HospitalInspections.org

Based on observation, interview, and record review, the hospital's GB failed to ensure the safe and effective operation of the hospital as evidenced by:

1. The hospital failed to ensure the availability and use of appropriate, non-expired Troponin QC materials for testing, thereby failing to ensure the quality, accuracy, and reliability of laboratory services for its patients.

The hospital laboratory did not ensure that all aspects of the test process were adequately controlled to produce accurate and reliable test results for patient care. Due to a vendor credit hold issue, the laboratory operated without appropriate, in-date Troponin QC materials for Troponin testing, from 5/1/25, to 10/10/25 (163 days). As a result, approximately 4,035 patient Troponin tests were processed using expired QC materials, placing all affected patients at risk for potential misdiagnosis or inappropriate treatment due to unreliable test results.

This situation represented an IJ because the non-compliance created a likelihood that serious harm, injury, or death to one or more patients could occur due to potentially inaccurate test results guiding critical medical decisions.

An IJ was called on 10/10/25 at 1539 hours.

The IJ was abated on 10/22/25 at 1107 hours.

Cross reference to A582, example # 1

2. The GB failed to ensure the availability of laboratory services to meet needs of its patients. Cross reference to A576.

3. The GB failed to protect and promote the rights of the patients. Cross reference to A115.

5. The GB failed to ensure a hospital-wide, data-driven, effective QAPI program was implemented and maintained. Cross reference to A263.

On 10/20/25 at 1100 hours, the CNO provided the following information:

- Governing Board meetings would be conducted monthly.

- The CNO started employment in June 2025 and did not receive a formal "hand-off" from the previous CEO, whose position was currently vacant following their separation from the hospital.

- The CNO was unaware that the vendor had placed a credit hold on the Troponin 1 Quality Control (QC) materials. As a result, expired Troponin QC was used by the laboratory starting in May 2025.

- The CNO was also unaware of the POC or monitoring status related to deficiencies found during previous surveys.

Review of the GB meeting minutes from February to September 2025 did not show evidence that the Board was informed of a credit hold on Troponin 1 Quality Control materials. As a result of this credit hold, the laboratory was using expired Troponin QC.

The meeting minutes did not address the POC or monitoring status related to deficiencies identified in previous surveys dated 2/25/25 and 7/2/25.

On 10/22/25 at 1435 hours, an interview with concurrent record review was conducted with the Governing Body or Physician 2. When asked, Physician 2 stated Physician 2 was aware of the "credit hold" related to the February Complaint Validation Survey and was not aware of the present situation. Physician 2 further stated Physician 2 was not aware of the ongoing "credit holds" until this IJ came out specific to the use of expired QC Troponin Level 1. When asked, Physician 2 stated Physician 2 was not aware of the STAT orders send-out to referral laboratory taking longer than the allotted time specified by the receiving laboratory.

The cumulative effect of these practices prevented the Governing Board from effectively ensuring safe, high-quality healthcare delivery.

Based on observation, interview, and record review, the hospital failed to protect and promote the rights of the patients as evidenced by:

1. The hospital failed to ensure Patient 6 was provided with the notice of rights. Cross reference to A116.

2. The hospital failed to ensure the patients received care in a safe setting. Cross reference to A144.

The cumulative effect of these deficient practices resulted in the hospital's inability to protect patient rights and ensure a safe care environment.

Based on observation, interview, and record review, the hospital failed to ensure a hospital-wide, data-driven, effective QAPI program was implemented and maintained as evidenced by:

The hospital failed to ensure the scope of the QAPI program included an ongoing program that showed measurable improvement related to the laboratory services. Cross reference to Q273.

The cumulative effect of these failings meant the hospital did not implement and maintain a quality improvement program to ensure the safety and quality of the services provided.

Based on observation, interview, and record review, the hospital failed to ensure the availability of laboratory services to meet needs of its patients as evidenced by:

1. On 10/10/25 at 1539 hours, the survey team notified the hospital's administrative staff including the CNO, ACNO, Chief of Staff, and Chief Medical Advisor of an Immediate Jeopardy (IJ) due to the following deficient practices related to the laboratory services:

The hospital failed to ensure the availability and use of appropriate, non-expired Troponin QC materials for testing, thereby failing to ensure the quality, accuracy, and reliability of laboratory services for its patients.

The hospital laboratory did not ensure that all aspects of the test process were adequately controlled to produce accurate and reliable test results for patient care. Due to a vendor credit hold issue, the laboratory operated without appropriate, in-date Troponin QC materials for Troponin testing, from 5/1/25, to 10/10/25 (163 days). As a result, approximately 4,035 patient Troponin tests were processed using expired QC materials, placing all affected patients at risk for potential misdiagnosis or inappropriate treatment due to unreliable test results. This situation represents an IJ because the non-compliance created a likelihood that serious harm, injury, or death to one or more patients could occur due to potentially inaccurate test results guiding critical medical decisions.

On 10/16/25 at 1246 hours, the CNO provided the survey team with the finalized accepted plan of action which included a summarized corrective action to be completed by 10/17/25.

On 10/22/25 at 1033 hours, the CQO provided the survey team with an updated and finalized accepted plan of action which included a summarized corrective action to be completed by 10/22/25. The IJ was abated on 10/22/25 at 1107 hours.

Cross reference to A582, example # 1.

2. The hospital failed to ensure the availability and use of non-expired quality controls for hematology. Cross reference to A582, example # 2.

3. The hospital failed to ensure that the Plan of Correction (POC) from previous Complaint Validation Surveys related to laboratory services was fully and effectively implemented, resulting in a recurrence of previously identified deficiencies. Cross reference to A582, example # 3.

4. The hospital failed to ensure the TAT of the STAT lab results for the STAT Sent-out were implemented for four of seven sampled patients (Patients 1, 2, 3, and 5) as per the hospital's P&Ps. Cross reference to A582, example # 4.

5. The hospital failed to implement its contingency plan for Laboratory Services as required regarding the notification of physicians, CDPH, staff, and patients about the disruption in services. Cross reference to A582, example # 5.

6. The hospital failed to ensure the laboratory's pneumatic tubing system was in operational condition. Cross reference to A582, example # 6.

The cumulative effect of these systemic problems resulted in the inability of the hospital to provide safe and effective laboratory services to the patients.

Based on interview and record review, the hospital failed to ensure that one of seven sampled patients (Patient 6) was informed of their rights upon admission as evidenced by the absence of a completed Condition of Services form in the patient's medical record. This deficient practice placed the patient at risk of not being fully informed of their rights and potentially affecting their involvement in their own care.

Findings:

Review of the hospital's P&P titled Consent Form Requirements dated July 2023 showed:

"To ensure regulatory guidelines are followed, allow for patients to provide consent for treatment, and to ensure patients are informed of all conditions of admission and rights while they are receiving care within the hospital...It is the responsibility of Patient Access to complete the required consent forms with the patient, or the patient's legal representative. Patient Access must explain each form in a capacity in which the patient understands. The patient must then sign and date the consent forms...Copies of all appropriate consent forms will be provided to the patient and/or representative...Patient Access will make a reasonable effort to contact a family member, legal guardian...in the even [sic] a patient lacks the capacity to make health care decisions, upon admission...Basic Consent Form Packet: These forms are provided to all patients...Condition of Services: (COS): Lists the terms and condition to being admitted to the hospital...Verbal Consent: If the patient is unable to physically sign the forms, if the legal representative is not available to sign, Patient Access may receive verbal consent. Verbal consent must be documented on the forms and the follow up process outlined below must be followed to try to obtain an actual signature at a later time...In the event the consent forms could not be signed at the time of the admission, Patient Access will properly document the reason on the COA [sic] in the provide [sic] space, make a note of in the registration system, and then follow up by reviewing the inpatient census. Over the following 24 hour period, (usually completed by the Patient Access morning staff), Patient Access will make an additional attempt to obtain signature form [sic] the patient or legal representative..."

Review of Patient 6's medical record conducted on 10/23/25, showed the patient was admitted to the hospital on 10/8/25, with diagnosis of GI bleed. Patient 6 was discharged on 10/12/25.

During an interview and concurrent review of Patient 6's medical record on 10/23/25 at 1300 hours, Director DOU/Tele stated the COS form was not found in the patient's medical record. Director DOU/Tele stated there was documentation showing the patient was unable to sign initially. Director DOU/Tele confirmed Patient Access staff failed to perform the necessary follow-up to ensure the COS was completed as per the hospital's P&P.

Based on observation, interview, record review, the hospital failed to ensure the patients received care in a safe environment as evidenced by:

1. The hospital failed to ensure the availability of laboratory services to meet needs of its patients.

2. The hospital failed to maintain a secure environment for medications, as evidenced by one unlocked crash cart containing a stocked medication tray found unsecured in the central supply department, an area accessible to unauthorized individuals.

These failures created the risk of substandard health outcomes for the patients in the hospital.

Findings:

1. During observation, interview, and record review from 10/7/25 to 10/23/25, the hospital failed to ensure the availability of laboratory services to meet needs of its patients. Cross reference to A576.

2. Review of the hospital's P&P titled Crash Carts dated January 2024 showed, "Scope, licensed clinical staff...Purpose, Crash carts must be locked in a secure area or under constant observation, so that unauthorized individuals do not have access to them...Standard emergency medications (e.g., epinephrine and cardiopulmonary medications...Crash Cart Exchange Procedure...Provide Central Supply (CPD) with the patient's medical record number...Call CDP to exchange crash cart...Remove medication tray for pharmacist to return to Pharmacy. If
pharmacist is temporarily unavailable, place tray in medication room for prompt pickup by pharmacy staff..."

A tour of the Central Supply Department was conducted on 10/13/25 at 1134 hours, with the Director of Central Supply Department.

On 10/13/25 at 1155 hours, a crash cart was observed in the central supply department. The cart was unlocked and unsecured, and one stocked medication tray containing various medications was present inside. The Director of Central Supply Department confirmed the findings and stated they were not aware that the medication tray was still in the crash cart. The Director of Central Supply Department was asked to provide specific details including the patient's information, the time the code occurred, and when the cart arrived in central supply.

The requested documentation was not provided before the exit date of the survey.

Based on observation, interview, and record review, the hospital failed to ensure the scope of the QAPI program included an ongoing program that showed measurable improvement related to the laboratory services. This failure of the QAPI program to monitor the effectiveness and safety of services and quality of care in the hospital had the potential for an unsafe patient care environment, and potential serious harm to patients.

Findings:

Review of the hospital's titled Organization-Wide Quality Assessment and Performance Improvement Program dated March 2024 showed the following:

* Mission,Vision,Values:

- The hospital system is committed to providing the very best quality healthcare to our current and future patients through a broad range of specialty care services and resources.

- We aspire to earn a reputation among patients as offering high quality, technologically advanced and compassionate medical care in a SAFE and clean environment.

* Introduction:

- The hospital is dedicated to meeting the needs of our patients in a manner which is consistent with our mission, vision, and belief statements. The Organization Quality Assessment and Performance Improvement Plan is designed to provide a systemic and organized program for the promotion of safe, quality patient care and services.

- Through an interdisciplinary and integrated process, patient care and processes that effect patient care outcomes shall be continuously monitored and evaluated to promote optimal achievement, with appropriate accountability assumed by the Governing Board, Medical Staff, Administration, and support personnel.

- The organization wide QAPI Plan encompasses major important aspects of care provided by the hospital and Medical Staff in support of the achievement of the hospital's mission and strategic goals.

- QAPI activities will be integrated across all the care and service areas of our organization. Each area should have a representative on the committee. Our QAPI activities will cross service areas and departments, and we will work together to ensure we address all concerns and strive to continuously improve the services provided. On an annual basis, and as needed, a Facility Assessment will be conducted to include an overview of the services and care areas that are provided.

