Suite # 113-114, Level 1, Master Mind IV, Royal Palms, Aarey Colony,
Goregaon East, Mumbai – 400 065. India.
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ON SITE ASSESSMENT REPORT
ISO 15189:2012 - Medical Laboratories –
Requirement for quality and competence
SUPPLEMENTARY CHECKLIST - HEMATOLOGY INSPECTION CHECKLIST
Part-I: GENERAL INFORMATION
ACCAB Reference No.: / Date(s) of Assessment:
Assessment Type: / Pre – Assessment / Initial Assessment / Surveillance Visit
Re - Assessment / Extension of Scope / Re-Instatement Visit
Short Notice Visit / On-site Clearance
Assessment Team:
Assessor / Technical Expert(s)::
Persons Interviewed:
Laboratory Details:
Laboratory’s Name:
Address:
Country: / Postcode:
Telephone No. / Fax. No.
Email address: / Web Site:
Principal Contact Name: / Designation:
part - II DETAILED checklist: HEMATOLOGY INSPECTION CHECKLIST
ClauseNo. / Requirement / (Doc. Ref. / Clause No.) / assessment COMPLIANCE
Y/N/NA / NOTES
1.0 / HEMATOLOGY INSPECTION CHECKLIST
1.1 / Is a specimen collection manual available at all collection sites?
1.2 / Does the specimen collection manual include:
1.2.1 / Patient preparation
1.2.2 / Specimen type and amount
1.2.3 / Proper handling
1.2.4 / Labelling instructions
1.3 / Are there written criteria for specimen rejection?
2.0 / Quality Control
2.1 / Are controls run and documented on each day of use?
2.2 / Are control specimens tested in the same manner and by the same personnel as patient samples?
2.3 / Is quality control data reviewed at least monthly by the laboratory director or designate and is this review documented?
2.4 / Are the day of use control results verified for acceptability before reporting patient results?
2.5 / Are tolerance limits established for the controls run on each day of use?
2.6 / Are criteria for referral of “out of control” results to the supervisor and/or senior staff identified?
2.7 / Is there evidence of documented corrective action taken when controls on day of use exceed defined tolerance limits?
2.8 / Does the documentation include:
2.8.1 / What was out of control?
2.8.2 / Why the analysis was out of control?
2.8.3 / Corrective action taken?
2.8.4 / Signature/initials of individual responsible
2.9 / Is lot number change of quality control material documented on the quality control record?
2.10 / Are quality control records retained for at least two years?
2.11 / Are quality control statistics (ie. SD and CV) calculated at specified intervals to define analytical imprecision?
2.12 / Are control data organized and presented so they can be evaluated daily by technical staff to detect problems, trends, etc.?
3.0 / Procedure Manual
3.1 / Is a current procedure manual available for laboratory staff?
3.2 / Is the procedure manual maintained as per the documented procedure?
3.3 / Are the following included for each procedure: (if applicable)
3.3.1 / Purpose
3.3.2 / Specimens (type, source, amount, storage)
3.3.3 / Equipment and Materials required
3.3.4 / Preparation and storage of reagents, standards and controls
3.3.5 / Procedure – including Step by step instructions
3.3.6 / Directions for calibration
3.3.7 / Derivation of results (ie. mathematical calculations, dilutions)
3.3.8 / Quality control
3.3.9 / Linearity limits
3.3.10 / Precision
3.3.11 / Reference ranges
3.3.12 / Critical values
3.3.13 / Reporting results (units, stats, critical values)
3.3.14 / Safety
3.4 / Is there documentation of annual review of the procedure manual by the laboratory director or designate?
3.5 / Does the laboratory have a system documenting review of procedure manuals by personnel, relevant to their scope of testing?
3.6 / Are all changes in methodology signed and dated by authorized staff?
3.7 / Are all new procedures reviewed by the medical director or designate?
3.8 / Are discontinued procedures retained for two years after the procedure is taken out of service?
3.9 / Is there a current file of manufacturer’s inserts?
3.10 / Are there adequate and up to date reference text books available to laboratory staff?
