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Revised: 09/27/2007 The College of American Pathologists (CAP) Ch ecklists are posted on the CAP's Web site for information only. If you are enrolled in the ation Program and are preparing for an inspection, you must use the Check lists that were mailed in your application or College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 2 of 132 HEMATOLOGY - COAGULATION SUMMARY OF CHANGES............................................................................................................. INSPECTION TECHNIQUES – KEY POINTS............................................................................................. LABORATORY SAFETY.............................................................................................................. PROFICIENCY TESTING............................................................................................................ QUALITY MANAGEMENT AN D QUALITY CONTROL......................................................................................... WAIVED TESTS................................................................................................................... GENERAL ISSUES................................................................................................................. PROCEDURE MANUAL............................................................................................................... SPECIMEN COLLECTION AND HA NDLING - HE MATOLO GY........................................................................... SPECIMEN COLLECTION AND HA NDLING - C ON.......................................................................... RESULTS REPORTING - GENERAL.................................................................................................... RESULTS REPORTING - COAGULATION................................................................................................ REAGENTS....................................................................................................................... INSTRUMENTS AND EQUIPMENT...................................................................................................... College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 3 of 132 Manual Coagula ems..................................................................................................... 114 Coagulation Studies by Electro phoresis......................................................................................... 116 D-Dimer Studies................................................................................................................ 116 Coagulation Factor Assays en)............................................................................... 120 udies................................................................................................................. 122 Coagulation Tests Based on Dir ect Measurement of Analytes...................................................................... 123 College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 4 of 132 9/27/2007 Edition ted in this edition of the checklist, or in the two editions immediately previous to this one. customized based on the laboratory's activity menu. The listing below is comprehensive; therefore some of the questions included may not appear in th applicable to the testing performed by the laboratory. Note: For revised checklist questio ns, a comparison of the previous and current text may be found on NEW Checklist Questions Question Effective Date HEM.05075 09/27/2007 HEM.21575 09/27/2007 HEM.35347 09/27/2007 HEM.35759 09/27/2007 HEM.35762 09/27/2007 HEM.35765 09/27/2007 HEM.35768 09/27/2007 HEM.35822 09/27/2007 HEM.35892 09/27/2007 HEM.35895 09/27/2007 HEM.35898 09/27/2007 HEM.35901 09/27/2007 HEM.35909 09/27/2007 HEM.35910 09/27/2007 HEM.35911 09/27/2007 HEM.35912 09/27/2007 HEM.35913 09/27/2007 HEM.35914 09/27/2007 HEM.35915 09/27/2007 HEM.35916 09/27/2007 HEM.35918 09/27/2007 HEM.35919 09/27/2007 HEM.35920 09/27/2007 HEM.35921 09/27/2007 HEM.35922 09/27/2007 HEM.35923 09/27/2007 HEM.35924 09/27/2007 College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 5 of 132 HEM.17385 10/31/2006 HEM.18038 10/31/2006 HEM.18691 10/31/2006 HEM.19344 10/31/2006 HEM.23453 10/31/2006 HEM.23476 10/31/2006 HEM.23787 10/31/2006 HEM.37905 10/31/2006 HEM.37910 10/31/2006 HEM.37915 10/31/2006 HEM.37923 10/31/2006 HEM.37925 10/31/2006 HEM.37930 10/31/2006 HEM.37935 10/31/2006 HEM.38003 10/31/2006 HEM.38004 10/31/2006 HEM.38005 10/31/2006 HEM.38006 10/31/2006 HEM.38007 10/31/2006 HEM.38008 10/31/2006 HEM.13466 04/06/2006 HEM.16732 04/06/2006 HEM.20143 04/06/2006 HEM.20146 04/06/2006 REVISED Checklist Questions Question Effective Date HEM.10185 09/27/2007 HEM.34400 09/27/2007 HEM.35832 09/27/2007 HEM.23360 10/31/2006 HEM.34687 10/31/2006 HEM.34798 10/31/2006 HEM.35100 10/31/2006 HEM.37960 10/31/2006 HEM.37991 10/31/2006 HEM.38002 10/31/2006 HEM.21000 04/06/2006 HEM.23430 04/06/2006 HEM.35851 04/06/2006 College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 6 of 132 Question Effective Date HEM.10200 09/27/2007 HEM.22666 10/31/2006 HEM.37187 10/31/2006 HEM.20250 04/06/2006 HEM.20300 04/06/2006 HEM.20350 04/06/2006 