Tyler Holmes Memorial Hospital

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the Abbott Cell Dyn Ruby Hematology Analyzer operator's procedure manual in use the day of survey and hematology control records and confirmation by the technical consultant (TC) at 11:00 am on the day of survey, 11/20 /20, the laboratory failed to follow the manufacturer's instructions for the assay verification process for the quality control (QC) material. Findings include: 1. The Abbott Cell Dyn Ruby hematology operator's manual states that each new lot of control material should be analyzed in parallel with current lots prior to the expiration date of the current QC. The lab should verify the values of each new control lot by running each level of control in triplicate along with replicate QC specimens or the old control when still in date. The new QC should be run twice a day for five days to establish a mean to verify that the new lot yields the expected results in the manufacturer's package insert. 2. Review of the hematology control records from the last survey on 8/1/18 through 11/20/20 revealed the following lot numbers of hematology control had been put in use since last survey: 8169 (L,N,H), 8225 (L,N, H), 9028 (L,N,H), 9308 (L,N,H), 9364 (L,N,H), 0055 (L,N,H), 0111 (L,N,H), 0167 (L, N,H), 0223 (L,N,H). These lot numbers of QC material were put into use with no assay verification performed. 3. Interview with the TC on the day of survey at 11:00 am revealed no assay verification was being performed before putting a new lot number of QC into use on the Cell Dyn Ruby hematology analyzer according to the manufacturer's instructions. 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 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 review of the TOSOH -AIA 900 PSA (prostate specific antigen) records from 3/13/17, through the day of survey 8/1/18 and confirmation with staff at 1:30 pm, the laboratory failed to perform calibration verification on the TOSOH-AIA 900 analyzer for PSA every 6 months. Calibration verification, including at least a minimal value, a mid-point value and a maximum value, should be performed every 6 months. As of the day of survey, calibration verification had been performed on the 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 -- PSA on 3/13/17, 2/15/18 and on 7/25/18. This time frame exceeds the calibration verification requirement by the manufacturer. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and personnel records since the last survey on 10-21-16, the technical consultant failed to evaluate the competency and document the performance of testing personnel #8 and #9, responsible for moderate complexity testing, at least semiannually during the first year these individuals tested patient specimens. Findings include: Testing personnel #8 initial training was 1-10-2017--next competency was performed on 2/11/18. Testing personnel #9 initial training was 3-8-2017--next competency was performed on 7/26/18. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: 38948 Based on review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and personnel records since the last survey on 10-21-16, the technical supervisor failed to evaluate the competency and document the performance of testing personnel #8 and #9, responsible for moderate/high-complexity testing, at least semiannually during the first year these individuals tested patient specimens. Findings include: Testing personnel #8 initial training was 1-10-2017--next competency was performed on 2/11/18. Testing personnel #9 initial training was 3-8- 2017--next competency was performed on 7/26/18. -- 2 of 2 --