Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on direct observation, record review, lack of documentation, and interview, the laboratory failed to enroll in an HHS approved proficiency testing (PT) program for tests performed in the specialty of Microbiology during the year of 2020 and 2021. Findings include: 1. The Affirm VPIII Lab testing log from 06/10/2020 to 09/25/2021 was reviewed. 2. On 09/27/2021 at 9:50 AM during a tour of the laboratory, the surveyor observed that the laboratory used BD Affirm VPIII Microbial Identification Test system to detect and identify Candida species (Yeast), Gardnerella vaginalis (GV) and Trichomonas vaginalis (Trich). 3. The VPIII test log showed the following: * The laboratory began testing on 06/10/2020 * 167 patients have been tested using the BD Affirm VPIII 4. Review of laboratory records found the laboratory lacked any documentation for proficiency testing enrollment for Gardnerella vaginalis testing using the VPIII Affirm test system. 5. On an Initial survey conducted on 09/27/2021 at 11:15 AM, the laboratory director confirmed the above findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview, the laboratory failed to establish and follow written policies and procedures to assess employees performing the Affirm VPIII Microbial Identification test for three out of three testing personnel (TP). Findings include: 1. The Affirm VPIII Lab testing log from 06/10/2020 to 09/25 /2021 and the Laboratory Personnel Report (CMS 209) were reviewed. 2. The laboratory used the BD Affirm VPIII Microbial Identification Test to detect and identify Candida species (Yeast), Gardnerella vaginalis (GV) and Trichomonas vaginalis (Trich). 3. CMS 209 listed three TP (TP1, TP2, and TP3) performing the BD Affirm VPIII test. 4. The laboratory failed to establish a step-by-step procedure that includes the following criteria to access TP competency: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing, as applicable; b). Monitoring the recording and reporting of test results (for example, recording patients and their results in the labs' test log and EMR system); c). Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; d). Direct observation of performance of instrument maintenance and function checks; e). Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; f). Assessment of problem solving skills; and g). Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually. 5. 167 patients were tested during the time period reviewed by TP1, TP2, and TP3. 6. On an Initial survey conducted on 09/27/2021 at 11:15 AM, the laboratory director confirmed the above findings. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on direct observation, record review, lack of documentation, and interview, the laboratory failed to verify the accuracy of the Candida species (Yeast) and Trichomonas vaginalis (Trich) testing performed during the years of 2020 and 2021. Findings include: 1. The Affirm VPIII Lab testing log from 06/10/2020 to 09/25/2021 was reviewed. 2. On 09/27/2021 at 9:50 AM during a tour of the laboratory, the surveyor observed that the laboratory used BD Affirm VPIII Microbial Identification Test system to detect and identify Candida species (Yeast), Gardnerella vaginalis (GV) and Trichomonas vaginalis (Trich). 3. Review of laboratory records found the laboratory lacked any documentation and failed to establish a method to verify the accuracy of its Yeast and Trich test system at least twice annually. 4. The VPIII test log showed the Yeast and Trich tests were reported for 167 patients during the time reviewed. 5. On an Initial survey conducted on 09/27/2021 at 11:15 AM, the laboratory director confirmed the above findings. -- 2 of 9 -- D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, manufacturer's instructions, lack of documentation, and interview, the laboratory failed to have written procedures (D5401); failed to monitor and document manufacturer required environmental and testing conditions to ensure accurate and reliable testing (D5411, D5413), and failed to establish and follow control procedures for 71 out of 91 days of BD Affirm Microbial Identification testing (D5441), affecting 117 patients. 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 direct observation, record review, lack of documentation, and interview, the laboratory failed to establish and follow a written procedure for the BD Affirm VPIII Microbial Identification Test Microbiology test performed affecting 167 patients. Findings include: 1. The Affirm VPIII Lab testing log from 06/10/2020 to 09/25/2021 was reviewed. 2. On 09/27/2021 at 9:50 AM during a tour of the laboratory, the surveyor observed that the laboratory used BD Affirm VPIII Microbial Identification Test system to detect and identify Candida species (Yeast), Gardnerella vaginalis (GV) and Trichomonas vaginalis (Trich). 3. The laboratory failed to have a written procedure manual that includes the following, as applicable: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Verification procedures; manufacturer's instructions. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures and manufacturer's requirements. (8)