Initial Comments:
This report is the result of a full State Licensure survey initiated on May 13, 2025 and concluded on May 28, 2025, at Jefferson Surgical 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:
555.22 (b) LICENSURE
Surgical Services - Preoperative Care
Name - Component - 00
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 review of facility documents, medical records (MR) and staff interview (EMP) it was determined the facility failed to inform patient of treatment consent in one of ten medical records (MR4) and failed to identify all practitioners who participated in the procedure in ten of ten medical records reviewed (MR1-10).
Findings Include:
Review of facility policy "Informed Consent" effective April 2025, revealed "Policy - It is the policy of Jefferson Surgical Center to protect the patient's right to be informed about their medical care. In accordance with the legal requirements governing informed consent, a patient's informed consent for specific medical treatments (see section A below), must be obtained prior to the time that the treatment is performed. ... Procedure A. When Written or Documented Informed Consent is Required 1. Administration of anesthesia (local, general, conscious sedation, etc.) 2. Performance of surgical procedures ... E. Documentation 2. Written Consent shall be obtained on the Jefferson Surgical Center's Procedure Consent Form, or any other form approved by the Medical Records Committee for the procedure being performed (see Section J below) and placed in the medical record prior to performance of the procedure. Where required by law or policy, applicable specific consent forms must be used (e.g., abortion, treatment of breast disease, sterilization). The attending physician or designee shall document confirmation of their explanation of the nature, material risks, benefits of and alternatives to the procedure, potential results of non-treatment, as well as the patient's understanding and consent, on the consent form. 4. The responsible attending physician or the attending physician's delegate shall identify by name any other member of the Medical Staff known to be performing the procedure on the consent form, including attending physicians within the same group practice.
Review of the Jefferson Surgical Center Anesthesia Protocol revealed "Informed consent for anesthesia will be obtained from the patient or guardian prior to surgery in accordance with JSC's informed consent policy."
On May 13, 2025, review of MR4 revealed the Anesthesia consent form did not note the type of anesthesia being provided and signed for consent.
On May 13, 2025, review of MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR9 and MR10 revealed all anesthesia practitioners who participated in the surgery were not noted on the Anesthesia consent form.
Interview with EMP1 on May 13, 2025, EMP1 confirmed the information above is accurate.
Plan of Correction:The Jefferson Surgical Center leadership team met with the anesthesia team on 5/20/25 and 6/4/2025 to discuss the citations and develop the corrective action plan. Re-education of the anesthesia providers will focus on the completion of all aspects of the consent process. Policies and protocols will be clarified as needed. The plan and initial outcomes will be reviewed at the Jefferson Surgical Center Quality Committee on 6/24/25. Monthly audits will be completed to ensure 100% compliance with consent completeness and correctness.
An email summarizing the citation and the consent documentation requirements will be developed and pushed out to the anesthesia providers. Proof of review will be collected.
Audits of 25 anesthesia consent forms will be conducted for 3 months or until 100% compliance is achieved and maintained for 3 consecutive months. Audits will be completed by JSC staff. Any consents found to be out of compliance will be sent to the JSC leadership and anesthesia team and immediate feedback will be provided to the provider. The JSC medical director and anesthesia chair are responsible for this corrective action plan. Progress toward this goal will be monitored and reported to the JSC Quality Committee and then quarterly to the Jefferson Board until goal met.
After the initial audit period, a sample of 25 anesthesia consents will be audited monthly to ensure that the improvements were sustained. The JSC team will complete the audits. Any consents found to be out of compliance will be sent to the JSC leadership and anesthesia team and immediate feedback will be provided to the provider.
561.25 LICENSURE
Distressed drugs, devices and cosmetics
Name - Component - 00
561.25 Distressed drugs, devices and cosmetics
Drugs, devices and cosmetics which are outdated, visibly deteriorated, unlabeled or inadequately labeled, recalled, discontinued or obsolete shall be identified by the licensed pharmacist or responsible practitioner and shall be disposed of in compliance with applicable Commonwealth and Federal regulations.
