Consultants Laboratory Of Wi, Llc

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 interview with a Technical Consultant/Technical Supervisor (TC/TS), Staff A, the laboratory did not establish a process for evaluating the competency of personnel performing delegated responsibilities in three of three Clinical Laboratory Improvement Amendment (CLIA) regulations named positions: TC, TS, and General Supervisor (GS). Findings include: 1. Review of the laboratory's procedure manual revealed no evidence of a written policy to assess employee competency for personnel performing delegated responsibilities in the TC, TS, and GS positions. 2. Interview with Staff A on January 15, 2026, at 9:30 AM confirmed the laboratory did not establish and follow written policies to assess employee competency for the personnel performing delegated responsibilities in the TC, TS, and GS positions. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (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 a Technical Consultant/Technical Supervisor (Staff A), the current laboratory director did not 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 -- approve three out of the five procedures reviewed from the laboratory's procedure manual. Findings include: 1. Review of the laboratory's procedure manual revealed no evidence the current laboratory director had approved the test procedures for performing urine microscopic testing, vaginal wet mount testing, and infectious mononucleosis testing using the Sekisui Diagnostics OSOM Mono Test Kit. 2. Interview with Staff A on January 15, 2026, at 1:10 PM confirmed the current laboratory director did not approve all of the procedures in use in the laboratory. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with a Technical Consultant/Technical Supervisor (TC/TS), Staff A, the laboratory could not show they evaluated performance characteristics for one of one new analyzers after moving the Sysmex XN-450 hematology analyzer into the clinic and before patient testing was performed starting on April 22, 2025. Findings include: 1. Review of laboratory records showed no evidence the laboratory demonstrated it could obtain performance specifications comparable to those established by the manufacturer for the Sysmex XN-450 analyzer. 2. In an interview on January 15, 2026, at 1:45 PM, Staff A stated the laboratory started patient testing with the Sysmex XN-450 on April 22, 2025, after verifying performance specifications at this location with the analyzer. Further interview confirmed records for the verification were not available. 52883 D6080 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with a Technical Consultant/Technical Supervisor (Staff A), the laboratory director did not meet the requirement of conducting and documenting an onsite visit at least once every six months, with at least four months between onsite visits, for two of two required visits in 2025. Findings include: 1. Review of laboratory records revealed no evidence the laboratory director conducted any onsite visits in 2025. 2. Interview with Staff A on January 15, 2026, at 9:40 AM confirmed the laboratory director had not conducted the two required onsite visits in 2025. -- 2 of 3 -- D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) (e)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and This STANDARD is not met as evidenced by: Based on surveyor observation in the laboratory, review of manufacturer specifications and environmental records, and interview with a Technical Consultant /Technical Supervisor (Staff A), the laboratory director did not ensure that the environmental conditions of the laboratory were appropriate for use of the Sysmex XN-450 hematology analyzer, one of one hematology analyzer in use in the laboratory. Findings include: 1. Observation on January 15, 2026, at 2:00 PM revealed a Sysmex XN-450 hematology instrument operating in the laboratory. 2. Review of manufacturer's performance specifications/characteristics for the Sysmex XN-450 showed the ambient temperature range for operating the instrument was 15 to 25 degrees Celsius and the relative humidity range was 20 to 85%. 3. Review of environmental records in the laboratory showed no evidence the laboratory monitored the ambient room temperature and relative humidity of the laboratory when the laboratory was operating and personnel were using the Sysmex XN-450. 4. Interview with Staff A on January 15, 2026, at 1:32 PM confirmed personnel did not monitor the ambient room temperature and relative humidity of the laboratory, and that the director had not ensured the laboratory could maintain temperature and humidity levels appropriate for the testing performed in the laboratory. -- 3 of 3 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of procedures, calibration records and interview with the technical consultant, the laboratory did not calibrate the Cell Dyn Ruby hematology analyzer at least every six months as required. The laboratory did not complete two of the four six-month calibrations required between September 2021 and September 2023. Findings include: 1. The laboratory's Cell Dyn Ruby Calibration procedure (SAT0020) defined the minimum frequency of calibration as, "at least every six months". 2. Review of laboratory records showed the laboratory calibrated the analyzer on September 16, 2021, November 30, 2022, and July 19 and 27, 2023. No additional records of calibration were available. 3. Interview with the technical consultant (staff B) on October 19, 2023, at 2:30 PM confirmed the records showed the laboratory had not calibrated the Cell Dyn Ruby analyzer every six months as required in their procedures. This is a repeat deficiency previously cited on November 18, 2019. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES 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 -- CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on surveyor review of competence evaluation records and interview with the previous technical consultant, the technical consultant did not evaluate the competence of six of six testing personnel for each non-waived test performed in the laboratory on a semi-annual basis for new employees or annually for testing personnel employed for more than one year at this laboratory. Findings include: 1. Review of competence evaluations for testing personnel revealed: Staff C: Started at this location in January 2023, records showed no site-specific competence evaluation documentation for this location and no semi-annual competence documentation. Staff D: The records showed no competence evaluations from 2022 or 2023. Staff E: The records showed training in March 2022 but no other competence evaluation records and no semi-annual competence evaluation documentation. Staff F: The records showed annual competence evaluations in January 2022 and August 2023 for urine microscopic exams, mononucleosis testing, and testing on the Cell Dyn Ruby analyzer. The records included no annual wet prep or manual differential competence evaluation documentation in 2022 or to date in 2023. Staff G: The records showed annual competence evaluation in January 2022 for urine microscopic exams, mononucleosis testing, and testing on the Cell Dyn Ruby analyzer. The records included no annual wet prep or manual differential competence evaluation documentation in 2022 or to date in 2023. Staff H: The records showed annual competence evaluation in January 2022 for urine microscopic exams, mononucleosis testing, and testing on the Cell Dyn Ruby analyzer. The records included no annual wet prep or manual differential competence evaluation documentation in 2022 or to date in 2023. 2. Interview with the previous technical consultant (staff A) on October 19, 2023, at 10:45 AM confirmed the laboratory procedures require semi-annual competence evaluations the first year and annual evaluations after the first year. Further interview confirmed the technical consultant did not complete the evaluations as required. This is a repeat deficiency previously cited on December 14, 2021, and November 18, 2019. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the previous technical consultant, the laboratory director did not ensure six of six testing personnel had demonstrated the ability to identify abnormal cells and morphology identified during performance of a hematology differential when the laboratory added abnormal differentials to their test menu in December 2022. Findings include: 1. Review of -- 2 of 3 -- laboratory records including training and competence evaluations showed no evidence the laboratory evaluated the ability of the six testing personnel to accurately identify abnormal findings when performing hematology differentials. 2. Interview with the previous technical consultant (staff A) on October 19, 2023, at 12:45 PM revealed the laboratory started reporting abnormal cells and morphology on differentials in December 2022 and confirmed the technical consultant had not evaluated testing personnel to ensure they had demonstrated the ability to accurately identify abnormal cells and morphology prior to testing patient specimens. -- 3 of 3 --

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on surveyor review of testing personnel competency assessments and interview with a technical consultant, staff A, the technical consultant did not complete a semi- annual competency evaluation for one of one new testing personnel, staff B. Findings include: 1. Review of testing personnel competency assessment records revealed competency evaluation for Staff B was not documented twice during the first year. 2. Interview with staff A on December 14, 2021 at 9:10 AM confirmed competency evaluation for Staff B was not documented twice during the first year of testing. This is a repeat deficiency from November 18, 2019. 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 --

Summary Statement of Deficiencies 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)