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

FRIENDS HOSPITAL 4641 ROOSEVELT BOULEVARD PHILADELPHIA, PA Aug. 9, 2017
VIOLATION: PATIENT RIGHTS: ADMISSION STATUS NOTIFICATION Tag No: A0133
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policy and procedures, medical records (MR), and interview with staff (EMP), it was determined the facility failed to ensure that the primary care physician (PCP) was notified of the patients respective admission to the facility for five (5) of ten (10) patient rights medical records reviewed. (MR12, MR16, MR24, MR26, and MR29).

Findings include:

Review on August 4, 2017, of the facility policy, "Coordination of Care: Medical/Primary Care Physicians", dated "04/2014", revealed "I. Purpose ... The purpose of this policy is to ensure timely communication, authorization and release of pertinent clinical patient information for coordination and continuity of care from admissions to post discharge care ... II. Procedure ... 1. The assessment clinician in the Admissions Dept. (department) will identify, on admission, the medical or Primary Care Physician ... 2. This completion will include the name of Primary care Physician (PCP) ... 3. If consent is unable to be completed in its entirety in the Admission Dept., due to acuity of the patient or refusal, it will be completed during the Psychosocial Assessment by the Social Services Therapist (SST) in the inpatient unit ... 4. If the SST is unable to obtain the PCP and treatment provider(s), information from the patient or family during the psychosocial, the SST will inform the Utilization Reviewer on the unit (UR) and UR will attempt to obtain this information directly from the healthcare provider ... 5. Unit Charge Nurse will be responsible for obtaining any additional signatures, PCP names ... 6. In the case of patient refusal or lack of PCP, Consent to Release Information form should be completed to reflect refusal/lack of PCP and treatment provider(s) by the Unit Charge Nurse."

Review on August 8, 2017, of MR12 revealed the patient was admitted on [DATE]. Further review of MR12 revealed a "Welcome to Friends Hospital" admission form with a section to record the "Primary Care Physician, Name, Phone". Further review of MR12 revealed documented evidence that the Primary Care Physician section was not completed as required by facility policy.

Review on August 8, 2017, of MR16 revealed the patient was admitted on July 6, 2017. Further review of MR16 revealed a "Welcome to Friends Hospital" admission form with a section to record the "Primary Care Physician, Name, Phone". Further review of MR16 revealed documented evidence that the Primary Care Physician section was not completed as required by facility policy.

Review on August 8, 2017, of MR24 revealed the patient was admitted on July 3, 2017. Further review of MR24 revealed a "Welcome to Friends Hospital" admission form with a section to record the "Primary Care Physician, Name, Phone". Further review of MR24 revealed documented evidence that the Primary Care Physician section was not completed as required by facility policy.

Review on August 8, 2017, of MR26 revealed the patient was admitted on [DATE]. Further review of MR26 revealed a "Welcome to Friends Hospital" admission form with a section to record the "Primary Care Physician, Name, Phone". Further review of MR26 revealed documented evidence that the Primary Care Physician section was not completed as required by facility policy.

Review on August 8, 2017, of MR29 revealed the patient was admitted on July 23, 2017. Further review of MR29 revealed a "Welcome to Friends Hospital" admission form with a section to record the "Primary Care Physician, Name, Phone". Further review of MR29 revealed documented evidence that the Primary Care Physician section was not completed as required by facility policy.

Interview with EMP3 and EMP4, on August 8, 2017, between 12:30 P.M. and 12:45 P.M. confirmed the above findings.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0164
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policy/procedures, review of medical records (MR), and interview with staff (EMP), it was determined that the facility failed to ensure policies and procedures for physical restraints (therapeutic holds) included types of physical restraints used or that the physical restraint used was the least restrictive option for five (5) of five (5) restraint medical records reviewed. (MR6, MR7, MR8, MR9, and MR10).

Findings include:

Review on August 4, 2017, of the facility policy, "Restraint and Seclusion", dated "12/2016", revealed "Policy ... Restraint or seclusion may only be used when less restrictive interventions have been determined to be ineffective to protect the patient or others from harm ... Definitions ... Physical Restraints ... The application of any manual method that immobilizes or reduces the ability of the patients to move his or her arms, legs, body, or head freely (also named therapeutic hold, protective hold, or manual restraint) ... Procedure ... 3.0 Physician Orders, Consultation, and Evaluation ... 3.2 The physician's order for use of restraint will be recorded in the medical record and include the following ... 3.2.3 The type of restraint to be used ... 4.0 Restraint Application and Assessment/Monitoring during the Use of Restraints ... 4.1 If physical restraint is indicated, at least 2 staff must participate in the physical hold application."

Review on August 4, 2017, of the facility document "Universal Health Services, Inc. Handle With Care Behavioral Management System Program Component Checklist", revealed "I have been exposed to, trained, and competently demonstrated the use of the following techniques of self-protection and approved methods of physical restraint ... Restraint Techniques ... Primary Restraint Technique (PRT) ... PRT in Settle ... Two Person Floor Transition Stop Position ... Two Person Floor Transition ... Supine Floor Containment ... Modified PRT for Very Small Children (DEMO) ... Pregnant Female-Settle vs. Supine (DEMO)."

