Fem Centre

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted CMS-209 form, review of College of American Pathologists (CAP) proficiency testing (PT) records from 2024, and confirmed in interview, the laboratory failed to ensure three of three consecutive hematology PT events were analyzed by personnel who routinely perform hematology testing in the laboratory. Findings include: 1. Review of the laboratory's submitted CMS-209 form determined the laboratory identified two testing persons performing hematology testing. 2. Review of CAP PT records from 2024 determined Testing Person-2 (as listed on the CMS-209 form) tested the following PT events: 2024 Hematology 1st event 2024 Hematology 2nd event 2024 Hematology 3rd event 3. Testing-person 1 (as listed on the CMS-209 form) confirmed the findings during an interview on 02/20/2025 at 1205 hours in the office. Key: CMS - Centers for Medicare and Medicaid Services D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing 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 -- using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of the manufacturer's package insert, review of quality control (QC) records from December 2024 (random review), review of patient final reports, and staff interview, the laboratory failed to have a mechanism in place to monitor QC for immediate error for one of one BioRad Liquichek Immunoassay Plus Control lots for the analyte estradiol reviewed in December 2024 (random review) to ensure accurate and reliable test results. Findings include: 1. Review of the laboratory's policy titled "Quality Control", approved by the laboratory director on 03/24/2009 stated: "Definitions: Acceptable Range: ...defined by the laboratory through repetitive testing and calculated Standard Deviations." 2. Review of the manufacturer's package insert "BioRad Liquichek Immunoassay Plus Control Levels 1, 2, and 3" stated: "ASSIGNMENT OF VALUES The mean values and corresponding +/-3SD ranges in the Assignment of Values Data Charts were derived from replicate analyses and are specific for this lot of product." Further review of the manufacturer's package insert determined QC values were established by the manufacturer at +/- 3SD ranges for the Siemens Advia Centaur Systems for the analyte estradiol: a) Lot 85380 - Expires: 11/30/2025 Level 1: Mean: 64.3 pg/mL 3SD range: 43.5 - 85.1 pg/mL Level 2: Mean: 457 pg/mL 3SD range: 387 - 527 pg/mL Level 3: Mean: 1333 pg/mL 3SD range: 1152 - 1514 pg/mL 3. Review of the laboratory's QC records from December 2024 (random review) determined the ranges used by the laboratory for the analyte estradiol were too wide to detect immediate error: a) Lot: 83580 - Expires 11/30/2025 Level 1: mean: 64.3 pg/mL 2SD: 20.8 pg /mL Laboratory's 2SD range: 43.5 - 85.1 pg/mL Level 2: mean: 457.0 pg/mL 2SD: 70.0 pg/mL 2SD range: 387 - 527 pg/mL Level 3: mean: 1333.0 pg/mL 2SD: 181.0 pg /mL 2SD range: 1152 - 1514 pg/mL 4. Review of patient final reports from December 2024 (random review) determined Estradiol testing was performed on the following patients: a) Accession #: 245920 Collection: 12/02/2024 08:12 AM Performed: 12/02 /2027 12:41 PM Result: 20.2 pg/mL b) Accession #: 247876 Collection: 12/02/2024 09:10 AM Performed: 12/02/2027 12:44 PM Result: 168.7 pg/mL c) Accession #: Collection: 12/02/2024 11:50 AM Performed: 12/02/2027 01:17 PM Result: 59.3 pg /mL d) Accession #: 248066 Collection: 12/04/2024 12:36 PM Performed: 12/04/2024 01:42 PM Result: 105.2 pg/mL e) Accession #: 248078 Collection: 12/05/2024 09:33 AM Performed: 12/06/ 01:36 PM Result: 77.7 pg/mL f) Accession #: 243775 Collection: 12/05/2024 10:09 AM Performed: 12/05/2024 11:21 AM Result: 103.2 pg /mL g) Accession #: 241833 Collection: 12/05/2024 10:40 AM Performed: 12/05 /2024 11:02 AM Result: 73.5 pg/mL h) Accession #: 248021 Collection: 12/05/2024 01:51 PM Performed: 12/05/2024 03:10 PM Result: 22.9 pg/mL i) Accession #: 242019 Collection: 12/17/2024 02:01 PM Performed: 12/17/2024 02:18 PM Result: 46.2 pg/mL j) Accession #: 243328 Collection: 12/20/2024 09:52 AM Performed: 12 /20/2024 01:53 PM Result: 34.7 pg/mL k) Accession #: 243467 Collection: 12/23 /2024 08:07 AM Performed: 12/23/2024 10:14 AM Result: 39.9 pg/mL 5. Testing- person 1 (as listed on the CMS-209 form) confirmed the findings during an interview on 02/20/2024 at 1430 hours in the office. Key: SD - standard deviations pg/mL - picograms per milliliter CMS - Centers for Medicare and Medicaid Services -- 2 of 3 -- D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted CMS-209 form, review of laboratory personnel records, and confirmed in interview, the technical consultant failed to evaluate the annual competency of one of two testing persons in 2023 and 2024. Findings include: 1. Review of the laboratory's submitted CMS-209 form identified two testing persons performing non-waived testing. 