Amg Ada Advanced Care Oncology And

Summary Statement of Deficiencies D5781

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to authorize PT data for Hematology events performed with the American Proficiency Institute (API) to be released to the Centers for Medicare and Medicaid Services (CMS) in calendar years 2022 and 2023. The findings include: 1. The Hematology PT records from API state "CLIA ID indicates results available to CMS." 2. All Hematology PT records performed with API in calendar years 2022 and 2023 stated the CLIA Number was "Not on file". 3. TP #2 as listed on the CMS-209 form confirmed the PT results performed with API were not being released to CMS. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview 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 -- with the Testing Personnel (TP), the laboratory failed to follow its policies and procedures for assessing the competency of Testing Personnel (TP) in calendar years 2022 and 2023. The findings include: 1. The laboratory CA policy stated: "Competency must be assessed: at least semiannually(first assessment within seven months from initiation of testing and second assessment no later than 12 months for the start of testing during the first year and individual tests patient specimen (new employee)." " At least annually after an individual has performed assigned duties for one year." 2. TP #6 as listed on the CMS-209 form, had a competency assessment form that did not have any competency areas marked as met or not met. The form was signed by the evaluator and employee and the employee was marked as competent. 3. Three out of Six TP did not have a semiannual CA performed after initial their training. 4. Two of of Six TP did not have a CA performed in 2023. 5. TP #2 as listed on the CMS-209 form confirmed on 2/14/24 at 11:00 am, the laboratory failed to follow its policies and procedures for assessing the competency of TP. 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 surveyor review of the Proficiency Testing (PT) records and interview with Testing Personnel (TP), the laboratory failed to document the evaluation of all unacceptable scores and

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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the Laboratory Director failed to sign attestation statements for Hematology/Coagulation 1st event 2022, all events 2021 and 2nd, 3rd events 2020 with the American Proficiency Institute (API). The TP confirmed on 7/14 /22 at 10:00 am that PT records were not maintained. 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. 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 -- 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-500 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 7/14/2022 at 11:00 am that the all QC records were not retained. 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), Operators Manual (OM) and interview with the Testing Personnel (TP), the laboratory failed to have all procedures written for Hematology tests performed in on the Sysmex XN-550 analyzer from 2/4/2022 to the date of the survey. The findings include: 1. The PM stated "Complete this section with your Laboratory policy for documenting and retaining commercial controls and X=barM data" 2. The laboratory had two policies on Quality Control verification. 3. The PM states "Follow laboratory protocol for troubleshooting Quality Control results exceeding the upper or lower limit of acceptability. Complete this section with you laboratory's QC action plan for out of range commercial control products and X-barM" 4. On page 26 the PM states "refer to the Sysmex XN-L series automated hematology systems flagging interpretation guild for additional information on flagging". a. The laboratory did not have the aforementioned guild. 5. The TP confirmed on 7/14/22 at 10:30 am that the laboratory did not have all procedures written for Hematology tests. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of Quality Control (QC) material in use, Manufacture Package Insert (MPI) and interview with the testing Personnel (TP), the laboratory failed to put expiration dates on QC material for Hematology tests run on the Sysmex XN-550 analyzer at the time of survey. The TP confirmed on 7/14/22 at 11:45 am the laboratory failed to put expiration dates on the control material. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the -- 2 of 5 -- 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 7/14/22 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: a. Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to follow the procedure to verify new lot numbers of Quality Control (QC) used in Hematology tests at the time of the survey. The finding includes: 1. The PM stated new lots of QC will be run "once before using" use but there was no documented evidence any QC lots were run before use. 2. The TP #1 listed on CMS form 209 confirmed 2/4/20 at 11:30 am that the laboratory did not follow the PM. b. Based on surveyor review of the PM, patient Work Records (WR) and interview with the TP, the laboratory failed to follow the PM for "Abnormal, WBC abn Scattergram" for Hematology tests run on the Sysmex XN550 from June 2019 to the time of survey. The finding includes: 1. The laboratory did not have a its own policy to review flags but used the PM. 2. The PM stated " * Verify WBC differential and PLT results according to your laboratory policy" but a review of patient WR revealed instrument flags as below: a. Hgb critical: Repeat b. WBC critical: Repeat c. Comment "FLAG in LIS" d. Reflex to low WBC mode e. PLT IP Message 3. There was no documented evidence samples were repeated, scanned or run in "low WBC mode" for ten of ten samples with flags reviewed. 4. The TP #1 confirmed on 2/4/20 at 11:05 am the above mentioned procedures were not followed. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 -- 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)