Regional Cancer Care Assoc At Toms River

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: Based on surveyor review of the Competency Assessment (CA) records, Procedure Manual (PM) and interview with the Technical Consultant (TC), the laboratory failed to follow its policies for assessing the competency of Testing Personnel (TP) from 1/1 /24 to 6/17/25. The findings include: 1. TP#4 and TP #5 as listed on the CMS 209 form, had incomplete CA for calendar year 2024. 2. TP #7 and TP#8 as listed on the CMS 209 form, did not have a CA performed in 2024. 3. The TC confirmed on 6/17 /25 at 11:25 am, the laboratory failed to follow its policies for assessing the competency of TP. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(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 (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration 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 -- verification. This STANDARD is not met as evidenced by: Based on surveyor review of the Calibration records, Procedure Manual (PM), Medonic User Manual (MUM) and interview with the Technical Consultant (TC) the laboratory failed to perform and document Calibration procedures at least once every six months for Hematology Tests performed on the Medonic analyzer from 7/1/24 to 1 /1/25. The findings include: 1. A review of calibration records revealed that the laboratory did not perform calibration every 6 months as per the manufacturer. 2. The TC confirmed on 6/17/25 at 11:15 am, the laboratory failed to perform and document calibration of the analyzer at least every six months. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Instrument Correlation Records (ICR) and interview with the Technical Consultant (TC), the laboratory did not have acceptable criteria to evaluate and define the relationship for Hematology test results between the two Medonic analyzers from 1/7/24 to 6/17/25. The finding includes: 1. The procedure did not have written acceptability or rejection criteria for the delta values between the Medonic analyzers. 2. The TC confirmed on 6/17/25 at 11:50 am, the laboratory failed to have written criteria for acceptable differences in test values for correlation studies performed on the two Medonic analyzers. D5779

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on June 10, 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 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 -- provider reports, the laboratory failed to achieve 80% or more in two out of three events for Hematology for the analyte Hematocrit (HCT) with the College of American Pathologists (CAP). 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 consecutive events in the subspecialty Hematology for the analyte Hematocrit (HCT) resulting in initial unsuccessful performance. The findings include: 1) A review of the CASPER 155 report revealed the following. a) The laboratory scored 60% for HCT in event 1-2025. b) The laboratory scored 20% for HCT in event 2-2025. 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 American Association of Bioanalysts (AAB), 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 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; This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from College Of American Patholgiosts (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 analyte Hematocrit (HCT), resulting in initial unsuccessful performance. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D5781

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: Based on surveyor review of Competency Assessment (CA) records and interview with the Technical Consultant (TC), the laboratory failed to perform CA for all Testing Personnel (TP) from 10/23/18 to the date of the survey. The finding includes: 1. One out of five TP did not have a CA performed from 10/23/18 to the date of the survey. 2. The TC confirmed on 11/1/21 at 10:00 am that the CA was not performed. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on surveyor review of the Laboratory Records (LR) and interview with the Technical Consultant (TC) ,the laboratory failed to perform correlation studies for Complete Blood Counts (CBC) performed on the Medonic M series Hematology A and B analyzers twice per year in the calendar years 2020 and 2021. The finding includes: 1. A review of the LR revealed there was no documented evidence that an 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 -- instrument correlation study was performed from 10/23/18 to 10/1/21. 2. The TC confirmed on 11/1/21 at 11:00 am that the laboratory did not perform a correlation study twice a year. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files (PF) and interview with the Technical Consultant (TC), the Laboratory Director (LD) failed to have appropriate education documentation for all Testing Personnel (TP) performing laboratory testing from 10/23/18 to the date of survey. The findings include: 1. The laboratory did not have education records for one out of five TP listed on the CMS form 209. 2. The TC confirmed on 11/1/21 at 10:00 am the above records were not on file. -- 2 of 2 --

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Technical Consultant (TC), the laboratory failed to undertake appropriate training and employ technical assistance necessary to correct problems associated with PT failures performed with the College of American Pathologists (CAP). The findings include: 1. There was no remedial action or documented taken for unacceptable grade in the FH1-A 2017 event for samples FH1-01 through 05 for Hematocrit % and received an CMS analyte score of 0%. 2. The TC confirmed on 10/23/18 at 10:55 am that