State Of Franklin Healthcare, Wic

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 laboratory observation, a review of calibration verification records for the Chemistry EPOC Blood Analysis System, and an interview with the laboratory technical consultant, the laboratory failed to ensure calibration verification at six- month intervals during 2024. The findings include: 1. Observation of the laboratory on 05.14.2025 at 9 a.m. revealed an EPOC Blood Analysis System (serial # 53093) used for patient testing for chemistry analytes. 2. A review of calibration verification records for the EPOC Blood Analysis System for Blood Urea Nitrogen (BUN), Chloride, Carbon Dioxide (CO2), Creatinine, Glucose, Ionized Calcium, Sodium, and Potassium revealed no documentation of calibration verification at 6 months 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 -- (documented on 03.24.2024 only) in 2024. 3. An interview with the laboratory technical consultant on 05.14.2025 at 12:05 p.m. and a follow-up electronic communication on 05.20.2025 at 5:04 p.m. confirmed the above survey findings. -- 2 of 2 --

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 direct observation, review of the laboratory's procedures and environmental logs, and interview with the laboratory's technical consultant, determined the laboratory failed to follow their own written procedure for performing and documenting

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: ================================== Based on direct observation, review of laboratory environmental logs, review of laboratory's Sysmex XN-L Series Operator's Manual, review of laboratory's EPOC System Manual, and interview with technical consultant, determined the laboratory failed to document laboratory humidity for 28 of 28 months (01/2020 through 04/2022). The findings include: 1. During a tour of the laboratory on 05.25.2022 at 9:30 A.M., the surveyor observed a Sysmex XN430 analyzer and an EPOC analyzer on the laboratory counter. 2. Review of laboratory environmental logs revealed laboratory failed to document laboratory room humidity for 28 of 28 months (01/2020 through 04/2022). 3. Review of the laboratory's Sysmex XN-L Series Operators's Manual stated, "Relative humidity: 10 to 95% (no condensation)." 4. Review of the laboratory's EPOC System Manual stated, "Humidity of less than 85%." 5. Interview with the technical consultant at 11: 30 A.M. on 5.25.2022 in the laboratory confirmed the above findings. ================================= 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 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: =================================== Hematology: The laboratory failed to maintain satisfactory participation in two consecutive events for the Cell I.D. or White Blood Cell (WBC) Diff analyte resulting in the initial unsuccessful proficiency testing (PT) occurrence for Cell I.D. or WBC Diff. (Refer to D2130) =================================== D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: =================================== Based on a Proficiency Testing (PT) desk review of the CMS CASPER Report 0155D and the laboratory's 2021 Proficiency Testing (PT) performance summary records from the American Proficiency Institute (API) Proficiency Testing program, the laboratory failed to maintain satisfactory performance for the Cell I.D. or WBC Diff analyte in the 1st event 2021 and 2nd event 2021, resulting in the initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed unsatisfactory Cell I.D. or WBC Diff analyte scores of 7% for the 1st event of 2021 and 0% for the 2nd event of 2021. 2. A review of the laboratory's API Proficiency Testing records revealed unsatisfactory Cell I.D. or WBC Diff analyte scores of 7% for the 1st event of 2021 and 0% for the 2nd event of 2021. =================================== -- 2 of 2 --