Bel Air Oncology Center

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the competency assessment of the technical consultant (TC) and interview with the TC, the laboratory director did not ensure that the competency assessment for the TC had been completed for 2022. Findings: 1. Review of the competency records for the TC showed that the worksheet for 2022 was missing. 2. During the survey on 02/29/2024 at 12:15 PM the TC confirmed that the evaluation of the TC for 2023 was not available at the time of the survey. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of the quality control (QC) lot number documentation, "QC Problem 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 -- and Observation Chart'', and interview with the technical consultant (TC), the TC did not ensure that the testing personnel (TP) were documenting the correct start dates for the QC materials and that all QC activity worksheets were maintained. Findings: 1. The QC records for April 2023 showed that the new lot of QC materials were opened on 04/14/2023 and started on 04/10/23; July 2023 showed that the new lot of QC materials were dated/opened 07/27/23 and were put into use on 07/03/23; and October 2023 showed that the new lot of QC materials was opened 10/04/23 but may have been put into use on 09/29/23. 2. According to the TC, the QC materials are good for more than three months. The QC materials are to be put into use every three months at the beginning of the month even if the expiration date is in the middle of the month. 3. The activity worksheets for documenting unacceptable QC results,"QC Problem and Observation Chart", were not available for the months of August and December 2023. 4. During the survey on 02/29/2024 at 12:15 PM the TC confirmed that the she/he was not verifying that the TP's were documenting accurate open and start dates for the QC materials and that the "QC Problem and Observation Chart" were missing for months of August and December in 2023. -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and interview with the technical consultant (TC), the laboratory failed to document performance of monthly preventive maintenance on the hematology analyzer for six of 18 months reviewed. Findings: 1. The laboratory documented routine preventive maintenance on a monthly form that included daily and monthly activities. 2. Monthly maintenance forms were reviewed from 01/2021-06 /2022 for a total of 18 months. 3. Six of the 18 months of maintenance forms reviewed did not include documentation of the monthly maintenance activity (03/2022, 02 /2022, 12/2021, 11/2021, 08/2021 and 07/2021). 4. During the survey on 07/28/2022 at 4:30 pm, the TC confirmed that monthly maintenance was not documented on the monthly instrument maintenance forms for six of 18 months. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the technical consultant (TC), the TC failed to ensure that competency evaluations were performed annually 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 -- for all testing personnel (TP). Findings: 1. The Laboratory Personnel Report, form CMS-209, listed ten TP. 2. Of the ten TP listed on form CMS-209, TP #8 and TP #10 were missing competency evaluations for 2021. 3. During the survey on 07/28/2022 at 4:20 pm, the TC confirmed that TP #8 and TP #10 were missing competency evaluations for 2021. -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of maintenance records and interview with the technical consultant (TC), the laboratory did not maintain all records when service was performed on the hematology analyzer. Findings: 1. The laboratory did not have written documentation of analyzer problems nor the completed service reports technicians completed when on site. 2. The hematology analyzer was serviced during the month of March 2018 for issues with the motor. The manufacturer analyzer technician replaced the motor during this time. The laboratory did not maintain a copy of the written service report. 3. The hematology analyzer was serviced during the month of March 2018 for issues with the lamp. The analyzer consultant replaced the bulb during this time. The laboratory did not maintain a copy of the written service report. 4. The TC confirmed that all maintenance records were not available. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. 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 2 -- Based on review of laboratory records and interview with the technical consultant (TC), the laboratory did not ensure that analytic processes were maintained for the overall quality of laboratory testing. Findings: 1. The lab name on federal licensure is "Bel Air Oncology Center". 2. During the time of the survey the laboratory had five different names documented on laboratory records and identification of the name error was not discovered and corrected to ensure the overall quality of laboraotry testing. 3. The name of the lab printed on five patient final reports was "MedStar Oncology Center at Belair". 4. The name of the lab printed on calibration records from June 12, 2019 was "Medstar Georgetown Cancer Institute. 5. The name of the lab printed on proficiency testing records for the years 2018 and 2019 was "Franklin Square Oncology Center" 6. The name of the lab printed on quality control records from the year 2018 was "Medstar Oncology Center at Belair" 7. The name of the lab printed on calibration and verification documents from June 2018 was "Medstar Belair Oncology" 8. The TC stated that she was not aware that the lab had that many names on various lab documents throughout the lab. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the patient final report and interview with the technical consultant (TC), the laboratory did not ensure that the name of the lab where testing was performed printed on the final report. Findings: 1. The lab name on federal licensure is "Bel Air Oncology Center". 2. The name of the lab printed on five patient final reports was "MedStar Oncology Center at Belair". 3. The TC stated that she was not aware that the name on patient final reports were different than the name of the license. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on review of maintenance records and interview with the technical consultant (TC), the TC failed to ensure that all maintenance records were available when service was performed on the hematology analyzer. Findings: Refer to D5429 -- 2 of 2 --

Summary Statement of Deficiencies 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)