Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with the Technical Consultant (TC-1), the laboratory failed to have the current laboratory director approve, sign and date test procedures before use. Findings include: 1. The current laboratory director indicated in the CLIA Federal Database and assigned on the CMS-209, Laboratory Personnel Form presented for review during the survey has been listed as laboratory director since 09/07/2022. 2. The policy and procedure manual presented for review during the survey conducted on 10/04/23 was not approved, signed and dated by the current laboratory director. 3. The TC-1 interviewed on 10/04/23 at 01:20 PM confirmed that the policy and procedure manual indicated above was not approved, signed and dated by the current laboratory director. 4. The laboratory performs testing in the specialties of Chemistry and Hematology with an annual test volume of 11,108. D5813 TEST REPORT CFR(s): 493.1291(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: Based on review of test results for Chem8+ testing performed on the i-Stat analyzer 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 -- and interview with the Technical Consultant (TC-1), the laboratory failed to immediately alert the individual or entity requesting the test when the test result indicates an imminently life-threatening condition, or panic or alert values. Findings include: 1. Review of the chemistry test results for patient ID# 00127308 performed on 08/16/2022 at 3:50 PM indicated one critical test result: Potassium (K), Venous = 2.0 mmol/L (critical low). 2. No documentation was presented for review to indicate the laboratory notified the entity requesting the test of the critical test result for the patient indicated above. 3. The TC-1 interviewed on October 4, 2023 at 1:17 PM confirmed the laboratory failed to provide documented evidence showing the critical test result referenced above was communicated to the entity requesting the test. 4. The laboratory performs testing in the specialties of Chemistry and Hematology with an annual test volume of 11,108. -- 2 of 2 --