Review on August 7, 2017, of MR6 revealed the patient was admitted on July 3, 2017. Further review of MR6 revealed a physical restraint/hold was applied to the patient on July 13, 2017. Further review of MR6 reveals no documented evidence of the specific type of physical restraint/hold that was applied to the patient, if the physical restraint/hold applied to the patient was the least restrictive technique, and which employee(s) actually applied the physical restraint/hold to the patient.

Review on August 7, 2017, of MR7 revealed the patient was admitted on [DATE]. Further review of MR7 revealed a physical restraint/hold was applied to the patient on July 5, 2017. Further review of MR7 reveals no documented evidence of the specific type of physical restraint/hold that was applied to the patient, if the physical restraint/hold applied to the patient was the least restrictive technique, and which employee(s) actually applied the physical restraint/hold to the patient.

Review on August 7, 2017, of MR8 revealed the patient was admitted on [DATE]. Further review of MR8 revealed a physical restraint/hold was applied to the patient on June 30, 2017. Further review of MR8 reveals no documented evidence of the specific type of physical restraint/hold that was applied to the patient, if the physical restraint/hold applied to the patient was the least restrictive technique, and which employee(s) actually applied the physical restraint/hold to the patient.

Review on August 7, 2017, of MR9 revealed the patient was admitted on July 16, 2017. Further review of MR9 revealed a physical restraint/hold was applied to the patient on July 16, 2017. Further review of MR9 reveals no documented evidence of the specific type of physical restraint/hold that was applied to the patient, if the physical restraint/hold applied to the patient was the least restrictive technique, and which employee(s) actually applied the physical restraint/hold to the patient.

Review on August 7, 2017, of MR10 revealed the patient was admitted on [DATE]. Further review of MR10 revealed a physical restraint/hold was applied to the patient on July 5, 2017. Further review of MR10 reveals no documented evidence of the specific type of physical restraint/hold that was applied to the patient, if the physical restraint/hold applied to the patient was the least restrictive technique, and which employee(s) actually applied the physical restraint/hold to the patient.

Interviews with EMP3 and EMP4, on August 7, 2017, between 12:04 P.M. and 12:27 P.M. confirmed the above findings.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on review of facility polices and procedures, facility documents, and interviews with staff (EMP), it was determined that the facility failed to ensure the quality assessment and performance improvement (QAPI) program measured, analyzed, and tracked quality indicators for Pharmaceutical Services.

Findings include:

Review on August 4, 2017, of the facility policy, "Adverse Drug Reactions", dated "11/2014", revealed "I. Purpose: To provide a standardized mechanism for identifying, reporting, and monitoring adverse drug reactions (ADRs) ... II. Policy ... The reporting program is coordinated through the Pharmacy and Therapeutics Committee who reviews and evaluates ADR reports and determines the appropriateness of action taken ... ADR Reporting and Trending ... 2. The Director of Pharmacy reports any serious ADR at the following P&T meeting for review, evaluation, and recommendations."

Review on August 4, 2017, of the facility policy, "Adverse Events", dated "11/2016", revealed "Definitions ... An Adverse Event is any happening or omission including Incidents, Sentinel Events, Serious Events and Infrastructure Failures, which is not consistent with the routine operation of the facility or the routine care of a particular patients, and any event or situation that harmed or could have harmed a person. For example ... Patient care ... Medication issues."

Review on August 9, 2017, of the facility document, "Amended and Restated Board of Governors Bylaws of Friends Hospital", revealed "In accordance with the operation and management of Friends Hospital, the Board of Governors (the Board) hereby adopts the following as its Bylaws ... Article IV ... Purpose of the Facility ... The Board shall be accountable for the safety and quality of care, treatment and services of the Facility ... Article V ... Duties and Responsibilities ... 1. Be responsible for the planning, management and operational activities of the Facility ... 2. Adopt policies and procedures related to Facility operation and management in compliance with all applicable laws, regulations and accreditation standards ... 5. Ensure continuous quality improvement through monitoring of professional services provided by the Medical Staff, allied health professionals and other health care providers who provide services at the Facility ... 10. Make recommendations to the CEO/Managing Director and the Corporate Entity regarding support systems for quality assessment/performance improvement and risk management ... 11. Take all reasonable steps to ensure that Facility conforms with all applicable Federal, State, and local laws and regulations ... Article VII ... Meetings ... 7. Minutes. Written minutes of all meetings shall be prepared by the Secretary ... Article XIII ... Quality of Professional Services ... 1. Board Responsibilities ... a. The Board shall review and evaluate activities of the Medical Staff and other professional staffs in the Facility on a continuing basis to assess, preserve and continuously improve the quality and efficiency of patient care in the facility. The Board shall further, within the reasonable capabilities of the Facility, make effort to provide the administrative assistance necessary to support the implementation and evaluation of Quality Assessment/Improvement activities, including use of medications, medical record review, pharmacy and therapeutics functions, infection control, utilization review, risk management, safety management, and all other department and facility-wide monitoring and evaluation activities ... b. The Board shall approve the Quality Assessment/Performance Improvement Plan and the annual reappraisals thereof. The Board shall require and receive summary reports, at least quarterly, of the findings of quality assessment activities, including patient care problems, and of the implementation of appropriate actions to solve problems and the results of the actions ... 2. Accountability of the Medical Staff and Other Professional Staffs."

