Pennsylvania Department of Health
DERMATOLOGIC SURGICENTER - PHILADELPHIA
Patient Care Inspection Results

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Severity Designations


Minimal Citation - No Harm	Minimal Harm	Actual Harm	Serious Harm

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DERMATOLOGIC SURGICENTER - PHILADELPHIA - Inspection Results	Scope of Citation Number of Residents Affected By Deficient Practice

Initial comments:

This report is the result of a State licensure survey conducted on March 28, 2023, and completed April 5, 2023, at 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:

553.25 (1-6) LICENSURE Discharge Criteria:

553.25 Discharge Criteria

A patient may only be discharged from an ASF if the following physical status criteria are met:
(1) Vital signs. Blood pressure, heart rate, temperature and respiratory rate are within the normal range for the patient's age or at preoperative levels for that patient.
(2) Activity. The patient has regained preoperative mobility without assistance or syncope, or function at his usual level considering limitations imposed by the surgical procedure.
(3) Mental status. The patient is awake, alert or functions at his preoperative mental status.
(4) Pain. The patient's pain can be effectively controlled with medication.
(5) Bleeding. Bleeding is controlled and consistent with that expected from the surgical procedure.
(6) Nausea/vomiting. Minimal nausea or vomiting is controlled and consistent with that expected from the surgical procedure.

Observations:
Based on a review of facility policy, medical records (MR) and interview with staff (EMP), it was determined the facility failed to ensure patients met appropriate discharge criteria prior to discharge from the ambulatory surgery center in two or two medical records reviewed (MR1 and MR7).

Findings include:

A review of facility policy "Criteria for Discharging Patients at the Dermatologic SurgiCenter" last revised March 2022, revealed "POLICY: Upon discharge from the DSC (Dermatologic SurgiCenter) the following criteria must be met: ...B. 1. Vital Signs are taken (temperature, pulse, respiratory, blood pressure). 2. Mental status is assessed. Patient will be awake, alert or functioning at his preoperative mental status. 3. Post-operative physical activity is determined by attending physician. Patients are verbally told what limitations are expected. The patient will have regained his preoperative mobility without assistance or syncope, or functions at his usual level considering limitations imposed by the surgical procedure. 4. Bleeding and pain management are reviewed by the nurse and physician. Patient's are given instructions reviewing wound care, how to stop bleeding and how to relieve pain. C. Nausea is generally unexpected with the use of local anesthesia. In the post operative period, if a patient experiences nausea and vomiting, this will require further evaluation by the treating physician to elucidate the underlying cause of these symptoms prior to medical clearance for discharge. All patients will be assessed for nausea and vomiting."

A review on March 23, 2023, of MR1, admitted February 21, 2023, revealed MR1 was admitted for a surgical excision of a mole procedure. Further review revealed there was no evidence of documentation that MR1 had been evaluated for physical activity, bleeding, nausea and vomiting in accordance with facility policy prior to discharge from the ambulatory surgery center.

A review on March 23, 2023, of MR7, admitted February 7, 2023, revealed MR7 was admitted for an allograft placement procedure. Further review revealed there was no evidence of documentation that MR7 had been evaluated for vital signs (temperature, pulse, respiratory, blood pressure), mental status, mobility, bleeding, pain, or nausea and vomiting, in accordance with facility policy prior to discharge from the ambulatory surgery center.

An interview conducted March 23, 2023, at 12:14 PM with EMP2 confirmed MR1 and MR7 did not contain evidence of documentation that MR1 and MR7 met appropriate discharge criteria prior to discharge from the ambulatory surgery center in accordance with facility policy prior to discharge from the ambulatory surgery center.

Plan of Correction - To be completed: 01/31/2024

The Policy Criteria for Discharging Patients was reviewed by the Medical Director and Director of Nursing on October 19 2023. An In-service will be conducted on December 18, 2023 for all physicians and nursing staff as to the requirements of the components of the discharge criteria. Staff signature sign in sheets will be available as proof of attendance.

