River's Edge Point Of Care Testing

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the profiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 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 Certification and Survey Provider Enhanced Reporting (CASPER) 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 -- 0155D and College of American Pathologist (CAP) proficiency testing (PT) records, the laboratory (lab) failed to successfully participate in a PT program for hematology analyte hematocrit (HCT) in 3 out of the last 4 PT events in 2025 and 2026 resulting in non-initial unsuccessful performance. Findings include: 1. The lab failed to attain satisfactory PT performance scores for HCT in events 1 and 2 of 2025 and event 1 of 2026. Refer to D2121. 2. The lab obtained unsatisfactory scores for HCT in 3 (events 1 and 2 of 2025 and event 1 2026) out of the last 4 PT events in 2025 and 2026 resulting in non-initial unsuccessful participation. Refer to D2130. D2121 HEMATOLOGY CFR(s): 493.851(a) (a) 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 review of Certification and Survey Provider Enhanced Reporting (CASPER) 0155D and College of American Pathologist (CAP) proficiency testing (PT) records, the laboratory (lab) failed to attain satisfactory PT performance scores for hematocrit (HCT) in 3 out of the last 4 events in 2025 and 2026. Findings include: 1. Review on 5 /4/2026 of CASPER 0155D revealed the lab attained unsatisfactory PT scores of 60% for HCT in events 1 and 2 of 2025 and event 1 of 2026. 2. Review on 5/4/2026 of CAP PT evaluations for FH1-A 2025 (event 1 of 2025), FH1-B 2025 (event 2 of 2025), and FH1-A 2026 (event 1 of 2026) confirmed the lab attained unsatisfactory PT scores of 60% for HCT in events 1 and 2 of 2025 and event 1 of 2026. 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 Certification and Survey Provider Enhanced Reporting (CASPER) 0155D and College of American Pathologist (CAP) proficiency testing (PT) records, the laboratory (lab) failed to achieve satisfactory proficiency testing (PT) performance for hematocrit (HCT) for 3 out of the last 4 events in 2025 and 2026 resulting in non-initial unsuccessful PT performance. Findings include: 1. Review on 5 /4/2026 of CASPER 0155D and CAP PT evaluation forms for PT events 1 and 2 of 2025 and event 1 of 2026 revealed the lab attained unsatisfactory PT scores for HCT in 3 (event 1 of 2025, event 2 of 2025, and event 1 of 2026) out of the last 4 events, resulting in non-initial unsuccessful participation. Refer to D2121. 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 Certification And Survey Provider Enhanced Reports (CASPER) 0155D and College of American Pathologists (CAP) laboratory Evaluation Proficiency Testing Service Program scores (year 2025 and 2026), the laboratory director (LD) failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. 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 the 5/4/2026 desk review of proficiency testing (PT) records from Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and College of American Pathologists (CAP) 2025 and 2026 PT records, the laboratory director (LD) failed to ensure successful PT participation for hematocrit (HCT) in 3 out of the last 4 events in 2025 and 2026. Cross reference D2016, D2121, and D2130. -- 3 of 3 --

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) (a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory (lab) failed to authorize the release of Hematology and Chemistry proficiency testing (PT) results to the New Hampshire State Agency in 2023, 2024, or 2025. Findings include: 1. Review on 6/13 /2025 of the laboratory's complete blood count (CBC) PT evaluation forms from Events 1 and 2 of 2025 revealed NH DHHS (State Agency) was not listed as an organization to report PT results to. 2. Review in the State Agency's online portal with the PT company revealed no PT results for regulated Chemistry or Hematology in 2023, 2024, or 2025. 3. Interview by email on 6/13/2025 with the PT company revealed the lab had not authorized the release of PT results to the State Agency. 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- 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 -- 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 record review, the laboratory (lab) failed to successfully participate in a proficiency testing (PT) program for hematocrit (HCT) in 2025. Findings include: 1. The lab failed to achieve satisfactory performance in PT events 1 and 2 of 2025 for HCT. Refer to 2121. 2. The lab obtained unsatisfactory scores in two consecutive PT events in 2025 resulting in unsuccessful participation. Refer to D2130. D2121 HEMATOLOGY CFR(s): 493.851(a) (a) 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 record review, the laboratory (lab) failed to obtain satisfactory proficiency testing (PT) scores for hematocrit (HCT) in events 1 and 2 of 2025. Findings include: 1. Review on 6/13/2025 of CASPER Report 0155D revealed the lab obtained a 60% score for HCT in both events 1 and 2 of 2025. 2. Review on 6/13/2025 of the lab's PT evaluation forms for FH1-A 2025 (event 1) and FH1-B 2025 (event 2) confirmed the lab obtained 60% PT scores for HCT in events 1 and 2 of 2025. 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 record review, the laboratory (lab) failed to achieve satisfactory proficiency testing (PT) performance for hematocrit for consecutive events in 2025 resulting in unsuccessful PT performance. Findings include: 1. Review on 6/13/22025 of CASPER report 0155D and the lab's PT evaluation forms for PT events 1 and 2 of 2025 revealed the lab obtained unsatisfactory scores in consecutive events 1 and 2 of 2025. Refer to D2121. -- 2 of 2 --