Automated External Defibrillator (AED's) a portable device which diagnoses and manages irregular heart rates whereas ACLS utilizes other medical equipment for a higher level of emergency care. Intravenous medications like the ones list above in the hospital's E-Kit, ECGs and intubation (inserting a tube into a person's trachea), along with more invasive methods are only used by ACLS trained individuals.

Further interview the hospital's staff revealed that the hospital had failed to develop a policy and procedure to guide staff as to what to do if a medical emergency occurs.

During an interview with LPT 3 on 6/21/16, he was asked what he would do if a patient was having a cardiac emergency. LPT3 indicated that he would contact his "lead" and follow whatever direction the lead would provide. LPT3 was also asked during the interview, if the "lead" asked him to go to the hospital's emergency drug supply (E-Kit) and administer a medication from the E-Kit, would he? LPT3 replied: "yes, I would administer a medication out of the E-Kit if my lead directed me to do this".

2) Inspection of one of the hospital's emergency drug supplies (E-Kits) on 6/21/16 at 2:10 pm revealed that this E-kit had been opened by hospital staff on 6/11/16 at 9:00 am for the drug Wellbutrin XL (an antidepressant), for the administration of this medication to a patient. This E-Kit was continually used to administer multiple medications to multiple patients without replacement until 6/21/16 at 2:10 pm, (for a period of more than 10 days). During a concurrent interview with the hospital's ADM1 1, she stated that the hospital's policy was to have these E-Kits exchanged out by hospital's Pharmacy on their next schedule Pharmacy delivery. The ADM1 1 indicated that these E-Kits do not stay in the hospital more than 24 hours after they are first opened. A second E-Kit was found on 6/22/16 at 10:05 am and it had also been opened on 6/15/16 at 8:00 am and not replaced since 6/22/16 at 10:05 am. This E-Kit had been opened for 7 days and continually used for several patients without replacement during this period, which was contrary to the hospital's policy and procedure.

3) Interview with LPT 2 on 6/22/16 at 10:10 am revealed that the hospital's understanding was that the purpose for the E-Kits was for the administration of first doses, missing doses, delayed doses, or any other reason that a patient needed a dose of medication. Review of the hospital's "Emergency Medication Box" policy and procedure, dated May 2006 revealed: "XXX (PHF) Nursing staff will follow these guidelines regarding the Emergency Medication Box. An Emergency Medication Box will be maintained in the PHF at all times which will contain a supply of emergency drugs. The Emergency Medication Box shall apply only for bonafide emergencies and shall not be used when medication can be obtained from the pharmacy..." These E-Kits were being used by the hospital staff for patient administration contrary to the hospital's established policy and procedure above.

On 6/19/16 at 11:50 pm, a hospital's staff member had faxed a physician order over to the hospital's Pharmacy for Ativan (an antianxiety medication) 1 milligram (mg) by mouth every 4 hours as needed for anxiety for Patient 13. On 6/22/16 at 10:15 am, Patient 13 was administered the Ativan 1 mg by LPT 2 from the hospital's E-Kit. When the surveyor asked LPT 2 why this medication was taken from the E-Kit, LPT 2 stated that Pharmacy had not sent this medication to the hospital yet. After verifying that the hospital had faxed this order over to the Pharmacy, LPT 2 went and found a fax confirmation in the hospital's fax log. LPT 2 called the Pharmacy on 6/22/16 at 10:45 am to confirm that Pharmacy had received this order for Ativan. After the Pharmacist pulled his records, he stated that the Pharmacy had indeed received this medication order from the hospital on 6/20/16 at 12:08 am, but somehow the Pharmacy had missed this order and never reviewed this order until LPT 2's call on 6/22/16 at 10:45 am (3 days later). This Ativan order was never reviewed by a Pharmacist for drug interactions, patient allergies, and general patient safety prior to this medication being administered by LPT 2 to Patient 13 on 6/22/16. The hospital was using the E-Kit to administer first doses, to their patients, contrary to the hospital's policy and procedure which stated that E-Kits were to be used for "Bonafide emergencies" only.

4) Interview with the hospital's ADM1 1 on 6/21/16 at 2:10 pm revealed that the hospital's Pharmaceutical Service Committee nor the hospital's Pharmacy and Therapeutics Committee had approved the current drugs, which were inside the hospital's current E-Kits. Review of the hospital's "Emergency Medication Box" policy and procedure, dated May 2006 revealed: "...The contents of the Emergency Box shall be determined by the pharmaceutical service committee. The Pharmacy and Therapeutics Committee or a committee consisting of the consulting pharmacist to the PHF and at least one licensed physician, shall sign the list of medications to be contained in the Emergency Box. Signed copies of the list shall be on file in the PHF." None of these items could be provided to the surveyor at the time of the survey.

5) Interview with the hospital's LPT 2 on 6/22/16 at 10:05 am revealed that the only record of the medications which had been taken from the E-Kits, were the slips of paper which the hospital staff placed back inside the E-Kits and returned to the hospital's Pharmacy. The hospital maintained no documentation of what had been removed or used in regards to the medications which had been administered from the E-Kits. Review of the hospital's "Emergency Medication Box" policy and procedure, dated May 2006 revealed: "7. Separate records of use shall be maintained for drugs administered from the supply. Such records shall include the name and dose of the drug administered, name of the patient, the date and time of administration and the signature of the person administering the dose."

6) Review of the hospital's "Emergency Medication Box" policy and procedure on 6/22/16 at 10:00 am, the policy was dated May 2006, revealed: "..Oral medications may be included with a maximum of 3 doses". Inspection of the hospital's "General E-Kit" on 6/22/16 at 10:10 am revealed that the hospital's E-Kit contained multiple oral medications which were more than three doses as outlined in the hospital's policy and procedure above. The following are examples of some of these medications which exceeded 3 oral doses. They include, but are not limited to: Wellbutrin (also known as Bupropion, which is used for depression) 150 mg extended release (XL), quantity 12 tablets (for a total of 1,800 mgs); Topirimate (also known as Topamax, used as a seizure medication) 100 mg tablets, quantity 18 tablets; and Citalopram (also known as Celexa, antidepressant medication) 10 mg, quantity 12 tablets.

Review of the most current package insert dated 1/05 from GlaxoSmithKline, the manufacturer of Wellbutrin XL states: "As with other antidepressants the full antidepressant effect of WELLBUTRIN XL Tablets may not be evident until 4 weeks of treatment or longer. An increase in dosage to the maximum of 450 mg/day..." The hospital' s E-Kit contained 1,800 mg of WELLBUTRIN XL tablets, which was equivalent to four (4) doses of the maximum dose of this medication, clearly exceeding the 3 dose maximum in the hospital's policy and procedure above.

Review of the most current package insert dated 2009 from Janssen Pharmaceuticals, the manufacturer of Topamax states: "...Approximately 58% of patients randomized to 400 mg/day achieved this maximal dose..." The hospital's E-Kit contained 1,800 mg of Topamax tablets, which was equivalent to four and 1/2 (4.5) doses of the maximum dose of this medication, clearly exceeding the 3 dose maximum in the facility's policy and procedure above.

Review of the most current package insert dated 7/14 from Forest Pharmaceuticals, the manufacturer of Celexa states: "Doses above 40 mg/day are not recommended due to risk of QT prolongation (a marker for abnormal heart rhythms) ..." The hospital's E-Kit contained 1,200 mg of Celexa tablets, which was equivalent to 30 doses of the maximum dose of this medication, clearly exceeding the 3 dose maximum outlined in the hospital's policy and procedure above.

7)Review of the hospital's standardized insulin sliding scale order for Lispro on 6/27/16 read as follows: "Sliding Scale Insulin Lispro AC, *if Blood Sugar is less than or equal to 70, give a cup of orange juice* ...greater than 400 equals 12 units Lispro subcutaneous and notify MD".

During an interview on 6/27/16 at 12:40 pm with MD 2 the surveyor asked if MD 2 had any concerns with the insulin order above. The physician was also asked if there was a patient had a blood sugar of 60 milligram per deciliter (mg/dl) or less, would he want nursing to notify the him? MD 2 indicated that he would want to be notified by nursing when the patient's blood sugar fell below 60 mg/dl. The order above did not guide hospital staff to contact the physician when the patient's blood sugar fell below 60 mg/dl. The American Diabetic Association stated: "Hypoglycemia is a condition characterized by abnormally low blood glucose, usually less than 70 mg/dl."

Based on observation and interview, the hospital failed to ensure that unauthorized personnel did not have access to the hospital's drug storage area. This could have resulted in missing drugs from the hospital's Drug Room.

On 6/20/16 at 4:55 pm one of the surveyors was walking down one of hallways where the hospital's drug storage room was. The surveyor observed the hospital's Janitor 2 inside the drug storage room alone emptying the drug storage room's trash cans. When the surveyor saw this, he approached the Janitor 2 and asked if there was anyone else inside the room with him. Janitor 2 indicated that no one else was in the room with him and that someone had just let him inside the room and that they (the other person) had left the drug storage room just one minute ago.