Observations:
Based on review of facility documents, observation, and staff interview (EMP) it was determined the facility failed to identify, document and dispose of expired medications and supplies.
Findings include:
Review of facility policy "Storage of Sterile Supplies" effective April 2024, revealed "Policy Sterile items should be stored in a manner that reduces the potential for contamination. ... Procedure 3. Stock shall be rotated so that items do not outdate. Stock is checked monthly in order to verify that no item in the sterile storage area is outdated. Stock shall be rotated so that older stock is in front and newer stock is placed in back or older stock is on the right and new stock is on the left."
Observation on May 13, 2025, Operating Room (OR) five (5) supply cart revealed: one laryngeal Aura #3 expiration date April 25, 2025; laryngeal Aura #5 expiration date April 29, 2025; EEG Snap Adult expiration date May 1, 2025.
Observation on May 13, 2025, OR 8 anesthesia cart two (2) revealed: 100 ml O. 9% Sodium Chloride expiration date April 2025; extension tubing out of bag no expiration date.
Observation on May 13, 2025, revealed open blood glucose testing strip vial in supply holding case for patient use with no open date or expiration date noted on the vial.
Observation on May 13, 2025, in Medication Room one (1) revealed: Insyte Autoguard BC Winged 24 GA x 0.75 expired February 28, 2025.
Observation on May 13, 2025, Supply cart two (2) revealed: 3M Tegaderm Transparent Film Dressing expired August 28, 2024.
Interview with EMP1 on May 13, 2025, EMP1 confirmed the information above
is accurate and does not follow facility policy.
Plan of Correction:The Jefferson Surgical Center leadership team met with the anesthesia team on 5/20/2025, 6/2/2025 and 6/4/2025 to discuss the citation and develop the corrective action plan. This action plan will address the deficiencies in our process for maintaining supplies. The plan will be reviewed at the Jefferson Surgical Center Quality Committee on 6/24/25. Audits will be conducted to ensure 100% compliance with re-stocking and removing expired items.
Education was provided to the anesthesia technicians on removing expired supplies. This was completed on 6/5/2025.
Education will be provided to the anesthesia technicians to enforce the change in practice. The anesthesia supervisor will doublecheck the supplies to ensure no outdated supplies are present. Audits will be conducted by the supervisor for 3 months or until 100% compliance is achieved and maintained for 3 consecutive months. The medical director and anesthesia chair are responsible for this corrective action plan. Progress toward this goal will be monitored and reported to the JSC Quality Committee and then quarterly to the Jefferson Board until the goal is met.
The anesthesia technician supervisor will be responsible for co-signing monthly audits on an ongoing basis and will provide real-time feedback to the staff. This will reinforce the initial education and support the continuation of these practices.
567.1 LICENSURE
Principle
Name - Component - 00
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 policy, observations, and interview with staff (EMP), it was determined that the facility failed to follow their policy and procedures for hand hygiene and exposure control program.
Findings include:
Review of facility "Infection Control Plan" approved June 27, 2023, revealed "I. Purpose: The purpose of the Infection Prevention and Control (IP&C) Plan of the Jefferson Surgical Center (referred to as JSC) is to identify and reduce the risks for acquisition and transmission of infectious agents among patients, staff, providers, contractors, students, visitors, and volunteers. ... 1. Hand hygiene a) The JSC follows the Center for Disease Control ' s (CDC) Hand Hygiene Guideline which references the World Health Organization (WHO) " Five Moments of Hand Hygiene " b) Hand hygiene opportunities: i. Before touching a patient: i. At the beginning of work ii. Upon entry into the patient care areas iii. Upon entry to the patient ' s room iv. Before patient contact, including dry skin contact v. Before contact with a wound vi. Before donning gloves when providing direct patient care (wearing gloves does not substitute for hand hygiene) ii. Before clean/aseptic procedure: i. Before handling sterile or clean supplies including medications ii. When inserting indwelling urinary catheters or other invasive devices that do not require a surgical procedure. iii.After body fluid exposure: i.After contact with wounds ii. When moving from a contaminated body site to a clean body site during patient care iii. Between completing a "dirty" task and starting a clean task (e.g. emptying the urine Foley bag and doing a BP check) iv. After removing a dirty dressing and before applying a new dressing v. After contact with patient's body substances vi. After handling equipment, supplies, or linen contaminated with body substances vii. After removing other personal protective equipment including gloves iv.After touching a patient: i. After removing gloves ii. Upon exiting the patient room v. After touching a patient's surroundings: i. After touching any part of the patient care environment (bed rail, overhead table, blood pressure cuff) ii. Exiting the patient room iii. Before leaving the unit vi. Additional hand hygiene indicators: i. Before preparing food ii. After using the restroom iii. After touching your face, nose or hair or personal device (e.g. pager, phone) iv. Additional hand hygiene may be required if hands become contaminated with blood or body fluids, or when caring for a patient on Enteric Isolation."
Observation in operating room (OR) one (1) on May 13, 2025, EMP2 was using personal device in sterile field, after using personal device did not perform hand hygiene prior to touching patient. EMP2 left sterile field to chart on wall mounted computer and computer at desk without removing gloves or performing hand hygiene. While wearing the same gloves after charting outside the sterile field EMP2 reentered the sterile field touch sterile equipment, performed two procedures on the patient and did not change gloves, nor perform hand hygiene. EMP2 was observed removing gloves, did not perform hand hygiene and touched the patient before leaving OR1 to perform hand hygiene.
Observation in OR1 on May 13, 2025, EMP3 was assisting with sterile supplies removed gloves without performing hand hygiene and began charting at desk.
Interview with EMP1 on May 28, 2025, EMP1 confirmed all information submitted is complete and accurate.
_____________
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 guidelines.
Findings include:
Review of facility document "Intercept Detergent" IFU dated February 22, 2023, revealed "Directions of Use: For cleaning of fully immersible endoscopes, related accessories, surgical instruments, and other apparatus where blood, mucus, protein or other hard to remove soils are encountered, use INTERCEPT Detergent at 1/3 oz/gal of water (0.25% use concentration) with one full stroke of the hand-pump (1 oz.) to three gallons of water. For best manual results, mix INTERCEPT Detergent with cool to warm water (20(68and ensure a minimum contact time of (1) one minute. Rinse all surfaces and internal channels thoroughly with water."
Review of "Karl Storz rhino-laryngoscope Instructions for Use (IFU)" revealed "Complete cleaning of the patient-used flexible HD video rhino-laryngoscope should be started within 2 hours of the bedside pre-cleaning. ... When preparing and using the cleaning solutions, follow the manufacturer ' s instructions for proper solution concentration and temperature. ... 1. Disinfect the cleaning sink or basin according to your healthcare facility's recommended method. 2. Rinse the sink or basin thoroughly with tap water to remove all of the disinfectant chemicals. 3. Prepare the diluted mild/neutral pH enzymatic cleaning solution (e.g. Enzol) in the sink or basin. 4. Immerse the flexible HD video rhino-laryngoscope completely in the enzymatic cleaning solution."
Observation on May 13, 2025, graduated cylinder with enzymatic detergent located at each sink where instruments are cleaned.
Interview with EMP4 on May 13, 2025, EMP4 confirmed the enzymatic detergent in the graduated cylinder is used to clean the rhino-laryngoscope. EMP4 also confirmed one notch of enzymatic detergent with five gallons of water was used to clean the rhino-laryngoscope. The amount of detergent in one notch was requested, the amount was not provided.
Interview with EMP5 on May 13, 2025, EMP5 confirmed they clean rhino-laryngoscopes using the enzymatic detergent in the graduated cylinder. EMP5 denied knowing the amount of enzymatic detergent required by manufacturer guidelines to clean the rhino-laryngoscopes.
