SC 28 Annex : Checklist on Compliance with HOKLAS Requirements - Haematology SC 28 Annex

SC 28 Annex : Checklist on compliance with HOKLAS requirements - Haematology SC 28 Annex – Page 28 of 29

Issue No. 3

HOKLAS Requirement / Clause / * / Y / N / NA / QM Clause / Remarks / Questions to be asked at laboratory /

Management requirements

Quality and technical records

/ 4.13

Are there documented policies and operating procedures to guide the proper storage and handling of records (such as retrieval and disposal) so as to ensure their integrity and confidentiality?

/ 4.13.1

Technical requirements

Personnel

/ 5.1
Are there personnel policies and job descriptions that define qualifications and duties for all laboratory staff? / 5.1.2 / ●
Are staff numbers adequate and qualifications appropriate? / 5.1.2, 5.1.4g, 5.1.5 / ●
Does staff have appropriate and adequate training? / 5.1.2 / ●
Accommodation and environmental conditions / 5.2
Facilities
Does the laboratory have adequate and orderly space for:
- workbench? / 5.2.1 / ●
- equipment, e.g. microscopy and/or photomicroscopy, photographic processing or darkroom (if this procedure is used for karyotyping), fume cupboard (for reagent preparation) and Class II safety cabinet? / 5.2.1 / ●
- administrative and clerical work? / 5.2.1 / ●
- storage (including refrigerated storage)? / 5.2.9 / ●
Does the laboratory have adequate:
- fume-hoods or fume-cupboards? / 5.2.2 / ●
- lighting? / 5.2.4 / ●
- ventilation? / 5.2.4 / ●
- water supplies (tap, deionized, or distilled)? / 5.2.4 / ●
- drainage or sewage disposal; are procedures for solvent disposal and procedures for biological waste disposal all conform to relevant local authorities’ requirements? / 5.2.4 / ●
- ambient temperature and humidity control (particularly where sensitive instruments are in use)? / 5.2.5 / ●
Are reagents correctly kept according to manufacturer recommendations, especially where special storage conditions are required (refrigeration, flammable store, dark storage)? / 5.2.9 / ●
Electrical
Are adequate power points available (the use of double adapters and long extension cords is undesirable)? / 5.2.5 / ●
Is the electricity voltage monitored or checked periodically? / 5.2.5 / ●
Are voltage regulators / stabilizers / uninterruptible power supply used on instruments that require these items? / 5.2.5 / ●
Is essential electrical supply available? / 5.2.5 / ●
Safety
Does the laboratory comply with the professional, statutory and legislative safety requirements? / 5.1.4m, 5.2.2 / ●
Does the laboratory adopt and implement universal precaution guidelines? / 5.1.4m, 5.2.2 / ●
Laboratory equipment / 5.3
Is equipment adequate for the range and number of tests being performed? / 5.3.1 / ●
Is a list of all major equipment used available? / 5.3.1 / ●
Is there planned preventive maintenance for all instruments in use? / 5.3.2 / ●
Is there instruction and documentation for checking instruments? / 5.3.2, 5.3.4 / ●
Is the temperature checked and recorded regularly for temperature-controlled devices, e.g., water-baths, incubators, refrigerators and freezers? / 5.3.2, 5.3.4 / ●
Are function and performance of instruments documented in a manner that may reveal trends of malfunctions? / 5.3.4 / ●

Is there evidence of active review of instrument maintenance, function and temperature on all shifts?

