Initial Comments:
This report is the result of a State licensure survey conducted on January 17, 2024, at Lancaster General Health Ambulatory Surgical Facility. It was determined the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Ambulatory Care Facilities, Annex A, Title 28, Part IV, Subparts A and F, Chapters 551-573, November 1999.
Plan of Correction:
553.3 (1) LICENSURE
Governing Body Responsibilities
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553.3
Governing Body responsibilities include:
(1) Conforming to all applicable Federal, State, and local laws.
Observations:
Based on review of facility documents, and staff interview (EMP), it was determined that the facility failed to conform to applicable State Laws.
"Act 13 of 2002 MEDICAL CARE AVAILABILITY AND REDUCTION OF ERROR (MCARE) ACT ... Section 310. Patient safety committee ...
(b) Responsibilities.--A patient safety committee of a medical facility shall do all of the following:
(1) Receive reports from the patient safety officer pursuant to section 309.
(2) Evaluate investigations and actions of the patient safety officer on all reports.
(3) Review and evaluate the quality of patient safety measures utilized by the medical facility. A review shall include the consideration of reports made under sections
304(a)(5) and (b), 307(b)(3) and 308(a).
(4) Make recommendations to eliminate future serious events and incidents.
(5) Report to the administrative officer and governing body of the medical facility on a quarterly basis regarding the number of serious events and incidents and its recommendations to eliminate future serious events and incidents."
This is not met as evidenced by:
Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to have a stand alone Patient Safety Committee.
Findings include:
On January 17, 2024, review of facility's Quality Assurance and Patient Safety Committee Meetings dated April 17, 2023, July 17, 2023 and November 15, 2023 did not note a difference in time between the Quality Assurance Committee meeting and Patient Safety Committee meeting taking place.
Interview with EMP1 on January 17, 2023, EMP2 confirmed that the facility conducts the Quality Assurance and Patient Safety meetings at the same time.
Plan of Correction:Action: Leader responsible for oversight of Plan of Correction to ensure the safety of surgical patients.
Responsible Party: Administrator, LGH ASF
Completion Date: February 26, 2024
Action: Separate Quality and Patient Safety Meetings will occur and be documented appropriately.
Responsible Party: Administrator, LGH ASF
Completion Date: February 26, 2024
553.23 LICENSURE
Discharge by transfer
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553.23 Discharge by transfer
Prior arrangements made for admissions.
Clinical records shall accompany the patient.
Observations:
Based on review of facility documents, medical records (MR) and staff interview (EMP), it was determined the facility failed to complete the facility approved transfer form to ensure continuity of patient care for one of three transfer medical records reviewed (MR3).
Findings include:
On January 17, 2024, review of facility policy "Admission, Discharge, Transfer (ADT) & Patient Selection Policy Lancaster General Hospital Ambulatory Surgical Facility (LGHASF)" last reviewed November 2023, revealed "Policy Purpose: The policy is to identify the appropriate candidates for surgery or procedures, admitting process, discharge and transfer functions in Lancaster General Hospital Ambulatory Surgical Facility (LGHASF) ... B. Transfers Inter/Intra-facility Transport Guiding Principles: 3. Transfer Consent Form (LGHA3349) must be completed, with consent signatures obtained from the patient (or family) and physician. ..."
On January 17, 2024, review of MR3 revealed the patient was transferred from LGHASF to OTH1 on April 5, 2023, at 1610. A patient transfer consent form was not found in MR3 during review.
Interview with EMP1 on January 17, 2024, EMP1 confirmed MR3 does not have a patient transfer consent form.
Plan of Correction:Action: ASF medical staff education re: Admission, Discharge, Transfer (ADT) & Patient Selection Policy Lancaster General Hospital Ambulatory Surgical Facility (LGHASF).
Responsible Party: Director, LGH ASF
Completion Date: March 15, 2024
Action: Audit all transfers to include the presence of the signed Transfer Consent form with a goal of "0" defects from for the next 6 months.
Responsible Party: Assistant Nurse Manager, LGH ASF
Completion Date: March 25, 2024
567.1 LICENSURE
Principle
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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 a sanitary environment was maintained by adhering to facility policy and professionally acceptable standards of practice for cleaning equipment.
Findings include:
On January 17, 2024, review of facility policy "Cleaning and Disinfection of Patient care Equipment" last revised December 1, 2023, revealed "Policy Purpose: The purpose of the Cleaning and Disinfection of Patient Care Equipment policy is to provide guidance on ways to minimize risk of cross contamination through patient care equipment. Procedure: 3. Cleaning of Patient Care Equipment a. Cleaning and disinfection of patient-care equipment (e.g., blood pressure cuffs, thermometers, medication pumps, glucometers, etc.) is performed by the equipment use of a US Environmental Protection Agency (EPA) - registered hospital disinfectant according to manufacturer's instructions for use (IFU) after every patient use ... c. All equipment should be disinfected according to the Manufacturer's Instructions for Use. ..."
On January 17, 2024, review of facility document "Pan Cleaning information. - Excerpt from OneSource IFU database" last revised July 2023, revealed "Directions for Use: Enzyme cleaning solution preparation: For manual, automatic and ultrasonic applications add 1/2 fl oz of Bio-Zyme G per gallon of water."
Interview with EMP3 on January 17, 2024, EMP2 confirmed that they combine 25-30 ml of Bio-Zyme G with four gallons of water for pan cleaning.
Interview with EMP1 on January 17, 2024, EMP1 confirmed 25-30 ml of Bio-Zyme G Detergent in four gallons of water was not adhering to manufacturer's guidelines or facility policy.
Plan of Correction:Action: SPD staff education to Instructions for Use for appropriate pan cleaning with Bio-Zyme G.
Responsible Party: Interim SPD Manager
Completion Date: March 8, 2024
567.43 LICENSURE
Ventilation System
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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, and employee (EMP) interview it was determined the facility failed to ensure humidity levels in the operating room (OR) was maintained and out of range levels were addressed according to facility policy.
Findings include:
On January 17, 2024, review of facility policy "Relative Humidity, Air Exchanges, and Temperature Control in the Operating Room" last revised January 27, 2022, revealed "Policy Purpose: To ensure that operating room relative humidity, OR temperature, and air exchanges are maintained in accordance with recommended standards in the interest of patient safety with respect to both fire and safety and infection control ... Implementation Guidelines 1. The relative humidity of air supplied to the operating rooms will be continuously monitored by the Facilities Management Department. 2. The Facilities Management Department will take measures and will implement engineering controls when the relative humidity range drops below 20% or above 60% relative humidity. 3. The Facilities Management Department will notify the operating room unit manager or the Director of Perioperative and Anesthesia Services if the unit manager is not available. 4. The Facilities Management Department, Perioperative Leadership, Safety and Environment of Care will assess the relative humidity issue to determine the appropriate actions. 5. Information to be discussed includes the following: scope and impact of the relative humidity issue (Example 1 operating room vs. the entire operating room suite), estimate of time to correct the issue, and any immediate actions that should be taken to correct the issue. a. Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an oxygen-enriched environment or when flammable agents are in use. 6. If the relative humidity level drops below 20% or the level is above 60%, surgeries that are in progress will be completed while steps are taken to correct the relative humidity levels in the operating room. 7. If the relative humidity remains below 20% for more than two hours, the Perioperative Services Leadership and Facilities Management will meet to determine if all elective procedures will be suspended. Only life threatening surgical procedures will be performed under these conditions."
Review of facility document revealed on December 13, 2023, in OR six, the humidity level was below 20% from 11:00 AM until 2:15 PM. Surveyor request documentation that Facilities Management Department took measures for the humidity dropping below 20%, but none was provided. Request for documentation Facilities Management Department notified operating room manager or Director of Perioperative and Anesthesia Services regarding humidity range dropped below 20% but none was provided. Request for documentation noting Facilities Management Department, Perioperative Leadership, Safety and Environment of care assessed the relative humidity issue to determine appropriate actions and if all electives would be suspended in OR six but none was provided.
Review of facility document revealed on December 20, 2023, in OR six the humidity level was below 20% from 1:30 PM until 3:00 PM. Request for documentation Facilities Management Department took measures for the humidity dropping below 20%, but none was provided. Request for documentation Facilities Management Department notified operating room manager or Director of Perioperative and Anesthesia Services humidity range dropped below 20% but none was provided. Request for documentation noting Facilities Management Department, Perioperative Leadership, Safety and Environment of care assessed the relative humidity issue to determine appropriate actions and if all electives would be suspended in OR six but none was provided.
During interview with EMP1 on January 17, 2024, EMP1 confirmed surgeries took place in OR six on December 13, 2023 and December 20, 2023, during the times humidity was below 20%.
During interview with EMP4 on January 17, 2024, EMP4 confirmed Facilities Management Department did not notify operating room manager or Director of Perioperative and Anesthesia Services of humidity levels below 20% on the dates listed above.
Plan of Correction:Action: Building automation system updated with ASF leadership team contact numbers for notification when temp/humidity out of parameters.
Responsible Party: Director, Facilities
Completion Date: March 1, 2024
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