Pennsylvania Department of Health
VINCERA SURGERY CENTER, LLC
Patient Care Inspection Results

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Severity Designations


Minimal Citation - No Harm	Minimal Harm	Actual Harm	Serious Harm

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VINCERA SURGERY CENTER, LLC - Inspection Results	Scope of Citation Number of Residents Affected By Deficient Practice

Initial comments:
This report is the result of a State licensure survey conducted on October 11, 2022, at Vincera Surgery Center, Llc. 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)(i) LICENSURE Governing Body Responsibilities:

553.3 Governing Body responsibilities include:
(8) Establishing personnel policies and practices which adequately support
sound patient care to include, the following:
(i) Require the employment of personnel with qualifications commensurate with a job's responsibilities and authority, including appropriate licensure and certification.

Observations:

Based on a review of facility Bylaws, personnel files (PF) and interview with staff (EMP), it was determined the Governing Body failed to ensure personnel had appropriate certifications detailed in the job description for one of one personnel file reviewed (PF1).

Findings include:

A review on October 11, 2022 of the facility's" Bylaws of the Governing Body" not dated revealed "Article II Governance, Section 1: Authority and Responsibility:...The Governing Board is responsible for the conduct of the Facility in accordance with the stated objectives and philosophies of the Medical Staff and conformance with laws set forth by the State of Pennsylvania....The members of the Medical Staff of the Facility shall abide by the ethical standards adopted by...Article IV, Section 1 Medical Staff...State laws and regulations and the Federal Standard Conditions for Coverage..."

A review on October 11, 2022, of PF1 (Director of Nursing), revealed a signed job description dated August 31, 2015. Further review revealed "Qualifications: ...Current BLS (basic life support), ACLS (advanced cardiovascular life support), and PALS (pediatric advanced life support) (if pediatric patients' procedures are performed)". Further review revealed there was no documented evidence of current certification in ACLS or PALS.

An interview conducted on October 11, 2022, at 10:08 AM with EMP1 confirmed the qualifications listed in the job description for PF1 (Director of Nursing) was to have a current ACLS and PALS certification. EMP1 further confirmed PF1 did not contain evidence of certification in ACLS or PALS in accordance with the qualifications listed in the job description. EMP1 stated "(PF1) does not have either (ACLS or PALS) certification."

Plan of Correction - To be completed: 01/31/2023

1. The Administrator is responsible for this plan of correction. The Administrator and Director of Nursing will review all personnel files to ensure that all personnel have appropriate certifications indicated by the job description as determined by the Governing Board by 1/31/2023.

2. The personnel file will include the use of a Personnel Checklist. This checklist includes the confirmation of the required qualifications, licensures, and or certifications as indicated by the job description. The Personnel Checklist must be signed by both the Administrator and Director of Nursing upon completion prior to the employee's start date. The administrator shall present the checklist to the Quality committee who will report to the Governing Board for final approval and adoption upon completion by 1/31/2023.

3. The Administrator and the Director of Nursing will review job descriptions to determine that all personnel have appropriate certifications as determined by the job's responsibilities and authority. Any changes will be presented to the Quality committee and to the Governing Board for final approval and documented in the meeting minutes.
Administrator will present Personnel File Checklist to the Quality committees and to the Governing Board for final approval and documented in the meeting minutes.

4. The Administrator will monitor performance to make sure that solutions are sustained by conducting monthly Personnel file audits, five files per month, to ensure that proper confirmation of the required qualifications, licensures, and or certifications as indicated by the job description are present. The audits will be performed monthly for one year, or until 100% compliance is achieved for six months. The Monitoring of Continued performance and Personnel will be standing agenda items reported to the Quality and Governing Board committees and documented in the meeting minutes.

5. A. The Administrator and the Director of Nursing will review job descriptions to determine that all personnel have appropriate certifications as determined by the job's responsibilities and authority. Any changes will be presented to the Quality committee and to the Governing Board for final approval and documented in the meeting minutes by 1/31/2023.
B. The administrator will present the Personnel Checklist to the Quality committees and then to Governing Board committee for final approval and documented in meeting minutes by 1/31/2023.

553.3 (8)(iii) LICENSURE Governing Body Responsibilities:

553.3 Governing Body responsibilities include:
(8) Establishing personnel policies and practices which adequately support
sound patient care to include, the following:
(iii) Personnel records shall include current information relative to periodic work performance evaluations.

Observations:

Based on a review of facility policy, personnel files (PF), and interview with staff (EMP), it was determined the Governing Body failed to ensure an annual evaluation was completed for two of two personnel files reviewed (PF1 and PF3).

Findings include:

A review of facility policy "1.13 Performance Review," dated August 30, 2022, revealed "The Medical Director and the Administrator are responsible for evaluating work performance of their employees. ...A formal evaluation of performance for all new employees will be carried out three months after the date of hire and annually thereafter, typically at the employment anniversary. The performance evaluation and written recommendations will be signed and a copy of the form will be inserted in the employee's personnel file."

A review on October 11, 2022, of PF1, a registered nurse, revealed an employee performance evaluation form completed January 20, 2020. Further review revealed no evidence of documentation that performance evaluations were completed in January 2021 or January 2022 in accordance with the facility policy.

A review on October 11, 2022, of PF3, a registered nurse, hired February 22, 2021. Further review revealed no evidence of documentation that a performance evaluation was completed in February 2022 in accordance with the facility policy.

An interview conducted on October 11, 2022, at 10:15 AM with EMP1 confirmed PF1 did not contain evidence of documentation that annual performance evaluations were completed in January 2021 and January 2022. Further interview confirmed PF3 did not contain evidence of documentation that an annual performance evaluation was completed in February 2022.

Plan of Correction - To be completed: 01/31/2023

1. The Administrator, who is responsible for this plan of correction, will correct the deficiency by ensuring that annual evaluations are completed for all personnel files. This will be completed by 1/31/2023.

2. The Administrator and Director of Nursing will review the facility policy (1.13 Performance Review) regarding the formal evaluation of work performance. This will be completed and documented by 1/31/2023. The Administrator and Director of Nursing will meet monthly, and the documented minutes will include a review of personnel evaluations.

3. Personnel Files will be reviewed as standing agenda items at all future quarterly Quality and Governing Board committee meetings. The minutes of these meetings will include formal performance evaluations.

4. The Administrator will perform and document monthly personnel file audits, five per month, to ensure that all performance evaluations are completed annually. Results of these audits will be reported to the Quality and Governing Board and documented in the meeting minutes.

5. The Administrator will correct the deficiency by ensuring that all personnel file annual evaluations are completed by 1/31/2023.
The Administrator and Director of Nursing will review the facility policy (1.13 Performance Review) regarding formal annual evaluation of work performance. This will be completed and documented by 1/31/2023.

553.31 (a) LICENSURE Administrative responsibilities:

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, policies, personnel files (PF), and interview with staff (EMP), it was determined the Governing Body failed to ensure that a full time person in charge (administrator) was appointed who had the authority and responsibility for the operation of the ambulatory surgery center at all times.

Findings include:

1) A review of facility document provided by the facility October 31, 2022, revealed a letter addressed to EMP1, the facility Administrator, signed by the facility Chief Medical Officer, dated March 19, 2020, stating "This letter serves as your appointment as the Infection Control Officer (interim) at Vincera Surgery Center. Your responsibilities are to oversee, review, and refinement of the facility's Infection Control program."

A review of facility document "2022 Infection Prevention and Control Program," undated, revealed "Who is responsible for the Infection Prevention and Control Program? The Infection Prevention and Control Professional (IPCP). The IPCP - is ...responsible for the organization-wide Infection Prevention and Control Plan... The (IPCP) provides surveillance and reports findings and suggestions to the Medical Director, the Infection Control Committee, (Quality Assurance) committee and Governing Board. ...The IPCP will dedicate 20% of his/her time to Infection Prevention activities."

2) A review of facility document provided by the facility October 31, 2022, revealed a letter addressed to EMP1, the facility Administrator, signed by the facility Chief Medical Officer, dated November 15, 2021, stating "This letter serves as your appointment as the Patient Safety Officer (interim) at Vincera Surgery Center. Your responsibilities are to oversee, review, and refinement of the facility's Patient Safety program."

