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Based on interview and administrative record review, the hospital failed to ensure the Pharmacist in Charge (PIC) performance evaluation was completed in 2012, 2013, and 2014. The hospital did not complete a performance evaluation for the PIC in 2012, 2013, and 2014, to ensure the minimum requirements were maintained. These failures resulted in the potential for 599 out of 599 patients, from 7/5/14 through 1/5/15, to be exposed to the pharmacy services provided at less than the minimum required.

Findings:
During an interview, on 1/7/15 at 1:45 p.m., Clinical Director stated the hospital admitted 599 patients from 7/5/14 to 1/5/15.
During a concurrent interview and administrative record review, on 1/8/15 at 11:30 am, Director of Nursing (DON B) was requested to provide, for 2012, 2013, and 2014, the annual evaluation of the Pharmacist in Charge. DON B provided the Pharmacy 1 Hospital Pharmacy Services, Criteria-Based Job Description/Competence Assessment Summary/Performance Evaluation, Director or Pharmacy (responsible for directing the operation of the Department of Pharmacy and managing all aspects of the medication use process), for 2012, 2013, and 2014. Inspection of the 2012 evaluation did not show it was signed by the employee. Inspection of the 2013 evaluation did not show it was signed by the supervisor. Inspection of the 2014 document did not show it was signed by the supervisor. Further inspection showed the assessment evaluated multiple elements of principal duties/responsibilities, departmental standards, and organizational standards, on a scoring scale of outstanding through unacceptable. DON B acknowledged the three evaluations did not have the required signatures. The hospital did not show it completed an annual review for 2012, 2013, and 2014, of the required job duties for the Pharmacist in Charge.
During a concurrent interview and administrative record review, on 1/8/14, at 10:45 am, with DON B, the hospital's policy and procedure for Formulary (medications authorized to be used in the hospital) System was identified. Attached to the policy and procedure was RxLink Drug Formulary (dated Tuesday, October 11, 2011). DON B acknowledged the RxLink Drug Formulary was dated Tuesday, October 11, 2011. DON B was requested to provide the approved formularies for 2012, 2013, and 2014. The approved formularies for 2012, 2013 and 2014 were not provided before the end of the survey. The hospital did not approve medication formularies for 2012, 2013, and 2014.
During a concurrent interview and administrative record review, on 1/8/14, at 10:55 am, with DON B, the hospital's policy and procedure for Automated Dispensing System (ADS) Profile Override (medications authorized to be used without the prior review by a pharmacist) (Policy #; Section MM 5.7, Date of Revision: 10/12/11). Attached to the policy and procedure was Override Medications 2011-2012 (dated 4/14/11). DON B acknowledged the Override Medications was dated 4/14/11. DON B was requested to provide the approved override medications 2012, 2013, and 2014. The approved override lists for 2012, 2013, and 2014, were not provided before the end of the survey. The hospital did not approve medication override lists for 2012, 2013, and 2014.
An administrative record review, of the hospital's policy and procedure for Formulary System (Policy: MM 1.3, Date of Revision: 10/12/11) showed, Formulary Review, "The Pharmacy and Therapeutics Committee will review the formulary at least annually ...Pharmacy shall provide substantiating reasons for deletions, additions or maintenance of the existing formulary. These will be based on therapeutic value, indication for use, effectiveness, contraindications, risks (including propensity for medication errors, abuse potential, and sentinel (serious) events), AB-rating (therapeutic equivalent), availability and cost. Emerging safety and efficacy information will be considered in the annual review of the formulary. Specific patient monitoring to detect adverse events, if applicable, will be included in all drug reviews ...At least annually the printed hospital formulary shall be reviewed and revised ...The revised formulary will then be printed and presented to the P&T Committee and the Medical Staff Committee for approval." Continued review showed, Procedure, 1. "The medication formulary will be implemented, maintained and reviewed by the Pharmacy and Therapeutics (P&T) Committee and approved by the Medical Clinical staff." The hospital did not approve medication formularies for 2012, 2013, and 2014.
During an administrative record review, of the hospital's policy and procedure for Automated Dispensing System (ADS) Profile Override (Policy #: Section MM 5.7, Date of Revision 10/12/11) showed, Procedure, 6. "Override medications should be customized with consideration given to the scope of care within a patient car unit. The Pharmacy and Therapeutics Committee shall review the lists of approved override medications annually." The hospital did not approve medications override lists for 2012, 2013, and 2014.
During an administrative record review, of the hospital's Position Description, Pharmacist in Charge-Heritage PHF (dated 6/05) showed, Quality and Quantity of Work, "Maintains adequate documentation for all processes that deal with the maintenance of pharmacy for the clinical and distributive functions that conform to hospital policy and Joint Commission and CMS standards. The pharmacist in charge did not ensure the hospital approved medication formularies and medication override lists for 2012, 2013, and 2014.

The Condition of Participation-Governing Body is not met as evidenced by the Acute Psychiatric Facility's failure to:

Based on observation, interview and record reviews, the facility failed to have an effective governing body to ensure the written policies and procedures were maintained in regard to contracted services, screening and obtaining criminal background clearances, abiding by the credentialing process of the medical staff and by completing annual performance reviews of all employees.

The facility failed to have an effective governing body evidenced by the following:

1. Ensure the medical staff was appointed by the governing body (Refer to A-0046.)

2. Provide oversight of contracted housekeeping, dietary, and pharmacy services. (Refer to A-0084 A-0144 and A-0490)

3. Ensure the facility policies and procedures requiring criminal background clearances for all employees, review of the annual pharmacy formulary and override medications were implemented and monitored for compliance. (Refer to A-0144 and A-0490.)

4. Ensure an effective system to evaluate the services provided by the contracted services by establishing quality indicators, gathering data, and use of the data analysis results to monitor the effectiveness of the delivery of quality of care. (Refer to A-0263.)

The cumulative effect of these systemic problems resulted in the facility's failure to ensure patient safety and quality health care.

Based on interview and record review the hospital failed to ensure that the medical staff was appointed by the governing body, resulting in 2 members of the medical staff who were not appointed by the governing body, with potential adverse effects on patient safety and healthcare quality.
Findings: During the review of medical staff credentials on 1/6/15, two physician assistant files (PA-C1 & PA-C2) were noted to have a privilege list and no statement of acceptance to the hospital's Medical Staff in their files. When the Personnel Director was asked about the process, she replied that she did not think it was needed as they are under the supervision of the hospital's internist and a part of his medical group.
The Medical Staff Bylaws state that, " the Medical Staff shall account to the Governing Body for oversight of the Medical Staff " and not solely to the supervising physician when providing patient care to the hospital ' s patients.

Based on observation, interview and document review the acute psychiatric hospital failed to ensure services performed under contract are provided in a safe and effective manner as evidenced by the following:
1) Contracted food services were not provided for 8 therapeutic diets to ensure the therapeutic diets were served as ordered, with supervision of dietary staff, staff training, and oversight by the contracted registered dietitian. Cross Reference A618, A620, A622.
2) Registered dietitian was not providing nutrition Services based on patient needs for acute psych hospital. Cross Reference A 621
3) Contracted food services and Registered Dietitian (RD) services were not monitored by the facility in a quality assessment and performance improvement program (QAPI). The contract did not include requirements for the QAPI program in the food service or the clinical dietary. (A-265.
The result of these failures compromises patients' nutritional status.
4. The contracted management for the provision of pharmaceutical (pharmacy) services and care did not ensure the needs of the patients were met. The hospital did not implement a quality assessment and improvement program (QAPI,) process to ensure all services furnished under contract were reviewed on a routine basis to identify quality and performance problems. The hospital did not identify the failure to approve medication formulary (medications authorized to be used) and automated (medication) dispensing cabinet (ADC) medication override (medications authorized to be used without the prior review by a pharmacist) list annually in 2012, 2013, and 2014.