/ 5.3.4 / ●
Are there documented protocol and schedule for checking centrifuge speed? / 5.3.4 / ●
Are the operating temperature ranges defined for each temperature-controlled device? / 5.3.5 / ●
Reagents
Are reagents properly labelled with content, concentration (if applicable), date of preparation or date opened, and expiry date? / 5.3.2 / ●
Are reagents used within their shelf life? / 5.3.2 / ●
Are outdated reagents quarantined or discarded? / 5.3.2 / ●
Pre-examination procedures / 5.4
Are relevant clinical information and diagnosis provided on the request form? / 5.4.1 / ●
Are there procedures to verify sample identity and integrity? / 5.4.2 / ●
Are there written instructions for the collection and handling of specimens? / 5.4.2, 5.4.3 / ●
Does the laboratory provide a list of available tests to all users of the service? / 5.4.3a (1), 5.5.6 / ●
Are there documentations detailing methods for patient identification, specimen labeling, specimen preservation and storage before testing? / 5.4.3 / ●
Are specimens inspected to confirm proper labelling and authorization? / 5.4.5 / ●
Are there written criteria, procedures and records for specimen rejection? / 5.4.8 / ●
Is a documented procedure available for expedited handling of urgent specimens? / 5.4.11 / ●
Are all secondary samples traceable to the primary sample? / 5.4.12 / ●
Examination procedures / 5.5
Has the Laboratory Director or designee reviewed and approved all new policies and procedures as well as substantial changes to existing documents before implementation? / 5.1.4 , 5.5.2 / ●
Are new lots of reagents validated before being used? / 5.5.2 / ●
Are methods reviewed at least annually? / 5.5.2 / ●
Are written instructions available for all tests performed? / 5.5.3 / ●
Are copies of written instructions located in the work areas and are readily accessible? / 5.5.3 / ●
Are reagents used in accordance with recommendations of the manufacturer? / 5.5.3 / ●
When the recommendations of the manufacturer are not being followed, have the alternative procedures been evaluated? / 5.5.2, 5.5.3 / ●
Assuring quality of examination results / 5.6
Does the laboratory have a documented quality assurance program? / 5.6.1 / ●
Are test systems properly controlled? / 5.6.1 / ●
Are there records that document the results of control procedures? / 5.6.1 / ●
Are records of all quality assurance results being kept? / 4.13.3, 5.6.1 / ●
Are quality control results verified for acceptability before test results are reported? / 5.6.1 / ●
Are quality control charts kept up to date at all times and regularly reviewed? / 5.6.1 / ●
Does the laboratory participate in appropriate external quality assessment program(s)? / 5.6.4 / ●
Is there a designated person responsible for continual monitoring of quality control and evaluation of proficiency testing results? / 4.1.5(i), 5.6.4 / ●
If some analyses are done by more than one method or equipment, are there documentation and procedures to ensure that the results are comparable? / 5.6.6 / ●
Are there written criteria for validation of results? / 5.6.6 / ●
Is there evidence to show that nonconformities (e.g., culture or test failures, erroneous reports) are thoroughly investigated and corrective/preventive measures are being taken where necessary? / 4.9.1, 4.10.2, 5.6.7 / ●
Does the laboratory have guidelines for the estimation of uncertainty of measurement (MU) and establish MU for the following tests? / SC28 8.2 / ●
Has your laboratory documented the estimation of uncertainty for tests giving quantitative results such as
- CBP (automated), including Hb, WBC, Plt, MCV and reticulocyte count
- PT, APTT / SC28 8.2 / ●
Post-examination procedures / 5.7
Are results routinely reviewed by someone with supervisory responsibility for clerical errors, absurd results or results requiring special notification before they are released? / 5.7.1 / ●
Are primary samples and other relevant laboratory materials retained for appropriate time interval pursuant to the professional, statutory, legislative and HOKLAS requirements? / SC28 6.3, SC28 9.1 / ●
Reporting of results / 5.8
Can the staff that has performed a test and/or checked a set of results be identified from existing laboratory records? / 5.8.3 / ●
When computer systems are used, are there procedures to check for transcription, calculation, or data entry errors? / 5.8.3 / ●
Are the results on the report legible? / 5.8.3 / ●
Does laboratory retain records (electronic and/or hardcopy format) for an appropriate time interval pursuant to the professional, statutory, legislative and HOKLAS requirements? / 5.8.6, SC28 5.1 / ●
Is a documented procedure available for expedited handling of seriously abnormal results? / 5.8.7 / ●
Is the turnaround time set within a reasonable time frame? / 5.8.11 / ●
Are all test reports of tests that require direct input of pathologists reviewed and signed by a qualified haematologist (or qualified pathologist as advised by the HKCPath)? / SC 28 10.1 / ●