4.0 / Reagents/Supplies
4.1 / Are all reagents/supplies used within their expiry date?
4.2 / Are all reagents labelled with:
4.2.1 / Date prepared or opened
4.2.2 / Expiry date
4.2.3 / Content and concentration
4.3 / Are all reagents/supplies stored according to manufacturer’s instructions?
4.4 / If there are multiple components of a reagent kit, does the laboratory use components of reagent kits only within the same kit lot, unless otherwise specified by the manufacturer?
4.5 / Is there a record of reagent lots available?
5.0 / Instruments and Equipment
5.1 / Is there a procedure for maintenance of all instruments and equipment?
5.2 / Are there instructions for troubleshooting?
5.3 / Are service records maintained for the life of the instrument, plus two years?
5.4 / Is there emergency power for instruments and equipment?
5.5 / Are instruments equipped with surge protection? (this also includes computers)
5.6 / If the laboratory uses more than one instrument/method to test for a given analyte, are the instruments/methods checked against each other at least twice a year for correlation of results?
5.7 / Are there defined tolerance limits for result agreement of inter-instrument assays?
5.8 / Does the laboratory have a procedure for evaluating automatic pipette systems for carryover?
5.9 / Are pipettors and dilutors (fixed volume or adjustable) checked at least annually for accuracy and reproducibility, and results recorded?
5.10 / Is the temperature of water baths and/or heat blocks checked on days of use?
5.11 / Is the temperature of refrigerators and other temperature dependent equipment documented daily:
5.11.1 / Room temperature
5.11.2 / Freezer(s)
5.11.3 / Refrigerator(s)
5.12 / Is there evidence of review of instrument
maintenance and temperature by a
supervisor?
5.13 / Is this review documented?
5.14 / Is there a procedure available if acceptable
temperature ranges are exceeded?
6.0 / Testing
6.1 / Calibration Verification – is the process of confirming that the current calibration settings remain valid for a method.
6.1.1 / Is there documentation of calibration as recommended by the manufacturer?
6.1.2 / At change of reagent, is your calibration verified by performing QC?
6.1.3 / Are criteria established for frequency of calibration verification?
6.2 / Linearity – is the range of analyte values that a method can directly measure on the specimen without any dilution, concentration or other pre-treatment not part of the usual assay process.
6.2.1 / Is linearity validated initially as part of the instrument validation prior to putting into service?
6.2.2 / Is there documentation of linearity?
7.0 / Specimen Handling
7.1 / Are all blood specimens collected in anticoagulant for hematology testing mixed thoroughly immediately before analysis?
7.2 / Are CBC specimens checked for clots (visual, applicator sticks, or automated analyzer histogram inspection/flags) before reporting unexpected results?
7.3 / Are CBC specimens checked for significant ‘in vitro’ hemolysis and possible interfering lipemia before reporting results?
7.4 / Are all coagulation specimens collected into 3.2% sodium citrate?
7.5 / Are there documented guidelines for detection and special handling of specimens with elevated hematocrits?
7.6 / Are coagulation specimens checked for clots (visual, applicator sticks or by analysis of testing results) before reporting unexpected results?
7.7 / Are all coagulation tests performed on fresh plasma, or is the platelet-poor plasma frozen until testing can be performed?
8.0 / Complete Blood Count (CBC) Instruments
8.1 / Are background counts performed and documented on the diluent and lysing agent to check for contamination?
8.2 / When assayed controls are used for CBC instruments, do control values correspond to the methodology and have target values (mean and QC ranges) been verified or established by the laboratory?
8.3 / Are there data that annually compare results obtained for patient specimens analyzed in the multiple sample modes of the blood analyzer (e.g. “open” and “closed” modes) to ensure they are in agreement?
8.4 / Is there a documented procedure available for correcting automated WBC counts for the presence of nucleated red cells or megathrombocytes?
8.5 / Is there a documented procedure to detect and correct false CBC results that may be clinically significant? (lipemia, cold agglutinins)
8.6 / Are red cell indices (MCV, MCH, MCHC) monitored routinely to detect random errors?