- Patient Safety and Quality: Improving patient safety by proactively identifying and improving systems causes of medical errors. We will promote a fair culture of identification of risks to patient safety.

- Data-Driven Leadership: Rather than guess, we will measure our performance and progress, discovering where we are, deciding where we could be, and determining how to get there.

- Goals of the Quality Improvement Program are as follows: to improve the quality, safety and reliability of patient care processes and outcomes; to promote patient safety by prevention and reduction of medical errors; to integrate the principles of high reliability into our quality structure and culture.

- Scope of Activities: The scope of the Organizational Quality Assessment and Performance Improvement Program encompasses measurement and activities of the Medical Staff, Nursing and Ancillary or support services that includes every department and service of the hospital. Processes and outcomes of care are designed, measured, and analyzed. Quality Improvement activities will address both clinical and organizational functions. These activities are designed to address key functions of patient care and to identify, study, and correct problems, and improvement opportunities found in the process of care delivery. The Governing Board, Administration, Department Leaders and leaders of organized Medical Staff regularly communicate with each other on issues of safety and quality.

* Program Organization and Responsibility of Leaders: Responsibility of Leaders

- Participation in Quality Improvement activities are the responsibility of everyone employed by, on the medical staff of, or contracted with the organization. The organizational Plan for Quality is reviewed and approved annually by the Quality/Patient Safety Committee, MEC, and Governing Board.

- The Governing Board shall be responsible to ensure the provision of optimal quality care, safety, and organization-wide performance. The Board is ultimately accountable for the safety and quality of patient care provided in every department and service of the hospital and has legal responsibility and operational authority for hospital performance. The Board delegates operational responsibility to the Medical Staff and administration.

- The Board shall facilitate Quality Improvement by: The Governing Board authorizes the establishment of a committee structure to implement the QAPI Program; ensuring the quality program reflects the complexity of the hospital's organization and services; providing adequate resources, both material and manpower, to accomplish the QAPI function; assuring clear expectations for safety are established.

- Senior leadership supports the maintenance of the QAPI process through allocation of staff and resources necessary to fulfill the requirements of the program. Leaders also analyze data and information in decision making that supports the safety and quality of care; perform evaluation of clinically contracted service in collaboration with respective department directors and reporting the results of the evaluation through the Quality/Patient Safety Committee structure to the Medical Staff Committee and the Board; and regularly evaluate the culture of safety and quality using valid and reliable tools.

- The Department Directors and Managers are responsible for systemic monitoring and analysis of the quality and safety of care provided in their departments. Directors will monitor, analyze, and report the processes in their areas that effect patient care, safety, outcomes and satisfaction; report QAPI data and actions as appropriate; and communicate the status of departmental quality, patient safety, and survey readiness initiatives regularly to departmental staff members.

- The Quality/Patient Safety Committee is the hospital - based multidisciplinary body that serves to coordinate organizational quality improvement activities. Activities include but are not limited to receive and review reports regarding the effectiveness of organization-wide QAPI activities; to analyze and identify trends or patterns that might suggest an improvement opportunity.

- It is essential the patient Safety Program and Quality Assessment and Performance Improvement Program are integrated to assure the flow of information to the appropriate areas for review, action, and/or follow-up.

* Design - Quality Approach and Framework:

- Data Collection: The staff collects, analyzes data necessary to determine root causes, track performance, benchmarking, etc. Data is organized in such a manner as to facilitate comparison and trends. The data collection is conducted in a timely and efficient manner.

- Compilation of Data: Data shall be compiled in a manner that is usable to those individuals and entities charge both with analyzing the data and taking action on the information derived from data analysis.

- Analysis of Data: Data on performance measures will be analyzed to monitor the effectiveness and safety of services and quality of care and to identify opportunities for improvement and changes that will lead to improvement.

During the Complaint Validation Survey conducted from 10/7/25 to 10/23/25, the deficient practice was identified as follows:

* The hospital failed to ensure the availability of laboratory services to meet needs of its patients. Cross reference to A576.

On 10/22/25 at 1300 hours, an interview with concurrent record review was conducted with the CNO. When asked, the CNO stated the CNO attended the QAPI monthly meetings. The CNO further stated the meeting chairperson was Physician 1.

Review of the documents provided titled Quality/Patient Safety Council showed the following:

* No documented evidence to show the QAPI meeting was held in January 2025.

* The QAPI meeting was held on 2/25/25. The meeting minutes of Performance Improvement Dashboard failed to show ongoing concerns with the laboratory services in regard to shortage of supplies due to credit hold.

* The QAPI meeting was held on 3/25/25. Review of the Laboratory Topic of the QAPI meeting minutes showed the following:

- The section of "Problems Identified/Opportunities to Improve" showed staffing shortage for TAT and laboratory created and implemented a new send-out process which delay TAT.

- The section of "Focus Studies/Activities" showed laboratory manager and QA coordinator will monitor real time the specimen collection/received screen in Alab to remind staff if any test approaches the required TAT.

The March meeting minutes failed to address the ongoing shortage of supplies in the laboratory due to account blocked.

* The QAPI June meeting was held on 6/5/25, the meeting minutes showed the following meetings were canceled and reason for cancellation:

- January 28,2025 meeting was canceled due to Joint Commission Revalidation Visit.

- April 22,2025 meeting was canceled due to staffing challenges in quality.

- May 21,2025 meeting was canceled due to OCEMS visit.

However, the QAPI June meeting failed to mention the ongoing laboratory's shortage of supplies and the vendors refusal to process the orders due to nonpayment.

- The July QAPI meeting was held on 7/22/25, review of the July meeting minutes failed to show the ongoing issues with the laboratory's shortage of supplies due to "nonpayment," and refusal of the vendors to process the orders.

