Bagwell Medical Clinic

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(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: Based on observation of the laboratory procedure manual, quality control (QC), patient test log, lack of performance specifications, and interview with the Laboratory Director, the laboratory failed to verify performance specifications for Serum HCG pregnancy testing using the Consult HCG Combo Test Cassette, before it was put in use for patient testing on 11/13/2025. Findings include: 1. Observation of the Laboratory Procedure Manual revealed the Consult HCG Combo Test Cassette procedure was added to the manual and introduced to the laboratory by performing QC on 11/4/2025. 2. Review of quality control and patient test records for the Consult HCG Serum Pregnancy revealed the laboratory performed the first patient's serum pregnancy on 11/13/2025. 3. On the day of the survey, 3/10/2026, there was no documentation available for review of verification of performance specifications, to include accuracy, precision, and reportable range, for the Consult HCG Combo (serum) Test Cassette. 4. In an interview on 3/10/2026 at 2:30 p.m., the Laboratory Director confirmed the Consult HCG Combo Test Cassette was used for serum pregnancy, and performance specifications were not verified for Serum Pregnancy testing, before it was put in use for patient testing on 11/13/2025. 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of Cell Dyn Emerald QC (quality control) records from instrument installation on 1/31/22 through 6/28/22 and confirmation with the laboratory director /technical consultant (LD/TC) at 4:00 p.m., the laboratory failed to retain the QC assay sheets for each lot used. QC assay sheets include acceptable ranges, storage requirements, lot numbers and standard deviations and should be kept for a minimum of 2 years. Findings include: 1. Review of the Cell Dyn Emerald records indicated that QC lot #2150 was in use on the day of the survey. The assay sheet for lot # 2150 was the only assay sheet available for review. 2. Review of the Cell Dyn Emerald QC records from the analyzer installation on 1/31/22 until 6/28/22 revealed the following hematology QC lots had been used: a. Cell Dyn QC lot # 1347 low, normal, high put in use on 1/31/22 b. Cell Dyn QC lot # 2038 low, normal, high put in use on 3/10/22 c. Cell Dyn QC lot # 2066 low, normal, high put in use on 4/4/22 3. Interview with the LD/TC at 4:00 p.m. on 6/28/22 confirmed the lab did not retain QC assay sheets for each lot number of QC material for the Cell Dyn Emerald hematology analyzer. 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 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 -- 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 review of laboratory records since the Abbott Cell Dyn Emerald installation on 1/31/21 and confirmation with the laboratory director/technical consultant (LD /TC) at 2:30 p.m. on 6/28/22, the laboratory failed to monitor and document the room temperature where hematology testing was performed. Findings include: 1. Observation of the laboratory room where hematology testing was performed revealed no thermometer to monitor the room temperature for optimal performance of the Cell Dyn Emerald hematology analyzer. 2. Cell Dyn Emerald manufacturer's instructions require: a. The Cell Dyn Emerald reagent, lyse and detergent should be stored at a temperature range of 18-32 degrees Celsius (C) b. Operating specifications for the Cell Dyn Emerald hematology analyzer require a room temperature of 18- 32 degrees C. c. Quality control and calibration materials for the Cell Dyn Emerald must be allowed to come to room temperature before testing. 4. Interview with the LD/TC at 2: 30 p.m. on 6/28/22 confirmed no room temperatures were being monitored and documented. -- 2 of 2 --