Initial Comments:
This report is the result of a State licensure survey conducted on March 27th and 28th, 2025, at Delmont Surgery Center. 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:
555.33 (b) LICENSURE
Anesthesia Policies and Procedures
Name - Component - 00
555.33 Anesthesia policies and procedures
(b) In ASF's where there is no anesthesiologist, the governing body
shall designate a physician to function as the Director of Anesthesia Services, who shall be
responsible for directing the anesthesia services and establishing the general policies and procedures
for the administration of anesthesia in the ASF which shall be approved by the governing body.
Observations:
Based on a review of credential files, facility documents, and employee interview (EMP), it was determined that the facility failed to appoint a physician as the Director of Anesthesia following contract termination of the anesthesiologist (EMP3).
Findings include:
Review of "Medical Advisory Board Meeting Minutes, August 19, 2024" revealed signature of participation by EMP3 (anesthesiologist), functioning as Director of Anesthesiology.
Review of the facility's letter of termination to EMP3, dated August 14, 2024, revealed notice of termination was to be effective November 12, 2024.
Review of the governing body's "MAB (Medical Advisory Board) Special Meeting", dated Monday August 26, 2024, revealed appointment of EMP4, CRNA, by the medical advisory board, to be effective November 13, 2024.
Review of "Medical Advisory Board Meeting Minutes, November 19, 2024" revealed signature of participation by EMP4.
Interview conducted with EMP1 on March 28, 2025, at 11:15 AM revealed that EMP4 was appointed as the Director of Anesthesiology.
The above was confirmed on March 28, 2025, at 11:20 AM, by EMP1.
Plan of Correction:A special Governing Board meeting was called and held on 4-7-2025 to discuss the appointing of a Physician to serve as the Director of Anesthesia Services for Delmont Surgery Center. Dr. Jay Chung, an anesthesiologist, has been selected to fill this role as the Director of Anesthesia Services. A formal letter was sent to Dr. Chung on 4-7-2025 requesting appointing him to serve as the Director of Anesthesia for Delmont Surgery Center and will will oversee all anesthesia services as well as establishing and maintaining policies and procedures relating to the administration of anesthesia. Dr. Chung will serve on the Medical Advisory board as well.
4/14/25: After discussion and clarification from Ms. Taylor on 4/11/25, A special meeting was called with the Governing Board and it was determined that Dr. Francis Johns will serve as the Director of Anesthesia for Delmont Surgery Center. Dr. Johns will oversee all anesthesia services and establish and maintain policies that relate to the administering anesthesia. All anesthesia personnel will report directly to Dr. Johns.
557.4 (a)(1-4) LICENSURE
Quality Assurance & Improvement Committee
Name - Component - 00
557.4 Quality Assurance & Improvement Committee
(a) The committee shall consist of the following:
(1) A practitioner who is not an owner,
(2) A representative of administration,
(3) A registered nurse,
(4) Other health care personnel, as appropriate.
Observations:
Based on a review of the facility committee meeting minutes, policies, and employee interview (EMP), it was determined that the facility failed to have a practitioner, who is not an owner, participate in the Quality Assurance and Improvement Committee.
Findings include:
A review of "Policy: 201 Ownership" (effective April 8, 2010; revised February 2019) revealed: "Delmont Surgery Center is owned by Delmont Surgery Center, LLC ... The members of the LLC are: [EMP5]..."
A review of the facility's Quality Assurance Performance Improvement committee meeting minutes for May, 21, 2024, August 6, 2024, November 19, 2024, and February 18, 2025 revealed EMP5 as a participating member of the committee.
An interview conducted on March 28, 2025, at 11:30 AM with EMP1 confirmed the Quality Assurance Improvement Committee does not include a practitioner that is not an owner of the facility.
Plan of Correction:On 4-7-2025 a special Governing Board Meeting was held to nominate Dr. Jay Chang - a non-member physician to serve on Delmont Surgery Center's Quality Assurance and Improvement Committee. Dr. Chang will be invited to participate at QAPI quarterly meetings. The next quarterly meeting will be held in the second quarter (Date TBD) in which Dr. Chang will be introduced to the Committee.
4/14/2025: Dr. Jay Chang is a practitioner that is a non-owner of the facility and has been selected to participate in the Quality Assurance and Improvement Committee.
561.11 LICENSURE
Pharmaceutical Facilities - Principle
Name - Component - 00
561.11 Principle
The ASF shall provide equipment and supplies for the pharmaceutical service to implement its professional and administrative functions and to ensure patient safety through the proper storage and dispensing of drugs. Facilities shall be provided for the storage, safeguarding, preparation, and dispensing of drugs.
Observations:
Based on tour of the facility and employee interview(EMP), it was determined that the facility failed to implement proper storage and dispensing of medications.
Findings include:
A tour conducted on March 27, 2025, at 11:00 AM, revealed concerns related to management of drugs in the facility.
Observation of the controlled substance cabinet revealed that Vicodin was being stored outside of its original packaging, in small plastic boxes to facilitate easier visualization, per EMP1.
This storage did not include the original manufacturers label, expiration, or strength.
Observation of the non-controlled medication storage system revealed a cabinet which contained various medications. When asked about the process for ordering, and maintaining availability of these drugs, EMP1 replied that they do a visual check to see if anything looks like it is "running low". When asked how medication is dispensed for patient administration, EMP1 replied that the nurse will remove it. The surveyor then asked EMP1 how they monitor the stock of drugs in the cabinet. EMP1 replied that they do not utilize a daily or weekly count system in maintaining the stock of non-controlled substances, but that they periodically check for product expiration.
The above was confirmed by EMP1 on March 28, 2025, at approximately 12:00 PM.
Plan of Correction:It is the intended preference of Delmont Surgery Center to purchase controlled substances in a unit dose packaging supply. However, at times the Center's main distributor, Curascript, has been unable to provide controlled substances in unit dose packaging due to backorders. In this instance the Center had to purchase controlled substances in a bottle form with a quantity of 100 and stored them in a plastic pill dispensing container that was labeled with the medication name, lot number and expiration date. This has been stored in a triple locked cabinet in which by policy the inventory of controlled substances is counted by two licensed professionals upon opening and closing of the Center.
One of these substances, Vicodin, was stored in a plastic container without the strength labeled on the container. The strength is noted in the narcotic log book. On 4-7-2025 the Nurse Administrator created a label to note the strength of the medication (Hydrocodone 7.5 mg/Acetaminophen 325 mg) was affixed it to each container. Again, best practice is to purchase controlled narcotics in unit dose packaging in their respective boxes; that is the first goal when purchasing controlled medications. If unable to secure this type of packaging when ordering controlled narcotics, the Center will retain original packaging and store with plastic containers in addition to clearly labeling each medication with the strength, lot number and expiration date.
In regards to non-controlled medications that are stored at the Center, a weekly inventory is being completed every Monday by the PACU nurses. Any inventory that is low (under a quantity of five) will be relayed verbally to the DON whom is responsible for ordering medications and will place an order to fulfill the low count with the Center's weekly order.
In addition, at the beginning of every month, within the first week, a monthly inventory of all mediations and crash carts are being completed by nurses, taking note of the quantity and expiration dates of each medication. Logs are completed and then given to the Nurse Administrator and is kept on file in the Life Safety Manual. Any expired medications are discarded and then relayed to the DON to order a replacement.
|