Virginia Health Consultants

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Virginia Health Consultants on February 25, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations Specific deficiencies cited are as follows and includes the Conditions under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems, D6000 -42 CFR. 493.1403 Laboratory Director, D6063 -42 CFR. 493.1421 Testing personnel qualifications. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of the laboratory's policies and procedures, instrument calibration records, quality control records (QC), manufacturer's instrument instruction manual, patient records, lack of documentation, and interviews, the laboratory failed to: 1. Perform instrument calibration procedures for Testosterone (Testo) every fifteen days according to their procedure during the four (4) months reviewed from November 2024 to January 25, 2025. Refer to D5437. 2. Follow their established policy and perform daily QC procedures for the Qualigen FastPack IP system for one of one patient testing days from November 2024 until the date of the survey on February 25, 2025 while reporting one patient Testosterone (Testo). Refer to D5447. 3. Ensure 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 6 -- name and address of the testing facility, source of specimen, and the reference ranges for Testosterone were included on one of one patient test record from November 2024 until February 25, 2025. Refer to D5805. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, instrument calibration records, patient records, lack of documentation, and an interview, the laboratory failed to perform instrument calibration procedures for Testosterone (Testo) every fifteen days according to their procedure during the four (4) months reviewed from November 2024 to January 25, 2025. The findings include: 1. Review of the laboratory's policy and procedure manual revealed a Qualigen FastPack IP System Calibration procedure outlining when calibration is required. The policy stated: "The analyzer display will prompt you automatically when a calibration is due. The prompt will occur for two reasons. 1. When Attempting to Use New Lots of FastPaks or Calibrators. 2. When it's Time to Recalibrate...Calibration expires every 15 days for the following assays: TSH, Free T4, Testo." 2. Review of the laboratory's patient records from November 2024 to February 25, 2025 revealed one patient was tested for Testosterone on 02/13/2025. 3. Review of the laboratory's Qualigen FastPack IP System Calibration documentation from November 2024 to the date of the survey on February 25, 2025, a total of 4 months, revealed the following 2 calibration records for Testosterone: 11/23/2024 and 1/7/2025. The surveyor requested to review calibration documentation for February 2025. The laboratory provided no additional calibration documentation for review. 4. In an exit interview with the facility's nurse on February 25, 2025 at 3:00 PM, the above findings were confirmed. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on a review of the laboratory's quality control records (QC), laboratory policies and procedures, patient testing records, lack of documentation, and interview, the laboratory failed to follow their established policy and perform daily QC procedures for the Qualigen FastPack IP system for one of one patient testing day from -- 2 of 6 -- November 2024 until the date of the survey on February 25, 2025 while reporting one patient Testosterone (Testo) result. The findings include: 1. Review of laboratory patient testing records from November 2024 until February 25, 2025 revealed one patient was tested for Testo on February 14, 2025. No other records of patient testing were observed. The surveyor inquired if additional testing records were available. The laboratory provided no additional documentation for review. In an interview with the provider on February 25, 2025 at 2:25 PM, the provider stated they have been the only staff member who has consistently worked at this location from November 2024 until February 2025. The staff member did not remember more than one patient Testo test being performed. 2. Review of the laboratory's policies and procedures and manufacturer's instruction manual revealed the following statement, "When control testing is performed, two control levels must be used. Qualigen recommends that users run controls whenever: Patient testing is performed...." 3. Review of the Qualigen FastPack IP System QC records from November 2024 until February 25, 2025, revealed QC procedures performed on November 23, 2024 during the performance of the initial instrument verification. No additional documentation of QC performance was observed. The surveyor requested to review documentation of QC performance for 2/14/2025. The laboratory provided no documentation to review. 4. In an exit interview with the facility's nurse on February 25, 2025 at 3:00 PM, the above findings were confirmed. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of available patient records, lack of documentation and interview, the laboratory failed to ensure the name and address of the testing facility, source of specimen, and the reference ranges for Testosterone were included on one of one patient test record from November 2024 until February 25, 2025. The findings include: 1. Review of available patient records from November 2024 until February 25, 2025 revealed one patient was tested for Testosterone on 2/14/2025. Review of the patient test report revealed a lack of documentation of the testing facility's name and address, source of the specimen, and the reference ranges for Testosterone. 2. In an exit interview with the facility's nurse on February 25, 2025 at 3:00 PM, the above findings were confirmed. 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. -- 3 of 6 -- This CONDITION is not met as evidenced by: Based on a review of the laboratory's policies and procedures, manufacturer's instrument manual, quality control (QC) documents, calibration records, patient records, Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, lack of documentation, and interviews, the laboratory director failed to ensure: 1. The current quality control and calibration procedures were maintained in the specialty of chemistry from November 2024 until the date of the survey on February 25, 2025. Refer to D6020. 