Sovereign Laboratory Services, Llc

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Techincal Supervisor (TS), the laboratory failed to review and evaluate PT results obtained from the College of American Pathologists (CAP) for Pharmacogenetics tests and American Proficiency Institute (API) for Microbiology tests from 1/10/24 to 4/29/26. The findings include: 1. Surveyor review of the PT records revealed the following analytes had Code 11 (not graded) results that were not reviewed or evaluated for API 2025 Microbiology - 3rd event as follows: a) Molecular Resist. Genes - Urine CTX-M for samples UIT-12, 13 and 15. b) Molecular Resist. Genes - Urine NDM for samples UIT-12, 13 and 15. c) Molecular Resist. Genes - Urine vanA for samples UIT-11, 12, 13, and 14. d) Molecular Resist. Genes - Urine vanB for samples UIT-11, 12, 13, 14 and 15. e) Molecular Resist. Genes - Urine VIM for samples UIT-12, 13 and 15. 2. Surveyor review of the PT records revealed the following analytes had Code 27 (Lack of participant or referee consensus) results that were not reviewed or evaluated for event CAP PGX-A 2025 as follows:. a) CYP2D6 Genotype, for samples PXG-01, 02, and 03. 3. Surveyor review of the PT records revealed the following analytes had Code 11 (not graded) results that were not reviewed or evaluated for API 2025 Microbiology - 2nd event as follows: a) Molecular Resist. Genes - Urine CTX-M for samples UIT-06, 07, 09, and 10. b) Molecular Resist. Genes - Urine vanA for samples UIT-06, 07, 08, and 10. c) Molecular Resist. Genes - Urine vanB for samples UIT-06, 07, 08, 09 and 10. d) Molecular Bacti-STI Treponema Pallidum, for sample STI-06. e) Molecular Resist. Genes - Urine NDM for samples UIT-06, and 09. f) Molecular Resist. Genes - Urine VIM for samples UIT-06, and 09. 4. Surveyor review of the PT records revealed the 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 -- following analytes had Code 11 (not graded) results that were not reviewed or evaluated for API 2025 Microbiology - 1st event as follows: a) Molecular Bacti Urine Citrobacter spp. for sample UTI-01. b) Molecular Bacti Urine Proteus spp. for sample UTI-02. c) Molecular Resist. Genes - Urine CTX-M for samples UTI-02, 03, and 04. 5. Surveyor review of the PT records revealed the following analytes had Code 26 (Educational challenge) results that were not reviewed or evaluated for event CAP PGX-A 2025 as follows: a) CYP2B6 Clinical Manage, for samples PXG-01, 02, and 03. b) CYP2B6 Predicted Pheno, for samples PXG-01, 02, and 03. c) CYP2C19 Clinical Manage, for samples PXG-01, 02, and 03. d) CYP2C19 Predicted Pheno, for samples PXG-01, 02, and 03. e) CYP2C9 Predicted Pheno, for samples PXG-01, 02, and 03. f) CYP2C9 / VKORC1 Clinical, for samples PXG-01, 02, and 03. g) CYP2D6 Clinical Manage, for samples PXG-01, 02, and 03. h) CYP2D6 Predicted Pheno, for samples PXG-01, 02, and 03. i) CYP3A4 Predicted Pheno, for samples PXG-01, 02, and 03. j) CYP3A5 Predicted Pheno, for samples PXG-01, 02, and 03. k) SLCO1B1 Clinical Manage, for samples PXG-01, 02, and 03. l) VKORC1 Predicted Pheno, for samples PXG-01, 02, and 03. 6. Surveyor review of the PT records revealed the following analytes had Code 11 (not graded) results that were not reviewed or evaluated for API 2024 Microbiology - 3rd event as follows: a) Molecular Resist. Genes - Urine CTX-M for samples UIT-11, 13, 14 and 15. b) Molecular Resist. Genes - Urine vanA/B for samples UIT-11, 12, 13, and 14. 7. Surveyor review of the PT records revealed the following analytes had Code 11 (not graded) results that were not reviewed or evaluated for API 2024 Microbiology - 2nd event as follows: a) Molecular Bacti-STI Treponema Pallidum, for sample STI-06. b) Molecular Resist. Genes - Urine CTX-M for samples UIT-06, 09, and 10. c) Molecular Resist. Genes - Urine NDM for samples UIT-06, and 09. d) Molecular Resist. Genes - Urine vanA for samples UIT-06, 07, 08 and 10. e) Molecular Resist. Genes - Urine vanB for samples UIT-06, 07, 08, 09 and 10. f) Molecular Resist. Genes - Urine VIM for samples UIT- 06, and 09. 