Review on August 8, 2017, of the facility documents, "Friends GP LLC Governing Board Meeting Minutes" , dated "April 25, 2017", "January 20, 2017", and "October 19, 2016", revealed no documented evidence of the activities of the P&T Committee and no documented evidence of the review of quality assurance/performance improvement data related to Pharmaceutical Services performed at the facility.

Review on August 4, 2017, of the facility document, "Friends Hospital 2017 Performance Improvement and Patient Safety Plan", revealed "Purpose ... a. Provide high-quality, clinical services and demonstrates the outcomes of service ... d. Provide a culture where care is delivered in a safe environment and quality of care is measured, monitored, and continuously improved ... e. Minimize and prevent patient/organizational risks ... h. Achieve and maintain high performance standards through measurement, assessment, and continuous improvement processes ... Scope ... The requirements of this plan apply to all departments, services, committees and other organizational elements of Friends Hospital ... Objective ... To evaluate those organizational functions and processes that influence patient care and provide mechanism for the planning and implementation of continuous improvement ... Authority ... The Friends Hospital's Governing Board is responsible for the overall direction of hospital initiatives and the quality of services rendered at Friends Hospital ... Administration ... Administration responsibilities include ... 1. Encourage and facilitate implementation and maintenance of process improvement activities throughout the hospital ... 2. Support the development of specific goals, objectives, and targets for patient safety ... Medical Executive Committee ... 5. Make recommendations to Governing Board related to Performance Improvement and Safety activities ... 7. Assure quality review activities are consistent with hospital, Joint Commission, state and federal accrediting and regulatory agency requirements ... Organizational Leadership ... 1. Expectations are set and plans developed for measuring, assessing, and improving targeted processes, systems, and functions. Leaders are able to describe how data are used to create a culture of quality and patient safety ... 5. Collected data is assessed using statistical quality control techniques ... 7. Internal and external comparisons of performance are made over time using information from up-to-date sources, practice guidelines, recognized standards and performance data of other hospitals with similar characteristics ... 11. Measurement and assessment is continued to insure that the improvement is sustained ... 12. Departmental and/or organizational-wide performance improvement/safety activity is reported to the Quality management Department utilizing approved format ... 13. Communication directed at all levels of the organization related to activities to monitor and improve patient care quality and safety ... Contracted Services ... Performance monitors must be done on all contracted services. The monitors/indicators must reflect how effective the contract services are relative to quality of service, high volume, high risk, and problem prone or safety issues inherent in its processes ... On an ongoing basis, data related to the process/service analyzed and submitted to the Quality Management department ... Quality Council ... The Quality Council has the responsibility for direct oversight of the Performance Improvement/Patient Safety program in the organization ... The Quality Council meets monthly and performs the following functions ... 4. Establishes the performance improvement methodology and prioritized performance activities and prioritizes hospital-wide team activity ... 8. Maintains an ongoing inventory and consolidated documentation of all performance improvement activities ... 12. Reviews, analyzes, and acts upon Joint Commission, Centers for Medicare and Medicaid Services, and state required measures ... Patient Safety Council ... led by the Patient Safety Officer ... membership includes ... community member."

Review on August 4, 2017, of the facility document "2017 Friends Hospital Performance Improvement Plan Monitors", revealed "Performance Indicator ... Medication Safety ... Goal, Source, and Measurement ... 90% or greater med room/supply audits reflect zero finding of expired medications."

Review on August 4, 2017, of the facility document, "Friends Hospital 2017 Quality Council Initiatives", revealed "Department ... Nursing ... PI Initiative ... Medication Management ... Monitor ... Medication variance, Serious adverse events, Medication usage evaluations, Pharmacy interventions."

Review on August 4, 2017, of the facility document, "Addendum to Agreement Joint Commission Human Resources Standards", revealed the facility entered into a contract for pharmaceutical services with "Comprehensive Pharmacy Services" effective "3/19/12". Further review of facility document revealed "Agreement ... 4. As of the Effective Date, the following provision shall be added to the Agreement ... Pharmacist shall serve on Hospital's Pharmacy and therapeutics Committee (P&T Committee) or other committees as required by The Joint Commission, federal and state regulations as determined by mutual agreement between Pharmacy and Hospital. Based on the needs of the Hospital, there shall be at a minimum, quarterly P&T Committee meeting to address the medication management system of the Hospital. The Pharmacist shall perform and report the required Medication Use Evaluations as required by the regulatory agencies on a regular basis as part of the P&T Committee as well as any other appropriate committees. Pharmacist shall review and report any Adverse Drug Reactions according to Hospital policy in the P&T and any other appropriate committees."

Review on August 3, 2017, of the facility documents, "Pharmacy and Therapeutics Committee Minutes", dated "January 16, 2017", "March 20, 2017", "April 10, 2017", May 15, 2017", "June 19, 2017", and "July 17, 2017" revealed no documented evidence of review of facility medication error rates, medication variance incidents, and/or Adverse Drug reactions, with the exception of the "April 10, 2017". Further review of the "April 17, 2017" meeting minutes revealed "Medication Variances ... Nothing to report ... Adverse Drug Reactions ... Nothing to report." Further review of the "May 15, 2017" meeting minutes revealed "(... New Reporting for P&T Minutes ... beginning in June the P&T minutes will reflect the instances of adverse drug reaction and medication variances (e.g. missed doses, incorrect med sent to floor, etc.). " Further review of the "June 19, 2017" and "July 17, 2017" P&T meeting minutes revealed no documented evidence of facility reporting on adverse drug reactions and medication variances, as required by the facility P&T meeting minutes dated "May 15, 2017".

