Oncology & Hematology Specialists Pa

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on November 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 consecutive events for Hematology for the analyte Hematocrit (HCT) 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 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 20% for HCT in event 2-2025. b) The laboratory scored 40% for HCT in event 3-2025. 2. A review of CAP graded results confirmed the laboratory failed two out of three 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; 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 analyte Hematocrit (HCT), resulting in initial unsuccessful performance. Cross refer to D2130. -- 2 of 2 --

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 Laboratory Manager (LM), the laboratory failed to review PT performance codes "See note [26]", " Educational Challenge" results obtained for PT performed with the College of American Pathologists (CAP) in the calendar year 2024 The findings include: 1. The laboratory did not evaluate "See note [26]" results obtained for PT event FHS16-B-2024 for nRBC/100 WBC for specimens FH16 - 06, 07, 08, 09 and 10. 2. The LM confirmed on 10/30/24 at 11:30 am that the laboratory failed to evaluate PT performance codes. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Proficiency Testing (PT) records and interview with the Laboratory Manager (LM), the laboratory did not establish a

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods 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 ensure that all Testing Personnel (TP) who performed Hematology tests participated in the College of American Pathologists (CAP) PT events in the calendar years 2022 and 2021. The finding includes: 1. A review of all PT events revealed that two out of nine TP performed PT all events in 2022 and 2021. 2. The TP confirmed on 1/11/23 at 1:30 pm that PT events were not rotated between TP. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must 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 Personnel Records (PR) and interview with the Testing Personnel (TP), the Laboratory Director failed to ensure that the education records were available on the date of the survey. The finding includes: 1. Education records 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 -- were not available for five of nine TP. 2. The TP confirmed on 1/11/23 at 2:00 pm that education records were not available. -- 2 of 2 --

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 and interview with the Nursing Supervisor (NS), the laboratory failed to perform the CA correctly for six out of six Testing Personnel (TP) from 2/13/18 to the date of the survey. The finding includes: 1. The laboratory did not document monitoring and recording of test results or assessment of problem solving skills on six of six TP. 2. The NS confirmed on 2/5/20 at 1:30 pm that the CA was not performed correctly. 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 Work Records (WR) and interview with the Nursing Supervisor (NR), the laboratory failed to follow the flag procedure found in the PM from May 2019 to the date of the survey. The findings includes: 1. The PM stated "the laboratory will follow manufacturer guidelines addressing flag parameters" but a review of ten flagged patient work 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 -- records revealed flags as below: a. WBC Interpretation Not Possible b. Platelet Aggregates c. Differential Flags 2. Manufacturer guidlines stated samples should be repeated. 3. Results with flags and comments listed above were reported and there was no documented evidence patient samples were rerun. 4. five out of ten WR were not reviewed as stated in the PM "all flagged results will be signed by the hematologist." 5. The NS 2/5/20 at 2:30 pm the above mentioned procedures were not followed. 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 and interview with the Nursing Supervisor (NS), the laboratory failed to perform and document correlation studies for Complete Blood Counts (CBC) performed on the Beckman AcT 5 Differential (Diff) analyzers twice per year from 2/13/18 to the date of the survey. The NS confirmed on 2/5/20 at 1:20 pm that the laboratory did not do correlation studies. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the Nursing Supervisor (NS), the laboratory failed to identify problems on the FR from 2/13/18 to the date of the survey. The findings include: 1. Ten of ten FR reviewed had "CBC- Denville" but the Complete Blood Count (CBC) was performed in Mountain Lakes. 2. The NS confirmed on 2/5/20 at 2:00 pm that the laboratory failed to identify problems on the FR. -- 2 of 2 --

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 and interview with the Laboratory Director (LD), the laboratory failed to perform CA correctly on six out of six Testing Personnel (TP) from 1/6/16 to the date of survey. The findings include: 1. The laboratory did not document when testing personnel were observed, what records were reviewed and how assessment was done. 2. Assessment of problem solving skills was not documented on CA for six out of six TP. 3. The TP #6 listed on CMS form 209 performing Flow Cytometry did not have a CA performed. 4. The LD confirmed on 2/13/18 at 12:50 pm that the CA procedure was not performed correctly. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: 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 -- Based on surveyor review of Performance Specifications (PS) records and interview with the Laboratory Director (LD), the laboratory failed to verify accuracy and precision on Hematology tests performed on the Beckman AcT 5 Differential (Diff) analyzer before reporting patient test results from June 2017 to the date of survey. The LD confirmed on 2/13/18 at 1:50 pm PS were not done. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on lack of Maintenance Records (MR) and interview with the Laboratory Director (LD), the laboratory failed to establish a maintenance protocol for the Rotonta 460 Centrifuge from 8/20/15 to the date of survey. The LD confirmed on 2/13 /18 at 1:00 pm that a Centrifuge maintenance protocol was not established. 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 and interview with the Laboratory Director (LD), the laboratory failed to perform Correlation studies for Complete Blood Count (CBC) performed on the Beckman AcT 5 Differential (Diff) analyzers twice per year in the calendar year 2017. The finding includes: 1. Instrument Correlation was performed on 6/28/17 but there was no documented evidence it was performed again at the time of the survey. 2. The LD confirmed on 2 /13/18 at 2:40 pm that the laboratory did not perform a Correlation study twice a year. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for -- 2 of 3 -- acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the Laboratory Director (LD), the laboratory failed to ensure that the location of the laboratory where tests were performed was on the FR from June 2017 to the date of survey. The LD confirmed 2/13/18 at 2:20 pm that the FR did not indicate the laboratory location. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR), Panic Values (PV) found in the procedure manual and interview with the Laboratory Director (LD) the laboratory failed to correct problems in the postanalytic system when the test results were flagged as a PV but the result did not agree with established PV from 1/6/16 to the date of the survey. The findings include: 1. The FR revealed that White Blood Cell Count and Lymphocyte number were reported out as a PV but the laboratory did not define a PV for the above parameters. 2. The LD confirmed on 2/13/18 at 2:00 pm that PV flagging was incorrect on the TR. This was cited on previous survey performed on 1/6/16. -- 3 of 3 --