Wellmont Medical Associates Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Wellmont Medical Associates, INC (DBA - Ballad Health Medical Associates) August 19-20, 2026 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Wellmont Medical Associates, INC (DBA - Ballad Health Medical Associates) 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: D2016 - 42 CFR. 493.803 Condition: Successful Participation D5400 - 42 CFR 493.1250 Condition: Analytic Systems D6000 - 42 CFR 493.1403 Condition: 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 9 -- This CONDITION is not met as evidenced by: Based on a review of the Center for Medicaid and Medicare Services CASPER 0155D and 0096D reports, the laboratory's proficiency testing records and interviews, the laboratory failed to successfully participate within the Chemistry specialty for the Blood Urea Nitrogen analyte. The laboratory had unsatisfactory scores for the first and second event of 2026. Refer to D2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the Center for Medicaid and Medicare Services CASPER 0155D (CMS 0155) and CASPER 0096D (CMS 0096) reports, 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 Blood Urea Nitrogen (BUN) for two consecutive chemistry events in calendar year 2026 resulting in an initial unsuccessful PT performance. Findings include: 1. A review of the CMS 0155 and 0096 reports revealed the laboratory participated in the American Proficiency Institute (API) program and received the following unsatisfactory scores for regulated analyte #0505 BUN: API 2026 Event 1 - 40% API 2026 Event 2 - 60% 2. A review of the laboratory's PT records (2025 Events 1-3, 2026 Events 1-2), a total of five events, revealed BUN scores of less than 80% for the following 2 consecutive chemistry events: API 2026 Event 1: BUN scored 40% (challenge sample CH-02 reported as 2 with acceptable range 4-9, CH-03 reported as 2 with acceptable range 4-9, CH-04 reported as 13 with acceptable range 14-19); API 2026 Event 2: BUN scored 60% (challenge sample CH-07 reported as 22 with acceptable range 16-21, CH-10 reported as 26 with acceptable range 20-25); resulting in an unsuccessful PT performance noted by API. 3. Interviews with the laboratory's two Medical Technologists and the Technical Specialist (TS) Manager at 4 PM on 8/19/26 and TS Manager at 12:30 PM on 8/20/26 confirmed the above findings. 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. This STANDARD is not met as evidenced by: A. Based on a tour of the laboratory, review of protocols, maintenance records, lack of documentation, and interviews, the laboratory failed to retain documentation of weekly maintenance protocols for one of one personnel eyewash station for 52 of 52 weeks in calendar year 2025. Findings include: 1. During a tour of the laboratory on 8 /19/26 at 11 AM, the inspector noted one sink eyewash station in use perpendicular to the Beckman AU680 chemistry analyzer in core lab room #2. 2. Review of the laboratory's maintenance records revealed a safety protocol (titled: Weekly Eyewash -- 2 of 9 -- Form) that stated, "Initial and date verifying the eyewash station is checked weekly for the following: pathway to eyewash is free of obstructions, the eyewash fixture is free of obstructions in all directions, the nozzle dust caps/covers are in place and working properly, flush for 3 minutes and if problems are evident, call plant operations." 3. Review of the laboratory's maintenance logs for calendar year 2025 revealed no record of the eyewash weekly maintenance protocols outlined above. The inspector requested to review documentation that the eyewash station was flushed /checked weekly in calendar year 2025. The documentation was not available for review. 4. Interviews with the laboratory's two Medical Technologists and the Technical Specialist (TS) Manager at 4 PM on 8/19/26 and TS Manager at 12:30 PM on 8/20/26 confirmed the above findings. B. Based on tours of the laboratory, review of maintenance records, and interviews, the laboratory failed to follow established protocol to ensure a safe unobstructed pathway to one of one eyewash station as observed during the recertification survey, August 19-20, 2026. Findings include: 1. During a tour of the laboratory at 11 AM on 8/19/26, the inspector noted one sink eyewash station in use perpendicular to the core chemistry Beckman AU680 analyzer in lab room #2. 2. Review of the laboratory's maintenance records revealed a safety protocol (titled: Weekly Eyewash Form) that stated, "Initial and date verifying the eyewash station is checked weekly for the following: pathway to eyewash is free of obstructions." 