Clinical Labs Of Hawaii-Lanai Community Hospital

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency test records and interview with the laboratory general supervisor on 12/02/2022 at 9:45 a.m., the laboratory failed to review and evaluate its unaaceptable 2021 iSTAT Protime (PT) result. The laboratory performed 100 PT tests annually. The findings included: a. The laboratory reported a PT result of 31.1 seconds for sample PT1-06 in the 2nd Event of its Hematology/Coagulation survey. The exprected result range was 22.1-30.0 seconds. Evidence of laboratory review and evaluation of this result was not documented. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory director on 12/02/2022 at 10:30 a.m., the laboratory failed to twice annually verify the accuracy of the Potassium Hydroxide (KOH) testing it performed in 2021 and 2022. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on the lack of records and interview with the laboratory director and technical consultant on 5/28/19, the laboratory failed to retain quality control records of their prothrombin time/ INR controls for at least 2 years. Findings included: a. The laboratory tested two levels of control material each month for the prothrombin time/ INR tests. Their printout for prothrombin/INR control levels showed that control level 1 lot# 281097 and control level 2 lot# 291096 were run on 4/5/19. At the time of the survey, the manufacturer's assay information was not available for these two controls. b. The laboratory tested and reported prothrombin time and INR test results on approximately 36 patients a year. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 the lack of records and interview of the laboratory director and technical consultant on 5/28/19, the laboratory failed to perform and document calibration procedures on their troponin test at least every 6 months. Findings included: The laboratory performed and reported approximately 50 troponin test results on patients each year. Laboratory records showed calibration verification was done on 5/23/19 and 10/22/18. There was no documentation of calibration performed before 10/22/18. D5783