Review on August 4, 2017, of the facility documents, "Friends Hospital Quality Council Meeting Minutes", dated "January 4, 2017", "January 17, 2017", "February 8, 2017", "February 23, 2017", "March 23, 2017", "April 27, 2017", "May 25, 2017", and "June 30, 2017" revealed no documented evidence of medication safety initiatives being completed at the facility, no documented evidence of the activities of the P&T Committees medication safety initiatives being completed at the facility, and no review of QAPI data related to medication safety initiatives and/or Pharmaceutical Service's being completed at the facility.

Review on August 4, 2017, of the facility documents, "Medical Executive Committee Meeting", dated "January 5, 2017", "January 12, 2017", "January 13, 2017", "January 18, 2017", "February 10, 2017", "February 22, 2017", "March 22, 2017", "April 6, 2017", "April 26, 2017", "May 17, 2017", and "June 28, 2017" revealed no documented evidence of medication safety initiatives being completed at the facility, no documented evidence of the activities of the P&T Committees medication safety initiatives being completed at the facility, and no review of QAPI data related to medication safety initiatives and/or Pharmaceutical Service's being completed at the facility.

Review on August 4, 2017, of the facility documents, "Patient Safety Council Report", dated "January 16, 2017", "February 23, 2017", "March 16, 2017", "April 20, 2017", "May 18, 2017", "June 15, 2017", and "July 20, 2017", revealed no documented evidence of medication safety initiatives being completed at the facility, no documented evidence of the activities of the P&T Committees medication safety initiatives being completed at the facility, and no review of QAPI data related to medication safety initiatives and/or Pharmaceutical Service's being completed at the facility.

Interview with EMP2 and EMP7, on August 3, 2017, between 9:20 A.M. and 9:30 A.M., confirmed that the "Pharmacy and Therapeutics Committee Minutes", dated "January 16, 2017", "March 20, 2017", "April 10, 2017", May 15, 2017", "June 19, 2017", and "July 17, 2017" revealed no documented evidence of review of facility medication error rates, medication variance incidents, and/or Adverse Drug reactions, with the exception of the "April 10, 2017". Further interview with EMP2 and EMP7 confirmed that the "April 17, 2017" meeting minutes revealed "Medication Variances ... Nothing to report ... Adverse Drug Reactions ... Nothing to report." Further interview with EMP2 and EMP7 confirmed that the "May 15, 2017" meeting minutes revealed "New Business ... New Reporting for P&T Minutes ... beginning in June the P&T minutes will reflect the instances of adverse drug reaction and medication variances (e.g. missed doses, incorrect med sent to floor, etc.). " Further interview with EMP2 and EMP7 confirmed that the "June 19, 2017" and "July 17, 2017" P&T meeting minutes revealed no documented evidence of facility reporting on adverse drug reactions and medication variances, as required by the facility P&T meeting minutes dated "May 15, 2017".

Interview with EMP2 and EMP5, on August 7, 2017, between 12:30 P.M. and 12:52 P.M., confirmed that the facilities QAPI meeting minutes do not contain any documented evidence that Pharmaceutical Services is being reviewed. Further interview with EMP2 and EMP5 confirmed that the "Patient Safety Council Report", dated "January 16, 2017", "February 23, 2017", "March 16, 2017", "April 20, 2017", "May 18, 2017", "June 15, 2017", and "July 20, 2017", revealed no documented evidence of medication safety initiatives being completed by the facility, documented evidence of the activities of the P&T Committees medication safety initiatives being completed at the facility, and no review of QAPI data related to medication safety initiatives and/or Pharmaceutical Service's being completed at the facility. Further interview with EMP2 and EMP5 confirmed the facility documents, "Friends Hospital Quality Council Meeting Minutes", dated "January 4, 2017", "January 17, 2017", "February 8, 2017", "February 23, 2017", "March 23, 2017", "April 27, 2017", "May 25, 2017", and "June 30, 2017" revealed no documented evidence of medication safety initiatives being completed at the facility, no documented evidence of the activities of the P&T Committees medication safety initiatives being completed at the facility, and no review of QAPI data related to medication safety initiatives and/or Pharmaceutical Service's being completed at the facility. Further interview with EMP2 and EMP5 confirmed that the "Medical Executive Committee Meeting" minutes, dated "January 5, 2017", "January 12, 2017", "January 13, 2017", "January 18, 2017", "February 10, 2017", "February 22, 2017", "March 22, 2017", "April 6, 2017", "April 26, 2017", "May 17, 2017", and "June 28, 2017" revealed no documented evidence of medication safety initiatives being completed at the facility, no documented evidence of the activities of the P&T Committees medication safety initiatives being completed at the facility, and no review of QAPI data related to medication safety initiatives and/or Pharmaceutical Service's being completed at the facility. Further interview with EMP2 and EMP5 confirmed that the facility currently "does not" complete random medication pass audits in the facility, "does not" complete chart audits specific to medication administration records, and "does not" have a formal process that identifies additional oversight of the medication administration practices/activities to determine the scope and severity of medication errors occuring within the facility on an ongoing basis.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility polices and procedures, review of medical records (MR), and interviews with staff (EMP), it was determined the facility failed to ensure that all drugs and biologicals were administered in accordance with the approved medical staff policies and procedures for twelve (12) of twenty-five (25) medical records reviewed (MR6, MR7, MR10, MR12, MR13, MR14, MR15, MR16, MR17, MR21, MR26, and MR28).