2. The name and address of the testing facility, source of specimen, and the reference ranges were included in one of one patient test record from November 2024 up to the date of the survey on February 25, 2025. Refer to D6026. 3. Retention of education documentation for eight (8) of eight testing personnel from November 2024 until the date of the survey on February 25, 2025. (See Personnel Code Sheet.) Refer to D6029. 4. The outlining in writing of the non-waived chemistry patient testing duties/procedures for eight (8) of 8 TP from November 2024 to the date of the survey on February 25, 2025. Refer to D6032. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, Qualigen FastPack quality control (QC) records, instrument calibration records, patient records, manufacturer instrument manual, lack of documentation, and interviews, the laboratory director failed to ensure the current quality control and calibration procedures were maintained in the specialty of chemistry. Refer to D5437, and D5447. D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) (e)(8) Ensure that reports of test results include pertinent information required for interpretation; This STANDARD is not met as evidenced by: Based on review of the patient test results, lack of documentation, and interviews, the laboratory director failed to ensure the name and address of the testing facility, source of specimen, and the reference ranges were included on one of one patient test record from November 2024 up to the date of the survey on February 25, 2025. Refer to D5805. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (e)(11) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all -- 4 of 6 -- testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on a review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, lack of documentation and interviews, the laboratory director (LD) failed to ensure retention of education documentation for eight (8) of eight TP from November 2024 until the date of the survey on February 25, 2025. (See Personnel Code Sheet.) The findings include: 1. Review of CLIA CMS- 209 form revealed the laboratory director identified TP A, B, C, D, E, F, G and H (a total of 8 TP) as performing patient testing utilizing the Qualigen FastPack IP System. (See attached Personnel Code Sheet.) 2. Review of the available laboratory personnel records revealed TP A, B, C, D, E, F, G, and H's records contained initial training records. The inspector noted TP A, B, C, D, E, F, G, and H's files lacked a record of education. The surveyor requested to review documentation of education qualifications for the above listed TP. The laboratory provided no documentation for review. 3. In an exit interview with the facility's nurse on February 25, 2025, at 3:00 PM, the above findings were confirmed. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. 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), policies and procedures, testing personnel (TP) records, lack of documentation, and interview, the laboratory director (LD) failed to outline, in writing, the non-waived chemistry patient testing duties/procedures for eight (8) of 8 TP from November 2024 to the date of the survey on February 25, 2025. The findings include: 1. Review of the CMS 209 form revealed that the LD identified 8 TP as qualified/responsible for non-waived chemistry testing (See Personnel Code Sheet). 2. Review of the laboratory's Quality Assurance Manual revealed a statement "Personnel Supervision-The QA Manual Approval Form (QA Manual, last page) indicates the level of oversight and direct supervision required for personnel who perform System testing." 3. Review of the Quality Assurance Manual's last page revealed the LD's signature and the date testing began, "11-23-24". The "Procedures Read by Section, Date, Name/Title, Supervision Needed to Perform Test? Y/N, Supervision Needed to Review Reported Results? Y/N" were not completed. The surveyor requested to review the listing of the responsibilities and duties for the 8 TP performing non-waived chemistry testing. The laboratory provided no additional records for review. 4. In an exit interview with the facility's nurse on February 25, 2025, at 3:00 PM, the above findings were confirmed. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 -- 5 of 6 -- The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS-209), available testing personnel records, lack of documentation, and an interview, the laboratory failed to retain documentation of the personnel qualifications for eight (8) of 8 testing personnel (TP) responsible for reporting non-waived Chemistry Prostatic Specific Antigen (PSA) and Testosterone (Testo) testing from November 23, 2024 until the date of the survey on February 25, 2025. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and 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), personnel records, and interview, the laboratory failed to retain documentation of education qualifications for eight (8) of 8 testing personnel (TP) responsible for reporting non-waived Chemistry Prostatic Specific Antigen (PSA) and Testosterone (Testo) testing from November 23, 2024 until the date of the survey on February 25, 2025. The findings include: 1. Review of the laboratory's CMS 209 Laboratory Personnel Report revealed the Laboratory Director identified 8 TP listed as qualified to perform non-waived Chemistry Prostatic Specific Antigen (PSA) and Testosterone (Testo) testing from November 23, 2024 until the date of the survey on February 25, 2025 (see Testing Personnel Code sheet). 2. Review of the available laboratory personnel records revealed 8 of 8 TP's (TP A, B, C, D, E, F, G and H) files lacked a record of education. The surveyor requested to review documentation of education qualifications for the above listed TPs. The laboratory provided no documentation for review. 3. In an exit interview with the facility nurse on February 25, 2025, at 3:00 PM, the above findings were confirmed. -- 6 of 6 --