HEM.34150 04/06/2006 College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 7 of 132 The checklists used in connection with the ies by the Commission ege of American Pathologists have been works of the College. The College has boratories that are preparing for such inspections. Except as permitted by section 107, any other use of the checklists constitutes infringement of the College’s copyrights in the checklists. The College will take appropriate legal actio CONTINUING EDUCATION INFORMATION Beginning January 2008, you may earn continuing e click the Education Programs ta itation Program (LAP) Education College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 8 of 132 Ensures that outcomes for any problem areas, such as PT failures and issues/problems identified through the quality management proce Ensures that previously cited deficiencies have been corrected Observe laboratory practices is actually doing. Compare the policy/procedure accurately reflects laboratory pr actice. Note if practice deviates from the documented policies/procedures. amounts of information, and help you clarify your mentation you’ve seen and observations you’ve made. This eliminates th College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 9 of 132 : Choose a representative specimen and “follow" the specimen through the laboratory or section of the orm a comprehensive review of records, including procedure manuals y testing records, instrument maintenance records and method performance validations for the last 2 years, selecting timeframes at the beginning, mid-point, and end of this timeframe. Compare instrument print-outs to patient reports and proficiency testing results to ensure accurate data entry. If problems are identified, choose additional tests or months to review. ing problem have been resolved: College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 10 of 132 Proficiency testing Alternative assessment College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 11 of 132 NOTE: The list of analytes for which CAP require ] or by phoning 800-323-4040 (o r 847-832-7000), option 1. A performs patient testing. Participation in profic iency testing may be through CAP Surveys or another proficiency testing provider accepted by CAP. L aboratories will not be penalized if they are unable to CAP and CAP-accepted PT programs are oversubscribed, CMS requires the laboratory to attempt to For purposes of photomicrograph identification in CAP Surveys, it is strongly recommended that the current CAP Surveys Hematology Glossary (Blood Iden tification section) be re adily available to the COMMENTARY: REFERENCES: 1) Department of Health and Huma Services. Clinical laboratory improveme nt amendments of 1988; final rule. 28):7146 [42CFR493.801]; 2) Westgard JO, College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 12 of 132 HEM.10160 Phase II N/A YES NO For tests for which CAP does not require PT, do es the laboratory at least semiannually 1) participate in external PT, or 2) exercise an alternative pe ] or by phoning 800-323-4040 (or 847-832-7000), option 1. COMMENTARY: REFERENCES: 1) Department of Health and Huma Services. Clinical laboratory improveme nt amendments of 1988; final rule. College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 13 of 132 iciency testing program. Pr oficiency testing records College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 14 of 132 COMMENTARY: College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 15 of 132 r (even if the second laboratory is in the same health care system). COMMENTARY: REFERENCE: Department of H ealth and Human Services, Cent Services. Clinical laboratory improveme nt amendments of 1988; final rule. ()() ***************************************************************** QUALITY MANAGEMENT AND QUALITY CONTROL WAIVED TESTS **NEW** 10/31/2006 HEM.17385 Phase II N/A YES NO For tests that are waived under CLIA-88, does th e laboratory follow manufacturer instructions? COMMENTARY: **NEW** 10/31/2006 HEM.18038 Phase II N/A YES NO Are control results documented for quantitat ive and qualitative tests, as applicable? College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 16 of 132 controls, if (and only if) an unacceptable instrument control automatically locks the instrument and prevents release of patient COMMENTARY: **NEW** 10/31/2006 HEM.18691 Phase II N/A YES NO Is there evidence of corrective action when contro l results exceed defined acceptability limits? COMMENTARY: **NEW** 10/31/2006 HEM.19344 Phase II N/A YES NO Are the results of controls verified for acceptability before reporting results? COMMENTARY: NOTE: The remaining questions in this checklis interinstrument comparisons do not apply to waiv ed tests. The checklist section “RESULTS REPORTING-COAGULATION” also is not applicable to waived tests. HEM.20000 Phase II N/A YES NO Does the hematology laboratory have a wri tten quality management/quality control (QM/QC) College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 17 of 132 NOTE: The QM/QC program in the hematology labor analytic (reporting) ation; specimen collec lt reporting. The program must College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 18 of 132 NOTE: The goal is to have scient COMMENTARY: HEM.20050 Phase II N/A YES NO For numeric QC data, are Gaussian or calculated at specified intervals NOTE: For CBC data where stabilized whole blood is no COMMENTARY: REFERENCES: 1) Mukherjee KL. Introductory mathem College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 19 of 132 for the same control lot and instrume nt model show SD/CV values mark COMMENTARY: HEM.20120 Phase II N/A YES NO Are control specimens tested in the same manner It is implicit in quality control (QC) that cont participate in QC on a regular basis. To the extent po ssible, all steps of the testing process must be COMMENTARY: REFERENCE: Department of H ealth and Human Services, Cent Services. Clinical laboratory improveme nt amendments of 1988; final rule. ()() HEM.20140 Phase II N/A YES NO Are the results of controls verified for acceptability before reporting results? NOTE: It is implicit in QC logic acceptable results. When an unacceptable QC result is obtained, patient/client test results obtained since the last acceptable test run must be re-evaluat College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 20 of 132 REFERENCE: Department of H ealth and Human Services, Cent Services. Clinical laboratory improveme nt amendments of 1988; final rule. ()(Oct 1):1046[42CFR493.1282(b)(2)]. **NEW** 04/06/2006 HEM.20143 Phase II N/A YES NO Is there documentation of corrective action when limits? College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 21 of 132 HEM.20150 Phase II N/A YES NO Is there evidence of ongoing evaluation of instrument maintenance and function, College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 22 of 132 NOTE: The CAP does NOT require supervisory review 42CFR493.1489(b)(5) when a qualified gene ral supervisor is not present. COMMENTARY: REFERENCE: Department of H ealth and Human Services, Cent Services. Clinical laboratory improveme nt amendments of 1988; final rule. ()()493.1463(c)]: 7183 [42CFR493.1489(b)(1) and 42CFR493.1489(b)(5)]. ----------------------------------------------------------------- PROCEDURE MANUAL College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 23 of 132 NOTE 3: Card files or similar systems that summarize key information are acceptable for use review by the inspector at the time of the CAP inspection. e dated/signed (manual or electronic), and view). Documentation of revi such as “reviewed by [name of reviewer] on [date of review]” in the electr College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 24 of 132 monthly. Paper/electronic signature review must be at the level of each procedure, or as multiple COMMENTARY: REFERENCES: 1) Department of Health and Huma Services. Clinical laboratory improveme nt amendments of 1988; final rule. College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 25 of 132 HEM.21100 Phase II N/A YES NO hip, does the new director ensure (over a reasonable period of are well-documented and undergo at least annual review? COMMENTARY: REFERENCE: Department of H ealth and Human Services, Cent Services. Clinical laboratory improveme nt amendments of 1988; final rule. () HEM.21150 Phase II N/A YES NO College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 26 of 132 HEM.22000 Phase II N/A YES NO Are all blood specimens collected logy testing mixed thoroughly immediately before analysis? NOTE: There must be documentation that specim sure reproducibility of CB platforms may be adequate to maintain even cellular distribution of previously well-mixed specimens, College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 27 of 132 clumping. quately labeled with patient identification College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 28 of 132 NOTE: This applies to capillary tubes used College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 29 of 132 dwelling lines that may be cont ain heparin, the line should be flushed with 5 mL of saline, and the first 5 mL of blood or 6-times the line volume (dead space volume College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 30 of 132 1992;3:94-101; 3) Laxson CJ, Titler MG. Drawing coagulation studies from integrative literature review. College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 31 of 132 NOTE: The recommended proportion of blood to the COMMENTARY: College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 32 of 132 HEM.22871 Phase II N/A YES NO r clots (visual, applicator stic results) before testing or reporting results? NOTE: Coagulation specimens must be checked for clots of any size. Clotted specimens will have extremely low levels of fibrinogen and variably decrease d levels of other coagulat results of the PT, aPTT, fibrinogen and other coagul ation assays will be inaccurate or unobtainable. Checking for clots may be done with applicator sticks or by visual inspection of centrifuged plasma for College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 33 of 132 If testing cannot be performed within these times, COMMENTARY: College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 34 of 132 HEM.23000 Phase II N/A YES NO ormal ranges) established or verified by the laboratory for the NOTE: Age- and sex-specific refere nce intervals (normal values) must population studied (refer to CLSI guideline C28, referenced below). If a formal reference interval st cal, then the laboratory College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 35 of 132 NOTE: The results of commercial quality control plas ith a computerized laborat ory information system) is recommended. COMMENTARY: ey of aPTT reporting in Canadian medical College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 36 of 132 HEM.23120 Phase II N/A YES NO Is there documentation of prompt notification of the physician (or other clinical personnel responsible for patient care) of results of all critical results? COMMENTARY: REFERENCES: 1) Kost GJ. Critical limits for urgent clinician notification at US medical centers. 