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Tag No.: A0043
Based upon review of contract services, Performance Improvement Plan and Measures, Governing Body and Medical staff Meeting Minutes, the hospital failed to be in compliance with the Conditions of Participation related to Governing Body. This was evidenced by:
1) Failure to ensure there was a system in place to monitor all hospital services and operations related to contract services and failure to follow the Performance Improvement Plan related to a systematic process for monitoring and evaluating quality safety related to pharmacy services and infection control (A083, A084, A085, A0273, A0283)
2) Failure of the Governing Body to ensure there was a full-time, part-time, or consultant pharmacist. (A0492)
Tag No.: A0083
Based upon review of contract services, governing body meeting minutes for 2013, and interviews, the governing body failed to ensure: 1) all contract services were assessed through the Performance Improvement Program, and 2) there was a valid contract for pharmacy services and the provision of a pharmacist either on a full-time, part-time or contract basis. Findings:
Review of the Performance Improvement Measures for 2013 revealed there failed to be documented evidence the contracts were assessed through the Performance Improvement Program.
Interview with S3 CEO on 1/14/15 at 9:55 a.m. revealed the Contract C was providing pharmacy services; however, this contract had been canceled the beginning of December 2013. S3 CEO further indicated that a new local pharmacy was being utilized for the provision of patient medications, but did not supply a pharmacist.
There failed to be documented evidence the Governing Body identified there was no pharmacy contract or pharmacist responsible for the drug storage area. The last Governing Body Meeting Minutes for review was dated September 2013.
Tag No.: A0084
Based upon review of contract services, Performance Improvement (PI) Program and Performance Measures for the year 2013, and staff interview, the hospital failed to ensure all contracted services were reviewed through the PI Program. This was evidenced by the failure to develop a system related to implementation of performance measures for reviewing the contracts for Pharmacy, Radiology, Laboratory, and Respiratory Care Services. Findings:
Review of the list of contracted services revealed Pharmacy, Radiology, Laboratory and Respiratory Care Services were arranged to be provided by contract.
Review of the Performance Improvement Performance Measures for the year 2013 revealed there failed to be evidence the contracts for Pharmacy, Radiology, Laboratory, and Respiratory Care Services were reviewed through the PI Program to ensure the services were provided in accordance with the responsibilities identified in the contracts.
Tag No.: A0085
Based upon review of the list of contract services and staff interviews, the hospital failed to ensure a contract for the pharmacy services that was implemented in December 2013 was included in the list of services. Findings:
Review of the list of contract services revealed Contract C was to furnish pharmcy services. Interview with S3 CEO on 1/14/14 at 9:55 a.m. revealed Contract C had been canceled and the hospital was using a new local pharmacy for the provision of medications. When the contract for the new pharmacy was requested, S3 CEO replied there was no contract.
Tag No.: A0263
Based upon review of Governing Body Meeting Minutes, Performance Improvement Plan and Measures, and interviews, the hospital failed to meet the Condition of Participation for Quality Assurance. This was evidenced by:
1) Failure to monitor hospital services and operations related to the contract services for Pharmacy, Laboratory, Radiology, and Respiratory Therapy to ensure these services were provided in a safe and effective manner, and failure to develop measures related to Infection Control to ensure surveillance and monitoring of nosocomial infections were reported and the data analysed. (A0273)
2) Failure of the Governing Body and Medical Staff to ensure actions aimed at Performance Improvement were implemented to ensure the measures were successful and sustained. (A0283)
Tag No.: A0273
Based upon review of contract services, Performance Improvement Program and Measures, and staff interview, the hospital failed to ensure:
1) a system was in place to monitor hospital services and operations related to contract services, and
2) the Performance Improvement Plan was followed related to monitoring Pharmacy Services and Infection Control.. This was evidenced by:
a) the failure to include in the Performance Improvement Measures the contracted services related to Pharmacy, Laboratory, Radiology, and Respiratory Therapy to ensure these services were provided in accordance with the contract and were provided in a safe and effective manner, and
b) failure to follow the Performance Improvement Plan related to Pharmacy Services for ensuring there was a systematic process for ongoing, planned monitoring and evaluation of the quality safety and appropriateness of patient care services, and Infection Control related to surveillance and monitoring the rate of nosocomial infections and analysis of the data . Findings:
1) Review of the list on contract services revealed Pharmacy, Laboratory, Radiology and Respiratory Care Services were to be provided through contract.
