Checklist for SC No. 28 Haematology Annex - Issue No. 3…

SC 28 Annex : Checklist on compliance with HOKLAS requirements - Haematology SC 28 Annex – Page 1 of 29 Issue No. 3

Note: 1. * The assessor should concentrate on items marked with a ●; other items will be checked by the team leader.

2. QM Clause stands for the clause number of the laboratory’s quality documentation that describes the laboratory’s procedures for the areas concerned.

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







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 ●


Is the anticoagulant in use appropriate to the test and in the correct final concentration?

5.4.2 ●


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 ●

Are there appropriate controls (internal and/or external) for cytochemical studies?

5.6.1 ●

Immunocytochemical Studies

Are slides for immunocytochemical studies adequately identified, i.e. traceable to original sample?

5.4.12 ●

Is the quality of blood / bone marrow / cytospin films satisfactory with respect to (a) staining, (b) debris, (c) morphology and (d) distribution of cells?

5.5.1 ●

Are there appropriate controls (internal and/or external) for immunocytochemical studies?

5.6.1 ●

Coagulation Systems

If an automated coagulation instrument is used for routine coagulation studies (e.g. PT, APTT):

- Are guidelines available for determining when other procedures should be performed (e.g. specimens that have significant degree of lipaemia, hyperbilirubinaemia, turbidity, etc.)?

5.5.3 ●

- Are reference ranges re-established when there is a change in reagent lot? 5.5.5 ●

- Is the automated system checked with different levels of control material at the start of each shift, and when there is a change in reagent?

5.6.1 ●

Manual Coagulation Systems

If routine coagulation studies (e.g. PT, APTT) are performed by manual technique:





- Is the temperature of water bath or incubator verified with a certificated thermometer (or equivalent technique)?

5.5.1 ●

- Are criteria for accepting duplicate testing results available? 5.5.3 ●

- Is the manual coagulation system checked with different levels of control material in duplicate during each 8-hour period of patient testing, and when there is a change of reagent?

5.6.1 ●

Coagulation Factor Assays

If factor assays are performed:

- Are at least three points plotted for the standard curve? 5.5.1 ●

- Are at least two points plotted for the patient’s factor assay curve? 5.5.1 ●

Assuring quality of examination procedures 5.6

Manual Haemoglobin Determination

Are the procedure standardized with reference materials of known and certified values?

5.6.3, 5.6.H

●

Are at least three points or concentrations used to prepare the standard curve or to calibrate the readout instruments?

5.5.1, 5.6.3

●

Are calibration curves or calibrations of the instrument checked at least monthly and after servicing?

5.3.9, 5.6.3

●


Are slides and reports for cytochemical studies filed and readily accessible? 5.7.2 ●





Are slides and reports for bone marrow preparations filed and readily accessible? 5.7.2 ●

Are slides and reports for immunocytochemical studies filed and readily accessible?

5.7.2 ●


Do haematology reports include the appropriate reference ranges? 5.8.3 ●

Are diagnosis and classification of haematolymphoid malignancies given according to the WHO classification?

5.8.4

- Bone Marrow Preparations ●

- Cytochemical Studies ●

- Immunocytochemical studies ●

Cancer Cytogenetics


Quality and technical records 4.13

Do laboratory records indicate the media used, culture conditions and incubation times for all preparations?

4.13.3 (d) ●





Do laboratory records include the number of cells counted, analyzed microscopically and the cells from which photographic or digitalized karyotypes are prepared?

4.13.3 (d) ●

Do laboratory records include an assessment of banding resolution to indicate whether metaphase analysis is satisfactory?

4.13.3 (d) ●



Does the laboratory have adequate number of image processing systems? 5.3.1 ●

Are cell cultures manipulated under conditions that ensure sterility and protect staff?

5.3.2 ●

Is there a sterile biologic containment hood that is certified annually in the laboratory?

5.3.2 ●

Are incubators fitted with alarms or override systems that protect against malfunction of temperature and CO2 controls?

5.3.2 ●

Are microscopes equipped for high-resolution cytogenetics analysis? 5.3.2 ●

Is the quality of optical image-capture system high enough to minimize image degradation?

5.3.2 ●


Is there at least one unique identifier present on the primary sample? 5.4.1 ●






Is each lot of culture medium checked for sterility? 5.5.1 ●

Are there independently established or duplicate cultures for all cancers cytogenetics study to backup against unexpected failures, unless the sample contains insufficient cells to do so?

5.5.1 ●

Are culture methods, culture media and additives selected according to the nature of neoplastic disorder under study?