These failures resulted in the potential for 599 out of 599 patients, from 7/5/14 through 1/5/15, to be exposed to the medications which were not approved for hospital use, and medications which were not reviewed by pharmacist.

Findings:
On 1/3/2015 starting at 8:00 a.m., the contracted food service and contracted Registered Dietitian Memorandum of Understandings (MOU) were reviewed.
1) The Memorandum of Understanding (MOU) dated August 15, 2005 titled Dietary Services established an agreement between the the hospital and Facility 2, a contracted mental rehabilitation center. The MOU indicated Facility 2 would provide all dietary services including meals, snacks, necessary personnel, and other services would need in compliance to the requirement of Agency 1's (the licensing public agency) licensing regulatory requirements and Agency 2's (the accreditation agency) standards.
The MOU did not specify how the agreement would be monitored as part of a hospital wide quality appraisal and performance improvement plan. The agreement did not specify the relevant criteria for accuracy of all the prescribed diets and accuracy of following the planned menus. The MOU did not specify the dietary staff training, dietary staff supervision and monitoring by the registered dietitian at meal times.
2) The MOU dated July 11, 2005 titled Registered Dietitian Services, established an agreement between the hospital and Facility 2. The MOU indicated Facility 2 will provide the hospital the services of a registered dietitian for a period of up to eight hours per month for a current licensed capacity of 26 patients. Review of the patient roster showed the patients at the time of the survey had medical conditions ranging from hypertension, anemia (low red blood count,) fatty liver, gastrointestinal reflux disease (GERD) (gastric acid from stomach to wind pipe), food allergies, diabetes mellitus type 2 (elevated blood sugar), hyperlipidemia (elevated fat in the blood).
In an interview on 1/7/15, starting at 9:00 a.m., the registered dietician stated the hospital contracted Facility 2 which subcontracted with Agency 3 (a dietary service provider,) that employed her. The Consultant RD stated she only came to the hospital to complete admission nutrition assessments when there was a consult triggered from the nursing admission review of the medical condition. The Consultant RD stated she did not review patient's medical records to assess if the medical conditions or psychiatric conditions warranted nutrition interventions. The Consultant RD stated she did not provide group or patient/family education in regard to patient therapeutic diets, nutrition status, or potential nutrition related discharge issues. The Consultant RD stated she was not involved in treatment planning or care planning of the patients.
Review of the RD Report to the hospital for the past 5 months showed she completed one patient assessment per month for December, October, September and August 2014. There were 2 nutrition assessments completed for November 2014.
Interview on 1/8/15 at 8:00 a.m., with the Administrator and document review of the contract evaluation form showed a rating scale from excellent, good, and fair to poor. Review of the Food Service contract dated July 25, 2014 provided by Facility 2 rated good for timeliness and fair for quality of product and staff, cost and met contract quality performance objectives.
Review of the contract evaluation form dated July 2014 for the Registered Dietitian rated all areas as good based on "The dietitian Consultant will perform duties within the realm of the profession of dietetics including Consultant Dietitians Standards". These standards were not specified. The evaluation was also to include periodic reviews and audits. This was no documentation or periodic review or audits of the Consultant RD's work.
In concurrent interview the Administrator acknowledged there was no monitoring of the Consultant RD's work or how her clinical work met the needs of the acute psychiatric patient. The Administrator acknowledged that there was no system to evaluate the food service when there was no formal quality appraisal and performance improving plan in place.



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4. During a group interview, on 1/7/15 at 11:35 am, the hospital was requested to provide the approved medication formulary for 2012, 2013, and 2014. Those in attendance included Pharmacist in Charge (PIC), Director of Nursing (DON A), and Administrator.
During an interview, on 1/7/15 at 1:45 p.m., Clinical Director stated the hospital admitted 599 patients from 7/5/14 to 1/5/15.
During an interview, on 1/8/15 at 10:45 am, Director of Nursing (DON B) was asked to provide the approved medication formulary for 2012, 2013, and 2014. DON B acknowledged the hospital did not have an approved (by the Pharmacy and Therapeutics committee and the Medical Staff committee) medication formulary for the years requested,
During an interview, on 1/8/15 at 10:55 am, DON B was requested to provide the approved medication override list for 2012, 2013, and 2014. DON B acknowledged the hospital did not have an approved (by the Pharmacy and Therapeutics committee) medication override list for 2012, 2013, and 2014.
During a concurrent interview and administrative record review, on 1/8/15 at 11:35 am, DON B identified the hospital organization chart. DON B was asked to describe the hospital reporting structure for pharmacy. She stated that the hospital pharmacy services were provided under a contract with Pharmacy 1. DON B reviewed the organization chart and identified that the pharmacy contract services reported to Administrator.
During an administrative record review, of the Hospital Pharmacy Management Agreement (signed 9/30/08) showed, Agreement, 1. Manager's (Pharmacy 1 Pharmacy Services) Obligations "Manager shall have the following duties, obligations and responsibilities, a. Services. Manager shall provide to PHF (Hospital) the services and personnel set forth below in connection with the management and operation of the Pharmacy services (collectively, the "Services"). All such Services shall be provided by Manager in material compliance with all clinical, administrative and operational rules, regulations, polices, procedures, programs, professional standards and protocols approved and adopted by PHF from time to time with respect to the governance and operation of the Pharmacy Services (collectively, the "Pharmacy Policies and Procedures") and (ii) applicable local, state and federal laws, rules and regulations ("Applicable law").
During an administrative record review, of the hospital's policy and procedure for Automated Dispensing system (ADS) Profile Override (Policy #: Section MM 5.7, Date of Revision: 3/25/10) showed, Policy Statement, "To define the use of the override function on the ADS, and identify the best practices to provide safe medication management associated with its use." Continued review showed, Definitions, "Override: The process by which the user removes a medication from the Med-station for a patient that is not part of the patient's profile. Patient profile overrides appear on override reports printed the following morning ...Override Medications: Medications that are approved by the Pharmacy and Therapeutics committee, which can be accessed without pharmacist review of the medication order."
During an administrative record review, of the hospital's policy and procedure for Automated Dispensing System (ADS) Profile Override (Policy #: Section MM 5.7, Date of Revision 10/12/11) showed, Procedure, 6. "Override medications should be customized with consideration given to the scope of care within a patient car unit. The Pharmacy and Therapeutics Committee shall review the lists of approved override medications annually." Continued inspection showed an attachment titled Override Medications (dated 4/14/11).
An administrative record review, of the hospital's policy and procedure for Formulary System (Policy: MM 1.3, Date of Revision: 10/12/11) showed, Formulary Review, "The Pharmacy and Therapeutics Committee will review the formulary at least annually ...Pharmacy shall provide substantiating reasons for deletions, additions or maintenance of the existing formulary. These will be based on therapeutic value, indication for use, effectiveness, contraindications, risks (including propensity for medication errors, abuse potential, and sentinel (serious) events), AB-rating (therapeutic equivalent), availability and cost. Emerging safety and efficacy information will be considered in the annual review of the formulary. Specific patient monitoring to detect adverse events, if applicable, will be included in all drug reviews ...At least annually the printed hospital formulary shall be reviewed and revised ...The revised formulary will then be printed and presented to the P&T Committee and the Medical Staff Committee for approval." Continued review showed, Procedure, 1. "The medication formulary will be implemented, maintained and reviewed by the Pharmacy and Therapeutics (P&T) Committee and approved by the Medical Clinical staff." The hospital did not approve medication formularies for 2012, 2013, and 2014.

