Premier Medical Group

Summary Statement of Deficiencies 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: Intakes: TN00076839 Based on laboratory observation, staff interviews, a review of the laboratory procedure manual, testing personnel records, and a review of a patient test log, the laboratory failed to follow the separate procedures for training and competency assessments for nine of ten testing personnel. The findings include: 1. Laboratory observation on 09/25/25 at 8:20 a.m. revealed the following non-waived test systems used for patient testing: Sysmex XN 330 for Complete Blood Count with automated White Blood Cell differential (CBC w/Diff). Tosoh G8 for Hemoglobin A1c. A microscope used for performing urine microscopic examination, wet prep examination, and potassium hydroxide (KOH) examination. An Ortho Vitros 5600 was used for performing chemistry and endocrinology patient testing. 2. The laboratory manager stated during an interview on 09/25/25 at 8:50 a.m. that all non- waived testing is performed by the two Medical Laboratory Technicians (MLTs) and herself. The persons with laboratory assistant job descriptions performed waived testing and CBC w/Diff on the weekends. The technical consultant only performed CBC w/Diff. 3. A review of the laboratory procedures manual revealed separate procedures for training and competency assessment. The procedure titled "CENTRAL LABORATORY NEW EMPLOYEE ORIENTATION AND TRAINING" stated that each new employee would be trained in instrument maintenance, calibration, quality control, quality assessment process, and patient testing. It further stated that "all training is documented and reviewed by the Laboratory Director or designee." The procedure titled "COMPETENCY ASSESSMENT" stated that each employee would be assessed upon initial hire, during orientation. Verification of the employee 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 -- competency would be evaluated for each moderate procedure testing platform. 4. A review of testing personnel records revealed the following: There was no documentation of training on the processes stated in the training procedure for the performance of CBC w/Diff using the Sysmex XN 330 for testing persons three and seven. There was no documentation of training on calibration and quality assessment process for testing persons one, two, four, five, six, and nine for the performance of CBC w/Diff using the Sysmex XN 330. There was no documentation of training on the wet prep procedure and Potassium Hydroxide (KOH) for testing persons seven, eight, and nine. Separate competencies were not performed for the wet prep, KOH, and urine microscopy for testing persons seven, eight, or nine. There was no documentation of training on the Tosoh G8 for testing persons seven and nine. There was no documentation of training for urine microscopy for testing persons seven and nine. 5. A review of the urinalysis procedure revealed that urines are centrifuged for five minutes to prepare for microscopic examination. 6. Testing person seven stated during an interview on 09/25/25 at 1:40 p.m. that the urines would be centrifuged for 15 minutes. 7. A review of a patient test log revealed that a total of five patient tests for wet prep and KOH had been performed since testing began in the main laboratory area on 12/13/24 (patient numbers 711183, 25971, 229624, 634747, and 706625) without documented training on patient testing and reporting. 8. The laboratory manager and technical consultant confirmed the laboratory failed to follow the separate procedures for training and competency during an interview on 09/25/25 at 3: 00 p.m. Word Key: mL=milliliter -- 2 of 2 --

Summary Statement of Deficiencies 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 observation of the laboratory, a review of the laboratory policy, laboratory personnel records, and staff interviews, the laboratory failed to follow the policy for competency assessment when the competency assessments did not contain all six required elements for testing personnel (19 of 19 reviewed) that performed vaginal potassium hydroxide (KOH), wet prep, fern testing, and urine colony count patient testing in 2023. The findings include: 1. Observation of the Obstetrics and Gynecology department laboratory on 08/12/2024 at 2:00 p.m. revealed KOH, saline, and a microscope used for patient Wet Prep, KOH, and Fern testing. 2. An observation of the laboratory in the Pediatric department on 08/13/2024 at 11:00 a.m. revealed Uricult media and an incubator used for patient urine colony count testing. 3. A review of the laboratory policy titled "Competency Assessment" revealed that personnel would be evaluated for competency through direct observation of patient test performance, monitoring the recording of patient test results, review of intermediate test results or worksheets, direct observation of performance or instrument maintenance, assessment through blind testing or proficiency testing samples, and assessment of problem-solving skills. 4. A review of the laboratory's personnel records revealed competency assessment documentation did not contain direct observation of patient test performance, monitoring of the recording of patient test results, review of intermediate test results or worksheets, direct observation of performance or instrument maintenance, or assessment of problem-solving skills for eight testing persons who performed wet prep, KOH, and fern testing in the OB laboratory and eleven testing persons who performed urine colony count testing in 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 3 -- Pediatric laboratory for 2023. 5. An interview with the technical consultant on 08/13 /2024 at 11:30 a.m. confirmed the laboratory failed to follow the policy for competency assessment for testing personnel that performed wet prep, KOH, fern, and urine colony count testing in 2023. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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 observation of the laboratory, review of the laboratory's testing personnel policy/procedure, testing personnel records and interview with technical consultant number two, the laboratory failed to follow its' own testing personnel competency assessment policy when it did not include all six elements for five of twenty-five competency assessments reviewed from 2021 and 2022, and failed to perform interim competency assessment for one of seven semi-annual competencies due. The findings include: 1. Observation of the laboratory on 03/07/23 at 8:10 am revealed the following moderately complex test systems in use for patient testing: Complete blood count with differential performed on the Sysmex XN 330, General chemistry and endocrinology performed on the Siemens Dimension EXL 200, Glycosylated Hemoglobin (Hemoglobin A1c) performed on the Tosoh G8 and a microscope used for performing urine microscopic analysis. 2. Review of the laboratory personnel competency assessment policy revealed that a semi-annual competency would be performed during the first year of testing, and that all six of the required elements as described in subpart M of the Clinical Laboratory Improvement Amendments (CLIA) regulations would be included in the competency assessments performed. 3. Review of testing personnel records revealed the following: Testing person number two competency assessment did not include documentation/assessment of review of worksheets, quality control, proficiency testing and preventive maintenance, blind samples or proficiency testing samples, or problem solving skills for the Sysmex XN- 330, Dimension EXL 200, Urine Microscopy, and Tosoh G8 for initial and six month competencies performed in 2021 and annual competency performed in 2022. Testing 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 -- person number three competency assessment did not include documentation /assessment of review of worksheets, quality control, proficiency testing and preventive maintenance, blind samples or proficiency testing samples, or problem solving skills for the Sysmex XN-330, Dimension EXL 200, Urine Microscopy, or Tosoh G8 for the initial competency performed in 2021 and the six month and annual competencies performed in 2022. Testing person number nine did not have a semi- annual competency for performance of complete blood count when due in 2022. 4. Interview with technical consultant number two on 03/07/23 at 3:45 pm confirmed the laboratory failed to follow its' own policy for competency assessment when it did not include all six required competency assessment elements as described in the personnel policy for five of twenty-nine competency assessments reviewed, and failed to perform semi-annual competency assessment for one of seven semi-annual competencies when due. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 observation of the laboratory, review of manufacturer instructions for use, and interview with technical consultant number two, the laboratory failed to monitor humidity as required by the manufacturer for three of three moderately complex test systems used for performing complete blood count (CBC), glycosylated hemoglobin (Hemoglobin A1c) and general chemistry and endocrinology tests in 2021, 2022, and 2023. The findings include: 1. Observation of the laboratory on 03/07/23 at 8:10 am revealed the following moderately complex test systems in use for patient testing: Sysmex XN 330 (serial #s 11814 and 11822) for performing CBC to include white blood cell differential Tosoh G8 serial # 16371210 for performing Hemoglobin A1c Siemens Dimension EXL 200 serial # DE271895 for performing general chemistry and endocrinology No device for monitoring humidity was observed in the laboratory. 2. Review of the manufacturer environmental operating requirements revealed the following: Sysmex XN 330 - Humidity range of 20 to 85% Tosoh G8 - Humidity range of 40 to 80% Siemens Dimension EXL 200 Humidity range of 20 to 80% 3. Interview with technical consultant number two on 03/07/23 at 3:45 pm confirmed the laboratory did not monitor humidity in the areas where the CBC, Hemoglobin A1c, and chemistry/endocrinology instruments were in use in 2021, 2022, and 2023. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of control manufacturer instructions for use, and interview with technical consultant number two, the laboratory failed to label ten of ten controls observed on the date of the survey with a corrected expiration date. The findings include: 1. Observation of the laboratory on 03/07/23 at 8:40 am revealed multiple controls in use that were labeled with open date, but no corrected expiration date for the following: Complete blood count (CBC) controls XN-L (three levels) Immunoassay plus controls used for performing quality control on multiple chemistry and endocrinology tests (two levels) Multiqual controls used for performing general chemistry quality control (two levels) Pediatric (high) bilirubin control (one level) Hemoglobin A1c controls (two levels) 2. Review of the control manufacturer instructions for use revealed the following: XN-L controls are good for 15 days after opening. Immunoassay Plus controls are good for 14 days after opening. Multiqual controls: "All analytes: 14 days Except: - Alkaline Phosphatase, AST/SGOT, Bilirubin (neonatal) and Bilirubin (Total): 9 days -Bilirubin (Direct), Cholesterol (HDL), Cholinesterase, Creatine Kinase (CK), Phosphorus and Triglycerides: 7 days 3. Interview with technical consultant number two on 03/07/23 at 3:45 pm confirmed the laboratory did not label controls with a corrected expiration date after they were opened for ten of ten controls observed on the date of the survey. She also confirmed the expiration date of the controls changed after opening. -- 3 of 3 --