2. Review of the laboratory's personnel records determined the laboratory failed to ensure the six required elements of competency for non-waived testing for Testing Person-2 (as listed on the CMS-209 form) were documented for one of one event in 2023 and one of one event in 2024. The laboratory was asked to provide documentation of assessing the six required elements of competency for non-waived testing for Testing Person-2 in 2023 and 2024. No documentation was provided. 3. Testing Person-1 (as listed on the CMS-209 form) confirmed the findings during an interview on 02/20/2025 at 1204 hours in the office. Key: CMS - Centers for Medicare and Medicaid Services -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of laboratory policy, College of American Pathologists (CAP) testing records, laboratory's CMS (Centers for Medicare & Medicaid Services) 209 form, and staff interview, the laboratory failed to ensure that patient samples were analyzed with the laboratory's regular patient workload by personnel who routinely perform testing in the laboratory for 3 of 3 events in 2022 (Event 1, 2, 3). Findings included: 1. Review of the laboratory's proficiency testing policy revealed: "Policy: Proficiency Testing will consist of the following: A. Personnel performing testing materials 1. The personnel performing the proficiency tests will be the medical laboratory technologists who perform general patient samples. 2. The proficiency test samples should be integrated into the routine workload." 2. Review of the CAP testing records revealed the following instructions: "REGULARTORY INFORMATION Per CLIA, as published by the United States Federal Register Proficiency Testing (PT) specimens must be tested with the laboratory's regular workload, using routine methods, and testing the PT specimens the same number of times it routinely tests patient specimens" 3. Further review of the CAP testing records revealed the laboratory participated in the following events: 2022: General Chemistry; Events: C-A 2022, C-B 2022, C-C 2022 Hematology Auto Differentials; Events FH2-A 2022, FH2- B 2022, FH2-C 2022 Ligand; Events K-A 2022, K-B 2022, K-C 2022 Further review of the PT records revealed Testing Person 1 participated in all the above PT events. 3. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Review of the laboratory's CMS 209 form revealed 2 Testing Persons (TP) were listed as performing all moderate complexity tests performed by the laboratory. Testing Person-2 (TP-2) Hire date: 07/2008 TP-2 participated in testing patient specimens and did NOT participate in any of the above listed PT events for 2022. 4. During an interview on 03/30/2023 at 11:40 am, the Technical Consultant (who was also Testing Person-1) confirmed the above findings. The laboratory failed to ensure that patient samples were analyzed with the laboratory's regular patient workload by personnel who routinely perform testing. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory policy, College of American Pathologists (CAP) instructions, CAP proficiency testing (PT) records, and confirmed in interview, the laboratory failed to attest to the routine integration of proficiency samples into the patient workload for 1 of 3 chemistry events in 2022 (Event C-B 2022) and 1 of 3 ligand events in 2022 (Event K-C 2022). 1. Review of the laboratory's PT policy revealed: 1. Review of the laboratory's proficiency testing policy revealed: "Policy: Proficiency Testing will consist of the following: A. Personnel performing testing materials 1. The personnel performing the proficiency tests will be the medical laboratory technologists who perform general patient samples. 2. The proficiency test samples should be integrated into the routine workload ... 7. Sign and retain the Attestation Statement." 2. Review of CAP instructions revealed: "Attestation/Use of Other Form Attestation Statement As stated in the February 28, 1992 United States Federal Register under Subpart H 493.801(b)(1), "the individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient work load using the laboratory's routine methods." The laboratory director or designee and the testing personnel must sign on the result form. You may use the attestation page provided in the kit instructions or, alternatively, print, sign, and retain a copy of this page for your records and inspection purposes." 3. Review of chemistry PT records for Event C-B 2022 revealed the laboratory director and testing person 1 failed to sign the attestation statement. Review of ligand PT records for Event K-C 2022 revealed the laboratory director and testing person 1 failed to sign the attestation statement. 