Prosperity Labs Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Prosperity Labs, LLC on April 30, 2025 to May 2, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows and includes the Condition under 42 CFR part 493 CLIA Regulation: D6134-42 CFR. 493.1453 Clinical Consultant. 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 a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), policy and procedure manual, personnel records, and interview, the laboratory did not establish and follow a policy for one (1) of 1 Clinical Consultant competency assessment from December 2023 until May 2025. The findings include: 1. Review of the CMS 209 revealed the laboratory director (LD) identified a Clinical Consultant (CC) for the specialty of Microbiology. 2. Review of the laboratory policy and procedure manual revealed a lack of a policy outlining the documentation of the competency assessment of the Clinical Consultant. 3. Review of the laboratory's personnel records revealed the LD failed to document the competency assessment for the Clinical Consultant from December 2023 until May 2025. The surveyor requested to review the competency assessments for the CC. The laboratory provided no documentation for review. 4. In an exit interview with the Technical Supervisor on May 1, 2025 at 11:45 AM, the above findings were confirmed. D5433 MAINTENANCE AND FUNCTION CHECKS 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 -- CFR(s): 493.1254(b)(1) (b)(1)(i) 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. (b)(1)(ii) 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 a tour of the laboratory, review of the laboratory's policy and procedures, centrifuge records, lack of documentation, and interviews, the laboratory failed to follow their established policy for performing annual revolutions per minute (RPM) checks for one of one VWR high speed microcentrifuge for calendar year 2024. The findings include: 1. A tour of the laboratory testing area on April 30, 2025 at 9:00 AM revealed the laboratory used the VWR high speed microcentrifuge (serial number 110063054-00210) to centrifuge patient specimens during the extraction phase of the protocol for the determination of Urinary Tract & Vaginitis Pathogens using Real- Time Polymerase Chain Reaction (RT-PCR). 2. Review of the laboratory's policies and procedures revealed protocols for "Determination of Urinary Tract Infection Pathogens using Real-Time Polymerase Chain Reaction (RT-PCR) and Determination of STI & Vaginitis Pathogens using Real-Time Polymerase Chain Reaction (RT- PCR)", with the following statement, "15.3. Centrifuge Calibration, 15.3.1. The centrifuge used to extract the samples must be verified annually." 3. Review of available RPM checks for the microcentrifuge revealed the verification was performed on 04/17/2025. The surveyor requested to review the RPM verification for 2024. The laboratory provided no documentation for review. 4. In an exit interview with the Technical Supervisor on May 1, 2025 at 11:45 AM, the above findings were confirmed. D6134 CLINICAL CONSULTANT CFR(s): 493.1453 The laboratory must have a clinical consultant who meets the requirements of 493. 1455 of this subpart and provides clinical consultation in accordance with 493.1457 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form, available personnel records, lack of documentation, and an interview, the laboratory failed to ensure one of one Clinical Consultant possessed the required qualifications for a Clinical Consultant from September 2024 until May 2025. See D 6135. D6135 CLINICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1455 The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must-- (a) Be qualified as a laboratory director under 493. 1443(b)(1), (2), or (3) for the subspecialty of oral pathology, 493.1443(b)(5); or (b) Be a doctor of medicine, doctor of osteopathy, doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is -- 2 of 3 -- located. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Personnel Report Form (CMS 209), personnel files, Virginia (VA) Medical license look-up and interview, the laboratory failed to ensure the individual listed as a Clinical Consultant possessed the required qualifications for one (1) of 1 Clinical Consultants from September 2024 until May 2025. The findings include: 1. Review of the laboratory's CMS 209 form revealed the listing of one Clinical Consultant (CC). 2. Review of the laboratory personnel file for the Clinical Consultant revealed they possessed a "Doctor of Medicine" degree. The surveyor requested to review the CC's VA medical license. The laboratory provided a Virginia (VA) medical license certificate with no expiration date. 3. A review of the "Virginia Department of Health Professions License Lookup" revealed the CC's "License Status" was listed as "Suspended". After reviewing the documents attached to the lookup, it was determined the license was suspended on 09 /09/2024. 