Interview with EMP1 on May 28, 2025, EMP1 confirmed all information submitted is complete and accurate.
Plan of Correction:The Jefferson Surgical Center leadership team met on 5/21/25 to discuss the citation and develop the corrective action plan. OR staff meeting was held on 6/5/2025 to review proper hand hygiene protocols. All nursing staff have been signed off on this re-education. The plan will be reviewed at the Jefferson Surgical Center Quality Committee on 6/24/25. Audits will be conducted to ensure 100% compliance with weekly audits.
Education was provided to the nursing staff. This was completed on 6/5/2025 at the departmental staff meeting. All individuals have signed off on the process. Education will also be provided to the ENT residents with a sign-off.
Twenty-five observations will be conducted for 3 consecutive months by a trained observer until 100% compliance is achieved and maintained for 3 consecutive months. Audits will be completed by JSC staff and feedback will be provided in real-time to individuals who are found to be out of compliance and fail to follow proper hand hygiene procedures. Director of nursing will be responsible for this plan. Progress toward this goal will be monitored and reported to the JSC Quality Committee and then quarterly to the Jefferson Board until the goal is met.
After the initial goal is met, ten observations will be conducted quarterly for the rest of the year.
With regard to the rhino-laryngoscopes, the sterile processing leadership team met on 6/2/2025 to discuss the citation and develop the corrective action plan. SPD staff meeting was held on 6/6/2025 to review citations and discuss scheduled in-services. All staff will be signed off on this re-education. The plan will be reviewed at the Jefferson Surgical Center Quality Committee on 6/24/25. Audits will be conducted to ensure 100% compliance with weekly audits.
Education will be provided to the SPD staff related to the cleaning of rhinoscopes and the proper use of the "scope buddy". In-services with the vendors for re-education will be scheduled and completed prior to 7/28/2025. All individuals will be signed off on receiving the education and performing the process.
Ten physical observations of the SPD staff cleaning the rhinoscopes will be conducted monthly for 3 consecutive months or until 100% compliance is achieved and maintained for 3 consecutive months. Observations will be completed by SPD leadership team, and any staff found to be non-compliant with the protocols will receive immediate feedback. The Director of nursing will be responsible for this plan. Progress toward this goal will be monitored and reported to the JSC Quality Committee and then quarterly to the Jefferson Board.
After the initial audits are complete, the SPD leadership team will continue to complete audits for the rest of the year.
567.41 LICENSURE
MAINTENANCE SERVICE - Principle
Name - Component - 00
567.41 Principle
The ASF shall be equipped, operated and maintained to sustain its
safe and sanitary characteristics and to minimize health hazards in the ASF
for the protection of patients and employes.
Observations:
Based on review of the Pennsylvania Code for Labor and Industry, observation, and interview with staff (EMP), it was determined the facility failed to ensure the autoclaves used for sterilization of surgical supplies was inspected.
Findings include:
Review on May 13, 2025, of the Pennsylvania Code for Labor and Industry, 34 3a. revealed 3a.168. Autoclaves and quick opening vessels. (a) An inspector shall inspect autoclaves and quick opening vessels with close examination of all moving parts, locking devices, pins and interlocking devices, in accordance with ANSI/NB 23. (b) An autoclave and quick opening vessel must have interlocking systems to prevent charging the vessel until all openings and locking devices are fully in place. (c) A pressure-relieving device must be sized in accordance with the data plate for pressure. The capacity must be based on the pressure and pipe size or the total BTU valve of the boiler. (d) Inspection of autoclaves and quick opening vessels shall be performed in accordance with 3a.111(8) (relating to
field inspections).
Observation on May 13, 2025, of the facility's sterilization area revealed three Steris Steam Sterilizer autoclaves used for sterilization of surgical supplies.
A request was made on May 13, 2025, for documentation of the current boiler/pressure vessel inspections for all autoclaves. None was provided.
