Pennsylvania Department of Health
SALLY K. BALIN AMBULATORY SURGICAL CENTER, P.C.
Patient Care Inspection Results

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Severity Designations


Minimal Citation - No Harm	Minimal Harm	Actual Harm	Serious Harm

There are 32 surveys for this facility. Please select a date to view the survey results.

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SALLY K. BALIN AMBULATORY SURGICAL CENTER, P.C. - Inspection Results	Scope of Citation Number of Residents Affected By Deficient Practice

Initial comments:

This report is the result of an unannounced revisit survey conducted on September 19, 2024, following a State Licensure survey completed on April 18, 2024, at Sally Balin Ambulatory Surgical Center. It was determined that 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:

416.51(a) STANDARD SANITARY ENVIRONMENT:

The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.

Observations:

No federal revisit required.
Cross Reference 567.1 Principle

Plan of Correction - To be completed: 11/30/2024

As part of the Plan of Correction the administrator notified the governing body of deficiencies found from the survey. In compliance to fulfill the requirements of the Pennsylvania Department of Health's Rules and Regulations for Ambulatory Care:
The Sally K. Balin Ambulatory Surgical center provides a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice. See details of our plan of corrections below:
During November 2024 an in-service will be scheduled for education and competency that will be provided by the new administrator to review the infection control plan policies and procedures. All staff will be educated on infection control plan policies and procedures and job responsibilities by November 30, 2024. A Quality Improvement study will be completed to ensure proper cleaning and appropriate sanitary conditions are maintained to ensure 100% compliance. The new administrator and housekeeping staff will audit with check off sheets for operating room 1 cabinet monthly for 100% compliance. To fulfill compliance requirements the drawer in room 123 was cleaned and the brush found during the survey was properly disposed of and replaced with new. New brushes were purchased and sterilized. The new administrator and sterilization staff will audit with check off sheets for acceptable conditions of the brushes on a monthly basis to maintain 100% compliance.

551.64 LICENSURE Content of plan of correction:

551.64 Content of Plan of Correction

A plan of correction shall address deficiencies cited in the compliance directive of the Department. the plan shall state specifically what corrective action is to be taken, by whom and when.

Observations:

Based on review of the facility's Plan of Correction (POC), facility documents, and staff interview (EMP), it was determined Sally Balin Ambulatory Surgical Center failed to follow their POC that was submitted to and accepted by the Department with a completion date of June 30, 2024, to correct deficient practices.

Findings include:

On September 19, 2024, a review of the facility POC revealed, "To fulfill the compliance requirements of the Pennsylvania Department of Health's Rules and Regulations the employee employed as the acting administrator is to perform solely administrative responsibilities. Another nurse was hired and began training. H.R. [Human Resources] can monitor that the acting administrator acts in accordance with Department of Health's rules and regulations from the survey date April 18, 2024, to only perform administrative responsibilities. Plan of corrections are to be submitted to the quality meetings ..."

Review of the facilities documentation showed the Administrator resigned on August 28, 2024, and the nurse hired as the Director of Nursing (DON) resigned on September 18, 2024. The facility does not currently have an Administrator or DON on staff.

Interview with EMP1 confirmed the facility did not have an Administrator on staff or an acting Administrator appointed. EMP1 confirmed that the facility did not have a DON on staff. In addition, EMP1 confirmed that there was no documentation from HR on monitoring Administrator duties or that the issue was addressed in Quality Assurance Meetings.

On September 19, 2024, further review of the facility POC revealed, "... May 2024 a new walk through will be convened and performed to remove expired medications and products from rooms and cabinets in the surgery center ... An in-service will be scheduled to review inspecting expiration dates and use of inventory binders provided by the administrator. All staff will be educated on inspecting expiration dates and use of new inventory binders by June 30, 2024. The administrator and building manager will continue to perform quarterly OR [Operating Room] Inspections and remove any expired medications and products by June 30, 2024. The administrator will audit room 208 and room 209 bi-weekly for 3 months by September 30, 2024, to ensure 100% compliance. Plan of corrections are to be submitted to the quality meetings ..."

Review of facility documentation revealed there was no documentation showing a walk through was completed in May 2024 or that an in-service education was provided to staff. Requested the quarterly OR inspections, bi-weekly audits of rooms 208 and 209, and quality meetings and none were provided.

A tour of the facility completed on September 19, 2024, at 11:45 AM revealed the following: (2) Sodium Bicarb 8.4% 10 mEq/10 mL expired May 1, 2024, found in room 208. In OR 2, a drawer of 4-0 PGA Polyglycolic Acid suture 13 mm/ 3/8 expiration date of July 29, 2024; 5-0 PGA Polyglycolic Acid suture 13 mm/ 3/8 expiration date of July 29, 2024; and 6-0 Nylon 11 mm/ 3/8 with an expiration date of August 6, 2024.

Interview with EMP1 confirmed there was no documentation of a walk through or education to staff. EMP1 also confirmed there were no audits of the OR, rooms 208 and 209, and no documentation of quality meeting minutes and information above is accurate.

On September 19, 2024, further review of the facility POC for a sanitary environment revealed, "... In May 2024 an in-service will be scheduled for education and competency
that will be provided by the administrator and housekeeping supervisor to review the infection control plan and policies and procedures. All staff will be educated on infection control plan policies and procedures and job responsibilities by May 31, 2024. Starting in May 2024 a Quality Improvement study will be established to ensure proper cleaning and appropriate sanitary conditions are maintained to ensure 100% compliance. The administrator and housekeeping supervisor will audit operating room 1 cabinets weekly for 6 weeks and once monthly for 3 months to achieve 100% compliance ... The administrator will audit for acceptable condition of the brushes once weekly for 4 weeks and once monthly for 3 months by September 30, 2024, for 100% compliance. Plan of corrections are to be submitted to the quality meetings ..."

Review of facility documentation revealed there was no documentation of education, a quality improvement study, audits or quality meeting minutes being completed.

A tour of the facility on September 19, 2024, at 12:00 PM revealed a sterile processing machine which appeared to have parts missing and rust from the machine to the floor. The machine was marked as "Do Not Use". Further observation in the workroom found a brush for cleaning equipment was stored in a drawer that also contained debris.

Interview with EMP1 confirmed there was no documentation of education, quality improvement study, audits or quality meeting minutes and information above is accurate.

Cross reference:
Administrative Responsibilities 553.31 (a)
Distressed drugs, devices and cosmetics 561.25
Principle 567.1

Plan of Correction - To be completed: 11/30/2024

As of September 19, 2024 our facility named a new Director of Nursing and
Acting Administrator. The facility has identified a new full time administrator for hire effective November 1, 2024 who will only perform administrative responsibilities. During November 2024 an in-service will be scheduled for education and competency that will be provided by the new administrator to review the infection control plan policies and procedures. All staff will be educated on infection control plan policies and procedures and job responsibilities by November 30, 2024. A Quality Improvement study will be completed to ensure proper cleaning and appropriate sanitary conditions are maintained to ensure 100% compliance. The new administrator and housekeeping staff will audit with check off sheets for operating room 1 cabinet monthly for 100% compliance with cleanliness. To fulfill compliance requirements the drawer in room 123 was cleaned and the brush found during the survey was properly disposed of and replaced with new. New brushes were purchased and sterilized. The new administrator and sterilization staff will audit with check off sheet for acceptable condition of the brushes ongoing monthly to maintain 100% compliance.

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 review of facility policy and interview with staff (EMP), it was determined the Governing Body failed to ensure that a full time person, in charge, was appointed who had the authority and responsibility for the operation of the Sally K. Balin Ambulatory Surgical Center at all times.

Review of the facilities documentation showed the Administrator resigned on August 28, 2024, and the Director of Nursing (DON) resigned on September 18, 2024. The facility does not currently have an Administrator or DON on staff to oversee daily operations.

Interview with EMP1 confirmed there was no Administrator or DON on staff and they were unaware of who is appointed as the acting Administrator.

Interview with EMP2 (owner) confirmed there was no Administrator or DON on staff and the facility had help wanted advertisements in place but was not having any luck finding staff.

Plan of Correction - To be completed: 11/01/2024

Effective September 19, 2024 our facility named a new Director of Nursing. Effective November 1, 2024 the facility will hire a full time administrator who will only perform administrative responsibilities.

557.3 (d) (1-5) LICENSURE QA & Improvement Program:

557.3 The Quality Assurance and Improvement Program

(d) measures shall be implemented to resolve important problems or concerns identified. The results of these corrective measures shall be monitored to assure that the problem has been satisfactorily resolved. measures which may be taken include:
(1) changes in policies and procedures
(2) staffing and assignment changes
(3) appropriate education and training
(4) adjustments in clinical privileges
(5) changes in equipment or physical plant

Observations:

Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to implement measures to resolve ongoing noncompliance and failed to take corrective actions to ensure standards were maintained by the facility.

Findings include:

Review of "Governing Body Bylaws" revealed the "... Administrative responsibilities include: Enforcing policies delegated by the Governing Body ... Taking all reasonable steps to comply with applicable laws and regulations ... Communicating and reporting to ensure the orderly flow of information within the organization ..."

Review of the facility's "Quality Assurance Program" revealed "... The Quality Improvement, Peer Review and Risk Management Committees will have quarterly meetings. ... The Quality Improvement Committee will address clinical, administrative, and cost-of-care issues, as well as actual patient outcomes ... The Quality Improvement committee will meet quarterly to review the quality improvement activities of the medical staff, nursing staff, and anesthesia staff and direct special studies to investigate identified or suspected problems. Quality Improvement studies will be based on problems that are felt to be of significant importance. The study will assess the problem. The frequency, severity, and source of a suspected problem will be evaluated. Health care practitioners, as well as administrative staff, will participate in the resolution of the problem. ... Some areas of important concerns in the care of patients include: ... direct observations, staff concerns ...compliance issues ... Appropriate records of Quality Improvement activities shall be maintained."

