Elliot Urgent Care Lab At Bedford

Summary Statement of Deficiencies D0000 Tag D5805 on this Form CMS-2567 is edited from the original issued 6/12/2026. 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 review of College of American Pathologists (CAP) proficiency testing (PT) records and interview with a CAP customer service representative (CSR1), the laboratory (lab) failed to authorize the release of Hematology and Chemistry PT results to the New Hampshire State Agency in 2024, 2025, and 2026. Findings include: 1. Review on 6/9/2926 of the laboratory's complete blood count (CBC) PT evaluation forms from Event 2 of 2025 and Event 1 of 2026 revealed NH DHHS (State Agency) was not listed as an organization to report PT results to. 2. A State Agency search on 6/19/2026 on CAP's online PT portal revealed no PT records for the lab's regulated Chemistry or Hematology could be found from PT in 2024, 2025, and 2026. 3. Interview by email on 6/11/2026 with CSR1 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 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 -- 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 College of American Pathologist (CAP) proficiency testing (PT) records and interview with Technical Consultants (TC1 and TC2), the laboratory (lab) failed to achieve satisfactory proficiency testing (PT) performance for hematocrit (HCT) for 2 out of 3 PT events in 2025 and 2026 resulting in unsuccessful PT 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 College of American Pathologist (CAP) proficiency testing (PT) records and interview with Technical Consultants (TC1 and TC2), the laboratory (lab) failed to achieve satisfactory proficiency testing (PT) performance for hematocrit (HCT) for 2 out of 3 PT events in 2025 and 2026 resulting in unsuccessful PT performance. Findings include: 1. Review on 6/10/2026 of CAP PT evaluation reports for 3 PT events in 2025 and 2 PT events in 2026 revealed the lab attained the following unsatisfactory PT scores for HCT in 2 (Event 2 of 2025, and Event 1 of 2026) out of 3 events: Event 2 - 2025: 40% Event 1 - 2025: 40% 2. Interview on 6/10 /2026 at 11:00 a.m. with TC1 and TC2 confirmed the lab's attained 40% scores for Event 2 of 2025 and Event 1 of 2026. D5805 TEST REPORT CFR(s): 493.1291(c) (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 acceptability. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with Technical Consultants (TC1 and TC2), two (PT1 and PT2) of two laboratory (lab) complete blood count (CBC) and chemistry profile test reports failed to include the lab's correct address in 2026. Findings include: 1) Review on 6/9/2026 of 2 (PT1 and PT2) of 2 test reports from June 2026 for CBC (includes red cell count, white cell count, platelet count, hemoglobin, hematocrit, and automated cell differential) and chemistry profile testing (includes sodium, potassium, chloride, carbon dioxide, glucose, blood urea nitrogen, creatinine, ionized calcium) revealed the test reports for PT1 and PT2 stated the lab's street address was "24 Leavy Drive." 2) Interview on 6/9/2026 at 10:40 a.m. with TC1 and TC2 confirmed the test reports for PT1 and PT2 included the street address as "24 Leavy Drive" and revealed the correct street address of the lab is "25 Leavy Drive." -- 3 of 3 --

Summary Statement of Deficiencies 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: Based on record review and staff interview, the laboratory failed to verify performance specifications for the hematology analyzer after receiving the instrument from the manufacturer for service repairs in November 2021. Findings include: 1. Review on 3/31/2022 of service records for the POCH-100i hematology analyzer revealed the instrument was serviced at the manufacturer and shipped back to the laboratory on 11/3/2021. 2. Review on 3/31/2022 of calibration records for the POCH- 100i hematology analyzer revealed the laboratory performed a 1 point calibration upon receiving the instrument back from the manufacturer. There were no records that the laboratory verified accuracy, precision and reportable range after receiving the instrument back from the manufacturer. 3. Interview with the Technical Consultants on 3/31/2022 at 10:00 a.m. confirmed the laboratory did not verify performance specifications for accuracy, precision and reportable range after receiving the instrument back from the manufacturer. The Technical Consultants revealed that instrument was down from 10/18/2021 to 11/5/2021. The laboratory performs 1,100 complete blood counts on the POCH-100i analyzer annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review the laboratory director failed to sign and date a revised hematology procedure before being put into use on November 30, 2018. Findings include: 1) Review on 1/4/2019 of the "I-Stat Testing" procedure received on January 4, 2019 revealed the procedure had been revised in October 2018. The laboratory director's signature and date of approval were not on the revised procedure. 2) Review on 1/4/2019 of the laboratory's

Summary Statement of Deficiencies D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to determine hematology test system's control procedures based upon the performance specifications established by the laboratory in 2018. Findings include: 1) Review on 10 /26/2018 the laboratory's control procedure for prothrombin/international normalized ratio (PT/INR) revealed instruction to test two levels of PT/INR controls for each new lot or shipment of reagent test cartridges and every 30 days. 2) Review on 10/26/2018 of the i-STAT manufacturer's instructions revealed instruction to perform control testing on each new lot and shipment of PT/INR test cartridges. 3) Review on 10/26 /2018 of the laboratory individualized quality control procedure for PT/INR revealed the data used to determine the quality control procedure (QCP) was obtained in 2015 and 2016 by other laboratories. This laboratory did not establish its own performance specifications using its own i-STAT analyzers to determine the QCP for PT/INR. 4) Interview on 10/26/2018 at 11:30 a.m. with the technical consultants confirmed the above findings. 5) The laboratory has performed two PT/INR tests since opening in July 2018. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --