Capitol Medical Enterprises Llc Dba Capital Med Gr

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 review of proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to ensure that the testing personnel (TP) and laboratory director (LD) attested to the routine integration of the samples into the patient workload using the laboratory's routine methods in six of six PT events reviewed. Findings: 1. The laboratory was enrolled in PT with American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) in modules for 1) Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG), 2) Severe acute respiratory virus coronavirus 2 molecular (SARS CoV-2), 3) Influenza type A and B and respiratory syncytial virus antigen (Flu A & B/RSV), and 4) hematology. 2. Records from the third event (M3) in 2023 to the second event (M2) in 2025 were reviewed for a total of six events. 3. Attestations and signatures were missing as follows: a. AAB-MLE M2 2025 i. CT/NG: the LD signature was missing ii. SARS CoV-2: the LD signature was missing iii. Flu A & B/RSV: the LD signature was missing iv. Hematology: the attestation form was missing b. AAB-MLE M1 2025 i. CT/NG: the LD and TP signatures were missing ii. SARS CoV-2: the attestation form was missing iii. Flu A & B/RSV: the LD and TP signatures were missing iv. Hematology: the attestation form was missing c. AAB-MLE M3 2024 i. CT/NG: the TP signatures were missing and the LD name was typed, but there was no signature ii. SARS CoV-2: the LD and TP signatures were missing iii. Flu A & B/RSV: the attestation form was missing iv. Hematology: the attestation form was missing d. AAB-MLE M2 2024 i. CT/NG: the LD name was typed, but there was no signature ii. SARS CoV-2: the TP signatures were missing and the LD name was typed, but there Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- was no signature iii. Flu A & B/RSV: the LD name was typed, but there was no signature iv. Hematology: the LD signature was missing e. AAB-MLE M1 2024 i. CT /NG: the TP signatures were missing and the LD name was typed, but there was no signature ii. SARS CoV-2: the TP signatures were missing and the LD name was typed, but there was no signature iii. Flu A & B/RSV: the TP signatures were missing and the LD name was typed, but there was no signature iv. Hematology: the attestation form was missing f. AAB-MLE M3 2023 i. All attestation forms were missing 4. During the survey on 09/23/2025 at 12:58 PM, the TC confirmed that attestations were either missing or not signed by the LD and/or TP in six of six PT events reviewed. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the "Quality Assessment Program" procedure (QA procedure), proficiency testing (PT) records, and the PT provider's website, and interview with the technical consultant (TC), the laboratory failed to investigate all unacceptable PT results in three of six hematology PT events reviewed. Findings: 1. The QA procedure stated that "PT failures are investigated within 30 days and remedial action is taken." 2. The laboratory was enrolled in hematology PT modules with American Associate of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE). Records for the third event (M3) in 2023 through the second event (M2) of 2025 were reviewed for a total of six events. 3. AAB-MLE M3 2023 a. The laboratory received a score of 0% for hemoglobin. The laboratory also received a score of 0% for leukocytes and the three- part differential because results were not reported to the PT agency. b. There was no documentation of an investigation into the unacceptable results. 4. AAB-MLE M2 2024 a. The laboratory received a score of 80% for neutrophil (%) and lymphocyte (%) and a sore of 20% for monocyte (%). b. There was no documentation of an investigation into the unacceptable results. 5. AAB-MLE M1 2025 a. The laboratory received a score of 80% for leukocytes, eosinophil (%), and basophil (%); 60 % for neutrophil (%) and lymphocyte (%); and 20% for monocyte (%). b. The findings stated "Repeated out of range samples. All repeated values were [within] range except for the 2 lymph values" and that the issue "will resolve as this is probably an operator error." c. The investigation didn't specifically state which analytes were unacceptable and were repeated. There was no documentation of the repeat values for neutrophil (%), eosinophil (%), or basophil (%). d. The investigation didn't address whether patient samples had the potential to be affected or what

