Kenosha County Div Of Health Laboratory

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of testing supplies and interview with a Technical Consultant (Staff A), the laboratory did not label one of one KOH (Potassium Hydroxide) dropper bottle used for Provider Performed Microscopy (PPM) procedures with the solution preparation and expiration dates. Findings include: 1. Observation of the KOH used in the clinic for PPM procedures showed the dropper bottle label stated the contents expire when precipitate forms. No preparation date or expiration date was present on the bottle. 2. Interview with Staff A on July 25, 2024, at 12:30 PM revealed Staff A made the KOH solution on site and confirmed the label did not include the required information. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and 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 -- precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and interview with a technical consultant (Staff B), the laboratory procedure did not define the type, number and frequency of external controls required for the Syva RapidTest d.a.u. test for methamphetamine (mAMP) test, one of one cartridge test system in use in the laboratory, prior to starting testing in March 2024. Findings include: 1. Review of the laboratory procedure, 'Syva RapidTest d.a.u. mAMP', showed the procedure included the following statement concerning external controls. "External Controls may also be used to ensure that the reagents and assay procedures are performing properly. Control should be tested at regular intervals (e.g. once per lot or once per shipment) as part of a good laboratory testing practice." 2. Interview with Staff B on July 25, 2024, at 12:45 PM confirmed the laboratory procedure did not define the type, number, and frequency of external controls required prior to testing patient samples with the Syva RapidTest d.a.u. mAMP test. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and test records and interview with a technical consultant (Staff B), the laboratory did not test a positive and negative control material each day the laboratory performed patient methamphetamine (mAMP) testing in the last four of four months using the Syva RapidTest d.a.u. mAMP cassette test. Findings include: 1. Review of laboratory procedures for the 'Syva RapidTest d.a.u. mAMP' showed the procedure included the following statement concerning external controls. "External Controls may also be used to ensure that the reagents and assay procedures are performing properly. Control should be tested at regular intervals (e.g. once per lot or once per shipment) as part of a good laboratory testing practice." 2. Review of testing records for the Syva RapidTest d.a.u. mAMP showed no evidence the laboratory performed external controls for the test. 3. Interview with Staff B on July 25, 2024, at 12:45 PM confirmed the laboratory had not performed a positive and negative control each day of patient testing and did not develop an IQCP (Individualized Quality Control Plan) for the test system since the laboratory started testing in March 2024. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently -- 2 of 3 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on surveyor review of the verification studies for moderate complexity drug testing and interview with a technical consultant (Staff B), the director did not document review and approval of the verification studies the laboratory performed for thirteen of thirteen drugs tested with the Viva Pro-E analyzer. Findings include: 1. Review of verification studies for testing performed on the Viva Pro-E analyzer showed no evidence of review and approval of the accuracy, precision, and other pertinent performance characteristics of the test methods for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates, methadone, oxycodone, ecstasy, buprenorphine, phencyclidine, fentanyl, and ethyl alcohol. 2. Interview with Staff B on July 25, 2024, at 12:15 PM confirmed the director had not documented the review and approval of the performance specification verification studies for the drugs tested with the Viva Pro-E analyzer to ensure the procedures were adequate to determine the accuracy, precision, and other performance characteristics of the test methods. -- 3 of 3 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on surveyor review of Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records and interview with a technical consultant, staff A, testing personnel did not attest to the routine integration of the samples into the patient workload using the laboratory's routine methods for one of two MiscQA-POC events in 2021 used to assess provider performed microscopy (PPM) testing. Findings include: 1. Review of WSLH PT records showed testing personnel did not sign the attestation statement for PPM PT event number one, MiscQA-POC1. 2. Interview with staff A on July 12, 2022 at 10:25 AM confirmed testing personnel did not attest to the routine integration of the samples into the patient workload using the laboratory's routine methods for one of two MiscQA-POC events in 2021 used to assess provider performed microscopy (PPM) testing. This is a repeat deficiency from June 21, 2010 and November 5, 2020. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on surveyor review of the submitted Clinical Laboratory Improvement Amendments (CLIA) Application for Certification Form CMS-116 (Centers for Medicare and Medicaid Services) and the laboratory's test menu, and interview with the laboratory director and a technical consultant, staff A, the laboratory director did not ensure notification requirements were met as required at 493.51. Findings include: 1. Review of the CMS 116 for submitted during the survey showed the laboratory no longer performs testing in the Bacteriology subspecialty. 2. Review of the "Test Menu for Kenosha County Division of Health" showed no bacteriology testing listed. Further review showed the laboratory only performs moderate complexity testing with no high complexity testing as per previously classified. 3. Interview with the staff A on July 12, 2022 at 9:15 AM confirmed the laboratory discontinued bacteriology testing in 2020. 4. Interview with the laboratory director and staff A on July 12, 2022 at 10:45 AM confirmed the laboratory director did not ensure the laboratory notified Health and Human Services (HHS) or its designee within six months of discontinuing testing in a subspecialty as required at 493.51 (c). -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records from 2019 and 2020 and interview with the laboratory director, the laboratory director did not attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. Findings include: 1. Review of PT records showed the laboratory director did not sign the following attestation statements for Bacteriology and Syphilis testing: 2019 event one; bacteriology and syphilis 2019 event two; bacteriology 2020 event one; bacteriology and syphilis 2020 event two; bacteriology and syphilis 2020 event three; bacteriology and syphilis 2. Interview with the laboratory director on November 5, 2020 at 10:35 AM confirmed the laboratory director did not sign the attestation statements for PT events in 2019 and 2020. This is a repeat deficiency previously cited on June 21, 2010. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: 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 -- Based on surveyor review of manufacturer's instructions, laboratory records, and interview with the technical consultant, the laboratory has not followed the manufacturer's instructions for the BD (Becton Dickinson and Company) Macro-Vue RPR (Rapid Plasma Reagin) test system in 2019. Findings include: 1. The manufacturer's instructions for the BD Macro-Vue RPR Cards stated the antigen suspension should be warmed to room temperature (23 - 29 degrees Celsius (C), 73.4 - 84.2 degrees Fahrenheit) before use. 2. Review of documented room temperatures in the laboratory in 2019 showed the laboratory recorded temperatures on 246 days. Only 20 of the 246 recorded temperatures in 2019 showed an entry at or above 73.4 degrees. There were zero days from April 24 to November 18, 2019 with recorded room temperatures acceptable for testing with the Macro-Vue RPR Cards. 3. Interview with the technical consultant, staff A, on November 5, 2020 at 11:50 AM confirmed room temperatures recorded in the laboratory in 2019 did not meet the manufacturer's requirements for RPR testing. This is a repeat deficiency previously cited on June 12, 2014. D5785

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures, patient test results, and interview with the technical consultant, the procedure for the wet mount microscopic examination was not available to laboratory personnel. Findings include: 1. Review of the laboratory procedure manual revealed no procedure was available for the examination and result reporting of wet mount preparations. 2. Review of patient report from this laboratory (patient 1) revealed a wet mount examination was performed and reported on April 9, 2018. 3. Email correspondence received on July 2, 2018 at 3:15 PM from the technical consultant confirmed a procedure for wet mount examinations was not available to laboratory personnel. 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 --