Initial Comments:
This report is the result of a full Medicare recertification survey conducted on May 9-10, 2024, at East Side Surgery Center, with additional documentation review concluding on May 20, 2024. 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:
416.50(f)(2) STANDARD
SAFETY
Name - Component - 00
[The patient has the right to -]
(2) Receive care in a safe setting
Observations:
Based on facility tour and observation, it was determined that the facility failed to ensure that patients received care in a safe setting within the preoperative/postoperative care area.
Findings include:
Review, at approximately 3:29 PM on May 9, 2024, of the "Centre Avenue Group, LLC dba East Side Surgery Center Bylaws of the Governing Body," reviewed March 2024, revealed, "... Article V. Responsibilities ... 13. ... It [Governing Body] shall assure conformance to all applicable Federal, State and local laws. ... 19. It shall provide a safe physical plant equipped ... to maintain the facility and services. ..."
Review, at approximately 1:25 PM on May 20, 2024, of an East Side Surgery Center Policy titled, "Rotation of Supplies and Products; Removal of Expired Items," reviewed March 2024, revealed, "... Policy: ... All items with an expiration date will be considered to be sterile and usable if within the noted expiration date ... Procedure: 1. Expiration dates will be checked when items are placed into Sterile Supply. 2. Any items found in sterile supply that are expired will be removed and discarded appropriately according to federal, and/or state guidelines or manufacturer's instructions. 3. Items will be arranged and maintained to allow stock rotation on a 'first in, first out" [sic] system. ... 6. Prior to any items being presented for use, both sterile and non-sterile, it will be checked for expiration dates ..."
A tour of the pre-operative/post-operative area was conducted between approximately 11:37 AM and 12:15 PM on May 9, 2024.
1. Inspection of bedside stands and a storage room within the pre-operative and post-operative area revealed 18 expired nasal oxygen cannulas: one expired February 20, 2021; three expired August 24, 2021; one expired October 5, 2021; one expired June 21, 2022; four expired March 30, 2023; three expired December 3, 2023; and five expired December 18, 2023.
2. EMP10 confirmed the expiration dates at the time of observation.
Plan of Correction:The deficiency concerning that East Side Surgery Center failed to ensure that patients received care in a safe setting within the preoperative/postoperative setting was discussed with the executive board of ESSC along with a developed Correction Action Plan.
Corrective Action Plan:
1. All staff will be in-serviced on the necessity of providing a safe facility by reviewing the policy 'Rotation of Supplies; Removal of Expired Items'
2.It was determined that the third Friday of each month, the supplies and pharmaceutical inventory will be checked to ensure all products are within date and sterility has not been compromised. This will begin with the start of the third quarter (July) and continue through December 30, 2024.
3.If the December audit of supplies has no compromised or out of date products, then the audit will be completed. There will be a 3-month pause with the audit (1st Quarter of 2025) and a follow-up audit will occur for the 2nd Quarter.
4. Staff will report any products that are out of date to the Patient Safety Committee.
Initial Comments:
This report is the result of a State licensure survey conducted on May 9-10, 2024, at East Side Surgery Center, with additional documentation review concluding May 20, 2024. 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:
51.4 (c) LICENSURE
Change on Ownership/Management
Name - Component - 00
51.4. Change in ownership; change in management.
(c) A health care facility shall notify the Department in writing at least 30 days after a change of management of a health care facility. A change in management occurs when the person responsible for the day to day operation of the health care facility changes.
Observations:
Based on review of facility documentation, it was determined that the facility failed to notify the Department, in writing, at least 30 days after a change of management.
Findings include:
Review, at approximately 1:44 PM on May 20, 2024, of an East Side Surgery Center policy titled, "Notification Guidance for Division of Acute and Ambulatory Care Licensed Facilities," reviewed March 2024, revealed, "... Procedure: ... B. 30-day notification after event 1. Within 30 days after any change of management of a health care facility. A change in management occurs when the person responsible for the day to day operation of the health care facility changes. (51.4(c)). ..."