The Condition of Participation-Patient Rights is not met as evidenced by the facility's failure to:

Based on observation, interview, and record review, the facility failed to ensure that all staff had constant supervision until criminal background clearances were obtained, in accordance with the facility's policy and procedure.

The effect of this systemic problem had the potential for an unsafe care environment for a vulnerable patient population. (See A-0144)

DEFICIENCY CONSTITUTING IMMEDIATE JEOPARDY

Based on observation, interview, and record review, the facility failed to ensure that six (1,2,3,4,5,6) contracted staff with pending criminal background clearances, had constant supervision in accordance with the facility's policy and procedure, "Criminal Justice Information." This failure had the potential to place all in-patients at risk for emotional and physical harm from staff who were not cleared to work in a psychiatric facility.

THIS EVENT CONSTITUTED AN IMMEDIATE JEOPARDY (IJ) BECAUSE THE ACUTE PSYCHIATRIC FACILITY FAILED TO IMPLEMENT WRITTEN POLICIES AND PROCEDURES TO ENSURE THAT STAFF WITHOUT CRIMINAL BACKGROUND CLEARANCE HAD DIRECT AND CONSTANT SUPERVISION WHICH RESULTED IN THE POTENTIAL FOR SERIOUS PATIENT INJURY OR DEATH.

Findings:

On 1/8/15, review of the policy and procedure entitled, "Criminal Justice Information," dated 12/9/09, showed the following requirement: "...Upon employment of any direct care staff...shall submit fingerprint images and related information pertaining to the individual...for a criminal record check..." the definition of, "direct care staff" in the procedure was defined as "any person who is an employee contractor, or volunteer who has contact with clients, patients or residents in the provision of services." The policy and procedure had a specific instruction that "...no direct client contact shall occur prior to clearance..." unless the employee "...is constantly supervised." Constant supervision in the policy and procedure was defined as "...always being supervised."

On 1/8/15 at 10:35 a.m., during mutual record review and interview with the Director of Facility Services (Director,) the personnel files of Staff 1 and 2 did not contain criminal background clearances. There was documentation that the clearances were pending. The Director provided a work checklist showing that Staff 1 and 2 were expected to go into patients' rooms and rest rooms.

By observation, Staff 1 and 2 worked throughout the week of, 1/5/15 through 1/7/15, without having constant supervision. During an observation and interview on 1/7/15 at 2:50 p.m., Staff 1 was noted in the in-patient hallway, working independently. At 3 p.m., Staff 2 said he worked on 1/6/15 on the in-patient unit. On 1/8/15 at 10:20 a.m., during interviews and review of the work schedule, Staff 1 showed that he worked in the facility on 1/5/15 and 1/7/15. Staff 1 and 2 said that staffing was short that week so they alternated with each other between the facility and another facility next door. There were no supervisory personnel assigned on the schedule to either Staff 1 and 2 to ensure constant supervision.

During continued interview, on 1/8/15 at 10:35 a.m., the Director said he supervised Staff 1 and 2 and there was always nursing staff on the in-patient unit. The Director was out "sick" on 1/7/15 and was restricted to his office on 1/8/15 for having flu signs and symptoms. The Director said he didn't realize that constant supervision meant having another staff member working directly with Staff 1 and 2: "I didn't know constant supervision meant line of sight. I learned something." The Administrator of the facility, was present, and said she was unaware that Staff 1 and 2 were working without criminal background clearances. The Administrator told the Director to immediately provide the constant supervision required.

During further record review on 1/8/15 at 2:10 p.m., four additional Staff (3, 4, 5 and 6) of twenty-seven contracted staff did not have criminal background clearances. Review of work schedules showed that Staff 1, 2 and 3 worked in January and were scheduled for additional days. Staff 4, 5, and 6 were on call and did not work in January. Staff 1, 3, 5 and 6 had specific "Confirmation of Supervision" letters from Agency 1, mandating verification of "constant and direct supervision" (meaning within sight and sound) in affidavits. Copies of the four affidavits showed that the supervisors, of Staff 1, Staff 3, Staff 5 and Staff 6, signed and returned the affidavits to Agency 1, promising "constant and direct supervision" until each Staff received a criminal background clearance.

At 3:10 p.m. on 1/8/15 the Administrator, DON A, DON B, Clinical Directors 1 and 2, Administrator 2 and the Food Service Director were notified of the determination of an Immediate Jeopardy (IJ) situation due to staff working independently without criminal background clearances.

The IJ was abated at, 4:40 p.m. on 1/8/15, when staff presently working without criminal background clearances were sent home, when administration wrote letters to all staff without clearances prohibiting them from working in the facility until the clearances were secured, and when the facility presented a plan for oversight of the hiring process of the contracted services.

Based on observation, interview and administrative record review, the hospital failed to ensure the development and implementation of an effective quality assessment and performance improvement program (QAPI) as evidenced by:

1. Based on interview and administrative record review, the hospital failed to ensure contracted management for the provision of pharmaceutical (pharmacy) services and care met the needs of the patients. The hospital did not implement a quality assessment and performance program (QAPI, process to ensure services are provided are safe and effective), to ensure that all services furnished under contract were reviewed on a routine basis to identify quality and performance problems. The hospital did not identify the failure to approve medication formulary (medications authorized to be used) and automated (medication) dispensing cabinet (ADC) medication override (medications authorized to be used without the prior review by a pharmacist) list annually in 2012, 2013, and 2014. These failures resulted in the potential for 599 out of 599 patients, from 7/5/14 through 1/5/15, to be exposed to the medications that were not approved for hospital use, and medications that were not reviewed by pharmacist (see A-0084).

2. Based on observation, interview, and record review, the hospital failed to ensure the automated (medication) dispensing cabinet (ADC, cabinet to dispense medications) override data (medications removed without prior review by a pharmacist) was used to identify the lack of approved medication override (medications authorized to be used without the prior review by a pharmacist) lists for 2012, 2013, and 2014. The hospital's quality assessment and performance program (QAPI, process to ensure services are provided are safe and effective) did not identify, by the analysis of override data reported to the Pharmacy and Therapeutics committee, the lack of approved ADC medication override lists for 2012, 2013, and 2014. These failures resulted in the potential for 599 out of 599 patients, from 7/5/14 through 1/5/15, to be exposed to medications that were not reviewed by pharmacist (see A-0273)

3. Based on interview and administrative record review, the hospital failed to ensure the incorporation of quality data to monitor that medication formularies (medications authorized to be used) were approved for 2012, 2013, and 2014. The hospital did not approve medication formularies for 2012, 2013, and 2014. These failures resulted in the potential for 599 out of 599 patients, from 7/5/14 through 1/5/15, to be exposed to medications that were not approved for hospital use (see A-0273).
The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participator for Quality Assessment and Performance Improvement.