A review of the medical records was completed by the Medical Director and Director of Nursing to assure that the discharge criteria components from the regulations are met.
Director of Nursing or their designate will audit each medical record for compliance of the discharge criteria for four weeks until 100% compliance is achieved and sustained.
Audit results will be reported to the Patient Safety Committee, Quality Assurance Committee and Governing Body.
The Medical Director and Director of Nursing are responsible for plan of correction.

553.31 (a) LICENSURE Administrative responsibilities:

A full time person in charge shall be appointed who has authority and responsibility for the operation of the ASF at all times. Qualifications, authority, responsibilities and duties of the person in charge shall be defined in a written statement adopted by the governing body.

Observations:

Based on review of facility policy and interview with staff (EMP), it was determined the Governing Body failed to ensure that a full time person in charge was appointed who had the authority and responsibility for the operation of the Dermatologic SurgiCenter-Philadelphia at all times.

Findings include:

A review on March 10, 2022, of facility policy "Ownership, Governance and Management of Governing Body Responsibilities" last revised April 1, 2020, revealed "Policy: (CF2), is the Medical Director/Chief Administrative Officer of the Benedetto Dermatologic SurgiCenter... (CF1) is the Assistant Medical Director/Assistant Chief Administrative Officer of the Benedetto Dermatologic SurgiCenter... They are in charge and oversee the operation of the Dermatologic SurgiCenter according to the Board of Directors of Benedetto Dermatology, LLC."

A request was made by the survey team to speak with the facility's administrator (EMP5) to EMP1 and EMP3. EMP1 and EMP3 informed the survey team that the administrator was not on-sight at the facility and was at another ambulatory surgery center fulfilling other assigned duties. EMP3 stated "Why was the administrator need to be on-site during the hours of operation. This is a small ambulatory surgery center therefore there is not much for the administrator to do here but to sit and watch everyone else."

A review of PF3, for EMP5 (administrator) revealed the following notification for EMP5 (administrator), "To: Department of Health-Division of Acute and Ambulatory Care, Re: Benedetto Dermatologic SurgiCenter LLC (04841500). This is to advise you that according to our plan of correction accepted 04/29/2022, we are notifying you that [XXX] name redacted-EMP5 has been appointed to the Chief Administrative Office of the Benedetto Dermatologic SurgiCenter Philadelphia...signature line [XXXBody Member."

A review of PF3, for EMP5 (administrator) revealed the following notification for EMP5 (administrator), "This letter is to inform you that based on satisfactory ...the Governing Body of the Dermatologic SurgiCenter Drexel Hill has appointed you to the position of Chief Administrative Officer of the Dermatologic SurgiCenter Drexel Hill for a two year period. Please sign this letter to indicate your acceptance of this position and return it to the Governing Body...signature line [EMP6]-Governing Body Member and signature line [EMP5]."

A review of PF3, for EMP5 (administrator) revealed "Job Description...TITLE: CHIEF ADMINISTRATIVE OFFICER. REPORTS TO: Governing Body/Medical Director/Assistant Medical Director as an officer of both the Physician Practice and the Ambulatory SurgiCenter.
1. Oversees all responsiblities and duties of the operation of the ASF and the physician staff.
2. Attends Governing Body meetings and is an integral part of the same.
3. Overseas the Financial Officer and Billing Department, the Quality Committee, the Emergency Preparedness and Life Safety for the facility and the Department of Nursing.
4. Collaborates with the Human Resource aspects of the facility....signature line signed by EMP5 on April 28, 2022 and March 14, 2023."

An interview conducted on March 28, 2023, at 12:15 PM with EMP1 and EMP3 confirmed PF1 was concurrently the administrator of the Dermatologic SurgiCenter at Philadelphia, administrator of the Dermatologic SurgiCenter at Drexel Hill and the administrator of the "Dermatologic Practice" as appointed and designated by the facility's Governing Body for the ambulatory surgery center at Philadelphia and Drexel Hill. Further interview confirmed that EMP5 (administrator) was not available to come to surgery center due to commitments to work at the Drexel Hill ambulatory surgical center.

Plan of Correction - To be completed: 01/31/2024

The Governing Body met on April 4, 2023 and reviewed the policy on ownership government and management of the Governing Body and appointed a Chief Administration Officer. The Chief Administrator has the authority, responsibility, and duty of the Dermatologic SurgiCenter. The staff has been introduced to the new Administrator. Notification has been sent to the Pennsylvania Department of Health. The current Administrator is responsible to educate the Governing Body and the Quality Assurance Committee and staff of the role of a full time Administrator. The Administrator has the responsibility of notifying the Pennsylvania Department of Health of any changes to administration. Based upon the hours of the ASF, there will be no conflict of duties of the full time Administrator. The Administrator will be available when the ASF is open.

The Medical Director and Administrator are responsible for the Plan of Correction.

555.22 (a)(1-2) LICENSURE Surgical Services - Preoperative Care:

555.22 Pre-operative Care

(a) Pertinent medical histories and physical examinations, and supplemental information regarding drug sensitivities documented day of surgery or one of the following:
(1) If medical evaluation, examination and referral are made from a private practitioner's office, hospital or clinic, pertinent records thereof shall be available and made part of the clinical record at the time the patient is registered and admitted tot he ASF. This information is considered valid no more than 30 days prior to the date of surgery.
(2) A practitioner shall examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed. The information shall be clearly documented in the medical record.

Observations:
Based on a review of facility Bylaws, medical records (MR) and interview with staff (EMP), it was determined the facility failed to ensure patients received a pre-admission examination, vital signs, or a physical examination completed by the physician prior to the surgical procedure in one of one medical record reviewed (MR7).

Findings include:

A review of facility document "Benedetto Dermatologic Surgicenter, LLC Bylaws" last reviewed February 2022 revealed "Article XIII RULES & REGULATIONS OF MEDICAL STAFF 1. ADMISSION AND DISCHARGE OF PATIENTS: ...c. Admission to the facility is permitted only after pre-admission examination and proper work-up is completed and recorded in the patient's chart. ...2. MEDICAL RECORDS ...b. A full dermatologic evaluation and when indicated, a complete physical by the referring physician must be recorded within 24 hours of admission. ...The medical record shall document a current appropriate physical examination prior to the performance of surgery."

A review on March 23, 2023, of MR7, admitted February 7, 2023, for an allograft placement procedure revealed documentation of MR7's wound measurements. Further review revealed there was no documentation of a pre-admission examination, vital signs, or documentation of a current appropriate physical examination prior to the performance of the surgical procedure in accordance with the facility Bylaws.

An interview conducted March 23, 2023, at 1:30 PM with EMP2 confirmed there was no documentation in MR7's medical record of a pre-admission examination, vital signs, or documentation of a current appropriate physical examination prior to the performance of the surgical procedure.

An interview conducted March 23, 2023, at 2:28 PM with EMP3 confirmed MR7 should have received a physical examination completed by the physician prior to the surgical procedure. EMP3 stated "The physical examination paperwork should be in the medical record."

Plan of Correction - To be completed: 01/31/2024

The Medical Director and Director of Nursing reviewed the Policy and Procedure on Preoperative Admission to the Dermatologic SurgiCenter on October 19th 2023. An In-service will be conducted on December 18, 2023 for all physicians and nursing staff as to the requirements for performing and documenting the pre admission physical examination to be completed by the physician prior to the surgical procedure. Medical records will be revised to include attestation that the physical exam was completed by the physician. Staff signature sign in sheet will be available for proof of attendance.

Director of Nursing or their designate will audit each medical record for compliance of the preoperative care criteria which also includes a pre admission physical examination by the physician for four weeks until 100% compliance is achieved and sustained. Identified noncompliance will be addressed immediately by the Medical Director and the Director of Nursing.
Audit results will be reported to the Patient Safety Committee, Quality Assurance Committee and the Governing Body.
The Medical Director and Director of Nursing are responsible for the plan of care.

555.22 (b) LICENSURE Surgical Services - Preoperative Care:

555.22 Pre-operative Care

(b) A written statement indicating informed consent, obtained by the practitioner, and signed by the patient, or responsible person, for the performance of the specific procedures shall be procured and made part of patient's clinical record. It shall contain a statement which evidences the appropriateness of the proposed surgery, as well as any alternative treatments discussed with the patient. It shall also identify any practitioner who shall participate in the surgery.

