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501 BATH ROAD

BRISTOL, PA 19007

LICENSURE OF PERSONNEL

Tag No.: A0023

Based on review of facility policies and procedures, review of personnel files (PF), and interview with staff (EMP), it was determined that the facility failed to conform to Pennsylvania Hospital State laws/regulations:

Lower Bucks Hospital was not in compliance with the following State law/regulation:

§ 103.36(b)(1). Personnel records. There shall be an established standard of content for personnel records which shall contain at least the following: Information regarding the employee's education, training, and experience, including, if applicable, professional licensure status and license number, sufficient to verify the employee's qualifications for the job for which he is employed. Such information shall be kept current. Applicants for positions requiring a licensed person should be hired only after obtaining verification of
their licenses, records of education and written references.

This is not met as evidenced by:

Based on review of facility policies and procedures, personnel files (PF), and interview with staff (EMP), it was determined that the facility failed to ensure that written references were obtained upon hire for seven (7) of seven (7) licensed Registered Nurses (RN) personnel files reviewed (PF1, PF2, PF5, PF6, PF7, PF8, and PF9).

Findings include:

Review on November 29, 2017, of the facility policy, "Hiring and Selection Process", dated, "10/14", revealed "Purpose: To select and place personnel on the basis of merit, skills, qualifications, and competence."

Review of PF1, on November 29, 2017, between approximately 9:52 A.M. and 11:45 A.M., revealed the employee was hired as a RN on March 13, 2017. Further review of PF1 revealed no documented evidence that written references, verifying the applicants merit, skills, qualifications, or competence, were obtained, as required by the facilities hiring and selection process.

Review of PF2, on November 29, 2017, between approximately 9:52 A.M. and 11:45 A.M., revealed the employee was hired as a RN on September 26, 2011. Further review of PF2 revealed no documented evidence that written references, verifying the applicants merit, skills, qualifications, or competence, were obtained, as required by the facilities hiring and selection process.

Review of PF5, on November 29, 2017, between approximately 9:52 A.M. and 11:45 A.M., revealed the employee was hired as a RN on June 11, 2012. Further review of PF5 revealed no documented evidence that written references, verifying the applicants merit, skills, qualifications, or competence, were obtained, as required by the facilities hiring and selection process.

Review of PF6, on November 29, 2017, between approximately 9:52 A.M. and 11:45 A.M., revealed the employee was hired as a RN on May 13, 2013. Further review of PF6 revealed no documented evidence that written references, verifying the applicants merit, skills, qualifications, or competence, were obtained, as required by the facilities hiring and selection process.

Review of PF7, on November 29, 2017, between approximately 9:52 A.M. and 11:45 A.M., revealed the employee was hired as a RN on July 21, 2014. Further review of PF7 revealed no documented evidence that written references, verifying the applicants merit, skills, qualifications, or competence, were obtained, as required by the facilities hiring and selection process.

Review of PF8, on November 29, 2017, between approximately 9:52 A.M. and 11:45 A.M., revealed the employee was hired as a RN on August 31, 2015. Further review of PF8 revealed no documented evidence that written references, verifying the applicants merit, skills, qualifications, or competence, were obtained, as required by the facilities hiring and selection process.

Review of PF9, on November 29, 2017, between approximately 9:52 A.M. and 11:45 A.M., revealed the employee was hired as a RN on August 18, 2014. Further review of PF9 revealed no documented evidence that written references, verifying the applicants merit, skills, qualifications, or competence, were obtained, as required by the facilities hiring and selection process.

Interview with EMP1, on November 29, 2017, between approximately 9:52 A.M. and 11:45 A.M., confirmed that PF1, PF2, PF5, PF6, PF7, PF8, and PF9, "did not" contain documented evidence that written references, verifying the applicants merit, skills, qualifications, or competence, were obtained, as required by the facilities hiring and selection process.

