Initial Comments:
This report is the result of a follow up survey conducted on March 5, 2024, at Lancaster General Hospital, as the result of a previous complaint survey that was conducted on December 6, 2023. It was determined that the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Hospitals, 28 Pa Code, Part IV, Subparts A and B, November 1987, as amended June 1998.
Plan of Correction:
103.22 (b)(16) LICENSURE
IMPLEMENTATION
Name - Component - 00
103.22
(16) The patient has the right to
expect good management techniques to
be implemented within the hospital
considering effective use of the time
of the patient and to avoid the
personal discomfort of the patient.
Observations:
Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to provide appropriate sterile equipment supplies to ensure good management techniques and prevent delay of care for seven out of seven MR's reviewed (MR1, MR2, MR3, MR4, MR5, MR6 and MR7).
Findings Include:
Review of facility policy "Patient Bill of Rights" last revised October 2017, revealed "The following Statement of The Patient's Rights and Responsibilities is endorsed by the Administration and staff of this facility and applies to all patients ... 13. Right to good hospital management - Patients have the right to expect good management techniques to be implemented within LGH. They may expect every effort will be made to avoid unnecessary delay and, when possible, to avoid undue personal discomfort."
Review of MR1 facility document note entered on February 20, 2024, revealed, "Delay information, Delay Type - Intra-op; Delay Reason - SPD (Sterile Processing Department) did not have instruments sterile for case. The procedure was delayed 270 minutes."
Review of MR2 event tracking on February 21, 2024, revealed "Delay information, Delay Type - Intra-op; Delay Reason - 2-Intra-Periop Instruments - Delay. The procedure was delayed for 82 minutes."
Review of MR3 event tracking on February 21, 2024, revealed "Delay information, Delay Type - Intra-op; Delay Reason - contamination of instrumentation. The procedure was delayed for 90 minutes."
Review of MR4 facility document note entered on February 21, 2024, revealed "Mesh expired x2, no other units avail 1/31/2024 had to break to locate mesh not exp different type with diff type of mesh."
Review of MR5 facility document note entered on February 27, 2024, revealed, "Cart Delivery - Case Cart called for case cart at 0930 arrived at 1045, case delayed 75 minutes."
Review of MR6 event tracking entered on February 27, 2024, revealed "Delay information, Delay Type - Intra-op; Delay Reason- 2-Intra Case Cart not available. The procedure was delayed for 40 minutes."
Review of MR7 facility document note entered by EMP4 on March 3, 2024, revealed, "Patient brought back to OR and put to sleep for surgery. Surgical tech saw no signs of gross contamination of instruments during initial inspection. Once patient was prepped for surgery, surgical tech was threading cannulas to put together pieces of the set, and a piece of bone came out from inside cannula. Back table and set taken out of OR due to contamination, new supplies brought into room. Second set for case found to have hole in wrapper before placing on sterile field. This event caused a delay in the case while patient already under anesthesia."
Interview with EMP1 on March 11, 2024, confirmed the information above and documents submitted are complete and accurate.
Plan of Correction:Action: Executives responsible for oversight of Plan of Correction to ensure the safety of surgical patients.
Responsible Parties: Chief Operating Officer, Chief Physician Executive, President of the Medical Staff
Completion Date: April 2, 2024
Action: Revised pre-patient arrival time out to include notification of Sterile Processing Department (SPD) supervisor or designee to verify if an instrument defect is present in real-time and in-person to prevent delay of care.
Responsible Party: Senior Director, Perioperative Services
Completion Date: May 31, 2024
Action: Sterile processing leadership corrects any identified instrumentation defects in real-time prior to surgical case start.
Responsible Party: Senior Director, Perioperative Services
Completion Date: May 31, 2024
Action: Established standardized real-time communication process between Operating Room (OR) and Sterile Processing Department to address any needs that occur after the surgical case has started.
Responsible Party: Senior Director, Perioperative Services
Completion Date: May 31, 2024
Action: Educate SPD staff to newly developed standard work for case picking and case cart prep to reduce defects, such as holes, and to reduce incomplete case carts.
Responsible Party: Senior Director, Perioperative Services
Completion Date: May 31, 2024
Action: Implement standardized inventory out-date checks by clinical staff to routinely assess supplies housed in the OR to ensure are available and not expired.
Responsible Party: Senior Director, Perioperative Services
Completion Date: May 31, 2024
Action: Re-educate OR staff on expectations for care, handling and cleaning of instrumentation prior to sending to SPD decontamination room to ensure instruments can be properly cleaned and sterilized.
Responsible Party: Senior Director, Perioperative Services
Completion Date: May 31, 2024
Action: Audit weekly number of case delays due to contamination until at least 95% compliance is maintained for 3 months.