4. During an interview on 03/30/2023 at 11:40 am, the Technical Consultant (who was also Testing Person-1) confirmed the above findings. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and -- 2 of 6 -- precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory's quality control (QC) policy, BIO-RAD control material manufacturer's instructions, assignment of value sheets, ADVIA Centaur XP QC data, and in interview with staff, the laboratory failed to ensure their control procedures detected immediate error for 1 of 1 set of current lot numbers. Findings: 1. Review of the laboratory's policy "VERIFICATION OF MANUFACTURER'S ESTABLISHED MEANS AND RANGES" revealed: "Prior to introducing a new lot of BioRad Liquichek Immunoassay Plus Control or Horiba Pentra Carbon Dioxide control, both lots (old and new) must be run in parallel f or3 days to verify the manufacturer's published means and ranges. ESTABLISHING MEAN AND RANGES ON UNASSAYED CONTROL MATERIAL With each new lot of Bio-Rad Liquichek Immunoassay Plus Control and Siemens Vitamin D QC, controls will be run daily for a total of 20 replicates prior to use as daily QC. From these results the FEM Centre mean and +/- 2 SD ranges will be calculated and put into use for daily QC requirements. These means should fall within manufacturer's means [sic] The manufacturers stated ranges will be used until enough data points are collected and calculated to establish the FEM Centre ranges." 2. Review of BIO-RAD Liquichek Immunoassay Plus Control manufacturer's instructions (package insert) revealed: "ASSIGNMENT OF VALUES The means and values and corresponding +/-3SD ranges in the Assignment of Values Data Charts (available separately) were derived from replicate analyses and are specific for this lot of product ... It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides. Laboratory established ranges may vary from those listed during the life of this control." Further review of the Assignment of Values revealed the following sampling of analyte QC ranges: Liquichek Immunoassay Plus Control Level 1 Lot #85331; expiration date: 08/31/2024 Level 2 Lot #85332; expiration date: 08/31/2024 Level 3 Lot #85333; expiration date: 08/31/2024 Cortisol (COR) Level 1 Mean: 4.44; Range: 3.26-5.62 Level 2 Mean: 23.7; Range: 18.4-29.1 Level 3 Mean: 34.2; Range: 26.5-41.8 Dehydroepiandrosterone-Sulfate (DHEA) Level 1 Mean: 79.6; Range: 58.5- 101 Level 2 Mean: 129; Range: 97.7-160 Level 3 Mean: 442; Range: 337-547 Follicle Stimulating Hormone (FSH) Level 1 Mean: 6.83; Range: 5.39-8.27 Level 2 Mean: 17.6; Range: 14.5-20.8 Level 3 Mean: 40.5; Range: 33.6-47.3 Luteinizing Hormone (LH) Level 1 Mean: 3.42; Range: 3.42; Range: 2.76-4.08 Level 2 Mean: 18.5; Range: 15.0; Range: 15.0-22.1 Level 3 Mean: 63.1; Range: 50.9-75.4 Progesterone (PRGE) Level 1 Mean: 1.06; Range: 0.645-1.47 Level 2 Mean: 8.85; Range: 6.66-11.0 Level 3 Mean: 18.8; Range: 14.3-23.2 A handwritten note at the bottom of the sheet stated: "Due to shipment issues - ranges specific to FEM Centre will be established after 2 weeks of Data [sic]" 3. Review of ADVIA Centaur XP endocrinology/chemistry analyzer QC data (random review 11/2022 through 03/2023) revealed the ranges used did not detect immediate error, as follows (random sampling of analytes): Liquichek Immunoassay Plus Control (put into use 11/15/2022): Level 1 Lot #85331; expiration date: 08/31/2024 Level 2 Lot #85332; expiration date: 08/31/2024 Level 3 Lot #85333; expiration date: 08/31/2024 Laboratory Cortisol (COR) ranges used for day- to-day acceptability: Level 1 Mean: 4.44; Range: 3.3-5.6 Level 2 Mean: 23.70; Range: 18.4-29.1 Level 3 Mean: 34.20; Range: 26.6-41.9 Dehydroepiandrosterone-Sulfate (DHEA) Level 1 Mean: 79.60; Range: 58.4-100.9 Level 2 Mean: 129.00; Range: 97.9- 160.2 Level 3 Mean: 442.00; Range: 337.0-547.0 Follicle Stimulating Hormone (FSH) Level 1 Mean: 6.83; Range: 5.4-8.3 Level 2 Mean: 17.60; Range: 14.5-20.8 -- 3 of 6 -- Level 3 Mean: 40.50; Range: 33.7-47.4 Luteinizing Hormone (LH) Level 1 Mean: 3.42; Range: 3.42; Range: 2.8-4.1 Level 2 Mean: 18.50; Range: 15.0; Range: 15.0- 22.1 Level 3 Mean: 63.10; Range: 50.9-75.4 Progesterone (PRGE) Level 1 Mean: 1.06; Range: 0.6-1.5 Level 2 Mean: 8.85; Range: 6.7-11.0 Level 3 Mean: 18.80; Range: 14.4-23.3 The laboratory's QC ranges were too wide to detect immediate error. 4. During an interview on 04/30/2023 at 2:45 pm, the Technical Consultant confirmed she had not established QC ranges for the laboratory and was using the manufacturer's ranges at 3SDs. D5783

