Initial Comments:
This report is the result of an unannounced revisit survey conducted on December 21, 2022, following a State Special Monitoring Survey completed on May 16, 2022, at Aestique Ambulatory Surgical Center, Inc. It was determined that 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:
51.3 (d) LICENSURE
Notification
Name - Component - 00
51.3 Notification
(d) A health care facility shall submit to the Department architectural plans and blueprints of proposed new
construction, alteration or renovation to the facility. This material shall be submitted at least 60 days before
the initiation of construction, alteration or renovation. The Department will review these documents to assure compliance with relevant life safety code and other regulatory requirements. The Department will respond to the facility by either issuing an approval or disapproval or requesting further information with 45 days of receipt of the facility's submission. The facility may not initiate construction, alteration, renovation until it has received an approval from the Department.
Observations:
Based on a review of facility documents and interview (EMP), it was determined the facility failed to obtain approval from the Department prior to initiating renovations in their sterile processing room.
Findings include:
An unannounced on-site revisit survey was conducted on December 21, 2022. Upon arrival to the facility, a request was made to review the approval letter from the Department permitting the facility to make renovations to the sterile processing room. No letter was provided.
During an interview on December 21, 2022, at 12:05, EMP1 confirmed that "we finished [renovations] a couple of days ago."
On December 21, 2022, at 1:45 PM, a tour of the sterile processing room revealed that new renovations including a two basin sink and splash guards to the handwashing and two basin sink had been installed.
During an interview on December 21, 2022, at 2:00 PM, EMP2 confirmed that a plan for changes to the sterile processing room was submitted to the Department of Plan Review and the Department requested further information. EMP2 stated more information was provided, however, the facility received an email from the Department of Plan Review on September 12, 2022, denying the proposed construction.
Plan of Correction:Renovations completed to Sterilization Room December 16, 2002 compliant with exceptions granted by DOH but without Plan Approval. We subsequently resubmitted our revised plans to DOH Plan Review on 12/22/22.
Moving forward, prior to initiating any renovations Aestique will notify Plan Review for approval. We have developed a policy which outlines and complies with the DOH's process. Medical Director, Administrator, Clinical Director, Director of Nursing and Executive Assistant were educated on the policy. Any implemented DOH approved changes to facility will be monitored by our Governing Board and Administrator. The Administrator will be responsible for obtaining final approval from DOH prior to initiating any renovations.
Once Plan Approval is obtained from Plan Review (no later than 2/17/23), we will then request an onsite survey to determine occupancy compliance.
51.31 LICENSURE
Exceptions - Principle
Name - Component - 00
51.31. Principle
The Department may grant exceptions to this part when the policy and objectives contained therein are
otherwise met, or when compliance would create an unreasonable hardship and an exception would not impair or endanger the health, safety or welfare of a patient or resident. No exceptions or departures from this part will be granted if compliance with the requirement is provided for by statute.
Observations:
Based on a review of facility documents, observations, and interviews with staff (EMP), it was determined the facility failed to meet the condition under the exception that was granted for 28 Pa. Code 571.1 Minimum Standards.
Findings include:
On December 21, 2022, a review of the facility exception letter, dated October 31, 2022, revealed, "Conditions: The exception will be granted temporary for 18 months...The following additional requirements must be met:...Policy ICS-3 "Sterile Processing of Surgical Instruments" will be revised and physical changes within the room will be made within 60 days following Plan Review approval from the Department of Health..."
1. The updated policy ICS-3 Sterile Processing of Surgical Instruments was requested. When it was provided it was a draft copy with changes made in red. At the time of the request, EMP1 stated it was still being worked on.
During an interview on December 21, 2022, at 1:45 PM, EMP3 confirmed the policy was incomplete and had not yet been approved by the governing body.
2. A request for the Plan Review Approval letter from the Department permitting construction on the sterile processing room to begin was requested. No approval letter was provided.
During an interview on December 21, 2022, at 2:00 PM, EMP2 confirmed that a Plan for changes to the sterile processing room was submitted to the Department and the Department requested further information. EMP2 stated more information was provided, however, the facility received an email from the Department of Plan Review on September 12, 2022, denying the proposed construction.
During an interview on December 21, 2022, at 11:54 AM, EMP1 was shown the conditions of the exception letter and confirmed that the construction was done without plan approval. Further interview revealed EMP1 thought that it was ok to proceed with construction because an exception was granted by the Department.
Plan of Correction:Policy ICS-3 Sterile Processing of Surgical Instruments was reviewed and approved by Aestique Governing Board on December 29, 2022. The OR staff was educated on December 30, 2022 and educational sign in sheet completed. Each new OR employee will receive training upon hire. In order to monitor compliance, we will require documentation.
Renovations completed to Sterilization Room December 16, 2002 compliant with exceptions granted by DOH but without Plan Approval. We subsequently resubmitted our revised plans to DOH Plan Review on 12/22/22.
Moving forward, prior to initiating any renovations Aestique will notify Plan Review for approval. We have developed a policy which outlines and complies with the DOH's process. Medical Director, Administrator, Clinical Director, Director of Nursing and Executive Assistant were educated on the policy. Any implemented DOH approved changes to facility will be monitored by our Governing Board and Administrator. The Administrator will be responsible for obtaining final approval from DOH prior to initiating any renovations.
