Pennsylvania Department of Health
SUSQUEHANNA VALLEY SURGERY CENTER, L.L.C.
Patient Care Inspection Results

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Minimal Citation - No Harm Minimal Harm Actual Harm Serious Harm
SUSQUEHANNA VALLEY SURGERY CENTER, L.L.C.
Inspection Results For:

There are  38 surveys for this facility. Please select a date to view the survey results.

Surveys don't appear on this website until at least 41 days have elapsed since the exit date of the survey.
SUSQUEHANNA VALLEY SURGERY CENTER, L.L.C. - Inspection Results Scope of Citation
Number of Residents Affected
By Deficient Practice
Initial comments:

This report is the result of a full Medicare recertification survey conducted on February 19, 2025, at Susquehanna Valley Surgery Center. It was determined the facility was in substantial compliance with the requirements of 42 CFR, Title 42, Part 416 - Conditions for Coverage for Ambulatory Surgical Centers.







 Plan of Correction:


Initial comments:

This report is the result of a full State Licensure survey initiated on February 19, 2025, and concluded on February 24, 2025, at Susquehanna Valley Surgery 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:


416.44(a)(1) STANDARD PHYSICAL ENVIRONMENT:Not Assigned
The ASC must provide a functional and sanitary environment for the provision of surgical services.
Each operating room must be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area.

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, Post-anesthesia Care Unit (PACU) and Pre-Operating (Pre-Op) rooms met the humidity level requirements per policy.

Findings include:

On February 19, 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 February 19, 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 February 19, 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."

On February 19, 2025, review of facility Temperature and Humidity log revealed on July 31, 2024, OR2 humidity level was 62%.

On February 19, 2025, review of facility Temperature and Humidity log revealed on August 1, 2024, OR2 humidity level was 68%; OR3 humidity level was 61%.

On February 19, 2025, review of facility Temperature and Humidity log revealed on August 2, 2024, OR2 humidity level was 68%; OR3 humidity level was 61%.

On February 19, 2025, review of facility Temperature and Humidity log revealed on August 5, 2024, OR2 humidity level was 61%.

On February 19, 2025, review of facility Temperature and Humidity log revealed on August 7, 2024, OR1 humidity level was 61%; OR2 humidity level was 61%.

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

Request made for humidity readings in Pre-Op and PACU areas none provided.

Request made for documentation on timeline when readings will be rechecked, and determination will be made on if procedures will be continued or paused for OR's that have inappropriate temperature or humidity levels. None provided.

Review of facility procedure schedule on February 24, 2025, revealed:

On July 31, 2024, 12 procedures were performed in OR2 during times the humidity was out of range of appropriate levels.

On August 1, 2024, four (4) procedures were performed in OR2 during times the humidity was out of range of appropriate levels.

On August 1, 2024, seven (7) procedures were performed in OR3 during times the humidity was out of range of appropriate levels.

On August 2, 2024, one (1) procedure were performed in OR2 during times the humidity was out of range of appropriate levels.

On August 2, 2024, five (5) procedures were performed in OR3 during times the humidity was out of range of appropriate levels.

On August 7, 2024, four (4) procedures were performed in OR1 during times the humidity was out of range of appropriate levels.

Interview with EMP1 on February 24, 2025, confirmed the information provided above is complete and accurate.












 Plan of Correction - To be completed: 04/15/2025

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 Manager of Facilities collaborated with the continuous building automated system (BAS) monitoring vendor to reconfigure the temperature targets and alarm limits to align with the ASHRAE 170-2008 guidelines. This reconfiguration was completed on February 28, 2025. In addition, effective February 15, 2025, a report listing the temperature and relative humidity in each of the operating rooms and sterile storage room is being sent every day of operation to the Director of the UPMC Susquehanna Valley Surgery Center and key stakeholders. Lastly, effective March 4, 2025, the ASF team started to perform manual readings, using a calibrated device, to record the temperature and humidity in the procedure rooms, preop area, and postop area each day of operation. These manual measurements will transition to an electronic solution after the necessary hardware is installed. 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 Susquehanna Valley Surgery Center and the Facilities department were educated about the policy and workflow. All education will be completed by March 6, 2025.

Facilities staff are notified electronically with any out-of-range readings for areas that are continuously monitored. The ASC staff will call Facilities with any out-of-range readings noted in the areas that are being manually monitored. Any corrective actions taken by Facilities in response to the alerts will be documented in the electronic work order system.

416.48(a) STANDARD ADMINISTRATION OF DRUGS:Not Assigned
Drugs must be prepared and administered according to established policies and acceptable standards of practice.