8.7 / Is there an adequate system (such as microscopic correlation with the blood film) to prevent reporting of false platelet counts? (platelet clumps, giant platelets or platelet satellitism)
8.8 / Does the laboratory examine a blood film?
8.9 / If significant numbers of microcytic erythrocytes and/or small cell fragments are detected/suspected, is the platelet count determined or verified using an alternate method?
9.0 / Automated Differential Counters
9.1 / Is there documentation to indicate that the automated method was evaluated in the laboratory against previous automated or manual methods before it was placed into routine use?
9.2 / Does the quality control procedure include all parameters reported by your analyzer?
9.3 / Does the laboratory have a procedure for correlation of manual and automated differentials?
9.4 / Has the laboratory established criteria for reviewing leukocyte differential data, flagged by the automated differential counter?
10.0 / Reticulocyte Count
10.1 / Is there documentation that the automated method was evaluated against previous manual or automated reticulocyte methods before it was placed into routine use?
10.2 / Are there documented criteria for identifying samples that may give false reticulocyte results by the automated method?
10.3 / Are reticulocyte counts reported as an absolute count?
11.0 / Blood Films
11.1 / Are blood films labelled with two unique identifiers and the date?
11.2 / Are blood films of good quality and well stained?
11.3 / Does the laboratory have a process to ensure that staff is reporting blood films consistently?
11.4 / Is erythrocyte and platelet morphology reported as part of a manual WBC differential and/or blood film review?
11.5 / Is erythrocyte morphology examined for the presence of parasites?
11.6 / Is the platelet count estimated routinely when performing morphologic evaluations?
11.7 / Are differential WBC reported in absolute values?
11.8 / Are there written criteria for referral to a pathologist?
11.9 / Are peripheral blood smears that are reviewed by a pathologist retained for one year?
11.10 / Are normal blood films retained for at least one week?
12.0 / Bone Marrow Preparation
12.1 / Are specimens, slides and biopsies properly labelled?
12.2 / Is the bone marrow smear preparation and staining satisfactory for interpretation?
12.3 / Are fixed sections of bone marrow particles and/or touch preps available as required?
12.4 / Are iron stains done for evaluation of iron stores?
12.5 / Are the following special stains used:
12.5.1 / Acid phosphatase
12.5.2 / ASD chloracetate esterase (Leder)
12.5.3 / Giemsa
12.5.4 / Non-specific esterase
12.5.5 / PAS (periodic acid Schiff)
12.5.6 / Sudan black
12.5.7 / Myeloperoxidase
12.5.8 / TdT (terminal deoxynucleotidyl transferase)
12.6 / Are all special stains checked for reactivity each day of use?
13.0 / Bleeding Times
13.1 / Is a standardized template used for bleeding time?
13.2 / Is a platelet count done on the day of the test?
13.3 / If so, is the lowest acceptable criteria defined before bleeding time is tested?
14.0 / Coagulation
14.1 / Are therapeutic ranges stated on the report?
14.2 / Is there a system to measure the actual platelet count of the “platelet-poor” plasma used for coagulation tests?
14.3 / Are the partial thromboplastin time (PTT) or activated partial thromboplastin time ( aPTT or APTT)performed at 37 C?
14.4 / Are patient tests done in duplicate?
14.5 / Are tolerance limits between duplicate assays defined?
14.6 / Are two levels of control performed every 8 hours of operation?
14.6.1 / For quantitative tests, has a statistically valid target range (mean, SD, CV) been established for each lot of control material?
14.7 / Is there criteria established for determining when alternative procedures should be performed (e.g. Hyperbiliruinbemia, turbiditiy, etc.)?
14.8 / Is there documentation that the ISI is specific to the particular PT reagent and instrumentation used?
14.9 / Is the calculation of the INR adjusted for every new lot of PT reagent, changes in types of reagent or change in instrumentation?
14.10 / Is the geometric mean of the PT reference interval used in the INR calculation?
14.11 / Is there documentation that the APTT-based heparin therapeutic range is established and validated?
14.12 / Are reference intervals for PT validated for the current reagent lot number?