Review of the hospital's policy and procedure on 6/21/16 at 8:30 am entitled: "Labeling and Storage of Medications", dated 5/06 revealed: "Drugs shall be accessible only to personnel designated in writing by the facility." Inside the hospital Drug storage room was a hospital memo on County Letterhead, (signed by the hospital's ADM 1) dated 4/14/16 entitled: "Authorized Access to Medication Room". The memo revealed: "In accordance with PHF regulation 77079.3, ONLY the following persons may have access to the PHF medication room ..." The list contains 29 names with titles, and it did not include Janitor 2.

Based on inspection of the hospital's drug storage areas and interviews with hospital staff the hospital failed to ensure that expired medications were not available for patient administration.

Findings:

Inspection of the hospital's storage shed on the hospital's patio area on 6/20/16 at 10:00 am contained several First Aid kits which would be used on the hospital patients in the event of a disaster according to the Lead Psychiatric Technician (LPT1) on tour with the team. The first supply inside white bin contained a First Aid supply kit inside with 8 packets of Bacitracin Zinc Neomycin Sulfate (an antibiotic, used to reduce infection) 1/32oz. in size with an expiration date of 11/98. Further inspection of the white bin revealed a second First Aid supply kit with an additional 8 packets of Bacitracin Zinc Neomycin Sulfate 1/32 (ounce) oz. in size with an expiration date of 11/98. Deeper in the same white bin was a third metal First Aid supply kit which contained 10 packets of Neosporin (an antibiotic to reduce infection)1/32 oz. in size, all with an expiration date of 02/06. Inside the same metal First Aid kit was 20 packets of Triple Antibiotic Ointment (an antibiotic used to reduce infection) 1/32 oz. in size, all with an expiration date of 01/01.

Inspection of the hospital's Treatment Room area on 6/20/16 at 11:30 am revealed one open bottle of Sodium Chloride (salt water) for irrigation with a date of 10/15 written on the outside of this bottle in black marker. Interview with the hospital's Lead Psychiatric Technician (LPT 1) and RN 2 revealed that they were both uncertain of the date of which this bottle had been opened. Review of the manufacturer's label read: "Discard unused portion", indicating that the bottles could only be used one time and that this product should not be kept for later use. The Treatment Room also contained one 16 oz. bottle of Isopropyl Alcohol (a disinfectant)70% which had an expiration date of 10/15.

Interview with the hospital's ADM 1 along with the hospital's Medical Director revealed that the hospital had failed to develop a policy and procedure on medication error reporting and the hospital's Pharmacy and Therapeutics (P&T) Committee along with the hospital's Quality Assurance Performance Improvement (QAPI) Committee had not done anything when medication errors had been reported. Any medication error could have resulted in a patient injury.

Findings:

Interview with the ADM 1 and the hospital's Medical Director on 6/23/16 at 2:30 pm revealed that the hospital had one medication error since August 2015. The medication error revolved around the Pharmacy provider sending the wrong dose of Phenobarbital (used to treat seizures) for one patient and the patient received several doses of the incorrect dose of the medication before the medication error was identified. No recommendations were made by the hospital's P&T or the hospital's QAPI Committees in regards to how this type of error could have been caught before it reached the patient and how the hospital could minimize the number of these types of errors in the future.

This hospital services up to 16 patients per a day, yet from August 2015 to June 2016 only one other medication error (which was really not a true medication error) was reported during this 10 month period. During the interview with ADM 1, indicated that she realized that it was nearly impossible for a hospital with an average census of 16, to not have any medication errors during this 10 month period. The hospital's ADM 1 and the Medical Director both indicated that the hospital has been having a difficult time getting hospital staff to report medication errors. The ADM 1 and the Medical Director during the interview indicated that they understood how important it was for the hospital staff to report medication errors and that they both understood the need for both P&T and QAPI to review these types of errors, in order to help make changes within the hospital's systems and the need to modify policies and procedures to ensure patient safety.

Interview with the hospital's ADM 1 and the Medical Director on 6/23/16 at 3:10 pm revealed that the current hospital's Pharmacy provider was not a part of the hospital's QAPI Committee and this provider had not attended any of the hospital's QAPI Committee meetings. The copy of the QAPI Committee membership list contained a Dietician and the Medical Records Administrator, but the Pharmacist had not been a part of this membership list.

Based on interview with the hospital's ADM1 1 along with the Medical Director, the hospital failed to establish a formulary system. This failure could have resulted patient injury.

Findings:

Interview with the hospital's ADM1 1 and the hospital's Medical Director on 6/23/16 at 11:35 am revealed that the hospital had no established formulary for its Psychiatric Health Facility (PHF). During the interview, the Medical Director indicated that because of the long acting psychotherapeutic drugs needed, the hospital was able to order any medication that they needed. The medical staff in consultation with the hospital's Pharmacy services had not developed written criteria for determining what medications were available for dispensing or administration. The hospital had no process or mechanism established to monitor patient responses to newly added medications before the medication was made available for dispensing or administering within the hospital. The hospital was unable to provide a drug formulary with criteria for the indication for use, effectiveness, risks of each drug, and the costs of each drug.

Based on observation, interview, and document review the acute psychiatric hospital failed to ensure dietary services had met the needs of 16/16 patients as evidenced by:

1. Develop comprehensive organizational structure to ensure the nutritional needs of patients were met including: Accuracy of serving the menu for regular and therapeutic diets, maintaining sanitary conditions in the food service and securing ice from an approved source, disaster menu that provided detailed plan for food and adequate nutrition. (Cross Reference A-620)

2. Ensure qualified dietitian supervised the nutritional aspects of patient care and performed and documented nutritional assessment and follow-ups that addressed all patient nutrition risks in a timely and planned manner. (Cross Reference A-621)

3. Ensure policies for patient meal substitutions address adequate variety to accommodate food intolerance's like milk or lactose intolerance's. Ensure policies address patient food requests are individualized for additional food at meals. (Cross Reference A-629)

4. Provide therapeutic diets as ordered by the practitioner responsible for the care of the patient. (Cross Reference A -630)

5. Ensure Diet Manual included references for all diets ordered. (Cross Reference A-631)

6. Develop performance improvement activities that accurately reflected the scope and nature of the food and nutrition services and contracted food services. (Cross Reference, A-263)

The cumulative effect of these systemic problems resulted in the inability of the hospitals' food and nutrition services to direct and staff in such a manner to ensure that the nutritional needs of the patients' were met in accordance with practitioners' orders and acceptable standards of practice.

Based on observation, interview, and document review the hospital failed to ensure the full time person responsible for the food service ensured:

1. Safe food handling practices,
2. Planned menu was served as written for regular and therapeutic diets,
3. Detailed emergency food plan met needs of patients,
4. Quality program addressed scope of the department for food service and nutrition care.

These failures put 16/16 patients at risk of food borne illness, compromised medical, and nutrition status.
Findings:

1. During an observation and interview with RA 1 (Recovery Assistant) on 6/27/16, starting at 8:30 a.m., the following unsafe food practices were identified:
a. One quart container of Soy milk was open and not dated. RA1 stated he forgot to date the container when opened.
b. One large plastic food storage container and soiled cereal bowl was in the handwashing sink and a bottle of dish soap was on the adjacent counter. The handwashing sink consisted of two sides but would be considered one handwashing area because of cross contamination considerations. There is no way to separate the sinks effectively so they are in total considered one unit designate for handwashing only. There was no food preparation or equipment washing sink in the food service area. The food serving area contained approximately 20 large (approximately 15 inch wide by 20 inch long and 14 inched deep) plastic containers holding individual food packaged items. RA1 stated concurrently that food containers that were not sent back to the contract food service were washed out in the handwashing sink. Since the food service area did not contain ware washing equipment, all service items including the large plastic storage bins would be expected to be washed by the contractor at separate location.
Review of the policy ND1.6 titled Infection control in the Kitchen, dated 3/12/12, stated "make sure all used food service items are placed in the dirty dishes bin to return to the contractor for washing and sanitizing."
In addition, the policy did not address sending plastic food storage bins to contractor for washing and sanitizing.
Food and Drug Administration (FDA) Food Code 2013 states Food employees shall clean their hands in a handwashing sink and may not clean their hands in a sink used for food preparation or equipment washing. It is important that handwashing be done only at a proper equipped handwashing facility in order to ensure that food employees effectively clean their hands. It is inappropriate to wash hands in a food preparation sink or wash equipment in designated hand washing sink, since this may result in avoidable contamination of the sink and the food prepared or washing of hands.

c. PA 1 stated that he secured ice from the bin ice machine in the Deli kitchen. The Deli kitchen was not the contracted food service and was not an approved source for providing sanitary ice. Contracted food service should be the source of ice provided for patient use.

d. Four thawed pint milkshakes, in the reach in refrigerator, did not have dates when they were placed from the freezer. Directions on the milkshake carton stated "use in 14 days in thawed state." RA1 confirmed there was no system for dating the milkshakes when taken from the freezer and how to use within the 14 days thawed.

e. One patient soda was stored in the food service reach-in refrigerator. RA1 stated concurrently, sometimes staff will store patient food in the food service refrigerator.
Review of policy ND1.6 titled Infection Control in the Kitchen, dated 3/23/12, had line drawn through direction "for patient personal food to be stored in the patients' refrigerator."

