CLINICAL LABORATORY IMPROVEMENT PROGRAM

TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION

1-1. Basis and scope (§493.1)
1-2. References
1-3. Explanation of abbreviations and terms


CHAPTER 2 GENERAL PROVISIONS

2-1. Applicability (§493.3)
2-2. Categories of tests by complexity (§493.5)
2-3. Laboratories performing minimally complex tests (§493.15)
2-4. Provider-performed microscopy procedures (§493.19)
2-5. Test categorization (§493.17)
2-6. Laboratories performing tests of moderate complexity (§493.20)
2-7. Laboratories performing tests of high complexity (§493.25)


CHAPTER 3 CERTIFICATE FOR MINIMAL COMPLEXITY

3-1. Application for a certificate for minimal complexity testing (§493.35)
3-2. Requirements for a certificate for minimal complexity testing (§493.37)
3-3. Notification requirements for laboratories issued a certificate for minimal complexity testing (§493.37)


CHAPTER 4 REGISTRATION CERTIFICATE, CERTIFICATE FOR PROVIDER-PERFORMED MICROSCOPY PROCEDURES, AND CERTIFICATE OF COMPLIANCE

4-1. Application for registration certificate, certificate for provider-performed microscopy (PPM)procedures, and certificate of compliance (§493.43)
4-2. Requirements for a registration certificate (§493.45)
4-3. Requirements for a certificate for provider-performed microscopy (PPM) procedures (§493.47)
4-4. Requirements for a certificate of compliance (§493.49)
4-5. Notification requirements for laboratories issued a certificate of compliance (§493.51)
4-6. Notification requirements for laboratories issued a certificate for physician-performedmicroscopy procedures (§493.53)


CHAPTER 5 CERTIFICATE OF ACCREDITATION

5-1. Application for registration certificate and certificate of accreditation (§493.55)
5-2. Requirements for a registration certificate (§493.57)
5-3. Requirements for a certificate of accreditation (§493.61)
5-4. Notification requirements for laboratories issued a certificate of accreditation (§493.63)


CHAPTER 6 PARTICIPATION IN PROFICIENCY TESTING FOR LABORATORIES PERFORMING TESTS OF MODERATE COMPLEXITY (INCLUDING THE SUBCATEGORY),HIGH COMPLEXITY, OR ANY COMBINATION OF THESE TESTS

6-1. Condition: Enrollment and testing of samples (§493.801)
6-2. Condition: Successful participation (§493.803)
6-3. Condition: Reinstatement of laboratories performing tests of moderate or high complexity,or both, after failure to participate successfully (§493.807)
6-4. Proficiency testing for laboratories performing tests of moderate or high complexity,or both, for the specialty and subspecialties of microbiology (§493.821)
6-5. Proficiency testing for laboratories performing tests of moderate or high complexity,or both, for the specialty and subspecialties of diagnostic immunology (§493.833)
6-6. Proficiency testing for laboratories performing tests of moderate or high complexity,or both, for the specialty and subspecialties of chemistry (§493.839)
6-7. Proficiency testing for laboratories performing tests of moderate or high complexity,or both, for the specialty of hematology (§493.849) & (§493.851)
6-8. Proficiency testing for laboratories performing tests of moderate or high complexity,or both, for the specialty and subspecialties of pathology (§493.853)
6-9. Proficiency testing for laboratories performing tests of moderate or high complexity,or both, for the specialty and subspecialties of immunohematology (§493.857)


CHAPTER 7 PROFICIENCY TESTING PROGRAMS FOR TESTS OF MODERATE
COMPLEXITY TESTING (INCLUDING THE SUBCATEGORY), HIGH COMPLEXITY TESTING, OR ANY COMBINATION OF THESE TESTS

7-1. Approval of proficiency testing programs (§493.901)
7-2. Administrative responsibilities (§493.903)
7-3. Nonapproved proficiency testing programs (§493.905)


CHAPTER 8 REGULATED ANALYTES

8-1. Introduction
8-2. Bacteriology (§493.911)
8-3. Mycobacteriology (§493.913)
8-4. Mycology (§493.915)
8-5. Parasitology (§493.917)
8-6. Virology (§493.919)
8-7. Diagnostic Immunology (§493.921)
8-8. Chemistry (§493.929)
8-9. Toxicology (§493.937)
8-10. Hematology (including routine hematology and coagulation) (§493.941)
8-11. Cytology; gynecologic examinations (§493.945)
8-12. Immunohematology (§493.959)


CHAPTER 9 PATIENT TEST MANAGEMENT FOR MODERATE COMPLEXITY TESTING
(INCLUDING THE SUBCATEGORY), HIGH COMPLEXITY TESTING, OR ANY COMBINATION OF THESE TESTS

9-1. Condition: Patient test management; moderate complexity testing (including the subcategory), high complexity testing, or any combination of these tests (§493.1101)
9-2. Standard: Procedures for specimen submission and handling (§493.1103)
9-3. Standard: Test requisition (§493.1105)
9-4. Standard: Test records (§493.1107)
9-5. Standard: Test report (§493.1109)
9-6. Standard: Referral of specimens (§493.1111)


CHAPTER 10 QUALITY CONTROL FOR TESTS OF MODERATE COMPLEXITY TESTING
(INCLUDING THE SUBCATEGORY), HIGH COMPLEXITY TESTING OR ANY COMBINATION OF THESE TESTS

10-1. Condition: General quality control; moderate complexity testing (including the subcategory),high complexity testing, or any combination of these tests (§493.1107)
10-2. Standard: Moderate complexity testing (including the subcategory), high complexity testing, or any combination of these tests: Effective 1 September 1993 to 1 September 1996 (§493.1202)
10-3. Standard: Moderate Complexity (including the subcategory), high complexity testing, or any combination of these tests (effective beginning 1 September 1996) (§493.1203)
10-4. Standard: Facilities (§493.1204)
10-5. Standard: Test methods, equipment, instrumentation, reagents, materials, and supplies(§493.1205)
10-6. Standard: Procedure manual (§493.1211)
10-7. Standard: Establishment and verification of method performance specifications (§493.1213)
10-8. Standard: Equipment maintenance and function checks (§493.1215)43
10-9. Standard: Calibration and calibration verification procedures (§493.1217)
10-10. Standard: Control procedures (§493.1218)
10-11. Standard: Remedial actions (§493.1219)
10-12. Standard: Quality control records (§493.1221)
10-13. Condition: Quality control; Specialties and subspecialties for tests of moderate or high complexity, or both (§493.1223)
10-14. Condition: Microbiology (§493.1225)
10-15. Condition: Bacteriology (§493.1227)
10-16. Condition: Mycobacteriology (§493.1229)
10-17. Condition: Mycology (§493.1231)
10-18. Condition: Parasitology (§493.1233)
10-19. Condition: Virology (§493.1235)
10-20. Condition: Diagnostic immunology (§493.1237)
10-21. Condition: Syphilis serology (§493.1239)
10-22. Condition: General immunology (§493.1241)
10-23. Condition: Chemistry (§493.1243)
10-24. Condition: Routine chemistry (§493.1245)
10-25. Condition: Endocrinology (§493.1247)
10-26. Condition: Toxicology (§493.1249)
10-27. Condition: Urinalysis (§493.1251)
10-28. Condition: Hematology (§493.1253)
10-29. Condition: Pathology (§493.1255)
10-30. Condition: Cytology (§493.1257)
10-31. Condition: Histopathology (§493.1259)
10-32. Condition: Oral pathology (§493.1261)
10-33. Condition: Radiobioassay (§493.1263)
10-34. Condition: Histocompatibility (§493.1265)
10-35. Condition: Clinical cytogenetics (§493.1267)
10-36. Condition: Immunohematology (§493.1269)
10-37. Condition: Transfusion services and blood banking (§493.1271)
10-38. Standard: Immunohematological collection, processing, dating periods, labeling, anddistribution of blood and blood products (§493.1273)
10-39. Standard: Blood and blood products storage facilities (§493.1275)
10-40. Standard: Arrangement for services (§493.1277)
10-41. Standard: Provision of testing (§493.1281)
10-42. Standard: Retention of samples of transfused blood (§493.1283)
10-43. Standard: Investigation of transfusion reactions (§493.1285)


