Community Action Against Addiction

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on record review and an interview with the General Supervisor (GS), the laboratory failed to verify the accuracy of analytes not evaluated or scored by the College of American Pathologists (CAP) proficiency testing (PT) provider on five out of five Toxicology urine drug screen (UDS) testing events between 2021 and 2023. This deficient practice had the potential to affect 153,000 out of 153,000 patient toxicology testing procedures performed. Findings Include: 1. Review of the laboratory's "Proficiency Testing Policy", approved by the Laboratory Director on 08 /28/2021 and provided for the inspection, found the following statement: "Any analyte not evaluated by the PT provider (due to lack of consensus, limited participants, a zero score for non-participation, or late return of results) will require further investigation and documentation." 2. Review of five out of five CAP PT events for the third event of 2021, the first, second and third events of 2022 and the first event of 2023 for the high complexity UDS testing revealed the following ungraded results without any documentation of self-evaluation: 2021 UDS-C UDS-14 Fentanyl-insufficient peer group 2022 UDS-A UDS-04 Fentanyl-insufficient peer group UDS-05 Benzodiazepine-lack of consensus UDS-B UDS-06 Fentanyl-insufficient peer group UDS-C UDS-13 Fentanyl-insufficient peer group 2023 DAI-A DAI-01 qual; pH, specific gravity-edu. chal. DAI-02 qual; pH, specific gravity-edu. chal. DAI-03 qual; pH, specific gravity-edu. chal. DAI; drug adulterant indicator qual; qualitative edu. chal.; educational challenge 3. The Inspector requested the laboratory's self evaluation Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- documentation for the ungraded PT results listed above from the GS. The GS, via electronic mail (email) on 04/12/2023 at 1:39 PM, stated "Moving forward we will perform PT self-evaluation for samples not graded.". D5783

Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on record review and interviews with the General Supervisor (GS) and Testing Personnel (TP) #2, the laboratory failed to ensure that the test requisitions included (1) The name or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results. Findings Include: 1. Review of two out of six of the laboratory's 2018 and 2019 test requisitions, provided on the date of the inspection, did not find the name of the authorized individual who ordered the urine drug screen testing. 2. The Inspector requested the laboratory's requisition that included the authorized person requesting the test and responsible for using the test results from the GS and TP#2. The GS and TP#2 confirmed that the ordering individual was not indicated on two out of six test requisitions reviewed and were unable to provide the requested documentation on the date of the inspection. The interview occurred on 01/24/2019 at 12:40 PM. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --