QA Investigation Results

Pennsylvania Department of Health
AZURA VASCULAR CARE SOUTH PHILADELPHIA
Health Inspection Results
AZURA VASCULAR CARE SOUTH PHILADELPHIA
Health Inspection Results For:


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Initial Comments:

This report is the result of a State licensure survey conducted on August 12, 2022, at Azura Vascular Care 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:




555.32 (a) LICENSURE
Administration of Anesthesia

Name - Component - 00
Anesthesia Services

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).


Observations:
Based on a review of facility policy, medical records (MR), and interview with staff (EMP), it was determined the facility failed to ensure moderate sedation was administered by an anesthesiologist or certified registered nurse anesthetist as required by the Department of Health (the "Department") in two of ten medical records reviewed (MR6 and MR7).

Findings include:

A review of facility policy "Moderate Sedation" dated February 7, 2021, revealed "Definitions. Personnel ...Supervised Sedation Professional: A licensed registered nurse... who is trained to administer medications and monitor patients during moderate sedation under the direct supervision of a (physician) or an anesthesiologist. Policy. The organization is vitally interested in the safe administration of anesthesia and supports the use of Moderate Sedation on select adult patients administered in an appropriately equipped and staffed facility. The Organization demonstrates a commitment to patient safety and follows appropriate and acceptable practice standards adhering to all state and federal laws and regulations. It is the policy of the organization that: ...7. The supervised sedation professional a. must administer moderate sedation/analgesia within the scope of state-established scope of practice."

A review on August 12, 2022, of MR6, admitted May 20, 2022, for an angiogram procedure under moderate sedation revealed Fentanyl 100 mcg and Midazolam 2 mg was administered intravenously by a licensed registered nurse for moderate sedation during the procedure.

A review on August 12, 2022, of MR7, admitted July 15, 2022, for an angiogram procedure under moderate sedation revealed Fentanyl 50 mcg and Midazolam 1 mg was administered intravenously by a licensed registered nurse for moderate sedation during the procedure.

An interview conducted on August 12, 2022, at 3:29 PM with EMP5 confirmed moderate sedation was administered to MR6 and MR7 by a licensed registered nurse during their procedures and was not administered by an anesthesiologist or certified registered nurse anesthetist as required by the Department.














Plan of Correction:

Corrective Action:
a. Unable to correct for patients MR 6 and MR 7. Patients MR 6 and MR 7 were contacted within 72 hours of discharge, in accordance with facility policy, and reported no ill effects and successful surgery outcome.
b. The facility has reviewed 555.32 (a)(b)(c) and 551.3 (relating to definitions) and will comply with the regulations to ensure that all future instances where administration of sedation is deemed appropriate for the surgical case, that sedation shall be administered by a CRNA or physician as specified in the regulation.
c. Physicians and clinical staff will be educated on the requirements of 555.32(a)(b)(c) and the applicable definitions contained in 551.3. The education will reflect the requirement for sedation to be delivered by a CRNA or physician in all cases where sedation is deemed appropriate for the surgical case. This education will be conducted in person or telephonically and sign in sheets will be maintained.

Monitoring Activities: Compliance will be monitored through the Quarterly Medical Record Review and reported to the Quality Committee, Medical Executive Committee and Governing Body. Two (2) percent of patient records or a minimum of 10 records, whichever is greater, will be monitored quarterly. The audits will be discontinued after six (6) months if compliance is demonstrated.

Responsible Party: Facility Administrator, Director of Nursing and Medical Director.

Complete Date: 11/1/22



555.33 (d)(8)(i-v) LICENSURE
Anesthesia Policies and Procedures

Name - Component - 00
555.33 Anesthesia policies and procedures

(d) Anesthesia procedures shall provide at least the following:
(8) Before discharge from the ASF, a patient shall be evaluated for proper anesthesia recovery by an anesthetist, the operating room surgeon, anesthesiologist or dentist. Depending on the type of anesthesia and length of surgery, the postoperative check shall include at least the following:
(i) level of activity
(ii) respirations
(iii) blood pressure
(iv) level of consciousness
(v) oxygen saturation by pulse oximetry.