1990;263:704-707; 2) Department of Health a Medicaid Services. Clinical laboratory im provement amendments of 1988; final rule. 2003(Jan 24):[42CFR493.1291(g)]; 3) Steindel SJ, Heard NV. Critical values: data analysis and d, IL: College of American Pathol critical limits to improve patient outcome. Ben-Ezra J. Serial College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 37 of 132 Howanitz PJ. Physician satisfaction and emergenc y department laboratory test turnaround time. 2001;125:863-871; 5) Howanitz JH, Howanitz PJ. Timeliness as a quality attribute e(s); INR = International Normalized Ratio(s); ISI = International Sensitiv HEM.23220 Phase II N/A YES NO For PT, is there documentation that the ISI is appropriate to the particular PT reagent and instrumentation used? NOTE: The laboratory must demonstrate appropriatene ss of its ISI, a measurement of the sensitivity College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 38 of 132 decreased levels of the vitamin K-depe s should be implemented wherever the INR is College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 39 of 132 GM = antilog [(log(X1) + log(X2) + log(X3) + . . . log(Xn))/n] COMMENTARY: REFERENCES: 1) NCCLS. One-stage prothrombin time (PT) test and activated partial thromboplastin time (aPTT) test; approved guideline H47-A. Wayne, PA: NCCLS, 1996 ; 2) Fairweather RB, College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 40 of 132 **NEW** 10/31/2006 HEM.23453 Phase I N/A YES NO Is there documentation that the aPTT-based heparin therapeutic range is established and subsequently validated when appropriate? NOTE: The heparin-responsiveness of aPTT reagents may change from lot to lot and among different COMMENTARY: REFERENCES: 1) Rosborough TK. Comparison of an partial thromboplastin time in 2,773 plasma samples from unfracti one of two ways. (1) The aPTT and heparin activity heparin activity or (2) College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 41 of 132 COMMENTARY: REFERENCES: 1) Rosborough TK. Comparison of an partial thromboplastin time in 2,773 plasma samples from unfracti College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 42 of 132 used, but the heparin assay (factor Xa inhibition) heparin or danaparoid, monitoring is often not necessa ry, but the heparin assay (Xa inhibition assay) nerally insensitive to the using the aPTT. The tests available should be app pharmacy formulary at the medical institution. The laboratory should work closely with the pharmacy COMMENTARY: REFERENCES: 1) Rosborough TK. Comparison of an partial thromboplastin time in 2,773 plasma samples from unfracti College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 43 of 132 REAGENTS **NEW** 10/31/2006 HEM.23787 Phase II N/A YES NO For waived tests, does the laboratory follow manufacturer instructions for handling and storing COMMENTARY: The remaining checklist questions in the REAGE College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 44 of 132 COMMENTARY: HEM.24100 Phase II N/A YES NO Are all reagents used within their indicated expiration date? COMMENTARY: REFERENCE: Department of H ealth and Human Services, Cent Services. Clinical laboratory improveme nt amendments of 1988; final rule. () HEM.24150 Phase II N/A YES NO Are reagents for functional clotting assays ( e.g. , PT, aPTT, fibrinogen) prepared, stored, and discarded as recommended by the manufacturer? COMMENTARY: othrombin time (PT) test and activated partial thromboplastin time (aPTT) test; approved guideline H47-A. Wayne, PA: NCCLS, 1996. HEM.24575 Phase II N/A YES NO Are new reagent lots and/or shipments checked agai nst old reagent lots wi suitable reference material before or conc urrently with being placed in service? NOTE: The laboratory must run and compare resu performed before or at the same time that new reage known value may include patient samples or control material. For qualitative tests, minimum comparisons in many situations, e "controlled". A weakly positive College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 45 of 132 Appropriate checks must be performed on inert material s to ensure that new lots do not interfere with College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 46 of 132 COMMENTARY: REFERENCES: 1) Curtis RH. Performance veri College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 47 of 132 NOTE: Koehler illumination must be maintained College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 48 of 132 When stabilized