Cabot Emergency Hospital

Summary Statement of Deficiencies D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) (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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on written procedures and interviews, laboratory failed to follow written Quality Control Plan (QCP) annually review for the Individual Quality Control Plan (ICQCP). Findings follow: A) The Quality Assessment to monitor for QCP effectiveness states, "8. The IQCP will be reviewed annually". Laboratory could not provide any documentation of the IQCP annual review for iStat EG6+ for 2024, Triage - Cardiac for 2024, and Triage D-dimer for 2024. B) In an interview on 9/16 /2024 at 10:59 a.m., the Technical Consultant on the CMS 209 form confirmed that no annual review was performed for iStat EG6+, Triage - Cardiac, and Triage D-dimer for 2024. 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 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: Through a review of personnel files for the thirty one testing personnel listed on the form CMS-209, lack of documentation, and interviews with laboratory staff, it was determined the laboratory director failed to authorize thirty one of thirty one testing personnel to perform MeMed testing without direct supervision. Survey findings include: A) During a review of personnel files for testing personnel listed on form CMS-209 (Personnel #1 - #31) the it was noted all testing personell failed to have written authorization, from the laboratory director, to perform moderate complexity MeMed testing to differentiate between viral and bacterial infections without direct supervision. B) In an interview, at 2:23 pm on 02/05/24, laboratory employee #2 (as listed on the form CMS-209) confirmed the lack of written authorizations for employees to perform MeMed testing. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) 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 -- (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Through a review of personnel records for all testing personnel listed on the form CMS-209 and through interviews with laboratory staff, it was revealed the technical consultant failed to perform competency assessments using the six required methods for one of thirty one testing personnel. Survey findings include: A. During document review, competency assessments for testing person #5 (as listed on the CMS-209 form) were not available. B. During an interview, at 10:24 am on 02/05/24, laboratory employee #2 (as listed on the CMS-209 form) stated "I don't know where they're at" and "she has been performing testing" when asked for competency and training documentation of testing person #5. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: . Through observations made during a tour of the laboratory, as well as interview with staff, it was determined the laboratory had BD Vacutainer Lithium Heparin blood collection tubes available for use when they had exceeded their expiration date. Survey Findings Follow: A. During a tour of the laboratory on 02/28/2020 at 0945, the Surveyor observed twenty of twenty BD Vacutainer Lithium Heparin blood collection tubes (lot # 8215679 expiration date 12/31/2019) located on lower shelf in the laboratory available for use. B. In an interview on 02/28/2020 at 0945, laboratory personnel #2 (as listed on form CMS-209) confirmed the expiration date and the BD Vacutainer Lithium Heparin blood collection tubes were available for use. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: . Through a review of the Individualized Quality Control Plan (IQCP), lack of documentation and interviews with staff, it was determined the laboratory failed to specify which external control material will be utilized in the IQCP. Survey Findings Follow. A. A review of IQCP (three of three IQCP) for the Alere MeterPro Cardiac Panel, Alere MeterPro D-Dimer and Abott I-Stat System revealed the laboratory failed to specify which external controls will be utilized in the Quality Control component of the IQCP. B. In an interview at 1430 on 02/28/2020, laboratory personnel #2 (as listed on form CMS 209) confirmed the laboratory failed specify which external controls will be used in the Quality Control component of the IQCP. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Through a review of the laboratory Quality Control (QC) and