VERTICAL ASSESSMENT OF BLOOD TRANSFUSION SERVICES (Laboratories)

Transcription

1 VERTICAL ASSESSMENT OF BLOOD TRANSFUSION SERVICES (Laboratories) F Organisation s SANAS No/s. Facility Date Blood Collection Site Assessor/s & Observers Facility Representative REQUIREMENTS Compliance = C, Non-compliance = NC, Not applicable = NA Stds The order of assessment need not follow the order of the checklist. Assessors are expected to know Clause the Standards of Practice. Select a test report and an item of equipment to check maintenance/ calibration records etc Sample receipt and identification Request form/ documentation accompanying samples 13.2 Samples identified and traceable to source Procedures for receipt of samples, including actions for missing / unsuitable samples Procedures in place for transportation, handling, storage and disposal of samples C NC NA / 13.3 Testing: Sample preparation required? Performed correctly Procedures for testing performed, available Recognised test methods used Methods validated prior to implementation and verified as suitable Staff responsible for testing identifiable System for authorising staff to accept and release results Mandatory donation testing: Mandatory red cell serology for ABO and Rh group and screening for Transfusion Transmissible Diseases performed on each donation 38.2 Testing performed on a sample taken at time of blood collection or from pilot tubing which forms an integral part of the final container 38.3 Results of mandatory tests used to determine suitability of donations for patient use SANAS Page 1 of 8

2 F Additional /General Comments: SANAS Page 2 of 8

3 Tests for Infectious Agents: Test for Syphilis performed Test methods in accordance with manufacturer s instructions/ published methods /3 Serological and NAT testing for Hepatitis B Surface Antigen (HBsAg); Hepatitis C (HCV) antibodies; Human Immunodeficiency Virus (HIV 1 and 2) antibodies Test methods in accordance with manufacturer s instructions/ published methods 39.2 Algorithms in place for rejection and reinstatements of reactive donors/ units F Red Cell Grouping ABO blood group of unit confirmed before issue Test methods in accordance with manufacturer s instructions/ published methods 40.2 Rh of first time donors negative for D antigen subject to two independent tests for D prior to release Reagent used capable of detecting weak form of D 40.3 System for controlling release of products with unconfirmed blood groups or discrepant results System for investigating discrepancies in place SANAS Page 3 of 8

4 F Additional /General Comments: SANAS Page 4 of 8

5 Process Control Methods for handling, storage and disposal of test samples Test results reported accurately and unambiguously Accuracy and reliability of results determined by EQA/ IQA programme Results of EQA reviewed and corrective action implemented where necessary 9.3 Checks performed on incoming critical items. Records available 11.5 Quality Control programme in place for reagents, kits and equipment clause Assurance of validity of results control limits in place - control monitored - deviations investigated 39.4 Modifications to commercial methods validated before use Clause 5.4 Method suitability (capability) determination includes uncertainty, reproducibility, repeatability etc. Policy on rounding off of results (where applicable) F Equipment: 12.1 All required equipment available (eg. Centrifuges, thermometers, coldrooms,) Equipment and its software capable of achieving accuracy required 12.6 Defective equipment prevented from use and identified as such until shown by calibration or test to perform correctly 12.3 Each critical item is uniquely identified. Equipment operated by authorized personnel in accordance with procedures 12.4 Calibration plan for key instruments. Records of calibration kept. Calibration measurements traceable to the International System of Units, where possible Maintenance plan for key equipment and records kept 12.2 Equipment qualified on site. Records available SANAS Page 5 of 8

6 F Additional /General Comments: SANAS Page 6 of 8

7 Non-conforming Product: 14.1 Procedure for discard of non-conforming product 14.3 Bio-hazardous waste labelled and segregated Records of discard and disposal available F Documents and Records: 4.1 Quality Management System, including Quality Policy, in place 4.2 QMS and policy communicated to personnel 11.3 Validation records for new or changed processes or equipment 17.1 Internal audit system in place Clause Raw data and calculations available and correct Data transfer correct. Direct download validated 5.10 Test report contains: - Title - Customer name and address - Test method used - Test results - Operator s name - Any exclusions Personnel and Training: 2.2 Organogram shows reporting structure and inter-relationships and is reviewed at defined intervals 3.1.1/2 Job descriptions for all personnel that outline key responsibilities. Job descriptions reviewed at defined intervals and updated when required Job title and reporting structure in job description correlate with organogram 3.2.1,2 Training policy and programme plus system for identifying training needs System for competence assessment Records kept of staff training and competence Staff registered with professional body, where required SANAS Page 7 of 8

8 F Additional /General Comments: Signed : Lead/Technical Assessor Date SANAS Page 8 of 8