Findings include:

Review on August 4, 2017, of the facility policy, "Medication Administration", dated "7/17", revealed "I. Purpose ... To insure that medication will be safely and efficiently administered to the correct patient in the prescribed manner at the designated time ... III. Procedure ... b. When administering the medication(s) the nurse must ... 8. Document refusals or nurses holds on medication due to lab results, side effects, etc. in the EMAR and notify physician."

Review on August 7, 2017, of MR6 revealed the patient was admitted on July 3, 2017. Further review of MR6 revealed the patient was ordered to receive Lithium (Psychiatric medication) 300 mg, by mouth, on August 13, 2017, at 9:00 A.M. Further review of MR6 revealed the patient "refused" the medication. Further review of MR6 revealed no documented evidence that the patient's physician was notified that the patient refused the administration of the ordered Lithium.

Review on August 7, 2017, of MR7 revealed the patient was admitted on [DATE]. Further review of MR6 revealed the patient was ordered to receive Lisinopril (Blood pressure medication) 40 mg, by mouth, and Flomax (Urinary medication) 0.4 mg, by mouth, on June 24, 2017, at 9:00 A.M. Further review of MR7 revealed the patient "refused" the medications. Further review of MR7 revealed no documented evidence that the patient's physician was notified that the patient refused the administration of the ordered Lisinopril and Flomax.

Review on August 7, 2017, of MR10, revealed the patient was admitted on [DATE]. Further review of MR10 revealed the patient was ordered to receive Remeron (Sleep medication) 15 mg, by mouth, on July 1, 2017, at 10:00 P.M. Further review of MR10 revealed the patient "refused" the medication. Further review of MR10 revealed no documented evidence that the patient's physician was notified that the patient refused the administration of the ordered Remeron.

Review on August 8, 2017, of MR12, revealed the patient was admitted on [DATE]. Further review of MR12 revealed the patient was ordered to receive Ferosol (Iron supplement) 325 mg, by mouth, on April 29, 2017, at 9:00 A.M. Further review of MR12 revealed the patient "refused" the medication. Further review of MR12 revealed no documented evidence that the patient's physician was notified that the patient refused the administration of the ordered Ferosol.

Review on August 8, 2017, of MR13, revealed the patient was admitted on [DATE]. Further review of MR13 revealed the patient was ordered to receive Neurontin (Psychiatric medication) 400 mg, by mouth, on March 29, 2017, at 5:00 P.M. Further review of MR13 revealed the patient "refused" the medication. Further review of MR13 revealed no documented evidence that the patient's physician was notified that the patient refused the administration of the ordered Neurontin.

Review on August 8, 2017, of MR14, revealed the patient was admitted on July 18, 2017. Further review of MR14 revealed the patient was ordered to receive Zoloft (Psychiatric medication) 25 mg, by mouth, on July 20, 2017, at 9:00 A.M and July 21, 2017, at 9:00 A.M. Further review of MR14 revealed the patient "refused" the medication on both days. Further review of MR14 revealed no documented evidence that the patient's physician was notified that the patient refused the administration of the ordered Zoloft on both days.

Review on August 8, 2017, of MR15, revealed the patient was admitted on [DATE]. Further review of MR15 revealed the patient was ordered to receive Phenobarbital (Psychiatric medication) 32.4 mg, by mouth, on January 28, 2017, at 12:00 P.M. Further review of MR15 revealed the patient "refused" the medication. Further review of MR15 revealed no documented evidence that the patient's physician was notified that the patient refused the administration of the ordered Phenobarbital.

Review on August 8, 2017, of MR16, revealed the patient was admitted on July 6, 2017. Further review of MR16 revealed the patient was ordered to receive Catapres (Blood pressure medication) 0.1 mg, by mouth, on July 13, 2017, at 1:00 P.M. Further review of MR16 revealed the patient's medication was supposed to be held for a systolic blood pressure (SBP) of less than 100 mm Hg. Further review of MR16 revealed documented evidence that the patient's recorded SBP, prior to the Catapres administration, was "90/64". Further review of MR16 revealed no documented evidence that the patient's physician was notified that the patient's SBP was low prior to the administration of the ordered Catapres.

Review on August 8, 2017, of MR17, revealed the patient was admitted on [DATE]. Further review of MR17 revealed the patient was ordered to receive Seroquel (Psychiatric medication) 100 mg, by mouth, on June 12, 2017, at 9:00 A.M. Further review of MR17 revealed the patient "refused" the medication. Further review of MR17 revealed no documented evidence that the patient's physician was notified that the patient refused the administration of the ordered Seroquel.

