QA Investigation Results

Pennsylvania Department of Health
ENDOSCOPY ASSOCIATES OF VALLEY FORGE, LLC
Health Inspection Results
ENDOSCOPY ASSOCIATES OF VALLEY FORGE, LLC
Health Inspection Results For:


There are  16 surveys for this facility. Please select a date to view the survey results.

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Initial Comments:


This report is the result of a full Medicare Recertification survey conducted on January 23 and 24, 2019, at Endoscopy Associates of Valley Forge. It was determined the facility was not in compliance with the requirements of 42 CFR, Title 42, Part 416 - Conditions for Coverage for Ambulatory Surgical Centers.





Plan of Correction:




416.51(b)(1) STANDARD
INFECTION CONTROL PROGRAM - DIRECTION

Name - Component - 00
The program is -
Under the direction of a designated and qualified professional who has training in infection control.




Observations:

Based on review of facility documents, review of personnel files (PF) and interview with staff (EMP), it was determined the facility failed to ensure the designated Infection Control professional had additional training to direct the facility's Infection Control program.

Findings include:

Review on January 23, 2019, of facility's "Infection Control Plan," dated January 17, 2019, revealed, " ... Day to day oversight of the Center's Infection Control Plan is that of the Director of Nursing (DON), who has been appointed by the Board of Manager, has had training and current competence and services as the Infection Control Coordinator."

Review on January 23, 2019, of PF6 revealed they completed "Bloodborne Pathogen" education in 2017. Further review of PF6 revealed no further documentation of Infection Control training since 2017 to direct the facility's Infection Control program.

Review on January 23, 2019, of PF3, PF4, PF5, PF7 and PF8 revealed documentation dated 2018 that these licensed staff completed the same Infection Control education as PF6.

Interview with EMP1 on January 23, 2019, at 11:30 AM confirmed PF6 was the Infection Control Coordinator and there was no further documentation of Infection Control education since 2017 to direct the facility's Infection Control program. Further interview with EMP1 confirmed the licensed staff in PF3, PF4, PF5, PF7 and PF8 completed the same Infection Control education as PF6.









Plan of Correction:

Corrective Action
The Governing Body will ensure the Infection Control Officer will attend at least on a yearly basis one Infection control conference, and on a consistent basis throughout the year attend trainings and webinars to maintain continuing and progressive Infection Control training and education. To provide adequate opportunities for infection control education, the Infection Control Officer will become a member on the Association for Professional in Infection Control and Epidemiology (APIC). The center will also employ an Infection Control and Prevention consultant to provide Infection Control training and education for the Infection Control Officer, including review of infection control policies, the Infection Control QAPI program, and provide assistance and guidance in maintaining an Infection Control Program that adheres to nationally recognized guidelines as well as Federal and State regulatory requirements in Infection Control.

Responsible Party and Completion date
The Director of Nursing and the Governing Body will ensure implementation of this Plan of Correction (PoC) following an emergency Board of Managers (BOM) approval on February 11, 2019. To ensure that the PoC is sustained, Quality Assurance Committee will review the Infection Control Officer's continuing education every quarter and report the results to the BOM which is the Governing Body for the facility. This PoC will be implemented February 14, 2019.



Initial Comments:


This report is the result of a State licensure survey conducted on January 23 and 24, 2019, at Endoscopy Associates of Valley Forge. It was determined the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Ambulatory Care Facilities, Annex A, Title 28, Part IV, Subparts A and F, Chapters 551-573, November 1999.






Plan of Correction:




51.31 LICENSURE
Exceptions - Principle

Name - Component - 00
51.31. Principle

The Department may grant exceptions to this part when the policy and objectives contained therein are
otherwise met, or when compliance would create an unreasonable hardship and an exception would not impair or endanger the health, safety or welfare of a patient or resident. No exceptions or departures from this part will be granted if compliance with the requirement is provided for by statute.


Observations:


Based on review of facility policies and procedures, facility documents, and Credential Files (CF), and interview with staff (EMP), it was determined the facility failed to comply with the required criteria, as stated in the exception letter, granting a Class B facility to be allowed to administer Propofol to patients in an ambulatory surgical facility.

Findings include:

Review on January 23, 2019, of the facility exception letter dated "May 22, 2018", revealed "The Department of Health recently reexamined the use of Propofol in ambulatory surgical facilities. This resulted in the Department reviewing the requirements for 28 Pa Code 555.31(a) relating to anesthesia services, and aligning these requirements with best practices for the use of Propofol. Your facility currently has an exception for Propofol that includes conditions. To ensure that all facilities meet the revised requirements, we are issuing your facility a revised exception that includes new conditions that the facility must meet. If your facility readily can meet the revised exception you will have six (6) months from the date of this letter to come into full compliance. If you are unable to adhere to the new requirements you will need to notify the Department within thirty (30) days from the date of the letter. The Department will then contact your facility to discuss your options.

The Department will review your revised policies and compliance during your next licensure survey which could fall no sooner than six (6) months from the date of this letter. The Department will continue to monitor the safe use of Propofol and has the right to rescind your exception if concerns are identified.

The following conditions must be met at all times: ... ALL clinical staff involved in patient care must be ACLS certified. The facility must conduct unannounced quarterly safety drills related to adverse action to Propofol. These drills must include airway rescue scenarios as well as traditional ACLS cardiovascular scenarios that gauge staff ' s ability to urgently locate the equipment and ensure that the equipment is working properly. The facility must document the safety drills and develop a method to evaluate the team ' s performance during the safety drills and incorporate any identified areas into the facility ' s Quality Improvement Plan. At a minimum, documentation must include the date, time, participants, event details, and an assessment of the drill."

A request was made to EMP1 and EMP2 on January 23 and 24, 2019, for the quarterly safety drills related to adverse action to Propofol, and for the facility's Propofol policies and procedures. None was provided.

Review on January 23, 2019, of CF7, CF8, and CF9, revealed there was no documented evidence that these clinical personnel were ACLS certified.

Interview with EMP1 and EMP2, on January 24, 2019, at 10:15 AM, confirmed there was no documented evidence that the quarterly safety drills related to adverse action to Propofol were conducted. EMP2 confirmed the quarterly drills were not conducted. EMP2 further confirmed CF7, CF8, and CF9 are clinical staff who are involved in care of patients who receive propofol. EMP2 further confirmed there was no documented evidence in CF7, CF8, and CF9 that these personnel were ACLS certified. EMP2 further confirmed the facility did not develop a method to evaluate the team's performance during propofol safety drills and incorporate any identified areas into the facility's Quality Improvement Plan. EMP2 further confirmed there were no policies and procedures regarding the use of propofol.



















Plan of Correction:

Corrective Action:
The Governing Body will review and approve policy #12.20 PA-Propofol Use, which outlines the requirements for the safe use of Propofol in a Class B Ambulatory Surgery Facilities (ASF) in an Emergency Board of Managers (BOM) on February 11, 2019. The Director of Nursing (DON) and Medical Director will ensure implementation of the policy by February 12, 2019.

The DON will educate all nursing and medical staff about the requirements of the revised Propofol exception letter by February 8, 2019 . All clinical staff (RNs, CRNAs and physicians) will complete ACLS certification by March 4, 2019. The center will perform four (4) unannounced quarterly drills by December 31, 2019. The Patient Safety Officer along with the Anesthesia Director or designee will evaluate and critique the quarterly drills, and document each drill. The Patient Safety Committee will develop a method in which to evaluate the team's performance at the next Patient Safety Committee meeting scheduled on February 13, 2019 . The evaluation tool will include date, time, participants, event details, and an assessment of the drill. The results of these drills will be assessed at the Patient Safety Committee meeting. Results from the Patient Safety meeting will be reported at the Quality Assurance Committee, then reported to the Board of Managers (BOM).

