凝血相关Checklist
1.Controls should verify assay performance at relevant decision points. The selection of these points may be based on clinical or analytical criteria.
Evidence of Compliance:
✓Records of QC results including external and electronic/procedural/built-in control systems AND
✓Records documenting in-house verification of electronic/procedural/built-in control systems, if used
2. For quantitative tests, a statistically valid target range (e.g. mean, SD, CV) is verified or established for each lot of control material by repetitive analysis in runs that include previously te sted control materials.
Evidence of Compliance:
✓Written procedure defining method used to establish target range AND
✓Records of target range determination or verification, as applicable
3.For numeric QC data, Gaussian or other quality control statistics (e.g. SD and CV) are calculated mont
hly to define analytic imprecision.
Evidence of Compliance:
✓Written procedure for monitoring analytic imprecision including statistical analysis of data AND
✓QC records showing monthly monitoring of imprecision
4. The laboratory has an action protocol when data from precision statistics change significantly from previous data.
Evidence of Compliance:
✓Written protocol for investigation, documentation and corrective action should a significant change in precision statistics occur AND
✓Records of investigation and corrective actions taken
5.Control specimens are tested in the same manner and by the same personnel as patient samples.
Evidence of Compliance:
✓Records reflecting that QC is run by the same personnel performing patient testing
6. The results of controls are reviewed for acceptability before reporting results.
NOTE: It is implicit in QC logic that patient test results are not reported when controls do not yield
acceptable results.
Evidence of Compliance:
✓Written policy/procedure stating that controls are reviewed and acceptable prior to reporting patient results AND
✓Evidence of corrective action taken when QC results are not acceptable
7.There is documentation of corrective action when control results exceed defined acceptability limits.
8.Quality control data are reviewed and asse ssed at least monthly by the laboratory
director or designee.
Evidence of Compliance:
✓Records of QC review with documented follow-up for outliers, trends or omissions
9.There is a documented procedure regarding clearing (flushing) of the volume of intravenous lines before drawing samples for hemosta sis te sting.
10.There is a documented procedure regarding clearing (flushing) of the volume of
intravenous lines before drawing samples for hemosta sis te sting.
Evidence of Compliance:
✓Written procedure defining the use of 3.2% buffered sodium citrate for coagulation specimen collection OR procedure with an alternative anticoagulant defined with validation data
11. There are documented guidelines for rejection of under- or overfilled collection tube s.
Evidence of Compliance:
✓Records of rejected specimens
12.There are documented guidelines for detection and special handling of specimens with elevated he
matocrits.
13. Coagulation specimens are checked for clots (visual, applicator sticks, or by analysis of te sting re sults) before te sting or reporting re sults.
14. Coagulation tests are promptly performed on fresh plasma, or the platelet-poor
plasma is frozen until testing can be performed.
Evidence of Compliance:
✓Written procedure defining specimen stability requirements and sample preservation for delays in coagulation testing
15.Platelet functional studie s (platelet aggregation or initial platelet function te st) are performed within an appropriate period after venipuncture.
Evidence of Compliance:
✓Written procedure defining specimen stability for platelet function studies AND
✓Records reflecting completion of testing within defined time period
16.Patient results are reported with accompanying reference inte rvals or interpretive ranges.
17.For PT, there is documentation that the ISI is appropriate to the particular PT reagent and instrumentation used.
Evidence of Compliance:
✓Record showing information from the instrument/reagent manufacturer OR use of an ISI calculated from laboratory specimens
18.The calculation of the INR is adjusted using the appropriate ISI value for every new lot of PT reagent, changes in type s of reagent, or change in instrumentation.
Evidence of Compliance:
✓Records showing that the ISI values used in the INR calculation were appropriate for new lots and types of PT reagent and for any other changes
19.The appropriate geometric mean of the PT reference interval is used in the INR calculation.
Evidence of Compliance:
✓Written procedure for determining the geometric mean and its use in the INR calculation AND
✓Records for geometric mean determinations and INR calculations for each instrument and PT reagent lots used
20. There are checks of patient reports for correct INR calculations, patient values, and reference ranges under the following circumstance s.
1. Change in lot or type of PT reagent
2. Change in instrument
3. Establishment of new PT reference rangedocumented evidence
4. Change in INR calculation
5. At defined intervals, in the absence of the above changes
Evidence of Compliance:
✓Records of patient report checks documented at defined frequency
21.There is documentation that the aPTT-based heparin therapeutic range is established and subsequently verified using an appropriate technique.
Evidence of Compliance:
✓Written procedure defining criteria for establishing and verifying the aPTT heparin therapeutic range
22.Reference intervals for PT and aPTT are current for the reagent or lot number, and are appropriately determined.
Evidence of Compliance:
✓Written procedure with defined criteria for determining reference intervals for PT and aPTT AND
✓Reports showing verification of the reference interval with changes of lot or reagent AND
✓Patient reports reflecting the use of the correct reference intervals
23.Recommendations are available to clinicians concerning which laboratory te sts to
use for monitoring heparin, low molecular weight heparin, direct thrombin inhibitors (e.g. lepirudin, bivalirudin, argatroban) and/or oral anticoagulant therapy, and the therapeutic range for the tests.
Evidence of Compliance:
✓Memorandums to physicians, test reference guide, interpretive comments in patient reports, or other documented mechanism for providing recommendations to physicians for ordering and interpreting coagulation tests used to monitor anticoagulant therapy
24. Pipettors and dilutors (fixed volume or adjustable) are checked at least annually
for accuracy and reproducibility, (gravimetric, colorimetric or other verification procedure), and results recorded.
25.Volumetric glassware is of certified accuracy (Cla ss A), or checked by the
laboratory to verify accuracy.
Evidence of Compliance:
✓Glassware marked Class A OR NIST certificate OR validation study of accuracy for noncertified glassware
26. When the laboratory use s retained patient samples, statistically defined limits are
used to determine agreement of sequential assays of a given sample.
Evidence of Compliance:
✓Written QC procedure defining the control limits for repeat analysis of retained patient specimens AND
✓QC records showing the use of the defined control limits
27.Tests for defining or monitoring disseminated intravascular coagulation (DIC) problems are available, if applicable to the patient population served.
28.There is a system to at least annually measure the actual platelet count of the
"platelet poor" plasma used for many coagulation tests.
Evidence of Compliance:
✓Written procedure defining method for measuring platelet concentration of platelet-poor plasma AND
✓Records of platelet concentration checks on all centrifuges used to prepare platelet-poor Plasma
29.Coagulation tests (e.g. PT, aPTT, fibrinogen, and factor assays) are performed at 37°C.
Evidence of Compliance:
✓Records of temperature checks or automated internal instrument temperature monitoring
30.Controls are run using two different levels of control material each 8 hours of
patient testing and each time there is a change in reagents.
Evidence of Compliance:
✓Records of QC results including external and electronic/procedural/built-in control systems at defined frequency AND
✓Records documenting in-house validation of electronic/procedural/built-in control systems, if used.
31.For quantitative tests, a valid acceptable range has been established or verified for each lot of control material.
32. For electromechanical coagulation systems, if the system has reusable probes to detect a clot, documented guidelines for cleaning the probes are available.
33. For manual coagulation testing (e.g. PT, aPTT, fibrinogen) determinations are performed in duplicate and criteria for agreement are defined.

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