Jacksonville Medical Care

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: A review of laboratory policies and procedures for chemistry reviewed and approved by the laboratory director on 7/20/15, a review of the chemistry Quality Control (QC) records, and interviews with laboratory staff, demonstrated that the laboratory failed to follow written procedures for Chemistry QC. Survey findings include: A) Review of the "Siemens Dimension EXL Procedure revealed that the QC policy states: "2 levels of quality control material are performed on each day of patient testing "and "the following Westguard multirules for acceptance of quality control results are used: 1 3S A run is rejected when a single control measurement exceeds the mean plus or minus 3 SD" B) Review of the chemistry QC records for September 2023, revealed that three levels of Biorad Multiqual QC material lot numbers level one 56711, level two 56712, and level three 56713 were run on each day of patient testing. C) Review of the chemistry QC records for September 2023 revealed that 21 of 22 runs level one QC lot number 56711 was resulted as > 3 SD with a note "running with other two levels in range" for Calcium (CA) analysis, on 9/14/23 level one QC for for Sodium (NA) was resulted as >3 SD with a note "running with other two levels in range", and on 9/18/23 level two lot number 56712 for NA analysis was resulted as > 3 SD with a note "running with other two levels in range". D) In an interview, at 01:20 p.m. on 7 /23/24, the laboratory director confirmed that the procedure for QC performed on the Siemens Dimension EXL Procedure was not currently being followed, and 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 -- laboratory ran three levels of QC material on each day of patient testing with the rule that QC results were acceptable if two of the three levels resulted within 2 SD of the target mean. . -- 2 of 2 --

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on the lack of documentation and an interview the Survey Team determined that the laboratory failed to follow established written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the postanalytic systems. Findings include: A. The Survey Team requested and the laboratory provided written policies and procedures for an ongoing mechanism to monitor and assess the quality of the postanalytic system. B. Policies included a monthly review of five separate criteria, including reviewing 10 patient records and the turnaround times for five specimens. Documentation of those two criteria were requested and the laboratory could not provide them. C. These findings were confirmed by the Laboratory Director during an interview at 10:55AM on October 26, 2022. 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 D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through review of the policy and procedure "Sysmex CA-530", Levey-Jennings Report for prothrombin time, laboratory requisition listing and interview it was determined that the laboratory reported patient results when quality control results exceeded the range of acceptability on one of twenty-three days reviewed in March of 2017. Findings follow: A. Review of the policy and procedure for the "Sysmex CA- 530" revealed that "a run is rejected when a single control measurement exceeds the mean plus or minus 2SD" (standard deviation). B. Review of the Levey-Jennings Report for prothrombin for March, 2017 revealed that on March 10, 2017 at 07:14 AM, the abnormal prothrombin time control (lot # 548460) with an acceptable range of 39.3 to 43.1 was reported as 38.5 which was outside of the plus or minus 2 SD range. C. Review of the "requisition listing" report for March 10, 2017 revealed that prothrombin time results were reported on patient 607223 on 3/10/17and patient 607228 on 3/10/17 at 11:18 AM . D. In an interview on 4/19/18 at approximately 11: 00 AM the laboratory director identified as number one on the CMS 209 report confirmed that quality control results for prothrombin times on March 10, 2017 were below acceptable limits and results were reported on the patients identified above. D5783