A review of facility policy "8.13. Patient Safety Officer (PSO)," last revised August 1, 2021, revealed "The Patient Safety Officer's responsibilities, in accordance with Act 13, are as follows: Oversee the creation, review and refinement to the patient safety improvement and management program. Identify and secure the necessary resources to fully implement the patient safety improvement and management program. Coordinate and prioritize the activities of the Patient Safety Committee. Coordinate the development and implementation of policies and procedures that support the activities of the patient safety program. Develop and implement adequate internal information and management systems and utilize information from external sources to support the activities of the patient safety program. Oversee and coordinate the investigation of serious events and, as appropriate, identify incidents. Ensure compliance with sentinel event, serious event, and incident and infrastructure failure reporting requirements as mandated by the law/regulations. Ensure the disclosure of serious events to patients and/or families is carried out in accordance with organizational policy and law/regulations. Devise strategies to enlist medical staff, employee and patient family input into the organization's patient safety improvement and management program. Support and encourage error reporting throughout the organization through a non-punitive error reporting approach. Recommend and facilitate change within the organization to improve patient safety based on identified risks and proactive risk assessment. Assist in the identification and development of organizational and unit-based educational programs to promote an understanding of the organization's patient safety program and each individual's responsibility and accountability in the success of the program. Develop and implement mechanisms for internal communication of patient-safety related information. Serve as the direct link to the governing board and medical director on all matters related to patient safety. Provide periodic reports on specific event, actions taken, proactive risk assessment and barriers to implementation of various initiatives to improve patient safety in the organization. Serve as a resource for clinical departments on issues of patient safety."

A review on October 11, 2022, of the facility Administrator's (EMP1) job description revealed "Scope: Oversees all clinical and administrative operations of VSC (Vincera Surgery Center). ... Performing all clinical and administrative personnel evaluations and orientations. ... Essential Functions: Responsible for managing, directing and supervising all clinical aspects of VSC, including following services: nursing, sterile, processing, materials management, regulatory compliance, quality improvement, risk management. ...Runs all Clinical Committee meetings, participates in Board meetings."

An interview conducted on October 11, 2022, at 2:47 PM with EMP1 confirmed EMP1 was the facility's Administrator, Infection Control Officer and the Patient Safety Officer. EMP1 stated "I know that (as the facility Administrator) I should not be the Patient Safety Officer or the Infection Control Officer. I have not been able to delegate (those roles) to other staff yet."

Plan of Correction - To be completed: 01/31/2023

1. The Medical Director, who is responsible for this plan of correction, is educated on the regulation (553.31) that a full-time person in charge (Administrator) is appointed and has the authority and responsibility for the operation of the ambulatory center at all times. Receipt of this education will be confirmed by written attestation by 1/31/2023. The roles of the Infection Control and Patient Safety Officer will be appointed to staff members, not to include the Administrator. This is effective immediately, pending Governing Board approval by 1/31/2023.

2. The Medical Director will appoint such positions in the future, in coordination with the Administrator, and the complete personnel file will be presented to the Quality committees and then to the Governing Board for final approval. These will be documented in the meeting minutes.

3. The Medical Director is directly involved in the process. The job description for the Administrator will be reviewed and approved by the Medical Director and the Governing Board. It must be stated that the Administrator is a full-time person who has the authority and responsibility for the operation of the ASF. This is completed by 1/31/2023.

4. All Quality committee and Governing Board meeting minutes in the future will list the names of the new Patient Safety and Infection Control Officers. The appointed Patient Safety and Infection Control officers will have an appointment letter in his/her personnel file and the term will be audited and reviewed annually at the Quality and Governing Board committee meetings and documented in the meeting minutes.

5. The Medical Director is educated on the regulation (553.31) that a full-time person in charge (Administrator) is appointed and has the authority and responsibility for the operation of the ambulatory center at all times. Receipt of this education will be confirmed by written attestation by 1/31/2023.

The roles of the Infection Control and Patient Safety Officer will be appointed to staff members, not to include the Administrator. This is effective immediately, pending Governing Board approval by 1/31/2023.

555.22 (c)(1-5) LICENSURE Surgical Services - Preoperative Care:

555.22 Pre-operative Care

(c) Written instruction for preoperative procedures, which have been approved by the medical
staff, shall be given to the patient or responsible person, and shall include:
(1) Applicable restrictions upon food and drink before surgery
(2) Special preparations to be made by the patient
(3) The required proximity of the patient to the ASF for a specific time following surgery if applicable.
(4) An understanding that the patient may require admission to the hospital in the event of medical need.
(5) The requirement that, upon discharge of a patient who has received sedation or general anesthesia, a responsible person shall be available to escort patient home. With respect to patients who receive local or regional anesthesia, a medical decision shall be made regarding whether such patients require a responsible person to escort them home.