Once Plan Approval is obtained from Plan Review (no later than 2/17/23), we will then request an onsite survey to determine occupancy compliance.
551.64 LICENSURE
Content of plan of correction
Name - Component - 00
551.64 Content of Plan of Correction
A plan of correction shall address deficiencies cited in the compliance directive of the Department. the plan shall state specifically what corrective action is to be taken, by whom and when.
Observations:
Based on an unannounced follow-up on-site survey completed on December 21, 2022, review of the facility's plan of correction (POC), and staff interview (EMP), it was determined the facility failed to correct the deficient practice.
Findings include:
Review of 553.3 Governing body responsibilities include: (1) Conforming to all Applicable Federal, State, and Local Laws revealed the facility continued to be out of compliance with this regulation. The facility was not in compliance with 42 CFR, Title 42, Part 416 - Conditions for Coverage for Ambulatory Surgical Centers, specifically 416.44 (a) (1), "Each operating room must be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area. The final anticipated completion date for the facility's POC was June 20, 2022.
A review of the accepted facility plan of correction, reviewed on December 21, 2022, revealed the Policy ICS-3 "Sterile Processing of Surgical Instruments," will be revised and physical changes within the room will be made within 60 days following Plan Review approval from the Department of Health."
On December 21, 2022, a request for the Plan Review approval letter from the Department permitting construction on the sterile processing room to begin was requested. No approval letter was provided.
During an interview on December 21, 2022, at 11:54 AM, EMP 1 confirmed that the construction was done without plan approval.
Cross reference with 553.3 (1).
Plan of Correction:Policy ICS-3 Sterile Processing of Surgical Instruments was reviewed and approved by Governing Board on December 29, 2022. The OR staff was educated on December 30, 2022. Each new OR employee with receive training upon hire. In order to monitor compliance, we will require documentation.
Renovations completed to Sterilization Room December 16, 2002 compliant with exceptions granted by DOH but without Plan Approval. We subsequently resubmitted our revised plans to DOH Plan Review on 12/22/22.
Moving forward, prior to initiating any renovations Aestique will notify Plan Review for approval. We have developed a policy which outlines and complies with the DOH's process. Medical Director, Administrator, Clinical Director, Director of Nursing and Executive Assistant were educated on the policy. Any implemented DOH approved changes to facility will be monitored by our Governing Board and Administrator. The Administrator will be responsible for obtaining final approval from DOH prior to initiating any renovations.
Once Plan Approval is obtained from Plan Review (no later than 2/17/23), we will then request an onsite survey to determine occupancy compliance.
553.3 (1) LICENSURE
Governing Body Responsibilities
Name - Component - 00
553.3
Governing Body responsibilities include:
(1) Conforming to all applicable Federal, State, and local laws.
Observations:
Based on a review of facility documents and staff interview (EMP), it was determined that the facility failed to conform to all applicable Federal Conditions for Coverage.
The facility was not in compliance with 42 CFR, Title 42, Part 416 - Conditions for Coverage for Ambulatory Surgical Centers, specifically 416.44 (a)(1), "Each operating room must be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area."
Finding include:
A review of the accepted facility plan of correction, completion date of June 20, 2022, revealed the Policy ICS-3 "Sterile Processing of Surgical Instruments," will be revised and physical changes within the room will be made within 60 days following Plan Review approval from the Department of Health."
1. On December 21, 2022, the updated policy ICS-3 Sterile Processing of Surgical Instruments was requested. When it was provided it was a draft copy with changes made in red. At the time of the request, EMP1 stated it was still being worked on.
During an interview on December 21, 2022, at 1:45 PM, EMP 3 confirmed the policy was incomplete and had not yet been approved by the governing body.
2. On December 21, 2022, a request for the Plan Review Approval letter from the Department permitting construction on the sterile processing room to begin was requested. No approval letter was provided.
During an interview on December 21, 2022, at 2:00 PM, EMP2 confirmed that a Plan for changes to the sterile processing room was submitted to the Department and the Department requested further information. EMP2 stated more information was provided, however, the facility received an email from the Department of Plan Review on September 12, 2022, denying the proposed construction.
During an interview on December 21, 2022, at 11:54 AM, EMP1 confirmed that the construction was done without plan approval. Further interview revealed EMP1 thought that it was ok to proceed with construction because an exception was granted by the Department.
Plan of Correction:Renovations completed to Sterilization Room December 16, 2002 compliant with exceptions granted by DOH but without Plan Approval. We subsequently resubmitted our revised plans to DOH Plan Review on 12/22/22.
Moving forward, prior to initiating any renovations Aestique will notify Plan Review for approval. We have developed a policy which outlines and complies with the DOH's process. Medical Director, Administrator, Clinical Director, Director of Nursing and Executive Assistant were educated on the policy. Any implemented DOH approved changes to facility will be monitored by our Governing Board and Administrator. The Administrator will be responsible for obtaining final approval from DOH prior to initiating any renovations.
Once Plan Approval is obtained from Plan Review (no later than 2/17/23), we will then request an onsite survey by DOH to determine occupancy compliance.
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