Observations:

Based on a review of facility documents, observation, and staff interview (EMP), it was determined the facility failed to ensure multi-dose vials were stored properly.

Findings Include:

On February 19, 2025, review of facility policy "Medication Administration in the Operating Room" dated December 2, 2024, revealed "POLICY -It is the policy of UPMC to provide safe patient care by implementing and evaluating safe medication management practices specific to the perioperative setting. PURPOSE -To provide direction to perioperative nursing personnel to develop, implement, and evaluate safe medication management practices when caring for the patients undergoing surgeries or invasive procedures. Medication Safety 4. Medications in the OR are to be used only for one patient. Opened but unused
medications must be discarded after each patient leaves the operating room. 5. Multidose medications, if used due to medication shortages or lack of availability of the unit-dose form, should not be used for more than one patient for injection or on the sterile field. 6. Multidose medications should not be stored in the immediate area where direct patient contact occurs."

Observation of operating room (OR) five (5) on February 19, 2025, revealed an opened multi-dose vial of Labetalol 20ml/100mg was stored in the anesthesia cart with an opened date of February 10, 2025.

Interview with EMP1 on February 19, 2025, EMP1 confirmed the policy does not allow for multi-dose vials to be stored in the anesthesia cart.









 Plan of Correction - To be completed: 04/15/2025

The UPMC Policy HS-OR0009 Medication Administration in the Operating Room that includes guidelines for handling medication in the operating room was reviewed with the anesthesia providers on March 5, 2025. Specifically, providers were reminded that unused medications, including multidose containers, must be discarded after the patient leaves the operating room. In addition, multidose medication cannot be stored in the immediate area where direct patient contact occurs.

The ambulatory surgery center leader or designee will perform ten (10) monthly random audits to validate that all open medications were discarded at the end of the surgical procedure. Any employee that is noncompliant will receive additional education and coaching.

Audits will be performed monthly until 100% compliance is achieved for 3 consecutive months.

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

416.51(a) STANDARD SANITARY ENVIRONMENT:Not Assigned
The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.


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:

On February 19. 2025, review of facility policy "Hand Hygiene" dated October 4, 2024, revealed "POLICY It is the policy of UPMC to reduce the risk of transmission of pathogens and incidence of healthcare acquired infections by promoting and monitoring compliance with hand hygiene guidelines using guidance from the World Health Organization ' s (WHO), Your
Five Moments for Hand Hygiene and the Center for Disease Control and Prevention
(CDC). PURPOSE Effective hand hygiene removes transient microorganisms, dirt and organic material from the hands and decreases the risk of cross contamination to patients, patient care equipment and the environment. Hand hygiene is the single most important strategy to reduce the risk of transmitting organisms from one person to another or from one site to another on the same patient. Cleaning hands promptly and thoroughly between patient contact and after contact with blood, body fluids, secretions, excretions, equipment, and potentially contaminated surfaces is an important strategy for preventing healthcare associated and occupational infections. DEFINITIONS Direct Patient Contact refers to anyone who has contact with a patient and/or their environment. Indirect Patient Contact refers to anyone who has contact with a common area or equipment which patients may have had contact (corridors, waiting areas in ancillary areas, common areas, etc.) ... WHO Patient Zone - contains the patient and his/her immediate surroundings. This typically includes the intact skin of the patient and all inanimate surfaces that are touched by or in direct physical contact with the patient such as the bed rails, bedside table, bed linen, infusion tubing and other medical equipment. It further contains surfaces frequently touched by HCWs while caring for the patient such as monitors, knobs and buttons, trash and linen bins, and other 'high frequency' touch surfaces. PROCEDURES Indications for hand hygiene: In most cases, either an alcohol-based hand sanitizer or handwashing with soap and water may be used for hand hygiene. Hand hygiene is performed when entering and exiting a patient room (area) along with the World Health Organization's (WHO) five moments of hand hygiene. The five moments are:1. Before touching a patient (or patient zone) 2. Before clean/aseptic procedure (critical sites) 3. After body fluid exposure risk 4. After touching a patient 5. After touching patient surroundings (patient zone) ... Gloves - GLOVES DO NOT REPLACE THE NEED FOR HAND HYGIENE. Hand hygiene must be performed prior to donning gloves when gloves are being worn for interaction with a patient and/or patient zone. Hand hygiene must be performed after removing gloves when gloves are being worn for interaction with a patient and/or patient zone and patient surroundings. Remove gloves, clean hands and don a fresh pair of gloves when caring for a patient that requires moving from a dirty site to a clean site. i.e. after caring for a draining wound to changing a central line dressing. Do not wear the same pair of gloves between patients."

