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1001 STERIGERE STREET

NORRISTOWN, PA 19401

GOVERNING BODY

Tag No.: A0043

Based on review of Governing Body Bylaws, observation of the facility, review of policy and procedures, review of facility documents and interviews with staff, it was determined the Governing Body failed to ensure contracts were provided in a safe and effective manner (A084), failed to ensure Patient Rights Condition was met (A115), failed to ensure care in a safe setting (A144), failed to ensure Patient Rights for Restraint or Seclusion standards were met (A164) (A165) (A166), failed to ensure the QAPI Condition of Participation was met (A263), failed to insure QAPI data collection & Analysis (A273), failed to insure ongoing suicide risk assessments were conducted (A395), failed to ensure the administration of drugs standard was met (A405), failed to ensure Pharmacist Responsbilities were met (A492), failed to ensure Pharmacy Personnel Standard was met (A493), failed to ensure Radiologic Services Condition was met (A528), failed to ensure Radiology Safety Policy and Procedures was met (A535), failed to ensure Radiology Safety for Patients and Personnel (A536), failed to ensure monitoring of Radiation Exposure (A538), failed to ensure Radiologist Responsibilities (A546), failed to ensure the Laboratory Services Condition was met (A576), failed to ensure the adequacy of Laboratory Services (A582), failed to ensure there was a written description of services (A584), failed to ensure the Physical Environment Condition was met (A700), failed to ensure Facilities, Supplies, Equipment maintenance (A724,) failed to ensure Infection Control Program standard was met (A749), and failed to ensure the Organization of Rehabilitation Services (A1124).

Findings include:

Review on May 7, 2018, of facility's Governing Body Bylaws, dated April 26, 2018, revealed " ... The Governing Body's onsite representative is the Chief Executive Officer (CEO), who has the authority and responsibility of overall management and direction of Norristown State Hospital ... ".

Cross Reference:
482.12 (e) (1) - Standard - Contracted Services
482.13 Condition - Patient Rights
482.13 (c) (2) Standard -Patient Rights - Care in a Safe Setting
482.13 (e) (2) Standard - Patient Rights: Restraint or Seclusion
482.13 (e) (3) Standard - Patient Rights: Restraint or Seclusion
482.13 (e) (4) (i) Standard - Patient Rights: Restraint or Seclusion
482.21 - Condition - QAPI
482.21 (a), (b) (1), (b) (2) (i), (b) (3) - Standard -Data Collection & Analysis
482.23 (b) (3) Standard - RN Supervision of Nursing Care
482.23 (c) (1), (c) (1) (i) & (c) (2) - Standard - Administration of Drugs
482.25 (a) (1) - Standard - Pharmacist Responsibilities
482.25 (a) (2) - Standard - Pharmacy Personnel
482.26 Condition - Radiologic Services
482.26 (b) - Standard - Safety Policy and Procedures
482.26 (b) (1) - Standard - Safety For Patients and Personnel
482.26 (b) (3) - Standard - Monitoring Radiation Exposure
482.26 (c), (c) (1) - Standard - Radiologist Responsibilities
482.27 - Condition - Laboratory Services
482.27 (a) - Standard - Adequacy of Laboratory Services
482.27 (a) (2) - Standard - Written Description of Services
482.41 - Condition- Physical Environment
482.41 (c) (2) - Standard Facilities, Supplies, Equipment Maintenance
482.42 (a) (1) - Standard - Infection Control Program
482.56 (a) - Standard - Organization of Rehabilitation Services

CONTRACTED SERVICES

Tag No.: A0084

Based on review of facility policies and procedures, review of facility documents, and interviews with staff (EMP), it was determined the Governing Body failed to ensure that services performed under contract, for Laboratory Services, Radiology Services, Dental Services, Nursing Services (for Certified Nursing Assistants), and Infectious Waste Removal Services, were provided in a safe and effective manner.

Findings include:

Review on May 9, 2018, of the facility policy, "Plan For Improving Organizational Performance", dated February 2015, revealed "II. Dimensions of Performance: Quality performance at Norristown State Hospital is a top priority in providing patient care and safety. Specifically, it requires measurements of efficacy, and appropriateness, timeliness, effectiveness, continuity of care, safety, thoroughness and the delivery of care with respect and dignity towards those we serve. Performance measurement data and information from a variety of sources is continually monitored for the identification of problems or opportunities to improve the quality of services ... IV. Organization: The primary responsibility of the Norristown State Hospital Performance Improvement Program is to ensure the hospital has a planned, systemic organization-wide approach for performance measurement and improvement ..."

Review on May 9, 2018, of the facility document, "FY17 Contracts", revealed the facility had active contracts for clinical services including Laboratory Services, Radiology Services, Dental Services, Nursing Services (for Certified Nursing Assistants), and Infectious Waste Removal Services.

Review on May 9, 2018, of the facility documents, "Performance Improvement Council" meeting minutes", for the year of 2017 and up to April 2018 revealed no documented evidence of the ongoing monitoring, review, and analysis of specific performance indicators and/or data elements for contracted services including Laboratory Services, Radiology Services, Dental Services, Nursing Services (for Certified Nursing Assistants), and Infectious Waste Removal Services.

Interview with EMP3, on May 9, at 11:08 A.M., confirmed the facility has active contracts for Laboratory Services, Radiology Services, Dental Services, Nursing Services (for Certified Nursing Assistants), Physical Therapy Services, and Infectious Waste Removal Services. Further interview with EMP3 confirmed the facility does not have specific quality indicators and/or data elements for the active contracted services listed above. Further interview with EMP3 confirmed the Performance Improvement Council meeting minutes, for the year of 2017 and up to April 2018, did not contain documented evidence of the ongoing monitoring, review, and analysis of specific performance indicators and/or data elements for contracted services including Laboratory Services, Radiology Services, Dental Services, Nursing Services (for Certified Nursing Assistants), and Infectious Waste Removal Services.

Cross Reference:
482.12 - Condition - Governing Body
482.21 - Condition - QAPI
482.27 - Condition - Laboratory Services
482.27 (a) - Standard - Adequacy of Laboratory Services
482.27 (a) (2) - Standard - Written Description of Services

PATIENT RIGHTS

Tag No.: A0115

Based on review of policies and procedures, review of facility documents, review of medical records (MR), observation of patient care units, and interview with staff (EMP), it was determined the facility failed to ensure the Condition of Participation for Patient Rights by failing to ensure care in a safe setting (A-0144), failed to ensure care in a safe setting (A144), and failed to ensure Patient Rights for Restraint or Seclusion standards were met (A164) (A165) (A166). .

Cross reference:
482.12 - Condition - Governing Body
482.13 (c) (2) Standard -Patient Rights - Care in a Safe Setting
482.13 (e) (2) Standard - Patient Rights: Restraint or Seclusion
482,13 (e) (3) Standard - Patient Rights: Restraint or Seclusion
482.13 (e) (4) (i) Standard - Patient Rights: Restraint or Seclusion

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on review of facility policies and procedures, observation of patient care units, review of facility documents and interview with staff (EMP), it was determined the facility failed to ensure adequate observation rounding was conducted in 12 of 12 patient care areas identified to have ligature and safety risks (Units 10A2, 10C2, 10D1, 10E1, 51A1, 51A2, 51B1, 51B2, 51C1, 51C2, 1A1, 1C2).

Findings include:

Review on May 7, 2018, of facility policy "Patient Accountability," approved June 2015 revealed "... Standard of Care: The patient can expect to be monitored a minimum of every thirty minutes in the Civil Section and Night shift in the Forensic Section and every hour for Day and Evening shifts in the Forensic Section to: (1) acertain well-being ... (2) evaluate for a safe, secure and therapeutic environment ... ".

Observation on May 7, 2018, between 10:00 AM and 12:15 PM of patient care units 10A2, 10C2, 10D1, 10E1, 51A1, 51A2, 51B1, 51B2, 51C1, 51C2, and observation on May 8, 2018, of patient care units 1A1 and 1C2 between 10:30 AM and 11:40 AM revealed the following:

Patient bedrooms had ligature risks that included three pin door hinges, door knobs, slated beds, furniture not bolted, intake vents, thermostat covers and ceiling lights.

Dayroom patient bathrooms had ligature risks that included intake vents, grab bars, toilet plumbing, faucets, toilet paper dispensers and soap dispensers.

Review on May 7, 2018, of "Patient Accountability Checklists" for all patient care units dated May 2, 2018, through May 6, 2018, revealed documentation of 30 minute rounding on Civil Section Patient Units and on Night Shift in the Forensic Section and every hour rounding for Day and Evening shifts in the Forensic Section.

Interviews with EMP2, EMP3, EMP5 and EMP8 on May 7, 2018, at 12:30 PM confirmed the confirmed the above environmental risk findings during the observational tours of patient care units 10A2, 10C2, 10D1, 10E1, 51A1, 51A2, 51B1, 51B2, 51C1, 51C2. Interview with EMP3 who confirmed the findings during the observation tours for patient care units 1A1 and 1C2.

Interview with EMP1 on May 7, 2018, at 1:15 PM confirmed the above accountability roundings were 30 minutes on Civil section Patient Units and on Night shift in the Forensic Section and every hour rounding for Day and Evening shifts in the Forensic Section.

Cross Reference:
482.12 - Condition - Governing Body
482.13 - Condition - Patient Rights
482.13 (e) (2) Standard - Patient Rights: Restraint or Seclusion
482,13 (e) (3) Standard - Patient Rights: Restraint or Seclusion
482.13 (e) (4) (i) Standard - Patient Rights: Restraint or Seclusion
482.41 - Condition - Physical Environment

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0164

Based on review of facility policies and procedures, medical records (MR), and interview with staff (EMP), it was determined the facility failed to ensure less restrictive interventions were determined to be ineffective, prior to the application of a physical hold/restraint, for three of four restraint medical records reviewed (MR51, MR52, and MR53).

