QA Investigation Results

Pennsylvania Department of Health
Health Inspection Results
Health Inspection Results For:

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Initial Comments:
This report is the result of an Annual Registration survey conducted on September 21, 2023, at Allentown Women's Center. It was determined the facility was in compliance with the requirements of the Pennsylvania Department of Health Regulations 28 Pa Code, Chapter 29, Subchapter D, Ambulatory Gynecological Surgery in Hospitals and Clinics.

Plan of Correction:

Initial Comments:

This report is the result of an on-site State licensure survey initiated on September 21, 2023 and completed off-site on October 2, 2023, at Allentown Women's 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:

555.31 (a) LICENSURE

Name - Component - 00
Anesthesia Services

555.31 Principle
(a) Anesthesia services provided in the facility are limited to those techniques that are approved by the governing body upon recommendation of qualified medical staff. They shall be limited to those techniques appropriate to the assigned classification per ASF licence.


Definitions: "...Classification levels-ASFs shall be classified as follows:
(i) Class A-A private or group practice office of practitioners where procedures performed are limited to those requiring administration of either local or topical anesthesia, or no anesthesia at all and during which reflexes are not obtunded.
(ii) Class B-A single-specialty or multiple-specialty facility with a distinct part used solely for ambulatory surgical treatments involving administration of sedation analgesia or dissociative drugs wherein reflexes may be obtunded; and where patients are limited to Physical Status (PS) PS-I or PS-II patients, unless the patient's PS status would not be adversely affected or sought to be remedied by the surgery. A Class B ASF may be a distinct part of a private or group practice medical or dental office so long as the requirements of this subpart are met.
(iii) Class C-A single-specialty or multiple-specialty facility used exclusively for the purpose of providing ambulatory surgical treatments which involve the use of a spectrum of anesthetic agents, up to and including general anesthesia and where patients are limited to physical status (PS) PS-1, PS-2 or PS-3 patients ..."
Based on review of Food and Drug Administration (FDA) documents, Department documents, facility documents, medical records (MR), and interview with staff (EMP), it was determined this Class B facility failed to limit anesthesia service techniques to those appropriate to the facility's assigned classification per its Ambulatory Surgery Facility's license by using a general anesthetic (ketamine) during a procedure for one of fifteen medical records reviewed (MR2).
Findings include:
Review on October 10, 2023 of FDA document "KETALAR (ketamine hydrochloride)injection, for intravenous or intramuscular use", revised August 2020, revealed, "...(ketamine hydrochloride) injection, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic..."
Review on October 2, 2023 of Department document, "Commonwealth of Pennsylvania[,] Division of Acute & Ambulatory Care[,]Ambulatory Surgical Facility Application Request Form ..." , dated September 21, 2023, revealed the facility's registration status as Class B.
Review on October 2, 2023, of facility policy and procedure, "Guidelines for Moderate Sedation (Versed and Fentanyl)" no date revealed, "...Moderate sedation is a minimally depressed level of consciousness that retains the patient's ability to maintain a patent airway independently and continuously, to be easily aroused, and to respond appropriately to physical stimuli and verbal commands ..." Further review revealed, "...4. Anesthesia is induced by IV administration of combinations of the following: a. Versed 5 mg b. Fentanyl 100 mcg c. Ketamine 10-20 mg ..."
Review on October 2, 2023, of MR2, revealed the patient had a procedure performed at the facility on August 8, 2023, in which ketamine was used intravenously on the patient.
Email from EMP1 dated October 2, 2023, at 11:59 AM, confirmed the facility administered ketamine to the patient in MR2. Email from EMP1 further confirmed the facility uses ketamine during some procedures.

Plan of Correction:

The last time the Allentown Women's Center provided Ketamine was on September 16th, 2023. We will no longer be using Ketamine as an anesthetic agent, hence correcting the stated deficiency, protecting residents from similar situations, and ensuring that the problem will not reoccur.
There is no Ketamine on site and no more will be ordered unless our exception to using Ketamine is approved.
All medical and nursing staff have been educated that Ketamine is not to be used at the Allentown Women's Center.
For the next 3 months, 5 charts of patients who have underwent surgical procedures will be randomly selected and reviewed to verify that no Ketamine was administered.
Results of the chart review will be reported to the Quality Assessment and Improvement committee.
The AWC Medical Director will be responsible for verifying that this Plan of Correction shall be followed