Laboratory Of Molec Genetics Nidcd-Nih

Summary Statement of Deficiencies D0000 An onsite recertification survey was performed on 06/25/2024 under 42 CFR part 493 CLIA regulations. Standard level deficiencies were cited. D5315 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(c) The laboratory must refer a specimen for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS. This STANDARD is not met as evidenced by: Based on review of the laboratory's written procedure, CLIA certificate, Centers for Medicare & Medicaid Services-116 (CMS-116) database, electronic mail (email), and interview with staff, the laboratory failed to ensure patient specimens were sent to a CLIA-certified laboratory for DNA sequencing. Findings included: 1. Review of the laboratory's written procedure stated, "The LMG switched its testing model for patient samples in 2022 to that of a non-traditional, multiple site testing model. Site 1 is the LMG, which performs the wet chemistry process of PCR/Sanger Sequencing of patient DNA samples and has a CLIA certificate for High Complexity Testing. Site 2 is a local commercial vendor, ACGT, Inc., which has a CLIA certificate of Waiver. Site 2 runs the sequencing plates on a 3730XL or 3730 Genetic Analyzer, generates electropherogram data occurs at Site 1, the LMG. Site 2 does not perform any analysis of the data or send any reports back to patients." 2. During an interview on 06/25/2024 at 10:24 am, the technical supervisor stated treated patient plates are sent to a different laboratory for DNA sequencing in Germantown, MD. 3. The laboratory provided the CLIA certificate for the laboratory that performed DNA sequencing and it was a CLIA certificate of waiver, "CLIA # 14D2035148 ACGT, INC 35 Waltz Dr, Wheeling, IL 60090." 4. During an interview with the laboratory manager and technical supervisor on 06/25/2024 at 2:30 pm, were asked to clarify that the laboratory used for DNA sequencing was in Germantown or in Wheeling, IL. They 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 -- confirmed it was in Germantown, MD at 12321 Middlebrook Road, Suite 105. 5. Review of the CMS-116 database did not include a CLIA number for ACGT at 12321 Middlebrook Road, Suite 105, Germantown, MD. 6. The laboratory manager emailed ACGT on 06/25/2024 at 1:30 pm requesting their CLIA number and the vice president replied (06/25/2024 at 2:51 pm), "Our Germantown facility does not possess its own CLIA accreditation as it is a research grade Sanger sequencing facility. All clinical services are provided from our Wheeling, Illinois headquarters and lab ..." Word Key: LMG - Laboratory of Molecular Genetics DNA - Deoxyribonucleic acid PCR - polymerase chain reaction 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 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: I. Based on review of the laboratory's temperature records, direct observation, manufacturer's instructions, and interview with the Technical Supervisor, the laboratory failed to set freezer and refrigerator temperature ranges in accordance to storage requirements of the manufacturer for 1 of 1 Applied Biosystems BigDye Terminator V3.1 Cycle Sequencing Kits and 1 of 1 Applied Biosystems BigDye Terminator V1.1 Sequencing Buffer. Findings Included: 1. A review of the laboratory's Rees Scientific manufacturer's ranges for the freezer '004 1F210 (-20)' showed a temperature range set for -30C lower limit and -10C upper limit; for the refrigerator '003 1F210 (+4)' a temperature range set for 0C lower limit and 8C upper limit. 2. During a tour of the laboratory at 9:34am, the following reagents were found: [Freezer 004 1F210] - One box of Applied Biosystems BigDye Terminator V3.1 Cycle Sequencing Kit, Lot 2912514, expiration date 2025-05-31, manufacturer storage temperature requirement -25C to -15C. [Refrigerator 003 1F210] - One box of Applied Biosystems BigDye Terminator V1.1 Sequencing Buffer, Lot 2312322, manufacturer storage temperature requirement 2C to 8C. 3. In an interview in the laboratory on 6/25/24 at 10:09am, the Technical Supervisor corroborated that the temperature ranges set on the Rees Scientific monitoring system for freezer 004 1F210, and refrigerator 003 1F210 where the reagents were located, were beyond manufacturer's specifications. II. Based on direct observation, manufacturer's instructions, and interview with the Technical Supervisor, the laboratory failed to ensure temperature specifications were being monitored and documented for 1 of 1 Quality Biological Molecular Biology Water. Findings Included: 1. During a tour of the laboratory on 6/25/24 at 9:34am, one box of Quality Biological Molecular Biology Water, Lot 725281, expiration 3/2026, manufacturer storage temperature requirement 15C to 30C, was found in the pre-PCR testing area of the laboratory. 2. In an interview in the conference room on 6/25/24 at 1:08pm, the Technical Supervisor verified that the laboratory's facilities management did not monitor the room temperature in the pre-PCR area of the laboratory. D5781