Plan of Correction - To be completed: 01/31/2023

1. The Administrator is responsible for this plan of correction and will review the facility policy regarding written preoperative instructions.

2. The Administrator will review all written preoperative instruction templates and will ensure that they include all the required elements per regulation.
The templates will be presented to the Quality committees and then to the Governing Board committees for final approval. This will be documented in the meeting minutes and completed by 1/31/2023.

3. The Administrator will ensure the facility policy regarding written preoperative instructions, contains all the required elements per regulation. Any changes to the policy will be presented to the Quality committees and then the Governing Board committee for final approval. The Administrator will educate all physician and nursing staff on the facility policy regarding written preoperative instructions. Receipt of education will be confirmed via email or written attestation. This will be completed by 1/31/2023.

4. The Administrator will audit five charts per week, until 100% compliance is achieved for four consecutive weeks, to ensure the written preoperative instructions include the required elements per regulation. The results will be reported and documented at the quarterly Quality and Governing Board meetings beginning the first quarter in 2023.

5. The Administrator will ensure the facility policy regarding written preoperative instructions, contains all the required elements per regulation by 1/31/2023.
The Administrator will review all written preoperative instruction templates and will ensure that they include all the required elements per regulation by 1/31/2023.

The Administrator will educate physician and nursing staff on the facility policy regarding written preoperative instructions. Written or email confirmation will be completed by 1/31/2023.

565.14 (b)(3) LICENSURE Policies:

565.14

(b) Policies shall address the safety aspects of radiology services,
including, but not limited to:
(3) Proper shielding where radiation sources are used

Observations:

Based on a review of facility policy, documents, observation, and interview with staff (EMP), it was determined the facility failed to ensure radiographic protective garments was properly inspected for radiation safety.

Findings include:

A review of facility policy "6. Radiology Services" last revised September 1, 2022, revealed "6.1. Radiation Safety and Monitoring. Policy: Lead aprons and thyroid shields will be worn by all persons in the room while imaging is being performed. The integrity of all radiation safety PPE (Personal Protective Equipment) shall be checked annually. Frayed or torn PPE shall not be used."

A review on October 11, 2022, of facility document "Lead inventory and integrity inspection" dated July 22, 2022, revealed a form with columns containing the headers "Identifier, Apron, Collar" as well as comments pertaining to some of the items inspected. Further review revealed [XXXX] name redacted apron was listed as "Fair" with the comments "2 small defects, circled on apron;" [XXXX] name redacted apron was listed as "Good" with the comments "arm seams are torn;" [XXXX] name redacted apron was listed as "Good" with the comments "arm seams are torn, cracked crease;" [XXXX] name redacted apron was listed as "Good" with the comments "arm seams are torn, cracked crease;" [XXXX] name redacted apron was listed as "not found;" [XXXX] name redacted apron listed as "not found;" "OR4 Black" apron was listed as "not found;" "OR5 Black" apron was listed as "not found;" "OR7 Blue" apron was listed as "Good" with the comments "arm seams are torn;" "OR8 Blue" apron was listed as "Good" with the comments "arm seams are torn;" "OR10 Blue" apron was listed as "not found." Further review revealed there was no documentation on the form that the aprons noted to be damaged was acceptable for continued use.

An observation on October 11, 2022, at 11:02 AM in Operating Room 4 (OR4) with EMP2 revealed a black lead apron labeled "OR." No additional information was found on the apron indicating the apron had been inspected for radiation safety.

An observation on October 11, 2022, at 11:14 AM in OR2 with EMP2 revealed one black lead apron labeled "OR" and one blue lead apron labeled "OR." No additional information was found on the aprons indicating the aprons had been inspected for radiation safety.

An observation on October 11, 2022, at 11:22 AM in OR1 with EMP2 revealed a blue lead apron labeled "OR." No additional information was found on the apron indicating the apron had been inspected for radiation safety.

