Prevea Family Medicine-Eau Claire

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on surveyor review of Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records and interview with the technical consultant, the laboratory director or designee and testing personnel did not attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods for two of three chemistry events in 2020 and two of three hematology events in 2020. Findings include: 1. Review of WSLH PT records from 2020 showed the laboratory director or designee did not sign the attestation form for the following events: 2020-Chem/Endo/Tx1 2020-HemeReg1 Further review of the WSLH PT records from 2020 showed the testing personnel did not sign the attestation forms for the following events: 2020-Chem/Endo/Tx3 2020-HemeReg3 2. Interview with the technical consultant on February 3, 2022 at 10:00 AM confirmed the laboratory director or designee and testing personnel did not attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods for two of three chemistry events in 2020 and two of three hematology events in 2020. 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 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 -- for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of Wisconsin State Laboratory of Hygience (WSLH) proficiency testing (PT) records and interview with the technical consultant, the laboratory did not evaluate the accuracy for five of five "Not scored-insufficient peer group" alanine transferase (ALT) PT results for the 2020-Chem/Endo/Tx3 event. Findings include: 1. Review of Wisconsin State Laboratory of Hygiene (WSLH) PT records showed the laboratory did not evaluate the accuracy of the ALT PT results in 2020 for event 3. Further review showed sample CET-13 was out of the analyte range. 2. Interview with the technical consultant on February 3, 2022 at 10:00 AM confirmed the laboratory did not evaluate the accuracy for five of five "Not scored-insufficient peer group" ALT PT results for the 2020-Chem/Endo/Tx3 event. -- 2 of 2 --

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 procedures and interview with the technical supervisor, the laboratory has not established written policies and procedures to assess testing personnel, general supervisor, and technical supervisor competency. Findings include: 1. Review of laboratory procedures showed no evidence of a written procedure for the evaluation of testing personnel, general supervisor, and technical supervisor competency. 2. Interview with the technical supervisor on January 16, 2020 at 11:50 AM confirmed the laboratory did not have a procedure for evaluation of testing personnel, general supervisor, and technical supervisor competency. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Item 1: Based on surveyor review of laboratory records, policies and procedures, and interview with the technical supervisor, the laboratory does not have a quality assessment policy or procedure to address how the laboratory monitors, assesses, and 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 -- corrects problems identified in the lab. Findings include: 1. Review of laboratory quality control records,

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --