Pennsylvania Department of Health
UPMC COMMUNITY SURGERY CENTER
Patient Care Inspection Results

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Severity Designations


Minimal Citation - No Harm	Minimal Harm	Actual Harm	Serious Harm

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UPMC COMMUNITY SURGERY CENTER - Inspection Results	Scope of Citation Number of Residents Affected By Deficient Practice

Initial comments:

This report is the result of a full State Licensure survey initiated on March 20, 2025, and concluded on March 25, 2025, at UPMC Community Surgery Center. It was determined the facility was 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:

555.11 (a) LICENSURE MEDICAL ORDERS - Written:

555.11 Medical orders
Written orders

(a) Medication or treatment shall be administered by authorized persons to administer drugs and medications only upon written and signed orders of a practitioner acting within the scope
of the practitioner's license.

Observations:

Based on review of facility documents, medical records (MR) and staff interview (EMP) it was determined the facility failed to ensure written orders were signed/authenticated by a practitioner in six of ten medical records reviewed (MR1, MR4, MR5, MR6, MR7 MR10).

Findings include:

On March 20, 2025, review of facility document "Medical Staff Bylaws, Policies and Rules and Regulations of UPMC Medical Staff Rules and Regulations" effective date April 1, 2024, revealed "Article V Medical Orders 5. E. Standing Orders, Order Sets, and Protocols (1) The Medical Executive Committee (MEC) allows the use of pre-printed and electronic standing orders, order sets, and protocols for patient orders when the following criteria are met: (a) the MEC and the Hospital's nursing and pharmacy departments must review
and approve any standing orders, order sets, and protocols (collectively, 'standing orders') that permit treatment to be initiated by an individual (for example, a nurse) without a prior specific order from the Attending Physician; and (b) all standing orders must identify well-defined clinical scenarios for when the order is to be used. (2) The MEC will adopt the findings of the UPMC Electronic Practice Guidelines ('EPG') and/or the UPMC System Pharmacy & Therapeutics Committee, as applicable, confirming that all approved standing orders and protocols are consistent with nationally recognized and evidence-based guidelines. The MEC will also ensure that such standing orders and protocols are reviewed at least annually. (3) If the use of a standing order has been approved by the MEC, treatment may be initiated (i) by a nurse or other authorized individual acting within their scope of practice who activates the order; or (ii) when a nurse enters documentation into the
medical record that triggers the standing order. (4) When used, standing orders must be dated, timed, and authenticated promptly in the patient ' s medical record by the individual who activates the order or by another responsible practitioner. (5) The Responsible Practitioner must authenticate the initiation of each standing order after the fact, with the exception of those for influenza and pneumococcal vaccines, which may be administered per Hospital policy after an assessment for contraindications."

On March 20, 2025, review of MR1 revealed on December 13, 2024, EMP2 entered and carried out patient orders for Catheter Irrigation Standing Orders; Peripheral IV access; sodium chloride 0.9% flush; line clearing - sodium chloride 0.9% IV infusion. The orders entered by EMP2 were not authenticated by a Practitioner.

On March 20, 2024, review of MR4 revealed on October 24, 2024, at 10:20 am EMP2 entered and carried out patient orders for Outpatient surgery patients with a BS > 126; BGM Bedside Once; PREOPERATIVE Glycemic Control Standing Orders, Adult; Notify physician. The orders entered by EMP2 were not authenticated by a Practitioner.

On March 20,2024, review of MR5 revealed on November 1, 2024, at 0630 am EMP3 entered and carried out patient orders for sodium chloride 0.9% flush; line clearing - sodium chloride 0.9% IV infusion; Catheter Irrigation Standing Orders; Peripheral IV access. The orders entered by EMP3 were not authenticated by a Practitioner.

On March 20, 2024, review of MR6 revealed on November 13, 2024, at 9:18 am EMP4 entered and carried out patient orders for Peripheral IV access: sodium chloride 0.9% flush.
line clearing - sodium chloride 0.9% IV infusion; Lactated Ringers IV infusion. The orders entered by EMP4 were not authenticated by a Practitioner.

On March 20,2024, review of MR7 revealed on November 26, 2024, at 7:49 am EMP3 entered and carried out patient orders for sodium chloride 0.9% flush; line clearing - sodium chloride 0.9% IV infusion; Catheter Irrigation Standing Orders; Peripheral IV access; Outpatient surgery patients with a BS > 126; Notify physician (specify); BGM Bedside Once; PREOPERATIVE Glycemic Control Standing Orders, Adult. The orders entered by EMP3 were not authenticated by a Practitioner.