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, College of American Pathologists (CAP). The laboratory was found to be NOT in compliance with the conditions of participation of the CLIA program based on the following CONDITION LEVEL DEFICIENCIES: 493.803 Successful participation [proficiency testing] 493.1403 Laboratories performing moderate complexity testing; laboratory director Note: The CMS 2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representatives. The survey process was discussed, and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be NOT in compliance with the CLIA conditions for specialties /subspecialties surveyed for 42 CFR 493.1240 Pre-Analytic Systems 493.1403 Laboratory Director, (moderate complexity). Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, College of American Pathologists (CAP). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 Successful participation in a proficiency testing program 493.807 Condition: Reinstatement of laboratories performing nonwaived testing 493.1403 Laboratory Director, Moderate Complexity 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing records, it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Endocrinology for the Triiodothyronine analyte. Refer to D2107. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a desk review of Centers for Medicare and Medicaid Services (CMS) form 0155 and College of American Pathologists (CAP) proficiency testing records, it was determined the laboratory had not successfully participated in proficiency testing for the satisfactory performance in the specialty of Endocrinology for the Triiodothyronine (T3) analyte for two of three consecutive testing events and has not demonstrated sustained satisfactory performance on two consecutive proficiency events since the unsuccessful scores. Findings included: 1. Review of the CMS 0155 report revealed the following results: CAP 2019 -- 3rd Event laboratory received an unsatisfactory score of 0% Triiodothyronine. CAP 2020 - 1st Event laboratory received an unsatisfactory score of 0% Triiodothyronine. CAP 2020 -- 3rd Event laboratory received an unsatisfactory score of 0% Triiodothyronine. 2. Review of the laboratory's CAP proficiency testing records revealed the following results: CAP K-C 2019 Ligand General - 3rd Event laboratory received an unsatisfactory score of 0% for Triiodothyronine CAP K-A 2020 Ligand General - 1st Event laboratory received an unsatisfactory score 0% for Triiodothyronine CAP K-C 2020 Ligand General - 3rd Event laboratory received an unsatisfactory score of 0% for Triiodothyronine 3. The laboratory must demonstrate sustained satisfactory performance (>/= 80%) on two consecutive testing events for reinstatement. Note: Noninitial unsuccessful participation was cited on 07/09/2020. Review of the CMS 0155 report revealed the following results for CAP proficiency testing: CAP 2019- 3rd Event laboratory received an unsatisfactory score of 0% Triiodothyronine. CAP 2020- 1st Event laboratory received an unsatisfactory score of 0% Triiodothyronine. CAP 2020- 3rd Event laboratory received an unsatisfactory score of 0% Triiodothyronine. D2098 ENDOCRINOLOGY CFR(s): 493.843(a) -- 2 of 5 -- 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 a review of the CMS (Center for Medicare and Medicaid Services) national database and a proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2019-2020, it was revealed the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for theTriiodothyronine analyte in the specialty of Endocrinology. Findings included: 1. A review of the CMS (Center for Medicare and Medicaid Services) 0155 report revealed the following results: CAP 2019 -- 3rd Event laboratory received an unsatisfactory score of 0% Triiodothyronine. CAP 2020 - 1st Event laboratory received an unsatisfactory score of 0% Triiodothyronine. CAP 2020 -- 3rd Event laboratory received an unsatisfactory score of 0% Triiodothyronine. 2. A proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2019-2020 confirmed the laboratory received the following results: CAP K-C 2019 Ligand General - 3rd Event laboratory received an unsatisfactory score of 0% for Triiodothyronine CAP K-A 2020 Ligand General - 1st Event laboratory received an unsatisfactory score 0% for Triiodothyronine CAP K-C 2020 Ligand General - 3rd Event laboratory received an unsatisfactory score of 0% for Triiodothyronine D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2019-2020, it was revealed the laboratory failed to attain a satisfactory score of at least 80% for the overall event in the specialty of Endocrinology. Findings included: 1. A review of the CMS (Center for Medicare and Medicaid Services) 0155 report revealed the following results: CAP 2019 -- 3rd Event laboratory received an overall unsatisfactory score 75% for Endocrinology. CAP 2020 -- 1st Event laboratory received an overall unsatisfactory score 70% for Endocrinology. CAP 2020 -- 3rd Event laboratory received an overall unsatisfactory score of 70% for Endocrinology. 