Summary Statement of Deficiencies D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: The laboratory failed to define quality control ranges for the current lot number of glycated hemoglobin (Hb A1c) controls. (Refer to D5469) 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: Based on observation of the laboratory, interview with the obstetrics/gynecology supervisor, review of patient test reports, the laboratory procedure manual, and interview with technical consultant number one, the laboratory failed to have procedures for performing fern test and whiff test in 2020. The findings include: 1) Observation of the laboratory area in the obstetrics/gynecology area on February 13, 2020 at 9:00 a.m. revealed a microscope in use for patient testing for wet prep and potassium hydroxide (KOH) testing. 2) Interview on February 13, 2020 at 9:10 a.m. with the area supervisor revealed the providers report fern testing. 3) Review of KOH test reports for patient numbers thirteen, fourteen, and fifteen for KOH testing 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 -- revealed "Whiff" test reported. 4) Review of the laboratory procedure manual revealed no procedures were present for performing fern testing and whiff testing. 5) Interview with technical consultant number one on February 13, 2020 at 5:00 pm. confirmed there were no procedures for performing fern test and whiff test in 2020. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with technical consultant number one, the laboratory failed to label saline container with lot number and expiration date in 2020. The findings include: 1) Observation of the laboratory space in the obstetrics/gynecology area on February 13, 2020 at 9:00 a.m. revealed a bottle labeled "Nacl 0.9%" in use for patient wet prep testing. There was no lot number or expiration date on the vial. 2) Interview with technical consultant number one on February 13, 2020 at 9:30 a.m. confirmed the saline used for performing patient wet prep testing was not labeled with lot number and expiration date in 2020. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of quality control (QC) records, and interview with technical consultant number one, the laboratory failed to define the QC ranges for glycated hemoglobin (Hb A1c) for the current lot in use. The findings include: 1) Observation of the laboratory on February 13, 2020 at 8:45 a.m. revealed the Tosoh G8 instrument in use for patient testing for Hb A1c. 2) Observation of the laboratory on February 13, 2020 at 4:45 p.m. revealed QC lot number 7097 (levels one and two) in use for monitoring QC for the Tosoh G8 instrument. 3) Review of the current QC lot in the laboratory information system (LIS) revealed a different lot number and QC ranges configured in the LIS. 4) Interview with technical consultant number one on February 13, 2020 at 5:00 p.m. confirmed the laboratory failed define -- 2 of 3 -- the QC ranges for the current lot of QC for the Tosoh G8 instrument, resulting in the use of incorrect QC limits for the current QC lot (levels one and two). The current lot (7097) began sometime after December 5, 2019. -- 3 of 3 --

Summary Statement of Deficiencies 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: Based on observation of the laboratory, review of the laboratory's procedure for calibration verification, the manufacturer operator's manual for the Tosoh G8 instrument, the manufacturer package inserts for the Siemens Dimension EXL200 instrument, laboratory records, and interview with technical consultant number two, the laboratory failed to follow procedure for calibration verification when they did not perform calibration verification using a low, mid and high value that spanned the reportable range for the hemoglobin A1c, sodium, potassium, chloride and triglyceride analytes in 2016, 2017, and 2018. The findings include: 1. Observation of the laboratory on July 17, 2018 at 8:15 am revealed the Tosoh G8 instrument in use for patient testing for hemoglobin A1c and the Siemens Dimension EXL200 in use for patient testing for general chemistry. 2. Review of the laboratory's procedure for calibration verification revealed the following: Calibration verification is used to verify the calibration is valid through the reportable range for the analyte and is performed every six months using a low, mid, and high level standard. 3. Review of the manufacturer operator's manual for the Tosoh G8 instrument revealed that calibration for the hemoglobin A1c analyte is performed using a two-point calibration. 4. Review of the Siemens Dimension EXL 200 manufacturer's package insert for the sodium, potassium, and chloride analytes revealed that calibration is performed using a two point calibration. 5. Review of the Siemens Dimension EXL 200 manufacturer's package insert for the triglyceride analyte revealed typical calibrator levels of 120, 240, and 485 mg/dL and a measurement range of 15-1000 mg/dL. 6. Review of 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 -- laboratory records revealed there were no documents available documenting calibration verification using a low, mid, and high standard to verify the calibration through the reportable range of the test system for the hemoglobin A1c analyte on the Tosoh G8 instrument and the sodium, potassium, chloride and triglyceride analytes on the Siemens Dimension EXL 200 instrument in 2016, 2017, and 2018. 7. Interview with technical consultant number two on July 17, 2018 at 4:00 pm confirmed the laboratory failed to follow procedure for calibration verification for the hemoglobin A1c analyte performed on the Tosoh G8 instrument and the sodium, potassium, chloride and triglyceride analytes performed on the Siemens Dimension EXL 200 instrument when it did not perform calibration verification to include at least a low, mid and high standard that covered the reportable range of the instruments in 2016, 2017, and 2018. -- 2 of 2 --