On March 20, 2024, review of MR10 revealed on December 27, 2024, at 10:21 am EMP2 entered and carried out patient orders for Outpatient surgery patients with a BS > 126; BGM Bedside Once; PREOPERATIVE Glycemic Control Standing Orders, Adult; Notify physician. The orders entered by EMP2 were not authenticated by a Practitioner.

Interview with EMP1 on March 20,2024, EMP1 confirmed the above information is accurate.

Plan of Correction - To be completed: 04/02/2025

Leadership reviewed this finding and discovered that staff were entering standing orders using the order mode 'no cosign required.' As a result, the orders were not being routed to the providers for a co-signature. Nursing staff were instructed to select the order mode "Standing order: Cosign Required" when entering a UPMC system-wide standing order. The education on how to correctly enter standing orders was provided during a staff huddle via verbal instruction and demonstration in the electronic health record on March 28, 2025. An attendance sheet was utilized and will be available upon request. Any staff who were not present during March 28th huddle will be educated upon their return to work and will sign the attendance sheet.

In an email distributed on April 2nd, 2025, the Medical Director reminded all practicing providers of the requirement to cosign all standing orders within 48 hours, a read receipt was required to confirm delivery.

The ambulatory surgery center leader or designee will perform 30 audits per month to confirm that standing orders were entered correctly and have been cosigned by the treating provider within 48 hours.

Audits will be performed monthly until 100% compliance is achieved for 2 consecutive months.

Results of the audits will be reported to the Director, Surgical Services monthly for the duration of the action plan.

555.12 LICENSURE Medical Orders - Oral Orders:

§ 555.12. Oral orders.
Oral orders for medication or treatment shall be accepted only under urgent
circumstances when it is impractical for the orders to be given in written manner
by the responsible practitioner. Oral orders shall be administered in accordance
with § 555.13 (relating to administration of drugs) only by personnel qualified by
their professional license or certification issued by the Commonwealth and
according to medical staff bylaws or rules, who shall document the orders in the
proper place in the medical record of the patient. The order shall include the date,
time and full signature of the person taking the order and shall be countersigned
by a practitioner within 48 hours of the order. If the practitioner is not the attending
physician, the practitioner shall be authorized by the attending physician and
shall be knowledgeable about the patient ' s condition. Countersignatures may be
received by facsimile transmission.

Observations:

Based on review of facility documents, medical records (MR) and interview with
staff (EMP), it was determined the facility failed to ensure oral orders for medication or treatment were accepted only under urgent circumstances and Practitioners countersigned within 48 hours in four of ten MR reviewed (MR3, MR8, MR9, MR10).

Findings include:

A review of facility policy "Verbal and Telephone Orders" dated April 1, 2024, revealed "POLICY: It is the policy of the UPMC that a verbal order (via telephone or in person) for medication, biological, or treatment will be accepted only under circumstances when it is impractical for such order to be entered by the ordering provider or if a delay in accepting the order could adversely affect patient care. ... Procedure F. The ordering licensed practitioner, or another licensed practitioner who is responsible for the patient's care in the hospital will countersign a verbal order as soon as practical, but no later than seven days after the order was given. For Pennsylvania Ambulatory Surgical Facilities, verbal orders must be countersigned within 48 hours."

Review of MR3 on March 20, 2025, revealed EMP6 entered a verbal order on October 14, 2024, at 2:41 pm. Interview with EMP1 on March 20, 2025, EMP1 confirmed the verbal order entered by EMP6 is a treatment routinely used for the specific procedure therefore is not an urgent circumstance that could adversely affect patient care.

Review of MR8 on March 20, 2025, revealed EMP6 entered a verbal order on December 4, 2025, at 8:00 am and EMP7 cosigned on December 15, 2024, at 8:43 am greater than 48 hours later. Interview with EMP1 on March 20, 2025, EMP1 confirmed the verbal order entered by EMP6 is a treatment routinely used for the specific procedure therefore is not an urgent circumstance that could adversely affect patient care.

Review of MR9 on March 20, 2025, revealed EMP8 entered a verbal order on December 11, 2024, at 9:36 am that was prior to start of procedure therefore not an urgent circumstance that could adversely affect patient care.