Review on August 8, 2017, of MR21, revealed the patient was admitted on [DATE]. Further review of MR21 revealed the patient was ordered to receive Ativan (Psychiatric medication) 1.0 mg, by mouth, on May 28, 2017, at 1:00 P.M. Further review of MR21 revealed the medication was not confirmed as administered. Further review of MR21 revealed no documented evidence that the patient's physician was notified that the patient did not receive the ordered Ativan.

Review on August 8, 2017, of MR26, revealed the patient was admitted on [DATE]. Further review of MR26 revealed the patient was ordered to receive Seroquel (Psychiatric medication) 50 mg, by mouth, on June 19, 2017, at 5:00 P.M. Further review of MR26 revealed the medication was not confirmed as administered. Further review of MR26 revealed no documented evidence that the patient's physician was notified that the patient did not receive the ordered Seroquel.

Review on August 8, 2017, of MR28, revealed the patient was admitted on [DATE]. Further review of MR28 revealed the patient was ordered to receive Zoloft (Psychiatric medication) 50 mg, by mouth, on June 11, 2017, at 9:00 A.M. Further review of MR28 revealed the patient "refused" the medication. Further review of MR28 revealed no documented evidence that the patient's physician was notified that the patient refused the administration of the ordered Zoloft.

Interview with EMP4, on August 7, 2017, between 1:30 P.M. and 2:15 P.M., confirmed that MR6, MR7, and MR10 contained no documented evidence that the patient's physician was notified when the patient refused the administration of an ordered medication.

Interview with EMP4, on August 8, 2017, between 7:45 A.M. and 10:15 A.M., confirmed that MR12, MR13, MR14, MR15, MR16, MR17, MR21, MR26, and MR28 contained no documented evidence that the patient's physician was notified when the patient refused the administration of an ordered medication, was notified when a medication was administered incorrectly, or when a medication was not administered at all.
VIOLATION: REPORTING ADVERSE EVENTS Tag No: A0508
Based on review of facility polices and procedures, facility documents, and interviews with staff (EMP), it was determined the facility failed to ensure that drug administration errors and adverse drug reactions are reported to the hospital's quality assessment and performance improvement (QAPI) program on an ongoing basis.

Findings include:

Review on August 4, 2017, of the facility policy, "Adverse Drug Reactions", dated "11/2014", revealed "I. Purpose: To provide a standardized mechanism for identifying, reporting, and monitoring adverse drug reactions (ADRs) ... II. Policy ... The reporting program is coordinated through the Pharmacy and Therapeutics Committee who reviews and evaluates ADR reports and determines the appropriateness of action taken ... ADR Reporting and Trending ... 2. The Director of Pharmacy reports any serious ADR at the following P&T meeting for review, evaluation, and recommendations."

Review on August 4, 2017, of the facility policy, "Adverse Events", dated "11/2016", revealed "Definitions ... An Adverse Event is any happening or omission including Incidents, Sentinel Events, Serious Events and Infrastructure Failures, which is not consistent with the routine operation of the facility or the routine care of a particular patients, and any event or situation that harmed or could have harmed a person. For example ... Patient care ... Medication issues."

Review on August 9, 2017, of the facility document, "Amended and Restated Board of Governors Bylaws of Friends Hospital", revealed "In accordance with the operation and management of Friends Hospital, the Board of Governors (the Board) hereby adopts the following as its Bylaws ... Article IV ... Purpose of the Facility ... The Board shall be accountable for the safety and quality of care, treatment and services of the Facility ... Article V ... Duties and Responsibilities ... 1. Be responsible for the planning, management and operational activities of the Facility ... 2. Adopt policies and procedures related to Facility operation and management in compliance with all applicable laws, regulations and accreditation standards ... 5. Ensure continuous quality improvement through monitoring of professional services provided by the Medical Staff, allied health professionals and other health care providers who provide services at the Facility ... 10. Make recommendations to the CEO/Managing Director and the Corporate Entity regarding support systems for quality assessment/performance improvement and risk management ... 11. Take all reasonable steps to ensure that Facility conforms with all applicable Federal, State, and local laws and regulations ... Article VII ... Meetings ... 7. Minutes. Written minutes of all meetings shall be prepared by the Secretary ... Article XIII ... Quality of Professional Services ... 1. Board Responsibilities ... a. The Board shall review and evaluate activities of the Medical Staff and other professional staffs in the Facility on a continuing basis to assess, preserve and continuously improve the quality and efficiency of patient care in the facility. The Board shall further, within the reasonable capabilities of the Facility, make effort to provide the administrative assistance necessary to support the implementation and evaluation of Quality Assessment/Improvement activities, including use of medications, medical record review, pharmacy and therapeutics functions, infection control, utilization review, risk management, safety management, and all other department and facility-wide monitoring and evaluation activities ... b. The Board shall approve the Quality Assessment/Performance Improvement Plan and the annual reappraisals thereof. The Board shall require and receive summary reports, at least quarterly, of the findings of quality assessment activities, including patient care problems, and of the implementation of appropriate actions to solve problems and the results of the actions ... 2. Accountability of the Medical Staff and Other Professional Staffs."

Review on August 8, 2017, of the facility documents, "Friends GP LLC Governing Board Meeting Minutes" , dated "April 25, 2017", "January 20, 2017", and "October 19, 2016", revealed no documented evidence of the activities of the P&T Committee and no documented evidence of the review of quality assurance/performance improvement data related to Pharmaceutical Services performed at the facility.

