Sovah Internal Medicine (Pim)

Summary Statement of Deficiencies D0000 An announced CIA recertification survey was conducted at SOVAH Internal Medicine on August 7, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. SOVAH Internal Medicine was not in compliance with applicable Standards and Conditions with specific deficiencies cited as follows and include the Condition: D6000 - 42 CFR 493.1403 Condition: Laboratories performing moderate complexity testing- Laboratory Director. D2127 HEMATOLOGY CFR(s): 493.851(d) (d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of the Center for Medicaid and Medicare Services CASPER 0155 report (CMS 0155), proficiency testing (PT) records, and interviews, the laboratory failed to submit hematology PT results receiving unsatisfactory scores for one (1) of five (5) PT events reviewed (survey timeframe: October 2023 to the date of inspection on August 7, 2025). Findings include: 1. A review of the laboratory's CMS 0155 revealed zero percent (0%) scores were reported on 2024 Event 3 for the following speciality and six (6) analytes: 0760 HEMATOLOGY 0765 CELL ID- Automated Diff 0775 RBC - Red Blood Cell Count 0785 HCT - Hematocrit 0795 HGB - Hemoglobin 0805 WBC -White Blood Cell Count 0815 PLT - Platelets 2. Review of the laboratory's American Proficiency Institute (API) PT hematology module reports (2023 Event 3, 2024 Events 1-3, 2025 Event 1), a total of 5 events, revealed unsatisfactory scores were reported for the following event: API 2024 Event 3: PT samples ABT 11, ABT 12, ABT 13, ABT 14, and ABT 15 received 0% scores for Cell Identification (Lymphocyte, Monocyte, Granulocyte), Red Blood Cell Count, 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 -- White Blood Cell Count, Platelet Count, Hemoglobin, and Hematocrit. API reported "results not reported to API resulting in score of zero". 3. An exit interview with the lead testing personnel on 8/7/25 at 2:30 PM confirmed the above findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of instrument maintenance logs, manufacturer's operations manual, 2023 Centers for Medicare and Medicaid Services Statement of Deficiencies

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the SOVAH Internal Medicine (PIM) on October 10 & 11, 2023 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 was not in compliance with the following 42 CFR part 493 CLIA Regulations: D2000 - 42 C.F.R. 493-801 Condition: Enrollment and Testing of Samples. D5400- 42 C.F. R. 493-1250 Condition: Analytic Systems. 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: Based on a tour of the laboratory, the review of proficiency testing (PT) records, interview with the PT technical specialist and interviews with the primary testing personnel (TP), the laboratory failed to enroll in the correct chemistry PT module for the sodium (NA), potassium (K+), chloride (CL), carbon dioxide (CO2), urea nitrogen (BUN), creatinine (Creat), glucose (GLU), and ionized calcium (CA) analytes for the 2022 and 2023 calendar year events (a total of six events). Findings include: 1. Tour of the laboratory on 10/10/23 at 09:45 AM revealed an i-STAT portable hand-held analyzer. An interview with the primary TP during the tour revealed the lab uses the Abbott i-STAT Chem 8+ cartridge to perform chemistry testing on patients as needed. 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 -- 2. Review of the CASPER CLIA application and Survey Summary report 0096D revealed no results for the NA, K+, CL, CO2, BUN, Creat, GLU, and iCA analytes for 2022 and 2023 testing events (a total of six events). 3. A phone interview with the American Proficiency Institute (API) technical specialist on 10/10/23 at 10:30 AM and 11:30 AM revealed that the lab was enrolled in the waived module for the i-STAT Chem 8 profile. They stated, "this option allows for sites to test only two samples three times a year and it is for backup systems. Results are considered waived testing and not reported to CMS." The inspector reviewed the laboratory participation documents with the technical specialist and confirmed that the lab received and tested two samples per event for the calendar years of 2022 and 2023 and that the lab was currently enrolled in catalog #945 waived option for the specified analytes. 4. An interview with the lab director, office manager, market quality manager and primary TP on 10/10/23 at 1300 confirmed the 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 the review of manufacturer's operator's manual, manufacturer's package insert, external quality control (QC) records, patient records, lack of documentation, and interviews, the lab failed to: 1. provide documentation of performing the thermal probe check every six months from 12/01/21 up to the date of survey on 10/10/23. Refer to D5429; 2. provide documentation of performing the calibration verification procedures every six months for the non-waived Abbott Chem 8+ analytes from 12/01 /21 up to the date of survey on 10/10/23. Refer to D5439; and 3. perform at least two levels of external QC materials each day of patient testing for the non-waived Abbott i-STAT Chem 8+ cartridge analytes from 12/01/21 up to the date of survey on 10/10 /23 while reporting 117 patients. Refer to D5447. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A. Based on the review of manufacturer's operator's manual, lack of documentation, and interviews, the lab failed to provide documentation of performing the thermal probe check every six months from 12/01/21 up to the date of survey on 10/10/23 (22 months reviewed). Findings include: 1. Review of the Abbott i-STAT operator's manual revealed recommendations of performing the thermal probe check be verified every six months. 2. Review of the monthly external quality control (QC) and the daily electronic simulator check logs from 12/01/21 up to the date of survey on 10/10 -- 2 of 6 -- /23 revealed lack of documentation of the performance of the thermal probe checks every six months. The inspector inquired about the thermal probe checks. In an interview with the primary testing personnel on 10/10/23 at 11:30 AM, they stated, "I think the point of care person performs that with the hospital." In an interview with the point of care manager on 10/10/23 at 12:30, they stated, "we do the CLEW software updates for the lab as a courtesy about every six months and I do the thermal probe checks at that time." The inspector requested to review documentation of the thermal probe checks for the Abbott i-STAT analyzer serial number S10461. The documentation was not available for review. 3. An interview with the lab director, office manager, market quality manager and primary TP on 10/10/23 at 1300 confirmed the findings. 4. An exit interview with the office manager and market quality manager on 10/11/23 at 11 AM confirmed the findings. B. Based on the review of the manufacturer operator's guide, lack of documentation, and interview, the lab failed to perform and document the monthly maintenance for the hematology analyzer for 22 of 22 months reviewed from 12/01/21 up to the date of survey on 10 /10/23. Findings include: 1. Review of the manufacturer operator's guide revealed instructions for performing monthly cleaning procedures utilizing the Boule Cleaning Kit (cleaning procedure and clot prevention) listed under "Section 8: Cleaning, Maintenance & Transport", "8.2 Monthly Cleaning". 2. Review of the available maintenance records for the Medonic M-series hematology analyzer revealed lack of documentation of the performance of the monthly maintenance for 22 of 22 months reviewed from 12/01/21 up to the date of survey on 10/10/23. The inspector requested to review aforementioned documents. The documents were not available for review. 3. An exit interview with the office manager and market quality manager on 10/11/23 at 11 AM confirmed the findings. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on the review of manufacturer's package insert, lack of documentation, and interviews, the lab failed to provide documentation of performing the calibration -- 3 of 6 -- verification procedures every six months for the non-waived Abbott Chem 8+ analytes from 12/01/21 up to the date of survey on 10/10/23 (22 months reviewed). Findings include: 1. Review of the non-waived Abbott i-STAT Chem 8+ reagent cartridge package insert revealed the following statement, "Calibration Verification procedure is intended to verify the accuracy of results over the entire measurement range of a test as may be required by regulatory or accreditation bodies." 2. Review of the monthly external quality control (QC) and the daily electronic simulator check logs from 12/01/21 up to the date of survey on 10/10/23 (22 months) revealed lack of documentation of the performance of calibration verification procedures every six months. The inspector inquired about the procedures. In an interview with the primary testing personnel on 10/10/23 at 11:30 AM, they stated, "I think the point of care person performs that with the hospital." In an interview with the point of care manager on 10/10/23 at 12:30, they stated, "we do the CLEW software updates for the lab as a courtesy about every six months, and I do the thermal probe checks and the calibration verifications at that time." The inspector requested to review documentation of the calibration verification records for the Abbott i-STAT analyzer serial number S10461. The documentation was not available for review. 3. An interview with the lab director, office manager, market quality manager and primary TP on 10/10/23 at 1300 confirmed the findings. 4. An exit interview with the office manager and market quality manager on 10/11/23 at 11 AM confirmed the findings. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of manufacturer operator's manual, external quality control (QC) records, patient records, and interviews, the lab failed to perform at least two levels of external QC materials each day of patient testing for the non-waived Abbott i-STAT Chem 8+ cartridge analytes from 12/01/21 up to the date of survey on 10/10/23 (22 months) while reporting 117 patients. Findings include: 1. Review of the Abbott i- STAT operator's manual revealed the following statement, "Quality Control 14, For each lot in each shipment of cartridges, analyze multiple levels of i-STAT controls using verified analyzer.* *This is not a manufacturer's system instructions; it is a suggestion to comply with regulatory requirements." 