Amg Dba Atlantic Hematology/

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Laboratory Manager (LM), the laboratory failed to participate in the College of American Pathologists (CAP) PT for the 1st event of 2023 for Hematology tests. The findings include: 1. The laboratory failed to participate in the 1st event of 2023 for Hematology Auto Differentials. 2. The LM confirmed on 9/4/24 at 11:00 am that the laboratory did not participate in the 1st CAP event of 2023. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratories NJ State License, Proficiency Testing 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 -- (PT) and interview with the Laboratory Manager (LM), the laboratory failed to be in compliance with New Jersey Administrative code N.J.A.C. 8:44-2.5(b)3. for calendar years 2023 and 2024. The finding includes: 1. N.J.A.C. 8:44-2.5(b)3. states Laboratories shall: iii. Maintain records of all proficiency testing results in surveys in which they participate and make such records, including results, interpretations and cumulative performance data routinely available to the Department of Health and Senior Services. 2. The PT records for all PT events in 2023 and 2024 state the reports were only copied to Centers for Medicare and Medicaid Services (CMS) and not the Department of Health and Senior Services. 3. The LM confirmed on 9/4/24 at 11:30 am the laboratory failed to make PT for Hematology performance data routinely available to the Department of Health and Senior Services. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Laboratory Manager (LM), the Laboratory Director (LD) failed to ensure that PT samples were tested for Hematology Auto Differentials for the 1st event of 2023 from the College of American Pathologists (CAP). The findings include: 1. The laboratory failed to participate in the 1st event of 2023 for Hematology test from CAP. 2. The LM confirmed on 9/4/24 at 10:45 am that the LD failed to ensure PT samples for the 1st event of 2023 for Hematology Auto Differentials were tested. -- 2 of 2 --

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 Office Manager (OM), the laboratory failed to retain all QC records for tests performed on the Sysmex XN-L series analyzer from 10/15/19 to the date of survey. The finding includes: 1. The OM was unable to reveal current control values entered in the analyzer. 2. The OM confirmed on 8/4/2022 at 2:00 pm that all QC records could not be accessed. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Office Manager (OM), the laboratory failed to review and evaluate coded PT results obtained with the College of American Pathologists (CAP) in FH9-A and VPBS-A 2022. The findings include: 1. The laboratory did not evaluate Code 26 (educational challenge) for FH9-A 2022 Hematology Auto Differentials as below: a. IG %, samples FH9-1 thru FH9-5. b. IG % /Absolute, samples FH9-01 thru FH9-05. 2. The laboratory did not evaluate Code 26 (educational challenge) for VPBS-A 2022 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 -- Peripheral Blood Smear as below: a. Red Blood Cell Morphology, samples VPBS-01, 7 , 13 b. Platelet estimate, samples VPBS-1, 7 ,13 c. Blood Cell Identification, samples VPBS-02-06, VPBS-08 -18 3. The OM confirmed on 8/4/22 at 1:30 pm that the laboratory failed to evaluate coded results for PT events. Note: This was previously cited 10/15/19 D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on surveyor review of the Accession Log (AL) and interview with the Office Manager (OM), the laboratory failed to ensure that the laboratory accurately recorded the date and time specimens were received on ten out of ten AL entries reviewed. The OM confirmed on 8/4/22 at 12:20 pm that the laboratory did not ensure that specimen date and time was documented accurately. 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 Office Manager (OM) the laboratory failed to have a written procedure for Quality Control Verification (QCV) from 10/15/19 to the date of the survey. The OM confirmed on 8/4/22 at 1:30 pm that the laboratory did not have a written procedure for QVC. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) 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: -- 2 of 4 -- Based on surveyor review of Quality Control (QC) records and interview with the Office Manager (OM), the laboratory failed to verify commercial QC material with each new lot and/or shipment of QC used for Hematology tests performed on Sysmex XN-L series analyzer from 10/15/19 to the date of survey. The finding includes: 1. There was no documented evidence that QC was verified before being put into use. 2. The OM confirmed on 8/4/22 at 1:20 pm that the QC material was not verified before putting in use. D5779

