Potomac Family Planning Center

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 records and interview, the laboratory director and testing person did not attest to the testing of proficiency test samples in the same manner as patient testing. Findings: 1. The laboratory did not have signed attestation statements from the laboratory director or testing person for the first, second and third testing events in 2023 or the first testing event in 2024. 2. This was confirmed with testing person at 12:00 pm on April 11, 2024. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and interview with laboratory staff, the laboratory did not test Rh proficiency test samples the same number of times as patient specimens are tested, but instead instead of performing the Rh test only once the laboratory performed duplicate testing and had a second person perform additional testing prior to reporting results to the proficiency test provider. Findings: 1. The laboratory receives proficiency test samples from the proficiency test provider three times a year to check Rh testing proficiency. 2. The written procedure and description Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- given by testing person #1 for performing the Rh test is to perform the test once and if there is a weak reaction to repeat the Rh test result and if the result is questionable to then notify the laboratory director to interpret. 3. The laboratory had two staff members perform Rh testing on proficiency test samples and then perform repeat testing prior to submission of the test results to the proficiency test provider for evaluation of performance. 4. During event one for 2023, records show that testing person #1 tested the Rh proficiency samples twice and testing person #2 tested the samples once, prior to reporting results to the proficiency test provider. 5. During event two for 2023, records show that testing person #1 tested the Rh proficiency samples once and testing person #2 tested the samples once, prior to reporting results to the proficiency test provider. 6. During event three for 2023, records show that testing person #1 tested the Rh proficiency samples once and testing person #2 tested the samples once, prior to reporting results to the proficiency test provider. 7. During event one for 2024, records show that testing person #1 tested the Rh proficiency samples once and testing person #2 tested the samples once, prior to reporting results to the proficiency test provider. 8. Testing person #1 stated during interview on April 11, 2024 at 12:00 pm that the additional duplicate testing performed by the primary testing person and the second staff member was done before the proficiency test results were reported to the proficiency test provider. 9. The laboratory did not have written procedures to document any additional testing of proficiency test samples to ensure that it was performed only after the initial testing results were submitted to the proficiency test provider for evaluation. 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 Rh proficiency testing records and interview, the laboratory did not have the proficiency test reports evaluating the laboratory's performance from the proficiency test provider and did not have documentation showing the laboratory director reviewed the proficiency test providers evaluation of the laboratory's performance. Findings: 1. The proficiency test provider sends unknown samples to the laboratory for testing three times each year and provides the laboratory with an evaluation of their test performance including the result for each unknown sample. 2. The laboratory did not have the evaluation reports from the provider and the laboratory did not have documentation to show that the laboratory director reviewed the results returned from the provider for all three test events in 2023. 2. This was confirmed at 12:00 pm on April 11, 2024, during interview with testing person #1. 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 -- 2 of 4 -- 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 D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on standard operating procedure manual (SOPM), quality control (QC) and quality assurance (QA) record review and interview with the laboratory staff, the laboratory director (LD) failed to follow the established QA program to assure the quality of laboratory services provided and to identify failures in quality as they occur. Findings: 1. The procedure, "Quality Control Review and Approval" states, "On a monthly basis, the Laboratory Director/Technical Consultant will review all quality control documentation performed by the testing personnel. Upon review, the Laboratory Director/Technical Consultant will sign off and date the quality control review form designated for this purpose." 2. A review of "Rh Control Logs" from January through September, 2022 showed that the LD signed a "quality control review form" which states, "I have reviewed and approved the Rh Control log for (month reviewed)" for January through June, 2022. 3. There were no "quality control review forms" present at the time of the survey for July through September, 2022. 4. During an interview on 10/20/2022 at 12:30 PM the laboratory staff confirmed that the LD did not ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. 