Interview with EMP1 on May 13, 2025, EMP1 confirmed the facility does not have certification of operation certificates for the three autoclaves at the facility.
Plan of Correction:The Jefferson Surgical Center leadership met on 5/14/25 with the facilities leadership team to discuss next steps to obtaining the certificate of operations for the autoclave. JSC leadership team met on 5/21/25 to discuss the citation and develop the corrective action plan. The plan is to obtain the certification of operations from the insurance broker. Inspection is scheduled for 6/9/2025. This corrective action plan will be reviewed at the Quality Committee Meeting on 6/24/25.
Any new autoclave or other pressure vessels will have certificate of operations prior to use.
All new autoclaves or other pressure vessels will be discussed at the quality meeting. This citation and completion of the certification will be reported to the JSC Quality Committee and then to the Jefferson Board.
For the current autoclave, the leadership team will ensure that the certificate is obtained and displayed as soon as possible. Now that there is awareness of this requirement, the JSC leadership team will ensure that new inspections for new equipment are completed prior to use and that the certificate is displayed on the unit.
567.43 LICENSURE
Ventilation System
Name - Component - 00
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 PACU and Pre-OP rooms humidity level are inspected and meet the humidity level requirements per policy.
Findings include:
Review of facility policy "Temperature, Pressure and Relative Humidity at Jefferson Surgical Center" effective March 2024, revealed "Purpose: The key is to provide a safe environment for patients and staff at Jefferson Surgical Center (JSC), as well as the proper operation of the Heating Ventilation and Air Conditioning (HVAC) system. ... Relative humidity should be maintained at a maximum of 60% within the perioperative suite, including the Operating Room, Recovery area, and Instrument storage area. ...A continuous, electronic monitoring system is used to monitor temperature, relative humidity (RH), and pressure. If the temperature/RH/pressure is out of range, the facilities team will investigate and take
action to return to range. Facilities will notify the charge nurse or director of nursing and infection control. Communication may include text, phone call and/or email depending upon hours of operation. Depending on the severity of the findings by the above team, the temperature and humidity report form (attachment 1) will be completed. It will then be determined whether or not operation should be halted until the issue is resolved. The facility is encouraged to evaluate these infection risks in determining the established facility RH range. Areas of infection risk that are associated with low or high RH for the facilities team."
On May 13, 2025, review of facility temperature and humidity logs it was noted the Pre-Op and PACU areas did not have humidity monitoring results. Results for humidity levels in the Pre-Op and PACU areas was requested, none was received.
Interview with EMP1 on May 13, 2025, EMP1 confirmed the facility does not monitor the Pre-Op or PACU areas for humidity levels per facility policy.
Plan of Correction:The Jefferson Surgical Center leadership met on 5/14/25 and 6/5/2025 with the facilities leadership team to discuss the survey and review the citation for temperature and humidity not being monitored in pre- op and PACU. The plan is to monitor these areas of the unit. This corrective action plan will be reviewed at the Quality Committee Meeting on 6/24/25.
Sensors will be installed in PACU/Preop. The control room operators in the Gibbon building will continue to monitor the building control system that includes the temperature in the Honickman perioperative areas. Humidity sensors will be installed and connected to the BAS (Building automation System). Both temperature and humidity will be set up to alarm when they go out of range. Facilities operations will respond immediately through building controls and if that response is not sufficient, then a mechanic will be dispatched to check the equipment. A work order will be created to document the issue and the resolution. If necessary, temporary sensors will be installed until the larger system build can be completed.
The facilities team will review the BAS trending reports monthly to ensure that any out-of-range metrics were addressed promptly and to look for any trends of concern This citation, the actions taken and the results will be reported to the JSC Quality Committee for 3 consecutive months or until there are 3 consecutive months with values in range or addressed appropriately when out of range. and quarterly to the Jefferson Board for the remainder of this year.
The facilities leadership team will continue to review the reports on a monthly basis and respond to any trends of concern.
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