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 review of proficiency testing documentation and staff interview, the laboratory failed to enroll in an approved proficiency testing program for the regulated manual identification of blood cells for 2 of 2 years (2023, 2024) reviewed. The laboratory performed approximately 100 manual blood cell identifications on patient samples per year. The findings were: 1. Review of the 2023 Event #2 through the 2024 Event #2 Wisconsin State Laboratory of Hygiene proficiency testing records showed the laboratory was enrolled in an automated complete blood count with a white blood cell differential program; however, had failed to enroll in a program to evaluate the manual method for identifying blood cells. 2. Interview with the technical supervisor on 9/10/24 at 2 PM confirmed the laboratory had failed to enroll in a proficiency testing program for manually identifying blood cells. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and staff interview, the laboratory director failed to attest to the routine integration of the WSLH (Wisconsin State Laboratory of Hygiene) proficiency testing events into the patient workload using the laboratory's routine methods for 3 of 17 proficiency testing events reviewed from June 2023 through August 2024. The findings were: 1. Review of the 2023 WSLH Coagulation event #2, the 2023 WSLH Hematology event #2, and the 2024 WSLH Bacteriology-Viral event #2 records showed the laboratory director had failed to sign the attestation statements. 2. Interview with the technical supervisor on 9/10/24 at 10: 01 AM confirmed no further documentation was available. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, review of personnel records, policy and procedure review, and staff interview, the laboratory failed to ensure the 6-month competency assessment was completed for 2 of 3 (TP #1, TP #2) testing personnel; and a policy and procedure was developed for assessing the competency of the general and technical supervisors. The findings were: 1. Review of the CMS-209 Laboratory Personnel Report showed the laboratory employed one technical supervisor, one general supervisor, and three testing personnel. The following concerns were identified: a. Review of the personnel file for TP #1 showed she was hired in January of 2024. There was no evidence a 6-month competency assessment had been completed. b. Review of the personnel file for TP #2 showed she was hired on 8/23 /23. There was no evidence a 6-month competency assessment had been completed. c. Review of the personnel files for the general supervisor and technical supervisor showed no competency assessments had been completed for the responsibilities of either position. 2. Review of the Quality Assurance Plan policy, approved by the laboratory director on 4/8/24, showed "... PERSONNEL ASSESSMENT Twice a year the first year and at least annually thereafter, the Technical Consultant [the lab was previously a moderate complexity laboratory] will review performance of each employee working in the laboratory to assure employee competency. This will be accomplished by having each employee perform split sample testing, by direct observation of testing skills, and by continuing education seminars. The written results of the review will be filed in the individual's personnel file." Further review of the policy showed no evidence a procedure had been developed to ensure the competency of the general and technical supervisor's responsibilities. 3. Interview with the technical supervisor on 9/10/24 at 10:24 AM confirmed the 6-month competency assessments had not been completed and a procedure had not been developed to assess the competency of the technical and general supervisors. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) -- 2 of 5 -- The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing records, lack of documentation, policy and procedure review, and staff interview, the laboratory failed to have a system in place for reviewing proficiency test results that received an artificial score of 100% for 3 of 17 WSLH (Wisconsin State Laboratory of Hygiene) proficiency testing events reviewed from June 2023 through August 2024. The findings were: 1. Review of the WSLH 2024 Hematology Event #1 proficiency testing evaluation showed the laboratory received an artificial score of 100% on the reticulocyte count challenge due to an insufficient peer group. There was no documentation a self-evaluation of the reticulocyte count results had been completed. 2. Review of the WSLH 2024 Special Chemistry Event #1 proficiency testing evaluation showed the laboratory received an artificial score of 100% on the analyte of estradiol. Sample CS-03 was not graded to a lack of consensus. There was no documentation a self-evaluation of the estradiol result had been completed. 3. Review of the WSLH 2024 Bacti-Viral Event #1 proficiency testing evaluation showed the laboratory received an artificial score of 100% on the detection of norovirus. Sample EP-5 was not graded to a lack of consensus. There was no documentation a self-evaluation of the norovirus result had been completed. 4. Interview with the technical supervisor on 9/10/24 at 10:01 AM confirmed no further documentation was available. 5. Review of the Proficiency Testing