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 D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the immunohematology proficiency testing (PT) records, "Patient Lab Sheet" and interview with a testing person (TP), the laboratory failed to list the PT samples on the "Patient Lab Sheet" in the same manner as the patient specimens. Findings: 1. Review of the PT records for the Medical Laboratory Evaluation (MLE) event labeled 2020 MLE-M2 showed that the PT results were not integrated and recorded along with the patient workload on the "Patient Lab Sheet." 2. The "Patient Lab Sheet" requires the TP to record the results in the section labeled "RH FACTOR." This sections requires the TP to record the "TEST", "Cont. Alb.", and "Interp." The "Patient Lab Sheet" that was submitted on 09/10/2020 via email only had the PT "Interp" recorded. 3. When interviewed on 09/28/2020 the testing person confirmed that the PT results were not recorded in the same manner as the patients on the "Patient Lab Sheet." D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other 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 -- supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of the Rh [Rhesus factor] control logs and interview with the testing personnel, the laboratory failed to ensure that quality control (QC) materials used in the laboratory were not used after their expiration date. Findings: 1. Review of the laboratory's Rh control logs from December 2018 through February 2019 and November 2018 through March 2020 show the laboratory did not document the date that the new red blood cell control was put into use. 2. The records show that during the weeks of 12-03-2018, 12-31-2018, 01-28-2019, 02-25-2019, 11-04-2019, 12-02- 2019, 12-30-2019, 01-23-2020, 02-24-2020, and 03-23-2020 two lot numbers of red blood cell control were documented as being used. The date that the new lot was started was not recorded on the worksheet. 3. During the alternate survey on 09/28 /2020 at 1:39 PM the testing person confirmed that the laboratory records did not show when the laboratory switched to a new lot number and expiration date of the QC materials. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: I. Based on review of the "Potomac Family Planning Center" document and interview with a testing person, the laboratory director did not ensure that the section labeled "Test Comparison" was implemented. Findings: 1. The section labeled "Test Comparison" states, "Every six months, laboratory personnel(s) must evaluate procedures for obtaining a sample of blood from the patient when running Rh factor typing (proficiency testing samples can be used to determine results). It will be performed by venipuncture and lancet (finger stick). Results must be evaluated and compared to determine both methods to produce equal results." 2. When asked to review these records the testing person stated that the laboratory does not perform the "Test Comparison" procedure. 3. The "Test Comparison" procedure does not define acceptable results for the comparison and what to do when the results fail to meet the criteria for acceptability. 4. During the exit survey on 09/28/2020 at 1:39 PM the testing person confirmed that the laboratory did not inplement the "Test Comparison" procedure as part of their quality assurance plan. II. Based on review of the proficiency testing documentation and interview with a testing person, the laboratory director did not ensure that the testing personnel completed all the required information on the section labeled "RH FACTOR" of the "Patient Lab Sheet." Cross refer to Tag D2006 for details. -- 2 of 2 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on record review and interview, the lab did not test proficiency test samples in the same manner as patient samples. Findings: 1. The lab is enrolled in a proficiency testing program for the RH test that it performs on patient specimens. The proficiency test provider sends the lab five unknown samples three times a year. The lab tests the samples and submits them to the proficiency test provider for evaluation and the lab is notified if the pass or fail by numerical score; 2. The lab staff and the medical director sign an attestation statement to agree that the proficiency samples are tested in the same manner as patient samples; 3. During interview with staff on the day of survey, it was stated that a patient Rh test is performed by one testing person and unless a result is difficult to read a second or third staff member does not routinely perform a retest for a patient Rh test; 4. In 2017 four staff members tested all five RH samples for MLE event 3 (on 9/9/17) and during interview on the day of survey, staff stated that the results were compared and then reported to the proficiency test provider; three staff members tested all five RH samples for MLE event 2 (on 5/25/17) and during interview on the day of survey, staff stated that the results were compared and then reported to the proficiency test provider and three staff members tested all five RH samples for MLE event 1 (on 2/10/17) and during interview on the day of survey, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- staff stated that the results were compared and then reported to the proficiency test provider. 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)