3. During an additional tour/walk through of the laboratory at 3:30 PM on 8/19/26, the inspector noted no eye wash station in use for lab room #1. The inspector inquired regarding safety eyewash protocol for for the urinalysis processing and immunoassay laboratory room #1, noting that the laboratory's one single eyewash station was located in a different room and that the pathway would be obstructed if needed. The TS Manager stated at 3:30 PM on 8/19/26, "Currently the techs would have to go into the next laboratory room by the AU680 to get to the eyewash if needed. I can order an eyewash station to place near the analyzer and processing area so that they would be able to get to it unobstructed." 4. Interviews with the laboratory's two Medical Technologists and the TS Manager at 4 PM on 8/19/26 and TS Manager at 12:30 PM on 8/20/26 confirmed the above findings. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: A. Based on a review of proficiency testing (PT) records, procedures, lack of documentation, and interviews, the laboratory failed to evaluate 10 non-graded chemistry analyte challenges reported on three of five PT events in calendar year 2025 and year to date 2026. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) PT results (2025 Events 1-3, 2026 Events 1-2), a total of five Chemistry Module events, revealed that API released non-graded analyte responses for: Total Bilirubin (T Bili) due to variance on the following 3 events: API 2025 Event 2 - T Bili challenges CH-07, CH-09, CH-10; API 2025 Event 3 - T Bili challenge CH-12, CH-15; API 2026 Event 1 - T Bili challenge CH-06; D-dimer on the following event: API 2025 Event 2 - Ddimer challenges CM-07, CM-08; Folate on the following event: API 2025 Event 2 - Folate challenges IA-07, IA-09; --a total of 10 -- 3 of 9 -- non-graded Core Chemistry Module challenge samples were reported by API as outlined above; 2. Review of the laboratory's PT documentation revealed no evaluation /verification of accuracy recorded for the non-graded chemistry challenge sample results outlined above. The inspector requested to review an evaluation for the non- graded challenges. The documentation was not available. 3. Review of the laboratory's Standard Operating Procedure manual revealed a policy (title: Quality Assessment Plan) that stated (under heading: Proficiency Testing Policy), "We will grade any proficiency testing challenge that is not officially graded by the proficiency testing program due to lack of participant consensus or any other reason. We will respond/record this score in the same manner we respond to official score." 4. Interviews with the laboratory's two Medical Technologists and the Technical Specialist (TS) Manager at 4 PM on 8/19/26 and TS Manager at 12:30 PM on 8/20/26 confirmed the above findings. B. Based on a review of PT records, procedures, lack of documentation, and interviews, the laboratory failed to evaluate one non-graded hematology analyte challenge reported on one of five PT events in calendar year 2025 and year to date 2026. Findings include: 1. Review of the laboratory's API PT results (2025 Events 1-3, 2026 Events 1-2), a total of five hematology module events, revealed that API released a non-graded analyte response on 2025 API Event 3 - Blood Cell Identification challenge BCI-15. 2. Review of the laboratory's PT documentation revealed no evaluation/verification of accuracy recorded for the non- graded result outlined above. The inspector requested to review an evaluation for the non-graded hematology challenge. The documentation was not available. 3. Review of the laboratory's Standard Operating Procedure manual revealed a policy (title: Quality Assessment Plan) that stated (under heading: Proficiency Testing Policy), "We will grade any proficiency testing challenge that is not officially graded by the proficiency testing program due to lack of participant consensus or any other reason. We will respond/record this score in the same manner we respond to official score." 4. Interviews with the laboratory's two Medical Technologists and the TS Manager at 4 PM on 8/19/26 and TS Manager at 12:30 PM on 8/20/26 confirmed the above findings. 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 procedures, instrument maintenance logs, quality control (QC) records, lack of documentation, a tour, and interviews, the laboratory failed to: 1. follow their policy to record monthly maintenance procedures during 3 of 26 months reviewed and failed to retain 1 of 26 monthly logs record of daily/weekly/monthly maintenance for one of one Cepheid GeneXpert (timeframe: June 7, 2024 to August 19-20, 2026) - Refer to D5401; 2. document four of four Aerospray Hematology Stain reagents' lot numbers as opened per manufacturer's maintenance protocol for 26 of the 26 months reviewed (timeframe outlined #1) - Refer to D5415; 3. establish/document QC protocols for manual urinalysis sediment microscopic examinations for 26 of 26 months reviewed (timeframe outlined #1) - Refer to D5449; 4. establish/document QC -- 4 of 9 -- protocols for stain quality of hematology manual differential counts for 26 of 26 months reviewed (timeframe outlined #1) - Refer to D5473. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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: Based on a review of procedures, instrument maintenance logs, lack of documentation, and interviews, the laboratory failed to follow their protocol to record performance of monthly maintenance procedures during 3 of 26 months reviewed and failed to retain 1 of 26 monthly logs of daily/weekly/monthly maintenance for one of one Cepheid GeneXpert (timeframe: June 7, 2024 to August 19-20, 2026). Findings include: 1. Review of the laboratory's procedures revealed a "BHMA Southwest Virginia Cancer Center Cepheid GeneXpert Maintenance Log Serial Number 842138" that stated "For each maintenance activity listed below check the boxes under the day of the month that the activities were performed and enter tech initials. Save the maintenance file for each month for a retained complete record of maintenance activities." 2. During a review of the core laboratory analyzers' maintenance records for timeframe of 6/7/24 -8/20/26, the inspector noted Cepheid Serial Number 842138 logs that lacked documentation for monthly maintenance tasks (Archive Tests and Clean/Replace Fan Filter) recorded for the following 4 months: July 2025 December 2025 May 2026 July 2026 3. The inspector noted that the Cepheid Serial Number 842138 December 2025 monthly chart was missing from the provided core laboratory analyzers' maintenance folders therefore daily maintenance tasks (Clean work area, close module doors) and weekly maintenance tasks (Power Down, Hub 1) were not available for review. The inspector inquired regarding the lack of documentation of the monthly maintenance protocols as being performed for the 4 months outlined above and regarding the lack of retention for December 2025 Cepheid maintenance charting of daily/weekly tasks. The records were not available for review. 4. Interviews with the laboratory's two Medical Technologists and Technical Specialist (TS) Manager at 4 PM on 8/19/26 and TS Manager at 12:30 PM on 8/20/26 confirmed the above findings. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on a tour, review of instrument maintenance records, procedures, lack of documentation, and interviews, the laboratory failed to document four of four Aerospray Hematology Stain reagents' lot numbers when opened per manufacturer's -- 5 of 9 -- maintenance protocol for 26 of the 26 months reviewed (timeframe: June 7, 2024 to August 19, 2026). Findings include: 1. During a tour of the laboratory at 11 AM on 8 /19/28, the inspector noted one Aerospray Hematology Stat Stainer (Serial Number 915105) in use to prepare hematology stained slides for manual white blood cell differential microscopy evaluation. The inspector noted four ELITechGroup Aerospray onboard reagents: Reagent A Eosin Rinse, Lot 530353, open date written as 8/19/26, open stability 90 days; Reagent B Thiazin AzureB/Methylene Blue, Lot 531494, open date 7/24/26, open stability 90 days; Reagent C Eosin Stain, Lot 529623, open date 7/30/26, open stability 90 days; Reagent D Aerofix Fixative, Lot 536654, open date 8/11/16; 2. Review of the laboratory's hematology maintenance logs for the timeframe of 6/7/24 to 8/19/26, revealed the laboratory utilized the manufacturer's monthly "ELITechGroup Aerospray Hematology Stat Preventative Maintenance Chart" which outlined the following required documentation: Daily - Clean Cycle and Wipe Down Weekly - Nozzle Performance Checks Monthly - Clean Reagent Nozzles and Instrument Cleaning Reagent Lot Record Form - Instructions: Each time reagent bottles are replaced, record lot number from the new bottle in the box that corresponds to the reagent changed (Reagent A, B, C, D) and date of date when new bottle is opened. 3. The inspector noted that the Aerospray Hematology Stat Preventative Maintenance Charts for each of the 26 months reviewed lacked documentation on the Reagent Lot Record Form. The inspector inquired regarding the lack of documentation and requested to review the reagent lot records per the manufacturer's protocol for the timeframe outlined above. No records were available. 4. Review of the laboratory's Standard Operating Procedure manual revealed the following titled protocols: Preventative Maintenance of Equipment and Instruments- stated, under heading: Equipment Checks, "Technical staff will document required checks at the time they are performed on maintenance logs. The supervisor will review records monthly to ensure compliance.