1. Observation on February 19, 2025, EMP2, in the preoperative area retrieved patient from waiting room area without performing hand hygiene prior to contact with patient. EMP2 weighed patient, escorted patient to Pre-Op Bay 7 (G) assisted patient in getting set up on stretcher provided patient instructions and everything needed for changing, touched stretcher side rails, and items in bay area. EMP2 closed bay curtain leaving patient to dress and proceeded to document. EMP2 did not perform hand hygiene after contact with patient/patient zone with weighing, assisting patient in bay or closing bay curtain. After documenting EMP2 went back into bay area to assist patient did not perform hand hygiene prior to coming in contact with patient when returning into bay.

2. Observation on February 19, 2025, EMP3 entered bay pre-op bay 7 (G) to assist EMP2 with IV insertion. EMP3 did not perform hand hygiene before donning gloves and coming in direct contact with patient skin.

3. Observation on February 19, 2025, EMP4 entered bay 3 (C) was in direct contact with patient, stretcher, items in bay, patient shoes and then came out of area to chart. EMP4 was not observed performing hand hygiene prior to entering bay area nor performing hand hygiene after direct contact with patient/patient zone prior to charting outside of bay.

4. Observation on February 19, 2025, EMP4 donned gloves at pre-op nurses station to prepare medication. EMP4 did not perform hand hygiene prior to donning or when doffing gloves. EMP4 donned gloves and entered bay 3 (C) to clean surgical site with betadine sponge. EMP4 did not perform hand hygiene prior to donning gloves nor when doffing gloves after cleaning patient skin.

5. Observation on February 19, 2025, EMP5 entered PACU bay 10 came in direct contact with patient post-surgical site skin area. EMP5 did not perform hand hygiene prior to contact with patient. EMP5 left bay 10 after coming in direct contact with patient skin and opened supply cabinet retrieved a supply used for multiple patients. EMP5 did not perform hand hygiene after coming in contact with patient/patient zone prior to getting clean supplies. EMP5 returned to bay 10 came in direct contact with patient skin/patient zone then left bay to chart at nurse ' s station. EMP5 did not perform hand hygiene prior to direct contact with patient nor after contact with patient skin/patient zone.

Interview with EMP1 on February 19, 2025, EMP1 confirmed hand hygiene policy was not followed by EMP2, EMP3, EMP4 or EMP5.

-------------

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:

On February 19, 2025, review of "Bio-Zyme G Directions for use" reveal "Enzyme cleaning solution preparation: For manual, automatic, and ultrasonic applications add 1/2 fl. oz (3.9 ml per liter) of Bio-Zyme G per gallon of water."

Interview with EMP6 on February 19, 2025, EMP6 confirmed the facility uses two (2) pumps of the Bio-Zyme G enzymatic cleaner in five gallons of water. EMP6 also confirmed to get five gallons of water no measuring tool is used, but the water in the sink is filled using the eyeball method.

Observation noted on February 19, 2025, EMP6 deposited two pumps of Bio-Zyme G enzymatic cleaner into a measuring cup totaling two ounces of cleaner. Per manufacturer guidelines five gallons of water should have 2 1/2 fl oz.

Interview with EMP1 on February 19, 2025, EMP1 confirmed the facility was not adhering to the manufacturer's guidelines.

-------------

Based on a review of facility policy, observations, and interview with staff (EMP), it was determined that the facility failed to follow the recognized standards of infection control to prevent cross-infection and a clean environment for patient care.

On February 19, 2025, review of facility policy "Dress Code" dated July 30.2024, revealed
"POLICY- It is the policy of UPMC that personal appearance reflects overall cleanliness, good grooming and hygiene, and professional identity. These guidelines were developed in
careful consideration of employee and patient safety, infection control and public image.
Exceptions to this policy may be made based on verified medical and religious needs. ... D. Guidelines for Staff Members with Direct Patient Care and/or Uniform Requirements ... 4. In consideration for infection control and patient safety: ... f) Artificial nails are prohibited for staff who have direct patient contact, who prepare instruments for sterile procedures or who prepare sterile pharmaceuticals, or who have contact with a patient's environment.
The definition of artificial fingernails includes, but is not limited to, acrylic nails, all overlays, tips, bonding, extensions, tapes, inlays, and wraps."

1) On February 19, 2025, observation of EMP2 fingernails it was noted EMP2 had colored artificial nail bonding.

