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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 and interview with the technical supervisor (TS), the laboratory's procedures did not include instructions for the most current labeling practices employed for general immunology specimens. Findings: 1. Patient specimens stored in the refrigerator for general immunology testing were labeled with a green sticker. 2. The TS explained that all the general immunology specimens were labeled with the green sticker to ensure that if additional testing was performed on the specimens, for example chemistry, the personnel would be sure to store the specimen for general immunology testing. 3. During the survey on 10/09/2024 at 2:00 PM, the TS confirmed that although the labeling procedure for immunology specimens was written up as a

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the manufacturer's product insert, patient worksheets, and interview with the technical consultant (TC), the laboratory failed to follow the manufacturer's instructions for testing general immunology specimens within the required 14 days of collection. Findings: 1. The manufacturer's product insert for the "Thera Test Labs Innovations in Immunoassays" for "EL-ANA Profiles" states "Serum samples may be stored at 2-8C [degrees Celsius] for up to 14 days prior to testing." 2. The patient worksheets were reviewed. On 04/27/2021 a specimen was collected and the serum was stored at 2-8C until 05/05/2021 when it was tested. The documentation included some questions about the validity of the test result and the specimen was stored at 2-8C until it was retested on 05/13/2021. The specimen was tested and the results released 19 days after collection. 3. During the survey on 02/08 /2023 at 12:30 PM, the TC confirmed that the specimen was tested and the results released after the 14 day limit required by the manufacturer and there were no procedures in effect to ensure that a specimen that needed to be retested was not held and retested past the 14 day limit. 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 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 -- 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 patients' final reports and interview with the technical consultant (TC), the laboratory failed to ensure that the final test report listed the date the test was performed. Findings: 1. The TC explained that some of the immunology and chemistry specimens that are collected are batched and the testing is performed up to 14 days after collection. 2. During the survey patient results were pulled from the electronic medical record (EMR) to review the final report with the patients test results. Review of the reports showed that the final report failed to include the date that the testing was performed for immunology and chemistry specimens not tested on the day of collection. 3. During the exit interview on 02/08/2023 at 12:30 PM, the TC confirmed that the final report failed to include the date that the testing was performed for immunology and chemistry specimens not tested on the day of collection. -- 2 of 2 --

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 proficiency testing records and interview with the technical consultant (TC), the laboratory did not have all proficiency testing (PT) attestations signed by the laboratory director and the testing person. Findings: 1. The testing person nor the laboratory director signed the PT attestations for hematology and chemistry testing during the year 2017. 2. The laboratory submitted all three events for each speciality of patient testing during the year 2017 without signed attestations. 3. The TC stated that she begin overseeing the laboratory testing during the month of November 2017 and was not aware that 2017 PT attestations did not have the required signatures prior to submitting results. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 the chemistry quality control (QC) and interview with the technical consultant (TC), the laboratory did not maintain all printed chemistry QC reports during the year 2017. Findings: 1. The laboratory did not keep the analyzer printed copies of the chemistry QC when the QC was out of range. 2. The laboratory kept only the repeated QC that was in range and without errors. 3. On dates November 13th, May 25th, and May 24th during the year 2017 chemistry QC was out of range and repeated by the testing person. 4. The TC stated that she was not aware that all printed analyzer copies of QC needed to be kept when QC was out of range or when errors were reported. D5781