J Richard Lilly Md Abfp Chartered

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of the standard operating procedures (SOP) and interview with the technical consultant (TC), the laboratory failed to ensure that rapid plasma reagin (RPR) analytic system records were maintained for at least two years. Findings: 1. According to the TC, a pending list is printed on Friday for RPR testing. Each patient is given a new identification number (ID#) that corresponds with one of the 10 circle positions on the RPR card where the testing is performed. The results are entered into the computer and the pending list with the new ID# is discarded. 2 During the survey on 10/11/2024 at 2:00 PM, the TC confirmed the laboratory did not maintain the original RPR pending list with the new specimen ID# that corresponds with the circle position on the RPR testing card for the required 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 the quality assurance (QA) program procedure, review of proficiency testing (PT) records, and interview with the technical consultant (TC), the laboratory failed to ensure that PT results evaluations were reviewed by the laboratory 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 -- director (LD) in 14 of 14 PT modules. Findings: 1. The QA program procedure stated that "All proficiency testing results are reviewed by the laboratory director." 2. The laboratory received six different PT modules. Records for 2023 and 2024 were reviewed for a total of 17 PT events. Of the 17 PT events, 3 PT events did not have the results evaluations available yet. 3. Of the 14 remaining PT events, 2 PT events (Immunology 2024 1st and 2nd events) had no results evaluations printed for review and the remaining 12 PT events had the results evaluations printed, but they were not signed or dated by the LD indicating that the results had been reviewed. 4. During the exit interview on 10/11/2024 at 2:00 PM, the TC confirmed that 14 of 14 of the available PT results evaluations were not reviewed by the LD. 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 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: A. Based on review of the written procedure manual and interview with the testing person, the afternoon of the day of survey, the laboratory did not have a written procedure for direct use of the TAXO A disk on initial inoculation of a throat swab to perform throat culture testing. Findings: 1. The written throat culture procedure instructs the laboratory to subculture throat cultures and then perform TAXO A disk testing on the subculture, but the laboratory was performing throat culture testing by placing the TAXO A disk directly on an initial inoculation (from throat swab) of strep selective agar (direct throat culture test). 2. The laboratory did not have a written procedure for direct throat culture testing and this was confirmed by interview with the testing person. B. Based on review of the written procedure manual and interview with the testing person, the afternoon of the day of survey, the laboratory did not follow written procedures to receive Uricult test media for bacteriology testing. Findings: 1. The written laboratory procedure states that the laboratory checks each shipment of Uricult media for contamination and substandard media and also maintain a copy of the manufacturer's quality control testing results for the lot(s) of media received. The laboratory did not document the condition of each shipment of Uricult media received and did not keep the manufacturer's quality control testing report for each lot received. 2. This was confirmed with the testing person during interview. C. Based on observation and interview with the testing person the afternoon of the day of survey, the laboratory did not have an approved written procedure for testing performed on the TOSOH chemistry analyzer. Findings: 1. The laboratory did not 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 -- have a written procedure approved by the laboratory director to perform chemistry testing on the TOSOH chemistry analyzer. 2. The laboratory was using the manufactures instruction manual as the written procedure, this manual was not reviewed and approved and dated by the laboratory director and was not reviewed to ensure that it was specific in describing activities performed by the laboratory, such as storage of patient samples prior to testing, labeling and separation of serum or plasma from samples prior to testing, if applicable. 3. The laboratory did not have copies of the manufacturer instructions for each test performed using the TOSOH. These reagent instructions may be used as part of the written procedure, provided they are reviewed and approved and dated by the laboratory director to show when they were palced in use and date of discontinuence if needed. D. Based on review of the laboratory written procedure manual, and interview with the testing person on the afternoon of the day of survey, the laboratory did not have a wrtitten procedure to test proficiency testing samples like a patient specimen. Findings: 1. The written procedures did not state that proficiency test samples must be tested the same number of times a patient sample is tested, and repeat testing may only be performed if the proficiency test sample meets the same requirements to test a patient specimen. 2. This was confirmed during interview with the testing person. D5781

