Summary:
Summary Statement of Deficiencies 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: a. Based on surveyor review of the Procedure Manual (PM), review of Quality Control (QC) data and interview with the Technical Consultant (TC), the laboratory failed to follow the "Procedure For Change In Lot Of Control Material" for Hematology tests from 4/13/17 to the date of the survey. The findings include: 1. The PM stated " Prior to use the laboratory should run each level of new control material at least once, to verify that control samples fall within manufactures stated ranges." 2. There was no documented evidence the laboratory followed the procedure stated above. 3. The TC confirmed on 2/14/19 at 11:50 am that the procedure stated above was not followed. b. Based on surveyor review of the PM, and interview with the TC, the laboratory failed to follow the "Flag Procedure" for flags obtained Hematology tests performed on the Beckman Coulter Act 2 Diff analyzer from 4/13/17 to the date of the survey. The findings include: 1. The PM stated to repeat samples with flags but there was not documented evidence flagged samples were repeated. 2. The Testing Personnel stated at the time of the survey that the laboratory does not repeat samples with flags. 3. The TC confirmed on 2/14/19 at 10:50 am that the Flag procedure was not followed. c. Based on surveyor review of the Quality Assurance (QA) procedure and interview with the TC, the laboratory failed to follow the QA procedure in the calendar years 2017 and 2018. The finding includes: 1. The QA procedure stated a QA review is to be performed very six months but there was no documented evidence a QA review was performed. 2. The TC confirmed on 2/14/19 at 12:50 pm that the QA procedure was not followed. 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 -- D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of the Quality Control (QC) material and interview with the Technical Consultant (TC), the laboratory failed to put expiration dates on QC material for Hematology tests at the time of the survey. The findings include: 1. The expiration date of control material shortens once opened. 2. The laboratory did not put new expiration dates on the Coulter 4C control Lot 1685499K in use. 3. The TC confirmed on 2/14/19 at 11:50 am the laboratory failed to put expiration dates on the control material. Note: This was cited on previous survey performed on 4/13/17.