Summary Statement of Deficiencies D0000 The Centers for Medicare and Medicaid Services (CMS) Federal Surveyor conducted an announced routine CLIA recertification survey at Laboratory of Molecular Genetics - NIDCD/NIH on June 22, 2022. The laboratory was surveyed under 42 CFR part 493 CLIA regulations. The follwoing deficiencies were found during the announced routine CLIA recertification survey: 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 laboratory personnel records, laboratory procedures and interview with laboratory staff, the laboratory failed to establish a competency assessment policy to assess the competency for one of one clinical consultant (CC), five of five technical supervisors (TS), seven of seven general supervisors (GS) and testing personnel (TP). Findings Include: 1. One the day of survey, June 22, 2022 around 10: 35 am, the laboratory could not provide a competency assessment policy that assesses the competency for CC, TS, GS and TP. 2. The laboratory could not provide competency assessment records for one of one CC, five of five TS and seven of seven GSs. 3. During the exit conference on June 22, 2022 around 11:45 am, the laboratory staff and the laboratory Director confirmed a competency assessment policy had not been established and that the CC, TS, GS were not assessed for competency. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 -- For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on lack of maintenance records and interview with laboratory staff, the laboratory failed to establish protocols for one of one Synene NuGenius/NuGenius plus imaging system. Findings Include: 1. The Synene NuGenius/NuGenius+ user manual states, "The system does not require regular maintenance or calibration other than occasional checking and cleaning." 2. On the day of survey, June 22, 2022 around 11:00 am, laboratory staff could not provide maintenance protocols established by the laboratory for one of one Synene NuGenius/NuGenius plus imaging system. 3. The laboratory staff and laboratory director confirmed at the exit conference around 11:45 am, that the Synene NuGenius/NuGenius plus imaging system has not been maintenance and that a maintenance protocols for the imaging system has not been established. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

Summary Statement of Deficiencies D0000 The Centers for Medicare and Medicaid Services (CMS) Philadelphia Regional Office Federal Surveyor conducted an announced routine CLIA recertification survey at Laboratory of Molecular Genetics NIDCD- NIH on November 20, 2020. The laboratory was surveyed under 42 CFR part 493 CLIA regulations. Specific deficiencies includes the following: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's molecular genetics sequencing proficiency testing (PT) events documentation and staff interview, the laboratory failed to retain attestation statements signed by the laboratory director (LD) and testing personnel (TP) for three(3) of three(3) events reviewed for the calendar year 2019 and 2020. Findings Include: 1. Review of the laboratory's College of American Pathologist (CAP) (2019) and (2020) Molecular Genetics Sequencing Events 3 for 2019 and Molecular Genetics Sequencing Events 1 and 2 , a totals three of three events revealed no attestation statement signed by the (LD) for the following testing events 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 -- December 2, 2019 Kit 32678403 0 01 42 b.January 7, 2020 Kit 32678537 1 01 10 c. August 6, 2020 Kit 33672261 4 01 25 2.At 12:30 pm during interview with the testing person (TP1) and the Technical Supervisor (TS) for the (PT) records, the surveyor requested documentation of the attestation page electronically or physically. The laboratory provide blank copies in the (CAP)(PT) records binder. 3.At approximately 1:00 PM,the exit interview with the (TS) and the (LD) on November 20, 2020 confirmed the laboratory did not retain signed copies of the PT attestation statements. -- 2 of 2 --