Review of MR10 on March 20, 2025, revealed EMP6 entered a verbal order on December 30, 2024, at 1:00 pm and EMP7 cosigned on January 1, 2025, at 7:41 pm greater than 48 hours later. The procedure the verbal order entered by EMP6 was completed in four (4) minutes providing Practitioner accessible time to enter the order for lab work therefore not an urgent circumstance that could adversely affect patient care.

Interview with EMP1 on March 20, 2025, EMP1 confirmed the above findings do not follow facility policy.

Plan of Correction - To be completed: 04/02/2025

The leadership and regulatory team reviewed this finding. Staff were re-educated on UPMC Policy HS-HD-CP-19 Verbal and Telephone Orders, and that per regulation, verbal orders were to only be taken under urgent circumstances. The education on policy HS-HD-CP-19 Verbal and Telephone Orders was completed on March 28th, 2025, during a staff huddle via verbal instruction and reinforced via an email distributed the same day. An attendance sheet was utilized and will be available upon request. Any staff who were not present during March 28th huddle will be educated upon their return to work and will sign the attendance sheet.

In an email distributed on April 2nd, 2025, the Medical Director reminded all practicing providers of the requirement to cosign all standing orders within 48 hours. A read receipt was required to confirm delivery.

Leadership or designee will perform 30 chart audits per month to evaluate compliance with accepting verbal orders in emergent situations only. If a verbal order is taken, the audit will assess compliance with cosigning the order within 48 hours.

Staff or providers that are noncompliant will receive additional education and coaching. Audits will be performed monthly until 100% compliance is achieved for 2 consecutive months.

Results of the audits will be reported to the Director, Surgical Services monthly for the duration of the action plan.

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 upon review of facility documents, medical records (MR), and staff interview (EMP) it was determined that the facility failed to ensure each patient was evaluated and assigned an ASA (physical status) for two of ten medical records reviewed (MR8 and MR10).

Findings include:

On March 20, 2025, review of facility policy "Admission of Patients to Peri anesthesia Department" dated July 2024, revealed "POLICY It is the policy at UPMC Pinnacle to make an immediate assessment of patient's condition, safety, and comfort needs. To orient and create a positive impression of the hospital environment and routine. PURPOSE
The purpose of this policy is to provide guidance on establishing baseline information,
beginning with discharge planning, and providing an efficient transition from the home to
the Health Care Facility.

Review of MR8 on March 20, 2025, revealed no documentation that the patient was assigned an ASA level (physical status) prior to undergoing a procedure.

Review of MR10 on March 20, 2025, revealed no documentation that the patient was assigned an ASA level (physical status) prior to undergoing a procedure.

Interview with EMP1 on March 12, 2025, EMP1 confirmed MR8 and MR10 did not have an ASA level assigned.

Plan of Correction - To be completed: 04/02/2025

The Medical Director of the Community Surgery Center was notified of the failure to document an ASA level on two of ten medical records. The Medical Director coached the provider that failed to document the required ASA in the two records identified during the survey. In addition, the Medical Director communicated with all practicing providers on April 2nd, 2025, via email as a reminder that they are required to assign an ASA level for all patients using the available template in the electronic health record. A read receipt was required to confirm delivery.

The ambulatory surgery center leader or designee will perform 30 audits per month to confirm documentation of an ASA level on all patients.

Audits will be performed monthly until 100% compliance is achieved for 2 consecutive months.

Results of the audits will be reported to the Medical Director monthly for the duration of the action plan

557.4 (a)(1-4) LICENSURE Quality Assurance & Improvement Committee:

557.4 Quality Assurance & Improvement Committee

(a) The committee shall consist of the following:
(1) A practitioner who is not an owner,
(2) A representative of administration,
(3) A registered nurse,
(4) Other health care personnel, as appropriate.

Observations:

Based on a review of facility documents and interview with staff (EMP), it was determined the facility failed to ensure the required committee members of the Quality Improvement Committee were in attendance as representatives of the Ambulatory Surgical Center (ASC) during the Quality Assurance and Process Improvement (QA PI) Committee meetings.

Findings include:

Review of facility document "QA PI Committee 1st Quarter 2024 (Jan-Feb-Mar) Committee Meeting Minutes" dated April 26, 2024, revealed a practitioner who is not an owner was not present at the quality meeting.

Review of facility document "QA PI Committee 2nd Quarter 2024 (Apr-May-Jun) Committee Meeting Minutes" dated July 31, 2024, revealed a practitioner who is not an owner was not present at the quality meeting.

Review of facility document "QA PI Committee 3rd Quarter 2024 (Jul-Aug-Sep) Committee Meeting Minutes" dated October 31, 2024, revealed a practitioner who is not an owner was not present at the quality meeting.

Review of facility document "QA PI Committee 4th Quarter 2024 (Oct-Nov-Dec) Committee Meeting Minutes" dated January 24, 2025, revealed a practitioner who is not an owner was not present at the quality meeting.

Interview with EMP1 on March 20, 2025, EMP1 confirmed the above findings.

Plan of Correction - To be completed: 03/31/2025

The leaders of the Community Surgery Center reviewed the regulation for Quality Improvement committee membership requirements, confirming that the committee membership list consisted of; a practitioner who is not an owner, a representative of administration, a registered nurse, and other health care personnel as appropriate. For future scheduled Quality Assurance and Process Improvement (QAPI) committee meetings, the meeting will not proceed without all required attendants and will be rescheduled to a later date within that quarter.

Attendance of all QAPI meetings will be recorded on all meeting minutes.

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 review of facility documents, observation, and employee (EMP)
interview it was determined the facility failed to ensure instruments/equipment are being cleaned and disinfected properly to protect the health and safety of patients according to manufacture directions.

Findings include:

On March 21, 2025, review of "Boston Scientific Pure Enzymatic Detergent Directions for use" revealed "Enzyme cleaning solution preparation: For manual, automatic, and ultrasonic applications add 1/2 fl. oz (3.9 ml per liter) of Pure Enzymatic Detergent per gallon of water.

On March 20, 2025, review of facility document "Leakage Test with Maintenance Unit (MU-1") instructions are noted for employees to "Fill line 10 Gallons, Use 2 Pumps of Detergent."

Observation on March 20, 2025, facility's Dose Tech DMS machine has a sticker on it noting "use 2 pumps."

Observation on March 20, 2025, EMP5 pushed two (2) pumps on Dose Tech DMS machine was able to fill a four (4) ounce specimen cup. One (1) less ounce required by Pure Enzymatic Detergent manufacturer directions for 10 gallons.

Interview with EMP5 on March 20, 2025, EMP5 confirmed if only one instrument is being cleaned EMP5 uses one (1) pump from a bottle of Pure Enzymatic Detergent and fill the sink with half the amount of water. EMP5 also confirmed to get half the amount of water no measuring tool is used, but the water in the sink is filled using the eyeball method.

Observation on March 20, 2025, EMP5 deposited one (1) pump of Pure Enzymatic Detergent from the bottle into specimen cup and the total amount of detergent was 1.35 ounces. The amount from the bottle would be 1.15 ounce less than the directed amount from the manufacturer if the amount of water used was measured to be five (5) gallons.

Interview with EMP1 on March 20, 2025, confirmed information above is correct.

Plan of Correction - To be completed: 03/31/2025

The leaders reviewed the manufacturer instructions for use (MIFU) for the Boston Scientific Pure Enzymatic Detergent. To support the ability to prepare the mixture accurately, an in-service for all technicians who are responsible to disinfect the instruments was held on March 27, 2025, reviewing the manufacturer's instructions for use, proper use of automatic dosing system for the detergent, and the pre-marked water volume line. In addition, the technician will measure the dose of detergent using a graduated cylinder at the beginning of each shift to verify that the automatic Dose Tech DMS pump is accurately dosing 2.5 ounces per dose. If the Dose Tech DMS pump is not dosing 2.5 ounces per dose, a graduated cylinder will be used to manually measure detergent, and a work order will be placed with Property Management to have the Dose Tech DMS equipment re-calibrated. Manual measurements will continue until confirmation of calibration by approved technician.

The ambulatory surgery center leader or designee will perform 10 audits per month to confirm compliance with accurate concentration of Boston Scientific Enzymatic Detergent to water per manufacturer instructions for use (MIFU). Any employee that is noncompliant will receive additional education and coaching.

Audits will be performed monthly until 100% compliance is achieved for 2 consecutive months.

Results of the audits will be reported to the Director, Surgical Services monthly for the duration of the action plan.

567.43 LICENSURE Ventilation System:

The ventilation system shall be inspected and maintained in accordance with the written maintenance schedule to ensure that a properly conditioned air supply meeting minimum filtration, humidity and temperature requirements is provided in critical areas such as the surgical and recovery suites under
Chapter 571 (relating to construction standards).

