Regional Cancer Care Associates At Holmdel

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on December 19, 2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 80% or more in two out of three events for Hematology for the analyte Hemoglobin (HGB), Neutrophils/Granulocytes 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 -- % (NEU/GRAN %), Neutrophils/Granulocytes Absolute (NEU/GRAN Absolute) , Monocytes % (MONO %) , Monocytes Absolute (MONO absolute) with the College Of American Pathologists (CAP). Cross refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) 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 review of the CASPER 155 report and graded results from College Of American Pathologists (CAP). The laboratory failed to achieve satisfactory performance (80% or greater) for two constitutive proficiency testing (PT) events in the subspecialty Hematology for the analytes Hemoglobin (HGB), Neutrophils /Granulocytes % (NEU/GRAN %), Neutrophils/Granulocytes Absolute (NEU/GRAN Absolute) , Monocytes % (MONO %) , Monocytes Absolute (MONO absolute) resulting in initial unsuccessful performance. The findings include: 1) A review of the CASPER 155 report revealed the following. a) The laboratory scored 0% for HGB in event 2-2025. b) The laboratory scored 0% for NEU/GRAN % in event 2-2025. c) The laboratory scored 0% for NEU/GRAN Absolute in event 2-2025. d) The laboratory scored 0% for MONO % in event 2-2025. e) The laboratory scored 0% for MONO Absolute in event 2-2025. f) The laboratory scored 0% for HGB in event 3- 2025. g) The laboratory scored 0% for NEU/GRAN % in event 3-2025. h) The laboratory scored 0% for NEU/GRAN Absolute in event 3-2025. i) The laboratory scored 0% for MONO % in event 3-2025. j) The laboratory scored 0% for MONO Absolute in event 3-2025. 2. A review of CAP graded results confirmed the laboratory failed two consecutive Proficiency Testing (PT) events. 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 review of the CASPER 155 report and graded results from the College of American Pathologists (CAP). The Laboratory Director (LD) failed to provide overall management and direction to laboratory personnel to ensure that the Proficiency Testing (PT) surveys are performed satisfactorily and in compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations. The findings include: 1. The LD failed to ensure PT surveys are performed satisfactorily and in compliance with CLIA regulations. Cross refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the College of American Pathologists (CAP), the Laboratory Director (LD) failed to ensure successful participation in a Department of Health and Human Services (DHHS) approved Proficiency Testing (PT) program for two consecutive PT events for the analytes Hematocrit (HCT),Neutrophils/Granulocytes % (NEU/GRAN %), Neutrophils/Granulocytes Absolute (NEU/GRAN Absolute) , Monocytes % (MONO %) , Monocytes Absolute (MONO absolute) , resulting in initial unsuccessful performance. Cross refer to D2130. -- 3 of 3 --

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 Test Records (PTR) and interview with the Technical Consultant (TC) via phone, laboratory personnel failed to follow the procedure for Flagged Differentials for Hematology tests performed from 1/3/24 to 10/1/24. The findings include: 1. The PM states "For any reports that are flagged differentials (BD, NM,OM,TM), these must be reviewed by physicians/nurse practitioner, to either accept flag report or request slide to be sent out for review. Report must be documented (signature or initials of ordering physician /nurse practitioner) on any flagged report to be accepted by physician/nurse practitioner without further review." 2. PTR 1010324450 and 1051324711 had "OM" flags on the reports. There was no documented evidence the reports were reviewed by a physician/nurse practitioner to accept flagged reports or requested slides to be sent out for review. 3. The TC confirmed via phone on 10/1/24 at 12:20 pm, laboratory personnel failed to follow the PM. 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 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 -- 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 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 Technical Supervisor (TS) via telephone at 10:00 am on 3/1/2021, the laboratory failed to follow the procedure for Critical Value (CV) Reporting from 10/16/2020 to the date of the survey. The findings include: 1. The PM stated "The following procedure is to be followed when calling critical values: Document in the comment box of the EMR the critical result notification and/or stamp analyzer printout with critical value stamp and fill in the appropriate information" 2. Three out of four patient test reports with a CV box stamped on the report did not have the CV box filled in with the appropriate information. 3. The TS confirmed via telephone at 10:00 am on 3/1/2021, the laboratory failed to follow the procedure for CV Reporting. b. Based on surveyor review of the PM and interview with the TS via telephone at 10:00 am on 3/1/2021, the laboratory failed to have the Medonic User Manual from 10/16 /2020 to the date of the survey. The TS confirmed via telephone at 10:00 am on 3/1 /2021 the laboratory did not have the Medonic User Manual. 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 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 -- 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)