Summary:
Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on record review and interview with testing personnel #1 (TP1), the laboratory failed to document maintenance per the manufacturer and the laboratory's quality assurance policy. Findings include: 1. Record review of the cryostat maintenance manual on 6/30/2022 revealed the statement: "Have the instrument inspected by a qualified service engineer authorized by us once a year." 2. Record review of the laboratory's procedure manual on 6/30/2022 revealed the following statements: " The cryostat is checked every 6 months for proper functioning", "Preventative maintenance and grounding checks are done and documented annually", and "Preventative maintenance and grounding checks are done at 6 months." 3. Staff interview with TP1 on 6/30/2022 at 9:30 AM confirmed confilicting procedure manual policies and no documentation of the maintenance as noted above. 4. The laboratory performs 1800 compliance level tests per year. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on record review and interview with testing personnel #1 (TP1), the laboratory 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 -- director failed to document approval of the procedure manual prior to testing patient samples. Findings include: 1. Record review of the laboratory's procedure manual on 6 /30/2022 revealed the statement: "The manual must be reviewed / updated annually. The lab director must document and review / updates." 2. Staff interview with TP1 on 6/30/2022 at 9:00 AM confirmed the LD did document approval of the laboratory manual. 3. The laboratory performs 1800 compliance level tests per year under the specialties of Microbiology and Pathology. -- 2 of 2 --