- The August QAPI meeting was held on 8/26/25, the August QAPI minutes showed "Laboratory - CDPH POC Monitoring - July 2025. Met goal for all indicators. Continue with plan."

Per the CNO, the September QAPI meeting minutes was not available.

On 10/22/25 at 1350 hours, an interview and concurrent record review was conducted with the QAPI Chair or Physician 1. When asked the QAPI Chair stated the QAPI Chair was not aware of lack of supplies in the laboratory, became aware about two weeks ago by the laboratory manager, also became aware of the laboratory staff using the expired QC in the last month or so. The QAPI Chair, further stated the data was collected by the QAPI personnel, sent to MEC, and forwarded to the Governing Board.

When asked, the QAPI Chair stated they did not recall any discussion in the QAPI meetings related to the laboratory's shortage of supplies addressed in the February Complaint Validation Survey POC.

On 10/22/25 at 1435 hours, an interview with concurrent record review was conducted with the Governing Body or Physician 2. When asked, Physician 2 stated Physician 2 was aware of the "credit hold" related to the February Complaint Validation Survey and was not aware of the present situation. Physician 2 further stated Physician 2 was not aware of the ongoing "credit holds" until this IJ came out specific to the use of expired QC Troponin Level 1. When asked, Physician 2 stated Physician 2 was not aware of the STAT orders send-out to referral laboratory taking longer than the allotted time specified by the receiving laboratory.

On 10/22/25, the above findings were verified by the CNO.

Based on observation, interview, and record review, the hospital failed to ensure the availability of laboratory services to meet the patient's care needs as evidenced by:

1. The hospital failed to ensure the availability and use of appropriate, non-expired Troponin QC materials for testing, thereby failing to ensure the quality, accuracy, and reliability of laboratory services for its patients. The hospital laboratory did not ensure that all aspects of the test process were adequately controlled to produce accurate and reliable test results for patient care.

2. The hospital failed to ensure the availability and use of non-expired quality controls for hematology.

3. The hospital failed to ensure that the Plan of Correction (POC) from previous Complaint Validation Surveys related to laboratory services was fully and effectively implemented, resulting in a recurrence of previously identified deficiencies.

4. The hospital failed to ensure the TAT of the STAT lab results for the STAT Sent-out were implemented for four of seven sampled patients (Patients 1, 2, 3, and 5) as per the hospital's P&Ps.

5. The hospital failed to implement its contingency plan for Laboratory Services as required regarding the notification of physicians, CDPH, staff, and patients about the disruption in services.

6. The hospital failed to ensure the laboratory's pneumatic tubing system was in operational condition.

These failures had the potential to result in missed or incorrect diagnosis, delay in treatment, and longer hospital stay for the patients.

Findings:

1. Review of the manufacturer package insert for Multichem hsTN undated showed "...Do not use the product past the expiration date..."

Review of the hospital's P&P titled Reagent Extension Procedures dated 3/28/24, showed, "Laboratories may use expired supplies until unexpired supplies become available...'Reagent Extension' may ONLY be allowed under extreme circumstances in which the inability to perform critical testing would cause serious patient harm or delays in critical treatment or surgery under the direction and discretion of the Laboratory Medical Director...Laboratories are sometimes faced with limited reagent, kit and material inventories, with some reagents approaching or passing expiration dates. Critical supply shortages may necessitate the use of expired reagents to maintain testing...Procedures...Attempt to borrow from local medical centers...If all efforts to secure the necessary reagent/materials are unsuccessful, notify the Medical Director, the Regional Director, and Manager/Supervisor of the need to extend a reagent/material ... Consult the reagent's manufacture to check whether expiration dates have been extended for specific lots. Also, notify manufacture when testing has been interrupted because of expired test kits and supply shortages. When possible, request that the manufacture provide a letter of expiration extension for the reagent or test kit, or if applicable, document in writing that the manufacture would vouch for the accuracy and reliability of the reagents while in use past the expiration date. Place these letters in the laboratory's binder of QVRs...If possible, consult with the medical center's regulatory agency such as CAP, the AABB, TJC, or the California Department of Public Health (CDPH) for guidance and advice as to how to handle a need for reagent extension...Additionally, when using outdated QC material, it is also required that patient samples be re-examined to assess previous results as an added measure of acceptability..."

Review of the hospital's P&P titled Quality Variance Patient Safety Report (QVR) Submission, Tracking dated 4/3/24, showed, "This Standard Operating Procedure (SOP) outlines the process for recording and submission of all events/"variances"...that range from minor events to reports requiring notification of agencies outside our facility...such as the state of California Department of Public Health (CDPH). Additionally, the QVR will allow tracking and trending of "variances" (errors, accidents, omissions etc.) for quality assurance (QA) and allow for careful examination for focused performance improvement (IP)...This can also assist in identifying opportunities to develop and implement new SOPs, which may not be in place to assist in reducing errors, omissions, etc. and improved outcomes and enhance patient safety...". Any potential sentinel event [see reference (a)] to be recorded immediately to the Laboratory Services Manager, the Regional Director ... Laboratories, the Quality Assurance/Performance Improvement (QAPI) Department and the Medical Director, Laboratory Services. Staff will utilize LS Form 019 (Enclosure 1), Quality Variance/Patient Safety Report (QVR) to record/complete the QVR and submit the "Type of Variance", the "Description of Variance" and whether an SOP exists or not, to his/her direct report "Supervisor" or his/her "Coordinator." The respective lead may assist in the completion of the QVR by selecting the "Contributing Factors" and the "Immediate Corrective Action." Submitting staff will note in the description of the variance if an RLDatix report has been submitted. The Manager, Laboratory will determine whether to forward the QVR to the Quality or Compliance Department and/or the Medical Director.

During a tour of the Laboratory on 10/9/25 at 1421 hours, CLS 5 was interviewed and stated the laboratory had been using expired Troponin QC for testing. CLS 5 stated the Laboratory Director had approved the use of the expired QC and had signed the "QVR."