2. Observation of lunch meal on 6/27/16 at 12:30 p.m., showed RA2 served mashed potatoes with number 8 scoop (4 ounce serving size), zucchini squash with a 3 ounce spoodle (measured spoon with drain holes), and sliced beef with 4 ounce scoop.
Review of the menu dated Monday 6/27/16 for the regular and CCHO (consistent carbohydrate) diet portions were to be 3 ounce mashed potatoes, 4 ounce zucchini squash. The roast beef was a 4 ounce serving that would have be by weight and not volume as served.
PA2 stated concurrently at 12:35 p.m., she served with whatever serving utensils come from the contracted food provider. PA 1 stated the scale was in the dietitian's office. No scale was provided to ensure the correct serving of roast beef. RA2 did not serve mashed potatoes, zucchini squash or roast beef according to the menu.
Review of the PHF (Psychiatric Health Faclity) Diet Orders form showed three CCHO diets and 13 regular diet ordered.

3. Review of the two documents provided by facility, Psychiatric Health Facility: Disaster Planning for Dietary Service Disaster Menu rotation for 72 hours (not dated), and Psychiatric Health Facility: Emergency Menu Plan for Dietary Services dated 12/17/13.

The Emergency Menu plan was for a minimum of one day in the event food was not received from the contracted food service.

The Disaster Planning for Dietary Services policy was for 72 hours and consisted of a list of items that included "ER" bars located in the Patio shed. The plan utilized the "ER bars" for three days with additional items for puree consistency. Review of the manufacturer's literature on "ER BARs emergency ration food provision designated for 3 day food supply. The nutrient content showed 1200 calories and 21 grams protein per day. The 1200 calorie per day bars alone do not provide adequate calories or protein to be used solely as a daily ration. There were no directions on the use or how to integrate in to the disaster plan that provided adequate nutrition.

Review of the Diet Manual dated 4/20/16, showed the regular diet provided approximately 2000 to 2200 calories and 80- 90 grams of protein per day. The disaster plan of ER Bars did not provide adequate calories or protein to meet adult requirements.

In addition, the plan did not detail how therapeutic diets restrictions would be served. Theses therapeutic diet could include renal, potassium restricted diets, diabetic, and carbohydrate controlled diets.

In addition, other disaster food products were stored in the Patio shed. These products consisted of just add water meals for one person for 30 days and what was identified MRE (meals ready to eat). There were no directions included in the disaster plan for use of these products.

4. During an interview on 6/27/16 at 2:30 p.m., the Registered Dietitian stated the quality appraisal and performance approval program that was currently in place was monitoring the food temperatures when they arrived from the contracted food service and one time week test tray evaluation. She stated she did not know how to identify or develop quality program for the food service and patient nutrition care.

Based on observation, staff interview, and document review, the acute psychiatric hospital failed to ensure the contracted Registered Dietitian supervised the nutritional aspects of patient care including, implement patient assessment to ensure all aspects nutritional care are met, in timely manner for two patients (Patient 1 and Patient 2). These failures put 2/16 patients at risk of compromised nutritional status.

Findings:

1. Patient 1 was admitted 4/29/2016 with diagnoses of major depression and Diabetes Mellitus type 2 (A disease that affects the way your body handles glucose), hypothyroidism (underative thyroid gland), renal cell cancer (kidney cancer) status post left nephrectomy the surgical removal of a kidney), and bipolar disorder.
Physician diet order 4/30/16 for low tyramine (amino acid) diet. Physician diet order dated 6/16/16 for dietary consult for high salt diet. Diet order 6/23/16 for low potassium (mineral) diet, substitute regular milk with soy milk each meal.
Lab for potassium 6/23/16 was 5.9 mEq/L (normal 3.5 to 5.0 mEq/L).
Review of Patient 1's medical record on 6/27/16 showed a nursing screen dated 4/29/16 identified nutrition issues of unintended weight loss of 25 pounds over 5 months and decreases appetite. Weight on admission was 187.1 pounds. Referral to dietitian box is checked.
Review of Initial Nutrition Assessment dated 5/3/16 (initiated assessment) and was dated completed 5/17/16. Diet was listed as CCHO and tyramine restricted. Monitor and evaluate section was marked for nutrition status, PO (by mouth) intake, diet tolerance, and weight follow up.
Review of RD (Registered Dietician) interdisciplinary progress note dated 6/8/16, noted question of accuracy of admission weight. RD noted appetite ok and reviewed orders for health shakes.
There were no RD assessments regarding the low tyramine diet dated 4/30/16, dietary consults and high salt diet (dated 6/16/16) or low potassium diet ordered 6/16/16. The time to assess Patient 1 for initial assessment completion was 16 days after admission. There was no documentation at time of admission to verify accuracy of patient admission weight.
During an observation of lunch 6/27/16 at 12:30 p.m., Patient 1's diet was listed as CCHO (consistent carbohydrate). Patient received mashed potatoes and fresh fruit cup. Patient menu showed orange juice at breakfast. Mashed potatoes, fresh fruit, and orange juice are high in potassium content. Patient 1 had physician diet orders for both low potassium diet and high salt diet.

2. Patient 2 was admitted 6/8/16 with Diabetes Mellitus type 2, hypertension (high blood pressure), and schizophrenia (a mental disorder).
Review of initial nutrition assessment was dated 6/17/16 and 9 days after admission. RD marked monitoring section for follow as indicated, but no time parameters were specified.
Review of the Diet Manual dated 4/20/16 did not contain references for the low tyramine diet, low potassium diet, or the high salt diet prescribed by the physician.
During a telephone interview on 6/27/16 at 2:20 p.m., the RD stated she had no policy on when to follow up on patients. RD did not speak to the dietary consult for high sodium diet, diet orders being followed, or how the food service would implement the physician diet orders.
Review of the policy ND 1.0 titled Nutritional Assessment dated 8/29/11, noted nutrition assessments are completed on all patients within 7 days of admission. When nutritional risks are identified by licensed nurses or physicians, on admission or anytime during the patient stay, the Nutritional Risk tracking log is completed. There was no Nutritional Risk tracking log provided.
There were no time frames or nutrition risk levels developed to ensure patients with identified nutrition risks were assessed and monitored in timely manner to meet individual nutrition needs.

Based on interview and document review the hospital failed to ensure: 1) menus for patient meal substitutions addressed adequate food variety and of equal nutrition to accommodate food intolerances like milk or lactose intolerances. 2) Policies addressed patient food requests are individualized for requesting additional food at meals. This failure put 16/16 patient at risk of compromised nutritional status and malnutrition.

Findings:

1. Review of the Food Substitutions policy ND1.4 dated 8/29/11 stated, "A substitution of similar nutritional value and appropriate for the patient's diet order and preferences is offered." Review of the entrée items substitution offered were Cottage cheese, 2 ounce cheese, meat, or 2 tablespoons peanut butter.
During an interview RA (Recovery Assistant) 1 stated on 6/27/16 at 9:30 a.m., they had only sliced cheese or peanut butter for the entrée replacement for a patient who required a substitution. If a patient with lactose intolerance consistently refused an entrée item the only substitution would be peanut butter and this would limit the variety of substitutions available.
In addition, review of protein content of 2 tablespoons peanut butter is 8 grams protein. Review of protein in 2 ounces cheese is 14 grams protein. Review of menu showed 4 ounces roast beef served 6/27/16 lunch would provide 33 grams protein. Plan for substitutions did not provide equivalent protein. Reference from Bowe's and Church's Food Values of Portions Commonly Used 2010 edition.

2). During lunch observation 6/27/16 at 12:30 pm., two residents requested additional food items. RA 2 stated concurrently, the only extra food the patient could have was oatmeal at breakfast and hot soup at lunch and dinner.
Review of the policy Infection Control in the Kitchen dated 3/12/12, showed "When diet orders permit, serve patients who request second portions on a clean plate."
During an interview with the RD on 6/27/16 at 2:20 p.m., the RD stated the patients were not given seconds of food items because the menu has adequate calories for the patients. RD stated that she did think there was a written policy for denying seconds. RD stated she was not aware that this denied patient rights or if this practice had been approved with medical staff and governing body.

Based on observation, interview, and document review the hospital failed to provide therapeutic diets for low tyramine (amino acid) diet (57 days), High salt diet (11 days), and low potassium (mineral) diet (4 days), as ordered by the practitioner responsible for the care of the patient. This failure put 1/16 patients (Patient 1) at risk of compromised medical and nutrition risk.