2. Review of the QC test logs for the non-waived Abbott i-STAT Chem 8+ cartridge analytes sodium (NA), potassium (K+), chloride (CL), carbon dioxide (CO2), urea nitrogen (BUN), creatinine (Create), glucose (GLU), ionized calcium (iCA) and hematocrit (HCT) revealed the lab performed external QC procedures each month and with each new lot number of cartridges received from 12/01/21 up to the date of survey on 10/10/23. 3. An interview with the primary testing personnel (TP) on 10/10/23 at 09:45 AM revealed the lab received their Abbott Chem 8+ cartridges from the affiliated hospital. They stated, "We receive our cartridges from the hospital, and I do the external QC each month and with new lot number. We thought these tests were waived." 4. Review of patient test records revealed 117 patients resulted from 12/01/21 up to the date of survey on 10/10/23. 5. An interview with the lab director, office manager, market quality manager and primary TP on 10/10/23 at 1300 confirmed the findings. 6. An -- 4 of 6 -- exit interview with the office manager and market quality manager on 10/11/23 at 11 AM confirmed the findings. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on the review of manufacturer's operator's manual, manufacturer's package insert, external quality control (QC) records, patient records, lack of documentation, and interviews, the lab director failed to: 1) provide documentation of performing the thermal probe check every six months from 12/01/21 up to the date of survey on 10/10 /23. Refer to D5429; 2) provide documentation of performing the calibration verification procedures every six months for the non-waived Abbott Chem 8+ analytes from 12/01/21 up to the date of survey on 10/10/23. Refer to D5439; and 3) perform at least two levels of external QC materials each day of patient testing for the non-waived Abbott i-STAT Chem 8+ cartridge analytes from 12/01/21 up to the date of survey on 10/10/23 while reporting 117 patients. Refer to D5447. In an interview with the lab director, office manager, market quality manager and primary TP on 10/10 /23 at 1300, the lab director stated, "I didn't realize these cartridges were not CLIA waived." D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on a tour of the laboratory, the review of proficiency testing (PT) records, interview with the PT technical specialist and interviews with the primary testing personnel (TP), the laboratory director failed to ensure the enrollment of the correct chemistry PT module for the sodium (NA), potassium (K+), chloride (CL), carbon dioxide (CO2), urea nitrogen (BUN), creatinine, glucose (GLU), ionized calcium (CA) and hematocrit (HCT) analytes for the 2022 and 2023 calendar year events (a total of six events). Refer to D2000. In an interview with the lab director, office manager, market quality manager and primary TP on 10/10/23 at 1300, the lab director stated, "I didn't realize these cartridges were not CLIA waived." -- 5 of 6 -- D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on the review of Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, lack of documentation, the quality assurance (QA) policy and interview with the primary TP, the technical consultant failed to perform and document annual competency assessments for one of one TP in 2022. Findings include: 1. Review of the CMS-209 form revealed that the lab director also performs the duties of technical consultant and that there was one TP performing patient testing in 2022. 2. Review of TP #1's records revealed lack of documentation of an annual competency assessments for the calendar year 2022. The inspector requested the competency assessments for TP #1. The documentation was not available for review. 3. Review of the QA policy revealed the following statement: "5. Personnel Assessment- at least annually, the laboratory director will review the performance of each employee working in the laboratory to assure employee competency. The written result of the review will be filed in the individual's personnel file." 4. An interview with the lab director, office manager, market quality manager and primary TP on 10/10 /23 at 1300 confirmed the findings. 5. An exit interview with the office manager and market quality manager on 10/11/23 at 11 AM confirmed the findings. -- 6 of 6 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at SOVAH Internal Medicine PIM on November 16, 2021 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: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), proficiency testing (PT) records, lack of documentation, and an interview, the laboratory failed to rotate PT among the two (2) personnel performing Complete Blood Count (CBC) patient testing during the twenty- six (26) months reviewed. Findings include: 1. Review of the CMS 209 form revealed 2 testing personnel (TP) performed CBC patient testing on the Medonic hematology analyzer during the inspection review timeframe of August 2019 to 11/16/21. 2. Review of the laboratory's American Proficiency Institute (API) PT records, a total of six (6) events (2019 Event 3, 2020 Events 1- 2 noted: laboratory testing was suspended event 3, and 2021 Events 1-3) revealed: TP A signed attestations /performed 6 of the 6 API hematology PT events outlined above. (See Personnel Code Sheet.) 3. In an exit interview with the lead testing personnel on 11/16/21 at approximately 2:00 PM, the above findings were confirmed. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) 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 -- 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. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, lack of documentation, and an interview, the laboratory failed to verify twice annual accuracy of urinalysis sediment microscopy in calendar year 2019. Findings include: 1. During a laboratory tour on 11 /16/21 at approximately 11 AM, the inspector noted a microscope stored in the laboratory and inquired regarding the use of the microscope. The primary testing personnel stated: "We do very few urine microscopics in our lab. We send almost all of them out but occasionally our doctor wants one done." 2. Review of the laboratory's American Proficiency Institute (API) Urine Microscopy module PT records (2019 Events 2-3, 2020 Events 1-3, 2021 Events 1-2) revealed the following unsatisfactory scores: 2019 Event 2- 50%; 2019 Event 3 - 50%; 2020 Event 1 - 50% - long term unsuccessful performance noted by API; 2021 Event 2 - 50%. The inspector requested to review documentation of

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the SOVAH Internal Medicine (PIM) on July 9, 2019 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: D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: **Repeat Deficiency** Based on the review of Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, lack of documentation, the quality assurance (QA) policy and interview with the primary TP, the technical consultant failed to perform and document annual competency assessments for one (1) of two (2) TP in 2018. Findings include: 1. Review of the CMS-209 form revealed that the lab director also performs the duties of technical consultant and that there were 2 TP performing patient testing in 2018. See attached TP code list. 2. Review of the 2 TP records revealed lack of documentation of an annual competency assessments for TP A in 2018. The inspector requested the competency assessments for TP A. The documentation was not available for review. 3. Review of the QA policy revealed the following statement: "5. Personnel Assessment- at least annually, the laboratory director will review the performance of each employee working in the laboratory to assure employee competency. The written result of the review will be filed in the individual's personnel file." 4. An interview with the primary TP at approximately 1:30 PM confirmed that the findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 An announced CLIA Initial survey was conducted at the SOVAH Internal Medicine (PIM) on March 13, 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: 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 the review of quality assurance (QA) policy, quality control (QC) records, and interviews, the laboratory failed to follow the written QA policy for the review of their analytic test system from October 17, 2017 to March 13, 2018. Findings include: 1. Review of the QA policy revealed the following statements: "Each month, one of the following systems in our laboratory will be evaluated to be sure that it meets our quality goals. If a problem is identified, we will design and implement a solution that is approved by the laboratory director. 1. Patient test management 2. Quality control and instrumentation 3. Proficiency testing 4. Relationship of patient information to patient results 5. Personnel assessment 6. Communication 7. Laboratory Errors 8. Complaints 9. Quality Assurance review 10. Quality Assurance records." 2. Review of QC records for the hematology analytic testing system and available QA documentation revealed that there was no documentation of the QA review according the to written policy from October 17, 2017 to March 13, 2018. 3. An interview with the primary testing personnel and lab director at approximately 4:00 PM confirmed that the staff had not performed the QA reviews as described within the written policy from October 17, 2017 to March 13, 2018. 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 -- D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on the review of Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, the quality assurance (QA) policy, and interviews, the technical consultant failed to perform and document annual competency assessments for two (2) of two (2) TP in 2017. Findings include: 1. Review of the CMS-209 form revealed that the lab director also performs the duties of technical consultant and that there were 2 TP performing patient testing in 2017. (See attached personnel code list.) 2. Review of the 2 TP records revealed no documentation of competency assessments performed by the lab director in 2017. The inspector requested the competency assessments for the 2 TP. The documentation was not available for review. 3. Review of the QA policy revealed the following statement: "5. Personnel Assessment- at least annually, the laboratory director will review the performance of each employee working in the laboratory to assure employee competency. The written result of the review will be filed in the individual's personnel file." 4. An interview with the primary testing personnel and technical consultant at approximately 4:00 PM confirmed that the technical consultant failed to perform the competency assessments in 2017. -- 2 of 2 --