Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to verify the accuracy of testing for the hematology PFA-100 platelet function testing at least twice annually for one (April to June) of one testing events in 2018. Findings include: 1. On June 4, 2018 at 11:50 AM, record review for the verification of accuracy of the PFA-100 platelet function testing revealed there was no documentation to show the testing was completed for one (April to June) of one testing events in 2018. 2. During the interview on June 4, 2018 at 11:50 AM, testing personnel #1 as listed on the CMS- 209 confirmed the event from April to June 2018 was not performed and documented. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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 procedure review and interview, the laboratory failed to establish and follow written procedures for the chemistry and hematology testing for 19 (November 2016 to June 2018) of 19 months of testing. Findings include: 1. On June 4, 2018 at approximately 1:30 PM, review of the "Lab Policy & Procedure Manual" and the lack 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 -- of documentation throughout the surveying process revealed the laboratory did not have procedures for the following: a. Operating procedures for the Beckman Coulter AcT diff 2 hematology analyzer - daily operating, maintenance, quality control, troubleshooting, and calibration. b. Competency c. Temperature - room temperature, refrigerator, and freezer monitoring d. Humidity monitoring e.