On 10/9/25 at 1503 hours, an observation and concurrent interview was conducted with Med LabTech 1. Medical Lab Tech 1 confirmed the laboratory had been using expired Troponin QC for testing. The vial of QC provided by Med Lab Tech 1 showed the expired date of 3/22/25. Med Lab Tech 1 stated having to utilize the expired Troponin QC due to a vendor credit issue. Med LabTech 1 stated the Laboratory Manager/Director had instructed the staff to utilize the expired Troponin QC.

On 10/10/25 at 1332 hours, CLS 4 was interviewed and stated the laboratory had not received in-date supply of Troponin QC due to an internal "credit hold." CLS 4 stated the laboratory had been using expired Troponin QC for testing.

On 10/10/25 at 1336 hours, Med Lab Tech 2 was interviewed about the expired QC for troponin and stated a QVR existed and permitted the use of expired Troponin QC. Med Lab Tech 2 confirmed that the Troponin QC currently in use had a manufacturer-assigned expiration date of March 31, 2025.

Review of the Quality Variance/Patient Safety Report (QVR) showed the following:

"Date Initiated 3/31/25 ...Date of Variance/Event 3/31/25, Variance Initiated by [Name of Laboratory Manager/Director] ...Description of Variance ...QC for HsTrop expired on 3/31/25 - will be using QC past expiration date due to order not being released from [name of vendor] Not -paid ...Ok to use per [Name of Laboratory Manager/Director] ..." The QVR form was signed by the Laboratory Manager/Director and by the Medical Director.

On 10/9/25 at 1519 hours, the Laboratory Manager/Director stated being notified on 3/31/25 that the Troponin QC had expired on 3/31/25 and authorizing the staff to utilize the expired Troponin QC. The Laboratory Manager/Director confirmed that the laboratory had not received its new supply of Troponin QC materials due to a "credit hold" with the vendor. The Director stated that this issue was escalated internally, and the CNO was notified of the supply disruption.

On 10/10/25 at 1135 hours, the Laboratory Manager/Director was interviewed and stated the laboratory's internal P&P permitted the use of QC materials past their manufacturer-assigned expiration dates. The Laboratory Manager/Director stated that there were no manufacturer guidelines or documented approvals from the manufacturer that approved the use of expired QC materials. The Laboratory Manager/Director acknowledged that there was no documented evidence or literature from accredited sources that supported or validated this practice. The Laboratory Manager/Director confirmed regulatory agencies had not been contacted for guidance for Troponin QC extensions.

On 10/10/25 at 1539 hours, the survey team notified the hospital's administrative staff including the CNO, ACNO, Chief of Staff, and Chief Medical Advisor of an Immediate Jeopardy (IJ) due to the following deficient practices related to the laboratory services:

The hospital failed to ensure the availability and use of appropriate, non-expired Troponin QC materials for testing, thereby failing to ensure the quality, accuracy, and reliability of laboratory services for its patients.

The hospital laboratory did not ensure that all aspects of the test process were adequately controlled to produce accurate and reliable test results for patient care. Due to a vendor credit hold issue, the laboratory operated without appropriate, in-date Troponin QC materials for Troponin testing, from 5/1/25, to 10/10/25 (163 days). As a result, approximately 4,035 patient Troponin tests were processed using expired QC materials, placing all affected patients at risk for potential misdiagnosis or inappropriate treatment due to unreliable test results.

This situation represented an IJ because the non-compliance created a likelihood that serious harm, injury, or death to one or more patients could occur due to potentially inaccurate test results guiding critical medical decisions.

On 10/13/25 at 1431 hours, the CNO was interviewed and stated they were unaware that the laboratory was actively using expired Troponin QC materials. The CNO stated they were unaware of a "credit hold" issue with the vendor until after the Immediate Jeopardy (IJ) situation was declared on October 10, 2025. The CNO provided email correspondence with the Accounts Payable (AP) Supervisor, which was reviewed and showed:

- CNO Email dated 10/13/25 at 1110 hours: The CNO requested validation of an "aging AP" report, noting the hospital appeared to owe the vendor $16,256.

- AP Supervisor Email dated 10/13/25 at 1113 hours: The AP Supervisor responded that the cited amount was not owed by this hospital. The supervisor clarified that the outstanding balance was actually for two sister hospitals.

The CNO confirmed that the vendor had placed a credit hold impacting all connected hospitals, and this action prevented the hospital from receiving its new supply of necessary Troponin QC materials.

2. Review of the hospital's P&P titled Hematology Quality Control Policy dated May 2022 showed the following:

* Appropriate commercially prepared control materials will be used whenever possible for all assays and procedures.

* All control material will be prepared according to the manufacturer's recommendations.

* All materials are to be labeled with the prepared date (or the date they were put into use) and the expiration date, if applicable. All expired reagents are to be discarded.

* Controls will be run according to the specific policy for each assay.

* Expected results for each control will be defined by the manufacturer for each assay.

Review of the manufacture's instruction for use titled Coulter 6C Cell Control/QC revision history June 2025 showed 6C Cell Control is a hematology control material used to monitor the performance of UniCel DxH Coulter Cellular Analysis Systems listed in the table of expected results, in conjunction with specific Coulter reagent. It is not recommended to use the reagent after shelf-life expiration indicated on the label.

Review of the Quality Variance/Patient Safety Report (QVR) dated 9/20/25, showed the following:

- Description of Variance: 6 c QC, expires on 9/19/25
- SOP Title: Reagent Extension Procedure KPC-Gen-003
- Contributing Factors/Causes: "Credit Hold"
- Immediate corrective action taken: QC 6C has been ordered, awaiting payment for Vendor 2.
- Unit/Clinic/ED notified: No
- The Director of Laboratory Services and the Medical Director notified: Yes
- The section of "Pending Corrective Action" was left blank. The acknowledgement signature of the Laboratory Director was dated 9/22/25. The Medical Director section showed the physician signed and dated the form on 9/29/25.

Review of the report provided of the number of CBC /Differential testing dated 9/19 to 10/10/25 when the expired QC was used showed the following:

* Total tests: 1,325
* Total patients: 188

On 10/8/25 at 1005 hours, an interview with concurrent record review was conducted with CLS 2. When asked, CLS 2 state CLS 2 was responsible for the hematology in the core laboratory. CLS 2 further stated about a year or two, supplies had been taken a long time to deliver and had been running out of supplies for the last 12 months; the last six months had been worse. CLS 2 had been informed by the Laboratory Director that the shortage of laboratory supplies was related to non-payment. The hospital's laboratory had short of QC supply for CBC and differential. The QC testing was done 3 x/day, and the QC bottle expired in 16 days when opened. For the last two to four weeks, the laboratory staff had been using expired QC. This had been reported to the management. When asked, CLS 2 stated CLS 2 was not sure of the CBC/Differential accuracy of the results using the expired QC.

On 10/14/25 at 1010 hours, an interview and concurrent document review was conducted with the CNO. The CNO was asked about the P&P related to the use of expired supplies in the laboratory. The CNO stated the CNO was not aware and would look into correcting the P&P. The CNO was also informed about the manufacturer ' s instruction for use, related to the use of expired QC for CBC testing from 9/19 to 10/10/25.

On 10/23/25 at 1635 hours, an interview and review of the documents was conducted with the Chief Quality Officer. The document showed the CBC validation started on 10/10/25 at 1144 hours and completed on 10/17/25 at 1505 hours. Per the manufacturer's instructions, the results should be compared to a non-expired QC which was not available at the time of testing. Per the Chief Quality Officer, the available three QC boxes expired on 9/19/25, the machine showed it was passed, but unable to verify the accuracy of the test results.

3. Review of the POC accepted on 4/8/25, for the Complaint Validation Surveys completed on 2/25/25, showed the following:

Compliance and Monitoring:

- Once a week, the Director of the Lab/designee will update the CEO (via email or in person) on any issues related to the usage of [name of reference laboratory] services and any delays in send out labs. Any issues reported will be addressed immediately for resolution.

- Once a week, the Director of the Lab/designee will update the CEO (via email or in person) on any issues related to supplies, reagents, broken equipment, or credit holds. Any issues reported will be addressed immediately for resolution including escalation to the CFO, CMO, and the Governing Body.

- Data will be collected until 90% compliance is achieved for three consecutive months.

- Data collected from the above-listed audits will be added to the hospital-wide QAPI and presented quarterly to the Medical Executive Committee and the Governing Body.

Responsible Person:
- CEO and Director of Laboratory

Compliance and Monitoring:

- Once a week the CEO/Director of the Laboratory will round in the lab to ensure reagents and supplies are available, the equipment is functional and there are no reported issues impacting the adequacy of laboratory services. Any reported issues will be corrected and escalated through the appropriate Chain of Command. Records of rounding and findings/corrective actions will be kept.

- Once a month the Director of the Laboratory will audit 30 STAT orders to ensure the results are available timely as per hospital policies. Any issues identified will be corrected and the staff will be educated. Records of the audits and any corrective actions will be kept.

- Data will be collected until 90% compliance is achieved for three consecutive months.

- Data collected from the above listed audits will be added to the hospital wide QAPI and presented quarterly to the MEC and the GB.

Responsible Person:
CEO and Director of Laboratory
Corporate CFO

Compliance and Monitoring:

- Once every 2 weeks, the CEO will meet with the Director of the Laboratory to ensure all services are available in- house or via contracted services, equipment is functional, turnaround times are acceptable and within hospital
policy, and reagents and supplies are available. Any issues identified will be corrected. Unresolved issues will be escalated to corporate leadership and the GB.

- Data will be collected until 90% compliance is achieved for three consecutive months.

- Data collected from the above listed audits will be added to the hospital wide QAPI and presented quarterly to the MEC and the GB.

Responsible Person:
CEO and Director of Laboratory

Review of the POC with a date of completion of 8/16/25, for the Complaint Validation Surveys completed on 7/2/25, showed:

MONITORING:

- Once a month, The Laboratory Manager or designee will audit 20 STAT send out tests to ensure they were processed timely as per the vendor listed/promised times. Any issues identified will be corrected and the staff will be reeducated.

- Once a month the Laboratory Manager/designee will audit 30 send out test and the report provided by the vendor on processing times to ensure tests are process I accordance with agreed upon/promised/listed times. And delays noted will be addressed with the vendor immediately

- Daily, The Laboratory Manager or designee will monitor any laboratory services disruptions and ensure that appropriate staff, patients and physicians are aware. Any disruptions will be reported to the CNO and all other impacted parties as per the contingency plan.

- Once a week, the Laboratory Manager or designee will audit quality control for hematology to ensure that staff followed P&P on the use of expired reagents/quality control (if applicable). Any issues identified will be corrected and the staff will be reeducated.

- Data will be collected until 90% compliance is achieved for three consecutive months.

- The data collected from these audits will be added to the hospital wide QAPI and presented quarterly at Quality Council Meetings, the Medical Executive Committee and the Governing Board.

RESPONSIBLE PERSON:
Laboratory Manager/Director/Designee

During an interview on 10/20/25 at 1100 hours, the CNO stated they began employment in June 2025 and did not receive formal "hand-off" from the former CEO whose position was currently vacant following their separation from the hospital. The CNO was unaware of the POC or monitoring status related to deficiencies found during previous surveys.

On 10/22/25 immediately following the QAPI meeting, at approximately 1400 hours, the survey team requested this missing POC data from the CNO, CQO, Patient Experience, Trauma Program Director, and ACNO. This requested information was never provided to the survey team before the survey exit conference.