Observations:
Based on a review of facility documents, medical records (MR), and interview with staff (EMP), it was determined the facility failed to ensure a properly executed consent form was completed that specified the specific procedure that was to be performed in one of one medical records reviewed (MR7).

Findings include:

A review of facility document "Benedetto Dermatologic Surgicenter, LLC Bylaws" last reviewed February 2022 revealed "Article XIII RULES & REGULATIONS OF MEDICAL STAFF 3. GENERAL CONDUCT OF CARE a. A general consent form signed by or on behalf of every patient admitted to the facility, must be obtained at the time of admission. The admitting physician or nurse should notify the attending physician whenever such consent has not been obtained. When so notified, it shall, ...be the physician's obligation to obtain proper consent before the patient is treated in the DSC (Dermatologic Surgicenter)."

A review on March 23, 2023, of MR7, admitted February 7, 2023, for an allograft placement procedure revealed a "Consent for Surgery Permit" signed by the physician and patient February 14, 2023. Further review revealed "I herby [sic] authorize Dr. (CF2), and whomever he may designate as his assistant(s) _____(blank), to perform upon (left) ear the following operations _________ (blank)..."

An interview conducted March 23, 2023, at 1:28 PM with EMP2 confirmed the line on the consent form to document "the following operations" was blank. EMP2 further confirmed the specific procedure that was to be performed on MR7 was not specified on the consent form.

Plan of Correction - To be completed: 01/31/2024

The Medical Director and Director of Nursing have reviewed the preoperative care Policy and Procedure obtaining informed consent on October 19th, 2023. An In-service will be conducted December 18, 2023 for all physicians and nursing staff as to the requirements of the components of preoperative care for obtaining informed consent. Name of the specific procedure to be performed on the patient will be documented. Staff signature sign in sheets will be available as proof of attendance.
The specific procedure being performed on the patient is documented on the consent form prior to patient signing the consent. Medical records will include attestation that the exact procedure is identified and patient has signed informed consent. Identified noncompliance will be addressed immediately by the Medical Director and the Director of Nursing.
The Director of Nursing or their designate will audit each medical record for compliance of the preoperative care for obtaining completed informed consent for four weeks until 100% compliance is achieved and sustained.
Audit results will be reported to the Patient Safety Committee, Quality Assurance Committee and the Governing Body.
The Medical Director and Director of Nursing are responsible for this plan of correction.

555.22 (c)(1-5) LICENSURE Surgical Services - Preoperative Care:

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 policy, medical records (MR), and interview with staff (EMP), it was determined the facility failed to provide patients or their representatives with written preoperative instructions prior to procedures in three of three medical records reviewed (MR1, MR2 and MR7).

Findings include:

A review on March 23, 2023, of facility policy "Pre-Operative Instructions" dated January 5, 1995, revealed "PURPOSE: To ensure that the surgical patients of the Dermatological SurgiCenter have received preparatory materials and have an understanding of the surgical procedure they are scheduled to undergo. POLICY: ...2. Appropriate printed materials will be distributed and reviewed with patient as necessary."

A review on March 23, 2023, of MR1, admitted February 21, 2023, for a surgical mole excision procedure revealed there was no documented evidence MR1 had been provided with written preoperative instructions prior to the surgical procedure.

A review on March 23, 2023, of MR2, admitted February 21, 2023, for a surgical mole excision procedure revealed there was no documented evidence MR2 had been provided with written preoperative instructions prior to the surgical procedure.

A review on March 23, 2023, of MR7, admitted February 7, 2023, for an allograft placement procedure revealed there was no documented evidence MR7 had been provided with written preoperative instructions prior to the surgical procedure.

An interview conducted on March 23, 2023, at 12:28 PM with EMP1 confirmed MR1 and MR2 did not contain evidence of documentation that MR1 and MR2 was provided with written preoperative instructions prior to the surgical procedure. EMP1 stated "We do not provide (written preoperative) instructions for mole excisions. There is no preparation so patients do not get instructions."

An interview conducted on March 23, 2023, at 12:43 PM with EMP2 confirmed MR7 did not contain evidence of documentation that MR7 was provided with written preoperative instructions prior to the surgical procedure.

Plan of Correction - To be completed: 01/31/2024

The Medical Director and Director of Nursing reviewed the Policy and Procedure on Preoperative care written instructions for preoperative procedures for the Dermatologic SurgiCenter on October 19th 2023. An In-service will be conducted on December 18, 2023 for all physicians and nursing staff as to the requirements of the preoperative written instructions for procedures. Staff signature sign in sheets will be available as proof of attendance.
Medical records will include an attestation that the preoperative written instructions were given and reviewed with the patient by a nurse prior to the procedure.
A review of medical records will be completed by the Medical Director and Director of Nursing to assure the preoperative care written instructions for procedures have been given and attested. Identified noncompliance will be addressed immediately by the Medical Director and the Director of Nursing.
Director of Nursing or their designate will audit each medical record for compliance of the preoperative care written instructions for procedures criteria for four weeks until 100% compliance is achieved and sustained.
Audit results will be reported to Patient Safety Committee, Quality Assurance Committee and the Governing Body.
The Medical Director and Director of Nursing are responsible for the plan of correction.

555.24 (g) LICENSURE Surgical Services - Postoperative:

555.24 Post Operative Care

(g) Patients shall be discharged only upon the written signed order of a practitioner.

Observations:
Based on a review of facility policy, medical records (MR), and interview with staff (EMP), it was determined the facility failed to ensure discharge orders were written prior to discharge from the ambulatory surgery center in one of one medical records reviewed (MR7).

Findings include:

A review of facility policy "Criteria for Discharging Patients at the Dermatologic SurgiCenter" last revised March 2022, revealed "POLICY: Upon discharge from the DSC (Dermatologic SurgiCenter) the following criteria must be met: ...E. Physician is responsible for writing discharge orders and specifying limitation, medications, and for initiating any necessary referral forms. Patient to be discharged from ASC (ambulatory surgery center) only on the signed written order of the physician."

A review on March 23, 2023, of MR7, admitted February 7, 2023, revealed MR7 was admitted for an allograft placement procedure. Further review revealed there was no evidence of documentation that discharge orders were written prior to discharge.

An interview conducted on March 23, 2023, at 12:30 PM with EMP2 confirmed there was no evidence of documentation that discharge orders was written prior to discharge in MR7's medical record.

Plan of Correction - To be completed: 01/31/2024

The Medical Director and Director of Nursing reviewed the Policy and Procedure on Postoperative care written discharge orders for the Dermatologic SurgiCenter on October 19th 2023. An In-service will be conducted on December 18, 2023 for all physicians and nursing staff as to the requirements of the postoperative care written discharge orders. Revisions will be made to the medical records to ensure that discharge orders have been written and signed by the physician prior to discharge of the patient. Staff signature sign in sheets will be available as proof of attendance.
A review of medical records will be completed by the Medical Director and Director of Nursing to assure the postoperative care written discharge orders have been written and signed by the physician prior to discharge of the patient. Identified noncompliance will be addressed immediately by the Medical Director and the Director of Nursing.
Director of Nursing or their designate will audit each medical record for compliance of the postoperative care written discharge orders criteria for four weeks until 100% compliance is achieved and sustained.
Audit results will be reported to Patient Safety Committee, Quality Assurance Committee and the Governing Body.
The Medical Director and Director of Nursing are responsible for the plan of correction.

567.1 LICENSURE Principle:

567.1 Principle

The ASF shall have a sanitary environment, properly constructed,
equipped and maintained to protect surgical patients and ASF personnel from
cross-infection and to protect the health and safety of patients.

Observations:
Based on a review of the Centers for Disease Control and Prevention (CDC) recommendations, facility documents, product instructions for use, observation, and interview with staff (EMP), it was determined the facility failed to adhere to acceptable standards of practice for reprocessing surgical equipment prior to sterilization.