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Wellmont Medical Associates DBA Ballad Health Medical Associates on 08/30/22 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: The laboratory is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records, lack of documentation, and interview with the lab manager and technical consultant, the lab director failed to review and sign one of two attestation statements in 2022. Findings include: 1. Review of the American Proficiency Institute (API) PT records revealed the lack of documentation of the lab director review and signature on the 2022 Chemistry second event attestation statement. 2. An exit interview with the laboratory manager and technical consultant on 08/30/22 at approximately 1500 confirmed the above findings. 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. 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 -- This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records, lack of documentation and interviews, the lab failed to verify the accuracy of the folate and vitamin B12 analytes twice a year in 2021. Findings include: 1. The laboratory utilizes American Proficiency Institute (API) PT for verification of accuracy of the folate and vitamin B12 analytes, categorized as a non-regulated analyte. 2. API provides three events per calendar year for the folate and vitamin B12 analytes. Review of API PT results revealed the laboratory received the following scores: 2021 Routine Chemistry Event 1- unsatisfactory score of 60% for folate and vitamin B12, 2021 Routine Chemistry Event 2- 100% for folate and vitamin B12, and 2021 Routine Chemistry Event 3- unsatisfactory score of 60% for folate and vitamin B12. On 08/30/22 at approximately 11:15 AM, the surveyor requested the laboratory manager and technical consultant (TC) provide documentation of an alternative method(s) for verification of accuracy twice a year for the above-specified analyte in 2021. The documentation was not available for review. 3. An exit interview with the laboratory manager and technical consultant on 08/30/22 at approximately 1500 confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Wellmont Medical Associates on July 25 and 26, 2018 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: D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: A. Based on the initial tour of the laboratory, review of the manufacturer's verification protocol, policy manual, patient test logs and interviews, the laboratory failed to follow the written procedure in performing initial verification procedures for the automated Estimated Sedimentation Rate (ESR) Excyte Mini test system on February 6, 2017 prior to reporting one-thousand nine-hundred and ninety-six (1996) from February 6, 2017 to the date of survey on July 26, 2018. Findings include: 1. The initial tour of the laboratory on July 25, 2018 revealed that the laboratory was performing ESR tests using the automated ESR Excyte Mini test system. 2. Review of the manufacturer's recommended verification protocol for the automated ESR Excyte Mini test system revealed the following statements: "The laboratory must compare the accuracy and precision of the test results it obtains using a test system to the manufacturer's accuracy claims. This should be done by testing commercially available quality control materials with known values. If test results for these samples 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 -- fall within the manufacturer's published acceptable limits and are reproducible, a laboratory has demonstrated accuracy and precision of the test system." 3. Review of the general laboratory quality systems policy revealed the following statements: " 6. Performance Specifications- Before a new nonwaived quantitative test is added or a different test system is put into use, we will ensure that our laboratory verifies the performance specifications by the following methods: - We will run at least two levels of controls at least 10 times each to show accuracy and precision. - Our clinical consultant will evaluate our patient demographics to determine if the manufacturer's reference intervals are applicable. The laboratory director and/or the technical consultant will review all above data prior to the release of any patient results. All data will be stored with other instrument installation records." 