Medical College Of Wisconsin

Summary Statement of Deficiencies 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 surveyor review of the Centers for Medicare and Medicaid Services (CSM) Form 209 and competence assessment records and interview with the Technical Supervisor (Staff A), the laboratory had not assessed one of two testing personnel annually in 2023. Findings include: 1. Review of Form CMS-209 'Laboratory Personnel Report (CLIA)' submitted for this survey and signed by the director on June 24, 2024, showed the form identified two testing personnel in the laboratory (Staff A and B). 2. Review of testing personnel competence assessment records showed Staff A had no testing personnel competence assessment documented in 2023. 3. Interview with Staff A on June 24, 2024, at 1:45 PM confirmed the laboratory had not evaluated the competence of staff A in performing their responsibilities as a testing person. This is a repeat deficiency previously cited on November 20, 2020. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the Technical Supervisor (Staff A), the laboratory did not document the actual time of receipt for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- seventeen of seventeen specimens reviewed for disaccharidase testing received in June 2024. Findings include: 1. Review of laboratory requisitions showed the form included a space to record the date and time (with AM or PM) when personnel received the specimen in the laboratory. Seventeen requisitions reviewed from June 2024 for disaccharidase testing showed the testing person marked AM or PM but did not record the actual time of receipt. 2. Interview with Staff A on June 24, 2024, at 2: 00 PM confirmed testing personnel did not record the specific time they received the specimen and confirmed personnel only marked the requisition as AM or PM. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (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) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and interview with the technical supervisor, the current laboratory director did not approve, sign and date the procedures being used for patient testing. Findings include: 1. Review of the laboratory procedures showed no evidence the procedures were approved by the current laboratory director. 2. Interview with the technical supervisor on August 1, 2022, at 9:50 AM confirmed staff A became that laboratory director in February 2022. Further interview confirmed the laboratory had no documentation to show the current laboratory director approved, signed and dated the procedures used for patient testing. D5781

Summary Statement of Deficiencies 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 surveyor review of laboratory policies and procedures and interview with the technical supervisor, the laboratory did not establish procedures to assess employee competency. Findings include: 1. Review of laboratory procedures showed no evidence of a procedure for assessing employee competency. 2. Interview with the technical supervisor on November 20, 2020 at 3:00 PM confirmed the laboratory did not establish procedures for assessing employee competency. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (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) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D6134 CLINICAL CONSULTANT CFR(s): 493.1453 The laboratory must have a clinical consultant who meets the requirements of 493. 1455 of this subpart and provides clinical consultation in accordance with 493.1457 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor review of the CMS (Centers for Medicare & Medicaid Services) Form 209, Laboratory Personnel Report, and interview with the technical supervisor, the laboratory does not have a qualified clinical consultant to provide clinical consultation in accordance with subpart 493.1457. Findings include: 1. The laboratory has been without a qualified clinical consultant since June 30, 2018. See D6135. D6135 CLINICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1455 The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must-- (a) Be qualified as a laboratory director under 493. 1443(b)(1), (2), or (3)(i) or, for the subspecialty of oral pathology, 493.1443(b)(6); or (b) Be a doctor of medicine, doctor of osteopathy, doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located. This STANDARD is not met as evidenced by: Based on surveyor review of the CMS (Centers for Medicare & Medicaid Services) Form 209, Laboratory Personnel Report, and interview with the technical supervisor, 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 -- the laboratory has been without a qualified clinical consultant since June 30, 2018. Findings include: 1. Review of the CMS Form 209, signed by the laboratory director on July 2, 2018, showed a clinical consultant was not identified. 2. Interview with the technical supervisor on July 10, 2018 at 1:15 PM revealed the previous clinical consultant retired on June 30, 2018 and confirmed a replacement has not been identified. -- 2 of 2 --