Responsible Party:
The DON will ensure that all clinical staff are ACLS-certified by March 4, 2019. The DON and Anesthesia Director will ensure that unannounced Propofol drills will be completed quarterly and assessed. The Patient Safety Officer will document each quarterly Propofol safety drill. The Patient Safety Committee and Quality Assurance Committee will review the findings from each quarterly Propofol drill and results will be reported to the BOM.



553.3 (1) LICENSURE
Governing Body Responsibilities

Name - Component - 00
553.3
Governing Body responsibilities include:

(1) Conforming to all applicable Federal, State, and local laws.


Observations:

Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to conform to all applicable State laws.

Endoscopy Associates of Valley Forge, Llc was not in compliance with the following State law:

"Act 52 of 2007, Medical Care Availability and Reduction of Error (MCARE) Act Chapter 4. Health Care-Associated Infections 40 P.S.1303.403. Infection control plan (a) Development and Compliance. - Within 120 days of the effective date of this section, a health care facility and an ambulatory surgical facility shall develop and implement an internal infection control plan that shall be established for the purpose of improving the health and safety of patients and health care workers and shall include: (1) A multidisciplinary committee including representatives from each of the following if applicable to that specific health care facility: (i) Medical Staff that could include the chief medical officer ... (iii) Laboratory personnel ... (v) Pharmacy staff that could include the chief of pharmacy ... (vi) Physical Plant personnel ... ".

This is not met as evidenced by:

Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to ensure the required members of the Infection Control committee attending meetings.

Findings include:

Review on January 23, 2019, of the "Infection Control Plan," reviewed January 17, 2019, revealed it did not contain documentation of the required members of the Infection Control Committee.

Review on January 23, 2019, of the facility's "Infection Control Meeting Minutes," dated April 4, 2018, July 6, 2018, and December 5, 2018, revealed no documentation of a Medical Staff representative, a Pharmacist representative, Lab Personnel or Physical Plant representative attended each of these meetings.

Interview with EMP1 on January 23, 2019, at 11:30 AM confirmed there was no documentation that a Medical Staff representative, a Pharmacist representative, Lab Personnel or Physical Plant representative attended each of these meetings.

































Plan of Correction:

Corrective Action

The Infection Control Plan (policy # 8.01) was revised in accordance with PA Act 52 of 2007, Medical Care Availability and Reduction of Error (MCARE) Act Chapter 4. Health Care-Associated Infections 40 P.S. 1303.403. The facility will ensure a multidisciplinary Infection Control (IC) Committee is implemented. The IC Committee will include:
(i) Medical staff
(ii) Administration representatives
(iii) Laboratory personnel.
(iv) Nursing staff that could include a director of nursing or a nursing supervisor.
(v) Pharmacy staff
(vi) Physical plant personnel.
(vii) A patient safety officer.
(viii) Members from the infection control team,
(ix) A community member
The attendance of these members, will be either in person or by phone.
The revised Infection Control Plan Policy will be approved by the Governing Body by February 11, 2019.

Responsible Party
The Director of Nursing will ensure the revised Infection Control Plan is implemented. The Infection Control Officer will ensure that the appropriate IC Committee members are present at each quarterly Infection Control Meeting. The Quality Assurance Committee will monitor the minutes to ensure the proper personnel are attending the IC Committee meetings until 100% compliance is met for 4 consecutive quarters. The results of this monitoring will be reported to the Governing Body on a quarterly basis.



553.21 (a) LICENSURE
Admission, Transfer & Discharge - Principle

Name - Component - 00
553.21 Principle

(a) Written policies for admission, discharge, transfer and proper referral of patients

Observations:


Based on review of facility policies and procedures, and interviews with staff (EMP), it was determined the facility failed to ensure it had a written policy for the transfer of patients.

A request was made to EMP1 on January 24, 2019, for the facility's written policy for the transfer of patients. None was provided.

Interview with EMP1 on January 24, 2019, at 11:30 AM, confirmed the facility did not have a written policy for the transfer of patients.

