Cmg, Village Family Physicians

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at CMG, Village Family Physicians on May 29, 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: 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: Based on observations, a review of procedures, and interviews, the laboratory failed to follow established safety protocols that prohibited eating and storage of food and beverages in the laboratory as observed on the date of the survey May 29, 2025. Findings include: 1. During a tour of the laboratory on 5/29/25 at 11:00 AM, the inspector observed food items (salad dressing, coffee creamer, lunch containers, and soft drink beverages) stored in a dorm sized refrigerator under a table in the laboratory. The inspector inquired regarding the presence of the food and beverages stored in the laboratory refrigerator. The Laboratory Site Manager stated on 5/29/25 at 11 AM: "The staff wanted an area to put break and lunch items and we discussed designating that refrigerator as a clean area." 2. Review of the laboratory procedure manual revealed a policy (Titled: CMG Laboratory Safety, Universal Precautions, Bloodbourne Pathogen Standard for all Testing Personnel and Staff, CMG.01.16.311) that stated: "The following are prohibited in the clinical laboratory: eating, drinking, smoking, application of cosmetics, and handling of contact lenses." 3. While gathering additional records for review on 5/29/25 at 12 noon the inspector noted one testing personnel seated eating from a plate of food at the table in the laboratory. The inspector noted that the personnel was within inches of a biohazard trash receptacle 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 -- and adjacent to a specimen/reagent storage refrigerator. The inspector noted that the entrance door directly behind the lunch plate was a route for specimen delivery to the laboratory and specimen processing. The inspector inquired regarding protocols for eating in the laboratory. The Laboratory Site Manager stated on 5/29/25 at 12 noon, "We did discuss having a clean area for the staff at the table where they would not be required to wear PPE but our organization's protocol is to not eat in the laboratory. I will plan to huddle with the staff to review safety and we will remind staff to use the break rooms or offices to eat and store food." 4. An exit interview with the Medical Laboratory Technician, Laboratory Site Manager, and Laboratory Director on 5/29/25 at 1:30 PM confirmed the above findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of temperature logs, lack of documentation, procedure manual, and interviews, the laboratory failed to monitor the daily temperatures for room, two refrigerators, two freezers, and relative humidity percent (RH%) to ensure proper operating conditions, storage of reagents, specimens, and test kits according to policy for fourteen (14) of twenty-two (22) operational days in July 2024. Findings include: 1. Review of the laboratory temperature logs during the review timeframe of 5/26/23 to 5/29/25 revealed no record monitoring temperatures and RH% on the following 14 days in July 2024: 7/9, 7/11, 7/15-7/19, 7/22-7/26, and 7/29-7/30. The temperature log identified ambient, humidity, small and large refrigerator, small and large freezer to be documented daily. 2. The inspector requested to review environmental monitoring records documenting humidity, ambient, refrigerators and freezers' temperatures for the 14 days outlined above. No additional records were available for review. 3. Review of the laboratory's procedure manual revealed a policy (Titled: CMG Laboratory Quality Assurance Policy) that stated, "to ensure proper operating conditions and storage of reagents, specimens, and test kits per manufacturer's requirements, environmental assessments should be documented each day of operation". 4. An exit interview with the Medical Laboratory Technician, Laboratory Site Manager, and Laboratory Director on 5/29/25 at 1:30 PM confirmed the above findings. 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) -- 2 of 3 -- (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 proficiency testing (PT) records, analyzer calibration records, policies/procedures, lack of documentation, and interviews, the laboratory failed to perform hematology calibration procedures according to their policy for Complete Blood Count (CBC) patient testing after replacement of critical Abbott Emerald analyzer components on April 7, 2025. Findings include: 1. Review of the laboratory's 2025 American Proficiency Institute PT records revealed a Performance Review and

