Laboratory For Dna-Guided Medicine

Summary Statement of Deficiencies 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 record review and staff interview, the laboratory failed to establish competency assessment policy and procedures to assess competency for the regulatory responsibilities for the general supervisor (GS) and the technical supervisor (TS) in the specialties of chemistry and hematology. Findings include: 1. Record review on 01 /16/2025 of the staff 'training and competency files' revealed lack of competency assessment documentation for the regulatory positions of GS and TS. 2. Record review on 01/16/2025 of the laboratory's standard operating procedures revealed lack of established competency assessment policy and procedures to assess competency for the regulatory positions and defining frequency of assessment. 3. Staff interview on 01 /16/2025 at 10:00 AM with the laboratory's technical supervisor (TS) confirmed the above finding. The TS further commented that he/she was unaware of this requirement. 4. The laboratory performs 130 tests annually in the specialties of chemistry and hematology. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(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 2 -- Humidity. (b)(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 surveyor observation, record review and staff interview, the laboratory failed to define and provide evidence of monitoring and documenting humidity requirements in the specialties of chemistry and hematology. Findings include: 1. Surveyor observation on 01/16/2025 at 9:45 AM of the laboratory work bench area revealed the following instruments in use: a. QuantStudio 7 Pro Real-Time PCR System b. NanoDrop One, Micro-UV/Vis Spectrophotometer 2. Record review on 01 /16/2025 of the laboratory's maintenance records for 2023 and 2024 revealed lack of documentation of humidity levels for all laboratory areas. 3. Record review on 01/16 /2025 of the 'QuantStudio 6 Pro Real-Time PCR System and QuantStudio 7 Pro Real- Time PCR System User Guide' revealed an acceptable relative humidity requirement of 15% - 80% (non-condensing) while operational. 4. Record review on 01/16/2025 of the 'NanoDrop Micro-UV/Vis Spectrophotometer, NanoDrop One User Guide' revealed an acceptable relative humidity requirement of 20% - 80% (non-condensing) while operational. 5. Staff interview on 01/16/2025 at 10:00 AM with the laboratory's technical supervisor (TS) confirmed the above findings. The TS further commented that he/she was unaware of this requirement. 6. The laboratory performs 130 tests annually in the specialties of chemistry and hematology. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to perform the manufacturer required maintenance and function checks to ensure accurate and reliable test results are obtained prior to patient testing in the specialties of chemistry and hematology. Findings include: 1. Surveyor observation on 01/16/2025 at 9:45 AM of the laboratory work bench area revealed a 'NanoDrop One, Micro-UV/Vis Spectrophotometer' in use. 2. Record review on 01/16/2025 of the laboratory's 'NanoDrop One, Micro-UV/Vis Spectrophotometer' maintenance records for 2023 and 2024 revealed lack of documentation of performance verification every 6 months for the 'NanoDrop One, Micro-UV/Vis Spectrophotometer'. 3. Record review on 01/16/2025 of the 'NanoDrop Micro-UV/Vis Spectrophotometer, NanoDrop One User Guide' revealed 'run performance verification every 6 months to confirm pathlength accuracy is within specifications'. 4. Staff interview on 01/16/2025 at 10: 20 AM with the laboratory's technical supervisor (TS) confirmed the above findings. The TS further commented that he/she was unaware of this requirement. 5. The laboratory performs 130 tests annually in the specialties of chemistry and hematology. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review, lack of documentation and staff interview, the laboratory failed to enroll in an approved Proficiency Testing (PT) program for Bacteriology in 2021 and timely for 2022. Findings include: 1. Record review on 5/31/2022 on the 'BD Max CT/GC/TV Assay' procedure revealed: a. The molecular assay detects the analytes Chlamydia trachomatis (CT), Neisseria gonorrhea (GC) and Trichomonas vaginalis (TV). b. The procedure was signed and approved by the laboratory director on 12/18/2020. 2. Record review on 5/31/2022 of two patient test requisitions and reports revealed the following: a. Patient A urine specimen was collected on 2/10 /2021 with orders for CT, GC and TV testing. b. Patient B urine specimen was collected on 2/11/2021 with orders for CT, GC and TV testing. c. Results for CT, GC and TV were reported on Patients A and B on 2/11/2021. 3. Record review on 5/31 /2022 of the laboratory's 2021 Proficiency Binder revealed the lack of documentation of proficiency testing results for CT, GC and any correspondence with any PT program regarding testing. 4. Record review on 5/31/2022 of the laboratory's 2022 Proficiency binder revealed the following: a. An order confirmation form dated 2/4 /2022 for the American Proficiency Institute (API) program with the following information: i. Catalog # 311-22 Chlamydia/GC (molecular) with shipment dates 6/13 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 -- /2022 and 9/19/2022. ii. Catalog # 362-22 Trichomonas vaginalis with shipment dates 2/7/2022, 6/13/2022 and 9/19/2022. iii. Catalog # 386-22 SARS-CoV-2 Swab (molecular) with shipment dates 6/13/2022 and 9/19/2022. b. Lack of documentation of Event 1 results for CT/GC. 5. Record review on 5/31/2022 of the API web address, https://api-pt.com/catalog.aspv of the 2022 Catalog of Programs revealed: a. Microbiology enrollment requirements state 'regulated tests are in bold type'. b. page 76: Chlamydia/GC (molecular) program 311 includes the analytes CT and GC with shipment dates of February 7th, June 13th, and September 19th. c. Both CT and GC are in bold type. 6. Staff interview on 5/31/2022 at 1:00 PM with the technical supervisor (TS) confirmed the laboratory had not enrolled in proficiency testing in 2021 but had contacted API and was told API could not supply testing for 2021 for CT, GC. TS confirmed the laboratory enrolled in February 2022 for the above testing and had not performed Event 1 for CT/GC. 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 record review, lack of documentation and staff interview, the laboratory failed to enroll in an approved Proficiency Testing (PT) program or verify the accuracy for the analyte Trichomonas vaginalis in the subspecialty of parasitology in 2021. Findings include: 1. Record review on 5/31/2022 on the 'BD Max CT/GC/TV Assay' procedure revealed: a. The molecular assay detects the analytes Chlamydia trachomatis (CT), Neisseria gonorrhea (GC) and Trichomonas vaginalis (TV). b. The procedure was signed and approved by the laboratory director on 12/18/2020. 2. Record review on 5/31/2022 of two patient test requisitions and reports revealed the following: a. Patient A urine specimen was collected on 2/10/2021 with orders for CT, GC and TV testing. b. Patient B urine specimen was collected on 2/11/2021 with orders for CT, GC and TV testing. c. Results for CT, GC and TV were reported on Patients A and B on 2/11/2021. 3. Record review on 5/31/2022 of the laboratory's 2021 Proficiency Binder revealed the lack of documentation of the following: a. Proficiency testing results for TV. b. Any correspondence with any PT program regarding testing. c. Twice annual verification for accuracy for the TV analyte in 2021. 4. Staff interview on 5/31/2022 at 1:00 PM with the technical supervisor (TS) confirmed the laboratory had not enrolled in proficiency testing in 2021 but had contacted American Proficiency Institute (API) and was told API could not supply testing for 2021 for TV. The TS further commented that the laboratory did not verify the accuracy of the TV analyte by an alternate method. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other -- 2 of 5 -- materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)