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Summary Statement of Deficiencies D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's records of personnel training, competency evaluation, laboratory policies and procedures, random patient testing records, and interview with the laboratory 's technical supervisor (TS) and testing personnel (TP); the laboratory failed to provide records showing that the laboratory director (LD) has authorized, delegated, and approved lab personnel of any responsibilities and duties in writing. The findings include: 1. The laboratory did not have any records of written delegation and authorization of responsibilities and duties by the LD for the laboratory's technical supervisor and testing personnel. 2. On February 24, 2023, at approximately 2:00 p.m. the TS and TP affirmed that the LD did not assign, delegated, and authorized in writing duties and responsibilities to the laboratory personnel including the TS and TP. 3. The laboratory testing declaration form, signed by the LD on 2/23/23 stated that the laboratory performs 20,500 tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(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 second quarter (Q2-2018) event of the America Association of Bioanalysts (AAB) proficiency testing records and interview with the technical supervisor (TS); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for General Immunology. The findings included: 1. For Q2-2018, AAB reported an overall score of 66.0 % for General Immunology: Analyte Score Reported Antistreptolysin O 100% Infectious mononucleosis 0 Rheumatoid Factor 100% 2. Based on the laboratory's annual testing declaration for 2018-2020 the laboratory analyzed and reported approximately 500 General Immunology tests during the time the laboratory had unsatisfactory proficiency testing results. 3. The TS affirmed 12/9/2020 at approximately 1:00 p.m. that the laboratory received the above unsatisfactory proficiency testing score. D2082 GENERAL IMMUNOLOGY CFR(s): 493.837(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. 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 -- This STANDARD is not met as evidenced by: Based on review on the proficiency testing (PT) performance records,

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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialties of Routine Chemistry and Endocrinology constituting unsuccessful PT performances. (See D2097 and D2107) 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Magnesium (Mg), resulting in an "initial" (first) unsuccessful performance. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, Mg, as follows: 2018 Q1 2018 Q3 Mg 20% 0% Q1 = First Testing Event Q2 = Second Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analyte, Mg. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analytes, Human chorionic gonadotropin (HCG), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Thyroxine (T4), resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analytes, HCG, T3, TSH, and T4, as follows: 2018 Q2 2018 Q3 HCG 0% 0% T3 0% 0% TSH 0% 0% T4 0% 0% b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analytes, HCG, T3, TSH, and T4. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories -- 2 of 3 -- Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6016) 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 a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analytes, Mg, HCG, T3, TSH, and T4, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performances. (See D2016, D2096, and D2107) -- 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's proficiency testing (PT) result reports, and interview with the laboratory staff, it was determined that the laboratory failed 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. The findings included: a. The laboratory performed routine chemistry testing including, but not limited to, the following tests: Albumin (Alb), Amylase (Amy), Creatine (Cre), and total Iron. b. In order to meet the CLIA requirements and to verify the accuracy of the routine chemistry testing system annually , the laboratory elected to enroll its routine chemistry proficiency testing (PT) with American Association of Biocatalysts (AAB) PT provider. c. The laboratory attained a score of 60% for the analyze of Alb in the 3rd 2017 PT event which was unsatisfactory performance PT event. d. The laboratory attained scores of 60% and 0% for the analyte of Cre, Amy and Iron, respectively in the 3rd 2016 PT event which were unsatisfactory performance PT event e. The failures of Alb, Cre and Iron in PT events' scores showed as follow: Event Analyte Score (%) 3rd 2017 Alb 60 3rd 2016 Amy 60 3rd 2016 Cre 60 3rd 2016 Iron 0 f. The laboratory performed Alb, Cre, and Iron in approximately 110 each for patient samples per month. g. The laboratory staff affirmed (3/20/2018 @ 12: 15 PM) that the laboratory failed to attain at least 80% of the acceptable responses for the analyte of Cre, Amy and Iron in the 3rd 2016 PT event, which was unsatisfactory performance event. h. The laboratory staff affirmed (3/20/2018) that the laboratory failed to attain at least 80% of the acceptable responses for the analyte of Alb in the 3rd 2017 PT event, which were unsatisfactory performance event. 