Based on observation, staff interview, and document review the acute psychiatric hospital failed to ensure a quality assessment performance improvement program (QAPI) that included:
1. The incorporation of quality data to monitor that medication formularies (medications authorized to be used) were approved for 2012, 2013, and 2014. The hospital did not approve medication formularies for 2012, 2013, and 2014. These failures resulted in the potential for 599 out of 599 patients, from 7/5/14 through 1/5/15, to be exposed to medications that were not approved for hospital use.
The hospital's quality assessment and performance program (QAPI, process to ensure services are provided are safe and effective) did not identify, by the analysis of override data reported to the Pharmacy and Therapeutics committee, the lack of approved ADC medication override lists for 2012, 2013, and 2014. These failures resulted in the potential for 599 out of 599 patients, from 7/5/14 through 1/5/15, to be exposed to medications that were not reviewed by pharmacist.
2. The contracted Food Services including the contracted Consultant Registered Dietitian. The hospital's QAPI program did not have an effective ongoing program to monitor the services of Food Services. This failure would not track down nutritional quality indicators to identify and provide opportunities of improvement on patient care.
Findings:

Based on observation, staff interview, and document review the acute psychiatric hospital failed to ensure a quality assessment performance improvement program (QAPI) that included:

1. The incorporation of quality data to monitor that medication formularies (medications authorized to be used) were approved for 2012, 2013, and 2014. The hospital did not approve medication formularies for 2012, 2013, and 2014. These failures resulted in the potential for 599 out of 599 patients, from 7/5/14 through 1/5/15, to be exposed to medications that were not approved for hospital use.

2. The hospital's quality assessment and performance program (QAPI, process to ensure services are provided are safe and effective) did not identify, by the analysis of override data reported to the Pharmacy and Therapeutics committee, the lack of approved ADC medication override lists for 2012, 2013, and 2014. These failures resulted in the potential for 599 out of 599 patients, from 7/5/14 through 1/5/15, to be exposed to medications that were not reviewed by pharmacist.


Findings:

1. During a group interview, on 1/7/15 a 11:35 am, the hospital was requested to provide the approved medication formularies for 2012, 2013, and 2014. Those in attendance included Pharmacist in Charge (PIC), Director of Nursing (DON A), and Administrator.
During an interview, on 1/7/15 at 1:45 p.m., Clinical Director stated the hospital admitted 599 patients from 7/5/14 to 1/5/15.
During an interview, on 1/8/15 at 10:45 am, Director of Nursing (DON B) was asked to provide the approved medication formularies for 2012, 2013, and 2014. DON B acknowledged the hospital did not have an approved (by the Pharmacy and Therapeutics committee and the Medical Staff committee) medication formularies for the years requested,
During a concurrent interview and administrative record review, on 1/8/15 at 11:35 am, DON B identified the Heritage Governing Body and Committee Composition and Report Structure (undated). DON B reviewed the document and identified the Quality Assurance Performance Improvement (QAPI) Committee members. DON B acknowledged that the Director of Nursing was a member of the Quality Assurance Performance Improvement (QAPI) Committee. Upon further review DON B identified that the Pharmacy and Therapeutics committee reported to the Quality Assurance Performance Improvement (QAPI) committee. DON B acknowledged that the Director of Nursing was a member of the Pharmacy and Therapeutics committee.
During an administrative record review, of the hospital's P&T (Pharmacy and Therapeutics) meetings for 7/17/14, 8/21/14, 9/18/14, 10/16/14, 11/20/14, and 12/18/14, were reviewed. Review of the minutes did not show the hospital monitored, and identified, problems with the medication formularies for 2012, 2012, and 2013.
An administrative record review, of the hospital's policy and procedure for Formulary System (Policy: MM 1.3, Date of Revision: 10/12/11) showed, Formulary Review, "The Pharmacy and Therapeutics Committee will review the formulary at least annually ...Pharmacy shall provide substantiating reasons for deletions, additions or maintenance of the existing formulary. These will be based on therapeutic value, indication for use, effectiveness, contraindications, risks (including propensity for medication errors, abuse potential, and sentinel (serious) events), AB-rating (therapeutic equivalent), availability and cost. Emerging safety and efficacy information will be considered in the annual review of the formulary. Specific patient monitoring to detect adverse events, if applicable, will be included in all drug reviews ...At least annually the printed hospital formulary shall be reviewed and revised ...The revised formulary will then be printed and presented to the P&T Committee and the Medical Staff Committee for approval." Continued review showed, Procedure, 1. "The medication formulary will be implemented, maintained and reviewed by the Pharmacy and Therapeutics (P&T) Committee and approved by the Medical Clinical staff." The hospital did not approve medication formularies for 2012, 2013, and 2014.
2. During a concurrent observation and record review, on 1/6/15 at 8:45 am, Licensed Vocational Nurse (LVN 1) entered the medication storage area to obtain medications from the automated dispensing cabinet (ADC, cabinet to dispense medications). The ADC would not dispense triple antibiotic ointment for Patient 17. LVN 1 requested Registered Nurse (RN 3) to override the ADC. RN 3 provided the ADC override authority for Patient 17's triple antibiotic ointment (the hospital's pharmacy was open). LVN 1 obtained the triple antibiotic ointment from the ADC, At 8:56 am LVN 1 entered Patient 17's room and administered the triple antibiotic ointment to the patient's fingertip. RN 3 acknowledged she overrode the triple antibiotic ointment in the ADC. RN 3 stated that the triple antibiotic ADC override met the hospital's policy and procedure requirements.
During a concurrent interview and record review, on 1/6/15 at 10:30 am, Patient 17's medical record was identified. Review of the record showed the triple antibiotic ointment was ordered on 1/4/15. Review of the medication administration record showed the first dose of ointment was administered on 1/4/15. Pharmacist (Pharm 1) reviewed the records and acknowledged the triple antibiotic order was written on 1/4/14. Pharm 1 was asked if the ADC triple antibiotic override met the hospital's policy and procedure requirements. Pharm 1 stated that the ADC override did not meet the hospital's policy and procedure requirements. The hospital was requested to provide a list of all ADC overrides from 7/5/14 through 1/5/15.
During a concurrent group interview and record review, on 1/7/15 at 11:50 am, Pharmacist in Charge (PIC) identified the Vending System Charges From 7/5/2014 to 1/5/15 (overrides only) (ADC overrides). The group included Director of Nursing (DON A), and Administrator. Inspection of the override report showed it was 118 pages long. The approximate number of ADC overrides was 2832 (determined by sampling), The approximate number of ADC overrides, when the pharmacy was open was 826 (determined by sampling). The overrides included medications dispensed by the ADC. The list included medications nursing put back into the ADC. The group was asked how the hospital monitored pharmacy services using the override data. The group stated that the override data was presented at the Pharmacy and Therapeutics committee.
During an interview, on 1/7/15 at 1:45 p.m., Clinical Director stated the hospital admitted 599 patients from 7/5/14 to 1/5/15.
During a concurrent interview and administrative record review, on 1/8/14, at 10:55 am, with Director of Nursing (DON B), the hospital's policy and procedure for Automated Dispensing System (ADS) Profile Override (Policy #; Section MM 5.7, Date of Revision: 10/12/11) was identified. Attached to the policy and procedure was Override Medications 2011-2012 (dated 4/14/11). DON B acknowledged the Override Medications was dated 4/14/11. DON B was requested to provide the approved override medications for 2012, 2013, and 2014. The approved override lists for 2012, 2013, and 2014, were not provided before the end of the survey.
During a concurrent interview and administrative record review, on 1/8/15 at 11:35 am, DON identified the Heritage Governing Body and Committee Composition and Report Structure (undated). DON B reviewed the document and identified the Quality Assurance Performance Improvement (QAPI) Committee members. DON B acknowledged that the Director of Nursing was a member of the Quality Assurance Performance Improvement (QAPI) Committee. Upon further review DON B identified that Pharmacy and Therapeutics reported to the Quality Assurance Performance Improvement (QAPI) Committee. DON B acknowledged that the Director of Nursing was a member of the Pharmacy and Therapeutics committee.
During an administrative record review, of the hospital's P&T (Pharmacy and Therapeutics) meetings for 7/17/14, 8/21/14, 9/18/14, 10/16/14, 11/20/14, and 12/18/14, showed overrides were presented at each of the meetings. Review of the minutes did not show the committee identified the hospital did approve medication override lists for 2012, 2013, and 2014. The pharmacy and therapeutics committee failed to identify the hospital did not approve medication override lists for 2012, 2012, and 2013.
During an administrative record review, of the hospital's policy and procedure for Automated Dispensing System (ADS) Profile Override (Policy #: Section MM 5.7, Date of Revision 10/12/11) showed, Procedure, 6. "Override medications should be customized with consideration given to the scope of care within a patient car unit. The Pharmacy and Therapeutics Committee shall review the lists of approved override medications annually." The hospital did not approve override lists for 2012, 2013, and 2014.






