Consultants Laboratory Of Wi Llc West

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of the laboratory, review of patient testing reports and interview with the technical consultant, the laboratory had one of one Kova Stain bottle available for urine sediment testing that was expired and had been used for patient testing. Findings include: 1. Observation of the laboratory on May 22, 2023, at 11:02 AM revealed one Kova Stain bottle, Lot number K304864, available for patient testing had expired on January 31, 2023. 2. Review of patient testing reports from the laboratory information system showed forty-eight urine sediment patient tests were performed between February 1, 2023, and May 22, 2023. 3. Interview with the technical consultant on May 22, 2023, at 11:04 AM confirmed the laboratory had an expired Kova Stain bottle available for urine sediment testing and had been used for patient testing. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on surveyor review of personnel competency evaluations and interview with 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 technical consultant, the technical consultant did not document the performance of competency assessment for one of one testing personnel annually for 2022. Findings include: 1. Review of personnel competency evaluations showed staff A had documentation of annual competency assessment for 2021 and 2023. Further review showed no documentation of competency assessment in 2022. 2. Interview with the technical consultant on May 22, 2023, at 10:20 AM confirmed the technical consultant did not document competency assessment for one of one testing personnel in 2022. -- 2 of 2 --

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor review of training and competence evaluation records and interview with the laboratory supervisor, the technical consultant did not document the semiannual evaluation of performance of testing personnel, staff A, for White Blood Cell (WBC) counts on the HemoCue analyzer during the first year of patient testing. Findings include: 1. Review of training records for testing personnel, staff A, showed the records from October 2017 did not include a record of training to perform White Blood Cell (WBC) counts on the HemoCue analyzer. 2. Review of competence evaluation records for staff A (MediaLab Competency Assessment Program Report of assignments between January 1, 2018 and December 31, 2018) shows staff A completed the WBC HemoCue course / checklist on December 12, 2018. The record showed no other evaluation of staff A for the WBC HemoCue test system evaluation and showed no evaluation by the technical consultant. 3. Interview with the laboratory supervisor on May 28, 2019 at 2:00 PM confirmed the technical consultant (who is also the laboratory director) did not evaluate the performance of staff A in using the HemoCue WBC test system twice annually during the first year of testing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --