Kickapoo Valley Medical Clinic-Vmh

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing and laboratory records and interview with the technical consultant, the laboratory did not verify the accuracy of microscopic urinalysis testing for two of two events in 2023. Findings include: 1. Review of proficiency testing records showed no evaluation of accuracy of microscopic urinalysis testing in 2023. 2. Review of laboratory records showed no evidence of twice annual accuracy checks of microscopic urinalysis testing in 2023. 3. Interview with the technical consultant on November 28, 2023, at 11:24 AM confirm providers performed microscopic urinalysis testing in 2023 and confirmed the laboratory had not verified the accuracy of the test twice annually in 2023. 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 survey review of laboratory records, hematology procedures and interview with the technical consultant, the laboratory director did not approve, sign and date one of one new hematology procedures prior to patient use. Findings include: 1. Review of the verification of performance specifications for the Sysmex XN430 hematology analyzer showed the implementation date for the analyzer at this location 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 -- was October 25, 2023. 2. Review of the XN430 hematology analyzer procedure showed no evidence the procedure had been reviewed and signed at the time of survey on November 28, 2023. 3. Interview with the technical consultant on November 28, 2023, at 12:45 PM confirmed the laboratory director did not approve, sign and date new hematology procedure prior to patient use. -- 2 of 2 --

Summary Statement of Deficiencies D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory procedure manual and interview with technical consultant, the laboratory director did not ensure approved procedures were available to all testing personnel for three of three revised procedures. Findings include: 1. Review of laboratory procedures showed the following procedures and their revised dates: "KX-21N", revised January 18, 2021 "Chemistry Testing using the i-STAT Chem8+ Cartridge Type", revised June 23, 2020 "Courtesy/Critical Call: Lab Reporting Protocol", revised February 27, 2020 Further review of the procedures showed no evidence of approval by the laboratory director. 2. Review of the procedure manual showed the laboratory director reviews the procedure manual annually and signs a log stating the procedures had been reviewed. Further review showed the laboratory director last reviewed the procedure manual in 2019. 3. Interview with the technical consultant on January 26, 2022 at 10:30 AM, confirmed the laboratory director did not ensure approved procedures were available to all testing personnel for three of three revised procedures. 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 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 --