Summary:
Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based upon a review of manufacturer's instructions, test logs, and an interview with Testing Personnel (TP), the laboratory failed to document the time in which specimens were collected. This deficient practice had the potential to affect all patients tested under the specialty of chemistry. Findings were as follows: 1. The manufacturer Qualigen, states under its testing procedure for the Fast Pack ip system, document 65000160 Rev. 007 (06/15) "Sample should be centrifuged and serum separated from the clot within 3 hours from time of collection. Plasma should be separated within 3 hours from time of collection. If not tested within 24 hours, samples should be frozen at -20C or colder for up to 2 months." 2. Review of the laboratory document titled "Doctors Urgent Care, Specimen Requirements", effective date 09/14/1998 found the following requirements: Test Longevity Refrigerator CBC 8 hours 24 hours Sed Rate 2 hours 24 hours Chemistry 8 hours 72 hours *(refer to insert for specific analyte) PT/PTT 2 hours 8 hours Urine 1 hour 8 hours 3. Review of the laboratory's test log titled, "Immunoassay Daily Log"did not contain a section time of specimen collection. 4. Review of the laboratory's test log titled, "Interoffice Labs" used for CBC specimens sent out did not contain a section for time of specimen collection. 4. The surveyor requested documentation of specimen collection times for routine chemistry testing from TP#1. TP#1 verified specimen collection times were not recorded. The interview occurred 06/24/2019 at 11:30 AM. C; degrees Celsius D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by 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 3 -- laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of proficiency test records and the laboratory procedure manual, the Laboratory Director (LD), failed to follow the written procedure manual for proficiency testing and did not review and sign the results section. This deficient practice had the potential to affect all patients tested under the specialty of chemistry. Findings include: 1. Review of the approved laboratory procedure manual titled, "Quality Assessment Manual", approved and signed by the LD on 05/15/2019 found the following statement under section 8 subsection K: "The results are reviewed and signed by the medical director and laboratory supervisor. The laboratory director must ensure all proficiency testing reports received are reviewed by appropriate staff to evaluate the laboratory's performance and to identify any problems that require