Androscoggin Valley Hosp Laboratory

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] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high 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 Pathologists (CAP) proficiency testing (PT) records, the laboratory (lab) failed to successfully participate in a PT program for b-type natriuretic peptide (BNP) in 3 (events 2 and 3 of 2025 and event 2 of 2026) out of the last 4 PT events in 2025 and 2026 resulting in 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 a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and College of American Pathology (CAP) 2025 and 2026 PT records, the laboratory (lab) failed to obtain satisfactory performance scores for b-type natriuretic peptide (BNP) in 2025 events 2 and 3, and 2026 event 2. Findings include: 1. Review on 8/10/2026 of CASPER 0155D report revealed the lab obtained the following scores for BNP in 2025 events 2 and 3, and 2026 event 2: 2025 Event 2: 0% 2025 Event 3: 0% 2026 Event 2: 0% 2. Review on 8/10/2026 of CAP PT evaluation reports for events BNP5- B 2025 (2025 event 1), BNP5-C 2025 (2025 event 3), and BNP5-B 2026 (2026 event 2) confirmed the above scores and revealed the lab failed to participate in all three of these events. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of Certification and Survey Provider Enhanced Reporting (CASPER) 0155D and College of American Pathologists (CAP) proficiency testing (PT) records, the laboratory (lab) failed to successfully participate in a PT program for b-type natriuretic peptide (BNP) in 3 (events 2 and 3 of 2025 and event 2 of 2026) out of the last 4 PT events in 2025 and 2026 resulting in unsuccessful performance. Cross reference D2016 and D2096. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 review of Certification and Survey Provider Enhanced Reporting (CASPER) 0155D and College of American Pathologists (CAP) proficiency testing (PT) records, -- 2 of 3 -- the laboratory (lab) failed to successfully participate in a PT program for b-type natriuretic peptide (BNP) in 3 (events 2 and 3 of 2025 and event 2 of 2026) out of the last 4 PT events in 2025 and 2026 resulting in unsuccessful performance. Cross reference D2016 and D2096. -- 3 of 3 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory's (lab) test report for histopathology slide interpretation failed to include the lab's name and address for 2 of 3 reports in 2024 and 2025. Findings include: 1. Review on 9/18/2025 of 3 lab test reports for histopathology slide interpretation completed on 5/3/2024, 8/27/2024, and 7 /24/2025 revealed 2 of 3 reports documented the wrong lab and address where the slides were read. 2. Interview on 9/18/2025 at 10:40 a.m. with the Laboratory Director (LD) confirmed the above finding. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced 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 3 -- Based on record review and staff interview, the Technical Consultant (TC) failed to perform competency assessments semiannually in the first year for 1 of 1 new testing personnel in 2024 and 2025. Findings include: 1. Review on 9/17/2025 of personnel records revealed 1 new testing personnel (TP1) completed training in October 2024. Further review revealed semiannual competency assessments had not been performed for routine chemistry, urinalysis, endocrinology, toxicology, and serology test systems in 2024 or 2025. 2. Interview on 9/17/2025 2:15 p.m. with the TC confirmed competency assessments had not been performed semiannually for TP1 in 2024 and 2025. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Consultant (TC) failed to perform competency assessments annually for 3 of 4 testing personnel in 2025. Findings include: 1. Review on 9/17/2025 of 4 personnel records revealed 3 (TP2, TP3, TP4) of the 4 personnel were past due for annual competency assessments in 2025 and personnel records for TP2, TP3, and TP4 failed to include the annual competency assessments for routine chemistry, urinalysis, endocrinology, toxicology, and serology test systems in 2025. 2. Interview on 9/17/2025 2:15 p.m. with the TC confirmed competency assessments had not been performed semiannually for TP2, TP3, and TP4 in 2025. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Supervisor (TS) failed to perform competency assessments semiannually in the first year for 1 of 1 new testing personnel in 2024 and 2025. Findings include: 1. Review on 9/17/2025 of personnel records revealed 1 new testing personnel (TP1) completed training October 2024. Further review revealed semiannual competency assessments had not been performed for hematology and microbiology tests systems in 2024 or 2025. 2. Interview on 9/17 /2025 2:15 p.m. with the TS confirmed competency assessments had not been performed semiannually for TP1 in 2024 and 2025. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Supervisor (TS) failed to perform competency assessments annually for 3 of 4 testing personnel in 2025. Findings include: 1. Review on 9/17/2025 of 4 personnel records revealed 3 (TP2, TP3, TP4) of the 4 personnel were past due for annual competency assessments in 2025 and personnel records for TP2, TP3, and TP4 failed to include the annual competency assessments for hematology and microbacteriology tests systems in 2025. 2. Interview on 9/17/2025 2:15 p.m. with the TS confirmed competency assessments had not been performed semiannually for TP2, TP3, and TP4 in 2025. -- 3 of 3 --

Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory's quality assurance procedures failed to document