Review, at approximately 12:30 PM on May 10, 2024, of the facility's 2024 Application Request Form, revealed EMP9 identified as Director of Nursing.
Review, at approximately 12:32 PM on May 10, 2024, of the facility's 2023 Application Request Form, revealed EMP11 identified as Director of Nursing.
1. At approximately 12:45 PM on May 10, 2024, EMP10 confirmed that the Department had not been notified of the Director of Nursing change.
2. At approximately 2:02 PM on Monday, May 13, 2024, EMP10 confirmed that the Director of Nursing change was effective March 18, 2024.
Plan of Correction:The deficiency concerning compliance with the requirements of Pennsylvania Department of Health Rules and Regulations for Ambulatory Care Facilities, reporting the change of ownership/management 51.4(c), was discussed with executive board of East Side Surgery Center along with the developed correction plan.
Corrective Action Plan:
1. The managers at the East Side Surgery Center will review the 'Notification Guidance' set forth by the Division of Acute and Ambulatory Care License Facilities (rev. 8/20/2022).
2. The managers will notify the PA-DOH as instructed by the Notification Guidance.
3.A monthly checklist will be created reviewing any changes in ownership/management. This monthly checklist will start on July 1, 2024 and continue through December 31, 2024. The audit will be paused for the 1st quarter of 2025 and a recheck for compliance will be done in the 2nd quarter of 2025.
4. Results of the monthly checklist will be reported quarterly to the QI Committee along with any changes that do occur.
561.25 LICENSURE
Distressed drugs, devices and cosmetics
Name - Component - 00
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 facility observation, it was determined that the facility failed to ensure that devices which were outdated were identified and disposed of within the pre-operative/post-operative area of the surgical center.
Findings include:
Review, at approximately 3:29 PM on May 9, 2024, of the "Centre Avenue Group, LLC dba East Side Surgery Center Bylaws of the Governing Body," reviewed March 2024, revealed, "... Article V. Responsibilities ... 13. ... It [Governing Body] shall assure conformance to all applicable Federal, State and local laws. ... 19. It shall provide a safe physical plant equipped ... to maintain the facility and services. ..."
Review, at approximately 1:25 PM on May 20, 2024, of an East Side Surgery Center Policy titled, "Rotation of Supplies and Products; Removal of Expired Items," reviewed March 2024, revealed, "... Policy: ... All items with an expiration date will be considered to be sterile and usable if within the noted expiration date ... Procedure: 1. Expiration dates will be checked when items are placed into Sterile Supply. 2. Any items found in sterile supply that are expired will be removed and discarded appropriately according to federal, and/or state guidelines or manufacturer's instructions. 3. Items will be arranged and maintained to allow stock rotation on a 'first in, first out" [sic] system. ... 6. Prior to any items being presented for use, both sterile and non-sterile, it will be checked for expiration dates ..."
A tour of the pre-operative/post-operative area was conducted between approximately 11:37 AM and 12:15 PM on May 9, 2024.
1. Inspection of bedside stands and a storage room within the pre-operative and post-operative area revealed 18 expired nasal oxygen cannulas: one expired February 20, 2021; three expired August 24, 2021; one expired October 5, 2021; one expired June 21, 2022; four expired March 30, 2023; three expired December 3, 2023; and five expired December 18, 2023.
2. EMP10 confirmed the expiration dates at the time of observation.
Plan of Correction:The deficiency concerning devices/supplies which were outdated was discussed with the executive board of East Side Surgery Center along with the developed Correction Action Plan.
Corrective Action Plan:
1. All staff will be in-serviced on the policy "Rotation of Supplies,; Removal of Expired Items".
2. It was determined that the third Friday of each month, the inventory of supplies and pharmaceuticals will be checked to ensure all products are within date and sterility has not been compromised. This will begin with the start of the third quarter (July 2024) and continue through December 31, 2024.
3. If the December audit of supplies has no compromised or out of date products then the audit will be completed. There will be a 3-month pause with the audit (1st Quarter of 2025) and a follow audit will occur for the 2nd Quarter of 2025.
4. Staff will report any products that are out of date to the Patient Safety Committee.
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