2) On February 19, 2025, observation of EMP7 fingernails it was noted EMP7 had colored artificial nail bonding with spacing between end of product and cuticle where the nail had grown out.

Interview with EMP1 on February 19, 2025, EMP1 confirmed the above findings.







 Plan of Correction - To be completed: 04/15/2025

Immediately after the survey, EMP2, EMP3, EMP4, & EMP5 that were identified as being noncompliant, were counseled on expectations related to proper nail grooming per dress code policy.

The UPMC policy that addresses hand hygiene was reviewed with staff during morning huddles held on February 24 – March 7, 2025, and will be reinforced during the staff meeting scheduled for March 6, 2025. Specifically, per system policy HS-IC0615 Hand Hygiene, the triggers to perform hand hygiene were highlighted including the following: when entering or exiting a patient room (area), before donning and after doffing gloves, before touching a patient (or patient zone), before clean/aseptic procedure (critical sites), after body fluid exposure risk, after touching a patient, and after touching patient surroundings (patient zone).

Immediately after the survey, EMP6 who was identified as being noncompliant was counseled on expectations related to the proper cleaning solution preparation as determined by the product MIFU.
The leaders reviewed the manufacturer instructions for use (MIFU) for the Bio-Zyme G Enzymatic Cleaner.
To support the ability to prepare the mixture accurately, a graduated cylinder was purchased to measure the enzymatic cleaner concentrate, and a water level indicator was installed in the sink to accurately measure the volume of water. An informational sign was posted in CSSD providing directions for preparing the solution. An in-service for all technicians who are responsible to disinfect the instruments was held on March 5, 2025, to review the new process.


Immediately after the survey, EMP2 & EMP7 that were identified as being noncompliant were counseled on expectations related to proper nail grooming per dress code policy
The UPMC policies that define operating room dress code were reviewed with staff during morning huddles held on February 24 – March 7, 2025, and will be reinforced during the staff meeting scheduled for March 6, 2025. As stated in policy, HS-OR0010 Dress Code in the Operating Room and Sterile Processing Department, scrubbed personnel should not wear nail polish. The UPMC system policy HS-HR0714 Dress Code prohibits artificial nails for staff who have direct patient contact, who prepare instruments for sterile procedures or who prepare sterile pharmaceuticals, or who have contact with a patient's environment. The definition of artificial fingernails includes, but is not limited to, acrylic nails, all overlays, tips, bondings, extensions, tapes, inlays, and wraps.

The ambulatory surgery center leader or designee will perform 30 audits per month of staff interactions with patients to evaluate compliance with the hand hygiene guidelines. Any employee that is noncompliant will receive additional education and coaching.

The ambulatory surgery center leader or designee will perform 10 audits per month to confirm compliance with preparing the Bio-Zyme G enzymatic cleaner mixture per manufacturer instructions for use (MIFU). Any employee that is noncompliant will receive additional education and coaching.

The ambulatory surgery center leader or designee will perform 30 audits of surgical attire per month. Any employee that is noncompliant will receive additional education and coaching.

Audits will be performed monthly until 100% compliance is achieved for 3 consecutive months.

Results of the audits will be reported to the Director, Surgical Services monthly for the duration of the action plan.
555.13 LICENSURE Administration of Drugs:State only Deficiency.
555.13 Administration of drugs

Drugs shall be administered only upon the proper order of a practitioner acting within the scope of the practitioner's license and authorized according to medical staff bylaws, rules and regulations. Drugs shall be administered directly by a practitioner qualified according to medical staff bylaws, rules and regulations or by a professional nurse or by a licensed practical nurse with pharmacy training. Physician assistants and certified registered nurse practitioners shall be permitted to administer drugs within their authorized scope of practice. Further policies on the administration of drugs shall be established by the medical staff in conjunction with pharmaceutical services or personnel.
Observations:

Based on a review of facility documents, observation, and staff interview (EMP), it Based on a review of facility documents, observation, and staff interview (EMP), it was determined the facility failed to ensure multi-dose vials were stored properly.

Findings Include:

On February 19, 2025, review of facility policy "Medication Administration in the Operating Room" dated December 2, 2024, revealed "POLICY -It is the policy of UPMC to provide safe patient care by implementing and evaluating safe medication management practices specific to the perioperative setting. PURPOSE -To provide direction to perioperative nursing personnel to develop, implement, and evaluate safe medication management practices when caring for the patients undergoing surgeries or invasive procedures. Medication Safety 4. Medications in the OR are to be used only for one patient. Opened but unused
medications must be discarded after each patient leaves the operating room. 5. Multidose medications, if used due to medication shortages or lack of availability of the unit-dose form, should not be used for more than one patient for injection or on the sterile field. 6. Multidose medications should not be stored in the immediate area where direct patient contact occurs."