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on calibration record review and interview with the technical consultant (TC), the laboratory did not retain calibration records for the hematology analyzer for at least 2 years. Findings: 1. Calibration verification record review showed documentation that the Medonic M-Series hematology analyzer had been calibrated on 3/30/2020 and 1/21/2021. Calibration verification must be performed every 6 months. 2. In an email from 6/11/21 the TC stated, ""Medonic calibration: I did very regularly CBC calibration for Medonic. I think I misplaced couple calibration paper." 3. During an interview on 7/16/2021 at 1:00 PM, the TC confirmed that the laboratory did not retain calibration records for at least 2 years. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Note: This is a repeat deficiency. The laboratory was cited during the re-certification survey on 8/29/2018 for not ensuring that the date and time that specimens are received into the laboratory is documented. The

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on record review and interview with laboratory (lab) staff, the lab did not check the CRP test for accuracy (proficiency check) at least two times each year. Findings: 1. The lab performs CRP testing but is not checking the accuracy of the CRP test at least two times a year; 2. This was confirmed during interview with lab staff at 3:00 pm on the day of survey. 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 and interview with laboratory (lab) staff, the lab did not rotate proficiency testing duties among all testing personnel performing lab testing. Findings: 1. Testing person A is independently testing patient samples and reporting their test results for complete blood counts (CBC); 2. The proficiency test provider ships three separate challenges each year for the lab to test and report to the provider to evaluate for accuracy; 3. The proficiency test provider records include attestation statements for the testing person to sign and date to identify their responsibility for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- performing proficiency tests in the same manner as patient specimens; 4. The surveyor was informed by lab staff during interview on the afternoon of the day of survey, that testing person A was testing patient samples for CBC and was not rotated through proficiency testing challenges; and 5. The attestation records for the first and second event of 2018 identify testing person B as person responsible for performing proficiency tests for CBC challenges, even though testing person A was also trained and responsible for performing patient CBC tests. 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 and interview with lab staff, the lab did not document that blood lead quality control testing was performed on 5/13/18, 12/20/17, 9/3/17 and 7/1 /17 for either of the two quality control reagents. Findings: 1. Under the Code of Maryland Regulations 10.10.06.05 Quality Control - General. A. Primary Standard. A licensee operating under a permit shall ensure that the laboratory establishes and follows written quality control procedures for monitoring and evaluating the quality of the analytic phase of the testing process for each testing method and procedure to assure the accuracy and reliability of patient test results and reports; 2. The lab reports the results of the two levels of quality control reagent on the "Lead Testing System Data Sheet"; 3. During interview at 2:00 pm on the day of survey, staff stated that quality control tests are performed each day of patient testing; and 4. The results of the two levels of quality control tests were not reported on the "Lead Testing System Data Sheet" on 5/13/18, 12/20/17, 9/3/17 and 7/1/17. 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 record review and interview with laboratory (lab) staff, the lab did not have documentation that testing person A was provided chemical hygiene and biological hazard training. Findings: 1. Testing person A is performing laboratory tests as stated by staff during interview in the afternoon on the day of survey and that chemical hygiene and biological hazard training was not documented; and 2. There was no record that this training was conducted. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: -- 2 of 8 -- Based on record review and interview with laboratory (lab) staff, the lab did not report the date and time specimens are received in the lab. Findings: 1. The final report did not include the date and time the patient specimen was received by the lab for ten of ten final reports reviewed, since the lab receives specimens from other offsite offices within the practice, as reported by staff during interview (at 1:00 pm) on the day of survey, the date of receipt is important to determine acceptability of a patient sample and ensure tests were not performed on specimens that were too old, improperly stored and of substandard quality; and 2. There is a place to report the received date and time on the final report, but the data was missing. 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)