Liberty Clinic, The

Summary Statement of Deficiencies D0000 The New Liberty Hospital Clinic Laboratory was found to be in substantial compliance with 2 CFR Part 493, Requirements for Laboratories as a result of an offsite revisit survey July 10, 2023. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute proficiency testing (PT) records for 2022 and interview with the technical consultant(TC) #1, the laboratory failed to maintain a copy of all instrumentation data printouts for one of three PT events in 2022. Findings: 1. Review of 2022 PT records showed no instrument data printouts for 2022 Hematology/Coagulation third event. 2. Interview with the TC #1 on May 31, 2023 at 2:00 PM confirmed the laboratory failed maintain a copy of all instrumentation data printouts for one of three PT events in 2022. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 review of calibration records for Medonic hematology analyzer, policies and interview with the technical consultant(TC) #1, the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range. Findings: 1. Review of Medonic hematology analyzer calibration records for 2021, 2022, and to date May 31, 2023 showed calibration dates of February 2021, October 2021, January 2022, August 2022 and February 2023. 2. Review of the ploicy, "Quality Management For Moderate Complex Clinic Laboratories" states recalibration is to be done "every six months if not otherwise indicated." 3. Review of the calibration dates showed there were dates that exceeded 6 months from February 2021 to October 2021and January 2022 to August 2022 for the following Medonic hematology analytes: white blood cell count, red blood cell count, hemoglobin, hematocrit, and platelet counts. 4. Interview with TC #1 on May 31, 2023 at 2:00 PM confirmed the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range on the Medonic hematology analyzer. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation of the urinalysis centrifuge, review of 2019/2020/2021 function check records, and interview with the technical consultant (TC) #2, the laboratory failed to define a protocol to verify the urine centrifuge was operating at the appropriate speed for obtaining urine sediment for microscopic examination. Findings: 1. Observation of the urinalysis centrifuge showed the centrifuge was operating at a speed of 2500 RPMs. 2. Review of function check records showed no documentation to show the laboratory verified the urine centrifuge speed of 2500 RPMs. 3. Interview with TC #2 on June 16, 2021 at 10:00 AM confirmed the laboratory failed to define a protocol to verify the RPMs required for obtaining urine sediment. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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 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 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of reference ranges approved by the Director in the laboratory procedure manual and interview with the technical consultant #1 the laboratory failed to ensure the test report included pertinent normal ranges as determined by the laboratory. Ten of the twelve complete blood count (CBC) parameters listed on the patient report differed from those in the approved procedure manual. Findings: 1. Review of the patient report showed: RBC female 4.15-5.07, WBC 4.0-10.6, MCV 80- 94.1, MCH 27.1-32.7, MCHC 33.2-35.5, platelet 115-369, lymphocytes 12.1- 39.4, granulocytes 51.7-84.3 and MID 2.5-9.6. 2. Review of the approved procedure manual showed: RBC female 4.07-5.07, WBC 3.5-10, MCV 78-100, MCH 25-35, MCHC 31-36, platelet 150-400, granulocytes 35-80, lymphocytes 15-45 and MID 2- 15. 3. Interview with the technical consultant #1 on February 11, 2109 at 12:15 PM confirmed the laboratory failed to ensure correct reference ranges approved in the procedure manual were on the patient report. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. 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 -- This STANDARD is not met as evidenced by: Based on review of competencies and interview with technical consultant # 1 the technical consultant failed to evaluate and document performance of five of five testing personnel for urine microscopic and wet prep in 2017, 2018 and to date 2019. Findings: 1. Review of competencies for 2017, 2018 and to date 2019 showed no documentation of competencies for testing personnel #1, #2, #3, #4 and #5 for Urine microscopic and wet prep. 2. Interview with technical consultant #1 on February 11, 2019 at 12:15 PM confirmed the technical consultant failed to evaluate and document performance for urine microscopic and wet prep. -- 2 of 2 --