Summary:
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 the start of 2023 for regulated routine chemistry analytes. Findings include: 1. Review on 11/9/2023 of CASPER report 0096D revealed PT scores for chloride, creatinine, gluocose, potassium, sodium and urea nitrogen for event 3 of 2022 and event 2 of 2023. There were no scores for event 1 of 2023. 2. Interview on 11/9/2023 at 9:30 a.m. with the Technical Consultant (TC) revealed this lab's PT enrollment had not been renewed correctly at the start of 2023. The TC revealed the issue with PT enrollment had been realized at the start of the event 1 of 2023 and it was too late to update the PT order to enroll for the first PT event at that time. D5805 TEST REPORT CFR(s): 493.1291(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 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 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. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory's (lab) test reports for hematology and routine chemistry testing failed to include the address of the performing lab's location. Findings include: 1. Review on 11/9/23 of CASPER report 0096D revealed the physical address for the lab is 160 South River Road in Bedford, NH. 2. Review on 11/9/2023 of 3 of 3 lab reports from 1/11/22 to 4/18/23 for activated clotting time (ACT) and 2 of 2 lab reports from 2/3/22 to 1/17/23 for Chem8 panel testing (analytes include: chloride, potassium, sodium, creatinine, urea nitrogen, ionized calcium, gluocose and total carbon dioxide) revealed an address of 100 McGregor St in Manchester, NH. 3. Interview on 11/9/2023 at 10:45 a.m. with the Technical Consultant confirmed the address on the reports was incorrect for the performing lab and all results are reported using the same method. 4. The lab performed a combined total of 112 tests for ACT and Chem8 testing in 2022 and 2023. -- 2 of 2 --