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Based on observation, staff interview, and document review the acute psychiatric hospital failed to ensure a quality assessment performance improvement program (QAPI) that included:
1. The contracted foods service and contracted Consultant Registered Dietitian. This failure puts patient at risk of compromised patient care.
2. The incorporation of quality data to monitor that medication formularies (medications authorized to be used) were approved for 2012, 2013, and 2014. The hospital did not approve medication formularies for 2012, 2013, and 2014. These failures resulted in the potential for 599 out of 599 patients, from 7/5/14 through 1/5/15, to be exposed to medications that were not approved for hospital use.
3. The automated (medication) dispensing cabinet (ADC, cabinet to dispense medications) override data (medications removed without prior review by a pharmacist) was used to identify the lack of approved medication override (medications authorized to be used without the prior review by a pharmacist) lists for 2012, 2013, and 2014. The hospital's quality assessment and performance program (QAPI, process to ensure services are provided are safe and effective) did not identify, by the analysis of override data reported to the Pharmacy and Therapeutics committee, the lack of approved ADC medication override lists for 2012, 2013, and 2014. These failures resulted in the potential for 599 out of 599 patients, from 7/5/14 through 1/5/15, to be exposed to medications that were not reviewed by pharmacist.
Findings:
1. On 1/7/15 at 8:00 a.m., the Administrator stated that the contracts were evaluated using a form rating the contract from excellent, good, fair and poor. The Administrator stated they had two contracted services for the Consultant Dietitian and the food service. The Administrator stated that she met weekly with the food service manager to discuss patient complaints. Administrator stated more an informal process. The Administrator acknowledged there was no formal QAPI program to evaluate or identify indicators or established a performance improvements program to address the concerns.
Review of the Contract Evaluation Form dated Jul 7 25, 2014, for the contracted food service showed the evaluation was fair for quality of product and service, overall quality of product, quality of staff provided.
There was no QAPI program addressing performance improvement for a contracted food service evaluated as "fair."
The Administrator acknowledged that the nutrition clinical work provided by the Consultant RD was rated as " good " but she had not known what the Consultant RD standards were for nutrition care for the Acute Psychiatric Hospital after a discussion of the survey finding that brought to light the lack of Consultant services for the acute psychiatric care setting.
There was no QAPI program addressing performance improvement for the Consultant RD to meet the needs of the acute psychiatric patient.

Based on interview and record review the facility failed to ensure that there was an initial nursing assessment of care-needs and subsequent care planning for a diagnosis of hepatitis B carrier for one (2) of thirty-six patients. This failure resulted in a missed opportunity for patient education and had the potential that Patient 2 would not know what precautions to take to prevent transmission of hepatitis B while in the hospital and upon discharge to her family and community.

Definition:
Hepatitis B is a serious liver infection caused by the hepatitis B virus (HBV). If a person is infected with hepatitis B for more than six months, he/she is considered a carrier or chronic, even if there are no symptoms. This means that hepatitis B can be transmitted to others by having unprotected sex, exposing blood or open sores to another person, or sharing needles or syringes.

Findings:

On 1/5/15, review of the census sheet, showed that Patient 2 was on "blood/body fluid precaution" for being a "Hep B Carrier." On 1/6/15, review of the Summary of Findings in the initial nursing assessment, dated 1/2/5, showed that Patient 2 had diagnoses to include hepatitis B carrier. A problem list and treatment plan, dated 1/3/15, did not include the problem and interventions for the diagnosis of hepatitis B carrier.

During an interview on 1/7/15 at 2:40 p.m., the Registered Nurse Supervisor (RN 2) said recently the medical care plans switched from paper to electronic format. RN 2 did a search of the medical record, paper and electronic, and agreed there was no care plan and no education documented related to Patient 2 being a hepatitis B carrier. RN 2 said this will be a good learning experience for the nurses to not only concentrate on behaviors but also on the physical well being of patients.

At 4:15 p.m., Director of Nursing B (DON B) also in charge of infection control, said that since Patient 2 wasn't being actively treated for hepatitis B there may not be a care plan. DON B said blood precautions should be listed as a problem in the treatment care plan along with the precautions to take.

(Education of the patient about hepatitis B, is very important, especially in the carrier. This is a sensitive subject and must be handled tactfully, especially if the mode of transmission was sexual. Safe sex must be discussed. (National Institutes of Health)

( Persons with acute or chronic hepatitis B should prevent their blood and other potentially infective body fluids from contacting other persons. They should not donate blood or share toothbrushes or razors with household members. Saliva can be a vehicle of transmission through bites. The virus can survive outside the body for at least 7 days and still be able to cause infection. (Centers for Disease Control)

Based on interview and administrative record review, the hospital failed to ensure medications were administered safely and effectively (the implementation of policy and procedures) as evidenced by:
1. The failure of the hospital to ensure policy and procedure was implemented for the nursing override (medications removed without prior review by a pharmacist) of a medication in an automated (medication) dispensing cabinet (ADC, cabinet to dispense medications). The hospital did not follow policy and procedure to obtain (by override) triple antibiotic ointment for administration to one patient (Patient 17). This failure resulted in the potential for patients to be exposed to avoidable medication errors
2. The failure of the hospital to ensure QVAR (beclomethasone (steroid)) inhalation was administered following the manufacturer's information. The hospital administered QVAR to one patient (Patient 16). The nurse did not offer the patient a chance to rinse her mouth with water. This failure resulted in the potential for patients to be exposed to avoidable infections.
Findings:
1. During a concurrent observation and record review, on 1/6/15 at 8:45 am, Licensed Vocational Nurse (LVN 1) entered the medication storage area to obtain medications from the automated dispensing cabinet. The ADC would not dispense triple antibiotic ointment for Patient 17. LVN 1 requested Registered Nurse (RN 3) to override the ADC. RN 3 provided the ADC override authority for Patient 17's triple antibiotic ointment. LVN 1 obtained the triple antibiotic ointment from the ADC. At 8:56 am LVN 1 entered Patient 17's room and applied the triple antibiotic ointment to the patient's fingertip. RN 3 acknowledged she overrode ADC for the triple antibiotic ointment. RN 3 stated that the ADC override met the hospital's policy and procedure requirements.
During a concurrent interview and record review, on 1/6/15 at 10:30 am, Patient 17's medical record was identified. Review of the record showed the triple antibiotic ointment was ordered on 1/4/15. Review of the medication administration record showed the first dose of ointment was administered on 1/4/15. Pharmacist (Pharm 1) reviewed the records and acknowledged the triple antibiotic order was written on 1/4/14. Pharm 1 was asked if the ADC triple antibiotic override met the hospital's policy and procedure requirements. Pharm 1 stated that the ADC override did not meet the hospital's policy and procedure requirements.
During an administrative record review, of the hospital's policy and procedure for Automated Dispensing System (ADS) Profile Override (Policy #: Section MM 5.7, Date of Revision 10/12/11) showed, Procedure, 2. "In urgent situations when the resulting delays would cause harm to the patient, including situations in which the patient experiences a sudden change in clinical status." Continued review showed, 6. "Override medications should be customized with consideration given to the scope of care within a patient car unit. The Pharmacy and Therapeutics Committee shall review the lists of approved override medications annually." Further review showed an attachment titled Override Medications (dated 4/14/11). Review of the override medications did not show triple antibiotic ointment was on the list.
2. During a concurrent observation, interview, and record review, on 1/6/15 at 8:30 am, Licensed Vocational Nurse (LVN 1) obtained medications for Patient 16 from the medication storage area. Inspection of the medications showed they included QVAR. LVN 1 entered Patient 16's room and proceeded to administer the QVAR. LVN 1 did not offer Patient 16 water to rinse her mouth after the QVAR was administered. LVN 1 acknowledged that she did not offer Patient 18 water to rinse her mouth. LVN 1 stated that she usually offers her patient water to rinse after the administration of QVAR. LVN 1 was requested to provide QVAR drug information. LVN 1 provided the document titled LEXI-PALS Beclomethasone for QVAR drug information.
During an administrative record review, of the hospital provided LEXI-PALS Beclomethasone, showed, How is it best taken?, "Rinse out mouth after each use." LVN 1 did not offer Patient 16 an opportunity to rinse out her mouth.
During an administrative record review, of the QVAR Full Prescribing Information (manufacturer's information) (2014 Teva Respiratory) (drug information) showed, 5. Warnings and Precautions, 5.1 Local Effects, "Localized infections with Candida albicans (fungus or yeast) have occurred in the mouth and pharynx (throat) in some patients receiving QVAR. If oropharyngeal (mouth and throat) candidiasis (infection) develops, it should be treated with appropriate local or systemic (i.e. oral) antifungal therapy while still continuing with QVAR therapy, but at times therapy with QVAR may need to be temporary interrupted under close medical supervision. Rinsing the mouth after inhalation is advised."