Observation of operating room (OR) five (5) on February 19, 2025, revealed an opened multi-dose vial of Labetalol 20ml/100mg was stored in the anesthesia cart with an opened date of February 10, 2025.

Interview with EMP1 on February 19, 2025, EMP1 confirmed the policy does not allow for multi-dose vials to be stored in the anesthesia cart.







 Plan of Correction - To be completed: 03/17/2025


The UPMC Policy HS-OR0009 Medication Administration in the Operating Room that includes guidelines for handling medication in the operating room was reviewed with the anesthesia providers on March 5, 2025.

Specifically, anesthesia providers and clinical staff members were reminded that unused medications, including multidose containers, must be discarded after the patient leaves the operating room and that multidose medication cannot be stored in the immediate area where direct patient contact occurs. The policy was reviewed with all anesthesia providers.

The ambulatory surgery center leader or designee will perform ten (10) monthly random audits to validate that all open medications were discarded at the end of the surgical procedure. Any employee that is noncompliant will receive additional education and coaching.

Audits will be performed monthly until 100% compliance is achieved for 3 consecutive months.

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

561.25 LICENSURE Distressed drugs, devices and cosmetics:State only Deficiency.
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:

On February 19, 2025, review of facility document "McKesson True Metrix Pro Professional Monitoring Blood Glucose Test Strips" Instructions For Use: ... Caring For Strips ... Write date opened on test strip vial label when removing the first test strip. Discard all unused test strips in vial after either date printed on the test strip vial label or 4 months after date opened, whichever comes first. Using test strips past these dates may cause inaccurate results."

Observation on February 19, 2025, of Blood Glucose Test Strip vial revealed no opened date noted.

On February 19, 2025, review of facility "Blood Glucose Control Test log" revealed no documentation noted of date Test Strip opened.

Interview with EMP1 on February 19, 2025, confirmed the facility blood glucose test strip vial did not follow manufacturer instructions.








 Plan of Correction - To be completed: 04/15/2025

The ambulatory center leadership reviewed the manufacturer's instructions for use (MIFU) for the McKesson Glucose Meter. Leadership updated the current policy, Bedside Blood Glucose Monitoring, on March 4, 2025, to match the MIFU. Specifically, the policy directs staff to write the date on the test strip vial when opening a new container. All unused test strips in the vial must be discarded after either the expiration date printed on the test strip vial label or 4 months after the date the container was opened, whichever comes first. A task to check the expiration date of the glucose test strips was added to the daily charge nurse checklist. Staff were educated about the updated policy during morning huddles held on February 24 – March 7, 2025, and will be reinforced during the staff meeting scheduled for March 6, 2025.

The ambulatory surgery center leader or designee will perform random weekly audits to ensure compliance with proper dating of any open glucose test strips. Any employee that is noncompliant will receive additional education and coaching.

Audits will be performed monthly until 100% compliance is achieved for 3 consecutive months.