Findings:

Patient 1 was admitted 4/29/2016 with diagnoses of major depression and Diabetes Mellitus type 2 (a disease that effects the way your body handles glucose) , hypothyroidism (underative thyroid gland), renal cell cancer (kidney cancer), status post left nephrectomy (the surgical removal of a kidney), and bipolar disorder.
Patient 1's physician diet order 4/30/16 for low tyramine (amino acid) diet. Physician diet order dated 6/16/16 for dietary consult for high salt diet. Diet order 6/23/16 for low potassium (mineral) diet, substitute regular milk with soy milk each meal.
Review of PHF (Psychiatric Health Facility) Diet Orders form, dated 6/27/16, showed Patient 1 was on CCHO (consistent carbohydrate) diet. Review of the Diet Order form dated 6/27/16, did not show low tyramine, low potassium or high salt diet ordered for Patient1.
During an interview with Adm 1 on 6/17/16 at 10:30 a.m., she stated she thought the low tyramine diet had been discontinued. Review of physician diet orders did not show an order to discontinue the low tyramine diet. Adm 1 confirmed the review of physician orders.
There was no implementation of the physician orders for the physician diet order 4/30/16 for low tyramine (amino acid) diet, physician diet order dated 6/16/16 for high salt diet, and physician diet order 6/23/16 for low potassium (mineral) diet, substitute regular milk with soy milk each meal.
During a telephone interview on 6/27/16 at 2:20 p.m., the RD (Registered Dietician) did not speak to why the dietary consult for high sodium diet, and diet orders being followed, or how the food service would implement the physician diet orders for low tyramine, low potassium, or high salt diet. RD confirmed there was probably not documentation in Patient 1's medical record addressing these physician diet orders.

Based on interview and record review hospital failed to ensure Diet Manual included references for all diets ordered. This failure puts 1/16 residents at risk of compromised medical and nutritional status.

Findings:

Patient 1 had physician diet orders for low tyramine (amino acid) diet, high salt diet, and low potassium (mineral) diet.
Review of Diet Manual review dated 4/20/16, did not have references to include indications and rational, nutrition adequacy, sample menu, and foods allowed or limited for the low tyramine diet, high salt diet, or the low potassium diet.
During an interview on 6/27/16 at 2:30 p.m., the RD (Registered Dietician) did not speak to how the physician diet orders for low tyramine, low potassium and high salt diet would be implemented when there were not directions in the approved diet manual.

Based on observation, interview and record review, the hospital did not meet the condition of participation for Physical environment, when the hospital failed to ensure that 16 of 16 psychiatric patients received care in a safe and maintained setting, as evidenced by the following:
1. Five out of 5 shower and 2 out of 2 handicapped bathroom's emergency call systems went without repairs rendering them unavailable for months.(Reference A-071)
2. All showers in the facility (5/5) were noted to have shower heads that were not flush or slanted to the tile background, posing as anchor points capable of sustaining weight of a patient, with the potential for ligature access that could be used in a hanging attempt. (Refernce A-071)
3. The hospital failed to ensure the facility was maintained in a matter that would assure the safety and wellbeing of patients when emergency supplies were outdated. The condition of the hospital's ceilings, walls, floors and screens were not routinely maintained or monitored. The lack of proper storage of linen did not ensure that infection prevention techniques were maintained and practiced by staff. (Refer to A-071).
Because of the potential for harm to all patients with access to the only bathroom and shower facilities in the psychiatric hospital, an Immediate Jeopardy (IJ) situation was called on 6/20/16 at 3:40 P.M., with Hospital Director and Medical Director.
The Medical Director and Hospital Director were informed on 6/20/16 at 4:45 p.m. that the Immediate Jeopardy to patient safety was removed after a corrective action plan was submitted and accepted. (Refer to A-071 #1 and #2 ).
The cumulative effect of these systemic problems resulted in the hospital's inability to ensure patients received care in a safe maintained environment.

Based on observation, interview and record review, the hospital failed to ensure that 16 of 16 psychiatric patients' received care in a safe and maintained setting, as evidenced by:
1. All showers in the facility (5/5) were noted to have shower heads that were not flush or slanted to the tile background, posing as anchor points capable of sustaining weight of a patient, with the potential for ligature access that could be used in a hanging attempt.
2. All the shower (5 of 5) and handicapped bathroom emergency call systems (2 out of 2)went without repairs rendering them unavailable for months.
3. The hospital failed to ensure the facility was maintained in a manner that would assure the safety and wellbeing of patients when;
Emergency supplies were outdated.
The conditions of the ceilings, walls, floors and screens were not routinely maintained or monitored.
The lack of proper storage of linen did not ensure that infection prevention techniques were maintained and practiced by staff.
Findings:
According to Joint Commission on Accreditation of Healthcare Organizations (The Joint Commission) Joint Commission Resources (2007). Suicide prevention: Toolkit for implementing national safety goal 15A. Oakbrook Terrace, IL: Reports that in behavioral healthcare facilities, long-term care facilities, and acute care hospitals, hanging is the most common way to complete suicide. Seventy five percent of the suicides occurred in bathrooms, bedrooms and closets. The overwhelming majority of the incidents involved environmental concerns.
In a VA (Veteran Affairs) study Examination of the Effectiveness of Mental Health Environment of Care Checklist in Reducing Suicide on Inpatient Mental Health Units. Arch Gen Psychiatry. 2012 Jun 1;19 (6) author Watta BV indicated "Anchor points capable of sustaining the weight of a patient attempting to hang him or herself in bedrooms and bathrooms were the most common and dangerous identified hazards."
1. During an observation tour of the unit on 6/20/16, beginning at 10:30 a.m., accompanied with LPT1 (Licensed psychiatric technician) and MD1 (Medica Director), all showers in the unit (5/5) were noted to have shower heads that were not flush or slanted to tile background, with potential for ligatures that could be used in a hanging attempt. MD1 acknowledged the potential for safety issues stating, "This is a problem."
2. Further observations on 6/20/16 at 10:30, revealed all emergency call buttons (emergency button mounted in lavatories and showers that enable patients who are in need of assistance or have fallen to obtain help quickly. Activation of button flashes to an outside monitor accompanied with a sound) located in all handicapped bathrooms and showers did not work during testing. LPT1 indicated that the system had not been working since 12/15 and had been called into facilities management for repair. LPT 1 presented an area in nursing station where a white panel face was removed and wires were sticking out, LPT 1 indicated that this was where the alarm would have sounded if the emergency call lights were working.
During an interview with LPT1 on 6/20/16, at 2:30 p.m., LPT1 was asked if he believed the emergency call system was necessary, LPT1 stated, "Yes it's an overt hazard not having this working." Asked if patients are accompanied to the shower for safety reasons, LPT 1 stated, "No, they don't get escorted they (patients) can go into the shower on their own."
Because of the potential for harm to all patients with access to the only bathroom and shower facilities in the psychiatric hospital, an Immediate Jeopardy (IJ) situation was called on 6/20/16 at 3:40 P.M., with the Hospital Director and Medical Director.
The Medical Director and Hospital Director were informed on 6/20/16 at 4:45 p.m. that the Immediate Jeopardy to patient safety was removed after a corrective action plan was submitted, implemented, accepted and verified. The plan included locking all showers and escorting the clients to the shower on a 1 to 1 basis (one staff member to one patient). Work was started to replace ligature capable fixtures and the call light system during the survey.
During an interview with ADM 4 (Administration Staff) on 6/23/16, at 9:45 a.m., ADM 4 described the process for repairs involved nursing staff calling in to the facilities management division, the division enters a work order request into an electronic log and the repairs are triaged for urgency.
During a document review of 6 months of work orders there was no listing for request for emergency call system repairs. ADM 4 acknowledged request was not logged in stating, "Not sure why."
Review of Safety meeting minutes for 11 months ending in 4/16. Minutes did not indicate concerns of call light system or ligature proof showers noted. Minutes from 8/20/15 indicated county risk management safety officer inspects all facilities every 18 months and "Will be inspecting ADMHS (alcohol, drug and mental health services) soon".
During an interview with county risk management safety officer (ADM6), on 6/27/16, at 12:05 p.m., ADM 6 indicated the last time he was at the Psychiatric Health Facility (PHF) was in 2010, he was not aware of "facility problems."
3. During an observation tour of facility on 6/20/16, starting at 9:00 a.m., accompanied with LPT1 tour revealed the following:
a. Inspection of the hospital's "emergency shed" (shed that held emergency foods, first aid etc.), on the hospital's patio area on 6/20/16 at 10:00 am contained several First Aid kits which would be used on the hospital patients in the event of a disaster according to the Lead Psychiatric Technician (LPT1) on tour with the team. The first supply inside the white bin contained a First Aid supply kit with 8 packets of Bacitracin Zinc Neomycin Sulfate 1/32oz (a topical antibiotic) with an expiration date of 11/98. Further inspection of the white bin revealed a second First Aid supply kit with an additional 8 packets of Bacitracin Zinc Neomycin Sulfate 1/32 (ounce) oz. with an expiration date of 11/98. Deeper in the same white bin was a third metal First Aid supply kit which contained 10 packets of Neosporin 1/32 oz. (a topical antibiotic), with an expiration date of 02/06. Inside the same metal First Aid kit were 20 packets of Triple Antibiotic Ointment 1/32 oz. in size, with an expiration date of 01/01. Check of emergency flashlights held five flashlights, test of two flashlights' did not work despite battery changes.
b. Room 11- bathroom toilet paper taped across toilet bowl with sign saying "don't use."
LPT1 indicated it was "clogged." Caulking missing and gaps around bathroom sink, brown matter was observed around sink and drain.
c. In seclusion room (involuntary isolation of patients with or without restraint use) room 10- mattress had white and brown matter on it, at the base of the bed had red matter and the floor had rust colored and black and white matter on the floor, janitor 2 stated, "That is blood". Full length screens had dark brown matter covering large areas. LPT1 was not aware of when the screens had last been cleaned, stated "They should be cleaned."
d. Room 9- toilet had brown ring in the toilet, brown matter on the toilet, grey and black matter on the floor, and a approximately 8 by 2 inch opening on the wall behind the door.
e. Room 8 -above door jamb peeled from wall, red substance on blanket.
f. Room 6 -Paint chipped on walls by bed 2.
g. Utility room- chemicals used to clean and disinfect did not contain dates when they were opened and they were not clearly labeled, the secondary containers did not contain dates when they were mixed.
h. The telephone room (room approximately 8 feet by 10 feet where patients used to make personal phone calls) had multiple ceiling tiles that were missing, broken and or brown and yellowed stained.
I. The laundry room (where a washer, sink and dryer is stored for patient use), the sink was filled with black matter, there was black and grey matter around the sink and floors, tubing to a vent on the floor contained gray furry matter.
J. Utility room 3- located in a hallway of the hospital and the following was observed:
*Stacks of clean linen were piled on top of a bathtub, in bags on the floor, and adjacent to a red biohazard container. The container was opened by LPT 1 and inside the container were multiple sharps containers (containers which contain used bloody needles and syringes).
An immediate interview was conducted with LPT 1 who stated that the bathtub is no longer used and that the linen contracting service delivered the linen and then placed in the room. LPT 1 stated the biohazard bin and the sharp containers should not have been there and the "clean linen" (some linen not contained in bags and unable to determine the cleanliness) should not be stored in that manner. In addition, LPT 1 stated that it was his responsibility but had been busy and did not store them accordingly. LPT 1 also stated that he was not familiar with any policies that addressed the storage of the linen or the biohazard containers.
On June 21, 2016 at approximately 10 AM, a review of two hospital policies titled, "Linen/Laundry Management-Infection Control", reviewed 10/27/14 and "Infectious Waste Management", effective 5/07 was conducted. The policy titled, "Linen/Laundry Management-Infection Control", stipulated the following:
"The (name of hospital), recognizes that linen used in a health care facility needs special handling for infection control reasons. Clean linen is stored separately from soiled linen..."
The policy titled, "Infectious Waste Management" stipulated the following:
"...The following categories of waste are considered regulated waste.
· Liquid or semi-liquid blood or other potentially infectious materials (OPIM).
· Items contaminated with blood or OPIM and which would release these substances in a liquid or semi-liquid state if compressed...
· Contaminated sharps

Regulated wastes shall be placed in red bags and placed in a red collection container with BIOHAZARD label located in the utility room and covered with the lid. Infectious wastes are kept separate from other wastes; no other wastes are placed in this container..."
During an interview with ADM 4, on 6/23/16, at 1:30 p.m., ADM 4 confirmed that housekeeping service for hospital is contracted with an outside housekeeping service. ADM 4 acknowledged that the service has no monitoring in place, ADM 4 stated, "If there is a problem nursing would call me." ADM 4 also reviewed process to have repairs done as, nursing calls a request and a work order is placed electronically, and work orders are then triaged for urgency.
Review of "PHF work orders" log dated 12/1/15 through 6/20/16 did not reveal any requests for patching room 9 or replacing ceiling tiles in telephone room.

Based on observation, interview, and record review, the hospital did not meet the condition of Participation for Infection Control, when the hospital failed to ensure they had an infection control program that was systematically and consistently implemented. The hospital failed to deliver care in a sanitary manner and evade activities that could potentially be a source of transmission of infections and communicable diseases, in a universe of 16 of 16 patients, as evidence by:

1. The hospital failed to designate an effective and qualified Infection Control Preventionist (ICP) to oversee the hospital's Infection Control program. This failure resulted in inadequate infection control oversight. (Refer A-0748 & A-0749 #3).

2. The hospital failed to recognize and implement infection control measures with procedures to prevent potential patient exposure, when hospital staff used a "single patient use only" glucometer (blood glucose monitor device, meant for a single patient, that measures the level of patient blood sugars), on multiple patients (3 of 16 patients}.The hospital did not use the glucometer as indicated by the manufacturer and nationally recognized infection control standards. Furthermore, the hospital failed to ensure the glucometers were properly cleaned and disinfected according to the manufacturer's instructions.

Because of the serious potential harm to all patients who required the use of the hospital's glucometer at the hospital, the hospitals practice of not ensuring a single patient use only glucometer was not used on multiple patients, an Immediate Jeopardy (IJ) situation was called on June 20, 2016 at 3:40 p.m. with the hospital's Medical Director.

The Medical Director was informed on 6/20/16 at 4:20 that the Immediate Jeopardy to patient safety was removed after the corrective action plan to obtain individual patient gluometers with a long term plan for multi patient use glucometer was submitted, accepted, implemented, and verified. (Refer to A-0749 #1)

3. The hospital, QAPI (Quality Assurance and Program Improvement) and governing body failed to ensure they had an effective, active system wide infection surveillance control program for prevention, control and investigation of infections (Refer A-0749 #2).

4. Integrate active hospital-wide infection prevention and control program into the facilities QAPI program. (Refer to A-0749 #4)

5. The hospital failed to provide for and maintain patient care equipment (i.e. blood glucose {glucometer} monitor a device that measures the level of glucose in a patient blood). Staff failed to maintain the glucometer in a condition that would permit the equipment to be disinfected, according to manufacturer directions for use and nationally recognized infection control standards. (Refer to A-0749 #5)

6 The hospital failed to ensure hospital staff were able to use and verbalize the correct contact time, according to manufacturer instructions for use of sani wipes (cleaning and disinfecting cloths the hospital used). (Refer A-0749 #6)

7. The hospital's lack of proper storage of linen did not ensure that infection prevention techniques were maintained and practiced by staff to prevent the potential spread of infection throughout the hospital. (Refer A-0749 #7)

8. Healthcare workers did not have complete vaccination screening as required per nationally recognized infection control organizations. (Refer to A-0749 #8)

9. The hospital failed to perform active surveillance, identify, adopt and effectively utilize nationally recognized infection control standards, such as the Association for Professionals in Infection Control and Epidemiology (APIC), Center for Disease Control (CDC as the national recognized standards that "drive" the EOC (environment of care) program. (Refer to A-0749 #9)

The cumulative effects of these systemic problems resulted in the facility's inability to ensure an effective system-wide infection control program thus failing to provide a safe environment free of transmission sources of infections and communicable disease. The hospital failed to be in compliance with the Condition of Participation for Infection Control.

Based on observation, interview, and document review, the facility and governing body in governance of the infection control officer (ICF), and in accordance with facility policies, and nationally recognized infection control standards, failed to ensure they had a designated infection control officer to provide an active system wide infection surveillance program, and to ensure the ICF developed and implemented infection control (IC) polices throughout the hospital; in a universe of 16 patients, as evidence by:

The hospital failed to designate an effective and qualified Infection Control Preventionist (ICP) to oversee the hospital's Infection Control program. This failure resulted in inadequate infection control oversight.

Findings:

During an interview, with the Medical Director/Quality Assurance and Program Improvement (QAPI) Committee Chair Person, on June 20, 2016 at 11:15 AM, she stated that the hospital had an infection control nurse who "comes to the hospital once a month," but did not know her name. She also stated that the hospital's Nurse Supervisor (ADM 1) communicated and provided infection control data to the infection control nurse.

During an interview with ADM 1 (Nurse Supervisor/Infection Control Designee), on June 20, 2016 at 2:45 PM, she confirmed that the hospital had an infection control "person" but was not certain of her official title. She also stated that the infection control "person" lived in Los Angeles, and she (referred to herself) as the hospital's Infection Control Designee, submitted infection control data, related to any hospital issues such as hospital acquired infections and then generated a monthly report to submit to the hospital's Quality Assurance and Program Improvement (QAPI). ADM 1 stated that the Infection Control "Person, (identified later as the Infection Control Consultant) does not come to the facility to do rounds but I guess she could if I ask her."

During a telephone interview on June 22, 2016 at 1:33 PM with the hospital's Infection Control Consultant, she clarified and stated that she had been contracted as the hospitals "Infection Preventionist Consultant (IPC)" for 5 years (did not have an official job description). She stated that the hospitals nursing staff and ADM 1 conducted the surveillance and oversight of the infection control program and consulted her as needed. In addition, she stated that ADM 1 was the onsite Infection Control Individual but was not certain of her level of infection control knowledge. Furthermore, she stated that she had not visited the hospital in over 2.5 years and the hospital called her for consults, "probably one or two times," in 2 years. The Infection Control Consultant also stated, "There needs to be a day to day infection control person to conduct surveillance and take ownership and call her for consultative purposes."

During an interview on June 22, 2016 at 2:40 PM, with ADM 1, she stated that the hospital did not designate anyone to conduct daily infection control monitoring of the hospital and the only person with infection control knowledge or experience was the Infection Control Preventionist (Name provided). In addition, she stated that she did not have any infection control experience and did not know of a facility job description for an infection control designee.

