Medstar Shah Medical Group Philip J Bean Med Ctr

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on record review and interview with technical consultant #1 (TC #1), the TC failed to perform and document the competency reviews on all testing personnel (TP). Findings: 1. The laboratory currently has three TP listed on the "Laboratory Personnel Report (CLIA)" (CMS-209). 2. The TC documents each TP ' s competency assessment on the "Training Competency Assessment Criteria" form. The form lists 12 "Performance Criteria" which the TC used to evaluate the TP. The TC writes a check mark in the box below "Meets" or "Does Not Meet" to document the TP ' s competency in the different departments/testing areas of the laboratory, then signs and records the date that the TP was evaluated. 3. A review of competency assessment records from 2024 through 2025 showed that there were a total of nine "Training Competency Assessment Criteria" forms for moderate complexity testing performed by TP #3. TP #3 ' s initial training for "Throat Culture" was documented on 10/11 /2023, and their "6 month" competency assessment was performed on 05/13/2024. The most recent competency assessment was dated 06/06/2025, which was 16 days after the date of the onsite survey. All 12 of the performance criteria were checked "Meets" for each assessment date and signed by TC #1. 4. The competency assessment for TP #3 included additional "Training Competency Assessment Criteria" forms for "Urine Culture," "Dimension EXL," "Sysmex XN 550," "Urine/Serum Pregnancy," "Mono Test - One Step," "Urine Microscopy," "CA 500," and "ESR - Erythrocyte Sedimentation Rate." 5. Record review showed that eight of eight forms were dated and signed by TC #1 for initial training, the six month assessment, and the 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 -- most recent assessment (06/06/2025), however the forms were not filled out to document whether the TP met or did not meet the performance criteria. 6. During the survey on 05/21/2025 at 2:15 PM TC #1 confirmed that there was no documentation that competency assessments had been performed on TP #3. -- 2 of 2 --

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of proficiency test records and interview with the laboratory technical consultant the laboratory did not document

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 proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to record the PT sample results on the patient log in the same manner as the patient specimens. Findings: 1. The PT records from 2019 through 2021 were reviewed for a total of 8 events. 2. The manual PT testing results were recorded on a blank piece of paper used as a worksheet. The results of the PT specimens were recorded with the PT sample identification number along with the positive or negative results. The worksheet did not include the date of testing for the PT results recorded. 3. During the survey on 9/20/2021 at 2:00 PM TC #1 confirmed that the PT samples were not being recorded on the patient worksheet logs in the same manner as the patient specimens. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory did not test the coagulation PT samples the same number of times as the patient samples were tested. Findings: 1. The PT records from the 2020 through 2021 for a total of five events were reviewed. 2. The records showed that each of the coagulation PT samples were tested twice during each of the five events reviewed. 3. During the survey on 9/20/2021 at 2:00 PM, TC #1 confirmed that the coagulation PT samples had been tested twice for comparison and that the patient samples were only tested once. 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 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from Medical Laboratory Evaluation (MLE) proficiency testing (PT) program, the laboratory failed to successfully participate in the MLE PT program for hematology testing, in which the laboratory is certified under CLIA. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from Medical Laboratory Evaluation (MLE) proficiency testing (PT) program, the laboratory failed to successfully participate in the MLE PT program for hematology testing, in which the laboratory is certified under CLIA. The following analyte was noted as failed in the 2019 second and third event. Findings: 1. Medical Laboratory Evaluation 2019 2nd event Cell I.D. or WBC Diff 76% 2. Medical Laboratory Evaluation 2019 3rd event Cell I.D. or WBC Diff 52% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from Medical Laboratory Evaluation (MLE) proficiency testing (PT) program, the laboratory director failed to ensure that the laboratory successfully participated in the MLE PT program for hematology testing, in which the laboratory is certified under CLIA. (Refer to D2130) D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the microbiology, hematology, and chemistry proficiency testing (PT) records and interview with the laboratory supervisor, the laboratory did not ensure that the PT records identified which testing person performed the tests in each discipline. Findings: 1. The PT records from 2017 and 2018 (6 events) were reviewed. 2. Each event included PT samples for the disciplines of microbiology, hematology, and chemistry. 3. The attestation worksheet for each event included the initials of 2-3 testing personnel. The worksheet failed to identify which specialty each of the testing personnel performed. 4. During the survey on 02/14/2019 at 2:45 PM the laboratory supervisor confirmed that the PT worksheets did not identify who performed the PT tests for each of the disciplines of microbiology, hematology, and chemistry. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection 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 -- from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation in the combined Microbiology/Coagulation laboratory and interview with the laboratory supervisor, the laboratory did not have an eyewash in the Microbiology/Coagulation laboratory where testing was being performed. Findings: 1. The laboratory is required to implement safety policies and procedures to ensure safety in the testing personnel. The Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA) provide guidelines for laboratory safety. 2. The area where the laboratory was performing microbiology and coagulation testing was toured during the survey. Observation of the room showed that there was no eyewash attached to the sink to aid in flushing out the eyes of the testing personnel if they were to have been splashed with any chemicals or specimens during testing. 3. During the survey on 02/14/2018 at 2:45 PM the laboratory supervisor confirmed that there was no eyewash station in the microbiology and coagulation laboratory where testing was being performed. 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 hematology patient summary records and interview with the laboratory supervisor, the laboratory did not ensure that post analytic system records, e.g., patient reports/results were maintained for at least 2 years. Findings: 1. Review of the hematology patient summary records showed that when an abnormal or critical value was repeated for verification the original result was overridden with the new result. The original and repeated results were not within the hematology analyzer system or the computer system. 2. During the exit interview at 2:45 PM the testing person confirmed that the laboratory's hematology analyzer and computer system did not maintain original results after an abnormal or critical value was repeated for confirmation. 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)