Review of the Performance Improvement Plan and Measures for 2013 revealed there failed to be documented evidence quality measures were implemented for the contract services Pharmacy, Laboratory, Radiology, and Respiratory Therapy to ensure the services were provided in a safe and effective manner.
Review of the Performance Improvement Plan, Policy #6001, page 26 of 26, effective 07/2010 and revised 10/2013, revealed for Performance Improvement Functions, revealed no contract service was identified.
2) Review of the Performance Improvement Plan for Infection Control Review revealed "The PI Committee shall develop standard, clinically valid, approved written criteria for surveillance, monitoring the rates of nosocomial infections. Systems for the collection and analysis of data, the prevention and control of infection reporting by types of infection, (i.e., respiratory, wound, unusual epidemics, clusters of infections)...The PI Committee shall be responsible for the development, evaluation and implementation of improved patient care procedures relating to infection control..." Review of the Infection Control data collected for October, November, and December 2013 revealed a lists of the patient's name, the infection, and the treatment provided. Review of the Performance Improvement Measures for 2013 revealed for Infection Prevention and Control, the measures were 1) Healthcare Associated Infections, 2) UTI's (Urinary Tract Infections) implemented in 12/2009, 3) Hand Washing Competency: New Employees and Annually implemented 03/2010), 3) Lab supply tray cleaned weekly, implemented 12/2009, and 4) Patient Refrigerator cleaned weekly, implemented 12/2009. There failed to be documented evidence the nosocomial infection rate was identified as outlined in the PI Plan.
Further review of the Performance Improvement Plan, page 19 of 26, effective 07/2010 and revised 10/2013, revealed "Indirect Patient Care Review: Pharmacy: The Pharmacy shall be responsible for ensuring that there is ongoing, planned and systematic process for the monitoring and evaluation of the quality, safety and appropriateness of patient care services as they relate to the appropriateness of empiric and therapeutic use of medications, cost-effectiveness, medication incompatibilities, medication reactions and interactions and experimental or investigational use of drugs. Review and evaluation shall be based on the use of objective criteria that reflect current knowledge, clinical experience and relevant literature. Written reports of the findings, conclusions, recommendations, actions taken and the results of actions taken shall be maintained and reported at least monthly to the PI Coordinator and at each Medical Staff Meeting."
Review of the Performance Measures for 2013 revealed for pharmacy services, Medication Management was identified to include the following measures: 1) PRN Medication follow-up documented, 2) Medication Variance, 3) Medication involved in variance is documented in the medical record, and 4) Adverse Drug Reaction. There failed to be evidence performance measures were implemented related to the appropriateness of empiric and therapeutic use of medications, medication incompatibilities, and medication interactions. Interview with the S3 CEO on 1/14/14 at 9:55 a.m. revealed in December 2013, the hospital canceled Contract C who provided pharmacy services and was using a local pharmacy for the provision of medications. S3 CEO further added the new pharmacy did not provide an on-site pharmacist, therefore, no appropriateness of empiric and therapeutic use of medications, medications incompatibilities and interactions were not reviewed by a pharmacist.
Tag No.: A0283
Based upon review of the Performance Improvement Plan and Measures for 2013. Medical Executive Meeting Minutes for 2013, Governing Body Meeting Minutes for 2013, and staff interview, the hospital failed to ensure actions aimed at performance improvement were implemented to ensure the measures were successful and sustained. Findings:
Review of the Performance Improvement Plan revealed Reference #6001, page 3 of 26, "Serenity Springs Specialty Hospital also utilizes a systematic process to assess collected data in order to determine: Whether design specifications for new processes were met, The level of performance and stability of important existing processes, Priorities for possible improvement of existing processes, Actions to improve the performance of processes, and Whether changes in the processes resulted in improvement."