Based on observation, interview, and administrative record review, the hospital failed to ensure the provision of pharmaceutical services and care that meets the needs of the patients as evidenced by:

1. Based on interview and administrative record review, the hospital failed to ensure annual approval of override medications. The hospital did not approve override (medications authorized to be removed without prior review by a pharmacist) medications for 2012, 2013, and 2014. These failures resulted in the potential for 599 out of 599 patients, from 7/5/14 through 1/5/15, to be exposed to medications that were not reviewed by pharmacist (see A-0491 #1).
2. Based on interview and administrative record review, the hospital failed to ensure a medication formulary (medications authorized to be used) was approved for 2012, 2013, and 2014. The hospital's annual medication formulary was not implemented, maintained and reviewed by the Pharmacy and Therapeutics (P&T) Committee and approved by the Medical Clinical staff. These failures resulted in the potential for 599 out of 599 patients, from 7/5/14 through 1/5/15, to be exposed to medications that were not approved for use (see A-0511).
3. Based on interview and administrative record review, the hospital failed to ensure the Pharmacist in Charge (PIC) performance evaluation was completed in 2012, 2013, and 2014. The hospital did not complete a performance evaluation for the PIC in 2012, 2013, and 2014, to ensure the minimum requirements were maintained. These failures resulted in the potential for 599 out of 599 patients, from 7/5/14 through 1/5/15, to be exposed to the pharmacy services provided at less than the minimum required (see A-0023).

The cumulative effects of these systemic problems resulted in the pharmacy ' s inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services

Based on interview and administrative record review, the hospital failed to ensure the implementation of policy and procedures as evidenced by:
1. The failure of the hospital to ensure annual approval of override medications. The hospital did not approve override (medications authorized to be removed without prior review by a pharmacist) medications for 2012, 2013, and 2014. These failures resulted in the potential for 599 out of 599 patients, from 7/5/14 through 1/5/15, to be exposed to medications that were not reviewed by pharmacist.
2. The failure of the hospital to ensure patient's own schedule II medications (drugs with a high potential for abuse) were not administered. In 39 out of 599 patients, from 7/5/14 through 1/5/15, the hospital administered a patient's own schedule II medications. These failures resulted in the potential for the diversion of patient's own schedule II medications.
Findings:
1. During an interview, on 1/7/15 at 1:45 p.m., Clinical Director stated the hospital admitted 599 patients from 7/5/14 to 1/5/15.
During a concurrent interview and administrative record review, on 1/8/14, at 10:55 am, with Director of Nursing (DON B), the hospital's policy and procedure for Automated Dispensing System (ADS) Profile Override (Policy #; Section MM 5.7, Date of Revision: 10/12/11). Attached to the policy and procedure was Override Medications 2011-2012 (dated 4/14/11). DON B acknowledged the Override Medications was dated 4/14/11. DON B was requested to provide the approved override medications for 2012, 2013, and 2014. The approved override medications list for 2012, 2013, and 2014, were not provided before the end of the survey.
During an administrative record review, of the hospital's policy and procedure for Automated Dispensing System (ADS) Profile Override (Policy #: Section MM 5.7, Date of Revision 10/12/11) showed, Procedure, 6. "Override medications should be customized with consideration given to the scope of care within a patient car unit. The Pharmacy and therapeutics Committee shall review the lists of approved override medications annually." The hospital did not approve medication override lists for 2012, 2013, and 2014.
2. During a group interview, on 1/7/15 at 11:20 am, the hospital was asked to describe the process for ordering and dispensing schedule II medications. Those in attendance included Pharmacist in Charge (PIC), Director of Nursing (DON A), and Administrator. PIC's description included the physician writing an outpatient (not filled by the hospital pharmacy) prescription for the schedule II medication, Pharmacy 1 (an offsite retail pharmacy) filling the prescription, and the patient's prescription delivered to the hospital. PIC's description did not include the hospital ordering, and receiving, schedule II medication using their own DEA registration number (the hospital did not own the schedule II medication). PIC was asked if the hospital's policy and procedure allowed patient owned schedule II (controlled drugs) to be administered. PIC acknowledged the policy and procedure did not allow the hospital to administer a patient owned schedule II medication. The hospital was requested to provide the number of patients, from 7/5/14 to 1/5/15, who had received schedule II medication.
During an interview, on 1/7/15 at 1:45 p.m., Clinical Director stated the hospital admitted 599 patients from 7/5/14 to 1/5/15.
During an interview, on 1/8/15 at 11:06 am, DON B stated the hospital administered schedule II medications to 39 patients from 7/5/14 to 1/5/15.
During an administrative record review, of the hospital's policy and procedure for Patient-Owned Medications (Policy #; Section MM 5.2, Date of Revision: 3/25/10) showed, Procedure, Administration of Patients' Own Medication, 3. "Patients' own medications may be administered while in the facility if all of the following circumstances apply: ...c. The ordered medication is not a controlled drug." The hospital administered patient owned medications that were controlled drugs.