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

567.1 LICENSURE Principle:State only Deficiency.
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:

On February 19. 2025, review of facility policy "Hand Hygiene" dated October 4, 2024, revealed "POLICY It is the policy of UPMC to reduce the risk of transmission of pathogens and incidence of healthcare acquired infections by promoting and monitoring compliance with hand hygiene guidelines using guidance from the World Health Organization ' s (WHO), Your
Five Moments for Hand Hygiene and the Center for Disease Control and Prevention
(CDC). PURPOSE Effective hand hygiene removes transient microorganisms, dirt and organic material from the hands and decreases the risk of cross contamination to patients, patient care equipment and the environment. Hand hygiene is the single most important strategy to reduce the risk of transmitting organisms from one person to another or from one site to another on the same patient. Cleaning hands promptly and thoroughly between patient contact and after contact with blood, body fluids, secretions, excretions, equipment, and potentially contaminated surfaces is an important strategy for preventing healthcare associated and occupational infections. DEFINITIONS Direct Patient Contact refers to anyone who has contact with a patient and/or their environment. Indirect Patient Contact refers to anyone who has contact with a common area or equipment which patients may have had contact (corridors, waiting areas in ancillary areas, common areas, etc.) ... WHO Patient Zone - contains the patient and his/her immediate surroundings. This typically includes the intact skin of the patient and all inanimate surfaces that are touched by or in direct physical contact with the patient such as the bed rails, bedside table, bed linen, infusion tubing and other medical equipment. It further contains surfaces frequently touched by HCWs while caring for the patient such as monitors, knobs and buttons, trash and linen bins, and other 'high frequency ' touch surfaces. PROCEDURES Indications for hand hygiene: In most cases, either an alcohol-based hand sanitizer or handwashing with soap and water may be used for hand hygiene. Hand hygiene is performed when entering and exiting a patient room (area) along with the World Health Organization's (WHO) five moments of hand hygiene. The five moments are:1. Before touching a patient (or patient zone) 2. Before clean/aseptic procedure (critical sites) 3. After body fluid exposure risk 4. After touching a patient 5. After touching patient surroundings (patient zone) ... Gloves - GLOVES DO NOT REPLACE THE NEED FOR HAND HYGIENE. Hand hygiene must be performed prior to donning gloves when gloves are being worn for interaction with a patient and/or patient zone. Hand hygiene must be performed after removing gloves when gloves are being worn for interaction with a patient and/or patient zone and patient surroundings. Remove gloves, clean hands and don a fresh pair of gloves when caring for a patient that requires moving from a dirty site to a clean site. i.e. after caring for a draining wound to changing a central line dressing. Do not wear the same pair of gloves between patients."

1. Observation on February 19, 2025, EMP2, in the preoperative area retrieved patient from waiting room area without performing hand hygiene prior to contact with patient. EMP2 weighed patient, escorted patient to Pre-Op Bay 7 (G) assisted patient in getting set up on stretcher provided patient instructions and everything needed for changing, touched stretcher side rails, and items in bay area. EMP2 closed bay curtain leaving patient to dress and proceeded to document. EMP2 did not perform hand hygiene after contact with patient/patient zone with weighing, assisting patient in bay or closing bay curtain. After documenting EMP2 went back into bay area to assist patient did not perform hand hygiene prior to coming in contact with patient when returning into bay.

2. Observation on February 19, 2025, EMP3 entered bay pre-op bay 7 (G) to assist EMP2 with IV insertion. EMP3 did not perform hand hygiene before donning gloves and coming in direct contact with patient skin.

3. Observation on February 19, 2025, EMP4 entered bay 3 (C) was in direct contact with patient, stretcher, items in bay, patient shoes and then came out of area to chart. EMP4 was not observed performing hand hygiene prior to entering bay area nor performing hand hygiene after direct contact with patient/patient zone prior to charting outside of bay.

4. Observation on February 19, 2025, EMP4 donned gloves at pre-op nurses station to prepare medication. EMP4 did not perform hand hygiene prior to donning or when doffing gloves. EMP4 donned gloves and entered bay 3 (C) to clean surgical site with betadine sponge. EMP4 did not perform hand hygiene prior to donning gloves nor when doffing gloves after cleaning patient skin.

5. Observation on February 19, 2025, EMP5 entered PACU bay 10 came in direct contact with patient post-surgical site skin area. EMP5 did not perform hand hygiene prior to contact with patient. EMP5 left bay 10 after coming in direct contact with patient skin and opened supply cabinet retrieved a supply used for multiple patients. EMP5 did not perform hand hygiene after coming in contact with patient/patient zone prior to getting clean supplies. EMP5 returned to bay 10 came in direct contact with patient skin/patient zone then left bay to chart at nurse ' s station. EMP5 did not perform hand hygiene prior to direct contact with patient nor after contact with patient skin/patient zone.

Interview with EMP1 on February 19, 2025, EMP1 confirmed hand hygiene policy was not followed by EMP2, EMP3, EMP4 or EMP5.

-------------

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:

On February 19, 2025, review of "Bio-Zyme G Directions for use" reveal "Enzyme cleaning solution preparation: For manual, automatic, and ultrasonic applications add 1/2 fl. oz (3.9 ml per liter) of Bio-Zyme G per gallon of water."

Interview with EMP6 on February 19, 2025, EMP6 confirmed the facility uses two (2) pumps of the Bio-Zyme G enzymatic cleaner in five gallons of water. EMP6 also confirmed to get five gallons of water no measuring tool is used, but the water in the sink is filled using the eyeball method.

Observation noted on February 19, 2025, EMP6 deposited two pumps of Bio-Zyme G enzymatic cleaner into a measuring cup totaling two ounces of cleaner. Per manufacturer guidelines five gallons of water should have 2 1/2 fl oz.