Findings include:

Review on May 10, 2018, of the facility policy, "Use of Physical Holds/Physical Restraints and Protective Safety Devices", dated, "December 2016", revealed "... Policy: Physical Holds and Protective Safety Devices are interventions of last resort and are used only when all treatment interventions have been ineffective. Their use must be clinically justified and warranted by a patient's behavior that threatens the immediate physical safety of the individual, staff, or others. These situations are viewed as psychiatric emergencies of the highest priority and, therefore, require the immediate attention of all staff ... Expectations/General Procedures ... 2. Prior to the use of physical or protective safety device for aggressive behavior which presents an immediate danger to self and/or others, the patient (unless clinically contraindicated) will be given a choice of treatment options to enable him/her to regain self-control over injurious behavior ... Restraint: A restraint is any manual method, physical hold or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. 1. Restraint for Emergency Behavior Control: Permissible restraints shall include physical/manual holds. This method shall only be utilized in emergency situations where a patient's behavior presents an immediate risk of physical harm to self or others, less restrictive interventions have been used and exhausted ... Clinical Documentation Requirements: 1. The initial progress notes by both physican and registered nurse must include ... B. The list of less restrictive interventions tried. C. Patient's response to prior nonphysical interventions ... 5. Documentation shall provide at least the following information ... C. A description of prior interventions tried and the person's response. D. A description of the PR (Physical Restraint) techniques used and their duration ..."

Review on May 9, 2018, of MR51, revealed the patient was admitted to the facility on August 19, 2015. Further review of MR51 revealed the patient was placed in a physical hold/restraint on December 1, 2017. Further review of MR51 revealed no documented evidence that restraint alternatives and/or de-escalation techniques, were implemented and determined to be ineffective, prior to the application of a physical hold/restraint to protect a patient or others from harm.

Interview with EMP8, on May 9, 2018, at 3:11 P.M., confirmed that MR51 "did not" contain documented evidence that restraint alternatives and/or de-escalation techniques, were implemented and determined to be ineffective, prior to the application of a physical hold/restraint to protect a patient or others from harm.

Review on May 9, 2018, of MR52, revealed the patient was admitted to the facility on October 13, 2017. Further review of MR52 revealed the patient was placed in a physical hold/restraint on January 11, 2018. Further review of MR52 revealed no documented evidence that restraint alternatives and/or de-escalation techniques, were implemented and determined to be ineffective, prior to the application of a physical hold/restraint to protect a patient or others from harm.

Interview with EMP8, on May 9, 2018, at 2:43 P.M., confirmed that MR52 "did not" contain documented evidence that restraint alternatives and/or de-escalation techniques, were implemented and determined to be ineffective, prior to the application of a physical hold/restraint to protect a patient or others from harm.

Review on May 9, 2018, of MR53, revealed the patient was admitted to the facility on October 18, 2017. Further review of MR53 revealed the patient was placed in a physical hold/restraint on November 27, 2017. Further review of MR53 revealed no documented evidence that restraint alternatives and/or de-escalation techniques, were implemented and determined to be ineffective, prior to the application of a physical hold/restraint to protect a patient or others from harm.

Interview with EMP8, on May 9, 2018, at 2:59 P.M., confirmed that MR53 "did not" contain documented evidence that restraint alternatives and/or de-escalation techniques, were implemented and determined to be ineffective, prior to the application of a physical hold/restraint to protect a patient or others from harm.

Cross Reference;
482.12 - Condition - Governing Body
482.13 - Condition - Patient Rights
482.13 (c) (2) Standard -Patient Rights - Care in a Safe Setting
482,13 (e) (3) Standard - Patient Rights: Restraint or Seclusion
482.13 (e) (4) (i) Standard - Patient Rights: Restraint or Seclusion

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0165

Based on review of facility policies and procedures, medical records (MR), and interview with staff (EMP), it was determined the facility failed to ensure that the type or technique of physical hold/restraint used was the least restrictive intervention that would be effective, to protect the patient or others from harm, for four of four restraint medical records reviewed (MR51, MR52, MR53, and MR54).

Findings include:

Review on May 10, 2018, of the facility policy, "Use of Physical Holds/Physical Restraints and Protective Safety Devices", dated, "December 2016", revealed "... Policy: Physical Holds and Protective Safety Devices are interventions of last resort and are used only when all treatment interventions have been ineffective. Their use must be clinically justified and warranted by a patient's behavior that threatens the immediate physical safety of the individual, staff, or others. Restraint: A restraint is any manual method, physical hold or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. 1. Restraint for Emergency Behavior Control: Permissible restraints shall include physical/manual holds. This method shall only be utilized in emergency situations where a patient's behavior presents an immediate risk of physical harm to self or others, less restrictive interventions have been used and exhausted ... Clinical Documentation Requirements: 1. The initial progress notes by both physican and registered nurse must include ... B. The list of less restrictive interventions tried. C. Patient's response to prior nonphysical interventions ... 5. Documentation shall provide at least the following information ... C. A description of prior interventions tried and the person's response. D. A description of the PR (Physical Restraint) techniques used and their duration ..."

Review on May 9, 2018, of MR51, revealed the patient was admitted to the facility on August 19, 2015. Further review of MR51 revealed the patient was placed in a physical hold/restraint on December 1, 2017. Further review of MR51 revealed no documented evidence of what specific type of physical hold was utilized on the patient and that the type of hold was the least restrictive modality that would be effective to protect the patient or others from harm.

Interview with EMP8, on May 9, 2018, at 3:11 P.M., confirmed that MR51 "did not" contain documented evidence of what specific type of physical hold was utilized on the patient and that the type of hold was the least restrictive modality that would be effective to protect the patient or others from harm.

Review on May 9, 2018, of MR52, revealed the patient was admitted to the facility on October 13, 2017. Further review of MR52 revealed the patient was placed in a physical hold/restraint on January 11, 2018. Further review of MR52 revealed no documented evidence of what specific type of physical hold was utilized on the patient and that the type of hold was the least restrictive modality that would be effective to protect the patient or others from harm.

Interview with EMP8, on May 9, 2018, at 2:43 P.M., confirmed that MR52 "did not" contain documented evidence of what specific type of physical hold was utilized on the patient and that the type of hold was the least restrictive modality that would be effective to protect the patient or others from harm.

Review on May 9, 2018, of MR53, revealed the patient was admitted to the facility on October 18, 2017. Further review of MR53 revealed the patient was placed in a physical hold/restraint on November 27, 2017. Further review of MR53 revealed no documented evidence of what specific type of physical hold was utilized on the patient and that the type of hold was the least restrictive modality that would be effective to protect the patient or others from harm.

Interview with EMP8, on May 9, 2018, at 2:59 P.M., confirmed that MR53 "did not" contain documented evidence of what specific type of physical hold was utilized on the patient and that the type of hold was the least restrictive modality that would be effective to protect the patient or others from harm.

Review on May 9, 2018, of MR54, revealed the patient was admitted to the facility on November 29, 2016. Further review of MR54 revealed the patient was placed in a physical hold/restraint on November 3, 2017. Further review of MR54 revealed no documented evidence of what specific type of physical hold was utilized on the patient and that the type of hold was the least restrictive modality that would be effective to protect the patient or others from harm.

Interview with EMP8, on May 9, 2018, at 3:31 P.M., confirmed that MR54 "did not" contain documented evidence of what specific type of physical hold was utilized on the patient and that the type of hold was the least restrictive modality that would be effective to protect the patient or others from harm.

Interview with EMP8, On May 9, 2018, at 2:42 P.M., confirmed that the facility staff can use "several" different types of physical holds, depending on their individual level of training and the situation and/or behaviors in which the patient presents requiring the application of a physical hold/restraint.

Cross Reference;
482.12 - Condition - Governing Body
482.13 - Condition - Patient Rights
482.13 (c) (2) Standard -Patient Rights - Care in a Safe Setting
482.13 (e) (2) Standard - Patient Rights: Restraint or Seclusion
482.13 (e) (4) (i) Standard - Patient Rights: Restraint or Seclusion

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0166

Based on review of facility policy and procedures, review of medical records (MR), and interview with staff (EMP), it was determined that the facility failed to ensure that the patients plan of care was modified, in writing, post-application of a physical hold/restraint, for four of four restraint medical records reviewed (MR51, MR52, MR53, and MR54).

Findings include:

Review on May 10, 2018, of the facility policy, "Use of Physical Holds/Physical Restraints and Protective Safety Devices", dated, "December 2016", revealed "... Policy: Physical Holds and Protective Safety Devices are interventions of last resort and are used only when all treatment interventions have been ineffective. Their use must be clinically justified and warranted by a patient's behavior that threatens the immediate physical safety of the individual, staff, or others. These situations are viewed as psychiatric emergencies of the highest priority and, therefore, require the immediate attention of all staff ... Expectations/General Procedures ... 4. ... The use of restraint or protective restraint is in accordance with a written modification of the patient's plan of care ..."

Review on May 9, 2018, of MR51, revealed the patient was admitted to the facility on August 19, 2015. Further review of MR51 revealed the patient was placed in a physical hold/restraint on December 1, 2017. Further review of MR51 revealed no documented evidence that the patient's written plan of care was modified, post-application of a physical hold/restraint.

Interview with EMP8, on May 9, 2018, at 3:16 P.M., confirmed that MR51 "did not" contain documented evidence that the patient's written plan of care was modified, post-application of a physical hold/restraint.

Review on May 9, 2018, of MR52, revealed the patient was admitted to the facility on October 13, 2017. Further review of MR52 revealed the patient was placed in a physical hold/restraint on January 11, 2018. Further review of MR52 revealed no documented evidence that the patient's written plan of care was modified, post-application of a physical hold/restraint.

Interview with EMP8, on May 9, 2018, at 2:45 P.M., confirmed that MR52 "did not" contain documented evidence that the patient's written plan of care was modified, post-application of a physical hold/restraint.

Review on May 9, 2018, of MR53, revealed the patient was admitted to the facility on October 18, 2017. Further review of MR53 revealed the patient was placed in a physical hold/restraint on November 27, 2017. Further review of MR53 revealed no documented evidence that the patient's written plan of care was modified, post-application of a physical hold/restraint.

Interview with EMP8, on May 9, 2018, at 3:05 P.M., confirmed that MR53 "did not" contain documented evidence that the patient's written plan of care was modified, post-application of a physical hold/restraint.

Review on May 9, 2018, of MR54, revealed the patient was admitted to the facility on November 29, 2016. Further review of MR54 revealed the patient was placed in a physical hold/restraint on November 3, 2017. Further review of MR54 revealed no documented evidence that the patient's written plan of care was modified, post-application of a physical hold/restraint.