4. In a phone call with the Technical Supervisor on May 2, 2025 at 9:00 AM, the findings were confirmed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced initial CLIA survey was conducted at Mid Atlantic OBGYN on November 28-29, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies cited are as follows: 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 a review of the laboratory's policies and procedures, quality control (QC) documentation, patient logs, Individualized Quality Control Plan (IQCP) and interviews, the laboratory failed to follow their established protocol for the performance of weekly UTI+ (Urinary Tract Infection) controls prior to reporting patient results for three (3) of nineteen (19) weeks reviewed from July 18, 2023 until November 28, 2023. The findings include: 1. Review of the laboratory's procedure manual revealed a procedure/protocol, "UTI+", for the determination of Urinary Tract Infection Pathogens using Real-Time Reverse transcriptase Quantitative Polymerase Chain Reaction (RT-QPCR) which stated, "4.2 Test Procedure An Analytical run begins with a weekly calibration plate (Figure 1) containing: 1.) One set of positive controls (each containing Taq polymerase, reverse transcriptase, Primers and probe for each pathogen and the endogenous control containing known amounts of DNA or RNA templates); 2.) One set of no template controls (containing Taq polymerase, reverse transcriptase, Primers and probe for each pathogen and the endogenous control, no template DNA or RNA is included). The QC plates confirm that all assays are generating C1 numbers within the confidence level generated during validations Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- for each pathogen." and "6.6 Acceptable limits for Controls The positive control and endogenous control must show amplification to pass. The negative control must be negative to pass If all controls pass, then the patient results can be reviewed and released." 2. Review of the laboratory's records revealed an IQCP document with laboratory director approval on 07/13/2023, which stated "2.0 Quality Control Plan- Molecular Testing Assays Functional Testing documentation-FREQUENCY-Weekly and upon receipt of a new lot of reagents. ACCEPTANCE CRITERIA-Molecular testing assays will be verified of their functionality once per week using the manufacturers supplied controls when a new lot of assays are received." 3. Review of the laboratory's QC documentation for the UTI+ method from July 18, 2023 until the date of the survey on November 28, 2023 revealed a lack of documentation of QC performed for the RT-QPCR UTI method for the following weeks: 09/18/2023 (QC ran 09/11/2023 and on 09/26/2023), 10/11/2023 (QC ran on 10/04/2023 and 10/31 /2023), 10/18/2023 (QC ran on 10/04/2023 and 10/31/2023), A total of 3 weeks. The surveyor requested to review documentation of the QC for the weeks listed above. The laboratory provided no documentation for review. 4. Review of the laboratory's Excel spreadsheet of patient's tested with the RT-QPCR UTI+ method revealed the following: 09/18/2023 to 09/25/2023-4 patients, 10/11/2023 to 10/18/2023-9 patients, 10/18/2023 to 10/31/2023-1 patient, A total of 14 patients. 5. In an exit interview with the general supervisor/testing personnel on November 29, 2023 at approximately 12: 00 PM, the findings were confirmed. B. Based on a review of the laboratory's policies and procedures, quality control (QC) documentation, patient logs, Individualized Quality Control Plan (IQCP) and interviews, the laboratory failed to follow their established protocol for the performance of weekly vaginitis panel controls prior to reporting patient results for three (3) weeks of twenty (20) weeks reviewed from July 12, 2023 until November 28, 2023. The findings include: 1. Review of the laboratory's procedure manual revealed a procedures/protocols, "Vaginitis Panel", for the determination of Vaginal Pathogens using Real-Time Reverse transcriptase Quantitative Polymerase Chain Reaction (RT-QPCR) which stated, "4.2 Test Procedure An Analytical run begins with a weekly calibration plate (Figure 1) containing: 1.) One set of positive controls (each containing Taq polymerase, reverse transcriptase, Primers and probe for each pathogen and the endogenous control containing known amounts of DNA or RNA templates); 2.) One set of no template controls (containing Taq polymerase, reverse transcriptase, Primers and probe for each pathogen and the endogenous control, no template DNA or RNA is included). The QC plates confirm that all assays are generating C1 numbers within the confidence level generated during validations for each pathogen." and "6.6 Acceptable limits for Controls The positive control and endogenous control must show amplification to pass. The negative control must be negative to pass If all controls pass, then the patient results can be reviewed and released." 2. Review of the laboratory's records revealed an IQCP with laboratory director approval on 07/11 /2023, which stated "2.0 Quality Control Plan-Molecular Testing Assays Functional Testing documentation-FREQUENCY-Weekly and upon receipt of a new lot of reagents. ACCEPTANCE CRITERIA-Molecular testing assays will be verified of their functionality once per week using the manufacturers supplied controls when a new lot of assays are received." 3. Review of the laboratory's QC documentation from July 12, 2023 until the date of the survey on November 28, 2023 revealed a lack of documentation of QC performed for the RT-QPCR Vaginitis method for the following weeks: 09/04/2023 (QC ran on 08/28/2023 and 09/13/2023), 10/11/2023 (QC ran on 10/04/2023 and 10/27/2023), 10/18/2023 (QC ran on 10/04/2023 and 10/27/2023). The surveyor requested to review documentation of the QC for the weeks listed above. The laboratory provided no documentation for review. 4. Review of the laboratory's Excel spreadsheet of patient's tested with the RT-QPCR UTI+ and -- 2 of 4 -- Vaginitis methods revealed the following: 09/04/2020 to 09/11/2023-3 patients, 10/11 /2023 to 10/18/2023-8 patients, 10/18/2023 to 10/27/2023-3 patients, A total of 14 patients. 5. In an exit interview with the general supervisor/testing personnel on November 29, 2023 at approximately 12:00 PM, the findings were confirmed. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of the laboratory's temperature and humidity records, instrument environmental/operating requirements, lack of documentation, and interview, the laboratory failed to monitor and document the relative humidity for ninety-two (92) of 92 days reviewed from July 3, 2023 to November 29, 2023. The findings include: 1. During a tour of the laboratory on November 28, 2023, at approximately 9:00 AM, the surveyor noted a BioRad CFX96 Real-Time PCR Detection System with a C1000 Touch Thermal Cycler in use for patient testing in the laboratory. 2. Review of the BioRad CFX96 Real-Time PCR Detection System Instruction Manual revealed the following instrument environmental/operating requirements, "Temperature-indoor use-Relative humidity maximum of 80% noncondensing." Review of the C1000 Touch Thermal Cycler Instruction Manual revealed the following: Environment requirements-Humidity Range 0-80%, non- condensing. 3. Review of the laboratory's temperature records from July 1, 2023 until November 29, 2023 revealed a lack of documentation of the relative humidity recordings for the following days from July 1, 2023 until November 29, 2023: 07/03 /2023, 07/05/2023-07/07/2023, 07/10/2023-07/14/2023, 7/17/2023-7/21/2023, 07/24 /2023-07/28/2023, 07/31/2023-08/4/2023, 08/07/2023-08/11/2023, 08/14/2023-08/18 /2023, 08/21/2023-08/25/2023, 08/28/2023-09/01/2023, 09/05/2023-09/08/2023, 09/11 /2023, 09/13/2023-09/15/2023, 09/18/2023-09/22/2023, 09/25/2023-09/29/2023, 10/02 /2023-10/04/2023, 10/10/2023-10/13/2023, 10/17/2023, 10/23/2023-10/24/2023, 10/27 /2023, 10/30/2023-11/3/2023, 11/06/2023-11/08/2023, 11/10/2023, 11/14/2023-11/17 /2023, 11/20/2023-11/22/2023, 11/27/2023-11/29/2023. Total of 92 days of 92 days reviewed. The surveyor requested to review documentation of the relative humidity for the above listed 92 days. The laboratory provided no documentation to review. 4. In an exit interview with the general supervisor/testing personnel on November 29, 2023 at approximately 12:00 PM, the findings were confirmed. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, monthly quality control -- 3 of 4 -- (QC) records, temperature logs and an interview, the laboratory failed to follow their "Laboratory Quality Assurance Plan" to monitor/review QC and temperature logs monthly in order to monitor, assess and correct problems within the speciality of Microbiology for two (2) of four (4) months of QC and temperature logs reviewed from July 2023 until October 2023. The findings include: 1. Review of the laboratory's policies and procedures revealed a quality assurance (QA) plan to monitor, assess and correct problems within the speciality of Microbiology that outlined the laboratory director (LD) was to review Quality Control logs and Temperature logs on a monthly basis. 2. Review of the laboratory's monthly QC logs for the UTI+ (urinary tract infection) and Vaginitis methods and temperature logs from July 2023 to October 2023 (4 months) revealed the laboratory director did not sign as reviewed the QC or temperatures logs for September 2023 and October 2023, a total of 2 months. The surveyor requested to review documentation of the QC document review for September 2023 and October 2023. The laboratory provided no documentation for review. In an interview with the General supervisor (GS) on November 28, 2023, at approximately 1:15 PM, the GS stated they had emailed the documents to the laboratory director but had not received the reviewed/signed documents back yet. 3. In an exit interview with the general supervisor/testing personnel on November 29, 2023 at approximately 12:00 PM, the findings were confirmed. -- 4 of 4 --