Rnj Services Inc

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 Laboratory Director (LD), the laboratory failed to follow its policies for assessing the competency of Testing Personnel (TP) from 1/1 /24 to 5/14/25. The findings include: 1. There was no documented evidence CA was performed on TP # 1 in calendar year 2024. 2. The LD confirmed on 5/14/25 at 2:30 pm, the laboratory failed to follow its policies for assessing the competency of TP in calendar year 2024. 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 Director (LD), it was revealed that the laboratory failed to review PT performance codes "See note [42]" (No credit assigned due to absence of response) results obtained for PT performed with the College of American Pathologists (CAP) for Immunnoglobulin E, event K-A 2024 Ligand-General. The findings include: 1. K- A 2024 Ligand-General samples K-01,02,03,04,05 had coded results for see note 42 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- which were not evaluated. 2. The LD confirmed on 5/13/25 at 11:00 am, the laboratory did not evaluate coded results for PT results obtained for the above mentioned PT event. 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 LD, the laboratory failed to verify the accuracy of all not graded results for PT events for Antibiotic Resistance Genes (ABR) performed on the Quantstudio 12K Flex RTPCR with the American Proficiency Institute (API) from 1/1/23 to 12/31/24. The findings include: 1. Review of ABR PT records revealed the laboratory received not graded results from API due to "no appropriate peer group." 2. There was no documented evidence the laboratory evaluated all not graded results for ABR PT events 1, 2, and 3 in calendar years 2023 and 2024. 3. The LD confirmed on 5/14/25 at 1:20 pm, the laboratory failed to verify the accuracy of all not graded PT scores from API. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. 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 Director (LD)), the laboratory failed to verify the accuracy and reliability of Urinary Tract Infection (UTI) testing performed on the Quantstudio 12k Flex from 1/1/23 to 12/31/24. The finding includes: 1. Surveyor review of PT records revealed all organisms tested by the laboratory were not included in PT events 1, 2 and 3 in 2023 and 2024 performed with the American Proficiency Institute (API). 2. The following organisms were not verified for accuracy twice annually on the Quantstudio 12k Flex analyzer: a) Actinobaculumchaalii b) Alloscardovia omnicolens c) Candida auris d) Corynebacterium reigelii e) Enterobacter Aerogenes f) Pantoea Agglomerans g) Viridians Strep Group 3. The LD confirmed 5/14/25 at 1:10 pm, the laboratory did not verify the accuracy of all oragnsims performed on the Quantstudio 12k Flex. 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 -- 2 of 8 -- examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), the lack of Quality Control Records (QCR) and interview with the General Supervisor (GS), the laboratory failed to follow the PM for "Quality Control protocol" and "Evaluation Of Quality Control Results" from 4/29/19 to 5/13/25. The findings include: 1. The PM stated"Quality Control protocol", "5. If control results and/or instrument checks are not within acceptable limits, the

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 graded results from the College of American Pathologists (CAP), the laboratory failed to successfully participate in three out of four Proficiency Testing (PT) events in the subspecialty Routine Chemistry 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 2 -- the analyte Chloride (CL) resulting in non-initial unsuccessful performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an desk review of the CASPER reports 153 and 155 and graded results from College of American Pathologists (CAP), the laboratory failed to achieve satisfactory performance (80% or greater) for three out of four events in the subspecialty Routine Chemistry for the analyte Chloride (CL) resulting in non-initial unsuccessful performance. The finding includes: 1) A review of the CASPER 155 report revealed the following: a) The laboratory scored 0% in event 1-2022 b) The laboratory scored 40% in event 1-2023. c) The laboratory scored 0% in event 3-2023 2) A review of the CAP graded results confirmed the the laboratory failed three out of four 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 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. 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 Proficiency Testing (PT) program for three out of four PT events for subspecialty Routine Chemistry for the analyte Chloride (CL) resulting in subsequent unsuccessful performance. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on December 4, 2024, 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 graded results from the College of 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 -- American Pathologists (CAP), the laboratory failed to achieve 80% or more in two out of three events for Endocrinology for the analyte Human Chorionic Gonadotropin (hCG). Refer to D2107. D2100 ENDOCRINOLOGY CFR(s): 493.843(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 review of CASPER report 155 and graded results from the College of American Pathologists (CAP), the laboratory failed to participate in Endocrinology PT events 1 and 2 of 2024 for Human Chorionic Gonadotropin (hCG) test. The findings include: 1) hCG PT results for event 1 samples HCG-01 through 05 obtained Code 47 "No credit assigned due to absence of response". 