Coal Country Community Health Center

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 record review, staff interview, and policy/procedure review, the laboratory failed to verify calibration at least every six months for 1 of 2 analytes (Vitamin B12) calibrated with less than three calibrators on the Vitros 5600 in 2024. The laboratory performed approximately 400 Vitamin B12 patient tests in 2024. Findings include: 1. Reviewed on 02/10/25, the 2024 Vitamin B12 calibration records indicated the use of two levels of calibrators for calibration of Vitamin B12. 2. Reviewed on 02/10/25, the 2024 calibration verification records failed to include Vitamin B12. 3. Upon request on 02/10/25, the laboratory failed to provide evidence of calibration verification at least twice annually for Vitamin B12 in 2024. 4. During interview at 12:10 p.m. on 02 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 -- /10/25, the laboratory manager (#1) confirmed the laboratory had failed to verify calibration at least twice annually for Vitamin B12 in 2024. 5. Reviewed on 02/10/25, the policy/procedure "Ortho Vitros 5600," dated 09/2022, failed to include a requirement for at least twice annual calibration verification for analytes calibrated with less than levels of calibrators. -- 2 of 2 --

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: Based on American Proficiency Institute proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte human chorionic gonadotropin (hCG) for two consecutive events in 2022 (Event 2 and Event 3), resulting in unsuccessful performance. (Refer to D2107) D2107 ENDOCRINOLOGY CFR(s): 493.843(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 or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte human chorionic gonadotropin (hCG) in two consecutive events in 2022 (Event 2 and Event 3), resulting in unsuccessful performance. Findings include: 1. Review of 2022 American Proficiency Institute (API) proficiency testing reports on 11/28/22 for the analyte hCG (quantitative) revealed the following results: Event 2-2022 - 60% Sample Lab Results Acceptable Range #06 0.9 0.0 - 11.0 #07 1090.3 770.6 - 1006.8 #08 1.5 0.0 - 11.0 #09 45.4 40.4 - 60.5 #10 225.8 168.4 - 225.5 Event 3-2022 - 60% Sample Lab Results Acceptable Range #11 129.0 136.8 - 181.0 #12 0.8 0.0 - 11.0 #13 1077.5 810.3 - 1076.4 #14 1.0 0.0 - 11.0 Sample Lab Results Acceptable Range #15 3351.5 2152.6 - 3446.0 The subspecialty of endocrinology requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at 10:45 a.m. on 11/28 /22, the laboratory supervisor (#1) confirmed the laboratory had scored 60% in Events 2 and 3 in 2022 for quantitative hCG. -- 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, staff interview, and policy review, the laboratory failed to verify calibration for 4 of 4 analytes (amylase, conjugated bilirubin, unconjugated bilirubin, and lipase) not calibrated at least once every six months in 2020. Findings include: 1. Reviewed at 12:00 p.m. on 03/16/21, the 2019-2021 Ortho Vitros calibration records indicated the laboratory did not calibrate the following analytes every six months during these timeframes: - Amylase calibrated on 08/02/19 and next 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 -- on 07/13/20 (approximately 11 months); - Conjugated bilirubin calibrated on 08/05/19 and next on 05/13/20 (approximately 9 months); - Unconjugated bilirubin calibrated on 08/05/19 and next on 05/13/20 (approximately 9 months); and - Lipase calibrated on 08/02/19 and next on 07/13/20 (approximately 11 months). 2. Upon request at 1:25 p.m. on 03/16/21, the laboratory failed to provide evidence of calibration verification for amylase, conjugated bilirubin, unconjugated bilirubin, and lipase in 2020. 3. During interview at 1:25 p.m. on 03/16/21, a technical consultant (#1) confirmed the laboratory did not calibrate amylase, conjugated bilirubin, unconjugated bilirubin, and lipase at least every six months in 2020 and had not verified calibration for these analytes in 2020. 4. Reviewed at 4:15 p.m. on 03/16/21, the undated policy "Chemistry Vitros" stated, ". . . Calibration 1. Calibration - will be done: . . . c) government regulations specify - every six months . . ." -- 2 of 2 --