An interview conducted on October 11, 2022, at 11:24 AM with EMP2 confirmed the Lead inventory and integrity inspection form did not indicate if the aprons noted to be damaged was acceptable for continued use, and that there was several "OR" aprons that had not been found for inspection. EMP2 further confirmed inability to determine if the blue and black aprons found in OR1, OR2 and OR4 labelled "OR" had been inspected for radiation safety.

Plan of Correction - To be completed: 01/31/2023

1. The Administrator is responsible for this plan of correction and will ensure that all radiographic protective garments are properly inspected for radiation safety by 1/31/2023.

2. All radiographic protective garments will have a dated annual inspection label placed that will confirm that it was properly inspected for radiation safety. Any garments that do not have a documented inspection will be removed from service. New garments will not be placed into service without being properly inspected beforehand.

3. The Administrator will educate physician and nursing staff on facility policy regarding radiation safety and monitoring (6.1). Receipt of education will be confirmed via email or written attestation. This will be completed by 1/31/2023.

4. The Administrator will document and inspect five radiographic protective garments per month to confirm that they are properly inspected for radiation safety. This will occur for six months or until 100% compliance is achieved for three months.
Radiation Safety will be a standing agenda item at the quarterly Quality and Governing Board committee meetings. The meeting minutes will include radiographic protective garment inspection audits beginning in the first quarter of 2023.

5. The Administrator is responsible for this plan of correction and will ensure that all radiographic protective garments are properly inspected for radiation safety by 1/31/2023.
The Administrator will educate physician and nursing staff on facility policy regarding radiation safety and monitoring (6.1). This will be documented and completed by 1/31/2023.

567.41 LICENSURE MAINTENANCE SERVICE - Principle:

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 observation, review of facility documents, and interview with staff (EMP), it was determined the facility failed to discard expired glucometer control solutions for patient use in accordance with the manufacturer's instructions for use.

Findings include:

An observation on October 11, 2022, at 10:28 AM in the post operative recovery area with EMP1 and EMP3 revealed [XXXX] vendor name redacted glucose testing supplies. Further observation revealed the High and Low glucose control solutions was opened June 2, 2022.

A review on October 11, 2022, of the [XXXX] vendor name redacted glucose control solution instructions for use revealed "Discard any unused control solution 90 days after first opening or after expiration date."

An interview conduction on October 11, 2022, at 10:30 AM with EMP3 confirmed the High and Low glucose control solutions was opened June 2, 2022, and should have been discarded after 90 days.

Plan of Correction - To be completed: 01/31/2023

1. The Administrator is responsible for this plan of correction and has removed the expired glucometer control solutions from inventory. On 10/11/2022.

2. A patient care supply inspection will be performed monthly to confirm the maintenance of patient care supplies within the expiration dates. This inspection will be documented on a Patient Care Supply Inventory Checklist and will be signed by the staff member who performs the inspection. The inventory checklist will include glucometer control solutions.
The Patient Care Supply Inventory Checklist and updated policy will be presented to the Quality committee and then to the Governing Body committees for final approval.
The Administrator will review and update facility policy to include the use of the Patient Care Supply Inventory Checklist. It will be presented to the Quality committee and then the Governing Board for final approval by 1/31/2023.

3. The Administrator will educate nursing staff on the facility policy "Outdated and/or Deteriorated Supplies and Medications" that will include monthly supply inspections using the Patient Care Supply Inventory Checklist that include glucometer control solutions. Nurses will be educated on the proper dating and discarding of the glucometer control solutions per manufacturer recommendations. Receipt of nursing staff education will be confirmed via email or written attestation by 1/31/2023.

4. The administrator will audit the Patient Care Supply Inventory Checklist monthly to confirm that patient supply inspections are being performed and that any products, including glucometer control solutions, that are beyond expiration dates are removed from inventory. The audits will be conducted monthly for one year or until 100% compliance is reached for six months. Results of the audits will be reported to the Quality and Governing Board Committee meetings and noted in the meeting minutes starting in the first
quarter 2023.

5. The Administrator discarded the expired glucometer control solutions on 10/11/2022.

The Administrator will present the updated policy and Patient Care Supply Inventory Checklist to Quality Committee and then Governing Board for final approval. This will be noted in meeting minutes by 1/31/2023.

The Administrator will educate the nursing staff on the updated policy, the Patient Care Inventory Supply checklist, and the proper dating and discarding of glucometer control solutions by 1/31/2023.

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