Review of the Performance Measures for 2013 revealed the majority of the measures were implemented in 2009 and 2010.
Review of the Medical Executive Meeting Minutes for 2013 revealed the following for QA (Quality Assurance)/Performance Improvement Reviews:
January 25, 2013: QA/Performance Improvement: The possibility of a Quality Assurance Committee was discussed. The following were suggested as potential members: The CEO, Program Director, the DON, the Medical Records Technician, the Social services Director, and a Mental Health Technician. Conclusions: None.
Action Items: None.
March 22, 2013: QA/Performance Improvement: (Contract D) sent containers for the nursing staff to use for medical waste. All unused medications, except for narcotics, are to be discarded in the containers. (S3 CEO) stated that the Performance Improvement tool must be revised in order to be useful to the hospital.
Conclusions: The containers are currently in use.
Action Items: Determine the frequency that the pharmacist comes to the unit to destroy the narcotics, (S1 Psychiatrist) will begin telling nurses how many medication dosages to order for each patient.
June 28, 2013: QA/Performance Improvement: The P.I. tool will be reviewed by the CEO in the Med Exec meetings, The use of chemical restraints according to CMS regulations was discussed. Implement a new process for the nursing staff to ensure delinquent forms in the charts were completed before the patient is D/C. The nurse who completes the chart check every night will report the delinquencies in the AM report. The staff will then have 24 hours to complete. The nurses are not accurately completing the intake forms for patients not admitted. They are not consistently circling why the patient is not admitted and are not signing the bottom of the back page.
Conclusion: CMS describes a chemical restraint as any medication given to a patient which restricts the freedom or movement or in some bases to sedate a patient. (S1 Psychiatrist) should be notified if it is noticed that a patient is sedated after medication has been administered. Need to indicate on the Intake form which exclusionary criteria is preventing the patient from being admitted. Indicate why we are not accepting patients. The nurses are to ask (S1 Psychiatrist) the amount of medications to order for each patient so there will not be a surplus after the patient is discharged. They are also to notify (S1 Psychiatrist) if the patient has more than one prescribed inhaler.
Action Items: Intake in-service needs to be scheduled for the nursing staff. The nurses are to asked (S1 Psychiatrist) the amount of medications to order for each patient so there will not be a surplus after the patient is discharged...
September 20, 2013: QA/Performance Improvement: (S2 DON) suggested that the interdisciplinary progress note form be revised. (S3 CEO) instructed (S2 DON) to revise the form and then submit to her for approval.
Conclusion: None listed.
Actions: Monitor the food temperature logs to ensure the updated version of the form is in use. Revise the interdisciplinary form and submit to (S3 CEO) for approval.
Review of the Governing Body Meeting Minutes related to the review of QA/Performance Improvement Measures revealed the following:
March 8, 2013: Discussion: (S3 CEO) reported that the current PI tool was being reviewed and revised to ensure that information gathered was accurate and valid. The current PI tool will be used until the new tool is completed and approved by the board.
Conclusions: It was agreed that the current PI tool needs to be revised.
Action: Revise PI tool.
June 14, 2013: Discussion: (S3 CEO) submitted the PI report for the past quarter.
Conclusion: None
Action: Revise PI tool
September 19, 2013: Discussion: (S3 CEO) submitted the PI report for the past quarter.
Conclusion: None
Action: None documented.
Interview with the S3 CEO on 1/14/14 at 9:55 a.m. revealed no evidence to indicate actions aimed at performance improvement were implemented to ensure the measures were successful and sustained
Tag No.: A0490
Based upon review of contract services, observations, and interviews, the hospital failed to meet the Condition of Participation for Pharmacy Services. This was evidenced by:
1) Failure to ensure there was a pharmacist on a full-time, part-time or contract basis responsible for supervising pharmacy activities. (A0492)
2) Failure to ensure there was a valid contract for the provision of Pharmacy Services. (A0492)
3) Failure to ensure all medication orders were reviewed by a pharmacist prior to dispensing the first dose. (A0500)
4) Failure to ensure the drug storage area was locked at all times. (A0502).
