Pennsylvania Department of Health
PLAZA SURGICAL CENTER, INC.
Patient Care Inspection Results

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Minimal Citation - No Harm Minimal Harm Actual Harm Serious Harm
PLAZA SURGICAL CENTER, INC.
Inspection Results For:

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PLAZA SURGICAL CENTER, INC. - Inspection Results Scope of Citation
Number of Residents Affected
By Deficient Practice
Initial comments:


This report is the result of a full Medicare recertification survey initiated on May 8, 2024 and completed on May 9, 2024, at Plaza Surgical Center. It was determined the facility was in substantial compliance with the requirements of 42 CFR, Title 42, Part 416 - Conditions for Coverage for Ambulatory Surgical Centers.









 Plan of Correction:


Initial comments:


This report is the result of a State licensure survey initiated on May 8, 2024 and completed on May 9, 2024, at Plaza Surgery 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:


416.51(a) STANDARD SANITARY ENVIRONMENT:Not Assigned
The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.


Observations:
Based on observation, review of facility policies and procedures, and interview with staff (EMP), it was determined the facility failed to follow its facility policies for infection control practices related to hand hygiene and soiled instrument transportation.
Finding include:
1)Observation on May 9, 2024, at 10:18 AM in pre-operative holding room, revealed EMP3 removed gloves after preparing medication for patient and did not perform hand hygiene. Further observation revealed EMP3 preparing a liquid mouth wash solution, for patient administration, without gloves on. Additional observation revealed EMP3 handing small, plastic medicine cup containing oral medications to patient without performing hand hygiene or donning gloves. Continued observation revealed EMP3 holding plastic basin for patient to spit out mouthwash in, without wearing gloves.
Observation on May 9, 2024, at 10:21 AM, in pre-operative holding room, revealed EMP2 enter room without preforming hand hygiene. Continued observation revealed EMP2 listening to patient's heart and lung without performing hand hygiene before touching patient.
Observation on May 9, 2024, at 10:33 AM, in pre-operative holding room, revealed OTH1 entered room without performing hand hygiene. Further observation revealed OTH1 marking patient's face for procedure without performing hand hygiene before or after touching patient.
Review on May 9, 2024, of facility policy and procedure, " Standard Precautions for Infection Control Practices " , revised March 4, 2024, revealed " ...Employees should routinely use appropriate barrier precautions to prevent skin and mucus membrane exposure when in contact with blood or other body fluids. Gloves should be worn for touching blood and body fluids, mucus membranes, or broken skin of all patients, for handling items or surfaces soiled with blood or body fluids... "

Review on May 9, 2024, of facility policy and procedure, " Hand Hygiene " , revised March 4, 2024, revealed " ...Clean hands before and after routine patient care activities, including entering and exiting the patient care environment and after hand-contaminating activities. Clean hands before handling medication ... Glove use does not replace the need for hand hygiene ... "
Interview on May 9, 2023, at 10:33 AM, with EMP3 confirmed above findings.
_____________
2)Observation on May 9, 2024, at 1:28 PM, in operating room one after procedure was completed, revealed two metal basins and two surgical light handles used during procedure stacked up on metal table, not enclosed or covered.
Review on May 8, 2024, of facility policy and procedure, " Instrument Care, Disinfection, Sterilization and Storage " , revised March 6, 2024, revealed " ...Transport instruments in a closed container or enclosed cart that is labeled with a biohazard legend ... "

Interview on May 8, 2024, at 11:19 AM, with EMP1 revealed that when the procedure is completed, EMP1 will spray soiled instruments with pre-cleansing spray and carry the instrument tray down the hallway to the soiled room. Further interview with EMP1 confirmed that EMP1 does not cover the soiled instruments with a wrap or place them in a closed container prior to leaving the operating room to transport instruments to soiled room for reprocessing.





 Plan of Correction - To be completed: 06/26/2024

1)The staff had an immediate in-service on Monday 5/20/24 on the importance of hand hygiene and doffing gloves. The center will do weekly hand hygiene audits for one-two employees randomly on any given day the administrator and/or Director of Nursing chooses. The Director of nursing, who is also the infection control officer will also be chosen at random for the audits. The audit will be conducted weekly for one month then bi-monthly the following month and then ongoing once a month. If the employee fails to pass any part of the hand hygiene audit corrective action and education will be taken immediately. The employee will then be re-audited randomly the following week until error/s have been corrected. The results will be reported to the Medical Director and Governing Body and included in the material reviewed at the Infection Control, Patient Safety and Quality Assurance meeting quarterly. Ways to improve staff practices will be discussed at these meetings and presented to the Governing Body at the quarterly Medical Advisory Board meetings for review and Analysis.