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 -- 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: Based on review of the laboratory's proficiency testing (PT) result reports, and interview with the laboratory staff, it was determined that the laboratory failed 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. The findings included: a. The laboratory performed endocrinology testing including, but not limited to, the following tests: Free T4 (FT4), Triiodothyronine (T3), and Ty (T4). b. In order to meet the CLIA requirements and to verify the accuracy of the endocrinology testing system annually , the laboratory elected to enroll its endocrinology proficiency testing (PT) with American Association of Biocatalysts (AAB) PT provider. c. The laboratory failed to attain scores of at least 80 % of the acceptable responses for the analyte of FT4, T3 and Ty in the 3rd 2016 PT event, which were unsatisfactory performance event. d. Prior to this routine re-certification survey, this laboratory had received and completed the responses to a PT Desk review, CMS 2567 report (10/24 /2016), for the failure to achieve satisfactory performance for FT4 testing in two out of three consecutive PT events. The laboratory attained scores of 0% for FT4 in both the 1st and the 3rd 2016 PT events. e. The failures of the 3rd 2016 endocrinology PT scores showed as follow: Analyte Score (%) FT4 0 T3 0 Ty 0 f. The laboratory performed T3 and Ty in approximately 100 each patient samples per month. g. The laboratory staff affirmed (3/20/2018 @ 12:20 PM) that the laboratory failed to attain at least 80% of the acceptable responses for the analyte of T3 and Ty in the 3rd 2016 PT event, which were unsatisfactory performance events. D2121 HEMATOLOGY CFR(s): 493.851(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's proficiency testing (PT) result reports, and interview with the laboratory staff, it was determined that the laboratory failed 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. The findings included: a. The laboratory performed Complete Blood Cell counts (CBC) and reported the following parameters including, but not limited to, the followings: White blood cells (WBC) with cell differentials , Red blood cell (RBC), Hemoglobin (Hgb), Hemotocrit (Hct) and Platelets count (Plt) for the patient samples. b. In order to meet the CLIA requirements, and to verify the accuracy of the CBC testing system annually, the laboratory elected to enroll its hematology proficiency testing (PT) with American Association of Biocatalysts (AAB) PT provider. c. The laboratory failed to attain a score of at least 80 % of the acceptable responses for its CBC parameters in the 1st 2017 for Cell differentials, Hgb, WBC, Platelet counts, which were unsatisfactory performance event. d. The 1st 2017 hematology PT scores showed as follow: Analyte Score (%) Cell diff 12 Hgb 60 WBC 0 Plt 60% e. The laboratory -- 2 of 4 -- performed CBC in approximately 560 patient samples per month. f. The laboratory staff affirmed (3/20/2018 @ 12:10 PM) that the laboratory failed to attain at least 80% of the acceptable responses for its CBC parameters in the 1st 2017 for Cell differentials, Hgb, WBC, Platelet counts, which were unsatisfactory performance event. 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 interview with the laboratory staff, it was determined that the laboratory failed to perform specifications comparable to those established by the manufacturer for the following performance characteristics, 1) Accuracy, 2) Precision, 3) Reportable range of test results for the test system, and 4) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. The findings included: a. The laboratory had moved from previous location to the current location in La Verne, CA. b. The laboratory re-installed the following equipments when they moved to the new location: 1) Celldyn 3700 for Complete Blood Cell Counts (CBC), Beckman Olympus 680 for routine chemistry tests. c. At the time of this survey (3/20/2018), based on interview with the laboratory staff that the laboratory had not completed its verification of the testing system performances for Celldyn 3750 and Olympus AU6800 and to ensure the accuracy of the testing system. 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's proficiency testing (PT) result reports, and interview with the laboratory staff, it was determined that the laboratory director failed to ensure that the proficiency testing samples were tested as required under Subpart H of 42 CFR part 493. The findings included: See D-2087, D-2098, and D- 2121 D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) -- 3 of 4 -- 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 review of the laboratory records, and interview with the laboratory staff, it was determined that the laboratory director failed to ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. The findings included: See D-5421 D6021 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 quality assessment programs are established and maintained to assure the quality of laboratory services provided. 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 director failed to ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. The findings included: See D-6016 and D-5421 -- 4 of 4 --