Marimn Health

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and an interview with the laboratory director, the laboratory failed to establish and follow a policy to perform initial training and to evaluate the competency for testing personnel in all specialties. 1. A review of the procedure manual revealed the laboratory failed to establish a writte procedure to perform initial training or to evaluate the competency of new employees at 6 months, annually and annually thereafter for all testing personnel. 2. A review of personnel records revealed the laboratory failed to document training for 1 of 2 new testing personnel listed on the CMS 209 Personnel Report form. 3. A review of competency documents for 4 of 4 testing personnel revealed that the laboratory failed to document a 6 month competency assessment for 1 testing personnel who has been employed greater than 12 months. 3. In an interview on November 18, 2020 at 9:10 AM, the laboratory director confirmed the laboratory did not have a personnel training and competency policy and that they failed to evaluate both initial training and 6 month competency assessments for new testing personnel. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. 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 -- This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory director, the laboratory failed to performed or document maintenance on the chemistry analyzer. Findings: 1. A review of the chemistry maintenance logs revealed that the laboratory failed to document monthly maintenance as prescribed by the manufacturer on the Siemens Dimension EXL chemistry analyzer from January 2020 through the date of the survey. 2. The laboratory performs approximately 62,000 test on the Dimension EXL annually. 3. In an interview on November 18, 2020 at 10:10 AM, the laboratory director confirmed the laboratory did not document monthly maintenance on the Dimension EXL. -- 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: Based on an observation of reagents in the lab and an interview with the laboratory manager, the laboratory had expired potassium hydroxide (KOH) solution in use for the detection of fungal elements in patient samples since October 2017. Findings: 1. An observation of the KOH solution by the microscope in the lab, revealed two HealthLink KOH bottles with lot number 1603217 and expiration date of 2017/10/31. 2. An interview on April 25, 2018 at 11:00 AM, with the laboratory manager, confirmed the KOH used in patient testing was expired. 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 --