Review on August 4, 2017, of the facility document, "Friends Hospital 2017 Performance Improvement and Patient Safety Plan", revealed "Purpose ... a. Provide high-quality, clinical services and demonstrates the outcomes of service ... d. Provide a culture where care is delivered in a safe environment and quality of care is measured, monitored, and continuously improved ... e. Minimize and prevent patient/organizational risks ... h. Achieve and maintain high performance standards through measurement, assessment, and continuous improvement processes ... Scope ... The requirements of this plan apply to all departments, services, committees and other organizational elements of Friends Hospital ... Objective ... To evaluate those organizational functions and processes that influence patient care and provide mechanism for the planning and implementation of continuous improvement ... Authority ... The Friends Hospital's Governing Board is responsible for the overall direction of hospital initiatives and the quality of services rendered at Friends Hospital ... Administration ... Administration responsibilities include ... 1. Encourage and facilitate implementation and maintenance of process improvement activities throughout the hospital ... 2. Support the development of specific goals, objectives, and targets for patient safety ... Medical Executive Committee ... 5. Make recommendations to Governing Board related to Performance Improvement and Safety activities ... 7. Assure quality review activities are consistent with hospital, Joint Commission, state and federal accrediting and regulatory agency requirements ... Organizational Leadership ... 1. Expectations are set and plans developed for measuring, assessing, and improving targeted processes, systems, and functions. Leaders are able to describe how data are used to create a culture of quality and patient safety ... 5. Collected data is assessed using statistical quality control techniques ... 7. Internal and external comparisons of performance are made over time using information from up-to-date sources, practice guidelines, recognized standards and performance data of other hospitals with similar characteristics ... 11. Measurement and assessment is continued to insure that the improvement is sustained ... 12. Departmental and/or organizational-wide performance improvement/safety activity is reported to the Quality management Department utilizing approved format ... 13. Communication directed at all levels of the organization related to activities to monitor and improve patient care quality and safety ... Contracted Services ... Performance monitors must be done on all contracted services. The monitors/indicators must reflect how effective the contract services are relative to quality of service, high volume, high risk, and problem prone or safety issues inherent in its processes ... On an ongoing basis, data related to the process/service analyzed and submitted to the Quality Management department ... Quality Council ... The Quality Council has the responsibility for direct oversight of the Performance Improvement/Patient Safety program in the organization ... The Quality Council meets monthly and performs the following functions ... 4. Establishes the performance improvement methodology and prioritized performance activities and prioritizes hospital-wide team activity ... 8. Maintains an ongoing inventory and consolidated documentation of all performance improvement activities ... 12. Reviews, analyzes, and acts upon Joint Commission, Centers for Medicare and Medicaid Services, and state required measures ... Patient Safety Council ... led by the Patient Safety Officer ... membership includes ... community member."

Review on August 4, 2017, of the facility document "2017 Friends Hospital Performance Improvement Plan Monitors", revealed "Performance Indicator ... Medication Safety ... Goal, Source, and Measurement ... 90% or greater med room/supply audits reflect zero finding of expired medications."

Review on August 4, 2017, of the facility document, "Friends Hospital 2017 Quality Council Initiatives", revealed "Department ... Nursing ... PI Initiative ... Medication Management ... Monitor ... Medication variance, Serious adverse events, Medication usage evaluations, Pharmacy interventions."

Review on August 4, 2017, of the facility document, "Addendum to Agreement Joint Commission Human Resources Standards", revealed the facility entered into a contract for pharmaceutical services with "Comprehensive Pharmacy Services" effective "3/19/12". Further review of facility document revealed "Agreement ... 4. As of the Effective Date, the following provision shall be added to the Agreement ... Pharmacist shall serve on Hospital's Pharmacy and therapeutics Committee (P&T Committee) or other committees as required by The Joint Commission, federal and state regulations as determined by mutual agreement between Pharmacy and Hospital. Based on the needs of the Hospital, there shall be at a minimum, quarterly P&T Committee meeting to address the medication management system of the Hospital. The Pharmacist shall perform and report the required Medication Use Evaluations as required by the regulatory agencies on a regular basis as part of the P&T Committee as well as any other appropriate committees. Pharmacist shall review and report any Adverse Drug Reactions according to Hospital policy in the P&T and any other appropriate committees."

Review on August 3, 2017, of the facility documents, "Pharmacy and Therapeutics Committee Minutes", dated "January 16, 2017", "March 20, 2017", "April 10, 2017", May 15, 2017", "June 19, 2017", and "July 17, 2017" revealed no documented evidence of review of facility medication error rates, medication variance incidents, and/or Adverse Drug reactions, with the exception of the "April 10, 2017". Further review of the "April 17, 2017" meeting minutes revealed "Medication Variances ... Nothing to report ... Adverse Drug Reactions ... Nothing to report." Further review of the "May 15, 2017" meeting minutes revealed "New Business ... New Reporting for P&T Minutes ... beginning in June the P&T minutes will reflect the instances of adverse drug reaction and medication variances (e.g. missed doses, incorrect med sent to floor, etc.). " Further review of the "June 19, 2017" and "July 17, 2017" P&T meeting minutes revealed no documented evidence of facility reporting on adverse drug reactions and medication variances, as required by the facility P&T meeting minutes dated "May 15, 2017".