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Office Manager (OM), the laboratory failed to review and evaluate coded PT results obtained with the College of American Pathologists (CAP) in 3-2018, 1-2019 and 2-2019 for Immature Granulocyte (IG). The findings include: 1. The laboratory did not evaluate Code 26 (educational challenge) as below: a. IG % /Absolute Number - A - 2018 event. Samples FH9-11 thru FH9-15. b. IG % /Absolute Number - A - 2019 event. Samples FH9-01 thru FH9-05. c. IG % /Absolute Number - B - 2019 event. Samples FH9-06 thru FH9-10. 2. The OM confirmed on 10/15/19 at 10:30 am that the laboratory failed to evaluate coded results for PT events. 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 Office Manager (OM), the laboratory failed to evaluate results when they received an unacceptable score in Hematology tests performed with the the College of American Pathologists (CAP) in event 3-2018. The findings include: 1. The laboratory received an "Unacceptable" result on sample FH9-11 Eosinophils % and sample FH9-14 Hemoglobin and Hematocrit. 2. There was no documented evidence 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 -- that the laboratory investigated the failures. 3. The OM confirmed on 10/15/19 at 10: 10 am that the laboratory did not perform and document an evaluation of unacceptable PT results. 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 Calibration Verification (CV) records and interview with the Office Manager (OM), the laboratory failed to perform and document CV procedures at least once every six months for Hematology Testing on the Sysmex XN550 analyzer in the calendar year 2019. The findings include: 1. The laboratory did not perform CV between 8/16/18 and 5/22/19. 2. The Certificate of Calibration issued from Sysmex stated Calibration Expiration date was 2/14/19 for the calibration performed on 8/6/18. 3. The laboratory performed approximately 50 Complete Blood Counts (CBC) per day from 2/14/19 to 5/22/19. 4. The OM confirmed on 10/15/19 at 11:30 am CV was not performed every six months. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Office Manager (OM), the Laboratory Director failed to establish a Competency Assessment (CA) procedure with the required elements for Hematology tests from 5/23/18 to the date of the survey. The OM confirmed on 10/15/19 at 10:40 am that a CA procedure was not established. -- 3 of 3 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Coordinator (CO), the laboratory failed to verify the accuracy of Hematology PT results obtained in event FH9 - C 2017 Comprehensive Hematology with Auto Differential from the College of American Pathologists (CAP). The findings include: 1. There was no evidence of the laboratory verified the accuracy of Hematology analytes when the laboratory received an exception code of 20 (no appropriate target /response cannot be graded on specimens FH9- 11-15 for: a. White Blood Cells (WBC) b. Red Blood Cells (RBC) c. Hematocrit d. Hemoglobin e. Platelets f. Lymphocytes, Monocytes, Eosinophils, Basophils - Absolute (#) and Percent (%) g. Absolute Neutrophil/Granulocyte - Absolute Count h. Mean Corpuscular Volume (MCV) i. Mean Corpuscular Hemoglobin (MCH) j. Mean Corpuscular Hemoglobin Concentration (MCHC) 2. There was no evidence of review when the laboratory received and exception code of 26 ( educational challenge) for Immature Granulocytes # and % on samples FH9-11 thru FH9-15. 3. The CO confirmed on 5/23 /18 at 10:40 am the accuracy of PT results were not verified D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by 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 4 -- 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), Quality Control Records (QC) and interview with the Coordinator (CO), the laboratory failed to follow their PM for Hematology Testing performed on the Sysmex XNL 550 from September 2017 to the date of the survey. The findings include: 1. The laboratory did not follow the PM as stated below: a. Sysmex calibration verification was required every six months but there was no documented evidence calibration was performed after 8/15 /17. b. New QC lots were to be verified against the old lot before using but there was no documented evidence QC lots were verified prior to use. c. There was no documented evidence QC was reviewed. d. There was no documented evidence QC was evaluated for shifts and trends monthly. e. Temperature charts were not reviewed monthly from October 2017 to the date of the survey. 2. The CO confirmed on 5/23 /18 at 11:40 am that the PM was not followed. 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)