Tc Fam Med Clintonville

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and procedures and interview with the Technical Consultant, the laboratory did not perform calibration verification procedures every six months in 2023 and 2024. Two of the last three calibration verifications did not meet the six-month requirement. Findings include: 1. Review of calibration verification records for the Siemens epoc analyzer showed the laboratory completed calibration verification on July 19, 2024, December 21, 2023, and May 18, 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 -- 2023. 2. Review of the "Siemens Epoc BGEM Orange Test Card" procedure, Section V. b. iv., 'Epoc Calibration Verification': "1. Perform every six months or after troubleshooting, and analyzer replacement." 3. Interview with the Technical Consultant on September 19, 2024, at 1:00 PM confirmed staff did not perform the calibration verification procedures within six months as required. D5785

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 records and interview with the Manager of Laboratory Services, the laboratory director did not approve the Siemens epoc blood analysis system procedure until January 25, 2021, six days after the laboratory started patient testing with the test system. Findings include: 1. Review of the 'Document Change Review Request Form' for the Siemens epoc BGEM Orange Test Card procedure shows the laboratory director approved the procedure on January 25, 2021. 2. Interview with the Manager of Laboratory Services (Staff A) on March 16, 2021 at 12:20 PM revealed the laboratory used the Siemens epoc blood analysis system for patient testing as of January 19, 2021. Further interview confirmed the laboratory director did not approve the procedure before the laboratory began patient testing with the test system. 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 D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(4)(iv) Ensure that an approved