29798


4. On 10/7/25 at 1650 hours, during an interview with the Laboratory Quality Coordinator regarding the hospital's P&P for TAT for STAT orders send-out to referral laboratory, the Laboratory Quality Coordinator stated the hospital did not have a P&P for STAT TAT send out tests.

Review of the hospital's P&P titled STAT Specimen Handling, Testing and Reporting showed the P&P was revised/reviewed on 10/20/25, for "Addition of #7 to procedure part III.A" and on 10/21/25, for "Addition of STAT Referral Testing TAT to .... (number 8 to part A)."

Further review of the P&P titled STAT Specimen Handling, Testing and Reporting showed in part:

* Scope: All Laboratory Staff

* Procedure for Specimen Handling:

- All specimens requested STAT will be brought or tubed to Triage within 15 minutes of collection.

- For send out testing, the facility will attempt to deliver the specimen to the outside laboratory as quickly as possible depending on the courier availability. TAT for send out tests depend on the receiving laboratory policies.

- All referral testing ordered as STAT will be called and documented in the "LS FORM 134 - STAT Referral Test Tracking Log." CPTs are responsible for keeping track of the time called Courier and pick up time. CLS are responsible for keeping track of the date/time result is finalized. The Courier will try to come to pick up within the hour called and deliver to the receiving lab as soon as possible. Actual TAT will depend upon transport time and destination, as well as the Reference Laboratory's Policy and Procedures.

- LS FORM 134 will be reviewed DAILY by the Chemistry Clinical Lab Scientist to ensure all STAT Send-outs are finalized in the LIS system in a timely manner once results are faxed to the Mail Lab printer. If results are not faxed within the appropriate TAT, the LAB will follow up to obtain status update from the STAT Referral Lab.

- Per [name of outside laboratory]'s Laboratory Outreach and Client Services Supervisor, providing a specific TAT from call for courier service to final report in-hand is test dependent. Published TATs are available in the [name of outside laboratory] Lab Test Directory. The two tables below would be considered a minimum/maximum for tests that are offered STAT. Reports are auto-faxed and available in LifePoint immediately upon completion. Courier TAT also varies based on our vendor's resources at time of call, but 2 hours is the outside limit of acceptability in Central Orange County.

- For basic chemistry/hematology tests with analytical time of one hour:

STAT Courier (from client call to delivery at [name of the outside laboratory]): 2 hours
Processing Time: 0.5 hours
Analytical time: 1.0 hours
Total: 3.5 hours.

- For specialty tests offered STAT such as pentobarbital with analytical time of eight hours:

STAT courier (from client call to delivery at [name of the outside laboratory]): 2 hours
Processing time: 0.5 hours
Analytical Time: 8 hours
Total: 10.5 hours

* Responsibilities:

- Phlebotomy and Triage staff is responsible for the timely collection of all STAT laboratory tests. Significant problems/delays should be documented using the Lab QI form.

- Lab Management will be responsible for monitoring TAT on at least a monthly basis or more frequently as required.

* If a delay of greater than 30 minutes beyond the expected TAT, the CLS should notify the affected floor of the expected time until completion or if the delay will be considerable, to offer testing at alternative sites.

Review of the random STAT send-out orders audit from 9/8/25 to 9/30/25, showed the following:

* For Patient 1, the urine urea test was picked up on 9/8/25 at 0824 hours. The urine urea test result was available on 9/11/25 at 2245 hours, which was approximately 86 hours later.

* For Patient 2, the fentanyl (an opioid) test was picked up on 9/14/25 at 1702 hours. The fentanyl test result was available on 9/16/25 at 1300 hours, which was approximately 43 hours later.

* For Patient 3, the acetaminophen (a pain medication) and salicylate (chemical used in products like aspirin [a pain medication]) tests were picked up on 9/23/25 at 1545 hours. The acetaminophen test result was available on 9/25/25 at 1700 hours and salicylate test results were available on 9/25/25 at 1703 hours, which was approximately 49 hours later.

* For Patient 5, the ETOH (ethanol, a type of alcohol) test was picked up on 9/28/25 at 2153 hours. The ETOH test result was available on 9/29/25 at 1927 hours, which was approximately 22 hours later.

On 10/23/25 at 1420 hours, the findings were verified by the CNO and Trauma Program Director.

5. Review of the hospital's Continuity of Operations Plan (undated) showed in part, "Laboratory Continuity of Operations Procedures...Notify physicians (explore alternative comparable testing), CDPH, staff and patients of the disruption in services..."

On 10/8/25 at 0905 hours, the Director of Laboratory Services stated some of the reagents to perform the laboratory testing were not available. The Director of Laboratory Services communicated the issue to the administration team via email. Upon request for evidence of reporting, the Director of Laboratory Services provided the email correspondence.

Review of the codependence between the laboratory staff, Laboratory Director, and the hospital's administration, showed the following:

* On 6/23/25 at 0946 hours, the Laboratory Director emailed that chemistry testing disruptions had occurred and would occur at multiple OC sites. The recipients included the CNO and the corporate CFO.

* On 7/8/25 at 1515 hours, an email from CLS 3 showed CLS 3 had just been notified by Vendor 1 that no reagents will be shipped due to a credit account blockage. On 7/21 at 1316 hours, and 8/4/25 at 0730 hours, the email showed the account was still blocked.

* A letter dated 7/29/25, showed the Laboratory Medical Director sent the hospital's CNO about the shortage of Blood Bank Reagents in the laboratory. Further review of the letter showed this served as official notification from the Laboratory Department of [Hospital B]. There would be testing disruption in the Blood Bank unless reagents are received by next week.

* On 7/29/25 at 1137 hours, an email from the Laboratory Director showed the reagents from Vendor 1 had not shipped and testing interruption was imminent due to a credit hold on the account. The email was addressed to the CNO and the corporate CFO.

* On 7/31/25 at 1040 hours, an email from the Laboratory Quality Coordinator showed Vendor 1 would not ship-out any products unless full payment is received. The recipients included the Laboratory Director, the CNO, the Laboratory Medical Director, and the Accounts Payable.

