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Based on interview and document review the facility failed to promptly investigate and analyze an adverse patient event occurring on 2/6/2019 in which a patient was diagnosed with and treated for an infection based on a laboratory error. The patient was given positive laboratory results based on a urinalysis performed on another patient's specimen. Findings are:

-Review of the laboratory incident report (QAILR) on 8/29/2019 indicates the report was not completed until 7/11/2019, five months after the event occurred. Interview with the Vice President of Patient and Clinical Services on 10/23/2019 confirmed the event was not reported to the hospital's patient safety officer thereby missing an opportunity for review and analysis by the hospital wide QAPI program.

-Laboratory policy had not been revised in response to this error. Review of the laboratory incident report (QAILR) on 8/29/2019 shows the hospital recommended corrective actions, but review of policy Xpert Assay Knowledge Assessment, which was provided as the policy for the CT/NG PCR, does not show the corrective actions described in the QAILR.

-During an interview on 8/29/2019, the Supervisor of the Microbial Lab stated that all the lab staff had not been retrained on these identified corrective actions with competencies documented.

Based on interview and record review the hospital failed to provide laboratory services in accordance with facility policies designed to ensure quality control and quality assurance.

Findings:

-An 8/29/2019 review of the medical record of patient #1 indicates the hospital emergency department sent a urine specimen collected from the patient to the hospital microbiology laboratory on 2/6/2019. The hospital laboratory reported the specimen out as positive for Chlamydia trachomatis. Department of Health survey staff reviewed Appendix A of the Critical Value Policy during the 8/29/2019 site visit to the hospital. The policy, in the microbiology section, includes CT/NG (GC/Chlamydia) PCR on the list of critical values where an alert is required.

- The Critical Value Protocol policy for the hospital in the Procedure section also states "that all critical/alert values will be verified. A specimen quality check will be done by manually looking at the sample for acceptable quantity and quality." The process section states "When a critical/alert value is encountered, the sample MUST have a specimen quality check." The patient's medical record from 2/6/2019 did not indicate a specimen quality check was done; no such field appears on the patient's lab report confirming a quality check was done following a detected result.

-Four days later, in response to a 2/10/2019 inquiry from the patient regarding the validity of the positive Chlamydia test result, the hospital microbiology laboratory retested patient #1's urine specimen.

-The laboratory technician at that time noticed that based on the amount of urine in the collection device, patient #1's specimen had never been tested, while another patient, patient #2 had been tested twice.

-The laboratory technician identified that on 2/6/19 she placed both patients CT/NG PCR cartridges in the hood at the same time. The Tech states she did not cross check the name and date of birth on patient #1's sample, and erroneously used patient #2's sample to set up the PCR cartridge for patient #1. This resulted in both patients testing positive. This error was not documented in an incident report (QAILR) until five months later on 7/11/2019. The laboratory supervisor stated on interview on 8/29/2019 that it is the lab's unwritten policy that only one patient specimen at a time should be under the hood.

-Corrective actions outlined in the QAILR indicated the following:

"It will be mandated that only one sample, one set of labels, and one PCR cartridge will be present in the BSC II cabinet at a time. This will prevent using the wrong sample when setting up testing, as well as prevent cross contamination.

-During set-up labels will be compared to the sample prior to labeling the PCR test cartridge, thus ensuring that the correct patient is being tested for the correct analyte using the appropriate cartridge.

-Prior to placing the cartridge on the instrument for testing the patient information and identifiers will be checked one last time to ensure that it is the correct patient and correct test.

-The specimen collection devises will also be checked prior to storing, to ensure that the appropriate volume has been removed for testing If there is any question or concern that samples were switched, the test will be canceled and reset with the remaining sample."

-The Lab Supervisor stated during an interview and document review on 8/29/19 that the majority of the lab staff had not been retrained regarding the corrective actions identified in the QAILR from event on 2/6/19.

-The laboratory supervisor also stated that annual employee competencies were 1-2 years behind and had not been completed for the Lab Tech involved in the incident nor for most of the staff.


-Review of the Policy & Procedure for Education and Staff Competency on 8/29/2019 states in the
Procedure section that:
a. all Staff are required to complete annual mandatory education (CORE) pertaining to key content.
b. Department and job specific competence will be established by the Director of the department.
i. These will be reviewed with the employee at their annual evaluation

Based on interview and record review, emergency department personnel failed to notify a discharged patient of his correct laboratory results.

Findings:

-Review of the medical record of Patient #1 indicates that the patient was discharged from the emergency department of the hospital on 2/6/2019 having been given a diagnosis of Chlamydia trachomatis identified in a urinalysis.

-Review of an e-mail from the Administrative Director of Laboratory Services of the hospital indicates that patient #1 telephoned the emergency department on 2/10/2019 questioning the validity of the positive test result for Chlamydia. Emergency department staff called the laboratory to inquire about the patient's results. Review of the e-mail documented that the laboratory suspected that they had tested the wrong specimen on 2/6/2019. They ran the test on the patient's specimen at 1204 on 2/10/2019, identifying a negative result. At 1251, a corrected report was called to a registered nurse in the emergency department.

-Review of the e-mail from the Administrative Director of Laboratory Services of the hospital indicates that the corrected report was not sent to patient #1's primary care physician, nor was the patient notified of the corrected result despite the fact that he (the patient) had called earlier that day to question the validity of the result he had been given on 2/6/2019.