------------------------------------------

Based on review of facility documents and medical records (MR), and interview with staff (EMP), it was determined the facility failed to ensure patients were transferred to a hospital upon a written physician order for two of three transfer medical records reviewed (MR 22 and MR23).

Findings include:

A request was made to EMP1 on January 24, 2019, for the facility's written policy for the transfer of patients. None was provided.

Review on January 24, 2019, of MR22 revealed this patient was transported to a local hospital's Emergency department on October 8, 2018. Further review of MR22 revealed there was no written physician order for the patient to be transferred to the local hospital's Emergency department.

Review on January 24, 2019, of MR23 revealed this patient was transported to a local hospital's Emergency department on September 26, 2018. Further review of MR23 revealed there was no written physician order for the patient to be transferred to the local hospital's Emergency department.

Review on January 24, 2019, of a facility document, dated October 8, 2018, revealed MR22 was "transported to [local hospital name] ER"

Review on January 24, 2019, of a facility document, dated September 26, 2018, revealed MR23 was "transferred to [local hospital name] ER ..."

Interview with EMP1 on January 24, 2019, at 12:35 PM, confirmed the facility did not have a written policy for the transfer of patients. Further interview with EMP1 confirmed there was no written physician orders for MR22 and MR23 to be transferred to the local hospitals' Emergency departments.

















Plan of Correction:

Corrective Action
A written policy for the Transfer of Patients to the Hospital (policy #15.01) will be reviewed and approved by the Governing Body by February 11, 2019.

At the time of the survey, the physician's orders were written for patient transfers to the hospital. However, the physician's order sheet was not scanned into the patient's chart. The Director of Nursing held a Staff meeting with the nursing staff on February 1, 2019 to discuss the current procedure for Hospital Transfers, including the need for a Hospital Transfer order. The Director of Nursing held a staff meeting with the Endoscopy Technicians on January 30, 2019 to discuss the importance of scanning the Hospital Transfer order into the patient's chart. All Hospital Transfer charts will be audited by the Quality Assurance Committee until 100% compliance is met for four (4) consecutive quarters. The results of the audit will be reported to the Governing Body quarterly.



553.31 (a) LICENSURE
Administrative responsibilities

Name - Component - 00
A full time person in charge shall be appointed who has authority and responsibility for the operation of the ASF at all times. Qualifications, authority, responsibilities and duties of the person in charge shall be defined in a written statement adopted by the governing body.


Observations:


Based on a review of facility documents and staff interview (EMP), it was determined the facility failed to appoint a full-time person who has authority and responsibility for the operation of the ASF (ambulatory surgery facility) at all times.

Findings include:

Review on January 23, 2019, of PF6's "Job Description" dated September 2018, revealed "Administrator/Director of Nursing".

Review on January 23, 2019, of the facility's License Request Application Form (551.31(d)(1-4) revealed PF6 was the Administrator of the facility. Further review of the application revealed PF6 was also the Director of Nursing of the facility.

Interview with EMP1 on January 23, 2019, at 10:56 AM confirmed PF6 had more than one role at the facility, PF6 served as the Administrator and the Director of Nursing of the facility. EMP1 further confirmed PF6's Job Description indicated that PF6 was both the Administrator and the Director of Nursing of the facility.












Plan of Correction:

Corrective Action
An Emergency Governing Body meeting will be held on February 11, 2019. A corrective action plan will be created at that time to ensure that the center will have an Administrator and a Director of Nursing. The Administrator will be a full-time person in charge, and shall be appointed to have authority and responsibility for the operation of the ASF at all times. Qualifications, authority, responsibilities and duties of the Administrator will be defined in a written job description approved by the Governing Body on February 11, 2019.
The facility will conduct a search for an Administrator and implement the corrective action by February 14, 2019.

Responsible Party
The Governing Body will discuss this finding and address the deficiency during an Emergency Governing Body meeting scheduled on February 11, 2019. The corrective action plan will be I implemented by February 14, 2019.