Interview with EMP8, on May 9, 2018, at 3:32 P.M., confirmed that MR54 "did not" contain documented evidence that the patient's written plan of care was modified, post-application of a physical hold/restraint.

Cross Reference;
482.12 - Condition - Governing Body
482.13 - Condition - Patient Rights
482.13 (c) (2) Standard -Patient Rights - Care in a Safe Setting
482.13 (e) (2) Standard - Patient Rights: Restraint or Seclusion
482.13 (e) (3) Standard - Patient Rights: Restraint or Seclusion

QAPI

Tag No.: A0263

Based on review of facility policies and procedures, review of facility documents, and interviews with staff (EMP), it was determined the facility failed to ensure it developed and implemented a hospital-wide, data-driven quality assessment and performance improvement program for clinical services performed under contract, for Laboratory Services, Radiology Services, Dental Services, Nursing Services (for Certified Nursing Assistants), and Infectious Waste Removal Services.

Findings include:

Review on May 9, 2018, of the facility policy, "Plan For Improving Organizational Performance", dated February 2015, revealed "II. Dimensions of Performance: Quality performance at Norristown State Hospital is a top priority in providing patient care and safety. Specifically, it requires measurements of efficacy, and appropriateness, timeliness, effectiveness, continuity of care, safety, thoroughness and the delivery of care with respect and dignity towards those we serve. Performance measurement data and information from a variety of sources is continually monitored for the identification of problems or opportunities to improve the quality of services ... IV. Organization: The primary responsibility of the Norristown State Hospital Performance Improvement Program is to ensure the hospital has a planned, systemic organization-wide approach for performance measurement and improvement ..."

Review on May 9, 2018, of the facility document, "FY17 Contracts", revealed the facility had active contracts for clinical services including Laboratory Services, Radiology Services, Dental Services, Nursing Services (for Certified Nursing Assistants), and Infectious Waste Removal Services.

Review on May 9, 2018, of the facility documents, "Performance Improvement Council" meeting minutes", for the year of 2017 and up to April 2018 revealed no documented evidence of the ongoing monitoring, review, and analysis of specific performance indicators and/or data elements for contracted services including Laboratory Services, Radiology Services, Dental Services, Nursing Services (for Certified Nursing Assistants), Physical Therapy Services, and Infectious Waste Removal Services.

Interview with EMP3, on May 9, at 11:08 A.M., confirmed the facility has active contracts for Laboratory Services, Radiology Services, Dental Services, Physical Therapy, Nursing Services (for Certified Nursing Assistants), and Infectious Waste Removal Services. Further interview with EMP3 confirmed the facility does not have specific quality indicators and/or data elements for the active contracted services listed above. Further interview with EMP3 confirmed the Performance Improvement Council meeting minutes, for the year of 2017 and up to April 2018, did not contain documented evidence of the ongoing monitoring, review, and analysis of specific performance indicators and/or data elements for contracted services including Laboratory Services, Radiology Services, Dental Services, Physical Therapy, Nursing Services (for Certified Nursing Assistants), and Infectious Waste Removal Services.

Cross Reference:
482.12 - Condition - Governing Body
482.12(e)(1) - Standard Contracted Services
482.21(a)(b)(1)(b)(2)(i)(b)(3) - Standard Data Collection & Analysis
482.25 (a) (1) - Standard - Pharmacist Responsibilities
482.25 (a) (2) - Standard - Pharmacy Personnel
482.26 Condition - Radiologic Services
482.26 (b) - Standard - Safety Policy and Procedures
482.26 (b) (1) - Standard - Safety For Patients and Personnel
482.26 (b) (3) - Standard - Monitoring Radiation Exposure
482.26 (c), (c) (1) - Standard - Radiologist Responsibilities
482.27 - Condition - Laboratory Services
482.27 (a) - Standard - Adequacy of Laboratory Services
482.27 (a) (2) - Standard - Written Description of Services

DATA COLLECTION & ANALYSIS

Tag No.: A0273

Based on a review of facility policy, facility documents, and interview with facility staff (EMP), it was determined that the facility failed to follow its adopted Quality/Performance Improvement Plan to ensure that program data is collected, as a means to monitor the effectiveness and safety of Pharmaceutical services and quality of care.

Findings Include:

Review on May 9, 2018, of the facility policy, "Plan For Improving Organizational Performance", dated February 2015, revealed "II. Dimensions of Performance: Quality performance at Norristown State Hospital is a top priority in providing patient care and safety. Specifically, it requires measurements of efficacy, and appropriateness, timeliness, effectiveness, continuity of care, safety, thoroughness and the delivery of care with respect and dignity towards those we serve. Performance measurement data and information from a variety of sources is continually monitored for the identification of problems or opportunities to improve the quality of services ... IV. Organization: The primary responsibility of the Norristown State Hospital Performance Improvement Program is to ensure the hospital has a planned, systemic organization-wide approach for performance measurement and improvement ..."

Review on May 9, 2018, of the "Departmental Performance Improvement Activity Goals 2017", revealed "Department: Pharmacy ... Date 1/23/18 ... Planned Action(s) Conduct monthly inspection of ... hour of administration on MAR [Medication Administration Record] for appropriateness ... On a daily basis, check contents of weekly med resupply boxes to ensure dispensing accuracy."

A request was made to EMP3 on May 9, 2018, for data collected regarding the hour of administration on MAR for appropriateness quality indicator. None was provided. EMP3 confirmed EMP6 did not have documented evidence of monthly data collection for the hour of administration on MAR for appropriateness quality indicator.

Review on May 9, 2018, of an untitled document, provided by EMP6 regarding the On a daily basis, check contents of weekly med resupply boxes to ensure dispensing accuracy quality indicator, revealed the data was collected six times in January 2018 (not daily), 11 times in February 2018 (not daily), 11 times in March 2018 (not daily), and ten times in April 2018 (not daily).

Interview with EMP3 on May 9, 2018, confirmed the data was not collected in accordance with the facility's Quality plan for the the hour of administration on MAR for appropriateness quality indicator and the On a daily basis, check contents of weekly med resupply boxes to ensure dispensing accuracy quality indicator.

Cross Reference:
482.12 - Condition - Governing Body
482.21 - Condition QAPI
482.25 (a) (1) - Standard - Pharmacist Responsibilities
482.25 (a) (2) - Standard - Pharmacy Personnel

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on review of facility policy and procedures, review of medical records (MR), and interviews with staff (EMP), it was determined the facility failed to ensure ongoing suicide risk assessments were conducted for five of five medical records reviewed (MR46, MR47, MR48, MR49, MR50).

Findings include:

Review on May 7, 2018, of facility policy and procedure "Management of Suicidal Patients," dated April 2018 revealed " ... Procedures: ... 1 ... all patients admitted to Norristown State Hospital are evaluated using the Suicidal Risk Assessment Form." Further review of this policy revealed it did not contain reference to ongoing Suicide Risk Assessments.

Review on May 10, and May 11, 2018, of MR46, MR47, MR48, MR49 and MR50 revealed these patients were admitted to the facility between May 11, 2016, and February 1, 2018. Further review of MR46, MR47, MR48, MR49 and MR50 revealed a Suicide Risk Assessment was conducted by the psychiatrist at the time of admission, at the time of the monthly treatment team meeting and then annually by the psychiatrist.

Interview with EMP8 on May 10, and 11, 2018, confirmed the Suicide Risk Assessments were completed for MR46, MR47, MR48, MR49 and MR50 at the time of admission, at the monthly Treatment Team meeting and then annually by the psychiatrist.

Interview with EMP1 on May 7, 2018, at 4:00 PM confirmed the facility's practice was to document the Suicide Risk Assessment on admission by the psychiatrist, at the monthly treatment team meeting and at the annual assessment by the psychiatrist.

Cross Reference:
482.12 - Condition - Governing Body
482.23 (c) (10, (c) (1) (i) & (c) (2) - Standard - Administration of Drugs

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on review of facility policy and procedures, observation, and interview with staff (EMP), it was determined the facility failed to ensure adopted policies and procedures were followed for administration of medications for one (1) of one (1) medical records reviewed (MR55).
Findings include:
Review on May 9, 2018, of facility policy, "Administration of Medications" dated July 13, 2017, revealed "... F. Controlled Drugs ... h. Administration of individual doses of controlled drugs is recorded on: 1.) The Narcotic Administration Record as they are moved from the control area. 2.) The patient ' s MAR ... i. ... Controlled drugs must be stored under two locks ... H. Charting Medications Administered 1. After the patient has received the medication/treatment, document by entering initials in the correct date and time space on the MAR ... 2. If the medication is not given, use the appropriate code and record the explanation in the Progress Notes ... ".
Observation on May 9, 2018, revealed a sealed Lorazepam 0.5mg on top of the medication cart in the nursing medication room.
Review of facility document, "Narcotic Administered Record (NAR)" dated May 4, 2018, to May 9, 2018, revealed no documented evidence of the Lorazepam 0.5mg signed out or recorded on the NAR.
Review on May 9, 2018, of MR55 "Medication Administration Record" (MAR), revealed "... Medications ... Lorazepam 0.5mg Tablet 1 Tablet at 8AM for Anxiety ...". Further review revealed no documented evidence the patient received the medication or documented evidence of patient refusal.
Interview on May 9, 2018, with EMP19 at 8:05AM, confirmed the medication had not been signed out on the NAR or the MAR for MR55. Further interview confirmed the patient had not received the medication yet and that the medication should have been signed out once removed from the locked medication control area.
Cross Reference:
482.12 - Condition - Governing Body
482.23 (b) (3) Standard - RN supervision of Nursing Care

PHARMACIST RESPONSIBILITIES

Tag No.: A0492

Based on review of facility documents and interview with staff (EMP) it was determined that the facilities Pharmaceutical Services Director failed to ensure the ongoing review, monitoring, and initiation of corrective action(s) for medication variances reported to the Pharmacy and Therapeutics Committee.

