Next Bio Research Services, Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Next Bio Research Services, LLC on March 17, 2026 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Next Bio Research Services, LLC was not in compliance with applicable Standards and Conditions under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and include the Conditions: D2000 - 42 CFR. 493.801 Enrollment and Testing of Samples D5200 - 42 CFR 493.1230 General Laboratory Systems D5400 - 42 CFR 493.1250 Analytic Systems D6000 - 42 CFR 493.1403 Laboratory Director 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: A. Based on a pre-survey review of the Centers for Medicare and Medicaid Services Application for Certification (CMS 116) form and CMS CLIA Application and Survey Summary Report (CASPER 96), a tour, review of analyzer validation records, proficiency testing (PT) records, patient test logs, lack of documentation, and interviews, the laboratory failed to enroll in a PT program for Complete Blood Count (CBC) for 12 of 12 months in calendar year 2024 while reporting 1,247 CBC panel test results. Findings: 1. During pre-survey workload, a review of the laboratory's Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- submitted CMS 116 form revealed that the laboratory director (LD) identified non waived CBC testing by Beckman Coulter DxH560 and a review of CMS CASPER 96 report revealed regulated analytes under speciality 0760 HEMATOLOGY were recorded for 2025 PT Events 1-3. 2. During a tour of the laboratory at 12:30 PM on 3 /17/26, the inspector noted one DxH560 hematology analyzer serial number (SN) BG030189 in use for CBC testing. Review of the DxH560 validation records revealed that the analyzer was installed by Beckman Coulter field service on 12/19/23 with validation and procedures approved by the LD on 1/5/24. 3. Review of the laboratory's American Proficiency Institute (API) PT records, a total of four events (2025 Events 1-3, 2026 Event 1) for timeframe of April 2024 to the date of the recertification, 3/17/26, revealed that the laboratory failed to participate in PT for CBC regulated analytes: White Blood Cell, Red Blood Cell, Hematocrit, Hemoglobin, Platelet Count, and WBC Differential -Automated in calendar year 2024. The inspector requested to review hematology PT documentation for calendar year 2024. No records were available for review. 4. Review of test log records revealed that patient CBC testing started on 4/8/2024. The inspector noted that 1,247 CBC panels were reported by the laboratory during the timeframe of 4/8/24 to 12/31/24 while failing to enroll in PT modules during 2024. 5. Interviews with the facility's President and the Director of Clinical Laboratory Operations at 5 PM on 3/17/26 confirmed the above findings. B. Based on a review of the CMS 116 form, CASPER 96 report, tour, analyzer validation records, PT records, patient test logs, lack of documentation, and interviews, the laboratory failed to enroll in a PT program for 24 of 26 regulated chemistry analytes in calendar year 2024 and for one of 26 regulated chemistry analytes in calendar years 2024, 2025, and year to date (YTD) 2026 assayed by Beckman Coulter AU480 while reporting 5,063 test results. Findings: 1. Review of the submitted CMS 116 form revealed that the LD identified non waived chemistry testing for the following 26 regulated analytes by AU480 instrument: Albumin (ALB), Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Blood Urea Nitrogen (BUN), Calcium (CA), Carbon Dioxide (CO2), Chloride (CL) Cholesterol (CHOL), Creatinine (CREA), Creatine Kinase (CK), Glucose (GLU), High Density Lipoprotein (HDL), Hemoglobin A1C, Iron, Low Density Lipoprotein (LDL), Magnesium (MG), Phosphorus (PHOS), Potassium (K), Sodium (NA), Total Bilirubin (TBILI), Total Protein (TP), Triglycerides (TRIG), Uric Acid (UA), Valproic Acid, and Vancomycin (VANC). 2. Review of CMS CASPER 96 report revealed results for 24 of the 26 regulated analytes outlined above under speciality 0245 ROUTINE CHEMISTRY and 0605 TOXICOLOGY in calendar year 2025 (Events 1-3). The inspector noted during the CASPER 96 review that CMS had no results for regulated CK analyte. 3. During a tour at 12:40 PM on 3/17/26, the inspector noted one Beckman Coulter AU480 analyzer SN 2023070734 in use for chemistry testing. Review of the AU480 validation records revealed that the analyzer verification and procedures were approved by the LD on 1/5/24. 4. Review of the laboratory's available API PT records for timeframe of April 2024 to 3/17/26 revealed four events (2025 Events 1-3, 2026 Event 1). The inspector noted no documentation for: Calendar year 2024: no PT records for ALB, ALP, ALT, AST, BUN, CA, CO2, CL, CHOL, CREA, GLU, HDL, A1C, Iron, LDL, MG, PHOS, K, NA, TBILI, TP, TRIG, UA, Valproic Acid, and VANC;. Calendar year 2024, 2025, YTD 2026: no PT documentation for CK. The inspector requested to review missing PT for the AU480 regulated chemistry analyte testing outlined above. No additional documentation was available. 5. Review of test log records revealed that patient chemistry testing by AU480 went live on 4/8/2024. The inspector noted that the laboratory reported 5,063 chemistry tests during the timeframe of 4/8/24 to 12/31/24 while failing to enroll in PT as outlined above in 2024 -2026. 6. Interviews with the facility's President and the Director of Clinical -- 2 of 10 -- Laboratory Operations at 5 PM on 3/17/26 confirmed the above findings. C. Based on a review of the CMS 116 form, CASPER 96 report, tour, analyzer validation records, PT records, patient test logs, lack of documentation, and interviews, the laboratory failed to enroll in a PT program for seven of nine regulated analytes assayed by Beckman Coulter Access 2 immunoassay instrument in calendar year 2024 and two of nine in calendar year 2024, 2025, and year to date (YTD) 2026 while reporting 1,569 test results. Findings: 1. Review of the submitted CMS 116 form revealed that the LD identified non waived chemistry testing for the following regulated analytes by Access 2 immunoassay instrument: Carcinoembryonic Antigen (CEA), Digoxin, Folate, Thyroid Stimulating Hormone (TSH), Free Thyroxine (FT4), B-Natriuretic Peptide (BNP), Prostate Specific Antigen (PSA), Parathyroid Hormone (PTH), and Vitamin B12. 2. Review of CMS CASPER 96 report revealed results for the following seven regulated analytes under specialities 0245 Routine Chemistry, 0525 Endocrinology, and 0605 Toxicology for calendar year 2025 (Events 1-3): Digoxin, Folate, TSH, FT4, PSA, PTH, and Vitamin B12. The inspector noted that the laboratory's CASPER 96 report did not include results for CEA or BNP. 3. During a tour at 12:40 PM on 3/17/26, the inspector noted one Beckman Coulter Access 2 immunoassay instrument SN 574715 in use for chemistry/endocrinology testing. Review of the Access 2 validation records revealed that the analyzer verification and procedures were approved by the LD on 1/5/24. 4. Review of the laboratory's available API PT records for timeframe April 2024 to 3/17/26 revealed a total of four events (2025 Events 1-3, 2026 Event 1). The inspector noted no PT records for the following: Calendar year 2024: no PT documentation for Digoxin, Folate, TSH, FT4, PSA, PTH, and Vitamin B12; Calendar year 2024, 2025, YTD 2026: no PT documentation for CEA and BNP. The inspector requested to review missing PT for the Access 2 chemistry/endocrinology testing outlined above. No additional documentation was available. 5. Review of test log records revealed that patient chemistry testing by Access 2 went live on 4/8/2024. The inspector noted that the laboratory reported 1,569 tests by Access 2 during the timeframe of 4/8/24 to 3/17/26 while failing to enroll in PT as outlined above in 2024 -2026. 6. Interviews with the facility's President and the Director of Clinical Laboratory Operations at 5 PM on 3/17 /26 confirmed the above findings. D2116 TOXICOLOGY CFR(s): 493.845(e) (e)(1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of CMS CLIA Application and Survey Summary Report (CASPER 96), proficiency testing (PT) records, procedures, lack of documentation, and interviews, the laboratory failed to document evaluation/remedial action taken for five of five unacceptable Vancomycin results on 2025 American Proficiency Institute (API) PT Event 2. Findings include: 1. During pre-survey preparation, a review of CMS CASPER 96 report revealed that 2025 PT Event 2 Speciality 0605 Toxicology was recorded as unsatisfactory (Score 66%) with analyte Vancomycin scored as -- 3 of 10 -- unsatisfactory (Score 0%). 2. Review of the laboratory's available API PT records (2025 Events 1-3, 2026 Event 1), a total of four events, revealed no evidence of remedial action for the following unacceptable Vancomycin challenge scores: 2025 Event 2 Chemistry/Toxicology Module: CH-06 reported as 8.3 (expected result 1.3- 5.4), CH-07 reported as 49.9 (expected result 27.9-37.9), CH-08 reported as 20.8 (expected result 11.8 - 16.0), CH-09 reported as 35.9 (expected result 20.8-28.3), CH- 10 reported as 82.5 (expected result 38.6-52.3); resulting in unsatisfactory performance for Vancomycin - scored as 0 %. 3. Review of the laboratory's procedures revealed a Proficiency Testing policy that stated: "Results that do not fall within the expected expected range will be investigated and documented on PT Exception Summary report form. Result discrepancies are researched and resolved by the laboratory manager in consultation with the supervisor. Document on PT Exception Summary Report form." 4. Review of the laboratory's PT

Summary Statement of Deficiencies D0000 An unannounced, off-site CLIA proficiency testing (PT) desk review was conducted for Next Bio Research Services, LLC on January 15, 2026 by the Virginia Department of Health's Office of Licensure and Certification. The survey concluded with an interview and review of records on 1/16/26. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The following deficiencies are a result of the PT desk review of scores obtained from the national database and verified with the proficiency testing company. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 CFR. 493.803 Condition: Successful Participation, D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing- Laboratory Director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. 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 -- This CONDITION is not met as evidenced by: Based on a review of the Center for Medicaid and Medicare Services CASPER 0155 report, the laboratory's proficiency testing (PT) records and interview, the laboratory failed to successfully participate in the hematology specialty for analyte Red Blood Cell Count (RBC). The laboratory had unsatisfactory RBC scores for the first and third PT events of calendar year 2025. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site desk review of the Center for Medicaid and Medicare Services (CMS) Certification and Survey Provider Enhanced Reporting CASPER 0155 report, the laboratory's proficiency testing (PT) records, and interviews, the laboratory failed to attain a score of at least eighty percent (80%) of acceptable responses for Red Blood Cell (RBC) counts on two of three Complete Blood Count (CBC) hematology testing events in calendar year 2025 resulting in an unsuccessful PT performance. Findings include: 1. Review of the CMS CASPER 0155 report revealed: Hematology 2025 1st Event - laboratory received an unsatisfactory score of 60% for analyte 0775 RBC; Hematology 2025 3rd Event - laboratory received an unsatisfactory score of 0% for analyte 0775 RBC. 2. Desk review of the laboratory's American Proficiency Institute (API) PT records revealed RBC scores of less than 80% for the following two 2025 hematology CBC events: 2025 API Event 1: RBC scored 60% (challenge sample DXH-02 reported as 2.20 with acceptable range 2.22-2.42, challenge sample DXH-05 reported as 2.20 with acceptable range 2.23-2.43); 2025 API Event 3: RBC scored 0% (challenge sample DXH-11 reported as 4.80 with acceptable range 5.00- 5.43, challenge sample DXH-12 reported as 4.37 with acceptable range 4.53-4.93, challenge sample DXH-13 reported as 4.43 with acceptable range 5.52-4.91, challenge sample DXH-14 reported as 4.94 with acceptable range 4.98-5.40, challenge sample DXH-15 reported as 2.21 with acceptable range 2.27-2.46); resulting in an unsuccessful PT performance. 3. Virtual interviews with the laboratory President and Director of Clinical Laboratory Operations on 1/16/26 at 12:30 PM confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the Center for Medicaid and Medicare Services (CMS) Certification and Survey Provider Enhanced Reporting CASPER 0155 report, proficiency testing records, and interview, the laboratory director failed to provide overall direction and management of the laboratory services. Refer to D6016. -- 2 of 3 -- D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of the Center for Medicaid and Medicare Services Certification and Survey Provider Enhanced Reporting CASPER 0155 report, proficiency testing (PT) records, and interview, the laboratory director failed to ensure successful participation in the laboratory's Health and Human Services PT program. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced Clinical Laboratory Improvement Amendments (CLIA) complaint investigation (#VA00050543) was conducted for Next Bio Research Services, LLC from January 13-26, 2021 by a Medical Facilities Inspector from the Virginia Department of Health, Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Based on a review of documents and interviews, the inspector found the complainant's allegation to be substantiated. Specific deficiency cited is as follows: D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based on a complaint investigation review of patient accession logs, patient result logs, protocols, incident reports, and interviews, the laboratory failed to have a system of specimen reconciliation/tracking mechanisms in place to identify one (1) missing SARS-CoV-2 (COVID-19) respiratory specimen (Patient #1) collected and sent from an urgent care (Client A) on December 11, 2020. Findings include: 1. Review of COVID-19 Transport Accession Log for Client A (date of service 12/11/20) revealed thirty (30) patients identified for SARS-CoV-2 (COVID-19) referral to Next Bio Research Services (NEXT) laboratory that included Patient #1. 2. Review of NEXT laboratory patient result logs (date of collection 12/11/20) referred for SARS-CoV-2 (COVID-19) testing from Client A revealed no receipt/results for Patient #1. The inspector noted for the date of service, 12/11/20, NEXT reported the 29 test results listed into Urgent Care A's portal within three (3) days of collection. The COVID-19 specimen processing and result reporting protocols did not document that Patient #1's sample was not received/tested during the timeframe of 12/12/20 to 12/20/20. 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 -- Review of NEXT laboratory policy ("Registration and Accessioning of Clinical Cases") revealed no protocols for a tracking communication mechanism or specimen manifest reconciliation in place with their ordering providers/clients. The inspector inquired regarding reconciliation of specimens received from Client A on the date outlined above. The Director of Clinical Business Operations (CBO) stated "We do have clients that send us manifests that are used and if there are any issues, we do contact the clients. This particular urgent care client does not provide manifest." 4. On 1/13/21 at approximately 4:00 PM, the inspector requested to review available NEXT quality assurance reports for the timeframe of 12/11/20 to 12/20/21. On 1/25/21, the CBO provided the above requested records. The inspector reviewed NEXT laboratory's operational effectiveness incident report (dated 12/21/20). The report revealed the following statements: "The findings of investigations show that the package containing the sample in question and the package that was sent from department store to a person in Illinois were next to each other for several scan points in the UPS package Richmond, Virginia sorting line. UPS has told us that their audit shows that the two packages were next to each other on the line, both packages opened during sorting, the package from our Urgent Care A client had a sample to fall out, and it was inadvertently placed in the package to the person in Illinois. As a