Endocrinology Consultants, Pc

Summary Statement of Deficiencies D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) (a)(3)(i) 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 surveyor review of the Performance Specifications (PS) for the Abott Emereald Cell Dyn and interview with the Technical Consultant (TC), the laboratory failed to retain instrument raw data reports used to verify normal population reference ranges for complete blood count (CBC) tests from 4/19/23 to 4/16/25. The findings include: 1. The laboratory failed to retain the instrument raw data reports used to verify the normal population reference ranges for CBC tests. 2. The TC confirmed on 4/16/25 at 2:00 pm, the intrument raw data reports were not available for review. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with Technical Consultant (TC), the laboratory failed to perform and document two levels of external controls on each day of patient testing for Folate, and Microalbumin run on the Abbott Alinity alayzer from 6/1/21 to 4/16/25. The findings include: 1. The laboratory did not select control material that correlated with the abnormal patient range. 2. The Patient Range (PR) for Folate was 7.0-31.4 ng/ml. a) The high QC mean 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 -- was 15.0 ng/ml 3. The TC confirmed on 4/16/25 at 12:20 pm that laboratory did not select control material that correlated with the abnormal patient range for the above mentioned analyte. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Operators Manual (OM) and interview with the Technical Consultant (TC), the laboratory failed to follow the OM for calibrating the Abbott Cell-Dyn Emerald analyzer from March 2021 to the date of the survey. The findings include: 1. The OM stated under "Pre-Calibration Procedure Checklist" to "Verify Instrument precision by running a fresh, normal whole blood specimen ten times into the PRECISION file." 2. The laboratory did not perform the aforementioned procedure when calibrating the Abbot Cell-Dyn Emerald. 3. The TC confirmed 10/7/21 at 10:30 am that the laboratory did not follow the PM. 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 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 -- established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with the Technical Consultant (TC), the laboratory failed to verify QC material before use for Chemistry, Endocrinology and Immunology tests performed on the Abbott Alinity analyzer from March 2021 to the date of survey. The findings include: 1. The laboratory failed to verify the following QC material: a) Alinity Intact PTH Controls. b) Alinity Folate controls. c) Alinity C-Peptide Controls. b) Alinity SHBG controls. d) Biorad liquichek urine chemistry controls. e) Biorad liquichek specialty immunoassay controls. 2. There was no documented evidence to show the above QC material was verified. 3. The TC confirmed on 10/7/21 at 11:15 am that the assayed values of QC material were not verified before putting in use. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), and interview with the Technical Consultant (TC), the laboratory failed to follow their procedure for "Auto- Calculation Check" to verify the accuracy of calculations performed by the Laboratory Information System (LIS) from 10/29/18 to the date of survey. The findings include: 1. The procedure "Auto-Calculation Check" stated "Obtain 5 printouts of results that have been calculated by the LIS and verify their accuracy by manually calculating them" 2. There was no documented evidence that the above procedure was performed. 3. The TC confirmed on 10/7/21 at 2:00 pm that the laboratory did not follow the procedure mentioned above. -- 2 of 2 --

Summary Statement of Deficiencies 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 having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records, Manufacturer's Package Inserts (MPI) and interview with the Technical Consultant (TC), the laboratory failed to establish the criteria for acceptability of QC material used for Unsaturated Iron-Binding Capacity (UIBC) tests performed on the Architect Plus ci4100 analyzer from 10/4/16 to the date of the survey. The finding includes: 1. The MPI for Biorad QC for UIBC stated that the laboratory must establish the criteria for acceptability but the laboratory did not have records to show that the ranges were established. 2. The TC confirmed on 10/29/18 at 11:45 am that acceptable QC ranges were not established. 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 --