4. The inspector requested to review the initial verification procedures performed for the new test system on or prior to testing patients on February 6, 2017. The documentation was not available for review. Review of the patient test logs revealed that 1996 patients were assayed and resulted from February 6, 2017 up to the date of survey on July 26, 2018. 5. An interview with the technical consultant and testing personnel on July 26, 2018 at approximately 1:00 PM confirmed that the laboratory failed to perform the initial verification procedures for the automated ESR Excyte Mini test system prior to resulting patients. B. Based on the tour of the laboratory, review of the policy manual, patient test logs and interviews, the laboratory failed to follow the written procedure for performing initial verification procedures for the Meridian ImmunoCard Mycoplasma EIA test system prior to resulting one-hundred and fourteen (114) patients from February 23, 2018 up to the date of survey on July 26, 2018. Findings include: 1. The initial tour of the laboratory on July 25, 2018 revealed that the laboratory was performing patient testing using the Meridian ImmunoCard Mycoplasma EIA test system. 2. Review of the general laboratory quality systems policy revealed the following statements: " 6. Performance Specifications- "Before a new nonwaived test or test system is used, we will run external negative and positive controls to establish that we can achieve results established by the manufacturer. The laboratory director and/or the technical consultant will review all above data prior to the release of any patient results. All data will be stored with other instrument installation records." 3. The inspector requested to review the initial verification procedures performed for the new test system prior to testing patients on February 23, 2017. The documentation was not available for review. Review of the patient test logs revealed 114 patients were resulted from February 23, 2017 up to the date of survey on July 26, 2018. 4. An interview with the technical consultant and testing personnel on July 26, 2018 at approximately 1:00 PM confirmed that the laboratory failed to perform the initial verification procedures for the Meridian ImmunoCard Mycoplasma EIA test system prior to resulting patients. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on the tour of the laboratory, review of the policy manual, patient test logs and -- 2 of 3 -- interviews, the laboratory director failed to ensure that written procedure for performing initial verification procedures for the automated Estimated Sedimentation Rate (ESR) Excyte Mini and Meridian ImmunoCard Mycoplasma EIA test systems was followed prior to testing and reporting patients in February 2017 (Cross Reference D5421). Findings include: 1. The initial tour of the laboratory on July 25, 2018 revealed that the laboratory was performing the automated Estimated Sedimentation Rate (ESR) Excyte Mini and the Meridian ImmunoCard Mycoplasma EIA test systems. 2. Review of the general laboratory quality systems policy (signed by lab director on March 16, 2016 and on April 17, 2017) revealed the following statements: " 6. Performance Specifications- Before a new nonwaived quantitative test is added or a different test system is put into use, we will ensure that our laboratory verifies the performance specifications by the following methods: - We will run at least two levels of controls at least 10 times each to show accuracy and precision. - Our clinical consultant will evaluate our patient demographics to determine if the manufacturer's reference intervals are applicable. Before a new nonwaived test or test system is used, we will run external negative and positive controls to establish that we can achieve results established by the manufacturer. The laboratory director and/or the technical consultant will review all above data prior to the release of any patient results. All data will be stored with other instrument installation records." 3. The inspector requested to review the initial verification performance documentation of each system listed. The documentation was not available for review. 4. An interview with the technical consultant and testing personnel on July 26, 2018 at approximately 1:00 PM confirmed that the laboratory director failed to ensure that the initial verification procedures were followed for the two (2) test system specified above prior to resulting patients. -- 3 of 3 --