14.13 / Are reference intervals for APTT validated for the current reagent lot number?
15.0 / Platelet Function Studies
15.1 / Are blood specimens for platelet aggregation and initial platelet function studies handled at room temperature before testing?
15.2 / If platelet aggregation studies are performed by an optical aggregation methodology using platelet rich plasma (PRP), is there a defined optimal platelet concentration?
15.3 / Are platelet aggregation studies completed within 4 hours of collection?
16.0 / D-dimer
16.1 / Are the limitations of the methodology or the cut off value for exclusion of VTE included with the patient report?
16.2 / Does the laboratory report D-dimer in FEU g/L?
16.3 / Is there documentation of annual verification of calculated results?
16.4 / Has the D-dimer method been evaluated for the exclusion of venous thromboembolism?
17.0 / Abnormal Hemoglobin Detection
17.1 / Are controls containing at least three known major hemoglobins, including both a sickling and a non-sickling hemoglobin applied with the patient specimen(s) and are separations satisfactory?
17.2 / Are all samples with hemoglobin variants migrating in “non-A” , “non-S” positions on alkaline electrophoresis, isoelectric focusing or HPLC further defined with electrophoresis at acid pH or other acceptable methods?
17.3 / Are samples that appear to have Hb S in the primary screening further examined to confirm the presence of Hb S by:
17.3.1 / Performing a second procedure, or
17.3.2 / Indicate on report, specimen referred for confirmation
17.4 / Are all samples that have Hb S as the predominant band by the primary method and confirmed as sickling further examined to determine whether the “Hb S” band contains solely Hb S or both Hb S and Hb D, Hb G or other variants?
17.5 / Are abnormal hemoglobin results reviewed by a pathologist or other qualified physician before result reporting?
18.0 / MALARIA AND OTHER BLOOD PARASITES
18.1 / Does the laboratory perform a Rapid Diagnostic Test (RDT) kit for malaria?
18.2 / Is the RDT result reported as a preliminary report?
18.3 / Are both thick and thin films made to provide thorough examination for blood parasites?
18.4 / Are an adequate number of fields examined under oil immersion?
18.5 / When blood films are positive for malarial parasites, is the level of parasitemia reported along with the organism identification?
18.6 / Is the blood smear referred to a pathologist for confirmation of parasite presence and speciation?
18.7 / Are the results of positive blood parasite films reported in accordance with provincial public health requirements?
19.0 / Body Fluids
19.1 / Please indicate types of body fluids tested in your laboratory:
Type of fluid:
19.2 / Are there defined lower limits for counting body fluid cells (erythrocytes, nucleated cells) below which the use of automated cell counters is not reliable?
19.3 / Does the laboratory indicate, on the report, that results may be inaccurate if the fluid specimen is partially clotted or has cell clumps or debris on the counting chamber?
19.4 / Are background counts performed and documented on the diluents fluid and lysing agent to check for contamination?
19.5 / Does the laboratory have a procedure to detect clumps of cells?
19.6 / For differentials, are stains always used to facilitate classification of nucleated cell types?
19.7 / Are slides with suspected malignant cells reviewed by a pathologist or other qualified physician before final results reporting?
19.8 / For samples counted using a hemocytometer, is each body fluid sample counted in duplicate?
20.0 / SEMEN ANALYSIS
20.1 / Does your laboratory perform semen analysis as part of a fertility investigation?
20.2 / If yes, is a full assessment made to include:
20.2.1 / Volume
20.2.2 / Viscosity
20.2.3 / pH
20.2.4 / Motility
20.2.5 / Abnormalities of liquefaction
20.2.6 / Viability
20.2.7 / Morphology
20.3 / Is testing performed within one hour?
20.4 / Is each sample counted in duplicate?
20.5 / Is a pathologist, supervisor or experienced technologist available for consultation?
Bibliography:
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- College of Physicians & Surgeons of Saskatchewan
- College of Physicians & Surgeons of Alberta
- Various other internet sources.
CRA-F-05-15189-S-11-HIC / RD-00-01/07/2014 / Page 1 of 13
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