2)A biohazard transport bin has been ordered and will arrive in the office by 5/31/24. The staff will have an Inservice including a visual demonstration on how to properly transport instruments from the Operating Room. Educational materials will be provided. In the meantime, the instruments will be covered with a wrap when leaving the OR and going to the dirty room. Once the biohazard transport bin arrives that will be used when transporting the instruments to the dirty room. Use of the transport bin will be audited. The audit will take place weekly for one month and then bi-monthly the following month then monthly for up to 6 months. After 6 months the audit will take place quarterly to ensure ongoing compliance. The audit will be performed by the Director of Nursing who is also the Infection Control Officer. The results will be reported to the Medical Director and Governing Body and included in the material reviewed at the Infection Control, Patient Safety and Quality Assurance meeting quarterly. Ways to improve staff practices will be discussed at these meetings and presented to the Governing Body at the quarterly Medical Advisory Board meetings for review and Analysis. This plan of correction is the responsibility of the Director of Nursing and the Administrator.

555.31 (a) LICENSURE ANESTHESIA SERVICES - Principle:State only Deficiency.
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.
Observations:

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 twelve (12) of twenty (20) medical records reviewed (MR3, MR5, MR8, MR9, MR11, MR12, MR13, MR14, MR16, MR17, MR18, and MR20).
Findings include:
Review on May 8, 2024 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 May 8, 2024 of Department document, "Commonwealth of Pennsylvania[,] Division of Acute & Ambulatory Care[,]Ambulatory Surgical Facility Application Request Form ..." , dated May 8, 2024, revealed the facility's registration status as Class B.
Review on May 9, 2024, of facility policy and procedure, " Types of Anesthesia " , dated March 6, 2024, revealed " ...Types of anesthesia techniques that may be provided ...1. Conscious sedation/moderate sedation/monitored anesthesia care/total IV anesthesia 2. Regional anesthesia 3. Field block 4. Local. "
Review on May 9, 2024, of MR3, revealed the patient had a procedure performed at the facility on December 19, 2023, in which ketamine was used intravenously on the patient.
Review on May 9, 2024, of MR5, revealed the patient had a procedure performed at the facility on November 16, 2023, in which ketamine was used intravenously on the patient.
Review on May 9, 2024, of MR8, revealed the patient had a procedure performed at the facility on July 18, 2023, in which ketamine was used intravenously on the patient.
Review on May 9, 2024, of MR9, revealed the patient had a procedure performed at the facility on July 25, 2023, in which ketamine was used intravenously on the patient.
Review on May 9, 2024, of MR11, revealed the patient had a procedure performed at the facility on August 15, 2023, in which ketamine was used intravenously on the patient.
Review on May 9, 2024, of MR12, revealed the patient had a procedure performed at the facility on September 28, 2023, in which ketamine was used intravenously on the patient.
Review on May 9, 2024, of MR13, revealed the patient had a procedure performed at the facility on March 19, 2024, in which ketamine was used intravenously on the patient.
Review on May 9, 2024, of MR14, revealed the patient had a procedure performed at the facility on September 7, 2023, in which ketamine was used intravenously on the patient.
Review on May 9, 2024, of MR16, revealed the patient had a procedure performed at the facility on August 29, 2023, in which ketamine was used intravenously on the patient.
Review on May 9, 2024, of MR17, revealed the patient had a procedure performed at the facility on April 22, 2024, in which ketamine was used intravenously on the patient.
Review on May 9, 2024, of MR18, revealed the patient had a procedure performed at the facility on June 27, 2023, in which ketamine was used intravenously on the patient.
Review on May 9, 2024, of MR20, revealed the patient had a procedure performed at the facility on December 7, 2023, in which ketamine was used intravenously on the patient.
Interview with EMP2 on May 9, 2024, at 9:30 AM, confirmed they administer ketamine on every case as part of multimodal anesthesia to decrease use of narcotics. EMP2 further confirmed the above findings.




 Plan of Correction - To be completed: 06/26/2024


The Medical Director and Director of Nursing ensured the discontinuation of Ketamine in the Ambulatory Surgery Center and the proper removal from the anesthesia cart. The Ketamine will be locked away. All Operating Room staff will be educated by the Medical Director and Director of Nursing about the discontinuation and use. The reason for discontinuation of the Ketamine will be discussed during the education. All patient charts will be audited to ensure there was no use of Ketamine and this audit will be done by the Director of Nursing and Administrator. The results will be reported to the Medical Director and Governing Body and included in the material reviewed at the Patient Safety and Quality Assurance meeting quarterly.


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