This report is the result of a State Re-licensure survey conducted on-site on June 16, 2022 and completed off-site on June 28, 2022, at Bethlehem Endoscopy, 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:
555.32 (a) LICENSURE
Administration of Anesthesia
Name - Component - 00
555.32 Administration of anesthesia
(a) Anesthetics shall be administered by anesthesiologists and certified registered nurse anesthetist and dentist anesthetists as defined in 551.3 (relating to definitions).
Based on review of facility policies, medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure conscious sedation was administered by the physician or a CRNA (certified registered nurse anesthetist) provider in five of fifteen medical records reviewed. (MR11 through MR15).
Review on June 16, 2022 of facility policy "Anesthesia", no date, revealed "Purpose: To provide standards for the non-anesthesia registered nurse. For the safe administration of drugs for the purpose of providing sedation to patients undergoing minor operative... when a member of the anesthesia team is not in attendance... Definition: Moderate Sedation: a drug induced depression of consciousness... Drugs which may be utilized includes: Fentanyl, Morphine, Versed...Qualifications for administering and monitoring Moderate sedation: Administration and/or monitoring moderate sedation may be performed by a qualified physician or a registered nurse trained in administering or monitoring Moderate sedation..."
Off-site review of MR11 on June 28, 2022, revealed, patient underwent a procedure on April 19, 2022. Further review revealed RN (EMP2) administered to the patient "Midazolam (Versed) 2mg at 7:38 AM and 7:39 AM, Fentanyl Citrate 50 mcg at, 7:39 AM."
Off-site review of MR12 on June 28, 2022, revealed, patient underwent a procedure on May 5, 2022. Further review revealed RN (EMP2) administered to the patient Midazolam (Versed) 3 mg Intravenous and 75 mcg of Fentanyl Citrate at 8:06 AM; as well as Fentanyl Citrate 25 mcg and Versed 2 mg at 08:09 AM.
Off-site review of MR13 on June 28, 2022, revealed, patient underwent a procedure on March 17, 2022. Further review revealed RN (EMP3) administered the patient Midazolam (Versed) 2mg and Fentanyl Citrate 50 mcg at 10:08 AM and Fentanyl Citrate 50 mcg at 10:11 AM as well as Midazolam (Versed) 2 mg at 10:12 AM Intravenous.
Off-site review of MR14 on June 28, 2022, revealed, patient underwent a procedure on May 5, 2022. Further review revealed RN (EMP1) administered to the patient Midazolam (Versed) 3 mg and Fentanyl Citrate 50 mcg Intravenous at 9:45 AM, Midazolam (Versed) 1 mg at 9:48 AM; as well as Fentanyl Citrate 25 mcg Intravenous at 9:49 AM.
Off-site review of MR15 on June 28, 2022, revealed, patient underwent a procedure on March 15, 2022. Further review revealed RN (EMP3) administered to the patient Fentanyl Citrate 50 mcg Intravenous at 7:41 AM, Midazolam (Versed) 2 mg at 7:43 AM ; as well as Fentanyl Citrate 50 mcg Intravenous at 7:44 AM and Versed 2 mg at 7:45.
Interview on June 16, 2022, with EMP1 at approximately 1:30 PM confirmed the nurses that administered conscious sedation in medical records eleven through fifteen were administered by Registered Nurses.
Plan of Correction:
A CRNA (Certified Register Nurse Anesthetist) will provide anesthesia care for all Moderate Sedation cases done at the facility effective 7/15/2022.
Monitor: The Center Manager or Director of Nursing will review the facility Daily Assignment Sheet daily for the upcoming day of endoscopy procedures to ensure that a CRNA is scheduled to cover all endoscopy cases. The Center Manager or Director of Nursing will sign and date the Daily Assignment Sheet to document daily assignment review.
Responsible: The Center Manager and Director of Nursing will monitor the Assignment Sheet daily. The compliance will be reported to the QAPI Committee quarterly. Noncompliance will be addressed with the Medical Director as needed. The QAPI Committee will report the monitoring of the Daily Assignment Sheet compliance quarterly. The Medical Director will report noncompliance to the Board Members and Board of Managers President as needed to promptly address.
Policy AN-11 Moderate Sedation Administered by Non-Anesthesia Provider has been removed from manual and the Table of Contents updated effective 7/29/2022 by Board of Managers Approval.
Policies LD-20(A) Delineation of Privileges Gastroenterology and LD-30(A) document-Approved Procedure List has been revised by removing of "Supervision of RN Sedation" effective 7/29/2022 by Board of Managers Approval.
Staff will be educated, in a Staff Meeting on 7/28/2022, that Registered Nurses will no longer administer moderate sedation. They will also be made aware of policy and procedural changes that will be effective by 7/29/2022. The physicians will be made aware of the same by written and verbal notice.