Findings include:

Review on May 10, 2018, of the facility document, "Position Description, Chief Pharmacist", dated, no date provided, revealed "... Description of Duties ... Plans, organizes and supervises all pharmaceutical services in accordance with established policies and procedures of the hospital ... Develops, implements and maintains an ongoing criteria-based Performance Improvement program which monitors the quality and appropriateness of pharmaceutical services at Norristown State Hospital. Submits monthly, quarterly and annual PI reports which include finding items monitored, corrective actions to be taken, effectiveness of the program and recommendations for future items to be monitored ..."

Review on May 8, 2018, of the facility document, "Norristown State Hospital Pharmacy & Therapeutics Committee Meeting", dated, "March 20, 2018", revealed "... Updates: Score Card: Variances (sent from nurses from unit)". Further review of the "Variances" section revealed a table listing the "Month" in one column and capitalized letters representing different types of variances being tracked. Further review of the table revealed the months tracked were listed as "Jan 17" through "Feb 18". Further review of the table revealed the letter "C", which equated to variances that were "Prescribed medication order not sent as specified" as per the included legend. Further review of the letter "C" column revealed ongoing variances that were consistenly, disproportionately higher than all of the other eleven variances being tabulated. Further review of the meeting minutes revealed no documented evidence of any discussions, review, and/or implementation of corrective actions related to the "Prescribed medication order not sent as specified" variance.

Interview with EMP3 and EMP6, on May 10, 2018, between 11:17 A.M. and 12:00 P.M., confirmed that EMP6 "is" directly responsible for the ongoing review, monitoring, and initiation of corrective actions related to medication variances that occur within the facility. Further interview with EMP6 confirmed that they "are aware" of the ongoing trend of "Prescribed medication order not sent as specified" medication variance, as documented within the "March 20, 2018" Pharmacy & Therapeutics Committee Meeting Minutes. Further interview with EMP6 confirmed that the variance has been going on since "2000" (year) and is equivalent to medications either "not being sent" by the Pharmacy or medications "missing" from the medication cart drawers for unknown reasons. Further interview with EMP6 confirmed that they "do not" review or monitor the potential, specific reasons for the monthly medication variances reported by the Nursing Staff. Further interview with EMP6 confirmed that they "do not know" the trends of when the medication variances may be occuring including the times of day, shift, unit, staff involved, or the actual medications involved, excluding controlled substances. Further interview with EMP6 confirmed that they "do not know" if the missing medications are being diverted by Pharmacy Staff and/or Nursing Staff. Further interview with EMP6 confirmed that they "have not" implemented any formal review and/or corrective actions for the trending medication variances, equivalent to letter "C", identifed within the "March 20, 2018" Pharmacy & Therapeutics Committee Meeting Minutes.

Cross Reference:
482.21 - Condition Governing Body
482.21 - Condition - QAPI
482.21 (a), (b) (1), (b) (2) (i), (b) (3) - Standard -Data Collection & Analysis
482.25 (a) (2) - Standard - Pharmacy Personnel

PHARMACY PERSONNEL

Tag No.: A0493

Based on review of facility policies and procedures, facility documents, and interview with staff (EMP), it was determined that the facility failed to ensure quality pharmaceutical services, including those for emergency services, were performed by qualified personnel.

Findings include:

Review on May 10, 2018, of the facility policy, "Medications: Obtaining When the Hospital Pharmacy is Closed", dated, "8/17", revealed "... Procedure: Refills for Orders Already Reviewed by Pharmacy by Pharmacy If a patient's supply of medication becomes depleted during the hours that pharmacy is closed, the nurse will ... 2. If the drug is not available from the Documed (medication dispensing machine), the Nurse will notify the Physician who will phone in an order to [National Pharmacy Chain name] on [street address], Norristown at [phone number]. a. An aide, FSE (Forensic Security Employee), or Security can be dispatched to the outside pharmacy to pick up the medication. A nurse or the Physician must pick up controlled drugs ... Obtaining Medications for New Orders Written When Pharmacy is Closed 1. If a patient requires a new medication when the NSH (Norristown State Hospital) Pharmacy is closed: a. The physician will write a prescription for an amount that will last for 24 hours after NSH pharmacy opens ... b. The nurse will fax the prescription and the current MAR (Medication Administration Record) to [National Pharmacy Chain name] at [phone number]. This will allow the [National Pharmacy Chain name] pharmacist to evaluate the prescription for drug, food/drug, and drug disease interactions ... e. Once it is confirmed that the prescription will be filled, a staff person or Security may be dispatched to pick up the medication ... g. A nurse or Physician must pick up controlled drugs ..."

Review on May 10, 2018, of the facility document, "Position Description, Chief Pharmacist", dated, no date provided, revealed "... Description of Duties ... Plans, organizes and supervises all pharmaceutical services in accordance with established policies and procedures of the hospital ..."

Review on May 8, 2018, of the facility document, "Norristown State Hospital Pharmacy & Therapeutics Committee Meeting", dated, "March 20, 2018", revealed "... 3. After Hours Orders to [National Pharmacy Chain name]" and a table containing a column for the months and a column for the amount of medications obtained. Further review of the table revealed the months tracked were from "Jan 17" through "Feb 17". Further review of the table revealed that forty-three (43) medications were obtained over the cumulated fourteen (14) month span. Further review of the medications obtained revealed "Antibiotics", "Regular orders out of tabs", and "out of stocks". Further review of the meeting minutes revealed no documented evidence of any discussions, review, and/or implementation of corrective actions related to the use of the non-contracted, national-chain pharmacy.

Interview with EMP3 and EMP6, on May 10, 2018, between 11:17 A.M. and 12:00 P.M., confirmed that Pharmaceutical Services "is not" open twenty-four hours per day and is "closed" during "night-shift". Further interview with EMP3 and EMP6 confirmed that Pharmaceutical Services "does not" have a specific, rotating on-call schedule to cover the hours that they are closed. Further interview with EMP3 and EMP6 confirmed that after-hour medications "are" obtained by the "Nursing Supervisor" using a "emergency box". Further interview with EMP3 and EMP6 confirmed that if a medication is not within the emergency box than "it must" be obtained through [National Pharmacy Chain name]. Further interview with EMP3 and EMP6 confirmed that the facility "does not" have a contract with [National Pharmacy Chain name] and "does not" have any personnel records, or access to personnel records, for the Pharmacist's employed by [National Pharmacy Chain name] to ensure that they meet required licensure and educational requirements for Norristown State Hospital. Further interview with EMP3 and EMP6 confirmed that the facilities Pharmaceutical Services "does not" review and monitor the medications received from the [National Pharmacy Chain name] to determine if they can be obtained and placed in the facilities emergency box for future use. Further interview with EMP3 and EMP6 confirmed that they "do not know" if a an aide, FSE (Forensic Security Employee), or Security personnel are allowed to handle and transport medications according to State and/or Federal law/regulations. Further interview with EMP3 and EMP6 confirmed that the employees handling and transporting the medications "do not" complete this task in a secure manner and that the [National Pharmacy Chain name] "just hands them the medication in a bag".


Cross Reference:
482.21 - Condition Governing Body
482.21 - Condition - QAPI
482.21 (a), (b) (1), (b) (2) (i), (b) (3) - Standard -Data Collection & Analysis
482.25 (a) (1) Standard - Pharmacist Responsibilities

RADIOLOGIC SERVICES

Tag No.: A0528

Based on review of facility policies and procedures, facility documents, observation, and interview with staff (EMP), it was determined that the facility failed to ensure compliance with the Condition of Participation for Radiological Services (A-0528); failed to ensure that safety policies and procedures were maintained for Radiological Services (A-0535); failed to ensure the safety of patients and personnel exposed to Radiological equipment (A-0536); failed to monitor radiation exposure to Dental Clinic personnel (A-0538); and failed to ensure that a full-time, part-time, or consultant Radiologist had oversight of the radiation emitting equipment in the Dental Clinic (A-0546).

Cross Reference:
482.12 - Condition - Governing Body
482.21 - Condition - QAPI
482.21 (a), (b) (1), (b) (2) (i), (b) (3) - Standard -Data Collection & Analysis
482.26(b): Radiological Services Safety Polices and Procedures
482.26(b)(1): Safety of Patient's and Personnel
482.26(b)(3): Monitoring Radiation Exposure
482.26(c)(1): Radiologist's Responsibilities

SAFETY POLICY AND PROCEDURES

Tag No.: A0535

Based on review of facility polices and procedures, facility documents, observation, and interview with staff (EMP) it was determined that the facility failed to maintain professional approved standards for the use of diagnostic radiological equipment within the Dental Clinic.

Findings include:

Review on May 11, 2018, of the facility policy, "Dental Care Services", dated, no date provided, revealed "... Policy: The Dental Services department is responsible for providing dental care which maintain the consumer's oral cavity in a hygienic, functional and comfortable manner commensurate with the consumer's ability to understand ... Procedure A. New Admission Examination ... 3. Consists of a review of medical history, clinical examination and necessary x-rays ..."

Review on May 8, 2018, of the facility document, "Pennsylvania Department of Environmental Protection" certificate for radiological equipment revealed the facilities certificate expired on "May 31, 2017".

Review on May 11, 2018, of the facility electronic document, [manufacturer name] Digital Panoramic X-ray Unit, dated "2014-03", revealed "... 7.2 User/patient warnings The unit may be dangerous to the user and the patient, if the safety regulations in this manual are ignored, if the unit is not used in the way described in this manual and/or if the user does not know how to use the unit. Because the x-ray limitations and safety regula¿tions change from time to time, it is the responsibility of the user to make sure that all the valid safety regulations are fulfilled ..."

A request was made on May 8, 2018, at 9:15 A.M., with EMP1, for the facilities updated Department of Environmental Protection (DEP) certificate, Radiation Safety Committee Meeting Minutes, and all policies/procedures that govern the oversight of Radiological Services within the facility. No documents were provided.

Observation on May 8, 2018, between 12:05 P.M. and 12:15 P.M., of the facilities Dental Clinic, with EMP3, EMP4, and EMP12, revealed one (1) [manufacturer name] Digital Panoramic X-ray Unit. Further review of the Dental Clinic revealed no evidence of a DEP certificate for the [manufacturer name] Digital Panoramic X-ray Unit. Further observations of the Dental Clinic revealed no evidence of policy/procedure manual(s) and/or owner's manual that govern the use of the [manufacturer name] Digital Panoramic X-ray Unit. Further observation of the Dental Clinic revealed no evidence of policy/procedure manual(s) that govern the oversight of Radiological Services within the facility.

