Bob Wilson Memorial Hospital

Summary Statement of Deficiencies D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results. This STANDARD is not met as evidenced by: Based on the review of immunohematology records from 7/16/19 to date of survey for quality control (QC), temperature and maintenance logs, thermographic temperature chart recordings for blood unit storage, emergency release requests, and interview with general supervior (GS) #1, the technical supervisor (TS) for immunohematology failed to evaluate the QC program, ensure analytical performance, and ensure storage of blood units were maintained at acceptable levels. Findings: 1. No documentation of review by the TS of immunohematology for QC, termperature and maintenance logs, thermographic temperature chart recordings for blood unit storage, and emergency release requests were available for 7/16/19 to date of survey. 2. Interview with GS #1 on 6/29/21 at 11:45 a.m. confirmed, the TS for immunohematology failed to evaluate the QC program, ensure analytical performance, and ensure storage of blood units were maintained at acceptable levels. D6123 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. 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 absence of documented review of patient testing logs for 7/16/19 to date of survey, absence of signature on immunohematology competencies and interview with GS #1, the TS for immunohematology failed to perform the 2020 competency evaluation for 3 of 3 high complexity test personnel performing immunohematology patient testing. Findings: 1. No documentation of review by the TS for immunohematology of patient testing logs were available for the time period of 7/16 /19 to date of survey. 2. The immunohematology competency documents for 3 of 3 high complexity test personnel performing immunohematology patient testing did not include the signature of the TS for immunohematology. 3. Interview with GS #1on 6 /29/21 at 2:10 p.m. confirmed, the TS for immunohematology failed to perform the 2020 competency evaluation for 3 of 3 high complexity test personnel performing immunohematology patient testing. -- 2 of 2 --

Summary Statement of Deficiencies 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 for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records, three events in 2016 and three events in 2017 and one event in 2018, and confirmed by interview of technical consultant #4 (refer to laboratory personnel report CMS-209) at 09:00 AM on June 21, 2018, the laboratory failed to evaluate ungraded PT scores. The findings include: 1. For API 2016 3rd event Chemistry Group 2, the laboratory received not graded test scores (no consensus) for the following: Sample: CH-13 Free Thyroxine CH-13 TSH 2. For API 2017 1st event Core Chemistry, the laboratory received not graded test scores (no consensus) for the following: Sample: CH-01 Free Thyroxine 3. For API 2017 1st event Core Chemistry, the laboratory received not graded test scores with "see Data Summary" for the following: Sample: CH-01 Triglycerides 4. The laboratory failed to provide documentation at the time of the survey evaluation of the ungraded PT test scores. 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) 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 -- -- (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 review of calibration verification records for the D-Dimer Triage Meter and interview with technical consultant #1 (refer to Laboratory Personnel Report CMS- 209) at 11:10 on June 21, 2018 revealed the laboratory failed to perform calibration verification due April 25, 2018. Finding are 1. Based upon review of D-Dimer calibration verification documentation records, the last documented calibration verification performed was October 25, 2017. 2. Note attached to front of instrument reminding calibration verification due April 25, 2018. 10 patients tested since calibration verification due. 3. Verified calibration verification not performed by interview with technical consultant #1 at 11:10 on June 21, 2018. Therefore the accuracy and the reliability of the testing can not be verified. -- 2 of 2 --