Summary:
Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) 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 surveyor review of proficiency testing (PT) results and interview with the manager, the laboratory did not verify the accuracy of test results that the PT provider did not score in four of six hematology events in 2021 and 2022. Findings include: 1. Review of PT reports from the Wisconsin State Laboratory of Hygiene (WSLH) for hematology events in 2021 and 2022 showed the laboratory had not documented review of the following unscored results: 2022 event three: Leukocytes (WBC), Erythrocytes (RBC), Hemoglobin (Hgb) 2021 event three: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, RBC, Mean Corpuscular Volume (MCV) 2021 event two: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, RBC, Hgb, Hematocrit, MCV, Platelets 2021 event one: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, RBC, MCV The reports from the WSLH PT program showed the program did not score the analytes due to insufficient peer groups. 2. Interview with the manager (staff B) on November 28, 2022 at 11:00 AM confirmed the laboratory did not review the results to verify accuracy of the unscored analytes. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification 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 -- requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor review of the Centers for Medicare and Medicaid Services (CMS) Laboratory Personnel Report (Form CMS-209) and interview with the manager, the laboratory has not had a technical consultant since July 14, 2022. Findings include: 1. The laboratory's previous technical consultant had not been employed by the laboratory since July 14, 2022 and a new technical consultant was not identified. See D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on surveyor review of the Centers for Medicare and Medicaid Services (CMS) Laboratory Personnel Report (Form CMS-209) and interview with the manager, the laboratory has not had a technical consultant since July 14, 2022. Findings include: 1. Review of Form CMS-209 showed the laboratory director signed the form on -- 2 of 3 -- November 21, 2022. The form showed staff A identified as the technical consultant, technical supervisor, general supervisor, and testing personnel. No other staff was identified as a technical consultant on Form CMS-209. 2. Interview with the manager on November 28, 2022 at 10:30 AM revealed staff A was the technical consultant until leaving employment with the laboratory on July 14, 2022 and confirmed the laboratory had not identified a new technical consultant after staff A resigned the position. -- 3 of 3 --