Observations:
Based on a review of facility policy, medical records (MR) and interview with staff (EMP), it was determined the facility failed to document a postoperative anesthesia recovery evaluation by a physician or certified registered nurse anesthetist (CRNA) that included level of activity, respirations, blood pressure, level of consciousness, and oxygen saturation prior to discharge as required by the Department of Health (the "Department") in four of four medical records reviewed (MR3, MR4, MR6 and MR7).

Findings include:

A review of facility policy "Patient Discharge" dated April 7, 2022, revealed "Anesthesia Recovery Evaluation. An evaluation of the patient's recovery from sedation or anesthesia, to determine whether the patient is recovering appropriately, must be completed, and documented before the patient is discharged. 1. a physician or anesthetist assesses the recovery from sedation/anesthesia."

A review on August 12, 2022, of MR3, admitted July 29, 2022, revealed MR3 received monitored anesthesia care for a tunneled catheter insertion procedure. Further review revealed "Patient Discharge From Procedure" note authored by CF2, a CRNA, July 29, 2022, at 1:39 PM that stated stated "Upon assessment, the patient has met discharge criteria." Further review revealed a "Patient Discharge From Procedure" note authored by CF1, a physician, July 29, 2022, at 1:47 PM that stated stated "Upon assessment, the patient has met discharge criteria." Further review revealed there was no documentation of an evaluation of level of activity, respirations, blood pressure, level of consciousness, and oxygen saturation by CF1 or CF2.

A review on August 12, 2022, of MR4, admitted July 29, 2022, revealed MR4 received monitored anesthesia care for an arteriogram procedure. Further review revealed "Patient Discharge From Procedure" note authored by CF2, a CRNA, July 29, 2022, at 10:50 AM that stated stated "Upon assessment, the patient has met discharge criteria." Further review revealed a "Patient Discharge From Procedure" note authored by CF3, a physician, July 29, 2022, at 10:53 AM. that stated "Upon assessment, the patient has met discharge criteria." Further review revealed there was no documentation of an evaluation of level of activity, respirations, blood pressure, level of consciousness, and oxygen saturation by CF2 or CF3.

A review on August 12, 2022, of MR6, admitted May 20, 2022, revealed MR6 received monitored anesthesia care for an angiogram procedure. Further review revealed a "Patient Discharge From Procedure" note authored by CF4, a physician, May 20, 2022, at 9:32 AM that stated "Upon assessment, the patient has met discharge criteria." Further review revealed there was no documentation of an evaluation of level of activity, respirations, blood pressure, level of consciousness, and oxygen saturation by CF4.


A review on August 12, 2022, of MR7, admitted July 15, 2022, revealed MR7 received monitored anesthesia care for an angiogram procedure. Further review revealed a "Patient Discharge From Procedure" note authored by CF3, a physician July 15, 2022, at 1:36 PM that stated "Upon assessment, the patient has met discharge criteria." Further review revealed there was no documentation of an evaluation of level of activity, respirations, blood pressure, level of consciousness, and oxygen saturation by CF3.


An interview conducted on August 12, 2022, at 2:00 PM with EMP1 and EMP5 confirmed the physician and CRNA discharge notes in MR3, MR4, MR6 and MR7 did not include documentation of an evaluation of level of activity, respirations, blood pressure, level of consciousness, and oxygen saturation as required by the Department. EMP1 stated "The physicians and CRNA's do not document the specifics of the anesthesia recovery evaluation."
















Plan of Correction:

Corrective Action:
a. A policy review was completed. Policy PC 107 Patient Discharge was reviewed and is sufficient.
b. The electronic medical record will be modified to include specific documentation regarding the required criteria. The change will document that the physician, anesthetist or both have evaluated the five (5) specific criteria. Those criteria will be listed in the Procedure Discharge note and Anesthesia Discharge note in the electronic medical record.
c. The physicians and anesthetists will be provided education regarding these changes to the medical record. This education will be conducted in person or telephonically and sign in sheets will be maintained.

Monitoring Activities: Compliance with the documentation will be monitored through the Quarterly Medical Record Review and reported to the Quality Committee, Medical Executive Committee and Governing Body. Two (2) percent of patient records or a minimum of 10 records, whichever is greater, will be monitored quarterly. The audits will be discontinued after six (6) months if compliance is demonstrated.

Responsible Party: Facility Administrator and Medical Director

Complete Date: 11/1/2022