During an interview, with the Medical Director/Quality Assurance and Program Improvement (QAPI) Committee Chair Person, on June 23, 2016, at 1:10 PM, she stated that she was aware the hospital had an infection control consultant but did not know if someone in the hospital was designated as the infection control designee, to conduct the infection control monitoring of the hospital.

No job description for an infection control officer/preventionist was provided throughout the survey.

Based on observation, interview and document review, the hospital failed to provide an effective Infection Control program as evidenced by failure to have systems in place to ensure an effective, facility-wide infection control program, in a universe of sixteen (16) patients. The hospital failed to ensure the following:
1. The hospital failed to recognize and implement infection control measures with procedures to prevent potential patient exposure to bloodborne infections, when hospital staff used a "single patient use only" glucometer (blood glucose monitor device, meant for a single patient, that measures the level of patient blood sugars), on multiple patients (3 of 16 patients}. The hospital did not use the glucometer as indicated by the manufacturer and nationally recognized infection control standards. The hospital failed to ensure the glucometers were properly cleaned and disinfected according to the manufacturer's instructions.
On June 20, 2016 at 3:40 p.m the hospital Medical Director was verbally notified that an Immediate Jeopardy (IJ) situation was identified because of the serious potential harm to 3 of 16 patients, any patient who required the use of the hospital glucometer and due to the hospitals practice of not ensuring a single patient use only glucometer was not used for multiple patients.
On June 20, 2016 at 4:20 p.m, the Medical Director was informed that the Immediate Jeopardy to patient safety was removed after the corrective action plan was submitted, accepted, implemented, and verified. The hospital purchased single patient use glucometers which were assigned to each patient who required a glucometer and staff were educated on the use of the new glucometers.
2. The hospital, QAPI (Quality Assurance and Program Improvement) and governing body failed to ensure they had an effective, active system wide infection surveillance control program for prevention, control and investigation of infections.
3. The hospital failed to ensure they had a qualified Infection Control Preventionist (ICP, per their hospital policy) and there was no documented evidence to indicate the hospital had designated an individual as their ICP.
4. The hospital failed to ensure they had an active system-wide Infection Prevention and Control Program which was integrated into the hospital's Quality Assurance and Performance Improvement (QAPI) program.
5. The hospital failed to properly maintain the glucometer in a condition that would permit the equipment to be disinfected, according to manufacturer directions for use and nationally recognized infection control standards.
6. The hospital failed to ensure hospital staff were able to use and verbalize the correct contact time, according to manufacturer instructions for use of Sani wipes (cleaning and disinfecting cloths the hospital used).
7. The hospital's lack of proper storage of linen did not ensure that infection prevention techniques were maintained and practiced by staff to prevent the potential spread of infection throughout the hospital.
8. Healthcare workers did not have complete vaccination screening as required per nationally recognized infection control organizations.
9. The hospital failed to perform active surveillance, identify, adopt and effectively utilize nationally recognized infection control standards, such as the Association for Professionals in Infection Control and Epidemiology (APIC) and the Center for Disease Control (CDC) for their environment of care.
Findings:
1. On June 20, 2016 at 11:45 AM, an observation was made in the hospitals medication room. A Licensed Psychiatric Technician (LPT 2) demonstrated the hospitals use of the glucometer (blood glucose monitor device used to obtain patient blood sugar levels). The back of the glucometer contained an affixed label which stipulated, "For Single Patient Use Only". When asked if the glucometers were for single patient use only, LPT 2 stated that it was not and they used them on every patient that needed a blood sugar check.
On June 20, 2016 at 2:45 PM, an interview was conducted with the Registered Nurse Supervisor/Infection Control Designee (ADM 1). She was asked if she was aware the hospital was using "single patient use only" glucometers. She stated that she became aware when she was hired as the supervisor, about 2 years ago, and indicated that the hospital was supposed to purchase new glucometers but did not.
On June 20, 2016 at 3:15 PM, a document review was conducted of the manufacturer's "Owners Booklet," which was provided by the hospital. The booklet stipulated the following:
* "For Single Patient Use Only"
* "This system is intended to be used by a single person and should not be shared"
* "WARNING The meter and lancing device should never be used by more than one person. Do not share the meter and lancing device with anyone, including family members, due to the risk of infection from blood borne pathogens"
On June 20, 2016 at 5:25 PM, an observation was made of LPT 2 who demonstrated the use of the glucometer earlier in the day, and after the IJ was called, at 11:45 AM. LPT 2 was carrying a small tray which contained the same glucometer which indicated "For Single Patient Use Only." LPT 2 was asked if the glucometer was the same one that he had previously used, the LPT 2 stated in a loud tone, "Yes, I have no choice because it's the only one I have and I needed to take a patient's blood sugar level." LPT 2 was asked if he was aware that the device was considered to be unsafe for use on multiple patients and an IJ was called. He stated, "Yes, but like I said, I had no choice."
On June 21, 2016 at approximately 3 PM, the following six (6) Infection Control Committee Meeting Agenda minutes were provided by ADM 1 and were reviewed:
· May 18, 2016
· January 27, 2016
· January 14, 2015
· April 8, 2015
· July 8, 2015
· October 21, 2015