Interview with EMP1 on February 19, 2025, EMP1 confirmed the facility was not adhering to the manufacturer's guidelines.

-------------

Based on a review of facility policy, observations, and interview with staff (EMP), it was determined that the facility failed to follow the recognized standards of infection control to prevent cross-infection and a clean environment for patient care.

On February 19, 2025, review of facility policy "Dress Code" dated July 30.2024, revealed
"POLICY- It is the policy of UPMC that personal appearance reflects overall cleanliness, good grooming and hygiene, and professional identity. These guidelines were developed in
careful consideration of employee and patient safety, infection control and public image.
Exceptions to this policy may be made based on verified medical and religious needs. ... D. Guidelines for Staff Members with Direct Patient Care and/or Uniform Requirements ... 4. In consideration for infection control and patient safety: ... f) Artificial nails are prohibited for staff who have direct patient contact, who prepare instruments for sterile procedures or who prepare sterile pharmaceuticals, or who have contact with a patient's environment.
The definition of artificial fingernails includes, but is not limited to, acrylic nails, all overlays, tips, bonding, extensions, tapes, inlays, and wraps."

1) On February 19, 2025, observation of EMP2 fingernails it was noted EMP2 had colored artificial nail bonding.

2) On February 19, 2025, observation of EMP7 fingernails it was noted EMP7 had colored artificial nail bonding with spacing between end of product and cuticle where the nail had grown out.

Interview with EMP1 on February 19, 2025, EMP1 confirmed the above findings.





 Plan of Correction - To be completed: 03/17/2025

Immediately after the survey, EMP2, EMP3, EMP4, & EMP5 that were identified as being noncompliant, were counseled on expectations related to proper nail grooming per dress code policy.

The UPMC policy that addresses hand hygiene was reviewed with staff during morning huddles held on February 24 – March 7, 2025, and will be reinforced during the staff meeting scheduled for March 6, 2025. Specifically, per system policy HS-IC0615 Hand Hygiene, the triggers to perform hand hygiene were highlighted including the following: when entering or exiting a patient room (area), before donning and after doffing gloves, before touching a patient (or patient zone), before clean/aseptic procedure (critical sites), after body fluid exposure risk, after touching a patient, and after touching patient surroundings (patient zone).

Immediately after the survey, EMP6 who was identified as being noncompliant was counseled on expectations related to the proper cleaning solution preparation as determined by the product MIFU.
The leaders reviewed the manufacturer instructions for use (MIFU) for the Bio-Zyme G Enzymatic Cleaner.
To support the ability to prepare the mixture accurately, a graduated cylinder was purchased to measure the enzymatic cleaner concentrate, and a water level indicator was installed in the sink to accurately measure the volume of water. An informational sign was posted in CSSD providing directions for preparing the solution. An in-service for all technicians who are responsible to disinfect the instruments was held on March 5, 2025, to review the new process.


Immediately after the survey, EMP2 & EMP7 that were identified as being noncompliant were counseled on expectations related to proper nail grooming per dress code policy.
The UPMC policies that define operating room dress code were reviewed with staff during morning huddles held on February 24 – March 7, 2025, and will be reinforced during the staff meeting scheduled for March 6, 2025. As stated in policy, HS-OR0010 Dress Code in the Operating Room and Sterile Processing Department, scrubbed personnel should not wear nail polish. The UPMC system policy HS-HR0714 Dress Code prohibits artificial nails for staff who have direct patient contact, who prepare instruments for sterile procedures or who prepare sterile pharmaceuticals, or who have contact with a patient's environment. The definition of artificial fingernails includes, but is not limited to, acrylic nails, all overlays, tips, bondings, extensions, tapes, inlays, and wraps.

The ambulatory surgery center leader or designee will perform 30 audits per month of staff interactions with patients to evaluate compliance with the hand hygiene guidelines. Any employee that is noncompliant will receive additional education and coaching.

The ambulatory surgery center leader or designee will perform 10 audits per month to confirm compliance with preparing the Bio-Zyme G enzymatic cleaner mixture per manufacturer instructions for use (MIFU). Any employee that is noncompliant will receive additional education and coaching.

The ambulatory surgery center leader or designee will perform 30 audits of surgical attire per month. Any employee that is noncompliant will receive additional education and coaching.

Audits will be performed monthly until 100% compliance is achieved for 3 consecutive months.

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

567.41 LICENSURE MAINTENANCE SERVICE - Principle:State only Deficiency.
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 February 19, 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 February 19, 2025, of the facility's sterilization area revealed two Steris Steam Sterilizer autoclaves. The autoclaves are used for sterilization of surgical supplies.