* On 7/31/25 at 1116 hours, an email from the Laboratory Medical Director to the Laboratory Director, the CNO, the Laboratory Quality Coordinator, and the Accounts Payable showed "please be advised that if we run out of requested reagents, there is no choice but to close the [Hospital B]'s blood bank down."

* On 8/4/25 at 1149 hours, an email from CLS 3 showed "Kindly process this order STAT ... This is a new order as replacement to the one created on 7/21/25." Per Vendor 1, no pending orders to process due to the credit backlog.

* On 9/9/25 at 1320 hours, CLS 3 sent an email with the subject line as "URGENT: Credit Hold and Critical Shortage" of Vendor 1 Red Cell Reagents. The recipients included the Laboratory Director, the CNO, and the Laboratory Quality Coordinator.

* On 10/15/25 at 1534 hours, an email from the Laboratory Quality Coordinator to the Laboratory Director, the CNO, and the Purchasing Department showed "Can we please get our hold clear from Med Water System? We are unable to borrow from other sites. The quality of our DI water used for testing will be below recommended level if this is unresolved."

Review of the Requisition dated 9/23/25, showed the requestor who was CLS 3. The handwritten note on this form showed on 10/16/25 at 1200 hours, it was still on credit hold.

On 10/16/25 at 1405 hours, an interview was conducted with CLS 1. CLS 1 stated orders dated 7/24, 9/3, and 9/19/25, for hematology reagents have not been received as of today or 10/16/25. CLS 1 further stated an email dated 10/12/25 at 1743 hours, was sent to the Laboratory Director, the CNO, and the Laboratory Quality Coordinator regarding these orders.

On 10/16/25 at 1635 hours, an interview was conducted with the Laboratory Director. The Laboratory Director stated there was no notification to the physicians (explore alternative comparative testing), CDPH, and patients of the disruption in services.

6. On 10/16/25 at 1505 hours, an interview was conducted with CLS 1. CLS 1 stated the laboratory's pneumatic tubing system had not been working for three to fourth months. The triage CLS had to go to each unit to collect the specimens for processing which contributed to the delay in results for in-house and send-out to the referral laboratory. Therefore, the results were not obtained within the allotted time of four to six hours. When asked, CLS 1 stated they were not aware of the reason for the delay with the work order.

Review of the hospital's P&P titled Work Order Assignment, Priority & Completion dated August 2023 showed the following:

* Scope: Facilities/Engineering Department

* Purpose: To establish a methodology for the prioritization and completion of both maintenance work order and preventive maintenance work orders (called PMs)

* Policy: Work orders classified as Emergency/Urgent have priority over work orders classified as Non-Emergency/Routine. Non - Medical Equipment work orders shall be completed in the following priority as identified by its equipment classification:

- Unscheduled Non-emergency or House HELP calls, projects and the remaining work orders shall be managed according to the Facility Manager workflow and priority based, first on risk, second on age/importance. (Less than 30 days is the established benchmark for work orders).

* Procedure:

- Assigned work is expected to complete on every shift by each individual unless the circumstances preventing the completion of the assigned work is communicated to your immediate supervisor.

- If the assigned work cannot be completed, notify the department supervisor of the circumstances surrounding the delay.

- Additionally, if applicable, notify the affected department supervisor/manage/director of the delay in completing the requested work and provide them with an estimated time of completion.

Review of the hospital's Continuity of Operations Plan (undated) showed the following:

- Laboratory & Pathology Services is a mission critical department requiring the continuity or immediate recovery of services and processes

- Interdependencies: To perform mission critical processes, the department depends on the following internal and external services... Pneumatic Tubing System.

Review of the document titled Request Work Order showed the following:

* WO# 723200
* Account: Plant maintenance
* Date Orig: 9/10/25 at 1425 hours
* Sub-status: Issued, Being Worked
* The sections of "Completed By:" "Date:" and "Time" were left blank.
* Comments section showed "Board is obsolete. Pending system upgrade."

On 10/16/25 at 1615 hours, the laboratory's pneumatic tubing system work order dated 9/10/25 was shared with the CNO. The CNO stated the CNO was aware of the issue with the tubing system being obsolete throughout the hospital and needed to be replaced. The replacement of the tubing system has been evaluated at the cost of $90,000 for replacement, and the administration had been working with the headquarters regarding replacement of the system.

On 10/23/25, the above findings were verified with the CNO and the Chief Quality Officer.

On 10/22/25 at 1140 hours, an interview was conducted with CLS 3. When asked, CLS 3 stated on October 8 or 9, 2025 at 0700 hours, a meeting was called by the Laboratory Manager. The Laboratory Manager stated per the administration, "whoever is calling CDPH to complain if this keeps happening, the staff will loose their job. This was repeated two times." CLS 3 further stated "I was offended, the staff is here to serve the patients and we rely on our paycheck we are going above and beyond what we need to do. Two staff members are leaving due to the laboratory's instable situation related to the ongoing shortage of supplies."

On 10/22/25 at 1200 hours, an interview was conducted with CLS 4. When asked, CLS 4 stated on 10/8/25 at 0700 hours, the Laboratory Manager held a meeting with the laboratory staff. The Laboratory Manager stated the Laboratory Manager had a message from the administration "someone keeps calling CDPH about the shortage of laboratory supplies. If you keep doing this we'll have to close the laboratory, and you'll loose your job." CLS 4 further stated "I felt threatened plan to leave the facility due to lack of supplies, lack of support, and feeling threatened by the laboratory manager."

On 10/22/25 at 1225 hours, an interview was conducted with CLS 5. When asked, CLS 5 stated CLS 5 attended the meeting with the Laboratory Manager regarding calls to CDPH. CLS 5 stated "felt more uncertain about my job, the CNO came and talk to us stating if we keep calling CDPH we'll loose our job. We need