Initial Comments:
This report is the result of a State licensure survey conducted on March 17, 2022, and completed March 21, 2022, at Azura Surgery Center South Philadelphia. 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:
555.22 (c)(1-5) LICENSURE
Surgical Services - Preoperative Care
Name - Component - 00
555.22 Pre-operative Care
(c) Written instruction for preoperative procedures, which have been approved by the medical
staff, shall be given to the patient or responsible person, and shall include:
(1) Applicable restrictions upon food and drink before surgery
(2) Special preparations to be made by the patient
(3) The required proximity of the patient to the ASF for a specific time following surgery if applicable.
(4) An understanding that the patient may require admission to the hospital in the event of medical need.
(5) The requirement that, upon discharge of a patient who has received sedation or general anesthesia, a responsible person shall be available to escort patient home. With respect to patients who receive local or regional anesthesia, a medical decision shall be made regarding whether such patients require a responsible person to escort them home.
Observations:
Based on a review of facility policies, medical records (MR), and interview with staff (EMP), it was determined the facility failed to provide patients or their representatives with complete written instructions containing all of the required elements of preoperative instructions as required by the "Department" prior to surgical procedures in six of six medical records reviewed (MR5, MR6, MR7, MR8, MR9 and MR10).
Findings include:
A review on March 17, 2022, of facility policy "Universal Protocol" dated April 9, 2021, revealed "Pre-Procedure Verification. ...2. Preoperative instructions will be provided to the patient or responsible person and shall include: a. Applicable restrictions on food and drink before surgery, b. Special preparations to be made by the patient, c. An understanding that the patient may require admission to the hospital in the event of medical need." Further review revealed the policy did not include "The required proximity of the patient to the ASF (Ambulatory Surgical Facility) for a specific time following surgery if applicable" as required by the "Department."
A review on March 17, 2022, of MR5, admitted on November 18, 2021, for a thrombectomy procedure under monitored anesthesia care, revealed written pre-operative instructions did not include information regarding the potential for the patient to remain in the required proximity to the ASF for a specific time following surgery and did not include information that the patient may require admission to the hospital in the event of medical need as required by the "Department."
A review on March 17, 2022, of MR6, admitted on December 23, 2021, for an angioplasty procedure under monitored anesthesia care, revealed written pre-operative instructions did not include information regarding the potential for the patient to remain in the required proximity to the ASF for a specific time following surgery and did not include information that the patient may require admission to the hospital in the event of medical need as required by the "Department."
A review on March 17, 2022, of MR7, admitted on January 7, 2022, for a dialysis catheter change procedure under monitored anesthesia care, revealed written pre-operative instructions did not include information regarding the potential for the patient to remain in the required proximity to the ASF for a specific time following surgery and did not include information that the patient may require admission to the hospital in the event of medical need as required by the "Department."
A review on March 17, 2022, of MR8, admitted on January 21, 2022, for a thrombectomy procedure under monitored anesthesia care, revealed written pre-operative instructions did not include information regarding the potential for the patient to remain in the required proximity to the ASF for a specific time following surgery and did not include information that the patient may require admission to the hospital in the event of medical need as required by the "Department."
A review on March 17, 2022, of MR9, admitted on February 17, 2022, for a thrombectomy procedure under monitored anesthesia care, revealed written pre-operative instructions did not include information regarding the potential for the patient to remain in the required proximity to the ASF for a specific time following surgery and did not include information that the patient may require admission to the hospital in the event of medical need as required by the "Department."
A review on March 17, 2022, of MR10, admitted on March 10, 2022, for an angioplasty procedure under monitored anesthesia care, revealed written pre-operative instructions did not include information regarding the potential for the patient to remain in the required proximity to the ASF for a specific time following surgery and did not include information that the patient may require admission to the hospital in the event of medical need as required by the "Department."
A telephone interview conducted on March 21, 2022, at 1:30 PM with EMP1, EMP2 and EMP4 confirmed the facility failed to provide patients with complete written instructions containing all of the required elements of preoperative instructions prior to a surgical procedure as required by "Department" regulations for an ambulatory surgical facility.
Plan of Correction:Corrective Action: The current Appointment Reminder document was revised to include all required elements of pre-op written education.
This new form was approved by the Medical Staff and during the 4/19/22 quarterly meeting.
The Front Desk Coordinators who provide the instructions were educated on the required elements and this new process on 4/25/22.
The revised form is being utilized by the Front Desk Coordinators and signed by the patient or responsible person prior to the patient's procedure.
Monitoring Activities: This element will be added to the quarterly medical record review checklist. 2% of patient records or a minimum of 10 records, whichever is greater, are monitored quarterly. Results will be reported to the Quality Committee and Governing Body. This will be reported for six (6) months through January 2023.
Responsible Party: Director of Nursing, Facility Administrator and Medical Director.
Corrective action will be completed by: 7/31/22
565.2 LICENSURE
Laboratory Service Policy
Name - Component - 00
565.2 Laboratory service policy
Laboratory services shall be provided under the Clinical Laboratory
Act and Chapter 5 (relating to clinical laboratories).
Observations:
Based on review of facility documents, and interview with staff (EMP) it was determined the facility failed to ensure laboratory services was provided in accordance with the Clinical Laboratory Permit issued by the Department of Health ("Department").
Findings include:
A review on March 17, 2022, of facility document "Clinical Laboratory Permit" issued by the Pennsylvania Department of Health dated August 15, 2021, with an expiration date of August 15, 2022, revealed the Authorized Categories/Tests did not include Prothrombin Time (PT) testing (blood coagulation testing).
A review of facility document "Master Results Log," undated, revealed columns labelled with various laboratory tests, including a column for "INR" (indicating the PT test result). Further review revealed 13 patient tests had been resulted in the INR column between September 3, 2021, and March 10, 2022.
An interview conducted on March 17, 2022, at 3:45 PM with EMP1 and EMP3 confirmed the facility continued to perform Prothrombin Time blood coagulation tests without "Department" approval. EMP1 stated "We just recently noticed the CLIA (Clinical Laboratory Permit) did not contain approval for Prothrombin Time blood coagulation tests."
Plan of Correction:Corrective Action: This deficiency was corrected with the Bureau of Laboratories addition of this test to the facility's Clinical Lab Act permit.
The request for the addition of the omitted test was sent to the Department of Health/Bureaus of Laboratories on 3/16/22. On 3/25/22 the Department of Health notified the Facility Administrator that the facility may start the testing immediately.
The revised CLIA certificate was later received and is posted in the clinical area.
Education Provided: The Director of Nursing who also monitors all licenses and certificates was educated on this finding and the need for complete certificates.
Monitoring Activities: The Facility Administrator will monitor the CLIA certificate quarterly to insure the document remains current and accurate. This finding and the completion of appropriate documents will be reported quarterly to the Governing Body for the next six (6) months.
Responsible Party: Director of Nursing, Facility Administrator and Medical Director.
Corrective action will be completed by: 8/31/22
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