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at CMG, Village Family Physicians on May 23, 2023 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: 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), procedure and policy manual, personnel files, lack of documentation, and an interview, the laboratory did not follow their policy for annual technical consultant (TC) competency assessments during the review timeframe of August 2021 to the date of the survey on May 23, 2023. Findings include: 1. Review of the CMS 209 revealed that Personnel # 1 serves as TC. (See Personnel Code Sheet.) 2. Review of the laboratory procedure and policy manual revealed a policy (titled: CMG Laboratory Quality Assurance Policy) that outlined a protocol for annual TC competency assessment documentation. The protocol stated, "Competency assessment of the technical consultant should be performed annually by the lab director for the duties assigned". 3. Review of the personnel files revealed no TC competency assessment records during the twenty-one month review timeframe of August 2021 to 5/23/23. 4. An interview with TC and lead testing personnel on 5/23 /23 at approximately 2:30 PM confirmed the above findings. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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 -- 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records (2021 Event 3, 2022 Events 1-3, 2023 Event 1) and an interview, the laboratory director failed to ensure that two (2) chemistry and urinalysis modules' analyte results were submitted timely for scoring on one (1) of five (5) PT events reviewed. Findings include: 1. Review of the laboratory's AAB-Medical Laboratory Evaluation (AAB-MLE) PT records (a total of 5 events) revealed the following: 2023 AAB-MLE 1st Chemistry Event : Direct Bilirubin - challenge sample CHM-01 scored as "no result submitted"; 2023 AAB-MLE 1st Urinalysis Event : RBC and WBC- challenge samples 1-5 scored as result absent (zero). The inspector inquired regarding the above analytes scored as "no results" submitted. The technical consultant (TC) stated on 5/23/23 at approximately 1:30 PM, "The MLE PT company changed the format when merged to AAB-MLE and the staff were unfamiliar with the new result entry process on the first event. We plan to contact the PT program and will document an evaluation of the analytes identified". The lead testing personnel stated at approximately 1:30 PM, "I cannot remember if the urinalysis RBC and WBC challenges were slides or photos" 2. An interview with the TC and lead tech on 5/23/23 at approximately 2:30 PM confirmed the above findings. 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 a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, lack of documentation, and an interview, the technical consultant (TC) failed to perform hematology and chemistry competency evaluations for one (1) of three (3) testing personnel (TP) in calendar year 2022. Findings include: 1. Review of the CMS 209 form revealed that the laboratory director identified a TC and 3 TP qualified to perform/report non- waived patient hematology Complete Blood Count (CBC) and routine chemistry testing. 2. Review of the available personnel files revealed no 2022 Abbott Emerald CBC or Ortho Clinical Vitros 350 chemistry competency evaluation performed/signed by the TC for Personnel # 2. (See Personnel Code Sheet.) The inspector requested to review competency assessment for Personnel # 2. The TC stated on 5/23/23 at approximately 1:30 PM, "The tech was a travel tech and came to help us in 2022. I did not get in to get the competency completed." 3. An interview with the TC and primary testing personnel on 5/23/23 at approximately 2:30 PM confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), procedures, laboratory personnel files, lack of documentation, and an interview, the technical consultant (TC) failed to perform annual Potassium Hydroxide (KOH) / Wet Prep and Urine Sediment Examination competency evaluations for six (6) of seven (7) microscopy testing personnel (TP) in 2022. Findings include: 1. Review of the CMS 209 form revealed that the laboratory director identified one TC and 7 qualified personnel responsible for patient KOH/Wet Prep and Urine Sediment Examination testing (TP A - G). (See Personnel Code Sheet.) 2. Review of the laboratory's procedure manual revealed a policy that outlined competency assessment that stated, "Evaluating the competency of all testing personnel to ensure staff maintain their competency to perform test procedures and report results promptly, accurately, and proficiently. This will be documented twice per year during the employee's first year and annually thereafter." 3. Review of the laboratory personnel files revealed no microscopy competency assessment documentation for TP A - F in calendar year 2022. The inspector requested to review microscopy competency assessments for the 6 TP outlined above. No documentation was unavailable for review. 4. A follow up interview with the TC and lead tech on 5 /24/23 at approximately 1:40 PM confirmed the above findings. -- 3 of 3 --