Dc Medical Offices, Llc

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 testing person (TP), the laboratory director (LD) failed to review and sign PT attestations to ensure that testing was performed in the same manner as patient testing. Findings: 1. The LD failed to review and sign all DRho Typing PT attestations for the; a. AAB (American Association of Bioanalysts) Non Chem Q1 2022 DRho Typing PT that was performed by the TP on 2/3/22. b. AAB Non Chem Q3 2021 DRho Typing PT that was performed by the TP on 9/1/21. c. AAB Non Chem Q2 2021 DRho Typing PT that was performed by the TP on 5/22/21. d. AAB Non Chem Q1 2021 DRho Typing PT that was performed by the TP on 2/6/21. e. AAB Non Chem Q3 2020 DRho Typing PT that was performed by the TP on 9/19/20. f. AAB Non Chem Q2 2020 DRho Typing PT that was performed by the TP on 5/11/20. g. AAB Non Chem Q1 2020 DRho Typing PT that was performed by the TP on 2/14/20. 2. The TP confirmed that the LD failed to review and sign all DRho Typing PT attestations. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the lab testing logs and interview with the testing person (TP), the laboratory did not maintain all patient test records on site for at least two years. Findings: 1. The lab did not have on site lab logs from 10/28/19-12/31/20. 2. The TP stated that the requested records were stored off site. 3. The TP confirmed that the laboratory did not maintain all patient test records on site for at least two years. 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 proficiency testing (PT) records and interview with the testing person (TP), the laboratory director (LD) failed to review and sign PT results to ensure accurate and reliable patient testing. Findings: 1. The LD failed to review and sign all DRho Typing PT results for the; a. AAB (American Association of Bioanalysts) Non Chem Q1 2022 DRho Typing PT. b. AAB Non Chem Q3 2021 DRho Typing PT. c. AAB Non Chem Q2 2021 DRho Typing PT. d. AAB Non Chem Q1 2021 DRho Typing PT. e. AAB Non Chem Q3 2020 DRho Typing PT. f. AAB Non Chem Q2 2020 DRho Typing PT. g. AAB Non Chem Q1 2020 DRho Typing PT. 2. The TP confirmed that the LD failed to review and sign all DRho Typing PT results to ensure accurate and reliable patient testing. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on an interview with the Laboratory's Operation Manager and the review of policies and procedures, manufacturer's instructions and patient test results on March 30, 2018 at approximately 11:30 AM, the laboratory's policies and procedures for Rhesus Factor (RhD) testing failed to include the laboratory's policy regarding testing for weak D (Du) when RhD test is negative. The findings included: Review of Bioclon the manufacturer of the of the Anti-D reagent revealed that red blood cells that test RhD negative may be further tested for Du, if desired. Although the Laboratory's Operation Manager indicated that testing for Du is not performed in this laboratory, review of the laboratory's procedure did not include information regarding its policy for not testing for Du. Review of patients' test results with negative RH also failed to state that the patients were not tested for Du. 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 --