Dhart - Manchester

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 review of Certification and Survey Provider Enhanced Reporting (CASPER) 0096D report, College of American Pathologists (CAP) proficiency testing (PT) records, and interview with the Technical Consultant (TC1), the laboratory (lab) failed to authorize CAP to release routine chemistry and hematology PT results for 4 of 4 PT events reviewed from 2025 and 2026 to Centers for Medicare and Medicaid Services (CMS) and New Hampshire Department of Health and Human Services (NH DHHS). Findings include: 1. Review on 8/7/2026 of CASPER 0096D report revealed no PT results for the following regulated analytes tested by the lab: hydrogen concentration (pH), partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), sodium (Na), potassium (K), and hematocrit (Hct). 2. Review on 8/7/2026 of CAP PT evaluation reports from 2025 (3 events) and 2026 (1 event) revealed the lab was enrolled in PT for pH, pO2, pCO2, Na, K, Hct, and ionized calcium (iCa). The evaluation reports failed to include CMS and NH DHHS in the "Copied To" section on page 1 of the reports. 3. Interview on 8/7/2026 at 10:15 a.m. with TC1 confirmed the lab's PT results for pH, pO2, pCO2, Na, K, Hct, and iCa were not copied to CMS and NH DHHS. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed 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 2 -- 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 observation of laboratory's (lab) test equipment and supplies, review of quality control (QC) procedures and records, and interview with the Technical Consultant (TC1), lab personnel failed to follow procedures to perform chemistry and hematology control testing for i-STAT EG7+ test cartridges available for use in 2026. Findings include: 1. Observation on 8/7/2026 at 10:45 a.m. of the storage bag containing the i-STAT testing device and EG7+ test cartridges revealed 3 EG7+ test cartridges available for use with a lot number of N26074. No other EG7+ test cartridges from this lot could be found in the lab. EG7+ test cartridges include the following analytes: hydrogen concentration (pH), partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), sodium (Na), potassium (K), ionized calcium (iCa), and hematocrit (Hct). 2. Review on 8/7/2026 of the lab's individualized quality control plan (IQCP) signed by the Lab Director (LD) on 4/4/2025 revealed on page 1 in "Monthly" and "Periodic" sections, instruction to perform testing using 3 levels of QC for each new lot and shipment and monthly thereafter. 3. Review on 8/7 /2026 of QC records for EG7+ lot number N26074 revealed no QC testing was performed by the lab for any of the analytes listed above. 4. Interview on 8/7/2026 at 10:45 a.m. with TC1 confirmed the above findings. TC1 revealed each new box of EG7+ test cartridges includes 25 test cartridges. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to enroll in an approved proficiency testing (PT) program in 2024 or 2025 for regulated routine chemistry and hematology analytes. Findings include: 1. Review on 1/15/25 of the lab's enrollment for PT for 2025 revealed the laboratory ordered PT samples through another laboratory's CLIA number. The PT order included the following analytes: hematocrit, ionized calcium, potassium, sodium, hydrogen concentration (pH), partial pressure of oxygen, and partial pressure of carbon dioxide. 2. Interview on 1/15/25 at 9:20 a.m. with the Technical Consultant (TC) revealed the lab was testing patients in August of 2024 and did not enroll in proficiency testing in 2024. The TC confirmed the lab had ordered samples under another lab's CLIA number and not their own CLIA number. The TC revealed that they had performed no proficiency testing to date. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)