Findings include:

A review of the Centers for Disease Control and Prevention (CDC) "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" updated May 2019 revealed "Physical Facilities. The central processing area(s) ideally should be divided into at least three areas: decontamination, packaging, and sterilization and storage. Physical barriers should separate the decontamination area from the other sections to contain contamination on used items. In the decontamination area reusable contaminated supplies ...are received, sorted, and decontaminated. The recommended airflow pattern should contain contaminates within the decontamination area and minimize the flow of contaminates to the clean areas. The American Institute of Architects ...recommends negative pressure and no fewer than six air exchanges per hour in the decontamination area..."

A review of facility document "Dermatological SurgiCenter Infection Control Plan," undated, revealed "The Dermatologic SurgiCenter maintains a sanitary environment, properly constructed, equipped and maintained to protect surgical patients and Surgi-center personnel from cross-infection and to protect the health and safety of patients. The DSC (Dermatological SurgiCenter) will adhere to CDC guidelines which are appropriate for their facilities."

1) An observation on March 28, 2023, at 9:40 AM with EMP2 and EMP3 in Operating Room 1 (OR1) revealed there was a work-counter in the corner of OR1 containing a single sink. Further observation revealed there was instrument reprocessing supplies on the work-counter including a bottle of enzymatic cleaner, and an ultrasonic (instrument) washer. Further observation revealed a table-top sterilizer with supplies for wrapping and sterilizing surgical instruments. Further observation revealed there was a small container of instruments soaking in a blue solution inside the sink.

An interview conducted on March 28, 2023, at 9:45 AM with EMP3 confirmed surgical instruments were reprocessed inside OR1 where surgical procedures were performed and not in a separate room. EMP3 further confirmed there was no handwashing sink in OR1 and that facility staff utilized the same sink the instruments were soaking in throughout the day for hand hygiene. EMP3 stated "We just wash our hands off to the side of the basin (containing instruments)."

2) A review on March 28, 2023, of [name redacted] enzymatic solution Instuctions for Use (IFU) revealed "Use fresh [name redacted] enzymatic solution for each instrument or set of instruments. Discard diluted [name redacted] enzymatic solution after each use. Manual cleaning: Add 1 oz. (1 pump yields 1 oz) of concentrate to one gallon of warm water (68-104 degrees F). Soak instruments and equipment immediately after use, until soil is dissolved and removed. Soak for a minimum of 1 minute."

An interview conducted on March 28, 2023, at 9:45 AM with EMP3 confirmed the surgical instruments were soaking in enzymatic solution prior to reprocessing and sterilization. EMP3 further confirmed the temperature and the amount of water mixed with [name redacted]enzymatic cleaner was not measured. EMP3 stated "I put about one half inch of water in the basin and add a squirt of [name redacted] enzymatic cleaner. I do not check the temperature of the water with a thermometer. I let the instruments sit in the solution for 15-20 minutes before cleaning and sterilizing them."

Plan of Correction - To be completed: 01/31/2024

The Medical Director and Director of Nursing reviewed the professional standard guidelines for maintaining sterilization of instruments in order to protect surgical patients and ASF personnel from cross-infection. An In-service will be conducted on December 18, 2023 for nursing staff and histotechnologists as to the requirements of proper standard of care sterilization techniques. Staff signature sign in sheets will be available as proof of attendance.
Following the Clinical Laboratory Improvement Amendments guidelines, the Director of Nursing or their designate will administer a competency skill checklist to any staff responsible for sterilization of instruments semi-annually. A current copy of the Center for Disease Control guidelines for Disinfection and Sterilization has been incorporated into our Policy and Procedure Manual.
A review of acceptable standards of practice for reprocessing surgical equipment prior to sterilization will be completed by the Medical Director and Director of Nursing in order to protect ASF personal from cross infection and to protect the health and safety of patients.
Director of Nursing or their designate will be monitoring staff to assure that they are following the posted procedure guide of steps to follow for decontamination, packaging, sterilization and storage.
Competency skilled check list results will be reported to the Patient Safety Committee, Quality Assurance Committee and Governing Body. Identified noncompliance will be addressed immediately by the Director of Nursing.
The Director of Nursing will be responsible for Plan of Correction.

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