Doctor's Data, Inc

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of laboratory records, direct observation and interview with the technical supervisor (TS), the laboratory failed to discontinue use of one of one synthetic urine concentrate (RICCA, Lot #1102B58) past the date of expiration (August 2022) for urine elements toxicology testing from 10/01/2022 to 11/08/2024, affecting more than 2,271,820 patient tests. Findings include: 1. Review the "Doctor's Data, Inc. Elements in Urine using the ESI Inline prepFAST and Agilent 8900 ICP- QQQ" procedure manual revealed the following information: "Equipment Calibration /Maintenance (cont.) ...Table 24. Pre Calibration Wash ... Wash Solution ...Synthetic urine pool is used in vial #8 to condition the system ..." 2. During the laboratory tour on 11/08/2024, at 9:57 a.m., the surveyor identified one of one synthetic urine concentrate "RICCA, 20L, Lot #1102B58, EXP Aug 2022" utilized for urine elements toxicology testing that exceeded the expiration date, affecting more than 2,271,820 patient tests. 3. On 11/08/2024, at 9:57 a.m., an interview with the TS confirmed the expired synthetic urine concentrate "RICCA, 20L, Lot #1102B58, EXP Aug 2022" utilized for the analytic process of urine elements in toxicology. 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 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 -- 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 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 review of laboratory records, direct observation, lack of documentation, and interview with the technical supervisor (TS), the laboratory failed to establish the performance specifications for three of three analyzers (Agilent Technologies 6460 Triple Quad LC/MS, Model Number: G6490A, Serial Number: SG1325A204, Agilent Technologies 6495 Triple Quad LC/MS, Model Number: G6495A, Serial Number: SG1709D003, Agilent Technologies 6495 Triple Quad LC/MS, Model Number: G6495A, Serial Number: SG1606D002) utilized for lab developed test (LDT) Hormone & Urinary Metabolites Assessment Profile (HuMap) prior to reporting patient test results in 06/2022 to 11/08/2024, affecting 341,586 patient tests. Findings include: 1. Review of the laboratory's "RD-P-105 (version 4.1) Test Performance Validation of Quantitative and Semiquatitative Analysis" policy revealed the following information. "To define the methodology at Doctor's Data Inc. (DOI) for validating a diagnostic kit that has been modified, or a method developed at DOI for determining the quantity of an analyte or measurand. CLIA'88 requires that before any patient samples are analyzed, the following parameters be evaluated for quantitative or semiquantitative analyses. 1. Accuracy 2. Precision 3. Analytical sensitivity 4. Analytical specificity to include interfering substances 5. Reportable range of test results for the test system 6. Reference intervals (normal values) 7. Any other performance characteristics required for adequate test performance" 2. During the laboratory tour on 11/08/2024, at 11:21 a.m., the surveyor identified three analyzers (Serial Number: SG1325A204, Serial Number: SG1709D003, Serial Number: SG1606D002) utilized for LDT Hormone & Urinary Metabolites Assessment Profile (HuMap) testing. 3. Review of the "Validation of Urinary Steroids Hormones by LC- MS/MS" document and lack of documentation revealed the laboratory failed to: a) document the names and serial numbers for three of three analyzers (Serial Number: SG1325A204, Serial Number: SG1709D003, Serial Number: SG1606D002) utilized for validation testing; b) identify Accuracy, Precision, Analytical sensitivity, Analytical specificity to include interfering substances, Reportable range of test results for the test system, Reference intervals (normal values), and any other performance characteristics required for adequate test performance for three of three analyzers (Serial Number: SG1325A204, Serial Number: SG1709D003, Serial Number: SG1606D002); c) provide documentation of instrument raw data validation runs for three of three analyzers (Serial Number: SG1325A204, Serial Number: SG1709D003, Serial Number: SG1606D002). 4. Review of laboratory documentation revealed 341,586 patient tests were performed for HuMap testing on one Agilent Technologies 6460 Triple Quad LC/MS analyzer, Serial Number: SG1325A204 and two Agilent Technologies 6495 Triple Quad LC/MS analyzers, Serial Numbers: SG1709D003 and SG1606D002 from 06/2022 to 11/08/2024. 5. On 11/08/2024, at 12: 41 p.m., the TS stated the validation documents for three of three analyzers (Serial Number: SG1325A204, Serial Number: SG1709D003, Serial Number: SG1606D002) for the HuMap assay were not on file for surveyor review. D6168 TESTING PERSONNEL -- 2 of 3 -- CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory personnel records and interview with general supervisor #1; the laboratory failed to ensure 1 of 73 testing personnel (TP) were qualified for high complexity laboratory developed testing. See D6171. D6170 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(a) Each individual performing high complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records and interview with general supervisor (GS) #1; the laboratory failed to ensure 1 of 73 testing personnel (TP) were qualified for high complexity laboratory developed testing. Findings include: 1. Review of personnel educational documentation revealed 1 of 73 TP (TP #57) failed to meet the education requirements to qualify as a high complexity TP. 2. On survey date 11/08/2024, at 2:26 pm, GS #1 confirmed TP #57 was not qualified for high complexity laboratory developed testing. -- 3 of 3 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of annual test volumes; patients' test reports; and interviews with the owner of the laboratory and technical supervisor, the test report did not include the name and address of the laboratory location where the test was performed. Findings: 1. Review of worksheets of the laboratory's tests volumes for tests performed in 2017submitted to the surveyor on October 10, 2018, the laboratory performed a total of 13, 621 Saliva Hormone tests. 2. On September 10, 2018 at 3:00 PM, the surveyor performed a look back of patients' tests. Review of patients' test reports revealed that there was a different test report generated for Adrenal Hormone Reports for saliva. The surveyor observed that the name "Labrix" was used as the company logo on the heading for Adrenal Hormone Reports for saliva. However, the name Doctor's Data Inc was used on the company logo for all other testing. The address location for both was that of Doctor's Data. The surveyor could not determine if "Labrix" was even a laboratory. 3. On October 10, 2018 at 3:30 PM, the owner of the laboratory and the technical supervisor confirmed the surveyor's findings. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) 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 -- 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 review of the laboratory's procedures manual; test runs; test reports; and interview with the technical supervisor, the laboratory failed to 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. Findings include: 1. Review of the laboratory's procedures for reporting Serum Calcium on the Beckman Coulter AU680 Analyzer revealed, in a section titled: "Calculations, " it states, "The instrument reports the serum calcium concentrations directly in the unit of mg/dL and hence no calculation is needed. For reporting calcium in SI units of mmol/L, results in mg/dL are multiplied by 0.25. 2. Review of test run data revealed that tests were reporting in units of mg/dL, while actual patients' test results were reported in mmol/L in the laboratory's information system (LIS). 3. There was no documentation to show that the laboratory periodically verified the accuracy of the calculated data interfaced in its LIS. 4. On October 10, 2018 at 3:00 PM, the technical supervisor confirmed the surveyor's findings. -- 2 of 2 --