whole blood or other commercial pre parations are used for the periodic recalibration College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 49 of 132 . Calibration and Quality Control of Automated Hematology Analyzers; 8-398-1]. NCCLS, 940 West Valley Road, Wayne, Pennsyl HEM.25550 Phase II N/A YES NO Does the initial or primary instrument calibratio College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 50 of 132 College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 51 of 132 . Calibration and Quality Control of Automated Hematology Analyzers; 8-398-1]. NCCLS, 940 West Valley Road, Wayne, Pennsyl Commercial Calibrators Commercially available calibrator materials repr esent a convenient way to ensure that CBC results. Because of differences in t College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 52 of 132 College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 53 of 132 1. Use of preserved or stabilized whole blood controls 2. "Moving average" monitoring 3. College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 54 of 132 mmendations for preparing a whole blood control material. 1998;32:107-111; 6) Springer W, College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 55 of 132 (stabilized control material or retained patient specime ns) is employed. The latter is needed to detect random error and to avoid bias due to masking of dr ift by characteristics of the subpopulations within Laboratories analyzing fewer than 100 CBC specim ens daily (long term average) should not use College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 56 of 132 HEM.25990 Phase II N/A YES NO If a "moving averages" system is comb ined with another control system ( , commercial College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 57 of 132 COMMENTARY: HEM.27330 Phase I N/A YES NO Is there a defined range of CBC values for which these limits are applicable? NOTE: Because imprecision (st cient of variation) is dependent upon the College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 58 of 132 REFERENCES: 1) Department of Health and Huma CLIA programs; CLIA fee collect FR493.1249(a) and (b)]; 2) Stanworth SJ, s of the CBC analyzer ( NOTE: Different modes may involve dilution or a different sample path before analysis. When properly. Re-analysis of a previously analyzed samp le should be performed in the alternate mode(s), College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 59 of 132 COMMENTARY: HEM.30100 Phase II N/A YES NO Is there a documented procedure available and in College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 60 of 132 REFERENCES: 1) Gagne CC, College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 61 of 132 HEM.30250 Phase II N/A YES NO Are upper and lower limits of all reportable para College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 62 of 132 College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 63 of 132 College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 64 of 132 HEM.30650 Phase II N/A YES NO Are performance or tolerance lim its defined for each instrument, component, or procedure in COMMENTARY: HEM.30700 Phase II N/A YES NO College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 65 of 132 HEM.32100 Phase II N/A YES NO If a mechanical timer is us ed, is its accuracy checked at specified intervals? NOTE: Not applicable to electronic timers. COMMENTARY: HEM.32150 Phase II N/A YES NO Is the constant packing time (minimum spin to reach maximum packing before initial use and reassessed when there has b COMMENTARY: College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 66 of 132 HEM.33250 Phase II N/A YES NO When there is leukopenia or thrombocytopen College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 67 of 132 REFERENCE: Department of H ealth and Human Services, Cent Services. Clinical laboratory improveme nt amendments of 1988; final rule. () HEM.33350 Phase II N/A YES NO College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 68 of 132 ed variability in differential leukocyte counts. In: Differential leukocyte counting, CAP conference/ Kalish RJ, Becker K. Evaluation of the Coulter S- rential in a community Ross DW, Bentley SA. Evaluation of an automated hematology system (Technicon H-1). 1986;110:803-808; 4) Clinical and Labor (WBC) Differential Count (Proportional) and Eval ypes are enumerated by the College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 69 of 132 ed variability in differential leukocyte counts. In: Differential leukocyte counting, CAP conference/ Kalish RJ, Becker K. Evaluation of the Coulter S- rential in a community Ross DW, Bentley SA. Evaluation of an automated hematology system (Technicon H-1). 