Based on observation, interview, and record review, the hospital failed to ensure medications stored in the treatment room maintained labeled sterility. The hospital stored opened bottles of sterile water. The sterility of the contents of the opened bottles was not maintained. This failure resulted in the potential, from 12/6/14 to 1/6/15, for patients to have been exposed to avoidable infections.
Findings:
During a concurrent tour, interview, and record review, on 1/6/15 at 2:35 p.m., on the nursing unit, Pharmacist in Charge (PIC) identified the treatment room. Inspection of the treatment room showed a cabinet labeled as Doctors Supplies, Dressing Supplies. Inspection of the cabinet showed that it contained two 1 liter bottles of sterile (germ free) water. Both of the bottles were opened (no longer sterile as labeled) and some of the contents were removed. One of the bottles was dated 12/6/14 (31 days prior). The other bottle was undated. Licensed Vocational Nurse (LVN 1) was asked to describe how the hospital used the sterile water. LVN 1's description included CPAP (continuous positive airway pressure (assists breathing at night)) and wound dressing changes. PIC was asked to describe the hospital's expectation for the dating, and storage, of opened bottles of sterile water. PIC stated that opened bottles of sterile water were to be used once and then discarded. PIC stated that the opened bottles should not have been in the treatment room.
During an administrative record review, of the hospital's policy and procedure for Medication Storage (Policy #: Section MM 2.1, Date of Revision: 10/12/11) showed, Procedure, 2. "Medications must be stored under proper conditions of sanitation, light, humidity, ventilation, segregation, and security as determined by the USP/NF compendia and/or manufacturer's labeling, as well as in compliance with applicable federal and state laws/regulations and accreditation standards." The sterility of the opened bottles of sterile water was not maintained as labeled.

Based on interview and administrative record review, the hospital failed to ensure a medication formulary (medications authorized to be used) was approved for 2012, 2013, and 2014. The hospital's annual medication formulary was not implemented, maintained and reviewed by the Pharmacy and Therapeutics (P&T) Committee and approved by the Medical Clinical staff. These failures resulted in the potential for 599 out of 599 patients, from 7/5/14 through 1/5/15, to be exposed to medications that were not approved for use.
Findings:
During an interview, on 1/7/15 at 1:45 p.m., Clinical Director stated the hospital admitted 599 patients from 7/5/14 to 1/5/15.
During a concurrent interview and administrative record review, on 1/8/14, at 10:45 am, with Director of Nursing (DON B), the hospital's policy and procedure for Formulary System was identified. Attached to the policy and procedure was RxLink Drug Formulary (dated Tuesday, October 11, 2011) (medication formulary). DON B acknowledged the RxLink Drug Formulary was dated Tuesday, October 11, 2011. DON B was requested to provide the approved medication formularies for 2012, 2013, and 2014. The approved formularies for 2012, 2013 and 2014 were not provided before the end of the survey.
An administrative record review, of the hospital's policy and procedure for Formulary System (Policy: MM 1.3, Date of Revision: 10/12/11) showed, Formulary Review, "The Pharmacy and Therapeutics Committee will review the formulary at least annually ...Pharmacy shall provide substantiating reasons for deletions, additions or maintenance of the existing formulary. These will be based on therapeutic value, indication for use, effectiveness, contraindications, risks (including propensity for medication errors, abuse potential, and sentinel (serious) events), AB-rating (therapeutic equivalent), availability and cost. Emerging safety and efficacy information will be considered in the annual review of the formulary. Specific patient monitoring to detect adverse events, if applicable, will be included in all drug reviews ...At least annually the printed hospital formulary shall be reviewed and revised ...The revised formulary will then be printed and presented to the P&T Committee and the Medical Staff Committee for approval." Continued review showed, Procedure, 1. "The medication formulary will be implemented, maintained and reviewed by the Pharmacy and Therapeutics (P&T) Committee and approved by the Medical Clinical staff." The hospital did not approve medication formularies for 2012, 2013, and 2014.

Based on observation, interview, and document review the acute psychiatric hospital failed to ensure dietary services had met the needs of all patients as evidenced by:
1. Develop comprehensive contracted organizational structure to ensure the nutritional needs of patients were met including dietary staff supervision, following the planned menu, accuracy of serving the menu for regular and therapeutic diets, dietary staff training, (Cross Reference A620, A621, A622)
2. Develop performance improvement activities that accurately reflected the scope and nature of the contracted services (Cross Reference A82, A265.)
3. Ensure safe and effective ice machine cleaning and sanitizing (Cross Reference A749)
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 comprehensive contracted organizational structure to ensure the nutritional needs of patients were met including dietary staff supervision, serving hot food at correct temperature, following the planned menu, accuracy of serving the menu for regular and therapeutic diets, dietary staff training. These failures put patients at risk of compromised medical and nutrition status.

Findings:
Starting on 1/6/15 at 9:30 a.m., the Dietary Services Supervisor ' s job description (revised 2/10 RD ' s for HealthCare) stated she was responsible dietetic staff supervision, staff training and in-servicing, provide and utilize an accurate tray card for each patient.

On 1/6/15 starting at 11:15 a.m., lunch dining service was observed. Review of the daily shift report for 1/6/15 showed a census of 20 and included 2 patient ordered low fat low cholesterol diets (LFLC), and 3 patients on no concentrated sweets NCS diets, 12 regular diets, and 2 on no added salt (NAS) diet . One patient on census did not have a diet listed.

1. Food temperature of the hot food was taken the facility digital thermometer for the pasta was 113 degrees Fahrenheit (F) at 11:15 a.m. The zucchini and chicken temperatures recorded at 153 degrees F and 165 degrees F respectively. Cook 1 wrote the temperatures in the meal temperature log and served the lunch.

Concurrent interview with the DSS regarding the temperature of the pasta confirmed that the 113 degrees F was too low. The hospital did not provide a policy to verify the temperature of hot food at serving. The standard of practice for serving hot food is 135 degrees F or more. (Food and Drug Administration (FDA) Food Code 2013).

2. The menu dated Week 4 Tuesday specified Milk 4 ounces for regular, no concentrated sweets (NCS) diets. There was no milk served. Low fat low cholesterol menu specified fat free milk (FF). No FF milk was served.

The regular diet Week 4 Tuesday menu stated Mediterranean herbed wheat pasta. The patients received egg noodles.

The Week 4 Tuesday menu specified Blushing Tapioca Pudding for regular and NCS diet, Vanilla pudding was served. Low fat low cholesterol diet specified blushing tapioca pudding made with FF milk. Cook 1 stated on 1/14/15 at 8:00 a.m. that the vanilla pudding that was served was made with low fat milk.

The week 4 Tuesday Low fat low cholesterol diet was served garlic bread (bread buttered) when the menu specified wheat bread 1 slice- no margarine. The menu had an asterisk noting the low fat diet could have low fat margarine spread. On 1/14/15 at 11:30 a.m., the Dietary Service Supervisor was not able to state if the spread served was a low fat margarine product.

The week 4 Tuesday menu for No Concentrated Sweets diet (NCS) was to receive ¼ cup pasta and 1/2 slice garlic bread. The NCS received ½ cup pasta and 1 slice garlic bread.
Interview concurrently with the LVN 1 in the dining room, stated she was to write down the meal percentage intake for each patient. The LVN 1 stated the dietary servers knew " every body ' s diet. "
Concurrent interview with the mental health specialist 1 stated her job was to take attendance for the meal.
Concurrent interview with cook 1 stated she served all the diets as regular because she was not informed by the LVN of the patients with therapeutic diets.
Interview with Food Service Worker 1 stated she was told who was diabetic so she would not give the sugar for their coffee.
Interview with Nurse Director on 1/7/15 at 8:20 a.m. stated the hospital mental health specialist and LVN assigned to the dining room will monitor to ensure the patient receive the therapeutic diet as ordered. The patient ' s diet is sent to the dietary department on admission and if the diet changes. The patients ' diets are included on the census report available in the dining room.
3. Interview with the Dietary Services Supervisor (DSS) on 1/8/15 at 8:30 a.m., stated there were no quality indicators or QAPI plan to evaluate the food service at Heritage. The DSS could not show documentation of supervising the accuracy of the therapeutic diets or the menu accuracy.

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 patient and family counseling, evaluating patient tolerance to therapeutic diets, collaborating with hospital staff to plan and implement patient care to ensure all aspects nutritional care are met, in timely manner. These failures put patients at risk of compromised nutritional status and goals for maintaining nutrition status after discharge.
Findings:
1. Review of the responsibilities of the consultant dietitian provided by RDs for Healthcare policy dated revised 2/10, stated the dietitian will sign a consulting agreement with the Administrator, specifying hours or consultation per month, responsibilities of the Registered Dietitian.
There was no documentation of a consulting agreement for the Heritage PHF stating specific job duties and extent of nutrition services.
The RDs for Healthcare policy stated the Dietitian will provide staff development programs, in-service or dietary and nursing staff and consultations that assure the professional dietetic service needs of the facility are met.
There was not documentation of the Dietitian developing the in-services program for Heritage PHF.

Based on interview and document review the hospital failed to ensure dietary staff providing meals under contract was provided in-service training to ensure they were competent to perform their assigned jobs. These failures put patients at risk of compromised nutrition status.
Findings:
Review of the policy titles staff development stated in-service training will be presented to the dietary staff at least monthly. The employee record of In-service contained 28 topics for 2014. There was no topic for serving therapeutic diets or following the menu. However the topic was on the 2013 Employee record.
Review of the Employee Record of In-Service Attendance 2014 for cook 1 showed 7 in-service topics presented over 4 months. These classes included kitchen sanitation dish and pot washing food safety and glove use. There were no in-services documented for the dietary staff that served the Heritage meals regarding following the therapeutic diet menu or following recipes.
Interview with Consultant RD on 1/7/15 at 9:00 a.m. stated that she provided brief and informal topics to the dietary staff that were not documented.

Based on observation, interview and record review the facility failed to implement appropriate infection control practices when:

1. Nursing staff did not clean the glucometer as recommended by the manufacturer.
2. Staff 1 was unaware that a patient had blood borne precautions for being a Hepatitis B carrier.
3. Staff 2 did not have a class on blood borne pathogens prior to working independently.
4. Two of two ice machines used to serve ice to 20 to 27 patients per day were cleaned and sanitized according to the manufacturer's directions.

These failures could potentially place patients and staff at risk for transmission and spread of infections. Failure to follow specific manufacturer ' s directions for cleaning and sanitizing the ice machines put all patients at risk of food borne illness (infection by food or ice that contain harmful bacteria, parasites, viruses, or chemicals).

Findings:

1. On 1/6/15 at 10:25 a.m., during an observation and interview, Licensed Vocational Nurse 2 (LVN 2) cleaned the Easy Max glucometer with alcohol swabs before and after use on Patient 15. LVN 2 said that the glucometer was used for multiple patients. LVN 2 pointed to the Super Sani-Cloth Germicidal Disposable Wipes container and said sometimes he used them for cleaning the glucometer but thought the alcohol swabs were easier to use.

Review of the Easy Max Long Term Care Blood Glucose System User's Manual, undated, showed that the device could be used for multiple patients. The User's Manual had instructions to clean the glucometer after every use to prevent any possibility of cross infection. Wipes used should be EPA-registered as a disinfectant with care to adhere to the recommended wet contact time. (EPA registration means that the product has been approved by the Environmental Protection Agency for healthcare use as being effective against the most common emerging bacteria and viruses. To disinfect means to cleanse so as to destroy or prevent the growth of disease-carrying microorganisms.) The alcohol swabs did not have a an EPA registration number listed on the packet. The Super Sani-Cloths had the EPA Reg. NO.9480-4 listed on the container.)

On 1/7/15 at 1 p.m., during an interview, DON B, also in charge of infection control, said staff should use the Super Sani-Cloths but one drawback was that they were big (about 6 inches square.) DON B said she ordered smaller sized Sani-Cloth wipes that were individually wrapped. By observation DON B was unable to find smaller wipes in the medication room where the glucometer was kept. DON B said she would order the individually wrapped EPA registered wipes and in the meantime ensure staff used the Super Sani-Cloth Germicidal Wipes already available.

2. On 1/5/15 and 1/6/15, review of the census sheets showed that Patient 2 had "blood/body fluid precautions due to being a hepatitis B carrier.

On 1/7/15 at 2:30 p.m., during an observation, Staff 1 was in the hallway with the cleaning cart.

On 1/7/15 at 2:40 p.m., during an interview, the Registered Nursing Supervisor (RN 2) said that nursing staff communicated infection control problems via the shift reports and via information on the census sheet. Non-nursing staff did not attend the nursing shift reports and did not receive a daily census sheet. RN 2 referred to a document, "Red Flag Patients," which was in a plastic pocket on the back of the nursing station door, and said that usually the night nurse prepared the document which was a list of patients' names and room numbers, risk behavior/s and level of observations. At the end of the document was an explanation that red flags included any problematic behavior and to communicate the findings to all non-nursing department personnel. RN 2 said the red flags usually included medical conditions staff should be aware of. RN 2 said non-nursing staff knew to check the red flag list prior to starting their shifts. There were three red flag documents dated 1/4/15, 1/5/15, and 1/7/15. Patient 2 was not included on any of the red flag documents. One random patient was listed as having lice on 1/4/15 and 1/5/15.

At 3 p.m., during interviews, Staff 1 said he worked on 1/5/15 and 1/6/15 when Patient 2 was an inpatient on the unit. Staff 2 was unaware that Patient 2 was a hepatitis B carrier. During mutual review of the red flag list, Staff 1 said he never saw it before and was unaware to check it daily prior to starting his shift. Staff 1 said a fellow employee told him about the patient with lice. Staff 2 said he also worked 1/6/15 and remembered some one mentioning that a patient had hepatitis B. Staff 2 didn't know which body fluid/(s) were involve. Staff 2 worked in the facility about a month.

On 1/7/15, at 4:30 p.m., DON B and the Administrator said that they didn't know what training Staff 1 and 2 had related to infection control because they were under a contracted service. They suggested I talk with the supervisor of the contracted services, who was an employee of the adjacent facility and had responsibility for the Staff 1 and 2.

3. On 1/8/15 at 10:35 a.m., during interview and record review, the supervisor of the housekeepers, Director of Facility Operations, said that the director of nursing in the adjacent facility gave an infection control class to the newly hired contracted staff. Review of the inservice attendance record showed that Staff 1 attended the class on infection control on 11/12/14. Staff 1's date of hire was 11/10/14. Staff 2 was not listed on the attendance sheet. The Director of Facility Operations said that Staff 2 missed the class. Staff 2's date of hire was 11/24/15 and there was no make-up class. The handouts for the infection control class included Ebola information and donning personal protective equipment. There was no documentation of training methods, time frame of the class, and post training testing to establish competency. The Director presented an e-mail showing there was an OSHA (Occupational Safety and Health Administration) class scheduled for 1/13/15 with the topic of Bloodborne Pathogens Standard.



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4. On 1/7/15 stating at 1:15 p.m., the maintenance staff stated that the 2 ice machines were cleaned every 4 months. Maintenance staff stated this consisted of wiping interior with hot water, as he did not like to use chemicals.
Review of the two manufacturer ' s directions required specific chemicals for a descaling cycle to remove buildup of mineral deposits and a sanitizing step with a specified sanitizer for one brand and a chlorine bleach concentration for the other.
The maintenance staff was not cleaning or sanitizing the ice machines as directed by each manufacturer.
Interview with DON B on 1/7/15 at approximately 2:00 p.m. acknowledged she did not know how the ice machines were maintained and did not know that the maintenance staff that was responsible for the cleaning and sanitizing was not using the required cleaning and sanitizing chemicals.