2. A proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2019-2020 confirmed the laboratory received the following results: CAP K-C 2019 Ligand General -- 3rd Event laboratory received an overall unsatisfactory score 75% for Endocrinology CAP K-A 2020 Ligand General - 1st Event laboratory received an overall unsatisfactory score 70% for Endocrinology. CAP K-C 2020 Ligand General - 3rd Event laboratory received an overall unsatisfactory score of 70% for Endocrinology. 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 -- 3 of 5 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CMS (Center for Medicare and Medicaid Services) national database and a proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2019-2020, it was determined that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two out of three consecutive testing events. The laboratory failed to achieve satisfactory performance in the specialty of Endocrinology for the analyte Triiodothyronine. Two out of three unsatisfactory scores result in unsuccessful Proficiency Testing (PT) performance. Findings included: 1. A review of the CMS (Center for Medicare and Medicaid Services) 0155 report revealed the following results: CAP 2019 -- 3rd Event laboratory received an overall unsatisfactory score 75% for Endocrinology. CAP 2020 -- 1st Event laboratory received an overall unsatisfactory score 70% for Endocrinology. CAP 2020 -- 3rd Event laboratory received an overall unsatisfactory score of 70% for Endocrinology. 2. A proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2019-2020 confirmed the laboratory received the following results: CAP K-C 2019 Ligand General -- 3rd Event laboratory received an overall unsatisfactory score 75% for Endocrinology CAP K-A 2020 Ligand General - 1st Event laboratory received an overall unsatisfactory score 70% for Endocrinology. CAP K-C 2020 Ligand General - 3rd Event laboratory received an overall unsatisfactory score of 70% for Endocrinology. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for 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 a review of the CMS (Center for Medicare and Medicaid Services) national database and a proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2019-2020, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same testing event in two consecutive testing events or two out of three consecutive testing events in the specialty of Endocrinology. Two out of three unsatisfactory scores result in unsuccessful PT performance. Findings included: 1. A review of the CMS (Center for Medicare and Medicaid Services) 0155 report revealed the following results: CAP 2020 -- 1st Event laboratory received an overall unsatisfactory score 70% for Endocrinology. CAP 2020 -- 3rd Event laboratory received an overall unsatisfactory score of 70% for Endocrinology. 2. A proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2019-2020 confirmed the laboratory received the following results: CAP K-A 2020 Ligand General - 1st Event laboratory received an overall unsatisfactory score 70% for Endocrinology. CAP K-C 2020 Ligand General - 3rd Event laboratory received an overall unsatisfactory score of 70% for Endocrinology. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 4 of 5 -- 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 desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to 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 proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2107 and D2108. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, College of American Pathologists (CAP). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 Successful participation in a proficiency testing program 493.1403 Laboratory Director, Moderate Complexity 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: 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 a desk review of proficiency testing records, it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Endocrinology for the Triiodothyronine analyte. Refer to D2107. 