Request for Quality Assurance Meeting minutes to review the current citation plans of correction revealed that there had not been a quality assurance meeting held since April 14, 2024.

An interview conducted on September 19, 2024, with EMP1 confirmed there was no quality improvement meeting minutes since April 14, 2024. EMP1 stated the quality assurance meetings were the responsibility of the Administrator and they no longer have one.

Plan of Correction - To be completed: 11/30/2024

The new administrator will prepare the minutes of the previous quarter's quality assurance meeting and will keep up to date with current documentation and meeting requirements to ensure 100 % compliance.

561.25 LICENSURE Distressed drugs, devices and cosmetics:

561.25 Distressed drugs, devices and cosmetics

Drugs, devices and cosmetics which are outdated, visibly deteriorated, unlabeled or inadequately labeled, recalled, discontinued or obsolete shall be identified by the licensed pharmacist or responsible practitioner and shall be disposed of in compliance with applicable Commonwealth and Federal regulations.

Observations:

Based on review of facility policy, observation, and interview with staff (EMP), it was determined the facility failed to discard expired medications and supplies according to facility policy.

A review of facility policy "Pharmaceutical Services Guidelines" last revised, reviewed, and approved on 2/26/24, revealed "... As drugs come close to reaching their expiration date, they are discarded by appropriate means ..."

A tour of facility completed on September 19, 2024, at 11:45 AM revealed the following: (2) Sodium Bicarb 8.4% 10 mEq/10 mL expired May 1, 2024, found in room 208. In OR 2, a drawer of 4-0 PGA Polyglycolic Acid suture 13 mm/ 3/8 expiration date of July 29, 2024; 5-0 PGA Polyglycolic Acid suture 13 mm/ 3/8 expiration date of July 29, 2024; and 6-0 Nylon 11 mm/ 3/8 with an expiration date of August 6, 2024.

Interview with EMP1 confirmed the above findings.

Plan of Correction - To be completed: 11/30/2024

To ensure compliance regarding observation from unannounced survey monthly walk-throughs of rooms 208, 209, and the ORs will be conducted monthly by the administrator to ensure removal of any medications or products close to or at expirations dates. Inventory cards will be used to facilitate compliance. By November 2024 an in-service will be scheduled for education and competency that will be provided by the new administrator to review the infection control plan policies and procedures. All staff will be educated on infection control plan policies and procedures and job responsibilities by November 30, 2024. A Quality Improvement study will be completed to ensure proper cleaning and appropriate sanitary conditions are maintained to ensure 100% compliance. The new administrator and housekeeping staff will audit with check off sheets for operating room 1 cabinets monthly for 100% compliance. To fulfill compliance requirements the drawer in room 123 was cleaned and the brush found during the survey was properly disposed of and replaced. New brushes were purchased and sterilized. The new administrator and sterilization staff will audit with check off sheets for acceptable condition of the brushes on a monthly ongoing basis to maintain 100% compliance.

567.1 LICENSURE Principle:

567.1 Principle

The ASF shall have a sanitary environment, properly constructed,
equipped and maintained to protect surgical patients and ASF personnel from
cross-infection and to protect the health and safety of patients.

Observations:

Based on observation and staff interview (EMP), it was determined that the facility did not maintain a safe and sanitary environment.

Findings include:

A review of "The Sally Balin Ambulatory Surgical Center Infection Control Plan" under Housekeeping Service, revealed "... Clean inside cabinets (every day) ... Remove items ... to dust (once a week) ..."

A tour of the facility on September 19, 2024, at 12:00 PM revealed a sterile processing machine which appeared to have parts missing and rust from the machine to the floor. The machine was marked as "Do Not Use". Further observation in the workroom found a brush for cleaning equipment was stored in a drawer that also contained debris.

Interview with EMP1 confirmed the above findings.

Plan of Correction - To be completed: 11/30/2024

By November 30, 2024 an in-service will be scheduled for education and competency that will be provided by the new administrator to review the infection control plan policies and procedures. All staff will be educated on infection control plan policies and procedures and job responsibilities by November 30, 2024. A Quality Improvement study will be completed to ensure proper cleaning and appropriate sanitary conditions are maintained to ensure 100% compliance. The new administrator and housekeeping staff will audit with check off sheets for operating room 1 cabinet monthly for 100% compliance. Housekeeping staff has been instructed to remove rust from the floor near the sterilizer marked "do not use" and the administrator will conduct monthly walk-throughs to ensure compliance and document compliance via check off sheets.

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