5.5.1 ●

Are at least 10 cells analyzed for each case if possible? 5.5.1 ●

Are at least 2 karyotypes per mainline and 1 karyotype each from pertinent sidelines generated for each case?

5.5.1 ●

Are the band level, quality of banding and resolution sufficient to render the reported interpretation?

5.5.1 ●


Are fixed preparations of chromosomes and cells stored indefinitely if abnormal, and for 6 months if normal?

SC28 9.1 ●

Are slides stored for 2 years after final report if photographic record kept, or 5 years otherwise, unless degeneration is evident?

SC289.1 ●

Are negatives, prints or retrievable electronic media stored indefinitely? SC28 9.1 ●


Does the cytogenetics report contain:

- biological sex of the patient? 5.8.3 ●

- description of specimen / tissue studied? 5.8.3 ●





- indication for study and relevant clinical data? 5.8.3 ●

- number of cells (metaphases) analyzed? 5.8.3 ●

- banding method(s) used? 5.8.3 ●

- interpretation and clinical significance? 5.8.3 ●

- diagnosis and classification according to the WHO classification? 5.8.4 ●

Is ISCN 1995 used for description of cytogenetics results? SC28 10.2 ●

Immunohaematology and blood bank


Advisory services and continual improvement 4.7, 4.12

Does the institution have a Blood Transfusion Committee? 4.7, 4.12.4 ●



Preservation of blood and blood products

Is emergency power available for each blood storage equipment? 5.2.4 ●





If emergency power is not available for each blood storage equipment, are there written emergency procedures to maintain the proper storage of the donor units?

5.2.4 ●

Is there controlled access to blood stores? 5.2.7 ●

Is the blood storage space adequate for the needs of the facility? 5.2.9 ●

Are there standard operation procedures for handling blood outside the blood bank (avoidance of prolonged warming, need for filter)?

5.2.9 ●

Are donor units transferred to suitable storage device promptly after receipt? 5.2.9 ●

Are there documented policies for returning unused blood? 5.2.9 ●

Are donor units segregated in the blood storage device so as to avoid confusion regarding the following?

5.2.10

- blood group 5.2.10 ●

- blood under quarantined 5.2.10 ●

- blood suitable for crossmatch 5.2.10 ●

- crossmatched blood 5.2.10 ●

- rejected blood 5.2.10 ●

- autologous blood 5.2.10 ●

- expired blood 5.2.10 ●

Are blood storage equipment free of materials other than blood products? 5.2.10 ●

Are blood inventory control procedures conducted daily to ensure efficient use of the blood held?

5.2.10 ●






Are all grouping sera checked for potency and specificity? 5.3.2 ●

Are known positive and negative control cells used to check the reactivity of all grouping sera?

5.3.2 ●

Is there periodic check on the speed and timing of each serologic centrifuge so as to ensure that the supernatant is clear and the cells are not overpacked?

5.3.2 ●

Temperature Recorder

Is a temperature recorder attached to each piece of equipment in which blood is stored?

5.3.1, SC28 4.1.1

●

Are records of temperature recorder checked daily? 5.3.2 ●

Is the temperature sensor of blood refrigerator placed in 150-250 ml of fluid? 5.3.2 ●

Blood bank alarm

Is a visual alarm system installed? 5.3.2, SC28 4.1.1

●

Is an audible alarm system installed? 5.3.2, SC28 4.1.1

●

Is the alarm system continuously monitored at all times (either in or away from laboratory)?

5.3.2, SC28 4.1.1

●

Is checking of recording and alarm systems performed at least weekly? 5.3.2, SC28 4.1.1

●





Are the alarms set to trigger outside the preset range? 5.3.2, SC28 4.1.1

●

Does the alarm system operate independently of main electricity supply? 5.3.2, SC28 4.1.1

●

Is functional check of alarm performed at scheduled interval and after maintenance of equipment breakdown?

5.3.2, 5.3.10

●

Are there standard operation procedures to follow if temperature limits are exceeded?

5.3.7 ●


Is there documented standard operation procedure for collecting blood samples? 5.4.2 ●

Request form requirement

Does the request form contain the patient’s full name and a unique identification number?

5.4.1, SC28 6.4

●

Does the request form bear the phlebotomist’s identity, his name and signature? 5.4.1, SC28 6.4

●

Blood sample requirement

Are procedures available for positive identification of the intended recipient and verification between the information on the request form and the patient’s wrist-band?

5.4.3 ●

Is blood sample tube labeled with the patient’s unique identification information and the date of collection?

5.4.3, SC28 6.4

●

Blood sample reception procedure





Has a qualified blood bank staff confirmed that all identification information on the request form agree with that on the sample tube label prior to pre-transfusion testing?

5.4.2, 5.4.5 ●


Blood Grouping

Does the routine procedure include:

- anti-A (forward grouping)? 5.5.1 ●

- anti-B (forward grouping)? 5.5.1 ●

- anti-D? 5.5.1 ●

- A1 cells (reverse grouping)? 5.5.1 ●

- B cells (reverse grouping)? 5.5.1 ●

Is a defined haemagglutination grading/scoring system used? 5.5.3 ●

Compatibility Testing

Does the pre-transfusion procedure include:

- an investigation of cases in which patient’s ABO and Rh(D) typing disagree with the historical record?

5.5.1 ●

- confirmation of ABO group on all donor units and Rh(D) type on all Rh(D)-negative donor units for Rh(D)-negative recipients (testing for weak D is not required), using a sample from an attached segment?

5.5.1 ●

- a policy concerning the maximum interval during which a sample may be employed for testing before obtaining a new sample?

5.5.1, SC28 6.3

●





- test of each patient’s blood sample with anti-A, anti-B, anti-D, A1 and B red cells?

5.5.1 ●

- demonstration of compatibility between the recipient and the donor units issued?

5.5.1 ●

- performance of tests which can demonstrate ABO incompatibility and clinically significant red cell antibodies?

5.5.1 ●

- an antiglobulin or equivalent test in antibody detection tests? 5.5.1 ●

- consideration of previous findings in recipient’s transfusion record during interpretation of current test results?

5.5.1 ●

If investigation reveals no clinically significant antibody, and there is no historical record of such antibodies, has abbreviated crossmatch or computer crossmatch been performed to ensure ABO compatibility?

5.5.1 ●

(i) Abbreviated Crossmatch

Is abbreviated crossmatch performed by immediate spin test with patient’s serum and donor’s red cells?

5.5.1 ●

(ii) Computer Crossmatch

Has validation of the computer system been performed on site to prevent the release of ABO incompatible blood?

5.5.1 ●

Before the release of compatible blood, does the system check that:

- There is no history of clinically significant red cell antibodies? 5.5.1 ●

- The test result of antibody screening is valid? 5.5.1 ●





- There are two concordant determinations of the recipient’s ABO group: one by testing a current sample and the second by testing on the same or a second current sample, or by matching with previous records?

5.5.1 ●

If a patient is receiving repeated transfusions:

Is a fresh specimen taken immediately before blood is required if the previous specimen has elapsed the maximum interval for pre-transfusion testing?

5.5.1 ●

Is grouping performed on the new specimen? 5.5.1 ●

Is the new specimen screened for atypical antibodies and/or employed in subsequent crossmatch?

5.5.1 ●

Are there procedures for emergency release of blood prior to completion of compatibility testing ?

SC28 7.1 ●

Do the procedures include documenting a request for uncrossmatched blood by attending clinicians and collection of a pre-transfusion blood sample from the recipient for subsequent testing?

SC28 7.1 ●

Transfusion reactions

Are all transfusion incidents or reactions reported immediately to the blood bank? 5.5.1 ●

Are remnants of all packs administered immediately before or during the reaction retained for examination?

5.5.1 ●

Does the investigation include:

- double check that all packs have been given to the intended recipient? 5.5.1 ●

- examination for possible error in all clerical work? 5.5.1 ●





- repeated blood grouping and antibody screen on recipient’s pre-and post-transfusion blood samples?

5.5.1 ●

- direct antiglobulin test on recipient’s pre-and post-transfusion blood samples? 5.5.1 ●

- repeated crossmatch on residual blood in all available donor packs administered before or during the reaction with recipient’s pre-and post-transfusion blood samples?

5.5.1 ●

- repeated blood grouping on residual blood in all available donor packs administered before or during the reaction?

5.5.1 ●

- check for microbiological contamination of residual blood in all available donor packs?

5.5.1 ●

Is there a protocol detailing laboratory tests to be conducted on the recipient so as to determine the nature and extent of the recipient’s transfusion reaction?

5.5.1 ●

Is investigation of suspected haemolytic transfusion reaction reported by a qualified haematologist (or qualified pathologist as advised by the HKCPath)?

SC28 8.1.5 ●

Assuring quality of examination procedures 5.6

Transfusion procedure

Are there documented policies available including:

- indications for transfusion of blood and blood components? 5.6.1 ●

- maximum blood ordering schedule? 5.6.1 ●

- standard operation procedures for issuing blood and blood components? 5.6.1 ●





Are there instructions to require a compatibility label identifying the intended recipient being applied to each allocated donor unit?

5.6.1 ●

Is each unit of blood checked immediately for appearance and expiry date prior to allocation?