Review on August 4, 2017, of the facility documents, "Friends Hospital Quality Council Meeting Minutes", dated "January 4, 2017", "January 17, 2017", "February 8, 2017", "February 23, 2017", "March 23, 2017", "April 27, 2017", "May 25, 2017", and "June 30, 2017" revealed no documented evidence of medication safety initiatives being completed at the facility, no documented evidence of the activities of the P&T Committees medication safety initiatives being completed at the facility, and no review of QAPI data related to medication safety initiatives and/or Pharmaceutical Service's being completed at the facility.

Review on August 4, 2017, of the facility documents, "Medical Executive Committee Meeting", dated "January 5, 2017", "January 12, 2017", "January 13, 2017", "January 18, 2017", "February 10, 2017", "February 22, 2017", "March 22, 2017", "April 6, 2017", "April 26, 2017", "May 17, 2017", and "June 28, 2017" revealed no documented evidence of medication safety initiatives being completed at the facility, no documented evidence of the activities of the P&T Committees medication safety initiatives being completed at the facility, and no review of QAPI data related to medication safety initiatives and/or Pharmaceutical Service's being completed at the facility.

Review on August 4, 2017, of the facility documents, "Patient Safety Council Report", dated "January 16, 2017", "February 23, 2017", "March 16, 2017", "April 20, 2017", "May 18, 2017", "June 15, 2017", and "July 20, 2017", revealed no documented evidence of medication safety initiatives being completed at the facility, no documented evidence of the activities of the P&T Committees medication safety initiatives being completed at the facility, and no review of QAPI data related to medication safety initiatives and/or Pharmaceutical Service's being completed at the facility.

Interview with EMP2 and EMP7, on August 3, 2017, between 9:20 A.M. and 9:30 A.M., confirmed that the "Pharmacy and Therapeutics Committee Minutes", dated "January 16, 2017", "March 20, 2017", "April 10, 2017", May 15, 2017", "June 19, 2017", and "July 17, 2017" revealed no documented evidence of review of facility medication error rates, medication variance incidents, and/or Adverse Drug reactions, with the exception of the "April 10, 2017". Further interview with EMP2 and EMP7 confirmed that the "April 17, 2017" meeting minutes revealed "Medication Variances ... Nothing to report ... Adverse Drug Reactions ... Nothing to report." Further interview with EMP2 and EMP7 confirmed that the "May 15, 2017" meeting minutes revealed "New Business ... New Reporting for P&T Minutes ... beginning in June the P&T minutes will reflect the instances of adverse drug reaction and medication variances (e.g. missed doses, incorrect med sent to floor, etc.). " Further interview with EMP2 and EMP7 confirmed that the "June 19, 2017" and "July 17, 2017" P&T meeting minutes revealed no documented evidence of facility reporting on adverse drug reactions and medication variances, as required by the facility P&T meeting minutes dated "May 15, 2017".

Interview with EMP2 and EMP5, on August 7, 2017, between 12:30 P.M. and 12:52 P.M., confirmed that the facilities QAPI meeting minutes do not contain any documented evidence that Pharmaceutical Services is being reviewed. Further interview with EMP2 and EMP5 confirmed that the "Patient Safety Council Report", dated "January 16, 2017", "February 23, 2017", "March 16, 2017", "April 20, 2017", "May 18, 2017", "June 15, 2017", and "July 20, 2017", revealed no documented evidence of medication safety initiatives being completed by the facility, documented evidence of the activities of the P&T Committees medication safety initiatives being completed at the facility, and no review of QAPI data related to medication safety initiatives and/or Pharmaceutical Service's being completed at the facility. Further interview with EMP2 and EMP5 confirmed the facility documents, "Friends Hospital Quality Council Meeting Minutes", dated "January 4, 2017", "January 17, 2017", "February 8, 2017", "February 23, 2017", "March 23, 2017", "April 27, 2017", "May 25, 2017", and "June 30, 2017" revealed no documented evidence of medication safety initiatives being completed at the facility, no documented evidence of the activities of the P&T Committees medication safety initiatives being completed at the facility, and no review of QAPI data related to medication safety initiatives and/or Pharmaceutical Service's being completed at the facility. Further interview with EMP2 and EMP5 confirmed that the "Medical Executive Committee Meeting" minutes, dated "January 5, 2017", "January 12, 2017", "January 13, 2017", "January 18, 2017", "February 10, 2017", "February 22, 2017", "March 22, 2017", "April 6, 2017", "April 26, 2017", "May 17, 2017", and "June 28, 2017" revealed no documented evidence of medication safety initiatives being completed at the facility, no documented evidence of the activities of the P&T Committees medication safety initiatives being completed at the facility, and no review of QAPI data related to medication safety initiatives and/or Pharmaceutical Service's being completed at the facility. Further interview with EMP2 and EMP5 confirmed that the facility currently "does not" complete random medication pass audits in the facility, "does not" complete chart audits specific to medication administration records, and "does not" have a formal process that identifies additional oversight of the medication administration practices/activities to determine the scope and severity of medication errors occuring within the facility on an ongoing basis.