A request was made on May 8, 2018, at 12:15 P.M. of EMP3, EMP4, and EMP12 for the facilities updated Department of Environmental Protection (DEP) certificate and all policies/procedures that govern the oversight of Radiological Services within the facility. No documents were provided.

Interview with EMP2 and EMP3, on May 9, 2018, at 9:08 A.M., confirmed that the facilities current DEP certificate "was expired" since May 31, 2017. Further interview with EMP2 and EMP3 confirmed that the facility "does not" have a current, up-to-date DEP certificate for the facilities radiological emitting equipment located within the Dental Clinic.

A second request was made on May 9, 2018, at 3:00 P.M., with EMP1, for all policies/procedures that govern the oversight of Radiological Services within the facility and the Radiation Safety Committee Meeting Minutes.

Interview with EMP1, on May 10, 2018, at 10:28 A.M., confirmed that the facility "does not" have a current DEP certificate, "does not" have any policies/procedures that govern the oversight of Radiological Services within the facility, and "does not" have a Radiation Safety Committee and/or any other committee that has direct oversight of Radiological Services completed within the Dental Clinic.

Interview with EMP4, on May 11, 2018, at 9:44 A.M., confirmed that the facility "does not" have a current Physicist report, determining the safety of the [manufacturer name] Digital Panoramic X-ray Unit and/or the safety of the Dental Clinic environment regarding radiation exposure parameters within the physical room and adjacent hallway.

Interview with EMP2, on May 11, 2018, at 11:23 A.M., confirmed that the facility "does not" have a current Physicist report, determining the safety of the [manufacturer name] Digital Panoramic X-ray Unit and/or the safety of the Dental Clinic environment regarding radiation exposure parameters within the physical room and adjacent hallway. Further interview with EMP2 confirmed that the facility "does not" have a current policy or procedure on the use of the [manufacturer name] Digital Panoramic X-ray Unit or the owner's manual for the [manufacturer name] Digital Panoramic X-ray Unit. Further interview with EMP2 confirmed that the facility is in the process of obtaining the owner's manual, electronically, from the manufacturer of the Digital Panoramic X-ray Unit.

Cross Reference:
482.12 - Condition - Governing Body
482.21 - Condition - QAPI
482.21 (a), (b) (1), (b) (2) (i), (b) (3) - Standard -Data Collection & Analysis
482.26 - Condition - Radiologic Services
482.26(b)(1): Safety of Patient's and Personnel
482.26(b)(3): Monitoring Radiation Exposure
482.26(c)(1): Radiologist's Responsibilities

SAFETY FOR PATIENTS AND PERSONNEL

Tag No.: A0536

Based on review of facility polices and procedures, facility documents, observation, and interview with staff (EMP) it was determined that the facility failed to ensure that proper safety precautions were maintained against radiation hazards within the Dental Clinic.

Findings include:

Review on May 11, 2018, of the facility policy, "Dental Care Services", dated, no date provided, revealed "... Policy: The Dental Services department is responsible for providing dental care which maintain the consumer's oral cavity in a hygienic, functional and comfortable manner commensurate with the consumer's ability to understand ... Procedure A. New Admission Examination ... 3. Consists of a review of medical history, clinical examination and necessary x-rays ..."

Review on May 8, 2018, of the facility document, "Pennsylvania Department of Environmental Protection" certificate for radiological equipment revealed the facilities certificate expired on "May 31, 2017".

Review on May 11, 2018, of the facility electronic document, [manufacturer name] Digital Panoramic X-ray Unit, dated "2014-03", revealed "... 7.2 User / patient warnings The unit may be dangerous to the user and the patient, if the safety regulations in this manual are ignored, if the unit is not used in the way described in this manual and/or if the user does not know how to use the unit. Because the x-ray limitations and safety regula¿tions change from time to time, it is the respon¿sibility of the user to make sure that all the valid safety regulations are fulfilled. It is the responsibility of the user to decide if the x-ray exposure is necessary. Always use the lowest suitable x-ray dose to obtain the desired level of image quality. Always use suitable hygienic barriers on parts of the unit that the patient has contact with. Avoid taking x-ray exposures of pregnant wom¿en. If the patient is using a pacemaker, consult the manufacturer of the pacemaker to confirm that the x-ray unit will not interfere with the operation of the pacemaker before taking an exposure. The user of the unit must stand at least two me¿ters away from the unit and protect him/herself from radiation when taking exposures. It is recommended that a moveable radiation protection screen is used to protect the user. The radiation protection screen should be lo¿cated so that the user is able to see the control panel and patient from behind the radiation protection screen (the protected area or control zone). The radiation protection screen must be large enough to fully protect the user from radiation. The radiation protection area must be at least 60 cm wide, 60 cm deep and 200 cm high. The radiation protection screen must include lead shielding with a minimum thickness 0.5 mm and the screen must conform to all national regulations concerning radiation shielding of dental/medical devices. The user must be able to see and hear the pa¿tient at all times during an exposure. The user must be positioned so that he/she can see the exposure warning light/indicator and hear the audio exposure warning signal during the exposure. If the unit is installed in such a place where the exposure warning light/indicator cannot be seen or the audio exposure warning signal cannot be heard, then a separate expo¿sure warning light/indicator device should be used. Please contact your local service for help ..."

A request was made on May 8, 2018, at 9:15 A.M., with EMP1, for the facilities updated Department of Environmental Protection (DEP) certificate, Radiation Safety Committee Meeting Minutes, and all policies/procedures that govern the oversight of Radiological Services within the facility. No documents were provided.

Observation on May 8, 2018, between 12:05 P.M. and 12:15 P.M., of the facilities Dental Clinic, with EMP3, EMP4, and EMP12, revealed one (1) [manufacturer name] Digital Panoramic X-ray Unit. Further review of the Dental Clinic revealed one (1) one-piece lead apron, laying on top of the dental exam chair. Further review of the Dental Clinic revealed no evidence of any additional lead protective aprons and/or lead shields. Further review of the Dental Clinic revealed no evidence of a DEP certificate for the [manufacturer name] Digital Panoramic X-ray Unit. Further observations of the Dental Clinic revealed no evidence of policy/procedure manual(s) and/or owner's manual that govern the use of the [manufacturer name] Digital Panoramic X-ray Unit. Further observation of the Dental Clinic revealed no evidence of policy/procedure manual(s) that govern the oversight of Radiological Services within the facility.

A request was made on May 8, 2018, at 12:15 P.M. of EMP3, EMP4, and EMP12 for the facilities updated Department of Environmental Protection (DEP) certificate and all policies/procedures that govern the oversight of Radiological Services within the facility. No documents were provided. Further interview with EMP3, EMP4, and EMP5 confirmed that the Dental Clinic had "one" lead apron for "patient use" and "did not" have any additional lead aprons and/or shields for staff protection during the use of the [manufacturer name] Digital Panoramic X-ray Unit.

Interview with EMP2 and EMP3, on May 9, 2018, at 9:08 A.M., confirmed that the facilities current DEP certificate "was expired" since May 31, 2017. Further interview with EMP2 and EMP3 confirmed that the facility "does not" have a current, up-to-date DEP certificate for the facilities radiological equipment located within the Dental Clinic.

A second request was made on May 9, 2018, at 3:00 P.M., with EMP1, for all policies/procedures that govern the oversight of Radiological Services within the facility and any Radiation Safety Committee Meeting Minutes.

Interview with EMP1, on May 10, 2018, at 10:28 A.M., confirmed that the facility "does not" have a current DEP certificate, "does not" have any policies/procedures that govern the oversight of Radiological Services within the facility, and "does not" have a Radiation Safety Committee and/or any other committee that has direct oversight of Radiological Services completed within the Dental Clinic.

Interview with EMP4, on May 11, 2018, at 9:44 A.M., confirmed that the facility "does not" have a current Physicist report, determining the safety of the [manufacturer name] Digital Panoramic X-ray Unit and/or the safety of the Dental Clinic environment regarding radiation exposure parameters for the physical room and adjacent hallway.

Interview with EMP2, on May 11, 2018, at 11:23 A.M., confirmed that the facility "does not" have a current Physicist report, determining the safety of the [manufacturer name] Digital Panoramic X-ray Unit and/or the safety of the Dental Clinic environment regarding radiation exposure parameters for the physical room and adjacent hallway. Further interview with EMP2 confirmed that Dental Clinic Staff stood in the "hallway" during the use of the [manufacturer name] Digital Panoramic X-ray Unit and "did not" require the use of additonal shielding and/or protection while patient's were being exposed to emitting radiation from the unit. Further interview with EMP2 confirmed that they "do not know" if the walls of the Dental Clinic are lead-lined. Further interview with EMP2 confirmed that the facility "does not" have a current policy or procedure for the use of the [manufacturer name] Digital Panoramic X-ray Unit or the owner's manual for the [manufacturer name] Digital Panoramic X-ray Unit. Further interview with EMP2 confirmed that the facility is in the process of obtaining the owner's manual, electronically, from the manufacturer of the Digital Panoramic X-ray Unit.

Cross Reference:
482.12 - Condition - Governing Body
482.21 - Condition - QAPI
482.21 (a), (b) (1), (b) (2) (i), (b) (3) - Standard -Data Collection & Analysis
482.26 - Condition - Radiologic Services
482.26 (b) - Standard - Safety Policies and Procedures
482.26(b)(3): Monitoring Radiation Exposure
482.26(c)(1): Radiologist's Responsibilities

MONITORING RADIATION EXPOSURE

Tag No.: A0538

Based on review of facility polices and procedures, facility documents, observation, and interview with staff (EMP) it was determined that the facility failed to ensure that Dental Clinic personnel were checked periodically, by the use of exposure meters or badge tests, for amounts of radiation exposure.

Findings include:

Review on May 11, 2018, of the facility policy, "Dental Care Services", dated, no date provided, revealed "... Policy: The Dental Services department is responsible for providing dental care which maintain the consumer's oral cavity in a hygienic, functional and comfortable manner commensurate with the consumer's ability to understand ... Procedure A. New Admission Examination ... 3. Consists of a review of medical history, clinical examination and necessary x-rays ..."