2) hCG PT results for event 2 samples HCG-06 through 10 obtained Code 47 "No credit assigned due to absence of response". 3) A review of CASPER report 155 and CAP graded results confirmed the failure to participate in the above mentioned PT events. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing 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 Endocrinology for the analyte Human Chorionic Gonadotropin (hCG). The findings include: 1) A Review of the CASPER 155 report revealed the following: a) The laboratory scored 0% in event 1-2024. b) The laboratory scored 0% in event 2-2024. 2. A review of CAP graded results confirmed the aforementioned failed 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. -- 2 of 3 -- This CONDITION 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 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) 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 a review of the CASPER 155 report and graded results from College of American Pathologist (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 Human Chorionic Gonadotropin (hCG), resulting in initial unsuccessful performance. Refer to D2107. -- 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 provider reports, the laboratory failed to achieve 80% or more in two out of three events for Toxicology testing with the College of American Pathologists (CAP). D2111 TOXICOLOGY CFR(s): 493.845(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 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 -- 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 College of American Pathologists (CAP), 2024 General Chemistry /Therapeutic Drugs event A nad C. The laboratory failed to participate in the CAP aforementioned Proficiency Testing (PT) events of 2024 for Phenytoin test. D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an office review of the CASPER report 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of at least 80% or more for Toxicology and Phenytoin. The finding includes: 1. The laboratory scored 0 % in event 1-2024 and 0% in event 2-2024 PT for Phenytoin with the College of American Pathologists. 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 Chemistry tests performed with the College of American Pathologists (CAP). The finding includes: 1) The laboratory scored 0% for CL, in event C-C 2022 and 40% in event C-A 2023 with the CAP. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) 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 attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD 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 at least 80% for the Chloride (CL). The finding includes: 1) The laboratory scored 0% for CL, in event C- C 2022 and 40% in event C-A 2023 with the CAP. 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 Endocrinology tests performed with the College of American Pathologists (CAP). The finding includes: 1) The laboratory scored a 0% for Triiodothyronine (T3) 2-2021 with the CAP. 2) The laboratory scored a 0% for T3 1-2021 with the CAP. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) 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 attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on an office review of the proficecny testing provider reports and CASPER reports 153 and 155 and Proficiency Testing (PT), the laboratory failed to achieve a score of 80% or more in two out of three event for for Endocrinology tests performed with College of American Pathologists (CAP). The finding includes: 1) The laboratory scored a 0% for Triiodothyronine (T3) 2-2021 with the CAP. 2) The laboratory scored a 0% for T3 1-2021 with the CAP. 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 CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the Laboratory Director (LD) failed to provide appropriate direction to laboratory personnel to ensure that the PT surveys are performed satisfactorily and that the laboratory is in compliance with the CLIA regulations. -- 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 lack of Quality Control (QC) records and interview with the Laboratory Director (LD), the laboratory failed to retain Activated Partial Thromboplastin Time QC printouts for the month of January 2019. The LD confirmed on 4/29/19 at 11:30 am that QC printouts were not available for review. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on review of data entry audit trail in the computer, test requisitions and interview with the Owner, the laboratory failed to ensure that information from the patients' requisitions were transcribed accurately into the laboratory information system from 4/15/15 to the date of the survey. The findings include: 1. Accessioning Procedure stated 'Accuracy of the accessioning has to be double checked by the different accessionist at the end of shift' but there was no documentation to substantiate the procedure was followed. 2. The