Chesapeake Oncology Hematology Assoc

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory's technical consultant, the laboratory did not record daily temperature readings for two of three refrigerators in use. Findings: 1. One of the three refrigerators used by the laboratory is located within the laboratory and two other refrigerators are located in a room outside of the laboratory. The laboratory did not document the daily temperatures (taken each day of patient testing) for the two refrigerators that were located outside of the laboratory. 2. Review of the monthly temperature and humidity logs from December 2024 to June 2025 showed that the laboratory documented the temperature reading of the refrigerator located within the laboratory, but the temperature readings of the other two refrigerators were not recorded on the log. 1. During interview with the technical consultant on July 16, 2025 at 12:00 pm, it was confirmed that the temperature readings of the two refrigerators located outside of the laboratory, used for refrigerated storage by the laboratory, were not recorded each day of patient testing. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) 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 -- (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) 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 do the following: This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory preventive maintenance records were incomplete. Findings: 1. The laboratory documented daily, weekly and monthly preventive maintenance for the Medica chemistry analyzer on the daily cleaning and inspection log. Review of the log showed that the air filter cleaning (required monthly) was not dated or initialed as being performed for June thru November of 2024. 2. The laboratory documented daily, weekly and monthly preventive maintenance for the Tosoh chemistry analyzer on the TOSOH AIA Maintenance Schedule log. Review of twelve monthly logs from June 2024 to June 2025 showed that weekly maintenance was performed for only two of the four weeks in each month of August 2024, February 2025, and April 2025. 3. The laboratory documented monthly cleaning of the red cell and white cell transducer for the XP300 hematology analyzer on the monthly preventive maintenance log. Review of twelve logs showed that this was not performed or initialed for the months of June, April and January of 2025. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview, the lab did not have calibration documentation for the routine chemistry testing performed on the Medica. The calibration dates and records including data, calibration lot number and identification of testing staff could not be retrieved from the analyzer to show that calibrations were performed in a reliable and accurate manner. Findings: 1. The manufacturer requires different calibration intervals, depending on the analyte. For example: albumin requires calibration every sixty days, total bilirubin requires calibration every seven days and magnesium requires calibration every three days. 2. Records for previous calibrations performed in 2024 and 2025 were requested from the technical consultant on July 16, 2025, the records were not available and this was confirmed during interview with the technical consultant on July 16, 2023 at 11:30 am, the technical consultant stated that analyzer was calibrated as needed and every Monday, but was unable to provide -- 2 of 4 -- documentation showing that the calibrations were performed according to the performance standards for each test reagent. D5779

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 report for unsuccessful proficiency testing (PT) results and review of the performance evaluation report from American Proficiency Institute (API), the laboratory failed to successfully participate in the API PT program for routine chemistry testing, in which the laboratory is certified under CLIA (D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing 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 report for unsuccessful proficiency testing (PT) results and review of the comparative evaluation report from American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for the same analyte in two out of three consecutive testing events. Findings: 1. The laboratory received unacceptable results for the following routine chemistry analytes in two out of three PT events: a. Albumin i. 60% in the 2023 3rd PT Event ii. 40% in the 2024 2nd PT Event b. Total protein i. 60% in the 2023 3rd PT Event ii. 40% in the 2024 2nd PT Event c. BUN i. 60% in the 2023 3rd PT Event ii. 40% in the 2024 2nd PT Event 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 report for unsuccessful proficiency testing (PT) results and review of the comparative evaluation report from American Proficiency Institute (API), the laboratory director failed to ensure an approved

Summary Statement of Deficiencies D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to document the investigation into the root cause of and the remedial actions taken for unacceptable results for chemistry PT. Findings: 1. The laboratory's "Proficiency Testing" procedure stated "A FAILURE is any grade less than 80%. All Failures must be thoroughly investigated to determine cause and

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 proficiency testing (PT) record review and interview with the technical consultant (TC), the laboratory failed to ensure that the laboratory director (LD) and testing persons signed PT attestation statements, attesting that PT specimens were run in the same way as patient samples. Findings: 1. A review of chemistry PT records from 2018 showed that the LD did not sign the attestation statements for 2 out of 4 remedial PT events; and 2. The individuals performing PT failed to sign the attestation statements for 4 out of 4 remedial PT events. 3. During an interview on 5/28/19 at 2: 45 PM, the TC confirmed that the attestation statements were not signed by the LD of testing persons. 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 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 -- the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the technical consultant (TC), the laboratory did not ensure that a copy of all PT records were maintained for a minimum of two years from the date of the PT testing event. Findings: 1. A review of hematology PT records from 2018 to 2019 showed that the attestation form which documents that PT samples were tested in the same manner as patient specimens was not available for 3rd event, 2018. 3. During an interview on 5 /28/19 at 2:45 PM, the TC confirmed that PT documents for the events listed above were not maintained with the hematology PT records reviewed. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on quality assurance (QA) record review and interview with the technical consultant (TC), the laboratory did not ensure that QA records were maintained for at least 2 years. Findings: 1. A review of QA records from January, 2018 to April, 2019 showed that copies of the Levey-Jennings reports from hematology quality control were missing for 8 out of 16 months. 2. During an interview on 5/29/19 at 2:45 PM, the TC confirmed that hematology QA records were not maintained for a minimum of 2 years. 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 No Tags No deficiency details available. 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 --