Amg Ada Advanced Care Oncology &

Summary Statement of Deficiencies 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 surveyor review of the Proficiency Testing (PT) records, Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to ensure that all Testing Personnel (TP) who perform Hematology testing participated in the American Proficiency Institute (API) PT events for the 1st and 2nd events in the calendar year of 2022. The findings include: 1. The PM states "Analyze the survey specimen in the same manner as routine patients specimens. Testing should be performed by all qualified laboratory personnel and not restricted to individuals." 2. A review of PT attestation records showed that one TP performed the 1st and 2nd Hematology PT events of 2022. 3. TP#1 as listed on the CMS-209 form confirmed on 2/27/24 at 11:45 am that the laboratory failed to rotate all TP to participate for Hematology API PT events in 2022. 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: 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 surveyor review of the Procedure Manual (PM), New lot reagent logs and interview with the Testing Personnel (TP), the laboratory failed to follow the procedure for "Reagent Replacement" from 10/10/22 to 2/27/24. The findings include: 1. The PM states " New lots of reagents must be verified against the old reagent using Quality Control (QC) material and at least one patient run on the previous lot of the reagent." 2. There was no documented evidence the procedure was performed for all new lot reagents for the Sysmex XN 550 analyzer used in Hematology testing in the aforementioned timeframe. 3. TP #1 as listed on the CMS-209 form confirmed on 2/27 /24 at 12:00 pm, the laboratory failed to follow the PM. D5783

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 surveyor review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to retain all QC records for tests performed on the Sysmex XP-550 analyzer from 2/4/22 to the date of survey. The finding includes: 1. There was no record of QC past March 2022. 2. The TP confirmed on 7/27/2022 at 11:00 am that the all QC records were not retained. 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 surveyor observation of the Sysmex Hematology Control for Sysmex XN-L Analyzers Manufacturers Package Insert (MPI) and Control Values (CV) in the Sysmex XN-550 Analyzer interview with the Testing Personnel (TP), the laboratory failed to follow MPI for control values at the date of survey. The findings include: 1) MPI for XN-L QC Lot 2154140 had CV as follows: a. Level 1: Mean Corpuscular Volume (MCV) 67.5-76.1 FL b. Level 2: Red Blood Cell (RBC) 4.22 - 4.57 106/uL, 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 -- Mean Corpuscular Hemoglobin (MCH) 27.9 - 32.1 pg, Mean Corpuscular Hemoglobin Concentration (MCHC) 32.9 - 39.1 g/dL. c. Level 3: RBC count 5.11 - 5.53 106/uL, MCV 81 - 91.3 FL, Red blood cell Distribution Width-CV (RDW-CV) 14.0 -15.1 %. 2) CV in the Sysmex XN-550 Analyzer was as follows: a. Level l : MCV 68.7 - 74.9 FL b. Level 2: RBC 4.21 - 4.59 106/uL, MCH 28.7 - 31.3 pg, MCHC 32.6 - 39.1 g/dL c. Level 3: RBC 5.09 - 5.55 106/uL, MCV 82.7 - 89.7 FL, RDW-CV 13.8 - 15.2 % 3) The TP confirmed on 7/27/22 at 10:30 am the MPI was not followed. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of the Sysmex Certificate of Calibrations (COC) and interview with the Testing Personnel (TP), the laboratory failed to perform calibration verification every 6 months on the Sysmex XN-550 analyzer used for Hematology testing. The findings include: 1.There was no documentation of the number, type and concentration of the materials used for performing Calibration Verification (CV). 2. The COC did not provide lot numbers of calibration material used for CV. 3. The TP confirmed on 7/27/22 at 10:00 am that the laboratory failed to perform CV every 6 months. D5779

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: Based on surveyor review of the Procedure Manual (PM), Patient work records and interview with the Testing Personnel (TP), the laboratory failed to follow their PM policy for "Act Diff #2 Flags and Codes" for Hematology tests ran on the Beckman Coulter AcT diff 2 from September 2019 to the date of survey. The finding includes: 1) The PM stated "X flag indicates that one of the multiple Alert criteria was not met. 1. Thoroughly mix and rerun the sample. 2. If the flag does not repeat report result. 3. If flag repeats, clean the aperture as instructed in zapping the aperture. 4. if after cleaning, problem persists contact your Beckman Coulter Representative". a) Patient number 0821 run on 11/20/19 with "X" flaged results was not rerun. 2) The PM stated "- - - - flag indicates Total Voteout. Replaces result when: Two of the three count periods did not agree. or For WBC and RBC, the first count period. 1. Thoroughly mix and rerun the sample. 2. If the voteout repeats, zap apertures 3. Thoroughly mix and rerun the sample. 4. If the voteout repeats, run a previously run sample with known values. 5. If the voteout repeats, clean the baths according to Cleaning (Bleaching) the Baths in this chapter. 6. Thoroughly mix and rerun the sample. 7. If the voteout repeats, call your Beckman Coulter Representative. ". b) Patient numbers 6708 run on 1/2/20, and 4570 run on 1/8/20 with "- - - -" flagged results were not rerun. 2) The TP #1 confirmed on 1/29/20 at 11:05 am the above mentioned procedures were not followed. D5403 PROCEDURE MANUAL Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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)