Tag No.: A0492
Based upon review of contract services, list of hospital personnel, and interviews, the hospital failed to ensure there was a full-time, part-time or consultant pharmacist responsible for supervising activities of the pharmacy services. This was evidenced by: 1) the failure to have documented evidence of a written agreement with a Pharmacist, and 2) failure to identify the responsibilities of the Pharmacist. Findings:
Review of the list of Contracted Services revealed pharmacy services was to be provided by Contract C, however, a letter dated 12/16/13 from Contract C revealed "I am in receipt of the enclosed letter dated the 3rd of December 2013. (Contract C) has enjoyed working with Serenity since 2007 and certainly want to retain this relationship/business. In reviewing the current contract on file, it has expired the 4th of December 2012 'initial term'. There was a provision in the agreement that after the contract expired, it would automatically renew each year with a one (1) year term unless Serenity canceled the contract ninety (30) days from the expiration date; respectively September 1st. I certainly understand this may have been an oversight knowing you all have been moving locations..."
Interview with S3 CEO on 1/14/14 at 9:55 a.m. revealed when asked about the pharmacy services provided by Contract C, S3 CEO replied the contract was canceled the beginning of December 2013 and a local pharmacy was providing medications. When the contract for the new pharmacy services was requested, S3 CEO replied there was not a contract with this pharmacy and the pharmacy did not provide an on-site pharmacist.
Interview with S2 Registered Nurse/Director of Nurses (RN/DON) on 1/14/14 at 1:50 p.m. revealed when asked if the new pharmacist had been on-site at the hospital, S2 RN/DON replied he had been at the hospital in December 2013 and himself and the pharmacist "had destroyed some medications". When asked when the last pharmacy review of the drug storage area had been done, S2 RN/DON replied a Pharmacist from Contract C had been in the hospital in November 2013.
Observations of the drug storage area on 1/15/14 at 9:45 a.m. revealed in the medication refrigerator a bottle of Lantus Insulin was opened 10/22/13 and available for use. Interview with S5 LPN during the observation revealed any medication bottles that had been opened should be discarded within thirty days. Humalog insulin opened however, you could not read the date documented it was first used. Two bottles of Hep B vaccine expired (10/21/13 and 1/6/14).
Tag No.: A0500
Based upon review of the Pharmacy Contract and staff interview, the hospital failed to ensure all medication orders were reviewed for appropriateness by a pharmacist prior to dispensing the first dose. Findings:
Review of the list of contract services revealed pharmacy services was to be supplied by Contract C; however, the contract failed to identify the pharmacist who was to provide pharmacy services oversight. Further review of Contract C revealed a letter dated 12/16/13 from Contract C that identified the contract pharmacy service had been canceled.
Interview with S3 CEO on 1/14/14 at 9:55 a.m. revealed since moving to the new facility, a local pharmacy was being used to obtain medications, and the Contract C had been canceled the beginning of December 2013. When the contract for the new pharmacy was requested, S3 CEO replied there was no contract and added the new pharmacy did not provide an on-site pharmacist.
Further interview with S3 CEO and S2 RN/DON on 1/14/15 at 11:30 a.m. revealed when asked if patient medication orders were reviewed by a pharmacist for appropriateness prior to the first dose, both replied "no".
Interview with S2 RN/DON on 1/14/14 at 1:50 p.m. revealed when asked when the last time a pharmacist was in the hospital, S2 RN/DON replied the pharmacist from the new pharmacy was in the hospital in December 2013 and "some medications were destroyed". When asked when the last pharmacy review of the drug storage area was done, S2 DON replied "a pharmacist from Contract C was here in November 2013".
Tag No.: A0502
Based upon observations and staff interviews, the hospital failed to ensure the drug storage area was locked at all times. This was evidenced by the nursing personnel leaving the drug storage area door open during the days of the survey from 01/09/14 to 01/10/14 and 01/13/14 to 01/15/14. Findings:
Observations of the drug storage area, located behind the nursing station, revealed the medication storage area door was left open during the days of survey on 01/09/14 through 01/10/14 and 01/13/14 through 01/15/14.
Interview with S5 Licensed Practical Nurse (LPN) on 01/15/14 at 2:30 p.m. revealed when asked about the drug storage area door being left open, S3 LPN replied the door was always left open because the nursing staff were in the nursing station. It was also observed during the survey days that other hospital personnel, i.e., Recreational Therapist, Social Workers/Therapists, and Mental Health Technicians walked into and out of the nursing station and would have access to the open drug storage area.
Tag No.: A0546
Based upon review of the list of medical staff, physician credential files, contract services, and staff interview, the hospital failed to ensure a full-time, part-time, or consultant radiologist was on the hospital's medical staff. Findings:
Review of the medical staff physician list revealed there were only two physicians on the hospital's medical staff. Review of the physician credential files revealed S1 Psychiatrist was identified as the hospital's medical director, and S4 physician was identified as a Family Practice practitioner. There failed to be documented evidence a Radiologist was on the hospital's medical staff.
Review of the list of contract services revealed Contract A was identified as the entity which supplied mobile radiological services and identified "Board certified specialists making interpretations of service within 24 hours after notification for routine exams". Further review of the contract revealed the Radiologist who was responsible for radiological interpretations failed to be identified.
Interview with S3 CEO on 1/14/14 at 2:10 p.m. revealed when asked if the hospital had a Radiologist appointed to the medical staff, S3 CEO replied "no".
Tag No.: A0584
Based upon review of contract services and staff interview, the hospital failed to ensure the contract for Laboratory Services identified a description of "stat" services to be provided and the turn-around-time the hospital was to expect of the results for the laboratory tests. Findings:
Review of Contract B revealed the contract for Laboratory Services failed to identify the provision of "stat" (immediate) laboratory tests including the turn-around-time the hospital would expect for the "stat" laboratory results. Interview with S3 CEO on 1/14/14 at 2:20 p.m. confirmed the contract failed to identify the provision of "stat" laboratory services.
S3 CEO further added if a patient required "stat" lab, they would probably require a transfer to another hospital.
Tag No.: A0654
Based upon review of the Utilization Review (UR) Plan and staff interview, the hospital failed to ensure UR reviews were not conducted by any individuals who had a direct financial interest in the hospital or were professionally involved in the care of the patient being reviewed. This was evidenced by the hospital allowing S1 Psychiatrist, who had a financial interest in the hospital, conduct reviews of the patient's she had admitted and cared for while they were in the hospital. Findings:
Review of the Utilization Review Plan revealed the plan failed to identify reviews were not to be conducted by physicians who had ownership interests in the hospital. The Plan also failed to identify the professional involved in the care of the patient was not reviewing their own case.
Interview with S9 Utilization Review on 1/15/14 at 3:35 p.m. revealed when asked who was on the UR Committee, S9 UR replied just herself and S1 Psychiatrist. S9 UR further stated when asked who reviewed S1 Psychiatrist patient care, S9 UR replied the psychiatrist reviewed her own cases.
Tag No.: A0748
Based upon review of personnel files, infection control policies and procedures, and staff interviews, the hospital failed to ensure the designated infection control officer (S2) acquired specialized training in infection control. Findings
Interview with S2, Registered Nurse/Director of Nursing (RN/DON) on 1/15/14 at 11:20 a.m. revealed he was the designated Infection Control Officer. When asked if he had any specialized training for this position, S2 RN/DON responded "no, I just took Infection Control over about 5 months ago".
Review of the personnel file for S2 RN/DON revealed there failed to be documented evidence of any infection control training or a job description related to the position of Infection Control Officer. Interview with S3, Chief Executive Officer (CEO) on 1/15/14 at 11:25 a.m. revealed the hospital did not have a job description for this position.
