Cabot Medical Care

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 8/28/25 at 12:58pm, one (of three) container of GlucoTrol AQ Hemocue Glucose 201 analyzers level 1 and level 3 controls (lot (10) 18050018, REF 180.013.002, expiration date 6/30/25) was observed in the laboratory, available for use beyond the expiraton date. C) In an interview on 8/28/25 at 12:59pm the technical consultant (as listed on the CMS-209 form), confirmed that the item, identified above, had exceeded it's expiration date and was available for use in the laboratory. D5813 TEST REPORT CFR(s): 493.1291(g) (g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Through a review of the laboratory panic value policy, a review of the hematology instrument datalog and patient medical records, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to document that the healthcare provider was notified of panic values. Survey findings include: A. The 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 -- laboratory critical/panic value policy states that a White Blood Cell count (WBC) less than 3.0 and greater than 20.0 should be treated as panic values. The policy further states "Inform the requesting physician of the result. Document in CPSI who you gave the result to, the time, the date and your initials." B. One of three panic value results, observed on the instrument datalog, failed to document that the policy was followed. The medical record of Patient #213919 does not document that the provider was immediately notified of the patient's WBC result of 2.9 on 7/7/25. C. In an interview at 11:09am on 8/28/25, the technical consultant confirmed the lack of documentation that the panic value policy had been followed and the patient's healthcare provider had been notified in one of three patients with panic values reported. -- 2 of 2 --

Summary Statement of Deficiencies D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Base on review of the CMS-209 form presented at the time of the survey, a review of personnel records for seven personnel listed on the form CMS-209, and through interviews with laboratory staff, it was determined one of five testing personnel failed to have written authorization to perform testing without direct supervision. Survey findings include: A. Through a review of the CMS- 209 form, it was determined that five personnel were designated as testing personnel. B. A review of personnel records for seven personnel listed on the form CMS-209 revealed that one of five testing personnel failed to have written authorization to perform testing without direct supervision. Laboratory personnel # 6, did not have a written authorization to perform testing without direct supervision. C. In an interview at 10:31 a.m. on 11/07/2023, Technical Consultant (listed on the form CMS-209) confirmed that the laboratory did not have documented authorization for testing for employees performing testing. 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 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: . Through a review of the Proficiency Testing records for 2020 and 2021, Survey Exception Reports, lack of documentation, and interviews with staff, it was determined the laboratory failed to prevent the recurrence of problems in the General Laboratory Systems. Survey findings follow: A. A review of the Proficiency testing records for the third event of 2020 and the first event of 2021 (two of two testing events) revealed the laboratory received a score of 0% for the test Wet Prep in each proficiency testing event. B. A review of the Survey Exception Report for the third Hematology proficiency testing event of 2020 revealed the correction action: "retraining staff." C. A review of the Survey Exception report for the first Hematology proficiency testing event of 2021 revealed the correction action: "Retraining: will have testing personnel watch YouTube video and complete retesting." D. The

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --