QA Investigation Results

Pennsylvania Department of Health
CROZER-KEYSTONE SURGERY CENTER AT BRINTON LAKE (A DEPARTMEN
Health Inspection Results
CROZER-KEYSTONE SURGERY CENTER AT BRINTON LAKE (A DEPARTMEN
Health Inspection Results For:


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Initial Comments:
This report is the result of a State licensure survey conducted on September 21, 2023, at Crozer - Keystone Surgery Center at Brinton Lake. 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:




553.3 (8) LICENSURE
Governing Body Responsibilities

Name - Component - 00
553.3 Governing Body responsibilities include:
(8) Establishing personnel policies and practices which adequately support
sound patient care to include, the following:


Observations:

Based on review of facility policy, credential files (CF) and staff interview (EMP), it was determined the facility failed to obtain current background checks for ten of ten credential files reviewed (CF1, CF2, CF3, CF4, CF5, CF6, CF7, CF8, CF9, and CF10).

Findings include:

Review on September 21, 2023, of the facility policy "Criminal Background Checks," revealed "... In order to ensure compliance with the Patient Abuse Prevention Act ... Company conducts criminal background history checks, including Pennsylvania State Police Criminal History (PATCH), and FBI fingerprinting on all prospective employees as a condition of employment. In addition, Department of Public Welfare (DPW) Child History clearances are required on all hospital and physician practice employees."

Review of credential files on September 21, 2023, revealed the following:

CF1 did not contain current Pennsylvania State Police (PSP), Federal Bureau of Investigation (FBI) and Department of Public Welfare Childline verifications.

CF2 did not contain current Pennsylvania State Police (PSP), Federal Bureau of Investigation (FBI) and Department of Public Welfare Childline verifications.

CF3 did not contain current Pennsylvania State Police (PSP), Federal Bureau of Investigation (FBI) and Department of Public Welfare Childline verifications.

CF4 did not contain current Pennsylvania State Police (PSP), Federal Bureau of Investigation (FBI) and Department of Public Welfare Childline verifications.

CF5 did not contain current Pennsylvania State Police (PSP), Federal Bureau of Investigation (FBI) and Department of Public Welfare Childline verifications.

CF6 did not contain current Pennsylvania State Police (PSP), Federal Bureau of Investigation (FBI) and Department of Public Welfare Childline verifications.

CF7 did not contain current Pennsylvania State Police (PSP), Federal Bureau of Investigation (FBI) and Department of Public Welfare Childline verifications.

CF8 did not contain current Pennsylvania State Police (PSP), Federal Bureau of Investigation (FBI) and Department of Public Welfare Childline verifications.

CF9 did not contain current Pennsylvania State Police (PSP), Federal Bureau of Investigation (FBI) and Department of Public Welfare Childline verifications.

CF10 did not contain current Pennsylvania State Police (PSP), Federal Bureau of Investigation (FBI) and Department of Public Welfare Childline verifications.


Interview on September 21, 2023, with EMP1 confirmed the findings.








Plan of Correction:

The Director of Medical Staff Affairs will ensure that 100% of available Medical Affairs staff will be reeducated on the policy titled, "Criminal Background Checks" by Friday 11/17/23.

The Director of Medical Staff Affairs or a designee will complete a full audit of all provider files at Brinton Lake Surgery Center to ensure that all providers have the required background checks completed per hospital policy. All audit data will be reported monthly to the Quality of Care Committee by hospital leadership until the full provider audit is complete.

The Chief Medical Officer is ultimately responsible for this plan of correction.



555.22 (a)(1-2) LICENSURE
Surgical Services - Preoperative Care

Name - Component - 00
555.22 Pre-operative Care

(a) Pertinent medical histories and physical examinations, and supplemental information regarding drug sensitivities documented day of surgery or one of the following:
(1) If medical evaluation, examination and referral are made from a private practitioner's office, hospital or clinic, pertinent records thereof shall be available and made part of the clinical record at the time the patient is registered and admitted tot he ASF. This information is considered valid no more than 30 days prior to the date of surgery.
(2) A practitioner shall examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed. The information shall be clearly documented in the medical record.



Observations:

Based upon review of facility documents, medical records (MR), and interview of staff (EMP) it was determined that the facility failed to ensure that each patient was evaluated and assigned an ASA (physical status) for two of ten medical records reviewed (MR7 and MR9).

Findings include:
A review on September 21, 2023, of the facility policy "Admission Criteria of Patient to Perioperative Services" revealed "... Individuals scheduled for procedures at the Center should be limited to patients who: ... C. Patients are in good general health (ASA Class I or II, or III) with stable systemic disease ..."

Review of MR7 on September 21, 2023, revealed no documentation that the patient was assigned an ASA level (physical status) prior to undergoing a procedure.

Review of MR9 on September 21, 2023, revealed no documentation that the patient was assigned an ASA level (physical status) prior to undergoing a procedure.

Interview with EMP2 on September 21, 2023, confirmed the absence of ASA levels in MR7 and MR9.








Plan of Correction:

The Administrative Director of Brinton Lake Surgery Center will ensure that 100% of available Brinton Lake Surgery Center Providers will be re-educated on regulations 555.22 which details the requirement to ensure that each patient is evaluated and assigned an ASA (physical status.) Education will be completed by 11/17/23.

The Administrative Director of Brinton Lake Surgery Center or a designee will complete a minimum of 5 chart audits per week to ensure each patient is evaluated and assigned an ASA (physical status) per regulations. Any identified instance of noncompliance will be immediately addressed with the provider identified and reported to the Chief Medical Officer. Audits will continue until three consecutive months of 100% compliance has been achieved. All audit data will be reported monthly to the Quality of Care Committee by hospital leadership.

The Administrative Director of Brinton Lake Surgery Center is ultimately responsible for this plan of correction.



567.41 LICENSURE
MAINTENANCE SERVICE - Principle

Name - Component - 00
567.41 Principle

The ASF shall be equipped, operated and maintained to sustain its
safe and sanitary characteristics and to minimize health hazards in the ASF
for the protection of patients and employes.


Observations:

Based on review of the Pennsylvania Code for Labor and Industry, observation, and interview with staff (EMP), it was determined the facility failed to ensure the autoclave used for sterilization of surgical supplies was inspected.

Findings include:

Review on September 21, 2023, of the Pennsylvania Code for Labor and Industry, 34 3a. revealed 3a.168. Autoclaves and quick opening vessels.
(a) An inspector shall inspect autoclaves and quick opening vessels with close examination of all moving parts, locking devices, pins, and interlocking devices, in accordance with ANSI/NB 23.
(b) An autoclave and quick opening vessel must have interlocking systems to prevent charging the vessel until all openings and locking devices are fully in place.
(c) A pressure-relieving device must be sized in accordance with the data plate for pressure. The capacity must be based on the pressure and pipe size or the total BTU valve of the boiler. (d) Inspection of autoclaves and quick opening vessels shall be performed in accordance with 3a.111(8) (relating to field inspections).

Observation on September 21, 2023, of the facility's sterilization area revealed two Getinge autoclaves. The autoclaves are used for sterilization of surgical supplies.

A request was made on September 21, 2023, for documentation of the current boiler/pressure vessel inspections. No documentation was provided.

Interview with EMP1 on September 21, 2023, confirmed there was no documentation of current boiler/pressures vessel inspections for the autoclaves.






Plan of Correction:

The Senior Director of Facilities will provide education to the Facilities Management staff on the regulation for the need of inspections to be completed for autoclave machines at the time of install. This will be confirmed by receiving a Certificate of Operations from the department of Labor and Industry/Bureau of Occupational and Industrial Safety Boiler Division. Education will be completed on this regulation by 11/17/2023.
Updates surrounding completed inspections will be provided to the Quality of Care Committee by hospital leadership.

The Senior System Director of Facilities is ultimately responsible for follow up of this action.