Review on May 8, 2018, of the facility document, "Pennsylvania Department of Environmental Protection" certificate for radiological equipment revealed the facilities certificate expired on "May 31, 2017".

Review on May 9, 2018, of the facility documents, "[Company name] Radiation Detection Company Monthly Dosimetry Reports" for Norristown State Hospital, dated, "April 2017", "May 2017", "June 2017", "July 2017", "August 2017", "September 2017", "October 2017", "November 2017", "December 2017", "January 2018", "February 2018", "March 2018", and "April 2018", revealed no documented evidence of the monitoring of Dental Clinic Hygienist's badges and that only Physician badges were being monitored.

Review on May 11, 2018, of the facility electronic document, [manufacturer name] Digital Panoramic X-ray Unit, dated "2014-03", revealed "... 7.2 User / patient warnings The unit may be dangerous to the user and the patient, if the safety regulations in this manual are ignored, if the unit is not used in the way described in this manual and/or if the user does not know how to use the unit. Because the x-ray limitations and safety regula¿tions change from time to time, it is the respon¿sibility of the user to make sure that all the valid safety regulations are fulfilled. It is the responsibility of the user to decide if the x-ray exposure is necessary. Always use the lowest suitable x-ray dose to obtain the desired level of image quality. Always use suitable hygienic barriers on parts of the unit that the patient has contact with. Avoid taking x-ray exposures of pregnant wom¿en. If the patient is using a pacemaker, consult the manufacturer of the pacemaker to confirm that the x-ray unit will not interfere with the operation of the pacemaker before taking an exposure. The user of the unit must stand at least two me¿ters away from the unit and protect him/herself from radiation when taking exposures. It is recommended that a moveable radiation protection screen is used to protect the user. The radiation protection screen should be lo¿cated so that the user is able to see the control panel and patient from behind the radiation protection screen (the protected area or control zone). The radiation protection screen must be large enough to fully protect the user from radiation. The radiation protection area must be at least 60 cm wide, 60 cm deep and 200 cm high. The radiation protection screen must include lead shielding with a minimum thickness 0.5 mm and the screen must conform to all national regulations concerning radiation shielding of dental/medical devices. The user must be able to see and hear the pa¿tient at all times during an exposure. The user must be positioned so that he/she can see the exposure warning light/indicator and hear the audio exposure warning signal during the exposure. If the unit is installed in such a place where the exposure warning light/indicator cannot be seen or the audio exposure warning signal cannot be heard, then a separate expo¿sure warning light/indicator device should be used. Please contact your local service for help ..."

A request was made on May 8, 2018, at 9:15 A.M., with EMP1, for the facilities updated Department of Environmental Protection (DEP) certificate, any Radiation Safety Committee Meeting Minutes, and all policies/procedures that govern the oversight of Radiological Services within the facility. No documents were provided.

Observation on May 8, 2018, between 12:05 P.M. and 12:15 P.M., of the facilities Dental Clinic, with EMP3, EMP4, and EMP12, revealed one (1) [manufacturer name] Digital Panoramic X-ray Unit. Further review of the Dental Clinic revealed one (1) one-piece lead apron. Further review of the Dental Clinic revealed no evidence of any additional lead protective aprons and/or lead shields. Further Further review of the Dental Clinic revealed no evidence of a DEP certificate for the [manufacturer name] Digital Panoramic X-ray Unit. Further observations of the Dental Clinic revealed no evidence of policy/procedure manual(s) and/or owner's manual that govern the use of the [manufacturer name] Digital Panoramic X-ray Unit. Further observation of the Dental Clinic revealed no evidence of policy/procedure manual(s) that govern the oversight of Radiological Services within the facility.

A request was made on May 8, 2018, at 12:15 P.M. of EMP3, EMP4, and EMP12 for the facilities updated Department of Environmental Protection (DEP) certificate and all policies/procedures that govern the oversight of Radiological Services within the facility. No documents were provided. Further interview with EMP3, EMP4, and EMP5 confirmed that the Dental Clinic had "one" lead apron for "patient use" and "did not" have any additional lead aprons and/or shields for staff protection during the use of the [manufacturer name] Digital Panoramic X-ray Unit.

Interview with EMP2 and EMP3, on May 9, 2018, at 9:08 A.M., confirmed that the facilities current DEP certificate "was expired" since May 31, 2017. Further interview with EMP2 and EMP3 confirmed that the facility "does not" have a current, up-to-date DEP certificate for the facilities radiological equipment located within the Dental Clinic.

A second request was made on May 9, 2018, at 3:00 P.M., with EMP1, for all policies/procedures that govern the oversight of Radiological Services within the facility and any Radiation Safety Committee Meeting Minutes.

Interview with EMP1, on May 10, 2018, at 10:28 A.M., confirmed that the facility "does not" have a current DEP certificate, "does not" have any policies/procedures that govern the oversight of Radiological Services within the facility, and "does not" have a Radiation Safety Committee and/or any other committee that has direct oversight of Radiological Services completed within the Dental Clinic.

Interview with EMP4, on May 11, 2018, at 9:44 A.M., confirmed that the facility employed both Dentist's and Dental hygienist's to work in the Dental Clinic. Further interview with EMP4 confirmed that the facility "does not" have a current Physicist report, determining the safety of the [manufacturer name] Digital Panoramic X-ray Unit and/or the safety of the Dental Clinic environment regarding radiation exposure parameters within the physical room and adjacent hallway. Further interview with EMP4 confirmed that the "[Company name] Radiation Detection Company Monthly Dosimetry Reports" for Norristown State Hospital, dated, "April 2017", "May 2017", "June 2017", "July 2017", "August 2017", "September 2017", "October 2017", "November 2017", "December 2017", "January 2018", "February 2018", "March 2018", and "April 2018", "did not" contain documented evidence of the monitoring of Dental Clinic Hygienist's badges and that only Physician badges were being monitored. Further interview with EMP4 confirmed that they "do not know" if Dental Clinic Hygienist's were involved with the use of the [manufacturer name] Digital Panoramic X-ray Unit or who actually utilized the equipment during dental examinations. Further interview with EMP4 confirmed that the facility "does not" have a specific policy for the monitoring of radiation exposure badges and "does not" review the badge exposure reports in a Radiation Safety Committee and/or Quality Assurance Committee.

Interview with EMP2, on May 11, 2018, at 11:23 A.M., confirmed that the facility "does not" have a current Physicist report, determining the safety of the [manufacturer name] Digital Panoramic X-ray Unit and/or the safety of the Dental Clinic environment regarding radiation exposure parameters within the physical room and adjacent hallway. Further interview with EMP2 confirmed that Dental Clinic Staff stood in the "hallway" during the use of the [manufacturer name] Digital Panoramic X-ray Unit and "did not" require the use of additonal shielding and/or protection while patient's were being exposed to emitting radiation from the unit. Further interview with EMP2 confirmed that they "do not know" if the walls of the Dental Clinic are lead-lined. Further interview with EMP2 confirmed that the facility "does not" have a current policy or procedure on the use of the [manufacturer name] Digital Panoramic X-ray Unit or the owner's manual for the [manufacturer name] Digital Panoramic X-ray Unit. Further interview with EMP2 confirmed that the facility is in the process of obtaining the owner's manual, electronically, from the manufacturer of the Digital Panoramic X-ray Unit.

Cross Reference:
482.12 - Condition - Governing Body
482.21 - Condition - QAPI
482.21 (a), (b) (1), (b) (2) (i), (b) (3) - Standard -Data Collection & Analysis
482.26 - Condition - Radiologic Services
482.26 (b) - Standard - Safety Policies and Procedures
482.26(b)(1): Safety of Patient's and Personnel
482.26(c)(1): Radiologist's Responsibilities

RADIOLOGIST RESPONSIBILITIES

Tag No.: A0546

Based on review of facility polices and procedures, facility documents, observation, and interview with staff (EMP) it was determined that the facility failed to ensure a qualified full-time, part-time or consulting radiologist supervised the ionizing radiology services performed in the Dental Clinic.

Findings include:

Review on May 11, 2018, of the facility policy, "Dental Care Services", dated, no date provided, revealed "... Policy: The Dental Services department is responsible for providing dental care which maintain the consumer's oral cavity in a hygienic, functional and comfortable manner commensurate with the consumer's ability to understand ... Procedure A. New Admission Examination ... 3. Consists of a review of medical history, clinical examination and necessary x-rays ..."

Review on May 8, 2018, of the facility document, "Pennsylvania Department of Environmental Protection" certificate for radiological equipment revealed the facilities certificate expired on "May 31, 2017".

Review on May 11, 2018, of the facility electronic document, [manufacturer name] Digital Panoramic X-ray Unit, dated "2014-03", revealed "... 7.2 User/patient warnings The unit may be dangerous to the user and the patient, if the safety regulations in this manual are ignored, if the unit is not used in the way described in this manual and/or if the user does not know how to use the unit. Because the x-ray limitations and safety regula¿tions change from time to time, it is the responsibility of the user to make sure that all the valid safety regulations are fulfilled ..."

A request was made on May 8, 2018, at 9:15 A.M., with EMP1, for the facilities updated Department of Environmental Protection (DEP) certificate, any Radiation Safety Committee Meeting Minutes, and all policies/procedures that govern the oversight of Radiological Services within the facility. No documents were provided.

Observation on May 8, 2018, between 12:05 P.M. and 12:15 P.M., of the facilities Dental Clinic, with EMP3, EMP4, and EMP12, revealed one (1) [manufacturer name] Digital Panoramic X-ray Unit. Further review of the Dental Clinic revealed no evidence of a DEP certificate for the [manufacturer name] Digital Panoramic X-ray Unit. Further observations of the Dental Clinic revealed no evidence of policy/procedure manual(s) and/or owner's manual that govern the use of the [manufacturer name] Digital Panoramic X-ray Unit. Further observation of the Dental Clinic revealed no evidence of policy/procedure manual(s) that govern the oversight of Radiological Services within the facility.

