Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory supervisor, the laboratory failed to test the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) samples for complete blood counts (CBCs) by the same personnel who perform patient testing since the last survey on April 11, 2016. Findings: 1. A WSLH PT record review revealed the laboratory failed to rotate and test the CBC PT samples by the same testing personnel who perform patient testing since the last survey. 2. An interview on April 9, 2018 at 10:30 AM, with the laboratory supervisor, confirmed the laboratory failed to test the CBC proficiency samples from WSLH by personnel who routinely test patient CBCs since the last survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory supervisor, the laboratory director failed to sign the attestation statements from the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) program, and the laboratory failed to retain complete blood count (CBC) test results from the Medonic analyzer since the last survey on April 11, 2016. Findings: 1. A WSLH PT document review revealed the laboratory director failed to sign the attestation statements for the Hematology and Urinalysis events since the last survey. 2. A WSLH PT document review revealed the laboratory failed to retain CBC PT test results printed from the Medonic analyzer since the last survey. 3. An interview on April 9, 2018, at 10:30 AM, with the laboratory supervisor, confirmed the laboratory director failed to sign the attestation statements from WSLH, and the laboratory failed to retain the CBC PT sample test results since the last survey. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and an interview with the laboratory supervisor, the laboratory failed to document the evaluation of unsatisfactory PT results for the wet mount test from the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) program 2017 event 1. Findings: 1. A review of PT results from WSLH 2017 event 1, revealed the laboratory failed to document the evaluation and