GOVERNING BODY

Tag No.: A0043

Based on review of facility policies and procedures, review of facility documents, observations, review of medical records (MR), and interview with staff (EMP), it was determined the Governing Body failed to ensure compliance with the Patient Rights Condition of Participation (A-0115), failed to ensure compliance with the QAPI Condition of Participation (A-0263), and failed to ensure compliance with the Physical Environment Condition of Participation (A-0700) that would ensure a safe physical environment, was provided, to all patients within the Adult and Senior Adult Behavioral Health patient care units.

Findings include:

Review on November 30, 2017, of the facility policy, "Safety Management Plan for Environment of Care", dated, "10/15", revealed "Scope and Responsibility: The ultimate responsibility for ensuring a safe environment for patients, staff and visitors lies within the Governing Board."

Review on November 30, 2017, of the facility document, "Amended & Restated Governing Board Bylaws", dated, "February 10, 2017", revealed " ... Article II General Provisions. 2.1 Hospital Management ... The primary function of the Governing Board is to assure that the Hospital and its Medical Staff provide quality medical care that meets the needs of the community. For this purpose, the Board of Directors has delegated to the Governing Board the authority to ... oversee ... patient safety ..."

Cross Reference:
482.13 - Patient Rights
482.21 - QAPI
482.41 - Physical Environment

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 facilities Governing Body failed to ensure that services performed under contract, for Surgical Services, Nursing Services, and Medical Imaging Services, were provided in a safe and effective manner.

Findings include:

Review on November 30, 2017, of the facility policy, "Performance Improvement Plan", dated, "12/16", revealed "... Goals and Objectives ... The primary goal is to provide a comprehensive Performance Improvement Program that will coordinate and integrate all performance improvement activities Lower Bucks Hospital-wide to assure that the highest achievable safe and quality of care is delivered throughout the hospital. The PI program reflects the complexity of the hospital's organization and services (including those services furnished under contract or arrangement) ... All clinical contracted services will be reviewed, evaluated, and demonstrate a performance improvement summary/assessment on an annual basis and presented to the hospital's Performance Improvement Committee ..."

Review on November 30, 2017, of the facility document, "Amended & Restated Governing Board Bylaws", dated, "February 10, 2017, revealed "... Article II General Provisions. 2.1 Hospital Management ... The primary function of the Governing Board is to assure that the Hospital and its Medical Staff provide quality medical care that meets the needs of the community. For this purpose, the Board of Directors has delegated to the Governing Board the authority to ... oversee ... performance improvement ... 3.8 Duties ... The current duties of the Governing Board are as follows ... (n) Require the development of a Performance Improvement Program that includes a mechanism for review of the quality of patient care services ..."

Review on November 30, 2017, of the facility document, "Contracted Services 2017", revealed the facility had active contracts for clinical services including "Neurophysiologic Monitoring" and "Lithotripsy" for Surgical Services, "Dialysis" for Nursing Services, and "Speech" for Medical Imaging Services.

Review on November 30, 2017, of the facility documents, "Quality Council Meeting Minutes", dated "January 21, 2017", "February 18, 2017", "March 19, 2017", "April 20, 2017", "May 19, 2017", "June 2017", "August 17, 2017", "September 16, 2017", and "October 2017", revealed no documented evidence of the ongoing monitoring, review, and analysis of specific performance indicators and/or data elements for contracted services including "Neurophysiologic Monitoring", "Lithotripsy", "Dialysis", and "Speech".

Interview with EMP8, on November 30, 2017, at 11:08 A.M., confirmed that the facility "does" have active contracts for "Neurophysiologic Monitoring" and "Lithotripsy" for Surgical Services, "Dialysis" for Nursing Services, and "Speech" for Medical Imaging Services. Further interview with EMP8 confirmed the facility "does" have specific quality indicators and/or data elements for the active contracted services. Further interview with EMP8 confirmed that the "Quality Council Meeting Minutes", dated "January 21, 2017", "February 18, 2017", "March 19, 2017", "April 20, 2017", "May 19, 2017", "June 2017", "August 17, 2017", "September 16, 2017", and "October 2017", "did not" contain documented evidence of the ongoing monitoring, review, and analysis of specific performance indicators and/or data elements for contracted services including "Neurophysiologic Monitoring", "Lithotripsy", "Dialysis", and "Speech".