A request was made on May 8, 2018, at 12:15 P.M. of EMP3, EMP4, and EMP12 for the facilities updated Department of Environmental Protection (DEP) certificate and all policies/procedures that govern the oversight of Radiological Services within the facility. No documents were provided.

Interview with EMP2 and EMP3, on May 9, 2018, at 9:08 A.M., confirmed that the facilities current DEP certificate "was expired" since May 31, 2017. Further interview with EMP2 and EMP3 confirmed that the facility "does not" have a current, up-to-date DEP certificate for the facilities radiological equipment located within the Dental Clinic.

A second request was made on May 9, 2018, at 3:00 P.M., with EMP1, for all policies/procedures that govern the oversight of Radiological Services within the facility and any Radiation Safety Committee Meeting Minutes.

Interview with EMP1, on May 10, 2018, at 10:28 A.M., confirmed that the facility "does not" have a current DEP certificate, "does not" have any policies/procedures that govern the oversight of Radiological Services within the facility, and "does not" have a Radiation Safety Committee and/or any other committee that has direct oversight of Radiological Services completed within the Dental Clinic. Further interview with EMP1 confirmed that the physician who has direct oversight of the Dental Clinic is the facilities Medical Director, who "is not" a Radiologist, but is a credentialed "Psychiatrist". Further interview with EMP1 confirmed that the facilities contracted Radiology Service "does not" have oversight of the Dental Clinic [manufacturer name] Digital Panoramic X-ray Unit and "does not" have oversight of Radiological Services performed within the facilities Dental Clinic.

Cross Reference:
482.12 - Condition - Governing Body
482.21 - Condition - QAPI
482.21 (a), (b) (1), (b) (2) (i), (b) (3) - Standard -Data Collection & Analysis
482.26 - Condition - Radiologic Services
482.26 (b) - Standard - Safety Policies and Procedures
482.26(b)(1): Safety of Patient's and Personnel
482.26(b)(3): Monitoring Radiation Exposure

LABORATORY SERVICES

Tag No.: A0576

Based on review of facility policies and procedures, facility documents, observation, and interview with staff (EMP), it was determined the facility failed to comply with the Condition of Participation for Laboratory Services (A-0576); failed to maintain a personnel file on contracted Laboratory phlebotomists to determine compliance with required licensing, certification, and/or educational requirements (A-0023); failed to ensure the adequacy and maintenance of standards of practice for Laboratory Services (A-0582); and failed to maintain written descriptions of Laboratory Services within the facility for medical staff availability (A-0584).

Based on review of facility policies and procedures, review of facility documents, and interviews with staff (EMP), it was determined the facility failed to ensure that Laboratory services, which are performed under contract, were integrated into the hospital-wide Quality Assessment and Performance Improvement program.

Findings include:

Review on May 9, 2018, of the facility policy, "Plan For Improving Organizational Performance", dated February 2015, revealed "II. Dimensions of Performance: Quality performance at Norristown State Hospital is a top priority in providing patient care and safety. Specifically, it requires measurements of efficacy, and appropriateness, timeliness, effectiveness, continuity of care, safety, thoroughness and the delivery of care with respect and dignity towards those we serve. Performance measurement data and information from a variety of sources is continually monitored for the identification of problems or opportunities to improve the quality of services ... IV. Organization: The primary responsibility of the Norristown State Hospital Performance Improvement Program is to ensure the hospital has a planned, systemic organization-wide approach for performance measurement and improvement ...

Review on May 9, 2018, of the facility document, "FY17 Contracts", revealed the facility had active contracts for clinical services including Laboratory services.

Review on May 9, 2018, of the facility documents, "Performance Improvement Council" meeting minutes", for the year of 2017 and up to April 2018 revealed no documented evidence of the ongoing monitoring, review, and analysis of specific performance indicators and/or data elements for contracted services including Laboratory Services.

Interview with EMP3, on May 9, at 11:08 A.M., confirmed the facility has active contracts for Laboratory Services. Further interview with EMP3 confirmed the facility does not have specific quality indicators and/or data elements for the active contracted Laboratory service. Further interview with EMP3 confirmed the Performance Improvement Council meeting minutes, for the year of 2017 and up to April 2018, did not contain documented evidence of the ongoing monitoring, review, and analysis of specific performance indicators and/or data elements for contracted services including Laboratory Services.

Cross Reference:

482.12 - Condition - Governing Body
482.12 (e) (1) - Standard - Contracted Services
482.21 - Condition - QAPI
482.21 (a), (b) (1), (b) (2) (i), (b) (3) - Standard -Data Collection & Analysis
482.12 (e)(1) Contracted Services
482.27(a): Adequacy of Laboratory Services
482.27(a)(2): Written Description of Services

ADEQUACY OF LABORATORY SERVICES

Tag No.: A0582

Based on review of facility policies and procedures, observation, and interview with staff (EMP), it was determined that the facility failed to ensure that contracted laboratory services maintained acceptable standards of performance for the collection, processing, and storage of patient blood and urine specimens.

Findings include:

A request was made on May 8, 2018, at 9:15 A.M., with EMP1, for all policies and procedures that govern the oversight of Laboratory Services within the facility. None were provided.

Review on May 9, 2018, of the facility policy, "Infection Control Plan", dated, no date provided, revealed "Philosophy The Infection Control Program of Norristown State Hospital strives to provide a safe and therapeutic environment for patients, staff, families, and visitors ... Objectives 1. To maintain highest standards to reduce the risk of infections in patients and healthcare workers ... 3. To develop effective measures to prevent, identify, and control infection ... 4. To monitor an effective, hospital-wide infection control program that involves different aspects of infection control in all the services, departments listed in this program ..."

Observation on May 8, 2018, between 12:15 P.M. and 12:46 P.M., with EMP3, EMP4, and EMP12, of the facilities Laboratory Storage Area/Office, revealed one (1) office containing multiple storage cabinets, shelves, and two (2) work desks. Further review of the Laboratory office revealed a dirty, unkept in appearance, disorganized, cluttered environment with direct-patient care supplies, including lab tubes, specimen containers, gloves, tourniquets, covered needles, and alcohol wipes as well as patient care medical records, including facility lab draw receipts as well as a specimen order sheet from another facility within the region containing a patient's name, date of birth, and social security number, dated "2/12/18", scattered over the floor, across workspaces, and on multiple storage shelves in no discernible order. Further review of the Laboratory office revealed one (1) work desk, closest to the entry door, containing two unlabeled, metal racks with multiple blood collection tubes, and a main work area covered in multiple old, indiscernible spots and stains. Further review of the blood collection tubes revealed multiple expired tubes including one (1) gold-top serum separator tube that expired on "2015-15", two (2) blue-top coagulation tubes that expired on "2017-12-31", three (3) purple-top tubes that expired on "2018-04-30", "2016-04", and "2017-07", three (3) red-top tubes that expired on "2017-06", "2015-11", and "2018-02-28", one (1) yellow-top tube that expired on "2017-10", and six (6) green-top tubes that expired on "2013-07", "2011-06", "2013-10", "2016-04", "2017-12-31", and "2017-12-31". Further review of the work desk revealed two (2) black tackle boxes on the floor underneath the desk. Further review of the larger tackle box revealed multiple lab tubes. Further review of the lab tubes revealed three (3) blue-top coagulation tubes that expired on "2018-02-28", "2018-04-30", and "2018-04-30". Further review of the Laboratory office revealed a four-drawer steal filing cabinet. Further review of the storage cabinet revealed multiple lab tubes within the top drawer. Further review of the lab tubes revealed forty-two (42) green-top tubes, in a bag, that expired on "2017-04". Further review of the Laboratory office revealed one (1) refrigerator sitting on top of one (1) freezer unit. Further review of the refrigerator revealed a orange "Biohazard" sticker on the outside of the door next to a typed list of specimens that should be stored in the unit. Further review of the refrigerator revealed multiple food items inside the unit including a half-eaten sandwich, three containers of pudding, three containers of mixed fruit, and a bottle of soda. Further review of the freezer unit revealed multiple ice packs. Further review of the refrigerator/freezer units revealed no evidence of any functional temperature monitoring equipment or monitoring logs except for one sheet labeled "2016". Further review of the Laboratory office revealed one (1) large, multi-shelf/drawer, covered storage cabinet. Further review of the second storage shelve/drawer revealed four sealed boxes, containing one hundred (100) each, green-top lab tubes, expired on "2018-04-30", "2018-01-31", 2018-01-31", and "2018-04-30". Further review of the bottom drawer, when fully pulled out, revealed the exposed floor of the office with multiple lab tubes, tourniquets, covered needles, and trash. Further review of the Laboratory office revealed one (1) cardboard box on the floor container four (4) blood culture collection bottles. Further review of the box revealed a empty candy bag, on top of the blood collection bottles, that had food remnants still remaining in the bag that also spilled into the box. Further review of the Laboratory office revealed no evidence of cleaning supplies and/or handwashing/sanitation accommodations. Further review of the Laboratory office revealed no evidence of a any policy/procedure manual(s).

Interview with EMP3, EMP4, and EMP12, on May 8, 2018, between 12:15 P.M. and 12:46 P.M., confirmed all findings during the inspection of the facilities Laboratory Storage Area/Office.

A second request was made on May 8, 2018, at 3:00 P.M., with EMP1, for all policies and procedures that govern the oversight of Laboratory Services within the facility.