5.6.1 ●

Before giving blood transfusion, do qualified staff (doctors or nurses):

- check blood label for ‘Blood Group’, ‘Product type’ and ‘Expiry date’? 5.6.1 ●

- verify patient’s identity on blood unit with that on patient’s wrist band? 5.6.1 ●

- check ABO/Rh(D) group on donor units against Blood Transfusion Record? 5.6.1 ●

- check patient’s identity on donor units against Blood Transfusion Record? 5.6.1 ●

EQAP

Do staff taking part in the compatibility testing activities participate in External Quality Assessment Scheme ?

SC28 8.1 ●


Are specimens kept for at least 7 days after testing? 5.7.2, SC28 7.1

●

Are the following laboratory records (electronic and/or hardcopy format) retained for appropriate time interval pursuant to the professional, statutory, legislative and HOKLAS requirements?

5.8.6, SC28 5.1

- donor units received and issued by the blood bank 5.8.6, SC28 5.1

●





- temperature controls 5.8.6, SC28 5.1

●

- daily blood inventory 5.8.6, SC28 5.1

●

- results of grouping procedures, crossmatch and antibody studies 5.8.6, SC28 5.1

●

- batch numbers of all grouping sera 5.8.6, SC28 5.1

●

- reagent control studies 5.8.6, SC28 5.1

●

- transfusion requests 5.8.6, SC28 5.1

●

- transfusion reaction or incident reports 5.8.6, SC28 5.1

●

Immunophenotyping


Personnel 5.1

Does the person in charge of flow cytometry have qualification equivalent to that of a Medical Laboratory Scientist and have at least one year’s experience in flow cytometry?

5.1.2, 5.1.H

●






Are guidelines adopted and implemented for laser safety, carcinogenic dyes and infectious biohazard risks?

5.2.2, 5.3.6 ●


Are there actions and documentations to monitor optical alignment and laser sensitivity of flow cytometer each time prior to analysis?

SC28 4.1.2 ●

For flow cytometer, are fluorochrome standards run each day prior to analysis as part of calibration process; and are results documented for quality control purposes?

5.3.2, 5.6.1 ●

Are there processes to ensure acceptable and constant laser current of flow cytometry?

5.3.2 ●

Are there regular procedures for determining appropriate colour compensation settings of flow cytometer?

5.3.2 ●

Are logs of flow cytometer calibrations and laser integrity checks regularly reviewed and audited?

5.3.4 ●


Is there a procedure to adjust cell concentration to allow optimal antibody staining? 5.5.1 ●

Are gating procedures of acquisition signals validated and in line with those published in peer-reviewed journals or international guidelines?

5.5.1 ●

Are controls regularly used to validate reagents, preparation methods and staining procedures?

5.5.2 ●

For lymphocyte subset analysis:





Are lymphocytes gated for analysis? 5.5.1 ●

Are results of analysis of lymphocyte subset corrected for gating purity? 5.5.1 ●

Are markers set to distinguish fluorescence-negative and positive cell populations?

5.5.1 ●

Is an age- and sex-specific reference interval established for cell subsets? 5.5.5 ●

For leukaemia and lymphoma immunophenotyping:

Is the panel of monoclonal antibodies sufficiently comprehensive to determine lineage of differentiation of abnormal cells?

5.5.1 ●

Are methods available to distinguish cytoplasmic and surface immunoglobulin staining?

5.5.1 ●

Is a method available to confirm nuclear staining, eg TdT? 5.5.1 ●

For DNA content and Cell Cycle Analysis:

Are there established criteria for determining acceptable linearity for DNA content using control cells of known DNA fluorescence for testing with each specimen?

5.5.1 ●

Are the analytical procedures and concentration of nuclear acid-specific dye based upon established methodology?

5.5.1 ●

Are specimens treated with RNAse if the nucleic acid dye used is not DNA-specific?

5.5.1 ●

Are there analytical criteria for the identification of aneuploid cell population in the test specimen?

5.5.1 ●

For Cells of Interest in Rare Occurrence:





Is the mode (e.g., single-platform or dual-platform) of analysis stated in the report?

5.5.1 ●

Are there procedures to distinguish fluorescence-negative and positive cell populations?

5.5.1 ●


Does the immunophenotyping report contain: 5.8.3

- description of specimen / tissue studied? 5.8.3 ●

- interpretation (such as the immunophenotype of abnormal cellular population) and clinical significance?

5.8.3 ●

- diagnosis and classification of haematolymphoid malignancies according to the WHO classification?

5.8.4 ●

Documents

Checklist for SC No. 28 Haematology Annex - Issue No. 3…