Family Planning Associates Medical Group Ltd

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 surveyor review of laboratory records and interview with Testing Personnel (TP) #4, the laboratory failed to identify and document quality control materials in use and ensure they met the manufacturer's specimen acceptability requirements for Rhesus Factor D (Rh-D) quality control testing for 58 of 103 days reviewed affecting 1,809 patients. The findings include: 1. Review of quality control logs showed the laboratory failed to document Control Lot Numbers and Control Expiration Dates for: a. April 19, 2021 - April 30, 2021, 11 of 26 days in April b. May 1, 2021 - May 14, 2021, 12 of 25 days in May c. June 14, 2021 - June 30, 2021, 15 of 26 days in June d. July 1, 2021 - July 24, 2021, 20 of 26 days in July 2. TP #4 confirmed during an interview on 4/13/2022 at 11:15 a. m. that employee blood samples collected in EDTA (lavender top) tubes were utilized during this timeframe when quality control lot numbers and expiration dates were not documented. 3. TP#4 confirmed during an interview on 4-13-22 at 11:15 a.m. that the known employee Rh negative and positive controls were utilized for 28 days before redrawing new control samples. 4. Manufacturer's instructions for the anti-D reagent states, "clotted samples or those 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 -- collected in EDTA should be tested within fourteen days from collection". 5. Review of patient testing records found 1,109 patients were tested for Rh-D from April 19, 2021 to May 14, 2021 and 700 patients were tested for Rh-D from June 14, 2021 to July 24, 2021 when the laboratory failed to document the QC materials in use and the stability of the known Rh positive and Rh negative controls could not be confirmed for the testing dates reviewed. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review, manuals, the Laboratory Personnel Report (CMS 209), and an interview with the testing personnel (TP1), the laboratory failed to ensure proficiency testing (PT) samples are tested by the laboratory's regular personnel who routinely perform testing in the laboratory, using the laboratory's routine methods, during the years of 2017 through 2019 Findings include: 1. The CMS 209, personnel records, procedures manual, and PT documents were reviewed. 2. The laboratory failed to ensure all TP performing the Rhesus Factor (Rh) D slide test participates in PT sample testing. 3. TP1, TP2, TP3, TP4, TP5, and TP6 were listed on the CMS 209 for performing Rh testing. 4. The personnel records and PT documents revealed the following: *TP1, TP2, TP3, TP4, TP5, and TP6 were assessed as competent to perform Rh factor testing. *The laboratory participated in 6 PT events during the years of 2017 through 2019. *TP2, TP5 and TP6 participated in 0 out of 6 PT events during the above time period. 5. On a Recertification survey conducted on 07/30/2018 at 12:45PM, the TP1 confirmed the above findings. 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. 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 record review and an interview with the testing personnel (TP1), the laboratory failed to review and evaluate the results obtained on proficiency testing performed during the years of 2017 through 2019. Findings: 1. The proficiency testing (PT) result summaries and procedure manual were reviewed. 2. The laboratory's PT policy and procedure failed to include the review of PT results (scores) received from the PT program. 3. The laboratory participated in 6 PT events during the years of 2017 through 2019. The PT summaries revealed the laboratory failed to review 6 out of 6 PT results from the events the laboratory participated during the above time period. 4. On a Recertification survey conducted on 07/30/2018 at 12:45PM, the TP1 confirmed the above findings. -- 2 of 2 --