2080 Century Park Laboratory

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 05/27/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; Laboratory Director. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute (API) records (for 2024-3 and 2025-1), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the analyte Antinuclear Antibody (ANA) resulting in unsuccessful performance. Refer to D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) (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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API evaluation report, the laboratory failed to achieve satisfactory performance for two out of three proficiency events in 2024 and 2025 for the analyte ANA. Findings, the laboratory received the following ANA scores from API: a. 2024 third testing event - API 40%, b. 2025 first testing event - API 60%. A review of the 2024 and 2025 proficiency testing scores from American Proficiency Institute confirmed the above findings. 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 a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D report API records for 2024-3 and 2025-1 events, the laboratory director failed to provide overall management and a direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) 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 proficiency testing desk review of Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D report and API records for 2024-3 and 2025- 1 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2084. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of policies and procedures manuals and interview with the Technical Consultant (TC), the laboratory failed to establish written policies and procedures to assess employee competency. The findings include: 1. The laboratory's Technical Consultant affirmed on September 25, 2024, at approximately 1:30 pm, that the laboratory did not have written policies and procedures to assess employee competency. 2. The laboratory's testing declaration form, signed by the laboratory director on September 25, 2024, stated that the laboratory performed approximately 479,419 tests annually. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials 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 -- having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on interview with the Technical Consultant (TC) and review of Chemistry Quality Control (QC) records from April 2023 through September 2024, the laboratory failed to verify the stated values of the commercially assayed chemistry QC materials in use at the time of the survey. The findings include: 1. It was the practice of the laboratory to use BIO-RAD commercially assayed chemistry QC materials (Lyphocheck) to monitor patient chemistry testing using Beckman Coulter AU480. The technical consultant stated that on April 25, 2023, the laboratory switched the QC materials from the old lot number 89710 (L1: 89711 and L2: 89712) to the new lot number of 89730 (Level 1: 89731 and level 2: 89732). 2. The laboratory maintained no documentation to indicate the stated values of chemistry QC materials lot number 89730 had been verified for Beckman Coulter AU480 instrument by the laboratory prior to testing patient samples. 3. On September 25, 2024, at approximately 2:30 pm, the technical consultant affirmed that the laboratory did not verify the value of QC materials provided by the manufacturer. 4. The laboratory did not verify the Chemistry QC materials for 17 of 17 months. The laboratory's testing declaration form, signed by the laboratory director on September 25, 2024, stated that the laboratory performed 310,721 chemistry tests annually. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on interview with Technical Consultant (TC), review of laboratory's policies and procedures manuals, Quality Control (QC) records, and Proficiency Testing (PT) records, it was determined that the Laboratory Director (LD) failed to ensure that established quality control procedures were followed, approved

Summary Statement of Deficiencies 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 Surveyor review of laboratory's policy & procedure, patient, quality control & proficiency testing records, lack of annual test accuracy verification records and interview with the laboratory technical consultant on December 29, 2021 at 1:44 pm, the laboratory failed to verify, at least twice annually, the accuracy of its CTX-I test for the years of 2020 and 2021. The findings include: 1. The laboratory performed CTX-I test using IDS iSYS system. However, the laboratory did not have any documentation showing that it had verified its test accuracy, at least twice annually for the years of 2020 and 2021. Hence, the accuracy of the reported CTX-I results could not be assured and potentially harmed patients. 2. The laboratory technical consultant on December 29, 2021 at 1:44 pm, affirmed that the laboratory did not verify the accuracy of its CTX-I test, twice yearly. 3. The laboratory's testing declaration form, signed by the laboratory Director on 12/29/2021, stated that the laboratory performs 660 CTX-I tests, annually. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as 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 -- applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, establishment & verification of test performance specifications, patients test records and interview with the laboratory technical consultant on December 29, 2021 at 12:10 pm, the laboratory failed to establish and verify the performance specifications of HBA1C and HDL tests. The findings include: 1. The laboratory performed HBA1C and HDL tests using reagents from Caldon Biosciences on Beckman AU480 instrument which is not FDA approved. Moreover, the laboratory did not establish and verify the required test performance specifications. Therefore, the accuracy and the validity of the reported HBA1C and HDL tests results generated using Caldon Biosciences reagent can not be assured. 2. The laboratory technical consultant on December 29, 2021 at 12:10 pm, affirmed that Caldon Biosciences reagent is not FDA approved, and the laboratory did not establish and verify the required test performance specifications. 3. The laboratory's testing declaration form, signed by the laboratory director on 12/29/2021, stated that the laboratory performs about 10,000 tests, annually. D5813 TEST REPORT CFR(s): 493.1291(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, patient test records, and interview with the laboratory technical consultant on December 29, 2021 at 12:40 pm, the laboratory failed to immediately alert the ordering physician after determining the panic value of the BNP test for the patient # M9460 causing potential harm to the patient. The findings include: 1. The laboratory received the patient specimen, ID 402484 on 12/14/2021 at 16:31. The laboratory's test record printed on 12/14/2021 at 16:47 showed BNP test results in handwriting. The instrument printout paper showed the date as 12/12/21 for which the laboratory did not set the correct date. The laboratory's note on the test report showed that the staff notified the doctor on 12/15 /21 and did not have a time. The laboratory records should document the date, time, and person to whom the test results were reported. 2. The laboratory technical consultant on December 29, 2021 at 12:40 pm, affirmed that the laboratory did not immediately notify the ordering doctor after determining the panic value. 3. The laboratory's testing declaration form, signed by the laboratory director on 12/29/2021, stated that the laboratory performs 1,211 BNP tests, annually. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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 -- 2 of 3 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, establishment & verification of test performance specifications, patients test records and interview with the laboratory technical consultant on December 29, 2021 at 12:10 pm, the laboratory director failed to ensure that the verification procedure used for the HBA1C and HDL tests was adequate. The findings include: See D5423. 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 Surveyor review of laboratory's policy & procedure, patient, quality control and test accuracy verification records, and interview with the laboratory technical consultant on December 29, 2021 at 1:44 pm, it was determined that the laboratory director failed to ensure the establishment and maintenance of acceptable levels of analytical performance for the CTX-I, HBA1C and HDL tests. See D5217 and D5423. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, establishment & verification of test performance specifications, patients test records and interview with the laboratory technical consultant on December 29, 2021 at 12:10 pm, the laboratory technical consultant failed to establish the laboratory's HBA1C and HDL tests performance characteristics. The findings include: See D5423. -- 3 of 3 --

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 specialty of Hematology constituting unsuccessful PT performance. (See D2130) 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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, Prothrombin time (ProT), 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 analyte, ProT, as follows: 2017 Q3 2018 Q1 ProT 0% 60% Q1 = First 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, ProT. 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 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 analyte, ProT, 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 performance. (See D2016 and D2130) -- 2 of 2 --