CHAPTER 11 PERSONNEL FOR MODERATE COMPLEXITY TESTING (INCLUDING THE
SUBCATEGORY), HIGH COMPLEXITY TESTING, OR ANY COMBINATION OF THESE TESTS

11-1. General (§493.1351)
11-2. Laboratories Performing Provider-Performed Microscopy (PPM) Procedures: Scope (§493.1353)
11-3. Condition: Laboratories Performing PPM Procedures: laboratory director (§493.1355)
11-4. Standard: Laboratories Performing PPM Procedures: laboratory director qualifications (§493.1357)
11-5. Standard: Laboratories Performing PPM Procedures: laboratory director responsibilities (§493.1359)
11-6. Condition: Laboratories Performing PPM procedures: testing personnel (§493.1361)
11-7. Standard: Laboratories Performing PPM Procedures: testing personnel qualifications(§493.1363)
11-8. Standard: Laboratories Performing PPM Procedures: testing personnel responsibilities (§493.1365)
11-9. Condition: Laboratories Performing Moderate Complexity Testing: laboratory director (§493.1403)
11-10. Standard: Laboratories Performing Moderate Complexity Testing: laboratory director qualifications (§493.1405)
11-11. Standard: Laboratories Performing Moderate Complexity Testing: laboratory director responsibilities(§493.1407)
11-12. Condition: Laboratories Performing Moderate Complexity Testing: technical consultant (§493.1409)
11-13. Standard: Laboratories Performing Moderate Complexity Testing: technical consultant qualifications(§493.1411)
11-14. Standard: Laboratories Performing Moderate Complexity Testing: technical consultant responsibilities(§493.1413)
11-15. Condition: Laboratories Performing Moderate Complexity Testing: clinical consultant(§493.1415)
11-16. Standard: Laboratories Performing Moderate Complexity Testing: clinical consultant qualifications(§493.1417)
11-17. Standard: Laboratories Performing Moderate Complexity Testing: clinical consultant responsibilities(§493.1419)
11-18. Condition: Laboratories Performing Moderate Complexity Testing: testing personnel(§493.1421)
11-19. Standard: Laboratories Performing Moderate Complexity Testing: testing personnel qualifications (§493.1423)
11-20. Standard: Laboratories Performing Moderate Complexity Testing: testing personnel responsibilities(§493.1425)
11-21. Condition: Laboratories Performing High Complexity Testing; laboratory director(§493.1441)
11-22. Standard: Laboratories Performing High Complexity Testing: laboratory director qualifications (§493.1443)
11-23. Standard: Laboratories Performing High Complexity Testing: laboratory director responsibilities (§493.1445)
11-24. Condition: Laboratories Performing High Complexity Testing: technical supervisor(§493.1447)
11-25. Standard: Laboratories Performing High Complexity Testing: technical supervisor qualifications (§493.1449)
11-26. Standard: Laboratories Performing High Complexity Testing: technical supervisor responsibilities (§493.1451)
11-27. Condition: Laboratories Performing High Complexity Testing: clinical consultant (§493.1453)
11-28. Standard: Laboratories Performing High Complexity Testing: clinical consultant qualifications (§493.1455)
11-29. Standard: Laboratories Performing High Complexity Testing: clinical consultant responsibilities (§493.1457)
11-30. Condition: Laboratories Performing High Complexity Testing: general supervisor (§493.1459)
11-31. Standard: Laboratories Performing High Complexity Testing: general supervisor qualifications (§493.1461)
11-32. Standard: Laboratories Performing High Complexity Testing; General supervisor qualifications on or before 28 February 1992 (§493.1462)
11-33. Standard: Laboratories Performing High Complexity Testing; General supervisor responsibilities (§493.1463)
11-34. Condition: Laboratories Performing High Complexity Testing: cytology general supervisor (§493.1467)
11-35. Standard: Laboratories Performing High Complexity Testing: cytology general supervisor qualifications(§493.1469)
11-36. Standard: Laboratories Performing High Complexity Testing: cytology general supervisor responsibilities(§493.1471)
11-37. Condition: Laboratories Performing High Complexity Testing: cytotechnologist (§493.1481)
11-38. Standard: Laboratories Performing High Complexity Testing: cytotechnologist qualifications (§493.1483)
11-39. Standard: Cytotechnologist responsibilities (§493.1485)
11-40. Condition: Laboratories Performing High Complexity Testing: testing personnel (§493.1487)
11-41. Standard: Laboratories Performing High Complexity Testing: testing personnel qualifications (§493.1489)
11-42. Laboratories Performing High Complexity Testing: technologist qualifications on or before 28 February 1992 (§493.1491)
11-43. Standard: Laboratories Performing High Complexity Testing: testing personnel responsibilities(§493.1495)


