Amg Hematology & Oncology

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 failed to maintain the Attestation Statements (AS) signed by the analyst and laboratory director for Hematology Cell Identification performed with the College of American Pathologists in the calendar year 2023 and first and second events for 2024. The findings include: 1. The laboratory did not document handling, processing and each step in the testing and reporting of PT samples for events below: a. Hematology Blood Cell ID, photographs- Event 1 ,2 and 3 for 2023 (TP) failed to sign the attestation statements b. Hematology Blood Cell ID, photographs- Event 1, and 2 (TP) failed to sign the attestation statements 2. The TP confirmed on 9/24/24 at 10:35 am that the laboratory did not maintain all records for PT. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 -- 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 laboratory records and interview with the Testing Personnel (TP), the laboratory failed to maintain the patient raw data from the Sysmex XN-430 used for hematology testing from 4/19/24 to the date of survey. The TP confirmed on 9/24/24 at 10:00 am that raw data containing results and data alarm flags were not maintained 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 the Testing Personnel (TP) the laboratory failed to review coded results for Hematology Testing performed with the College of American Pathologists (CAP) in the first and second events of 2024. The findings include:. The finding include: 1. The laboratory received a coded result (Code 26 -Educational Challenge) for Blood Cell ID ungraded for event BCP-A, adn BCP-B 2024 and . 2. There was no documented evidence that coded PT results were reviewed. 3. The TP confirmed on 9/24/24 at 10: 15 am that the laboratory did not review coded PT results. 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 the surveyor review of the Procedure Manual and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to establish a complete Quality Control (QC) plan from 4/19/23 to the date of the survey. The findings include: 1) The QC procedure did not define the frequency on when to review and generated levy Jennings charts. 2) The QC procedure did not define the which Sysmex BeyondCare Quality Monitor (BCQM) reports to be generated and reviewed. 3) The QC procedure did not define the frequency in which to review BCQM reports. 4) The QC procedure did not define parameters for acceptable QC results. 5) The QC procedure did not specify who will review QC. 6) The TP confirmed on 9/24/24 at 11:00 am that the LD failed to establish a complete QC program. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) -- 2 of 5 -- Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control Verification (QCV) records and interview with the Testing Peronnel (TP), the laboratory failed to verify QC material before use for Hematology tests run on the Sysmex XN-430 analyzer on the date of survey. The finding include. 1) There was no documented evidenced that the QCV was performed on XN-check controls lot # 41801400. 2) The TP confirmed 9/24/24 at 11:15 am that QC material was not verified before putting in use. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyors observation of Quality Control (QC) material in use and interview with the Testing Personnel (TP), the laboratory failed to follow Manufacturers Specifications (MS) for controls from 4/19/23 to the date of survey. The finding includes: 1. Controls in use did not have open or expiration dates documented as per MS. 2. The MS states "XN-L Check is stored at 2-8C before and after opening. The period of use is 12 weeks per lot, with an open vial stability of 15 days if stored at 2 - 8 C. The volume is 3.0 mL per vial." 2. The TP confirmed on 9/24/24 at 11:20 am that MS were not followed. D5779

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to retain graded results for Hematology auto differentials performed with the College of American Pathologists (CAP). The findings include: 1) There were no Graded results for Event FH-9C 2022, FH-9 A 2022, FH-9 B 2021. 2) The TP confirmed on 4/18/22 at 10:45 am that all PT graded results were not retained. 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 the Testing Personnel (TP) the laboratory failed to review coded results for Hematology Testing performed with the College of American Pathologists (CAP) in the Calendar year 2022 and the first event of 2023. The findings include:. The finding include: 1. The laboratory received a coded result (Code 26 -Educational Challenge) for Blood Cell ID Upgraded for all three PT events in 2022 and the first event of 2023. 2. There was no documented evidence that coded PT results were reviewed. 3. The TP confirmed on 4/19/23 at 10:15 pm that the laboratory did not review coded PT results. Note: This was previously cited. 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 -- D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (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 (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (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 surveyor review of Calibration (CAL) records, Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to perform and document Calibration procedures at least once every six months for Hematology Tests performed on the Sysmex XN-L 430 analyzer from 3/4/20 to the date of survey. The findings include: 1. A review of Cal records revealed that the laboratory last performed CAL 3/4/20. 2. The TP confirmed on 4/19/23 at 11:32 am that the laboratory failed to perform and document Cal once every six months. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records, Procedure Manual (PM) and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that the QC program was maintained for laboratory services provided from 8/31/22 to 12/6/22 to the date of the survey. The findings include: 1. The QC peer group review stated the laboratory had an "accuracy Bias code for Red Cell Distribution Width (RDW-CV)" 2. There was no documented