Responsible Party: Senior Director, Perioperative Services
Completion Date: May 31, 2024
146.1 (b)(3) LICENSURE
PRINCIPLE
Name - Component - 00
146.1 (b)
The multidisciplinary committee
described in section (a) shall do the
following:
(3) Develop, evaluate, and revise
on a continuing basis the procedures
and techniques for meeting established
sanitation and asepsis standards.
Observations:
Based on review of facility documents, and staff interviews (EMP), it was determined the facility failed to follow adopted policies and procedures to ensure sterile instruments and supplies are maintained properly.
Findings include:
Review of facilities document "Handling and Assembling Trays/Peel Pouches in Prep and Pack" last update December 16, 2021, revealed "Purpose: To provide staff with standard instructions for proper handling, assembling and packaging trays/peel pouches ... Expected Outcome - Items will be neat, organized, and functional resulting in the OR staff having the best quality instruments available that are clean, sterile, and safe to use on the patient. Proper care and handling from SPD (Sterile Processing Department) staff will lead to less complications during the procedure ..."
On March 5, 2024, review of facility's Sterile Processing Department (SPD) "SPD Debrief Tool" noted by EMP3 on February 20, 2024, revealed "In Ortho OR, Dirty Instruments: Set Name: Zimmer Persona Tibia Set number - 10 Bone in set; Holes: Set Name: Large Power Battery."
On March 5, 2024, review of facility "SPD Debrief Tool "noted by EMP6 on February 22, 2024, revealed "Ortho OR, Sterility Issue: Set Name: Patella Cutter had a piece of bone in it."
On March 5, 2024, review of facility "SPD Debrief Tool "noted by EMP7 on February 24, 2024, revealed "Main OR, Sterility Issue: Set Name: Ortho Plastic Hand x2 - 1st had blood in casket, 2nd had suture in pan."
On March 5, 2024, review of facility "SPD Debrief Tool" noted by EMP8 on February 25, 2024, revealed "Main OR, Dirty Instruments: Set Name: Lap General Pan x2 Set Number: B40; B01 Debri in bottom of pan; Blood on instruments had to go through three trays to find clean lot #022524202 - blood on side of tray; 022424105 - blood in crevices."
On March 5, 2024, review of facility "SPD Debrief Tool "noted by EMP5 on February 27, 2024, revealed "Ortho OR, Dirty Instruments: Set Name: Stryker Large Battery Power Complete Set Number: 4 0227744302 Blood in Bottom of Pan."
On March 5, 2024, review of facility "SPD Debrief Tool" noted by EMP4 on March 2, 2024, revealed "Main OR, Dirty Instruments: Load #022124406 Set Name: Synthes Large Ex-fix Set number 2-Bone found in set; Set name: Synthes Large Ex-fix Set number 4 hole in pack; Please note this finding was after patient was put under anesthesia in OR!"
Interview with EMP1 on March 5, 2024, EMP1 confirmed all information above and documents submitted are complete and accurate.
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Based on review of facility documents, observations, and staff interview (EMP), it was determined the facility failed to follow adopted policies and procedures for proper reprocessing of instruments to ensure the instruments are thermally disinfected.
Findings include:
Review of facilities document "Transport and Cleaning of DaVinci Instruments ... Purpose: To provide staff with standard instructions for proper reprocessing of DaVinci instruments. Expected Outcomes: Consistent adherence to Standard Work for cleaning DaVinci instruments. Major Steps: SPD staff working in decontam: 1.Don gloves, gown, shoe covers, scrub hat, mask, and eye protection. 2.Prepare enzymatic solution. 3.Prime primary flush port (port 1) with 20 ML of water/enzymatic solution and soak DaVinci arms for 30 minutes. Expected Outcomes: Pre-cleaning is the removal of all visible soil. Instruments that are not properly pre-cleaned using both friction and detergent cannot be thermally disinfected."
On March 5, 2024, observation of container on sink with undiluted enzymatic solution, EMP 9 was observed flushing primary port of the DaVinci Instrument with undiluted enzymatic solution.
Interview with EMP9, on March 5, 2024, EMP9 confirmed they were flushing the primary port of the DaVinci Instrument with undiluted enzymatic solution.
Interview with EMP10, on March 5, 2024, EMP10 confirmed EMP9 was not following the policy/procedure for processing the DaVinci instruments for proper thermal disinfection.
Plan of Correction:Action: Re-educated SPD staff to policy/procedure for processing the DaVinci instruments for proper thermal disinfection.
Responsible Party: Senior Director, Perioperative Services
Completion Date: May 31, 2024
Action: Audit SPD decontamination staff compliance to the policy/procedure for processing DaVinci instruments for proper thermal cleaning. 10 audits will be conducted per week until at least 95% compliance is maintained for 3 months.
Responsible Party: Senior Director, Perioperative Services
Completion Date: May 31, 2024
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