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

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WATERFRONT SURGERY CENTER, LLC
Inspection Results For:

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WATERFRONT SURGERY CENTER, LLC - Inspection Results Scope of Citation
Number of Residents Affected
By Deficient Practice
Initial comments:

This report is the result of an unannounced special monitoring investigation completed on February 29, 2024, at Waterfront Surgery 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:


561.21 LICENSURE Policies & Procedures - Principle:State only Deficiency.
561.21 Principle

The scope of the pharmaceutical service shall be consistent with the medication needs of the patients and congruent with the licensed classification of the ASF. The pharmaceutical policies shall include a program for the control and accountability of drug products throughout the ASF. If drugs are used for experimental purpose, the use thereof shall be approved by an Institutional Review Board (IRB) or an IRB shall waive review and proper consent for use shall be obtained.
Observations:


Based on a review of facility documents, and employee interview (EMP), it was determined that the facility failed to adhere to policies and procedures surrounding narcotic counts.


Findings include:


On February 29, 2024, a review of policy, "DEA Controlled Substances" (Last Approved: 01/22/2024) was completed and revealed the following: "Objective: To assure the proper storage of and documentation of the use of narcotics ... Guidelines: Bullet 3: DEA controlled substances will be counted twice daily by two RN's and documented on the narcotic count record."


On February 29, 2024, a review of the narcotic count record in the anesthesia workroom revealed that a narcotic count was not completed in this location on the following dates: 01/15/2024; 01/29/2024; 01/30/2024; 02/01/2024; 02/02/2024; and 02/05/2024.


On February 29, 2024, at 1:15 PM, EMP 1 and EMP2 confirmed the above findings.






 Plan of Correction - To be completed: 03/14/2024

- On March 11, 2024, the Policy: Ordering, Dispensing and Documentation of Controlled Drugs was revised to include: "All Class II – V intravenous/intramuscular drugs will be stored in the main narcotic box located in the Anesthesia Workroom.
Class II - V drugs are to be counted twice daily by two CRNA/registered nurses and count confirmed with their signatures on the Narcotic Count Record.
All Class II – V drugs administered by anesthesia are documented by patient name, amount administered, amount wasted, and anesthesia personnel administering the narcotic.
All Class II - V medications wasted will be witnessed and confirmed with a second party signature (RN). All drug usage sheets will be turned in at the end of the shift and usage/usage sheets verified by CRNA/RN.
The Post-Anesthesia Unit maintains its own documentation of Class II - V oral narcotic usage and required narcotic counts. All PACU nursing staff will be required to adhere to the policy outlined above.
The Director of Nursing/designee will be responsible for overseeing the process and confirming completion of all required documentation."
- On March 12, 2024, the Board of Managers will vote on the proposed revisions to the Ordering, Dispensing and Documentation of Class II Drugs Policy.
- On March 13, 2024, upon approval of the policy revisions, education of the Waterfront Surgery Center staff and contracted anesthesia staff will begin.
- Beginning March 13, 2024, for a period of 30 days, the Director of Nursing/designee will confirm that narcotics are counted twice daily, with the count confirmed by signatures on the Narcotic Record, all wasted narcotics witnessed and countersigned, and all drug usage/usage sheets are accounted for and confirmed.
Compliance goal will be set at 100%. Once the compliance goal is met, the Director of Nursing/designee will continue to oversee the process and conduct weekly spot audits.

561.22 (a) LICENSURE Records:State only Deficiency.
561.22 Records

(a) Drug transactions of the pharmaceutical service shall be recorded, and those records shall be
correlated with other ASF records. Records and security shall be maintained to assure the control and
safe dispensing and compliance with Federal and Commonwealth statutes.

Observations:


Based on a review of facility documents and staff interview (EMP), it was determined that the facility failed to maintain accurate narcotic records for three of four DEA 222 forms reviewed.


Findings include:


On February 29, 2024, at approximately 12:00 PM, a review of facility DEA 222 forms with EMP2 revealed the following:


On December 15, 2023, per the DEA 222 forms, the facility placed an order for 4 boxes of fentanyl (each box contained 25 vials with 100mcg per 2 ml each). There is no evidence that two employees signed the medication into the facility. There is no evidence that the packing slip was verified against the DEA 222 form.


On January 4, 2024, per the DEA 222, the facility placed and order for 4 boxes of fentanyl (each box contained 25 vials with 100mcg per 2 ml each) and 1 package of 100 tablets of Oxycodone, 5mg. per tab. There is no evidence that 2 employees signed the medication into the facility. There is no evidence that the packing slip was verified against the DEA 222 form.



On January 31, 2024, 4 boxes of fentanyl (each box contained 25 vials with 100mcg per 2 ml each) were signed into the facility by two registered nurses. There was no matching DEA 222 forms on file at the facility.


On February 29, 2024 at 1:30 PM, EMP2 confirmed the above findings.








 Plan of Correction - To be completed: 03/14/2024

- On March 11, 2024, the Policy: Ordering, Dispensing and Documentation of Controlled Drugs was revised to include: "A copy of the completed 222 forms will be filed and locked in the Director of Nursing's office. Upon delivery, the controlled substances, along with the corresponding packing slip, will be given directly to the Director of Nursing/designee who will then accompany a CRNA to the Anesthesia Workroom.
The Class II – V narcotics will be added to the daily narcotic count sheet with the Director of Nursing/designee and CRNA signing the Narcotic Record confirming receipt.
The Class II – V narcotics will then be placed in the narcotic box and double locked.
The Director of Nursing/designee and the CRNA will sign and date the packing slip confirming receipt of the narcotics.
The packing slip will then be attached to the corresponding copy of the 222 form, filed, and locked in the office of the Director of Nursing.
All Class II – V intravenous / intramuscular drugs will be stored in the main narcotic box located in the Anesthesia Workroom.
Class II - V drugs are to be counted twice daily by two CRNA/registered nurses and count confirmed with their signatures on the Narcotic Count Record.
All Class II – V drugs administered by anesthesia are documented by patient name, amount administered, amount wasted, and anesthesia personnel administering the narcotic.
All Class II - V medications wasted will be witnessed and confirmed with a second party (RN) signature. All drug usage sheets will be turned in at the end of the shift and usage/usage sheets verified by CRNA/RN.
The Post-Anesthesia Unit maintains its own documentation of Class II - V oral narcotic usage and required narcotic counts. All PACU nursing staff will be required to adhere to the policy outlined above.
The Director of Nursing/designee will be responsible for overseeing the process and confirming completion of all required documentation."
- On March 12, 2024, the Board of Managers will vote on the proposed revisions to the Ordering, Dispensing and Documentation of Class II Drugs Policy.
- On March 13, 2024, upon approval of the policy revisions, education of the Waterfront Surgery Center staff and contracted anesthesia staff will begin.
- Beginning March 13, 2024, for a period of 30 days, the Director of Nursing/designee will confirm that all controlled substances ordered via 222 forms are properly ordered, received, logged, and tracked as per policy. Compliance goal will be set at 100%. Once the compliance goal is met, the Director of Nursing/designee will continue to oversee the process and conduct weekly spot audits.

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