1986;110:803-808; 4) Clinical and Labor (WBC) Differential Count (Proportional) and Eval College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 70 of 132 4) Ross DW, Bentley SA. Evaluation of an au tomated hematology system (Technicon H-1). Leukocyte (WBC) Differential Count (Proporti College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 71 of 132 NOTE: Slides or coverslips must be uniquely identif ied by element(s) such as specimen or accession COMMENTARY: HEM.34400 Phase II N/A YES NO observations among all personnel College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 72 of 132 HEM.34450 Phase II N/A YES NO College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 73 of 132 College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 74 of 132 HEM.34724 Phase I N/A YES NO Are both thick and thin films (routine blood fi lms and/or buffy coat fi COMMENTARY: guideline M15-A. Wayne, PA: NCCLS, 2000; 2) Thomson S, College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 75 of 132 HEM.34946 Phase II N/A YES NO reported in accordance with laboratory policy for COMMENTARY: College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 76 of 132 HEM.35050 Phase I N/A YES NO College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 77 of 132 College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 78 of 132 applications of flow cytome College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 79 of 132 1985;11:97-112; 3) NCCLS. College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 80 of 132 **NEW** 09/27/2007 HEM.35347 Phase I N/A YES NO Are the lines in the counting or motility chambers NOTE: The inspector should examine several chambers. COMMENTARY: HEM.35357 Phase II N/A YES NO For samples counted using a standard hemocytome College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 81 of 132 COMMENTARY: Body Fluid Cell Counting - Instrumental HEM.35414 Phase II N/A YES NO checking for the presence of significant backg round in the diluting fluids and lysing agents. COMMENTARY: HEM.35433 Phase I N/A YES NO Has the laboratory established a sensitivity limit for each class of particle counted? NOTE: The sensitivity li COMMENTARY: (ICSH). Protocol for evaluation of automated blood cell counters. College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 82 of 132 HEM.35452 Phase II N/A YES NO Has the laboratory defined lower limits for counti cells) below which the use of automated or NOTE: The laboratory must have an appropriate pr otocol that limits the use of automated or sensitivity. COMMENTARY: (ICSH). Protocol for evaluation of automated blood cell counters. College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 83 of 132 Body Fluid Nucleated Cell Differentials HEM.35528 Phase I N/A YES NO Is the method for differentiating body fluid ce NOTE: The laboratory should use stained cytocent rifuge preparations to facilitate quantitative College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 84 of 132 HEM.35547 Phase II N/A YES NO appropriate dilution so cells are not crowded, properly stained, adequate ion of cell types that COMMENTARY: College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 85 of 132 COMMENTARY: HEM.35604 Phase II N/A YES NO College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 86 of 132 College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 87 of 132 HEM.35680 Phase II N/A YES NO Are there specific patient instructio ns for collection and prompt delivery of a semen sample to College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 88 of 132 REFERENCE: World Health Organi zation laboratory manual for the ex amination of human semen and sperm-cervical mucus interaction, fourth edition. Ne w York, NY: Cambridge University Press, 1999. HEM.35737 Phase II N/A YES NO Are semen specimens mixed thoroughly before testing? COMMENTARY: REFERENCE: World Health Organi zation laboratory manual for the ex amination of human semen and sperm-cervical mucus interaction, fourth edition. Ne w York, NY: Cambridge University Press, 1999. HEM.35756 Phase II N/A YES NO Are all characteristics of the se e.g. COMMENTARY: REFERENCES: 1) Haugen TB, Grotmol T. pH of human semen. World Health Organization laboratory manual for the examination of human semen and sperm-cervical mucus interaction, fourth edition. New York, NY: Cambridge University Press, 1999. **NEW** 09/27/2007 HEM.35759 Phase I N/A YES NO Is there an additional procedure besides unstain ed bright-field microscopy to ensure the alkaline phosphatase, myeloperoxidase)? COMMENTARY: REFERENCES: 1) World Health Organization laborat ory manual for the examination of human semen and sperm-cervical mucus interactio n, 4th edition. New York: Cambridge College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 89 of 132 Hum Reprod. 1997;12:2418-2421; 3) Zimmermann BS, College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 90 of 132 College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 91 of 132 COMMENTARY: REFERENCE: World Health Organi zation laboratory manual for the ex amination of human semen and sperm-cervical mucus interaction, fourth edition. Ne w York, NY: Cambridge University Press, 1999. HEM.35813 Phase II N/A YES NO ocedure for evaluating a sufficient number of COMMENTARY: REFERENCE: World Health Organi zation laboratory manual for the ex amination of human semen and sperm-cervical mucus interaction, fourth edition. Ne w York, NY: Cambridge University Press, 1999. **NEW** 09/27/2007 HEM.35822 Phase I N/A YES NO Does the laboratory perform viability testing on specimens with low percent motility ( than 30%)? previously motile forms that have subsequently lost mo assessment is useful in College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 