QA Investigation Results

Pennsylvania Department of Health
DERMATOLOGIC SURGICENTER - PHILADELPHIA
Health Inspection Results
DERMATOLOGIC SURGICENTER - PHILADELPHIA
Health Inspection Results For:


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Initial Comments:

This report is the result of a State licensure survey conducted on February 24, 2021, and completed on March 16, 2021, at the Dermatologic SurgiCenter - 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:




51.31 LICENSURE
Exceptions - Principle

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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 review of facility documents, and interview with staff (EMP), it was determined the facility failed to adhere to the Department of Health ("Department") requirements for an "Exception Request" granted for the use of surgical skin preparations that contain combustible agents by not requiring the participation of all clinical staff in annual mandatory education.

Findings include:

A review on February 24, 2021, of the "Department" letter to the facility Chief Executive Officer dated April 6, 2016, revealed "The Department of Health is in receipt of your request for an exception to 28 Pa. Code 569.35(7), relating to the requirement that only nonflammable agents may be present in the surgical suite. You have completed the process established by the Department for requesting an exception to this regulation and agreed to the following: ...The facility shall institute annual mandatory education provided to all staff, including the physician staff, involved in the use of surgical skin preparations that contain combustible agents. The content of the education provided and documentation of same will be reviewed by the Department during survey activity."

A request was made by the survey team on February 24, 2021, at 12:58 PM to EMP4 for documentation of annual mandatory education for the use of surgical skin preparations that contain combustible agents provided to all staff for the period January 1, 2020, to February 24, 2021. The facility was unable to provide the documentation requested by the survey team.

An interview conducted on February 24, 2021, at 12:58 PM with EMP4 confirmed the facility had not provided annual mandatory education in the use of surgical skin preparations that contain combustible agents to all staff for the period January 1, 2020, to February 24, 2021. EMP4 stated "I do not think we did an inservice on that last year."






Plan of Correction:

We inserviced all medical and nursing personnel regarding the Surgical Site Preparations and Use of Isopropyl Alcohol/Hibiclens as a Surgical Site/Wound Antiseptic.

This is a written annual inservice. The Director of Nursing will check quarterly that all required inservices are completed for all medical and nursing staff. A summary of the result of the audit will be reviewed quarterly with the Quality Assurance Committee, Risk Management Committee, and Governing Body. These three committees have been notified that the inservice was completed.

The Director of Nursing will be responsible for this plan of correction.
Documentation will be kept in the Inservice Binder with the Emergency Preparedness Plan.



555.22 (e) LICENSURE
Surgical Services - Preoperative

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555.22 Pre-operative Care

(e) Prior to the administration of anesthesia, it is the responsibility of the primary operating surgeon and the person administrating anesthesia to properly identify the patient and the procedure to be performed and to document this identification in the patient's medical record. This procedure shall be in written policies designating the mechanism to be used to identify each surgical patient.

Observations:

Based on review of facility policy, medical records (MR) and interview with staff (EMP), it was determined the facility failed to ensure proper identification of the patient prior to the procedure in seven of seven medical records (MR1, MR2, MR3, MR4, MR5, MR6, and MR7).

Findings include:

A review of facility policy "Patient Identification/Proper Site Surgical Location/Time Out" dated January 1, 1990, revealed "Purpose: To ensure proper identification of patients prior to surgery. Policy: To ensure proper location of surgery/avoid wrong site surgery: 1. The attending physician will identify the patient before proceeding with surgery by interacting with the patient and stating the patient's name. 2. The attending physician will cross reference the information with the patient's chart."

A review of MR1, admitted on August 20, 2020, for a keloid scar removal procedure, revealed no evidence of documentation that the patient was identified by the attending physician prior to performing the procedure.

A review of MR2, admitted on September 24, 2020, for an excision procedure, revealed no evidence of documentation that the patient was identified by the attending physician prior to performing the procedure.

A review of MR3, admitted on December 3, 2020, for a lipoma excision procedure, revealed no evidence of documentation that the patient was identified by the attending physician prior to performing the procedure.

A review of MR4, admitted on January 7, 2021, for an excision procedure, revealed no evidence of documentation that the patient was identified by the attending physician prior to performing the procedure.

A review of MR5, admitted on December 3, 2020, for an epidermoid cyst excision procedure, revealed no evidence of documentation that the patient was identified by the attending physician prior to performing the procedure.

A review of MR6, admitted on October 1, 2020, for a Mohs Surgery procedure, revealed no evidence of documentation that the patient was identified by the attending physician prior to performing the procedure.

A review of MR7, admitted on November 5, 2020, for a Mohs Surgery procedure, revealed no evidence of documentation that the patient was identified by the attending physician prior to performing the procedure.

An interview conducted on February 24, 2021, at 11:55 AM with EMP3, confirmed there was no documented evidence that the attending physician identified the patient prior to performing the procedure. EMP3 stated "The physician doesn't identify the patient. The nurses identify the patient.












Plan of Correction:

Prior to surgery the patient is identified by the operating physician and person administering anesthesia. The "patient identified by the physician and the person administering anesthesia" verbiage has now been added to the electronic medical record.

The physician will make sure it is documented in the electronic medical record.

All staff physicians and nursing staff will be educated regarding this requirement. Documentation of this education will be kept in the Inservice Binder. A copy will be made available when requested.

To ensure compliance, ten (10) medical records will be audited each month. We will report our compliance for 6 months to the Quality Assurance, Risk Management, and Governing Body committees. The Director of Nursing and the Medical Director will be responsible for this plan of correction.



561.11 LICENSURE
Pharmaceutical Facilities - Principle

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561.11 Principle

The ASF shall provide equipment and supplies for the pharmaceutical service to implement its professional and administrative functions and to ensure patient safety through the proper storage and dispensing of drugs. Facilities shall be provided for the storage, safeguarding, preparation, and dispensing of drugs.


Observations:

Based on observation, review of facility policy, and interview with staff (EMP), it was determined the facility failed to follow their policy to ensure safe storage and dispensing of medications.

Findings include:

Review of facility policy "Multidose Vials" last revised June 2020 revealed "Multidose medications are dated when opened and marked with an expiration date also. They are discarded within 28 days of opening or sooner per manufacturer's recommendations... Multidose vials will not be used in the immediate patient treatment area. If this occurs they will be considered single dose vial and used only for that designated patient... In the Center City facility, the medications will be drawn up in Treatment Room 3."

An observation on February 24, 2021, at 9:47 AM, in Operating Room One (OR1), an immediate patient care area revealed two partially used multi-dose vials of medication. Further observation revealed a 50 ML vial of Lidocaine HCL (anesthetic), labeled with an open date of February 22, 2021, and a discard date of March 23, 2021, and a vial of Sodium Bicarbonate (alkalinizing agent), labeled with an opened date of February 2, 2021, and a discard date of March 2, 2021.

An interview conducted on February 24, 2021, at 10:00 AM with EMP1 and EMP3, confirmed the opened and partially used multidose vials were used for more than one patient and were accessed in the immediate patient care area (OR1). EMP1 stated "The multidose vials should be kept outside in the Treatment Room."

















Plan of Correction:

An inservice was completed with all medical and nursing staff regarding our multi-dose vial policy. The policy is as follows:

"Multidose medications are dated when opened and marked with an expiration date also. They are discarded within 28 days of opening or sooner per manufacturer's recommendations. If multidose vials must be used, both the needle or cannula and syringe used to access the multidose vial must be sterile. Multidose vials will be discarded when the beyond-use date has been reached, when doses are drawn in a patient treatment area, or any time the sterility of the vial is in question.

Multidose vials will not be used in the immediate patient treatment area. If this occurs they will be considered single dose vial and used only for that designated patient. In the Center City facility, the medications will be drawn up in Treatment Room 3. If that room is occupied with a patient, the medication will be drawn up in the adjacent unoccupied operating room.

When medications from a multidose vial is drawn up in a space separate from the operating room, procedure room, or exam area, it is acceptable to securely store that syringe for up to one hour assuming the dose is labeled with the patient name, date and time, name and dose of medicine, and initials of the healthcare worker preparing the syringe."


The Medical Director, Asst. Medical Director, or their designee, will confirm that all multidose vials are drawn up in treatment room 3 or an unoccupied OR. They will confirm that no multidose vials have been left in the OR to ensure compliance with this policy.

An audit will be performed and kept on all surgical days for a minimum of three months. The expected outcome will be 100% compliance with our Dermatologic SurgiCenter Philadelphia policy. Audit results will be reported to the Director of Nursing, Quality Assurance Committee, Risk Management Committee, and the Governing Body at the quarterly meeting.

The Medical Director and the Director of Nursing will be responsible for this plan of correction.