Summary Statement of Deficiencies 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: 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. Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to follow the Competency Assessment (CA) procedure to assess competency of three of twelve TP from 05/30/18 to the date of survey. The finding includes: 1. Three of the twelve TP were not assessed on " test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples" as required in the Competency Assessment procedure. 2. The TP # 2 listed on CMS form 209 confirmed on 3/11/21 at 1:00 pm that the laboratory did not follow the CA procedure. 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: All proficiency testing evaluation and verification activities must be documented. Based on surveyor review of Proficiency Testing (PT) results and interview with the 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 -- Testing Personnel ( TP), the laboratory failed to review coded results for Hematology Testing performed with the College of American Pathologists (CAP) in 2020. The findings include: 1. The laboratory received a coded result (Code 26 -Educational Challenge) for Immature Granulocytes (IG) Percentage and Absolute Number in event FH9-B and C for samples FH 9 (5-10 ) and (11- 15) respectively. 2. There was no documented evidence that coded PT results were reviewed. 3. The TP #2 listed on CMS form 209 confirmed on 3/11/21 at 1:15 pm that the laboratory did not review coded PT results. . 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) and interview with the Testing Personnel (TP), the laboratory failed to follow the procedure for reviewing results with flags obtained on the Sysmex XNL 430 analyzer used for Hematology testing from 5/30/18 to the date of the survey. The findings include: 1. The PM stated "What to do if indicators appear." "Send specimen to main hospital lab" * Review smear according to office" "+/- Criteria. Many labs out of range" 2. A review of ten patient results with indicators (*, +, -) revealed ten of ten had no documented evidence smears were made or any samples were sent to the hospital. 3. The TP # 2 listed on CMS form 209 confirmed on 3/11/21 at 1:40 pm that the laboratory did not follow the procedure for flag review. 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 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 an office review of the CASPER reports 153 and 155 and proficiency testing provider reports, the laboratory failed to achieve a score of at least 80% or more in two out of three events for White Cell Differential test with the College of American Pathologists. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% for White Cell Differential (WCD) test. The finding includes: The laboratory scored 0% in 3-17 and 60% in 2-18 for WCD PT events with the College of American Pathologists (CAP). 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 an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with the CLIA regulations are maintained. -- 2 of 2 --

Summary Statement of Deficiencies 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 the Testing Personnel (TP), the laboratory failed to evaluate results when the laboratory received an unacceptable score in PT for Hematology Auto Differentials, FH9 performed with the College of American Pathologists (CAP) in 2017. The finding includes: 1. There was no review or evaluation documented when the laboratory received an unacceptable result for BCP-05 RBC Agglutinates event A 2017. 2. The TP #6 on CMS form 209 confirmed on 5/30/18 at 11:00 am that the laboratory did not perform and document an evaluation of unacceptable PT performance. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the Testing Personnel (TP), the laboratory failed to have an accurate system in place to ensure test results are accurately reported for Hematology testing from 7/18/17 to the date of the survey. The finding includes: 1. The laboratory reported both Automated Differential and the Manual Differential (MD) results on all patients that had a MD test performed. 2. The TP #6 on CMS form 209 confirmed on 5/30/18 at 11:30 AM that the laboratory did not report results accurately. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files and interview with the Testing Personnel (TP), the Technical Consultant (TC) failed to ensure that a qualified professional performed Competency Assessment (CA) on six out of six Testing Personal (TP) in the calendar year 2017. The finding includes: 1. The TP had a high school diploma and was not qualified to perform CA. 2. The TP #6 on CMS form 209 confirmed on 5/30/18 at 12:00 pm that the TC did not perform CA. -- 2 of 2 --