Interview with EMP15, on May 9, 2018, between 9:48 A.M. and 10:34 A.M., confirmed that all Laboratory Services within the facility are performed by a contracted Laboratory. Further interview with EMP15 confirmed all findings from the observational tour of the Laboratory storage area/office, conducted on May 8, 2018, between 12:15 P.M. and 12:46 P.M. Further interview with EMP15 confirmed that the Laboratory storage area/office is cleaned "every other week". Further interview with EMP15 confirmed that they "do not" maintain any documented evidence of when cleaning is completed or maintain any log for cleaning/disinfection protocols. Further interview with EMP15 confirmed that cross-contamination of lab specimens "could have" occurred while using the workspace desk, located closest to the entry door, due to the unsanitary conditions of the area. Further interview with EMP15 confirmed that the larger, black tackle box "was their" work-box used for specimen draws throughout the facility. Further interview with EMP15 confirmed that they "did not know" why expired lab tubes were kept with non-expired lab tubes. Further interview with EMP15 confirmed that some expired lab tubes are used to "counter-balance the centrifuge", but they "are not" specifically labeled for that application. Further interview with EMP15 confirmed that lab specimens "are not" kept in the refrigerator within the Laboratory area/office and that refrigerator is specifically for personal food items due to the individual being "diabetic". Further interview with EMP15 confirmed that all collected blood and urine specimens, requiring refrigeration, are kept in the refrigerator located in the Physical Therapy gym and/or on the respective Nursing units refrigerators where the patient resides. Further interview with EMP15 confirmed that all refrigerators utilized for storage of lab specimens "are not" monitored for ideal temperature control and that the refrigerators doors are "left open half of the time". Further interview with EMP15 confirmed that the Laboratory area/office "is not" temperature and humidity controlled and that specific parameters for the storage of lab collection supplies, including urine containers and blood tubes, "are not known". Further interview with EMP15 confirmed that they "do not " draw blood from patients in the Laboratory office, but specimens are collected on multiple different Nursing units, in multiple areas, depending on the needs of the patient and their cooperation with the collection process. Further interview with EMP15 confirmed that they "do not" have a current policy/procedure manual(s) that governs the oversight of Laboratory Services for the facility or that governs the protocols of the contracting agency. Further interview with EMP15 confirmed that they use a policy/procedure manual "from a previous employer", for reference, that they have had for at least "eight years". Further interview with EMP15 confirmed that the contracting laboratory service "does not" submit any quality assurance or performance improvement data to the facility.

A request was made on May 9, 2018, at 11:20 A.M., with EMP1, for the personnel file of the contracted laboratory phlebotomist. No file was provided. A third request was made for all polices/procedures that govern the oversight of Laboratory Services. None was provided.

Interview with EMP1, on May 9, 2018, at 4:00 P.M., confirmed that the facility "does not" maintain a personnel file for the contracted laboratory phlebotomist.

A request was made on May 11, 2018, at 10:48 A.M., with EMP1 for the contracted Laboratories personnel file for the phlebotomist and their job description.

Interview with EMP1, on May 11, 2018, at 11:20 A.M., confirmed that the contracted Laboratory "refused" to send the phlebotomists personnel file and/or job description. Further interview with EMP1 confirmed that the facility "does not" have a policy/procedure manual(s) that governs the oversight of Laboratory Services within the facility.

Cross Reference:

482.11(c): Licensure of Personnel
482.12 - Condition - Governing Body
482.12 (e) (1) - Standard - Contracted Services
482.21 - Condition - QAPI
482.21 (a), (b) (1), (b) (2) (i), (b) (3) - Standard -Data Collection & Analysis
482.27(a)(2): Written Description of Services

WRITTEN DESCRIPTION OF SERVICES

Tag No.: A0584

Based on interview with staff (EMP) it was determined that the facility failed to ensure that contracted laboratory services maintained written descriptions of services provided that were readily available for the medical staff to review.

Findings include:

A request was made on May 8, 2018, at 9:15 A.M., with EMP1, for all policies and procedures that govern the oversight of Laboratory Services within the facility. None were provided.

A second request was made on May 8, 2018, at 3:00 P.M., with EMP1, for all policies and procedures that govern the oversight of Laboratory Services within the facility.

A third request was made on May 9, 2018, at 11:20 A.M., with EMP1, for all polices/procedures that govern the oversight of Laboratory Services. None was provided.

Interview with EMP1, on May 11, 2018, at 11:20 A.M., confirmed that the facility "does not" have a policy/procedure manual(s) that governs the oversight of Laboratory Services within the facility.

Cross Reference:

482.11(c): Licensure of Personnel
482.12 - Condition - Governing Body
482.12 (e)(1) Contracted Services
482.21 - Condition - QAPI
482.21 (a), (b) (1), (b) (2) (i), (b) (3) - Standard -Data Collection & Analysis
482.27(a): Adequacy of Laboratory Services

PHYSICAL ENVIRONMENT

Tag No.: A0700

Based on review of facility policies and procedures, review of facility documents, observation of patient care units and interview with staff (EMP), it was determined the facility failed to ensure the Condition of Participation for Physical Environment by not providing a safe environment for psychiatric patients for 12 of 12 patient care units observed (Unit 1A1, 1C2, 10A2, 10C2, 10D1, 10E1, 51A1, 51A2, 51B1, 51B2, 51C1, 51C2).

Findings include:

Review on May 7, 2018, of facility policy "Management of Suicidal Patients," revised April 2018 revealed, " ... Procedures ... 5. Environmental Considerations/Identifying Ligature Risks ... a. The Clinical and Administrative staff does ongoing risk assessments of the physical environment in order to improve the safety of the physical environment and prevent suicide ... c. Ligature risk (point) is identified as anything which could be used to attach a cord, rope or other material for the purpose of hanging or strangulation and includes items such as shower rails, hinges, door closure, hooks, and windows with commonly used ligatures including belts, sheets and towels, etc.".

Observation on May 7, 2018, between 10:00 AM and 12:15 PM of patient care units 10A2, 10C2, 10D1, 10E1, 51A1, 51A2, 51B1, 51B2, 51C1, 51C2, and observation on May 8, 2018, of patient care units 1A1 and 1C2 between 10:30 AM and 11:40 AM revealed the following:

Patient bedrooms had ligature risks that included three pin door hinges, door knobs, slated beds, furniture not bolted, intake vents, thermostat covers and ceiling lights.

Dayroom patient bathrooms had ligature risks that included intake vents, grab bars, toilet plumbing, faucets, toilet paper dispensers and soap dispensers.

Review on May 7, 2018, of facility documents "Environment of Care Rounds Falls/Suicide/Ligature Risk" dated May 31, 2017, through May 2, 2018, revealed the documents did not contain the above ligature risks identified during the observation of the patient care areas.

Interviews with EMP2, EMP3, EMP5 and EMP8 on May 7, 2018, between 10:00 AM and 12:30 PM confirmed the above findings during the observational tours of patient care units 10A2, 10C2, 10D1, 10E1, 51A1, 51A2, 51B1, 51B2, 51C1, 51C2. Interview with EMP3 who confirmed the findings during the observation tours for patient care units 1A1 and 1C2.

Cross Reference:
482.12 - Condition - Governing Body
482.13 (c) (2) - Standard - Patient Rights- Care in a Safe Setting
482.41 (c) (2 ) - Standard - Facilities, Supplies, Equipment Maintenance

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on review of facility policy and procedures, review of facility documents and interviews with staff (EMP), it was determined the facility failed to follow its own established policy that required inspections and monitoring of its pool which is used by patients.

Findings include:

Review on May 11, 2018, of facility policy "Pool PM [Preventative Maintenance], dated July 31, 2017, revealed "Maintenance Person Test for bromide and PH every Mon, Wed, and Fri ..."

Review on May 11, 2018, of facility documents "Checklist for Routine Inspection of Swimming Pools" revealed there was no documented evidence the facility inspected and monitored the pool on the following dates: February 9, 14, 16, 21, and 23, 2018, March 2, 9, 16, and 30, 2018, April 6, 11, 13, 20, and 27, 2018, and May 4, 2018.

Interview with EMP9 on May 11, 2018, at 10:51 AM, confirmed the facility did not follow its established pool maintenance policy and inspect and monitor the pool every Monday, Wednesday, and Friday.

Cross Reference:
482.12 - Condition - Governing Body
482.41 - Condition - Physical Environment

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on review of facility policy and procedures, observation, and interview with staff (EMP), it was determined the facility failed to ensure adopted policies and procedures were followed for proper disinfection of the glucometer after use.

Findings include:

Review on May 9, 2018, of facility policy, "Blood Glucose Monitoring: TrueTrack Smart System" dated July 31, 2017, revealed "Standard of Practice: The Nurse will accurately perform blood glucose testing using the procedure as outlined below ... Procedure: ... 2. Each patient who has blood glucose testing will have a personal blood glucose meter ... 4. The Nurse will maintain and clean the meter after each use and between patients. Clean with mild soap and water or Clorox wipe ...".

Observation on May 9, 2018, at 9:50 AM, revealed EMP10 using a glucometer for blood glucose testing on a patient. Further observation revealed EMP10 placed the device into a black case without cleaning the device after use.

Interview on May 9, 2018, with EMP10 at 9:52 AM, confirmed the device was placed into a black case after performing blood glucose testing on the patient. Further interview with EMP10 confirmed the device should be cleaned after each use.
_____________

Based on facility policy and procedures, observation, and interview with staff (EMP), it was determined the facility failed to ensure staff performed hand hygiene after contact with patients and after removing gloves.
Findings include:
Review on May 9, 2018, of facility policy, "Hand Hygiene" dated February 2018, revealed "... Indications for Handwashing and Hand Antisepsis ... 3. Decontaminate hands before having direct contact with patients ... Decontaminate hands after removing gloves ... Between patients when administering medications ...".
Review on May 9, 2018, of facility policy, "Using Gloves" dated February 2018, revealed "Purpose: To provide guidelines for the use of gloves for resident and employee protection ... E. Perform hand hygiene after removing gloves. Gloves do not replace hand hygiene ...".
Observation on May 9, 2018, between 8:20AM and 10:00AM of medication administration to patients, revealed EMP10 did not perform hand hygiene between patients. Further observation revealed EMP10 changed gloves between each patient, but did not perform hand hygiene after removal of gloves between each patient.
Interview on May 9, 2018, with EMP10 at 10:00AM, confirmed hand hygiene was not performed between patients and after the removal of gloves during the administration of medications.
Cross Reference:
482.12- Condition - Governing Body

ORGANIZATION OF REHABILITATION SERVICES

Tag No.: A1124

Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to ensure there were approved policies and procedures for Physical Therapy services.

Findings include:

Review of May 10, 2018, of facility's contract list revealed Physical Therapy services were provided through a contract.

On May 10, 2018, surveyor requested Physical Therapy Policies and Procedures. None were provided.

Interview with EMP1 on May 11, 2018, at 9:45 AM confirmed there were no approved Physical Therapy Policies and Procedures.

Cross Reference:
482.12 - Condition - Governing Body
482.12 (e) (12) - Standard - Contracted Services
482.21 - Condition - QAPI