8. Surveyor review of the PT records revealed the following analytes had Code 26 (Educational challenge) results that were not reviewed or evaluated for event CAP PGX-B 2024 as follows: a) CYP2B6 Clinical Manage, for samples PXG-04, 05, and 06. b) CYP2B6 Genotype, for samples PXG-04, 05, and 06. b) CYP2B6 Predicted Pheno, for samples PXG-01, 02, and 03. c) CYP2C19 Clinical Manage, for samples PXG-01, 02, and 03. d) CYP2C19 Predicted Pheno, for samples PXG-01, 02, and 03. e) CYP2C9 Predicted Pheno, for samples PXG-01, 02, and 03. f) CYP2C9 Predicted Activ, for samples PXG-01, 02, and 03. g) CYP2D6 Clinical Manage, for samples PXG-01, 02, and 03. h) CYP2D6 Predicted Pheno, for samples PXG-01, 02, and 03. i) CYP2D6 Predicted Activ, for samples PXG-01, 02, and 03. j) CYP3A4 Predicted Pheno, for samples PXG-01, 02, and 03. k) CYP3A5 Predicted Pheno, for samples PXG-01, 02, and 03. l) SLCO1B1 Clinical Manage, for samples PXG-01, 02, and 03. 9. Surveyor review of the PT records revealed the following analytes had Code 27 (Lack of participant or referee consensus) results that were not reviewed or evaluated for event CAP PGX-B 2024 as follows:. a) CYP2D6 Genotype, for sample PXG-05. 10. Surveyor review of the PT records revealed the following analytes had Code 26 (Educational challenge) results that were not reviewed or evaluated for event CAP PGX-A 2024 as follows: a) CYP2B6 Clinical Manage, for samples PXG-01, 02, and 03. b) CYP2B6 Genotype, for samples PXG-01, 02, and 03. b) CYP2B6 Interpretation, for samples PXG-01, 02, and 03. c) CYP2C19 Clinical Manage, for samples PXG-01, 02, and 03. d) CYP2C19 Interpretation, for samples PXG-01, 02, and 03. e) CYP2C9 Predicted Activ, for samples PXG-01, 02, and 03. f) CYP2C9 / VKORC1 Clinical, for samples PXG-01, 02, and 03. g) CYP2D6 Clinical Manage, for samples PXG-01, 02, and 03. h) CYP2D6 Interpretation, for samples PXG-01, 02, and 03. i) CYP2D6 Predicted Activ, for samples PXG-01, 02, and 03. j) CYP3A4 Interpretation, for samples PXG-01, 02, and 03. k) CYP3A5 Interpretation, for -- 2 of 3 -- samples PXG-01, 02, and 03. l) SLCO1B1 Clinical Manage, for samples PXG-01, 02, and 03. 11. The TS confirmed on 4/28/26 at 11:10 am, the laboratory did not review and evaluate all PT results obtained from CAP. -- 3 of 3 --

Summary Statement of Deficiencies 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 surveyor review of the Proficiency Testing (PT) records and interview with the General Supervisor (GS), the laboratory failed to maintain all work records and signed attestation records for Molecular Bacteriology Urine tests from American Proficiency Institute Associates (API) in the calendar years 2022 and 2023. The findings include: 1. Work records and signed attestation records for the 3rd PT event in 2022 were not maintained. 2. Work records and signed attestation records for all PT events in the calendar year 2023 were not maintained. 3. The GS confirmed on 1/9/24 at 1:35 pm work and attestation records were not maintained for PT events as mentioned above. D2021 BACTERIOLOGY CFR(s): 493.823(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories 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 -- failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the General Supervisor (GS) the laboratory failed to participate in PT for Molecular Bacteriology Urine tests from the American Proficiency Institute (API) for the 1st event of 2023 for Bacteriology. The GS confirmed on 1/9/24 at 12:00 pm the laboratory failed to participate in PT for Molecular Bacteriology Urine tests from API for the 1st event of 2023 for Bacteriology. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratories NJ State License, Proficiency Testing (PT) and interview with the State of New Jersey Proficiency Provider Program lead, the Laboratory Director (LD) failed to be in compliance with New Jersey Administrative code N.J.A.C. 8:44-2.5(b)3. The finding includes: 1. N.J.A.C. 8:44-2.5 (b)3. states Laboratories shall: iii. Maintain records of all proficiency testing results in surveys in which they participate and make such records, including results, interpretations and cumulative performance data routinely available to the Department of Health and Senior Services. 2. The LD failed to make PT chemistry and endocrinology data routinely available to the Department of Health and Senior Services. 