Mid-State Health Center

Summary Statement of Deficiencies D0000 Mid-State Health Center had an offsite documentation survey performed on 9/2/2025 for failed proficiency testing (PT) results. The survey for PT was performed pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at Title 42 CFR 493. 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: Based on record review, the laboratory (lab) failed to successfully participate in proficiency testing (PT) for hematocrit in 2025. Findings include: 1. The lab failed to 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 -- attain satisfactory HCT PT scores in events 1 and 2 of 2025. Refer to D2121. 2. The lab's unsatisfactory HCT PT scores in consecutive events 1 and 2 of 2025 resulted in unsuccessful performance. Refer to D2130. D2121 HEMATOLOGY CFR(s): 493.851(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review, the laboratory (lab) failed to attain satisfactory performance scores for hematocrit (HCT) proficiency testing (PT) in events 1 and 2 of 2025. Findings include: 1. Review on 9/2/2025 of American Proficiency Institute (API) Performance Summary for 2025 - Hematology / Coagulation Event 1 and Event 2 revealed the lab attained PT scores of 0% in Event 1 and 60% in Event 2 for HCT. 2. Review on 9/2/2025 of CASPER Report 0155D revealed the lab's PT scores for HCT in 2025 event 1 is 0% and 2025 event 2 is 60%. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) 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 record review and staff interview, the laboratory (lab) achieved unsuccessful performance for hematocrit (HCT) proficiency testing (PT) in 2025 events 1 and 2. Findings include: 1. The lab attained unsatisfactory scores for HCT in events 1 and 2 of 2025, refer to D2121. Unsatisfactory performance for HCT in two consecutive events in 2025 is unsuccessful performance. -- 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: Based on record review and staff interview, the laboratory (lab) failed to perform calibration verification every six months for 2 routine chemistry tests in 2023 and 2024. Findings include: 1. Review on 12/11/2024 of calibration records for prostate specific antigen (PSA) and ferritin revealed each test is calibrated using 2 levels. 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 -- lab had no record of calibration verification every six months for PSA and ferritin. 2. Interview on 12/11/2024 at 11:00 a.m. with the Technical Consultant revealed the lab had not performed calibration verification for PSA and ferritin in 2023 and 2024. -- 2 of 2 --

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to perform acceptable control testing before performing and reporting patient testing for 1 day in May 2023. Findings include: 1. Review on 6/8/2023 of the laboratory's "General QC Policy" revealed on page 2 "The technologist performing the assay must check that control results are within acceptable limits before reporting patient results." and on page 3 "Do not report patient results if QC is unacceptable." 2. Review on 6/8/2023 of control records from May 2023 for complete blood counts (CBC) revealed on 5/25 /2023 2 (Level 2 and Level 3) of 3 control results failed to fall within acceptable ranges. There was no record that testing for Levels 2 and 3 had been repeated and found to be within acceptable limits on 5/25/2023. CBCs include the following measured analytes: white blood cell count, red blood cell count, platelet count, hemoglobin and white blood cell differential. 3. Review on 6/8/2023 of patient testing for 5/25/2023 revealed the laboratory reported 17 CBC test results. 4. Interview on 6/8 /2023 at approximately 11:45 a.m. with the technical consultant confirmed the above findings. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to 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's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, 1 of 2 testing personnel failed to follow the laboratory's hematology control procedures in May 2023. Findings include: 1. Review on 6/8/2023 of the laboratory's "General QC Policy" revealed on page 2 "The technologist performing the assay must check that control results are within acceptable limits before reporting patient results." and on page 3 "Do not report patient results if QC is unacceptable." 2. Review on 6/8/2023 of control records from May 2023 for complete blood counts (CBC) revealed on 5/25/2023 2 (Level 2 and Level 3) of 3 control results failed to fall within acceptable ranges. There was no record that testing for Levels 2 and 3 had been repeated and found to be within acceptable limits on 5/25/2023. CBCs include the following measured analytes: white blood cell count, red blood cell count, platelet count, hemoglobin and white blood cell differential. 3. Review on 6/8/2023 of patient testing for 5/25/2023 revealed the laboratory reported 17 CBC test results. 4. Interview on 6/8/2023 at approximately 11: 45 a.m. with the technical consultant confirmed the above findings. -- 2 of 2 --