Tag No.: A0756
Based upon review of the Infection Control Program, Infection Control Worksheet, Performance Improvement Plan and Measures for 2013, and staff interview, the hospital failed to ensure all patient infections were reported to the QA/PI Program. Findings:
Review of the Infection Control Program, effective 07/2010 and revised 10/2013, titled "Interaction With Performance Improvement Programs" revealed "...The Infection Control Officer also supplied the Performance Improvement Coordinator with information that may be useful in identifying potential quality problems throughout the facilities. The link between performance improvement and infection control activities is information gathering and clinical analysis. Both are designed to identify patterns of patient care events that lead to suboptimal outcomes, thus identifying areas where patient care may need improvement."
Review of the Performance Improvement Plan, effective 07/2010 and revised 10/2013, titled "Infection Control Review" revealed "The PI Committee shall develop standard, clinically valid, approved written criteria for surveillance, monitoring the rates of nosocomial infections, systems for the collection and analysis of data, the prevention and control of infection reporting by types of infection, (i.e., respiratory, wound, unusual epidemics, clusters of infections), infections due to unusual pathogens and any concurrence of nosocomial infection that exceeds the usual baseline levels are also to be included...Nosocomial infections shall be reported to the Performance Improvement Committee and to the appropriate facility/departments/committees, as necessary."
Review of the Infection Control Worksheet for October, November and December 2013 revealed each month, a list was maintained that identified the patient's name, type of infection, treatment ordered, and if the infection was a nosocomial or community acquired (patient admitted to the hospital with the infection). Review of the Performance Improvement Measures for the year 2013 revealed the only information reported was in reference to Urinary Tract Infections. There failed to be documented evidence nosocomial and community acquired infections were reported to Performance Improvement.
Tag No.: A1153
Based upon review of Medical Staff Meeting Minutes, physician credential files, and staff interview, the hospital failed to appoint a director of respiratory care services to supervise the service and ensure respiratory care was properly administered. Findings:
Review of the Medical Staff Meeting Minutes for 2013 revealed there failed to be documented evidence a physician was appointed as director of respiratory care services.
Interview with S3, Chief Executive Officer (CEO), on 01/15/14 at 10:20 a.m. revealed when asked if a physician had been appointed as the director of respiratory services, S3 CEO replied "no" and further stated she was not aware a physician needed to be appointed.
Review of the credential files for the only two physicians on the medical staff (S1 Psychiatrist and S4 Family Practice Physician) revealed there failed to be documented evidence either physician was appointed to be the director of respiratory care services.
Tag No.: A1161
Based upon review of personnel files, respiratory care policies and procedures, contracts, and staff interview, the hospital failed to ensure: 1) policies and procedures were developed related to respiratory care services to identify the qualifications, education and training of nursing personnel who were responsible for the provision of respiratory care services, 2) if respiratory therapy service could be performed without supervision of the respiratory therapist, 3) documentation in the nursing personnel files of the required education, training, and evaluation conducted by a respiratory therapist to ensure the nursing staff were competent to perform respiratory therapy duties. Findings:
Review of the Respiratory Policies and Procedures revealed the policy failed to identify the specialized training and/or experience of the nursing personnel to ensure they were qualified to perform the respiratory treatments.
Review of the contract services revealed a contract, dated 6/1/11, revealed respiratory personnel were responsible for providing services in accordance with the patient's plan of care and treatment plan. The contract failed to identify a respiratory therapist who was to provide this service.
Review of the personnel files for S6 Registered Nurse (RN), S7 RN, S5 Licensed Practical Nurse (LPN), and S8 LPN, revealed there failed to be documented evidence specialized training by a respiratory therapist was conducted with the nursing personnel. There were no evaluations conducted by a Respiratory Therapist to ensure nursing personnel were qualified to conduct respiratory therapy treatments.
Interview with S3 CEO on 1/14/14 at 1:25 p.m. revealed when asked if there was a respiratory therapist on staff either on contract or a full-time or part-time basis, she replied "no".