For computer auto-validated reports, does the laboratory define and document the person(s) authorising the use of the particular algorithm for the automatic release of the results? Is the authorization for release of auto-validated reports traceable? / SC 28 10.4 / ●
Are the requesters informed on the reports that the results are auto-validated by computer system? / SC 28 10.4 / ●
General Haematology and Coagulation
Technical requirements
Laboratory equipment / 5.3
Does the list of equipment available include the following:
- haematology cell counter? / 5.3.1 / ●
- analyzers (coagulation, electrophoresis)? / 5.3.1 / ●
- spectrophotometer? / 5.3.1 / ●
- stainer? / 5.3.1 / ●
- centrifuge? / 5.3.1 / ●
- pH meter? / 5.3.1 / ●
Does the laboratory have copies of the Manufacturer’s Work and Maintenance Manuals for
- the Automated Haematology System? / 5.3.4 / ●
- the automated system for Reticulocyte Counts? / 5.3.4 / ●
Pre-examination procedures / 5.4
Is the anticoagulant in use appropriate to the test and in the correct final concentration? / 5.4.2 / ●
Examination procedures / 5.5
Are measures taken to ensure that anticoagulated blood is adequately mixed before sampling ? / 5.5.1 / ●
Manual Haematocrit
Has the constant packing time (minimum spin to reach maximum packing of cells) been determined and recorded for each instrument? / 5.5.1 / ●
Manual Platelet, Red and White Blood Cell Count
Are counting chambers for blood cells examined regularly to ensure that the lines are bright and free of scratches? / 5.5.1 / ●
Are correct standard thick glass cover slips used? / 5.5.1 / ●
Is the diluting fluid filtered before use, checked periodically for background count and changed when necessary? / 5.5.1 / ●
Is the number of cells counted statistically valid for the test (100 for white cell counts, 1000 for red cell counts, 100 for platelet counts)? / 5.5.1 / ●
Automated Haematology System: Cell Counting, Cell Size Measurement and Haemoglobin Determination
For semi-automatic systems, is the minimum/maximum time for lysing determined at regular intervals? / 5.5.1 / ●
Are background counts preformed on the diluent and lysing agent to check for contamination? / 5.5.1 / ●
Are procedures available to verify white cell counts that fall outside the action limits? / 5.5.1 / ●
Are adequate measures taken to prevent the possibility of “carry over”? / 5.5.1 / ●
Are performance or tolerance limits defined for each instrument, component or procedure of the system? / 5.5.1 / ●
Blood Film Examination
Are slides for blood film examination adequately identified, i.e. traceable to original sample? / 5.4.12 / ●
Is the quality of blood films satisfactory in respect of (a) staining, (b) debris, and (c) morphology and distribution of cells? / 5.5.1 / ●
Does the report include an evaluation of red cell morphology? / 5.5.1 / ●
Are abnormal slides kept and are they readily accessible? / 5.5.1 / ●
Is an estimation of platelets made from the blood film? / 5.5.1 / ●
When the platelet count falls outside the action limits, are quantitative counts correlated with an estimate from a blood film? / 5.5.1 / ●
Reticulocyte Counts – Manual
Are slides for reticulocyte counts adequately identified, i.e. traceable to original sample? / 5.4.12 / ●
Are blood films stained and examined within 24 hours? / 5.5.1 / ●
Is the reticulocyte stain filtered before use? / 5.5.1 / ●
Is the percentage of reticulocytes based on a count of at least 1000 red cells? / 5.5.1 / ●
Reticulocyte Counts – Automated
Are procedures available to verify reticulocyte counts when they fall outside the action limits? / 5.5.1 / ●
Are there adequate safeguards to prevent the possibility of “carry over”? / 5.5.1 / ●
Are performance or tolerance limits defined for each instrument, component or procedure of the system? / 5.5.1 / ●
Blood Films for Malarial Parasites
Are blood films for examination of malarial parasites adequately identified, i.e. traceable to original sample? / 5.4.12 / ●
Are both thick and thin films made? / 5.5.1 / ●
Are appropriate staining techniques used (e.g. Field’s Stain for thick films, Wright, Giemsa stains for thin films; appropriate buffers etc.)? / 5.5.1 / ●
For thick films, are at least 100 fields examined under oil immersion before a negative report is issued? / 5.5.1 / ●
Bone Marrow Preparations
Are slides of bone marrow preparation adequately identified, i.e. traceable to original sample? / 5.4.12 / ●
Is the quality of bone marrow films satisfactory with respect to (a) staining, (b) debris, (c) morphology and distribution of cells? / 5.5.1 / ●
Are histological sections of marrow specimens prepared routinely (marrow clot and/or trephine biopsy)? / 5.5.1 / ●
Is iron stain routinely performed for iron store assessment? / 5.5.1 / ●
Are facilities available for further investigation (cytochemistry and/or immunophenotyping, etc.)? / 5.5.1 / ●
Cytochemical Studies
Are slides for cytochemical studies adequately identified, i.e. traceable to original sample? / 5.4.12 / ●
Is the quality of blood / bone marrow films satisfactory with respect to (a) staining, (b) debris, (c) morphology and (d) distribution of cells? / 5.5.1 / ●