New Discovery Laboratories

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 record review and interview, the laboratory did not ensure that the attestation statements for the 2024 proficiency test events were signed and dated by the testing staff. Findings: 1. The laboratory director and testing person(s) are reported to the proficiency test provider (API) electronically when the results are submitted to the provider for evaluation and the laboratory prints a copy of the attestation for staff to sign and date. 2. The laboratory policy is to use the printed attestation report as a signed attestation, but there was no written procedure to ensure that the printed report with the preprinted staff names meets the definition of an electronically signed signature (where the person whose name that is printed on the report is using their secure pass code(s) to enter their name onto the report). The director and testing staff did not sign and date the printed attestation report. 3. This was confirmed during interview with laboratory staff on May 15, 2025 at 11:30 am. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD 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 2 -- Based on record review and interview, the laboratory did not document their evaluation of proficiency test results that were not graded by the proficiency test provider due to the providers decision to not evaluate for reasons such as a limited number of participants. Findings: 1. Review of the three proficiency test events evaluated in 2024 by the proficiency test provider (API) for molecular biology testing showed that one of twenty analytes reviewed were not evaluated by the proficiency test provider. 2. The laboratory did not have documentation to show that it evaluated the analyte that the provider did not grade to see if their responses were in line with the majority of respondents or explain why the data provided by the provider could not be used to to provide a reliable evaluation of the test results submitted by the laboratory. 3. This was confirmed during interview with laboratory staff on May 15, 2025 at 11:30 am. -- 2 of 2 --

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 review of the validation procedure and laboratory records and interview with the general supervisor (GS) and technical supervisor (TS), the laboratory failed to verify the accuracy of its reverse transcription polymerase chain reaction (RT-PCR) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing at least twice annually. Findings: 1. The laboratory performed SARS-CoV-2 testing using RT-PCR. 2. As part of the SARS-CoV-2 assay validation, the laboratory performed comparison studies in 12/2020 using four samples that were previously tested at another laboratory and four samples freshly collected from volunteer patients who had previous results determined by other laboratories. All validation results matched the known results. 3. As of 11/01/2021, the laboratory was not enrolled in an approved proficiency testing (PT) program for SARS-CoV-2 testing and had not performed any additional studies to verify the accuracy of the RT-PCR SARS-CoV-2 testing. 4. During the survey on 11/01/2021 at 2:00 PM, the GS and TS confirmed that the laboratory was not enrolled in an approved PT program for RT-PCR SARS-CoV-2 testing to verify the assay's accuracy at least twice annually. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if 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, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on procedure and record review and interview with the general supervisor (GS) and technical supervisor (TS), the laboratory failed to define acceptable ranges for room temperature and humidity. Findings: 1. The laboratory used a "Temperature Log" to record refrigerator, freezer and room temperature as well as room humidity. 2. Neither the procedure manual nor the "Temperature Log" defined the acceptable ranges for room temperature and humidity to ensure proper reagent storage and equipment operation. 3. During the survey on 11/01/2021 at 2:00 PM, the GS and TS confirmed that the acceptable ranges for room temperature and humidity were not defined. 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 review of validation documentation and interview with the general supervisor (GS) and technical supervisor (TS), the laboratory failed to verify the precision of the reverse transcription polymerase chain reaction (RT-PCR) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) assay. Findings: 1. The laboratory's validation procedure stated that the validation included "Repeatability (intra-assay precision)", "Accuracy", and "Limit of Detection." 2. The data reported in the procedure was from three separate test batches. One batch tested samples that were previously tested at another laboratory performing SARS-CoV-2 RT-PCR testing to verify accuracy of the assay. The second batch tested freshly collected samples from volunteer patients who had previous results determined by other laboratories to also verify accuracy of the assay. The third batch tested 21 unknown samples. 3. There was no additional data showing that the laboratory verified the precision of the test system by assessing day-to-day, run-to-run, and within-run variation within defined acceptable criteria. 4. During the survey on 11/01/2021 at 2: 00 PM, the GS and TS confirmed that the validation did not include verification of precision for the RT-PCR SARS-CoV-2 assay. D6101 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(11) The laboratory director must employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of personnel qualifications and interview with the general supervisor (GS) and technical supervisor (TS), the laboratory director failed to ensure that all testing personnel (TP) had documentation of educational qualifications. Findings: 1. The laboratory listed three TP on the Laboratory Personnel Report (form CMS-209). 2. Personnel records for TP#2 did not include a copy of TP#2's diploma or transcripts. 3. During the survey on 11/01/2021 at 2:00 PM, the GS and TP confirmed that TP#2 received a bachelor of science (BS) from a university in Nigeria, but the laboratory did not have documentation of the diploma, transcripts or an evaluation of foreign credentials from a credentialing agency. 4. In an email received on 11/03/2021 at 7:06 PM, the GS confirmed that TP#2 received a BS from the University of Lagos and was working with the university to obtain a copy of the diploma. -- 3 of 3 --