Penobscot Valley Hospital

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 proficiency testing reports from the laboratory. The facility was found to be out of compliance with the conditions of the CLIA program. The following: CONDITION and STANDARD level deficiencies were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation proficiency testing D2118- 42 C.F.R. 493.845 Standard: Laboratories performing Moderate Complexity testing: Chemistry 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 the proficiency testing (PT) data report (Casper Report 155D) and 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 -- staff interview, the laboratory failed to successfully participate for the regulated analyte Acetaminophen Serum. Refer to D2118. D2118 TOXICOLOGY CFR(s): 493.845(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 Review of the CASPER Proficiency Testing (PT) data report (155), and staff interview, the laboratory failed to successfully participate in PT for Chemistry. Findings include: 1. Record review on 8/29/2025 of the CASPER 155 report revealed scores of 60% for CAP 2025 Event 1 and 2025 Event 2, that were unsatisfactory for the regulated analyte: Acetaminophen Serum. 2. Email correspondence from the laboratory director of services on 9/3/2025 confirmed the findings above. 3. The laboratory performs 119,035 tests annually in the specialty of Chemistry. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and staff interview, it was determined that the laboratory did not have a quality systems policy for monitoring, assessing, and

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A proficiency testing desk review of the Penobscot Valley Hospital Laboratory was conducted on 10/15/21 pursuant to 42CFR Part 493 of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview with the laboratory manager (LM), the laboratory director (LD) failed to sign the attestation sheet for the College of American Pathologists (CAP) proficiency testing (PT) samples in the subspecialty of bacteriology. Finding include: 1. Record review on 10/15/2021 of the laboratory's PT attestation sheets for CAP Bacteriology Survey D-B 2021 revealed the LD did not sign the attestation sheet. The attestation sheet was signed by the LM who does not qualify as a technical supervisor. 2. Staff interview on 10/15/2021 with the LM confirmed the above findings. 3. The laboratory performs 4,675 tests annually in the specialty of microbiology. 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, 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 -- 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 the proficiency testing (PT) data report (Casper Report 155D) and PT graded results from the College of American Pathologists (CAP), the laboratory failed to successfully participate for the regulated analyte Bacteriology. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for 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 review of proficiency testing (PT) data reports (Casper Report 155D) and PT graded results from the College of American Pathologists (CAP) , the laboratory failed to successfully achieve a score of 80 percent (%) in two of three testing events for the subspecialty of bacteriology. Findings include: 1. Record review on 10/15 /2021 of the Center for Medicare & Medicaid Services (CMS) CASPER 0155D report revealed the laboratory obtained unsatisfactory scores for two of three consecutive PT events for analyte 0005 bacteriology as follows: a. 2020 - Event 3 - 83% b. 2021 - Event 1 - 76% c. 2021 - Event 2 - 70% 2. Record review on 10/15/2021 of the College of American Pathologists PT program results for the 2021 Bacteriology Survey D-A event 1 and D-B event 2 revealed the laboratory obtained unsatisfactory scores in two of three consecutive PT events as evidenced below. a. 2021 - Event 1 - 76% b. 2021 - Event 2 - 70% The laboratory performs 4,675 tests annually in the specialty of microbiology. -- 2 of 2 --