92 of 132 Stained Smear - Sperm Differential HEM.35832 Phase II N/A YES NO College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 93 of 132 N/A REFERENCES: 1) Souter VL, College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 94 of 132 COMMENTARY: College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 95 of 132 NOTE: Slide identification must include a unique specimen or accession number; patient name and/or COMMENTARY: REFERENCE: Guidelines for human em Fertil Steril. HEM.35908 Phase II N/A YES NO Are the stains used (Wright’s, Papanicolaou, eosin-nigrosin, College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 96 of 132 Anti-sperm Antibody (ASA) Tests **NEW** 09/27/2007 HEM.35910 Phase II N/A YES NO Are serum and follicular fluid specimens used for indirect ASA testing heat-inactivated before COMMENTARY: REFERENCE: Keel BA, Webster BW. CRC handbook of is and treatment of infertility. Boca Raton, FL: CRC Press, 19RLM.185. **NEW** 09/27/2007 HEM.35911 Phase I N/A YES NO If the testing for ASA requires motile sperm, a re specimens assayed with minimal delay and is the motility assessed and recorded? COMMENTARY: REFERENCE: Mortimer D. Practical laboratory a **NEW** 09/27/2007 HEM.35912 Phase II N/A YES NO and negative controls run with each assay? COMMENTARY: College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 97 of 132 REFERENCES: 1) Keel BA, Webster BW. CRC handbook agnosis and treatment 2) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clin ical laboratory improvement amendments of 1988; College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 98 of 132 NOTE: If stabilized control materials are used, they should represent different analytic levels (e.g., College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 99 of 132 **NEW** 09/27/2007 HEM.35916 Phase II N/A YES NO Does the laboratory have a procedure for reca libration of instrument College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 100 of 132 REFERENCES: 1) Mortimer D. Pr actical laboratory andr ology. New York, NY: Oxford University Press. 1994; 2) Lenzi A. Computer-aided semen an alysis (CASA) 10 years la European scientific 3) Mahmoud AM, College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 101 of 132 **NEW** 09/27/2007 HEM.35922 Phase I N/A YES NO Has the laboratory established reference interval s (normal values) for the motion variables COMMENTARY: REFERENCE: Schieferstein G, College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 102 of 132 3. After major maintenance or service 4. When recommended by the manufacturer 5. At least every six months COMMENTARY: REFERENCE: Department of H ealth and Human Services, Cent Services. Clinical laboratory improveme nt amendments of 1988; final rule. College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 103 of 132 HEM.35927 Phase II N/A YES NO Are controls containing at least three known majo r hemoglobins, including both a sickling and a non-sickling hemoglobin ( ., A, F, and S) applied with the patient specimen(s) and are COMMENTARY: s and thalassemias. Laboratory methods and College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 104 of 132 positions, such as fast hemoglobin variants, COMMENTARY: College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 105 of 132 n variant(s). Given the clinical implications of homozygous Hb S (or Hb S/ß-zero thalassemia) it is her hemoglobin variants, however rare. Referral of these specimens to a refe rence laboratory for further workup is acceptable. COMMENTARY: rrow clot and core biopsy specimens. COMMENTARY: HEM.36100 Phase II N/A YES NO Examine a slide prepared by the laboratory. Is College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 106 of 132 COMMENTARY: HEM.36150 Phase I N/A YES NO Are fixed sections (marrow biopsy r the clinical situation? COMMENTARY: REFERENCES: 1) Krause JR, ed. Bone marrow College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 107 of 132 HEM.36270 Phase II N/A YES NO College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 108 of 132 HEM.36350 Phase II N/A YES NO w evaluations of anemia where indicated? COMMENTARY: HEM.36375 Phase II N/A YES NO Are the following special stains used of high characteristics for which they were designed? College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 109 of 132 BLOOD COAGULATION STUDIES HEM.37050 Phase II N/A YES NO NOTE: Laboratories serving acute care hospitals College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 110 of 132 NCCLS document H30-A2 (ISBN 1-56238-439-2). NCCLS, 940 West Valley Road, Suite 1400, Wayne College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 111 of 132 approved guideline H48-A. Wayne College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 112 of 132 REFERENCE: Department of H ealth and Human Services, Cent CLIA programs; CLIA fee collect () HEM.37232 Phase I N/A YES NO Are there defined tolerance limits for resul ts agreement of interinstrument assays? NOTE: The laboratory should clearly define College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 113 of 132 HEM.37400 Phase I N/A YES NO College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 114 of 132 COMMENTARY: Manual Coagulation Systems HEM.37700 Phase II N/A YES NO Is the manual coagulation system checked by each testing person with 2 different levels of control material in duplicate during each 8 hour s of patient testing, and each time there is a NOTE: The term “each testing pe ssayed twice (i.e., once for each person). COMMENTARY: REFERENCE: Department of H ealth and Human Services, Cent Services. Clinical laboratory improveme nt amendments of 1988; final rule. ()() HEM.37750 Phase II N/A YES NO Are tolerance limits defined for each manual procedure? COMMENTARY: College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 115 of 132 HEM.37800 Phase II N/A YES NO College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 116 of 132 Coagulation Studies by Electrophoresis NOTE: These questions apply to multimers and Protein C antigen, or other fact College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 117 of 132 **NEW** 10/31/2006 HEM.37915 Phase I N/A YES NO in units other than those recommended by the NOTE: The units generated directly by the D-di FEU ng/ml D-DU ng/ml 0.5 1 FEU ng/ml = 0.5 D-DU ng/ml FEU ng/ml D-DU ug/ml 0.0005 1 FEU ng/ml = 0.0005 D-DU ug/ml FEU ug/ml FEU ng/ml 1000 1 FEU ug/ml = 1000 FEU ng/ml D-DU ng/ml FEU ng/ml 2 1 D-DU ng/ml = 2 FEU ng/ml D-DU ug/ml FEU ng/ml 2000 1 D-DU ug/ml = 2000 FEU ng/ml D-DU ug/ml D-DU ng/ml 1000 1 D-DU ug/ml = 1000 D-DU ng/ml COMMENTARY: REFERENCES: 1) Dempfle CE. D-dimer assays: Th College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 118 of 132 Blood Coagul Fibrinolysis . 2005 Sep;16(6):439-43; 4) Gardiner C, Pennaneac’h C, Walford C, College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 119 of 132 College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 120 of 132 **NEW** 10/31/2006 HEM.37935 Phase I N/A YES NO If a D-dimer test is not used fo does the laboratory inform clinicians that the test should not be used to exclude deep vein NOTE: This disclaimer may be included in th e laboratory report, or in a written memorandum to COMMENTARY: Coagulation Factor Assays (including fibrinogen) of factor-deficient plasma. The APTT or PT of mi be used to convert APTT or PT values of the test plasma mixtures to units of activity. HEM.37940 Phase II N/A YES NO For coagulation end point-based factor assays, a re three or more points plotted for the standard NOTE: Plotting less than 3 points may generate an erroneous line. COMMENTARY: College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 121 of 132 A. Wayne, PA: NCCLS, 1997; 3) N College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 122 of 132 Mixing Studies ma with normal plasma) may be performed to College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 123 of 132 drugs such as heparin or direct thrombin inhibitors cannot be excluded.” COMMENTARY: REFERENCES: 1) Jim RTS. A study of the plasma thrombin time. 2) Harsfalvi J, Mattsson C, Eriksson UG, College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 124 of 132 REFERENCES: 1) Department of Health and Hu man Services, Centers for Medicare & Medicaid Services. Clinical laboratory improveme nt amendments of 1988; final rule. 28):7165 [42CFR493.1217]; 2) Department of Health and Human Services, Ce Programs; Laboratory Re quirements Relating to Quality Systems and Certain Personnel Qualifications; final rule. [42CFR493.1255]; 3) Kroll MH, Emancipator College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 125 of 132 **NEW** 10/31/2006 HEM.38006 Phase II N/A YES NO Are criteria established for frequency of recali bration or calibration verification, and the acceptability of results? NOTE: Criteria typically include: College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 126 of 132 **NEW** 10/31/2006 HEM.38008 Phase II N/A YES NO Has an acceptable range been established or verified for each lot of control material? NOTE: For unassayed controls, the laboratory mu College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 127 of 132 REFERENCE: Winokur R, Hartwig JH. Mechanism of College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 128 of 132 HEM.40000 Phase II N/A YES NO ars experience (one of which is in clinical COMMENTARY: PHYSICAL FACILITIES College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 129 of 132 HEM.50150 Phase I N/A YES NO COMMENTARY: HEM.50200 Phase I N/A YES NO COMMENTARY: HEM.50250 Phase I N/A YES NO Is there adequate space for refrigerated/freezer storage? COMMENTARY: HEM.50300 Phase I N/A YES NO Is the space available efficiently utilized? COMMENTARY: HEM.50350 Phase II N/A YES NO Is sufficient space available so that there is no compromise of the quality of work, (including College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 130 of 132 REFERENCES: 1) Elin RJ. Workload, space, and personnel in hematology laboratories in teaching Am J Clin Pathol. 1983;80:190-196; 2) Elin RJ, Gersch SM. Considerations for the design Am J Clin Pathol. HEM.50375 Phase I N/A YES NO Have ergonomic aspects of desks (or benches), ch COMMENTARY: College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 131 of 132 HEM.50500 Phase I N/A YES NO College of American Pathologists Revised: 09/27/2007 HEMATOLOGY – COAGULATION (Web File) Page 132 of 132