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 surveyor review of the Competency Assessment (CA) records and interview with the General Supervisor (GS) the laboratory failed to follow its policies and procedures for assessing the competency of Testing Personnel (TP) in calendar years 2022 and 2023. The findings include: 1. The laboratory CA policy stated: "it is the policy of the Lab to perform and document employee training/competence at the following intervals after initial training has been documented." 6 months, at 1 year and annually thereafter. 2. 2 out of 4 TP did not have an annual CA performed in 2023. 3. 3 out of 4 TP did not have a 6 month CA performed after initial training. 4. -- 2 of 5 -- The GS confirmed on 1/9/24 at 11:00 am, the laboratory failed to follow the CA policy. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: A) Based on surveyor review of the Proficiency Testing (PT) records and interview with the General Supervisor (GS) the laboratory failed to review coded results for Special Chemistry and endocrinology Testing performed with the College of American Pathologists (CAP) in the calendar year 2022 and 2023 event VITD-A 2022 and Y-A 2023. The findings include: 1. The laboratory received coded results (Code 28 - Response qualifies with a great than or less than sign: unable to quantitative) results for 25 O-H Vitamin D. a) 25 OH Vitamin D samples VITD-01, VITD-03 were coded 28, there was no documented evidence of peer group comparison performed. 2. The laboratory received coded results (Code 11-unable to analyze) results for Prolactin and Testosterone. b) Prolactin and Testosterone samples Y-01, Y-02,and Y- 03 were coded 11, there was no documented

Summary Statement of Deficiencies 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 surveyor review of the Proficiency Testing (PT) records and interview with the Technical Supervisor (TS), the laboratory failed to maintain the attestation statements signed by the analyst and laboratory director for Drug Monitoring for Pain Management (DMPM) tests performed with the College of American Pathologists (CAP) in the DMPM- B2017 and DMPM- A2018 events. The TS confirmed on 3/21 /19 at 10:20 am that the above attestation statements were not maintained. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. 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 -- This STANDARD is not met as evidenced by: Based on surveyor observation of the Laboratory equipment and interview with the Laboratory Director (LD), the laboratory failed to ensure protection from chemical hazards at the time of the survey. The finding includes: 1. Observation of the hood used to exhaust fumes from histology reagents revealed the exhaust pipe was not attached to the hood. 2. The LD confirmed on 3/21/19 at 1:30 pm that the laboratory did not ensure protection from chemical hazards. 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 surveyor review of the Competency Assessment (CA) records and interview with the Technical Supervisor (TS), the laboratory failed to evaluate competency accurately on the TS from 4/25/17 to the date of the survey. The TS confirmed on 3/21 /19 at 10:50 am that the CA was not performed accurately. 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: a) Based on the lack of a Procedure Manual (PM) for the Leica ASP6025 tissue processor interview with the Laboratory Director (LD), the laboratory failed to have a written procedures for Tissue processing on the Leica ASP6025 from July 2018 to the date of the survey. The LD confirmed on 3/21/19 at 2:00 pm that the laboratory did not have procedures for Tissue processing. 35471 b) Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to follow their policy for Environmental Monitoring (EM) from 4/25/17 to the date of the survey. The finding includes: 1. The PM stated the grossing and histology area of the laboratory will have EM annually but there was no documented evidence this occurred. 2. The TP #3 listed on CMS form 209 confirmed on 3/21/19 at 2:50 pm the PM was not followed. 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. -- 2 of 5 -- (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other 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)