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 a review of the CMS (Center for Medicare and Medicaid Services) national database and a proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2019-2020, it was revealed the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for Triiodothyronine analyte in the specialty of Endocrinology. Findings included: 1. A review of the CMS (Center for Medicare and Medicaid Services) 0155 report revealed the following results: CAP K-C 2019 Ligand General - 3rd Event laboratory received an unsatisfactory score 0% for Triiodothyronine CAP K-A 2020 Ligand General - 1st Event laboratory received an unsatisfactory score of 0% for Triiodothyronine 2. A proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2019-2020 confirmed the laboratory received the following results: CAP K-C 2019 Ligand General - 3rd Event laboratory received an unsatisfactory score 0% for Triiodothyronine CAP K-A 2020 Ligand General - 1st Event laboratory received an unsatisfactory score of 0% for Triiodothyronine D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2019-2020, it was revealed the laboratory failed to attain a satisfactory score of at least 80% for the overall event in the specialty of Endocrinology. Findings included: 1. A review of the CMS (Center for Medicare and Medicaid Services) 0155 report revealed the following results: CAP K-C 2019 Ligand General - 3rd Event laboratory received an overall unsatisfactory score 75% for Endocrinology. CAP K-A 2020 Ligand General - 1st Event laboratory received an overall unsatisfactory score of 70% for Endocrinology. 2. A proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2019- 2020 confirmed the laboratory received the following results: CAP K-C 2019 Ligand General - 3rd Event laboratory received an overall unsatisfactory score 75% for Endocrinology. CAP K-A 2020 Ligand General - 1st Event laboratory received an overall unsatisfactory score of 70% for Endocrinology. D2107 ENDOCRINOLOGY -- 2 of 4 -- 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 a review of the CMS (Center for Medicare and Medicaid Services) national database and a proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2019-2020, it was determined that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two out of three consecutive testing events. The laboratory failed to achieve satisfactory performance in the specialty of Endocrinology for the analyte Triiodothyronine. Two out of three unsatisfactory scores result in unsuccessful Proficiency Testing (PT) performance. Findings included: 1. A review of the CMS (Center for Medicare and Medicaid Services) 0155 report revealed the following results: CAP K-C 2019 Ligand General - 3rd Event laboratory received an unsatisfactory score 0% for Triiodothyronine CAP K-A 2020 Ligand General - 1st Event laboratory received an unsatisfactory score of 0% for Triiodothyronine 2. A proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2019-2020 confirmed the laboratory received the following results: CAP K-C 2019 Ligand General - 3rd Event laboratory received an unsatisfactory score 0% for Triiodothyronine CAP K-A 2020 Ligand General - 1st Event laboratory received an unsatisfactory score of 0% for Triiodothyronine D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for 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 a review of the CMS (Center for Medicare and Medicaid Services) national database and a proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2019-2020, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same testing event in two consecutive testing events or two out of three consecutive testing events in the specialty of Endocrinology. Two out of three unsatisfactory scores result in unsuccessful PT performance. Findings included: 1. A review of the CMS (Center for Medicare and Medicaid Services) 0155 report revealed the following results: CAP K- C 2019 Ligand General - 3rd Event laboratory received an overall unsatisfactory score 75% for Endocrinology. CAP K-A 2020 Ligand General - 1st Event laboratory received an overall unsatisfactory score of 70% for Endocrinology. 2. A proficiency desk review of the College of American Pathologists (CAP) proficiency testing records from 2019-2020 confirmed the laboratory received the following results: CAP K-C 2019 Ligand General - 3rd Event laboratory received an overall unsatisfactory score 75% for Endocrinology. CAP K-A 2020 Ligand General - 1st Event laboratory received an overall unsatisfactory score of 70% for Endocrinology. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR -- 3 of 4 -- 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 desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to 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 proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2107 and D2108. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Entrance and exit conferences were held with the laboratory technical consultant. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The laboratory representative was given an opportunity to provide evidence of compliance with the noted deficiency, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the