CHAPTER 12 QUALITY ASSURANCE FOR MODERATE COMPLEXITY TESTING (INCLUDING THE SUBCATEGORY) OR HIGH COMPLEXITY TESTING, OR ANY COMBINATION OF THESE TESTS

12-1. Condition: Quality Assurance; moderate complexity (including the subcategory) or high complexity testing,or any combination of these tests (§493.1701)
12-2. Standard: Patient test management assessment (§493.1703)
12-3. Standard: Quality control assessment (§493.1705)
12-4. Standard: Proficiency testing assessment (§493.1707)
12-5. Standard: Comparison of test results (§493.1709)
12-6. Standard: Relationship of patient information to patient test results (§493.1711)
12-7. Standard: Personnel assessment (§493.1713)
12-8. Standard: Communications (§493.1715)
12-9. Standard: Complaint investigations (§493.1717)
12-10. Standard: Quality improvement review with staff (§493.1719)
12-11. Standard: Quality improvement records (§493.1721)


CHAPTER 13 INSPECTIONS

13-1. Condition: Inspection of laboratories issued a certificate for minimal complexity (§493.1775)
13-2. Condition: Inspection of laboratories issued a certificate for provider-performed microscopy (PPM)procedures (§493.1776)
13-3. Condition: Inspection of all laboratories requesting or issued a certificate of compliance (§493.1777)
13-4. Condition: Inspection of accredited DoD laboratories (§493.1780)


CHAPTER 14 ENFORCEMENT PROCEDURES

14-1. Basis and Scope (§493.1800)
14-2. General considerations (§493.1804)
14-3. Available sanctions: All laboratories (§493.1806)
14-4. Imposition and lifting of alternative sanctions (§493.1810)
14-5. Action when deficiencies pose immediate jeopardy (§493.1812)
14-6. Actions when deficiencies are at the condition level but do not pose immediate jeopardy (§493.1814)
14-7. Action when deficiencies are not at the condition level (§493.1816)
14-8. Ensuring timely correction of deficiencies (§493.1820)
14-9. Directed plan of correction and directed portion of a plan of correction (§493.1832)
14-10. Directed on-site monitoring (§493.1836)
14-11. Training and technical assistance for unsuccessful participation in proficiency testing(§493.1838)
14-12. Suspension, limitation, or revocation of any type of DoD CLIP certificate (§493.1840)
14-13. Review procedures (§493.1844)
14-14. Laboratory registry (§493.1850)


CHAPTER 15 CONSULTATIONS

15-1. Establishment and function of the DoD Clinical Laboratory Improvement Advisory Committee (§493.2001)99


CHAPTER 16 DEPLOYABLE MEDICAL UNITS

16-1. Applicability
16-2. Concept
16-3. Responsibilities


APPENDIX A REQUIRED AND RELATED PUBLICATIONS


APPENDIX B GLOSSARY