PATIENT RIGHTS

Tag No.: A0115

Based on review of facility policy and procedures, medical records (MR), and interview with staff (EMP), it was determined the facility failed to protect and promote the rights of each patient; by failing to ensure required elements for written grievance notifications were completed (A0123); by failing to promptly notify patients' physician of admission to the facility (A0133); by failing to use restraints in accordance with physician or other licensed independent practitioner orders, and by failing to ensure the restraint educator was qualified as evidenced by education, training, and experience in techniques used to address patients' behaviors (A207).

Cross Reference:
482.12 Governing Body
482.13(a)(2)(iii) Patient Rights: Notice of Grievance
482.13(b)(4) Patient Rights: Admission Status Notification
482.13(e)(5) Patient Rights: Restraint or Seclusion
482.13(f)(3) Patient Rights: Restraint or Seclusion
482.41 Physical Environment: Condition

PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION

Tag No.: A0123

Based on review of facility policies and procedures, review of medical records (MR), and interview with staff (EMP) it was determined that the facility failed to ensure that required elements for written grievance notifications were completed for three (3) of five (5) grievance medical records reviewed (MR26, MR27, and MR28).

Findings include:

Review on November 30, 2017, of the facility policy, "Grievance/Complaint Process", dated "8/17", revealed "... Purpose: 1. To describe the process for the prompt resolution of a patient grievance regarding an alleged violation of patient rights as mandated by the Center for Medicare/Medicaid Services (CMS) ... Grievance Process ... 5. If we are unable to resolve the issue on the spot, within seven (7) days following the submission, the patient will be provided with a written notice of: The name and number of the hospital contact person should further information be required ... The steps taken on behalf of the patient to investigate the grievance ... The results of the grievance process ... The date the investigation was completed ..."

Review of MR 26, on November 29, 2017, revealed the facility sent the patient a grievance letter dated "August 14, 2017". Further review of MR26 revealed the grievance letter was not a copy of the original letter sent to the patient, did not contain documented evidence of the facility name within the letter, and did not contain the phone number of the hospital contact person within the letter.

Review of MR 27, on November 29, 2017, revealed the facility sent the patient a grievance letter dated "8/2/17". Further review of MR27 revealed the grievance letter was not a copy of the original letter sent to the patient, did not contain documented evidence of the results of the grievance process within the letter, and did not contain the phone number of the hospital contact person within the letter.

Review of MR 28, on November 29, 2017, revealed the facility sent the patient a grievance letter dated "9/15/17". Further review of MR28 revealed the grievance letter was not a copy of the original letter sent to the patient, did not contain documented evidence of the results of the grievance process within the letter, and did not contain the phone number of the hospital contact person within the letter.

Interview with EMP7, on November 30, 2017, at 10:15 A.M., confirmed that the grievance letters for MR26, MR27, and MR28 "were not" copies of the original letters sent to the patients. Further interview with EMP7 revealed the facility "does not" keep a copy of the original grievance letter, sent on facility letterhead, within the medical record or within the Patient Advocate office/files. Further interview with EMP7 confirmed that the grievance letters for MR26, MR27, and MR 28 "were" missing required elements for grievance letters as required by facility policy.

PATIENT RIGHTS: ADMISSION STATUS NOTIFICATION

Tag No.: A0133

Based on review of facility policy and procedures, facility document, medical records (MR) and interview with staff (EMP) it was determined the facility failed to promptly notify a physician of patients' choice of his or her admission to the hospital for twelve (12) of twelve (12) medical records reviewed (MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR9, MR10, MR11 and MR12).

Findings include:

Review on November 30, 2017, of facility policy, "Patient Rights Policy" dated October 2017, revealed "Patient Rights ... 4. The patient has the right to have a family member or representative of his or her choice and his or her own physician notified promptly of his or her admission to the hospital ..."

Review on November 30, 2017, of MR1 revealed no documented evidence the patients' physician of choice was promptly notified of patients' admission to the hospital.

Review on November 30, 2017, of MR2 revealed no documented evidence the patients' physician of choice was promptly notified of patients' admission to the hospital.

Review on November 30, 2017, of MR3 revealed no documented evidence the patients' physician of choice was promptly notified of patients' admission to the hospital.

Review on November 30, 2017, of MR4 revealed no documented evidence the patients' physician of choice was promptly notified of patients' admission to the hospital.

Review on November 30, 2017, of MR5 revealed no documented evidence the patients' physician of choice was promptly notified of patients' admission to the hospital.

Review on November 30, 2017, of MR6 revealed no documented evidence the patients' physician of choice was promptly notified of patients' admission to the hospital.

Review on November 30, 2017, of MR7 revealed no documented evidence the patients' physician of choice was promptly notified of patients' admission to the hospital.

Review on November 30, 2017, of MR8 revealed no documented evidence the patients' physician of choice was promptly notified of patients' admission to the hospital.

Review on November 30, 2017, of MR9 revealed no documented evidence the patients' physician of choice was promptly notified of patients' admission to the hospital.

Review on November 30, 2017, of MR10 revealed no documented evidence the patients' physician of choice was promptly notified of patients' admission to the hospital.

Review on November 30, 2017, of MR11 revealed no documented evidence the patients' physician of choice was promptly notified of patients' admission to the hospital.

Review on November 30, 2017, of MR12 revealed no documented evidence the patients' physician of choice was promptly notified of patients' admission to the hospital.

Interview on November 30, 2017, with EMP15 at 1:08PM, confirmed no documented evidence of the patients' physician of choice being promptly notified of admission to the hospital in MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR9, MR10, MR11 and MR12.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0168

Based on review of facility policy and procedures, medical records (MR), and interview with staff (EMP), it was determined the facility failed to use restraints in accordance with physician or other licensed independent practitioners' (LIP) orders for one (1) of five (5) restraint medical records reviewed (MR11).
Findings include:
Review on November 30, 2017, of facility policy, "Restraints: Violent Behavior or Seclusion" dated March 2017, revealed "... Restraint - any manual method, physical 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 ... 2. ... All patients have the right to be free from restraint, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff ... 3. Restraint may only be imposed to ensure the immedi4. Restraint may only be used when less restrictive interventions have been determined to be ineffective to protect the patient and staff member or others from harm ... 13. The use of restraint is in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient ..."
Review on November 30, 2017, of MR11 nursing documentation, revealed the patient was admitted to the Emergency Room on September 10, 2017. Further review revealed the patient was in a four point restraint on September 10, 2017, with a start time of 9:24AM and end time of 10:30AM.
Review on November 30, 2017, of MR11 Physician Orders revealed no documented evidence of a physician or licensed independent practitioner order for the use of a four point restraint.
Interview on November 30, 2017, with EMP15 at 1:14PM, confirmed no documented evidence of a physician or licensed independent practitioner order for the use of a four point restraint for MR11.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0207

Based on review of facility policy and procedure, review of personnel files (PF), and interview with staff (EMP), it was determined that the facility failed to ensure that the restraint educator was qualified as evidenced by specific education, training, and experience in techniques used to address patients' behaviors and restraint application for one (1) of one (1) restraint educator personnel file reviewed (PF5).

Findings include:

Review on November 29, 2017, of the facility policy, "Restraints: Violent Behavior or Seclusion", dated, "3/17", revealed "... Staff Training Requirements ... Trainer Requirements 1. Individuals providing training are qualified as evidenced by education, training, and experience in techniques used to address patients' behavior."

Review of PF5, on November 29, 2017, between approximately 9:52 A.M. and 12:15 P.M., revealed the employee was a designated nursing educator. Further review of PF5 revealed no documented evidence of specific education, training, and experience in techniques used to address patients' behaviors and restraint application, identifying the employee as a qualified restraint educator.

Interview with EMP1, on November 29, 2017, at 12:15 P.M., confirmed that the employee in PF5 "was" a designated restraint educator for the facility. Further interview with EMP1 confirmed that PF5 "did not" have documented evidence that the designated restraint educator had specific education, training, and experience in techniques used to address patients' behaviors and restraint application, as required by facility policy.

QAPI

Tag No.: A0263

Based on review of facility policies and procedures, review of facility documents, and interview with staff (EMP), it was determined that the facility failed to ensure compliance with the QAPI Condition of Participation (A-0263).

Findings include:

Review on November 30, 2017, of the facility document, "Amended & Restated Governing Board Bylaws", dated, "February 10, 2017, revealed "Article II General Provisions. 2.1 Hospital Management ... The primary function of the Governing Board is to assure that the Hospital and its Medical Staff provide quality medical care that meets the needs of the community. For this purpose, the Board of Directors has delegated to the Governing Board the authority to ... oversee ... performance improvement ... 3.8 Duties ... The current duties of the Governing Board are as follows ... (n) Require the development of a Performance Improvement Program that includes a mechanism for review of the quality of patient care services ..."

Cross Reference:
482.21 - QAPI Governing Body
482.21(e)(5) - QAPI Executive Responsibilities

QAPI GOVERNING BODY, STANDARD TAG

Tag No.: A0308

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 the QAPI program involved the review of specific performance indicators and/or data elements for all active, contracted hospital services, including Surgical Services, Nursing Services, and Medical Imaging Services.

Findings include:

Review on November 30, 2017, of the facility policy, "Performance Improvement Plan", dated, "12/16", revealed "... Goals and Objectives ... The primary goal is to provide a comprehensive Performance Improvement Program that will coordinate and integrate all performance improvement activities Lower Bucks Hospital-wide to assure that the highest achievable safe and quality of care is delivered throughout the hospital. The PI program reflects the complexity of the hospital's organization and services (including those services furnished under contract or arrangement) ... All clinical contracted services will be reviewed, evaluated, and demonstrate a performance improvement summary/assessment on an annual basis and presented to the hospital's Performance Improvement Committee ..."

Review on November 30, 2017, of the facility document, "Amended & Restated Governing Board Bylaws", dated, "February 10, 2017, revealed "... Article II General Provisions. 2.1 Hospital Management ... The primary function of the Governing Board is to assure that the Hospital and its Medical Staff provide quality medical care that meets the needs of the community. For this purpose, the Board of Directors has delegated to the Governing Board the authority to ... oversee ... performance improvement ... 3.8 Duties ... The current duties of the Governing Board are as follows ... (n) Require the development of a Performance Improvement Program that includes a mechanism for review of the quality of patient care services ..."

Review on November 30, 2017, of the facility document, "Contracted Services 2017", revealed the facility had active contracts for clinical services including "Neurophysiologic Monitoring" and "Lithotripsy" for Surgical Services, "Dialysis" for Nursing Services, and "Speech" for Medical Imaging Services.

Review on November 30, 2017, of the facility documents, "Quality Council Meeting Minutes", dated "January 21, 2017", "February 18, 2017", "March 19, 2017", "April 20, 2017", "May 19, 2017", "June 2017", "August 17, 2017", "September 16, 2017", and "October 2017", revealed no documented evidence of the ongoing monitoring, review, and analysis of specific performance indicators and/or data elements for contracted services including "Neurophysiologic Monitoring", "Lithotripsy", "Dialysis", and "Speech".

Interview with EMP8, on November 30, 2017, at 11:08 A.M., confirmed that the facility "does" have active contracts for "Neurophysiologic Monitoring" and "Lithotripsy" for Surgical Services, "Dialysis" for Nursing Services, and "Speech" for Medical Imaging Services. Further interview with EMP8 confirmed the facility "does" have specific quality indicators and/or data elements for the active contracted services. Further interview with EMP8 confirmed that the "Quality Council Meeting Minutes", dated "January 21, 2017", "February 18, 2017", "March 19, 2017", "April 20, 2017", "May 19, 2017", "June 2017", "August 17, 2017", "September 16, 2017", and "October 2017", "did not" contain documented evidence of the ongoing monitoring, review, and analysis of specific performance indicators and/or data elements for contracted services including "Neurophysiologic Monitoring", "Lithotripsy", "Dialysis", and "Speech".

QAPI EXECUTIVE RESPONSIBILITIES

Tag No.: A0309

Based on review of facility policies and procedures, review of facility documents, and interviews with staff (EMP), it was determined the facilities Governing Body failed to ensure that a determination of the number of distinct improvement projects was conducted, annually, for the QAPI Program.

Findings include:

Review on November 30, 2017, of the facility policy, "Performance Improvement Plan", dated, "12/16", revealed "... Authority and Responsibility A. Governing Board The Governing Board of Lower Bucks Hospital has the authority and responsibility for: 1. Determining priorities regarding which processes to monitor (indicators and frequency) with data collection and the subsequent development of planned improvement efforts."

Review on November 30, 2017, of the facility document, "Amended & Restated Governing Board Bylaws", dated, "February 10, 2017, revealed "Article II General Provisions. 2.1 Hospital Management ... The primary function of the Governing Board is to assure that the Hospital and its Medical Staff provide quality medical care that meets the needs of the community. For this purpose, the Board of Directors has delegated to the Governing Board the authority to ... oversee ... performance improvement ... 3.8 Duties ... The current duties of the Governing Board are as follows ... (n) Require the development of a Performance Improvement Program that includes a mechanism for review of the quality of patient care services."

Review on November 30, 2017, of the facility document, "2017 PI Priority Grid", revealed the facility had six (6) defined performance improvement projects listed for 2017, including "1. Falls Prevention", "2. Restraints", "3. BHU-Daily Assessment", "4. Stroke Medication Mgt", "5. Lab-Blood C/S", and "6. ED Flow".

Review on November 30, 2017, of the facility documents, "Quality Council Meeting Minutes", dated "January 21, 2017", "February 18, 2017", "March 19, 2017", "April 20, 2017", "May 19, 2017", "June 2017", "August 17, 2017", "September 16, 2017", and "October 2017", revealed no documented evidence of the approval of the Governing Body for the determination of the number of distinct improvement projects selected for 2017.

Review on November 30, 2017, of the facility documents, "Governing Body Meeting Minutes", dated, "August 11, 2017", "May 12, 2017", "February 13, 2017", and "November 11, 2016", revealed no documented evidence of the approval of the Governing Body for the determination of the number of distinct improvement projects selected for 2017.

Interview with EMP8, on November 30, 2017, at 2:42 P.M., confirmed that the facility "does" have six (6) active performance improvement projects for 2017. Further interview with EMP8 confirmed that the Quality Council Meeting Minutes and Governing Body Meeting Minutes "do not" contain documented evidence of the approval of the Governing Body for the determination of the number of distinct improvement projects selected for 2017.

FORM AND RETENTION OF RECORDS

Tag No.: A0438

Based on review of facility policy and procedures, medical records (MR), and interview with staff (EMP), it was determined the facility failed to ensure patient medical records were completed within 30 days following discharge for three (3) of twelve (12) medical records reviewed (MR1, MR2 and MR5).

Review on November 30, 2017, of facility policy, "Completion of Medical Records" dated May 16, 2017, revealed "... A complete, current, and legible medical record shall be prepared for each patient on each occurrence of treatment within thirty (30) days from the date of discharge ... Completion, Timeliness, and Authentication of Medical
Records : All Medical records must be completed thirty (30) days from the date of discharge. All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing and evaluating the service provided, consistent with hospital policy and procedures ... Discharge Summary: All patient medical records (inpatient) shall include a discharge summary within 30 days from date of discharge ..."

Review on November 30, 2017, of MR1 revealed the patient was discharged on August 18, 2017. Further review of MR1 revealed physician electronic signature of "Discharge Summary ... 9/20/2017 ... 15:47 ..."

Review on November 30, 2017, of MR2 revealed the patient was discharged on September 3, 2017. Further review of MR2 revealed physician electronic signature of
"Discharge Summary ... 10/9/2017 ... 15:53 ..."

Review on November 30, 2017, of MR5 revealed the patient was discharged on September 16, 2017. Further review of MR5 revealed physician electronic signature of "Discharge Summary ... 10/20/2017 ... 11:52 ..."

Interview on November 30, 2017, with EMP15 at 1:33PM, confirmed the medical record was not completed within thirty (30) days from the date of discharge for MR1, MR2, and MR5.