Monmouth Hematology Oncology

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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), Quality Control (QC) and interview with the Techincal consultant (TC) the laboratory failed to follow the PM for "Policies for QC" and "Procedure for out of control control" for the Beckman Coulter DHX520 analyzer used to perform Hematology testing from 2/18/25 to 7/30 /25. The findings include: 1. The PM "Policies of QC" states "Do not run controls more than 3 times if they do not come out - start

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on February 7, 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 review of CASPER report 155 and the American Proficiency Institute (API), the laboratory failed to successfully participate in four out of six Proficiency Testing (PT) events in the subspecialty Hematology for analyte Cell Identification or 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 -- White blood Cell Differential resulting in non-initial unsuccessful performance. 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 American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance (80% or greater) for four out of six events in the subspecialty Hematology for the analyte Cell Identification or White blood Cell Differential (CELL ID or WBC DIFF) resulting in non-initial unsuccessful performance. The findings include: 1) A review of the CASPER 155 report revealed the following. a) The laboratory scored 33% for CELL ID or WBC DIFF in event 1-2022. b) The laboratory scored 33% for CELL ID or WBC DIFF in event 2-2022. c) The laboratory scored 76% for CELL ID or WBC DIFF in event 1-2023. d) The laboratory scored 72% for CELL ID or WBC DIFF in event 3-2023. 2. A review of API graded results confirmed the laboratory failed four out of six 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 Proficiency Institute (API), 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. 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 American Proficiency Institute (API), the Laboratory Director (LD) failed to ensure successful participation in a Department of Health and Human Services (DHHS) approved -- 2 of 3 -- Proficiency Testing (PT) program for four out of six PT events for subspecialty Hematology for the analyte Cell Identification or White blood Cell Differential resulting in subsequent unsuccessful performance. Refer to D2130. -- 3 of 3 --

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 (PT) provider reports, the laboratory failed to achieve a score of 80% or more for Hematology tests performed with the American Proficiency Institute (API). The finding includes: 1) The laboratory scored 0% White Bloodcell Count Differentrial, 0% for Hematocrit, 0% for Leukocyte count, 0% for Platelet count for events 2 and 3- 2022 with the API. D2123 HEMATOLOGY CFR(s): 493.851(c) 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 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 an office review of the CASPER reports 153, 155 and the performance summary form American Proficiency Institute (API). 2022 hematology events 2 and 3. The laboratory failed to participate in the third and second API aforementioned Proficiency Testing (PT) event of 2022 for Hematology tests. 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 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 (PT) provider reports, the laboratory failed to achieve a score of 80% or more for Hematology tests performed with the American Proficiency Institute (API). The finding includes: 1) The laboratory scored 40% for Leukocyte Count and 33% for White Blood cell Differential event 1-2022 with the API. 2) The laboratory scored 60% for Leukocyte Count and and 27% for White Blood cell Differential event 2- 2021 with the API. D2130 HEMATOLOGY 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 -- CFR(s): 493.851(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 surveyor review of Proficiency Testing (PT) and interview with the Testing Personnel (TP), the laboratory failed to achieve a score of 80% or more in two out of three events for for Hematology tests performed with the American Proficiency Institute (API). The findings include: 1) The laboratory scored 40% for Leukocyte Count and 33% for White Blood cell Differential event 1-2022 with the API. 2) The laboratory scored 60% for Leukocyte Count and and 27% for White Blood cell Differential event 2-2021 with the API. 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 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 Technical Consultant (TC), the laboratory failed to participate in American Association of Bioanalysts (AAB) PT for the first and second events of 2021 for Hematology tests. The TC confirmed on 8/3/21 at 2:00 pm that the laboratory did not participate in the first and second events of 2021. D5781

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 Office Manager (OM), the laboratory failed to retain copies of all PT records for testing performed with the American Association of Bioanalysts (AAB) in the calendar year 2017 and 2018. The findings include: 1. The laboratory did not have graded PT results for Q 1,2 and 3 2017 and Q 1 2018 Hematology. 2. The laboratory did not have the attestation statements for Q 1,2 and 3 2017 and Q 1 2018. Hematology. 3. The laboratory did not have work records Q 1,2 and 3 2017 and Q 1 2018. Hematology. 3. The OM confirmed on 1/10/19 at 10:10 am that PT records were not retained. 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 Testing Personnel (TP), the laboratory failed to use the "Instrument Action Log" for