Wamego Health Center

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the non-waived test list, lack of procedure for review, patient test information and interview, the laboratory failed to have a written procedure for the Siemens RapidPoint 500e analyzer available to and followed by, laboratory personnel. Findings: 1. Review of the non-waived test list revealed the RapidPoint 500 e was used to perform the regulated analytes pH, pCO2 and pO2. 2. Request was made to review the procedure(s) for the operation of the RapidPoint 500e. 3. No procedure(s) were made available at the time of survey. 4. Review of reported patient results revealed 38 patient's results were released from 4/1/22 to 10/10/22 4. Interview with the General Supervisor (GS) #1 on 10/10/22 at 1:45 p.m. confirmed, the laboratory failed to have a written procedure for the Siemens RapidPoint 500e analyzer available to and followed by, laboratory personnel. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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. 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 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's CMS-209 Laboratory Personnel Report, competency assessment documentation, Technical Supervisor (TS) Responsibilities policy and interview, the Technical Supervisors failed to evaluate the competency to perform immunohematology testing for seven of seven high complexity testing personnel for the year 2021 and to date of survey 2022. Findings: 1. Review of the CMS-209 Laboratory Personnel Report found seven individuals listed as high complexity testing personnel (TP) that had performed immunohematology testing at this site for more than six months. 2. Review of the competency assessments for seven of seven TP revealed no TS of immunohematology signature on the 2021 and to date 2022 competencies. 3. Review of the TS responsibilities policy revealed four individuals designated as TS for immunohematology delegated under (8) to: "Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results." 4. Interview with GS#1 10/10/22 at 1:50 p.m. confirmed, the Technical Supervisors failed to evaluate the competency to perform immunohematology testing for seven of seven high complexity testing personnel for the year 2021 and to date of survey 2022. -- 2 of 2 --

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: A review of calibration verification records for the Sysmex XT 4000i, and interview with staff revealed that the laboratory failed to perform calibration verification once every six months for a three year period. Finding were as follows 1. Review of the Sysmex XT 4000i calibration verification documentation revealed the laboratory failed to perform calibration verification at least once every six months. The laboratory performed calibration verifications on: January 12, 2018, January 22, 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 2 -- and January 28, 2020 but failed to perform the calibration verification that were due in July 2018, 2019 and 2020. This was confirmed in interview with Technical Supervisor #5 on November 3, 2020 at 2:30 PM. -- 2 of 2 --