Six (6) of six meeting agendas included under the topic of "Monthly Data Review" :Accu-check Machine Maintenance (with ADM 1's name next to it), there was nothing documented to indicate the hospital discussed the use of their "For Single Patient Use Only" glucometer.
On June 21, 2016 at 4:30 PM, the Licensed Psychiatric Technician Supervisor (LPT 1) was asked to produce the glucometer policy. LPT 1 stated they did not have a current policy for the glucometers that were currently being used by the hospital.
On June 22, 2016 at 1:33 PM, the hospital Infection Preventionist Consultant (IPC) was interviewed via telephone. She stated that she did not know the glucometer which was being used by the hospital was meant, "For Single Patient Use Only."
On June 22, 2016 at 3:15 PM interviews were conducted with the day shift nurse in charge of the unit (RN Charge), and RN 3, they both stated that they were not aware of the glucometer being "single patient use only".
According to the Centers for Disease Control (CDC), "Injection Practices - Infection Prevention during Blood Glucose Monitoring and Insulin Administration, May 2, 2012", the Centers for Disease Control and Prevention (CDC) has become increasingly concerned about the risks for transmitting hepatitis B virus (HBV) and other infectious diseases during assisted blood glucose (blood sugar) monitoring and insulin administration. CDC is alerting all persons who assist others with blood glucose monitoring and/or insulin administration of the following infection control requirements:
"Fingerstick devices should never be used for more than one person..."
"Unsafe Practices during Blood Glucose Monitoring and Insulin Administration
An underappreciated risk of blood glucose testing is the opportunity for exposure to bloodborne viruses (HBV, hepatitis C virus, and HIV) through contaminated equipment and supplies if devices used for testing and/or insulin administration (e.g., blood glucose meters, fingerstick devices, insulin pens) are shared ...Outbreaks of hepatitis B virus (HBV) infection associated with blood glucose monitoring have been identified with increasing regularity, particularly in long-term care settings, such as nursing homes and assisted living facilities, where residents often require assistance with monitoring of blood glucose levels and/or insulin administration. In the last 10 years, alone, there have been at least 15 outbreaks of HBV infection associated with providers failing to follow basic principles of infection control when assisting with blood glucose monitoring. Due to under-reporting and under recognition of acute infection, the number of outbreaks due to unsafe diabetes care practices identified to date are likely an underestimate..."
"...Although the majority of these outbreaks have been reported in long-term care settings, the risk of infection is present in any setting where blood glucose monitoring equipment is shared or those assisting with blood glucose monitoring and/or insulin administration fail to follow basic principles of infection control...Unsafe practices during assisted monitoring of blood glucose and insulin administration that have contributed to transmission of HBV or have put persons at risk for infection include:
· Using fingerstick devices for more than one person
· Using a blood glucose meter for more than one person without cleaning and disinfecting it in between uses..."
According to the U.S Federal Drug and Food Administration (FDA), "Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication: Update 11/29/10", stipulated
"Fingerstick devices should NEVER be used for more than one person. This is not a safe practice for several reasons. Improper use or device malfunction can lead to the use of a contaminated lancet blade on more than one patient. POC blood testing devices can also be a source of bloodborne infections if used on multiple patients, because it is difficult for healthcare staff to ensure that all blood has been removed from these devices and the reusable portions of the fingerstick device. If contaminated blood is left on them, this could result in bloodborne pathogen transmission among patients..."
On June 20, 2016 at 3:40 p.m the hospital Medical Director was verbally notified that an Immediate Jeopardy (IJ) situation was identified because of the serious potential harm to 3 of 16 patients, any patient who required the use of the hospital glucometer and due to the hospitals practice of not ensuring a single patient use only glucometer was not used for multiple patients.
On June 20, 2016 at 4:20 p.m, the Medical Director was informed that the Immediate Jeopardy to patient safety was removed after the corrective action plan was submitted, accepted, implemented, and verified. The hospital purchased single patient use glucometers which were assigned to each patient who required a glucometer and staff were educated on the use of the new glucometers.
2. During an interview, with the Medical Director/Quality Assurance and Program Improvement (QAPI) Committee Chair Person, on June 20, 2016 at 11:15 AM, she stated that the hospital had an infection control nurse who "comes to the hospital once a month," but did not know her name.
During an interview with ADM 1 (Nurse Supervisor/Infection Control Designee), on June 20, 2016 at 2:45 PM, she confirmed that the hospital had an infection control "person" but was not certain of her official title. ADM 1 stated that the Infection Control "Person, (identified later as the Infection Control Consultant) does not come to the facility to do rounds but I guess she could if I ask her."
A review was conducted on June 21, 2016 at approximately 4 PM, of a hospital policy, provided by ADM 1, titled, "Infection Control Plan, effective 5/07." The policy stipulated:
"The (name of hospital) recognizes the need to formalize the infection control efforts. The goal of the Infection Control Program is to reduce the risk of acquisition and transmission of Healthcare Associated Infection (HAIs). To accomplish this goal effectively requires an integrated process involving a collaborative effort by all staff in the facility...(name of hospital) Medical Director oversees the establishment of an Infection Control Program. This policy statement shall be adopted to ensure the organization has a functioning, coordinated process in place to reduce the risks of endemic, epidemic and HAIs in patients and Healthcare workers..."
A document review was conducted on June 21, 2016 at approximately 4:45 PM, of the hospital's "Bylaws of the (name of the hospital) Medical Staff & Rules and Regulations." The document, under "Section 7 - Infection Control Committee Composition:" identified the Medical Director, Infection Control Officer, Nursing Supervisor, among others as being members of the committee. In the section titled, "Duties," it included the following duties to be performed by the committee members,
· "...To develop, review, and enforce written policies and procedures defining specific indications for the isolation of patients"
· "To develop, and periodically revise, a facility-wide infection control manual"
· "To develop, revise, and conduct an employee health program"
· "To provide, document, and review in-service education relating to infection "
· "To periodically review cleaning procedures, agents, and schedules and approve any major changes"
· "To conduct surveillance, preventive, and control procedures relating to the inanimate facility environment."
· "To take corrective action as indicated by its own reviews and by the Quality Assurance Program of the facility."
During a telephone interview on June 22, 2016 at 1:33 PM with the hospital's Infection Control Consultant, she clarified and stated that she was contracted by the hospital as the Infection Preventionist Consultant (IPC) but did not have an official job description. She stated that she assumed the hospital nursing staff and ADM 1 conducted the daily surveillance and oversight of the infection control program. The IPC stated that she thought ADM 1 was the onsite Infection Control Individual but was uncertain of her level of infection control knowledge. The IPC stated she had not visited the hospital in over 2.5 years and the hospital had only called her for consults, "probably one or two times," in 2 years. The IPC also stated, "There needs to be a day to day infection control person to conduct surveillance and take ownership and call her for consultative purposes."
During an interview on June 22, 2016 at 2:40 PM, with ADM 1, she stated that the hospital did not designate anyone to conduct daily infection control monitoring of the hospital and the only person with infection control knowledge or experience was the Infection Control Preventionist (Name provided). She also stated that she did not know of a facility job description for an infection control designee or person.
During an interview, with the Medical Director/Quality Assurance and Program Improvement (QAPI) Committee Chair Person, on June 23, 2016, at 1:10 PM, she stated if the hospital had infection control issues, they would be taken to the committee (by hospital staff) and then up to Governing Body, "but there are no infection control issues." During the interview, she also indicated that she was aware the hospital had an infection control consultant but did not know if someone in the hospital was designated as a designee to conduct the infection control monitoring of the hospital. In addition, the Medical Director/Quality Assurance and Program Improvement Committee Chair Person did not conduct daily monitoring of the hospital.
3. During an interview, with the Medical Director/Quality Assurance and Program Improvement (QAPI) Committee Chair Person, on June 20, 2016 at 11:15 AM, she stated that the hospital had an infection control nurse but did not know her name. The Medical Director/QAPI Chair Person was not aware of which nationally recognized infection control organization standards they followed and indicated that she believed they did follow Centers for Disease Control (CDC) standards.
During an interview with ADM 1 (Nurse Supervisor/Infection Control Designee), on June 20, 2016 at 2:45 PM, she confirmed that the hospital had an infection control "person" but was not certain of her official title. ADM 1 stated that the Infection Control "Person, (identified later as the Infection Control Consultant) does not come to the facility to do rounds but I guess she could if I ask her." ADM 1 also stated that the hospital did not have an "official" infection control person and she (ADM 1), did not have any infection control experience and did not know of any nationally recognized infection control organization guidelines they followed.
A review was conducted on June 21, 2016 at approximately 4 PM, of the hospital policy titled, "Infection Control Practitioner, effective 5/07." The document stipulated:
"An infection Control Practitioner shall be appointed by the Infection Control Committee. This employee shall have specific education in infection prevention and control with emphasis on Microbiology and Epidemiology.
· Observational and organizational skills.
· A minimum of one (1) year of experience in an acute care medical hospital setting.
Job Description:
· Conducts daily surveillance of patient care areas to identify potential environment infection risk areas.
· Conducts daily surveillance of patient information in the medical records for diagnosis of infection, as well as any pertinent laboratory tests that have been done ... "
During a telephone interview on June 22, 2016 at 1:33 PM with the hospital's Infection Control Consultant, she clarified and stated that she was contracted by the hospital as the Infection Preventionist Consultant (IPC) but did not have an official job description. She stated that she assumed the hospital nursing staff and ADM 1 conducted the daily surveillance and oversight of the infection control program. The IPC stated that she thought ADM 1 was the onsite Infection Control Individual but was uncertain of her level of infection control knowledge. The IPC stated she had not visited the hospital in over 2.5 years and the hospital had only called her for consults, "probably one or two times," in 2 years. The IPC also stated, "There needs to be a day to day infection control person to conduct surveillance and take ownership and call her for consultative purposes."
During an interview on June 22, 2016 at 2:40 PM, with ADM 1, she stated that the hospital did not designate anyone to conduct daily infection control monitoring of the hospital and the only person with infection control knowledge or experience was the IPC (Name provided). In addition, she stated that she did not know of any facility job description for an infection control designee or person.
During an interview, with the Medical Director/Quality Assurance and Program Improvement (QAPI) Committee Chair Person, on June 23, 2016, at 1:10 PM, she stated if the hospital had infection control issues, they would be taken to the committee (by hospital staff) and then up to Governing Body, "but there are no infection control issues." During the interview, she also indicated that she was aware the hospital had an infection control consultant but did not know if someone in the hospital was designated as a designee.
A review was conducted on June 21, 2016 at approximately 4 PM, of the hospital policy titled, "Infection Control Practitioner", effective 5/07. The document stipulated:

"An infection Control Practitioner shall be appointed by the Infection Control Committee.

· This employee shall have specific education in infection prevention and control with emphasis on Microbiology and Epidemiology.
· Observational and organizational skills.
· A minimum of one (1) year of experience in an acute care medical hospital setting.
Job Description:
· Conducts daily surveillance of patient care areas to identify potential environment infection risk areas.
· Conducts daily surveillance of patient information in the medical records for diagnosis of infection, as well as any pertinent laboratory tests that have been done..."

4. A record review was conducted on June 21, 2016 at 11:45 AM, of nine (9) Quality Assurance Program Improvement (QAPI) Committee Meeting minutes dated:

· January 27, 2016
· February 24, 2016
· March 23, 2016
· April 27, 2016
· May 25, 2016
· July 22, 2015
· August 26, 2015
· September 23, 2016 and
· October 28, 2015

Nine of nine meeting minutes failed to show documented evidence to demonstrate that the hospital's QAPI program was actively involved nor that an Infection Prevention and Control Program was integrated into the hospital's QAPI program. In addition, there were no infection control topics or issues discussed in any of the meeting minutes and there was no staff identified as being an Infection Control Preventionist/Designee, in attendance in any of the meetings.
On June 23, 2016 at 1:10 PM, an interview was conducted with the Medical Director/ Quality Assurance Program Improvement (QAPI) Chair Person was conducted. The Chair Person stated that she had not been aware of the glucometer finding and did not know that the glucometer was meant for single patient use only.
During the same interview, the QAPI Chair Person stated if there were any infection control issues, they would be discussed with QAPI and then taken up to the Governing Board, and stated that the hospital did not have any infection control problems.
The QAPI Chair Person stated she was aware they had an Infection Control Consultant and if there were any infection control problems then it would also be reported to her. In addition, she stated that she was not the person responsible of conducting rounds of the hospital's environment. The QAPI Chair Person was asked if she was aware that nobody in the hospital was qualified or designated as the hospital's infection control designee. She stated, "If there were problems, they (staff) would report them" and felt there have been no infection control issues.
During an interview on June 23, 2016 at approximately 1:35 PM, with ADM 1 (Nurse Supervisor) and the QAPI Chair Person, they were asked about QAPI Committee's involvement with the hospital's Infection Control program, and to provide documented evidence to show they were actively involved. ADM 1 was unable to describe the Committee's involvement nor was she able to show documented evidence and stated, "I look at the environment but I don't document it. I understand, if it wasn't documented, it wasn't done."
5. On June 20, 2016 at 11:45 AM, an observation was made in the hospitals medication room. A Licensed Psychiatric Technician (LPT 2) demonstrated the hospitals use of the glucometer (blood glucose monitor device used to obtain patient blood sugar levels) and the cleaning and disinfecting technique used to clean the device. The LPT used a "Sani Cloth - Bleach" (cleaning and disinfecting wipe) to clean the outer surface of the glucometer. The back of the glucometer contained an affixed label which stipulated, " For Single Patient Use Only" and the Sani Cloth had an expiration date of "2/16." LPT 2 verified the expired expiration date and stated that he did not know they had expired and they had been using the wipes to clean the "single patient use only" glucometers.
During the same interview, with LPT 2, he was not aware of the Sani Cloth wipes contact time (the amount of time the item wiped must remain visibly wet in order for cleaning and disinfecting to be effective). He was asked if could explain the cleaning and disinfecting of the glucometer and he stated he wiped it and allowed it to dry for a "couple minutes".
During an immediate review of the Sani-Cloth Bleach wipes manufacturer directions for use, the following was stipulated:
"TO CLEAN, DISINFECT AND DEODORIZE: Use a wipe to remove heavy soil. Unfold a clean wipe and thoroughly wet surface. Treated surface must remain visibly wet for a full four (4) minutes. Use additional wipe(s) if needed to assure continuous 4 minute wet contact time..."
On June 20, 2016 at 3:15 PM, a document review from the manufacturer and provided by the hospital, was conducted of the glucometer's "Owner's Booklet". The booklet stipulated the following:
* " For Single Patient Use Only "
* " Approved Cleaning and Disinfecting Product: The following product has been approved for cleaning and disinfecting the meter and lancing device: Super Sani-Cloth (EPA Reg. no. 9480-4) ... Do not use any other cleaning or disinfecting solutions. Using solutions other than the Super Sani-Cloth could result in damage to the meter and lancing device ...Always use Super Sani-Cloth to clean and disinfect the meter and lancing device ... " The EPA Registration number of the PDI Sani-Cloth Bleach wipes which the hospital used to clean the glucometers, according to LPT 2, was 9480-8 and not 9480-4, which the glucometer indicated to use.
On June 21, 2016 at 4:30 PM, the Licensed Psychiatric Technician Supervisor (LPT 1) was asked to produce the glucometer policy. He stated that the only policy they had was for an older model glucometer which is no longer used by the hospital. LPT 1 also stated they did not have a current policy for the glucometers that were currently being used by the hospital.
According to the Centers for Disease Control (CDC), "Injection Practices - Infection Prevention during Blood Glucose Monitoring and Insulin Administration, May 2, 2012", the Centers for Disease Control and Prevention (CDC) has become increasingly concerned about the risks for transmitting hepatitis B virus (HBV) and other infectious diseases during assisted blood glucose (blood sugar) monitoring and insulin administration. CDC is alerting all persons who assist others with blood glucose monitoring and/or insulin administration to follow glucometer manufacturer directions for use and cleaning and disinfecting of devices.
6. On June 20, 2016 at 11:45 AM, an observation was made in the hospitals medication room. A Licensed Psychiatric Technician (LPT 2) demonstrated the hospitals cleaning and disinfecting technique used to clean the device. The LPT used a "Sani Cloth - Bleach" (cleaning and disinfecting wipe) to clean the outer surface of the glucometer and the Sani Cloth had an expiration date of "2/16." LPT 2 verified the expired expiration date and stated that he did not know they had expired and they had been using the wipes to clean the glucometers.
During the same interview, with LPT 2, he was not aware of the Sani Cloth wipes contact time (the amount of time the item wiped must remain visibly wet in order for cleaning and disinfecting to be effective). He was asked if could explain the cleaning and disinfecting of the glucometer and he stated he wiped it and allowed it to dry for a "couple minutes".
During an immediate review of the Sani-Cloth Bleach wipes manufacturer directions for use, the following was stipulated:
"TO CLEAN, DISINFECT AND DEODORIZE: Use a wipe to remove heavy soil. Unfold a clean wipe and thoroughly wet surface. Treated surface must remain visibly wet for a full four (4) minutes. Use additional wipe(s) if needed to assure continuous 4 minute wet contact time... "
On June 20, 2016 at 3:15 PM, a document review from the manufacturer and provided by the hospital, was conducted of the glucometer's "Owner's Booklet". The booklet stipulated the following:
* "Approved Cleaning and Disinfecting Product: The following product has been approved for cleaning and disinfecting the meter and lancing device: Super Sani-Cloth (EPA Reg. no. 9480-4)... Do not use any other cleaning or disinfecting solutions. Using solutions other than the Super Sani-Cloth could result in damage to the meter and lancing device...Always use Super Sani-Cloth to clean and disinfect the meter and lancing device..." The EPA Registration number of the PDI Sani-Cloth Bleach wipes which the hospital used to clean the glucometers, according to LPT 2, was 9480-8 and not 9480-4, which the glucometer indicated to use.
On June 21, 2016 at 4:30 PM, the Licensed Psychiatric Technician Supervisor (LPT 1) was asked to produce the glucometer policy. LPT 1 stated they did not have a policy for the glucometers that were currently being used by the hospital.
According to the Centers for Disease Control (CDC), "Injection Practices - Infection Prevention during Blood Glucose Monitoring and Insulin Administration, May 2, 2012", the Centers for Disease Control and Prevention (CDC) has become increasingly concerned about the risks for transmitting hepatitis B virus (HBV) and other infectious diseases during assisted blood glucose (blood sugar) monitoring and insulin administration. CDC is alerting all persons who assist others with blood glucose monitoring and/or insulin administration to follow glucometer manufacturer directions for use and cleaning and disinfecting of devices.
6(a). On June 20, 2016 at approximately 11:50 AM, an observation and concurrent interview were conducted of a registered nurse (RN 1), who provided a demonstration of the hospital's use of Sani-Cloth HB (wipes used to clean and disinfect patient care equipment and other surfaces of the hospital). RN 1 wiped a blood pressure cuff (a patient equipment used to obtain patient blood pressures) and stated that he wiped the cuff or any other item he needed to clean, and allowed it to remain wet for 30 seconds. RN 1 stated that the process was used for all patients, including patients with HIV (a chronic, potentially life-threatening condition caused by the human immunodeficiency virus, by damaging the immune system and could cause AIDS), and HBV (Hepatitis B, a serious liver infection), according to RN I, they treated all patients the same and used standard precautions.
A review of the manufacturer directions for use, located on the container of the wipes RN 1 used, indicated the following:
"CONTACT TIME: Leave surfaces wet for 30 seconds and 10 minutes for HIV-1 and HBV, respectively. Use the 10 minute contact time to mitigate other viruses, bacteria and fungi listed on the label..." RN 1 stated that he did not know there was a different contact time for different patients. In addition, he stated that he had no knowledge of a policy which addressed cleaning and disinfecting of patient equipment.
7. On June 20, 2016 at 11:25 AM, an observation (of the 16 bed facility) and a concurrent interview were conducted with LPT 1. LPT 1 opened a door (labeled utility room 3), located in a hallway of the hospital and the following was observed:
*Stacks of linen were piled on top of a bathtub, in bags on the floor, and adjacent to a red biohazard container. The container was opened by LPT 1 and inside the container were multiple sharps containers (containers which contain used bloody needles and syringes).
An immediate interview was conducted with LPT 1 who stated that the linen contracting service delivered the linen and placed in the room. LPT 1 stated the biohazard bin and the sharp containers should not have been stored with the "clean linen" (some linen not contained in bags and unable to determine the cleanliness). In addition, LPT 1 stated that it was his responsibility but had been busy and did not store them accordingly. LPT 1 also stated that he was not familiar with any policies which addressed the storage of the linen or the biohazard containers.
On June 21, 2016 at approximately 10 AM, a review of two hospital policies titled, "Linen/Laundry Management-Infection Control, reviewed 10/27/14 and Infectious Waste Management, effective 5/07," was conducted. The policy titled, "Linen/Laundry Management-Infection Control", stipulated the following:
"The (name of hospital), recognizes that linen used in a health care facility needs special handling for infection control reasons. Clean linen is stored separately from soiled linen ..."
The policy titled, "Infectious Waste Management" stipulated the following:
"...The following categories of waste are considered regulated waste.
· Liquid or semi-liquid blood or other potentially infectious materials (OPIM).
· Items contaminated with blood or OPIM and which would release these substances in a liquid or semi-liquid state if compressed...
· Contaminated sharps

Regulated wastes shall be placed in red bags and placed in a red collection container with BIOHAZARD label located in the utility room and covered with the lid. Infectious wastes are kept separate from other wastes; no other wastes are placed in this container..."
8. During an inter

Based on observation, interview, and record review, the hospital failed to ensure the CEO maintained oversight over the IC program, creating the risk of the program not addressing infection prevention needs and the increased risk of the spread of infections, in a universe of 16 patients.
Findings:
During the multiple observations and interviews from June 20, 2016 to June 27, 2016, in the hospital, and during the survey, breaches were seen in the design and implementation of the infection prevention program. (Cross reference A-0747, A-0748, A-0749).