Kos Laboratory

Summary Statement of Deficiencies D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's records, and interview with the laboratory staff, it was determined that the laboratory failed to retain records of test system performance specifications that the laboratory established or verified before relocation of the laboratory The findings included: a. The laboratory was relocated to the current address of 18200 Yorba Linda Blvd., Ste 105, Yorba Linda CA 92886 from 13830 Yorba Linda Blvd., Yorba Linda CA 92886 on 5/25/2021. b. No records and documentations of test system performance specifications that the laboratory established or verified after it was relocated on 5/25/2021 to the new address. c. No copies of documentations of calibration verification for Siemen Dimension testing of ISE (see D-5439) 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 review of the laboratory's proficiency testing (PT) test result reports, and interview with the laboratory staff, it was determined that the laboratory failed to verify, at least twice annually, accuracy of the test the laboratory performed that is not 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 -- included in the subpart I of 42 CFR part 493. The findings included: a. The laboratory performed PSA and 25-OH Vitamin D that are not included in subpart I of 42 CFR part 493. b. The laboratory elected to enroll with API (American Proficiency Institute) PT programs to verify the accuracy of the procedure the laboratory performed. c. The laboratory obtained a score of 50% for 25-OH Vitamin D in Q2 2020 which was unsatisfactory performance. d. The laboratory obtained a score of 50% and 0% for PSA in Q3 2020 and Q1 2021 PT events, respectively which were unsatisfactory performance. e. The laboratory performed PSA and 25-OH Vitamin D in approximately 85 and 137 patient samples each month, respectively. f. The laboratory staff affirmed (8/24/2022 @11:45 am) that the laboratory obtained score of 50% for PSA in Q3 2020 and 0% in Q1 2021 was unsatisfactory performance. g. The laboratory staff affirmed (8/24/2022 @11:45 am) that the laboratory obtained scores of 50% for 25-OH Vitamin D in Q2 2020 was unsatisfactory performance. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the laboratory's records, and interview with the laboratory staff, it was determined that the laboratory failed to demonstrate that it obtained performance specifications of the instruments the laboratory relocated to the new address comparable to those established by the manufacturer before the relocation of the laboratory before relocation. The findings included: a. The laboratory was relocated to the current address 18200 Yorba Linda Blvd, Ste 105, Yorba Linda, CA 92886 on 5/25 /2021 and began to operate and release patient's reports after 6/6/2021. b. The laboratory used Siemen Dimension, Sysmex XP 300, AIA instruments and others to perform hematology, routine chemistry, and endocrinology testing. c. The laboratory failed to verify and demonstrate that the laboratory can obtain performance specifications of all the instruments relocated to the new address comparable to those established before the relocation of the laboratory. 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 -- 2 of 3 -- 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 the laboratory records, and interview with the laboratory staff, it was determined that the laboratory failed to perform and document calibration verification (CV) procedure 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 at least once every 6 months. The findings included: a. The laboratory used Siemen Dimension to perform routine chemistry testing including ISE for electrolytes. b. The laboratory performed and documented calibration verification for ISE electrodes including Sodium, Potassium, Chloride on 5/14/2022. c. No previous records of CV documentations were available for 2021 at the time of survey (8/24/2022@12:25 PM). D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) 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)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on review of the laboratory records, proficiency testing (PT) test result reports, and interview with the laboratory staff, it was determined that the laboratory director failed to ensure the establishment and maintenance of acceptable levels of analytical performance for routine chemistry, endocrinology testing. The findings included: a. The laboratory director failed to ensure the establishment and maintenance of acceptable levels of analytical performance for routine chemistry, and endocrinology see D-5217, D-5421, D-5439 and D-3033 to ensure accuracy, reliability and timely of the patient test result reports. -- 3 of 3 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 review of the laboratory proficiency testing (PT) results reports, and interview with the laboratory staff and the technical consultant, it was determined that the laboratory failed to attained a score of at least 80 % acceptable responses for each analytic each testing event was unsatisfactory analyze performance for the testing event. The findings included: a. The laboratory performed and reported an analyte, total iron binding co (TIBC) in its routine chemistry panels. b. In order to ensure and verify the accuracy of the routine chemistry and meet the compliance with CLIA requirements annually, the laboratory enrolled its PT program with API. b. The laboratory attained a score of 0 % for analyze of TIBC in the 2nd 2017 PT event, which was unsatisfactory analyze performance for the testing event. d. The laboratory performed and reported the patient test reports in approximately 45 samples monthly. e. The laboratory staff affirmed (2/12/2018 @ 12:15 PM) that the laboratory attained a score of 0% for TIBC in the second 2017 PT event, which was unsatisfactory analyze performance for the testing event. D2098 ENDOCRINOLOGY CFR(s): 493.843(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: 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 -- Based on review of the laboratory proficiency testing (PT) results reports, and interview with the laboratory staff and the technical consultant, it was determined that the laboratory failed to attained a score of at least 80 % acceptable responses for each analytic each testing event was unsatisfactory analyze performance for the testing event. The findings included: a. The laboratory performed and reported analyze, T3, an endocrinology tests. b. In order to ensure and verify the accuracy of the endocrinology tests, and meet the compliance with CLIA requirements annually, the laboratory enrolled its PT program with API. c. The laboratory attained a score of 20 % for analyze of T3 in the 1st 2017 PT event, which was unsatisfactory analyze performance for the testing event. d. The laboratory performed and reported the patient test reports in approximately 40 samples monthly. e. The laboratory staff affirmed (2/12/2018 @ 12:15 PM) that the laboratory attained a score of 20% for T3 in the 1st 2017 PT event, which was unsatisfactory analyze performance for the testing event. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing (PT) results reports, and interview with the laboratory staff and the technical consultant, it was determined that the laboratory failed to evaluate or take actions to verify the accuracy of the testing system when the laboratory received not graded. The findings included: a. The laboratory implemented a new hematology analyzer, Sysmex XP 300, replaced its Celldyn analyzer, and enrolled its PT with API (American Proficiency Institute) to verify and ensure the accuracy of the testing system for the first time. b. The laboratory received a PT reports from API with "Grade" attained for all parameters including WBC with cell differentials, RBC, Hemoglobin, Hematocrit, Platelets as well as other parameters. c. The laboratory failed to take actions to find alternative procedures to verify and ensure the accuracy of the testing system, especially for the first time when the new instrument was implemented, and failed to document the activity. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the validation records, interview with the laboratory staff and the technical consultant, it was determined that the laboratory failed to follow the manufacture instructions and in a manner that provide test results within the -- 2 of 4 -- laboratory's state performance specifications for the test system, Sysmex XP 300, a hematology analyzer selected. The findings included: a. The laboratory implemented a new hematology analyzer, Sysmex XP 300, a hematology analyzer with automated 5 parts WBC electronic differentials. b. The laboratory staff experienced patient hematology testing result reports failed to provide WBC cell differentials occasionally. c. The manufacture's instrument in the paragraph of "Condition of collection" in Section 7: Specimen requirements states: "If specimens cannot be processed within 4 hours, they should be refrigerated at 2-8 oC. Before processing refrigerated specimens should be allowed to warm up to room temperature (minimum 15 minutes), then mixed, preferably for at least 2 minutes. d. The instruction also states in Section 7, Specimen requirements that "When the specimen is left unrefrigerated for more 4 hours certain changes occurs within blood cells, which may produce misleading results of clinical significance. Erythrocytes swell, the MCV increases, as does the RDW-SD. Platelets also swell resulting in an increase MPV. The total WBC count may decrease and the reliability of electronic differential leukocyte count diminishes. The degree of the change is variable depending on the specimen and the temperature at which it is stored. These changes are largely prevented by storage at 2-8 oC. e. The laboratory performed hematology samples including the specimens collected and delivered by the couriers from the outside of this laboratory located remote distance from the laboratory. The laboratory failed to establish and follow written policies and procedures to ensure the proper storage conditions to meet the CLIA requirements to provide quality laboratory services. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing (PT) results reports, and interview with the laboratory staff and the technical consultant, it was determined that the laboratory director failed to ensure the proficiency testing .... The findings included: See D-2087, D-2098 and D-5215 D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on interview with the laboratory staff, and review of the laboratory's instrument -- 3 of 4 -- manuals, it was determined that the laboratory director failed to ensure the quality assessment programs were established and maintained to ensure the quality of laboratory services provided. The findings included: See D-5411 -- 4 of 4 --