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review, the laboratory did not meet the Code of Maryland requirements (COMAR) for the frequency of external quality control testing for testing performed on the Cepheid analyzers that includes SARS CoV-2, respiratory pathogens (FLU and RSV) and CG/NG testing. Findings: 1. The laboratory performs patient testing for SARS CoV- 2, RSV, FLU and CG/NG using two Cepheid analyzers. 2. The laboratory tests the positive and negative external (liquid) quality control every 30 days or when a new lot of reagent is introduced. 3. The test cartridge for the tests performed on the Cepheid meet the definition under COMAR 10.10.01.B (73) for Single-use test device for nonforensic testing. 4. COMAR 10.10.06.06 (Laboratories, Single Use Test Device) states (6) Quality Control Tests. (b) Qualitative Test System. A licensee shall ensure that quality control testing for a qualitative test system is performed and documented using known positive and negative control materials before patient testing: (i) On each lot of a single-use test device received in a shipment; (ii) At least weekly for each lot of a single-use test device used for patient testing (iii) After a single-use test device is exposed to an environment or condition that could affect the accuracy or reliability of test results; and (iv) Each day of use during test system validation. 4. The laboratory does not perform weekly external quality control checks as required by COMAR. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish 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 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of competency check records for testing personnel and the technical consultant, the laboratory did not have competency records for 2022. Findings: 1. The laboratory director did not perform and document the technical consultants competency in 2022. 2. The technical consultant did not perform and document the testing personnel competency in 2022. 3. 2. This was confirmed with the technical consultant during interview on the morning of the survey. 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: Based on review of proficiency test records and interview, the laboratory did not document evaluation of influenza B proficiency test results returned by the proficiency test provider as not evaluated due to lack of participant consensus. Findings: 1. In the third proficiency test event of 2022, the proficiency test provider reported the laboratory's response to unknown sample #12 as not evaluated due to non consensus of participants, but the laboratory did not have documentation showing that the laboratory reviewed the result reported for Sample #12 with the given data that the proficiency test provider included in its evaluation. 2. This was confirmed with the technical consultant during interview on the afternoon of the survey. 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 D5783

Summary Statement of Deficiencies D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on review of the laboratory patient logs, interview with the laboratory manager, and the technical consultant (TC), the laboratory failed to validate procedures to perfrom high complexity bacteriology testing. Findings: 1. Patient A, one of the 8 patients that had a throat culture performed on June 12, 2019 with the Strep select agar and the BD Taxo A disc. Patient A culture result was documented as "pos+" in the "pos/neg/MD" section on the "throat culture worksheet" log. 2. The lab manager stated that patient A had a negative rapid strep on 6/12/19 and the physician ordered a throat culture on 6/12/19. The culture was read at 48 hours and the result was positive. 3. The "throat culture worksheet" log had a line with an arrow at the end drawn down the "pos/neg/MD" section with "neg" for all 8 patients including patient A tested for throat cultures on 6/12/19. 4. On June 14, 2019 patient A had a rapid strep performed and the result was "pos" on the "consult diagnostic strep" log. Patient A was not seen on 6/14/19 even though patient A appeared on the "consult diagnostic strep" log. 5. The lab manager stated that the physician ordered a rapid strep for patient A after the throat culture reading which was documented as "positive" on 6/12/19. 6. The lab 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 -- manager stated that the physician ordered the medical assistant to use a colony from the culture plate that was ran on 6/12/19 to run the rapid strep test on 6/14/19. 7. The laboratory modified the rapid strep test to perform high complexity testing with a colony from a throat culture with the Strep Select Agar plate and the BD Taxo A disc. 8. The rapid strep procedure states to use a swab that has been rubbed in the back of the patient's throat. 9. The laboratory did not follow the written procedure for incubating throat cultures with the Strep Select Agar plate and the BD Taxo A disc for the 18-24 hours and reading. 10. The TC confirmed that the physician performed high complexity testing with the rapid strep test kit and that the physician failed to follow the written procedure for performing throat cultures. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on review of hematology quality controls (QC) and interview with the technical consultant (TC), the TC failed to identify the training needs of testing persons performing hematology QC. Findings: 1. On March 21, 2019, the TP ran the hematology normal QC twice and the low QC once. The high QC was not ran. 2. The hematology procedure states to run a low, normal, and high level of QC each day of patient testing. 3. The TC stated that she was not aware that TP did not run all three separate levels of hematology QC. 4. The TC did not document the error in the TC notes for March 2019 nor was the TP advised of the error. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on review of bacteriology quality control (QC) results, review of the written procedure manual, and interview with the technical consultant (TC), the testing personnel (TP) failed to follow the written procedures for performing throat culture QC. Findings: 1. The TP did not follow the written QC procedure for performing throat cultures with the Taxo A disc. 2. The TP were incubating the "negative" throat culture QC plated with the Taxo A Disc up to 48 hours and reading. Once the plate was read the TP did not document the date read on the QC log and the plate was discarded. 3. The Throat culture written procedure for performing the negative throat culture QC states to plate the Group B Strep just as a patient specimen, add the Taxo A disc, incubate for 18-24 hours and read. 4. The TC stated that she was not aware that the TP were not following the procedure for performing throat culture QC. -- 2 of 2 --