Howard University Center For Sickle Cell Disease

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation of sample transportation coolers outside of the lab on the day of the survey 12/17/24 at 12:00 PM, review of the written procedure, and interview with the testing person (TP), the lab failed to validate coolers that transported Sickle Cell patient specimens. Findings: 1. The lab did not validate the four sample transportation coolers for temperature and optimal sample disposition when Sickle Cell samples were collected during the hospital blood drive once a month and transported to the lab for testing. 2. The TP stated on the day of the survey 12/17/24 at 12:00 PM that they have plastic and Styrofoam coolers that they give hospital personnel to transport Sickle Cell patient samples once they are collected during the blood drive once a month for testing in the lab. 3. The TP confirmed on the day of the survey 12/17/24 at 12:00 PM that the lab failed to validate the coolers that transported Sickle Cell patient specimens. 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, the laboratory did not follow safety precautions to ensure that staff were not exposed to chemical and biohazard materials. Findings: 1. Inside the laboratory where patient testing was performed, staff kept food items and utensils used for eating. These items included: a) Napkins, plastic ware, silverware, a pot with water and a ceramic teapot; b) One microwave oven that was not labeled for laboratory use only; and c) Tea bags. 2. There was no signage stating that eating, drinking or application of cosmetics was prohibited in the laboratory. 3. The laboratory was cluttered with empty plastic jugs and the interior of the fume hood was also cluttered and contained a large Erlenmeyer flask with cloudy crystals on the bottom (no identifying information was on the flask), a charger cord, an exposed electrical box sitting out in the open, file folders, empty plastic boxes and cardboard boxes. D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: 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 -- Based on observation and interview, paper records were not securely stored to prevent tampering or unauthorized access by individuals not on staff. Findings; 1. Patient records were stored in an unlocked file cabinet in an entry room that was between a common passageway and the laboratory. On the day of survey, the door to this entry room was propped open with a box and the file cabinet containing patient records was not locked; as the surveyor was able to open each drawer and pull out patient records; and 2. The laboratory did not ensure that patient test records were securely stored to protect privacy and this was confirmed during interview with the laboratory director on the afternoon of the day of survey. D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on review of instrument printouts and interview with the testing person (TP), the laboratory (lab) failed to retain patient final reports from each day Sickle Cell testing was performed. Findings: 1. Review of the analyzer printouts from August 2022-September 2022 showed that the lab did not retain the patient final test reports. 2. The TP stated that once the results are reported the final reports are locked in the General Supervisors office. 3. The lab was unable to retrieve copies of the final reports on the day of the survey. 4. The TP confirmed that patient final reports were not available on the day of the survey at 2:00 PM. 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish 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 the written procedure manual and interview with the testing person, the laboratory did not perform annual competency assessments for the technical supervisor (TS) and the general supervisor (GS) when performing hematology testing. Findings: Repeat deficiency 1. The laboratory "annual review general supervisor and technical supervisor" sheet was presigned with the signature of the laboratory director and dated 10/08/2018. 2. Competency procedures for sickle cell disease testing were not performed for the years 2019 and 2020 for the GS and the TS. 3. The testing person confirmed that annual competency procedures were not performed for the GS and TS. 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) 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 -- 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the review of the laboratory's policies and procedures manual and confirmation by interview with Testing Personnel, the laboratory failed to establish written procedures for assessing the competency of the Technical Supervisor and the General Supervisor. Findings include: 1. Review of the laboratory's policies and procedures manual failed to provide a written procedure for assessing the General Supervisor and the Technical Supervisor. 2. Interview with the Testing Personnel on 9 /20/18 at approximately 2:30 PM, the laboratory did not have written procedures for assessing the competency of the General Supervisor and the Technical Supervisor. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on the review of the laboratory's policies and procedures and confirmation by LD and the laboratory staff on September 20, 2018 at approximately 11:45 AM. The current Laboratory Director (LD) failed to approve, sign and date the laboratory's policies and procedures for one (1) of the one (1) laboratory test procedure used to 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 -- screen for hemoglobinopathy (High Performance Liquid Chromatography). The findings included: 1. Review of the laboratory's procedure and quality Assurance manual for the High Performance Liquid Chromatography (HPLC) procedure revealed that the procedure was last reviewed and signed on 9/1/2016. It should be noted that the LD that signed the procedure on 9/1/2016 was replaced by another director on 11/1/2016 who was again replaced by the current director on 5/31/2017. There was no documentation that the current director or the director who was on board on 11/1/2016 had approved and singed the procedure. 2. 2. Interview with the current LD and the laboratory staff on 9/20/18 at approximately 12:00 Noon confirmed the lack of signature by the current laboratory director. It should be further noted that this is a repeat deficiency from the 8/22/2016 recertification survey. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the review of records (pipette maintenance and the laboratory's policies and procedures) and interview with the Testing Personnel, the laboratory failed to develop a maintenance protocol that specify the frequency of pipette calibration. The findings included: 1. Review of the laboratory's procedure revealed a protocol for performing pipette calibration. However, the protocol did not specify how often each pipette should be calibrated. 2. Review of pipette maintenance performed by an outside pipette servicing company revealed that the pipettes have been calibrated every two (2) years the last calibration was done on 9/6/18. 3. Review of the manual pipette calibration log revealed that the staff calibrated the pipettes on 7/16/18 and 8/16/18. 4. Interview with the Testing Personnel on 9/20/18 at approximately 3:00 PM confirmed that the laboratory's procedure for calibrating pipettes did not include information indicating how often each pipette should be calibrated. -- 2 of 2 --