Observations:

Based on review of facility documents, observation, and staff interview (EMP), it was determined the facility failed to ensure the Procedure Rooms/Operating Rooms, PACU and Pre-OP rooms met the humidity level requirements per policy.

Findings include:

On March 25, 2025, review of facility policy "Humidity and Temperature Control" dated December 21, 2024, revealed "POLICY It is the policy of UPMC Pinnacle Harrisburg to maintain temperature and humidity within defined parameters in operating rooms to ensure a safe environment and reduce infection control concerns. PURPOSE: The purpose of this policy is to provide guidance regarding the management of humidity and temperature controls in operating rooms. Temperature and humidity controls shall be set according to the Ventilation Requirements for Areas Affecting Patient Care in Hospitals and Outpatient Facilities as outlined in the Guidelines for Design and Construction of Hospital and Health Care Facilities. ... IV. PROCEDURE 1. Humidity controls shall be set to maintain relative humidity ranges per Facility Guidelines Institute/American Society of Heating, Refrigerating and Air-Conditioning Engineers (FGI/ASHRE) guidelines in operating rooms. ... 3. The Facilities Maintenance Department performs computerized checks of the temperature and humidity in operating rooms daily. The report is made available to the Director of Surgical Services or their designee for review. 4. If temperature or humidity go out of range and cannot be rectified: a) The Manager of Facilities Maintenance or their designee will notify the Director of Surgical Services or their designee. b) The Facilities and Engineering staff member will generate a computerized work order, noting the corrective work performed."

On March 20, 2025, review of the 2018 FGI for Outpatient Facilities revealed "Table 8.1 Design Parameters-Outpatient Spaces...Operating room, Procedure room, Recovery Room ... Design relative humidity (k), %, 20-60."

On March 20, 2025, review of the 2022 FGI for Outpatient Facilities revealed "Table 8.1 Design Parameters-Outpatient Spaces ... Operating room, Procedure room, PACU 1...Design relative humidity (k), %, 20-60."

Review of facility "Temperature/Humidity Log" on March 20, 2025, revealed:
Operating room one (1); Operating room two (2); Procedure room one (1); Procedure room two (2); Pre-op and PACU areas humidity reading results to be below 20% December 2-8, 2024; December 12-16, 2024; December 22-24, 2024; January 1-17, 2025.

Review of procedure schedules revealed during the time the humidity levels were out of range the number of procedures were completed at the facility:
December 2, 2024 - 4
December 3, 2024- 24
December 4, 2024- 24
December 5, 2024- 26
December 6, 2024- 30
December 12, 2024- 23
December 13, 2024- 19
December 16, 2024-15
January 2, 2025- 14
January 3, 2025- 34
January 6, 2025- 19
January 7, 2025- 23
January 8, 2025- 26
January 9, 2025- 30
January 10, 2025- 23
January 13, 2025- 29
January 14, 2025- 9
January 15, 2025- 15
January 16, 2025- 14
January 17, 2025- 25

At total of 426 procedures were completed at the facility during the time the humidity level was out of range.

Request made for log of work orders completed to correct out of range humidity results. None provided.

Request for dates procedures were stopped due to out-of-range humidity results. None was provided.

Interview with EMP1 on March 20, 2025, confirmed information provided above is complete and accurate.

Plan of Correction - To be completed: 05/04/2025

The leadership and facilities team reviewed the process for monitoring temperature and humidity in the perioperative and operative areas. The team completed several corrective actions to ensure prompt awareness and response to out-of-range readings. First, the team realized that there were two methods being used to monitor temperature and humidity in the building. Going forward, the team will use the values from continuous building automated system (BAS) monitoring only. The property manager collaborated with the continuous building automated system (BAS) monitoring vendor to confirm that all required areas were monitored for temperature and humidity including the ORs, procedure rooms, PACU, and sterile storage areas. In addition, a report listing the temperature and relative humidity in each of the critical areas every day of operation to the Director of the Community Surgery Center and key stakeholders. On January 16, 2025, the humidifier was replaced. Using the algorithm contained within the policy, Humidity and Temperature Control, the appropriate staff members will take the defined action steps in response to out-of-range values.

The staff of both the UPMC Community Surgery Center and the Property Management department were educated about the policy and workflow. All education will be completed by April 4th, 2025.

Corrective actions taken by Property Management in response to the alerts will be documented in the electronic work order system.

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