A request was made on February 19, 2025, for documentation of the current boiler/pressure vessel inspections. None was provided.

Interview with EMP1 on February 20, 2025, EMP1 confirmed the facility also has two AMSCO Steam Sterilizer autoclaves. The autoclaves are used for sterilization of surgical supplies.

A request was made on February 19, 2025, for documentation of the current boiler/pressure vessel inspections. None was provided.

Interview with EMP1 on February 20, 2025, confirmed the facility does not have documentation for current boiler/pressure vessel inspections for all four steam sterilizers at facility.






 Plan of Correction - To be completed: 04/15/2025

The most recent inspection of the ambulatory surgery center's autoclaves occurred on 3/19/24. The on-line database for the PA Dept of Labor & Industry reflects our compliance with current inspections. The Factory Mutual Global Certified Boiler Inspector completed this year's inspection on March 4, 2025. The Department of Labor & Industry indicated that the updated certificate will take a minimum of 30 days for processing following this inspection. The certificates will be posted when available.

A task was created in the electronic work order system to trigger scheduling of the annual autoclave/boiler inspections and to ensure a new certificate is obtained from the PA Department of Labor & Industry every other year. The Manager of Facilities for the UPMC Community Hospital campus or designee will be responsible to perform those tasks.
567.43 LICENSURE Ventilation System:State only Deficiency.
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, Post-anesthesia Care Unit (PACU) and Pre-Operating (Pre-Op) rooms met the humidity level requirements per policy.

Findings include:

On February 19, 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 February 19, 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 February 19, 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."

On February 19, 2025, review of facility Temperature and Humidity log revealed on July 31, 2024, OR2 humidity level was 62%.

On February 19, 2025, review of facility Temperature and Humidity log revealed on August 1, 2024, OR2 humidity level was 68%; OR3 humidity level was 61%.

On February 19, 2025, review of facility Temperature and Humidity log revealed on August 2, 2024, OR2 humidity level was 68%; OR3 humidity level was 61%.

On February 19, 2025, review of facility Temperature and Humidity log revealed on August 5, 2024, OR2 humidity level was 61%.

On February 19, 2025, review of facility Temperature and Humidity log revealed on August 7, 2024, OR1 humidity level was 61%; OR2 humidity level was 61%.

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

Request made for humidity readings in Pre-Op and PACU areas none provided.

Request made for documentation on timeline when readings will be rechecked, and determination will be made on if procedures will be continued or paused for OR's that have inappropriate temperature or humidity levels. None provided.

Review of facility procedure schedule on February 24, 2025, revealed:

On July 31, 2024, 12 procedures were performed in OR2 during times the humidity was out of range of appropriate levels.

On August 1, 2024, four (4) procedures were performed in OR2 during times the humidity was out of range of appropriate levels.

On August 1, 2024, seven (7) procedures were performed in OR3 during times the humidity was out of range of appropriate levels.

On August 2, 2024, one (1) procedure were performed in OR2 during times the humidity was out of range of appropriate levels.

On August 2, 2024, five (5) procedures were performed in OR3 during times the humidity was out of range of appropriate levels.

On August 7, 2024, four (4) procedures were performed in OR1 during times the humidity was out of range of appropriate levels.

Interview with EMP1 on February 24, 2025, confirmed the information provided above is complete and accurate.






 Plan of Correction - To be completed: 04/15/2025

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 Manager of Facilities collaborated with the continuous building automated system (BAS) monitoring vendor to reconfigure the temperature targets and alarm limits to align with the ASHRAE 170-2008 guidelines. This reconfiguration was completed on February 28, 2025. In addition, effective February 15, 2025, a report listing the temperature and relative humidity in each of the operating rooms and sterile storage room is being sent every day of operation to the Director of the UPMC Susquehanna Valley Surgery Center and key stakeholders. Lastly, effective March 4, 2025, the ASF team started to perform manual readings, using a calibrated device, to record the temperature and humidity in the procedure rooms, preop area, and postop area each day of operation. These manual measurements will transition to an electronic solution after the necessary hardware is installed. 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 Susquehanna Valley Surgery Center and the Facilities department were educated about the policy and workflow. All education will be completed by March 6, 2025.

Facilities staff are notified electronically with any out-of-range readings for areas that are continuously monitored. The ASC staff will call Facilities with any out-of-range readings noted in the areas that are being manually monitored. Any corrective actions taken by Facilities in response to the alerts will be documented in the electronic work order system.

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