APPENDIX B

GLOSSARY

ABHES - Accrediting Bureau of Health Education Studies.

AFIP - Armed Forces Institute of Pathology.

Accredited institution - a school or program which:

a. Admits as regular students only persons having a certificate of graduation from a school providing secondary education, or the recognized equivalent of such certificate, such as a GED examination;

b. Is legally authorized within a State to provide a program of education beyond secondary education;

c. Provides an educational program for which it awards a bachelor's degree or provides not less than a two-year program which is acceptable toward such a degree, or provides an educational program for which it awards a master's or doctoral degree;

d. Is accredited by a nationally recognized accrediting agency or association.

This definition includes any foreign institution of higher education that DoD or its designee determines meets substantially equivalent requirements.

Alternative Sanctions - any action less than limitation, suspension, or removal of a CLIP certificate taken in response to a laboratory's deficiencies in meeting CLIP requirements.

Analyte - a substance or constituent for which the laboratory conducts testing.

Authorized person - an individual authorized under military regulations to order tests or receive test results, or both.

CAHEA - Committee on Allied Health Education and Accreditation.

CDC - Centers for Disease Control, Atlanta, GA.

CLIP Certificate - any of the following types of certificates issued by TSG or their designee:

a. Certificate of compliance - issued to a laboratory after an inspection that finds the laboratory to be in compliance with all applicable condition level requirements, or reissued before the expiration date.

b. Certificate for provider-performed microscopy (PPM) procedures - issued or reissued to a laboratory in which a physician, midlevel practitioner or dentist performs no tests other than PPM procedures and, if desired, minimally complex tests.

c. Certificate of accreditation - issued on the basis of the laboratory's accreditation by an accrediting organization approved by DoD (indicating that the laboratory is deemed to meet applicable CLIP requirements) or reissued before the expiration date.

d. Certificate of registration or registration certificate - issued or reissued to an entity that enables that entity to conduct moderate or high complexity laboratory testing or both until the entity is determined to be in compliance through a survey by CLIP, or its agent; is accredited by an approved accreditation organization; or becomes exempt from CLIP.

e. Certificate for minimal complexity (called Certificate of Waiver under CLIA)- issued or reissued to a laboratory to perform only minimally complex tests.

Challenge - for quantitative tests, an assessment of the amount of substance or analyte present or measured in a sample. For qualitative tests, a challenge means the determination of the presence or the absence of an analyte, organism, or substance in a sample.

CLIA - the Clinical Laboratory Improvement Amendments of 1988.

CLIP - the DoD Clinical Laboratory Improvement Program.

CLIPO - the Clinical Laboratory Improvement Program Office, located within the Center for Medical Laboratory Affairs (CMLA) at the Armed Forces Institute of Pathology (AFIP) and operated under the auspices of OASD(HA).

CMLA - the Center for Medical Laboratory Affairs located within the the Armed Forces Institute of Pathology.

Condition Level Deficiencies - any deficiency to stated conditions within the CLIP document.

Credential - written record of individual's ability to perform specified procedures.

DoD - Department of Defense.

DoD CLIAC - Department of Defense Clinical Laboratory Improvement Advisory Committee.

Dentist - a doctor of dental medicine or doctor of dental surgery who is licensed by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and privileged to practice dentistry in a DOD medical treatment facility.

Deployable medical units - medical units of the Marines, Navy, Air Force, or Army that are designed to temporarily operate in non-fixed facilities or perform in medical contingency operations.

FDA - Food and Drug Administration.

Federal Register - uniform system for making available to the public regulations and legal notices issued by Federal agencies.

HCFA - Health Care Financing Administration.

HHS - the Department of Health and Human Services, or its designee.

Kit - all components of a test that are packaged together.

Laboratory - a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered laboratories.

Midlevel practitioner - a nurse midwife, nurse practitioner or physician assistant who is licensed by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and privileged to practice their specialty in a DOD medical treatment facility.

NAACLS - National Accrediting Agency for Clinical Laboratory Sciences.

OASD(HA) - Office of the Assistant Secretary of Defense for Health Affairs.

Performance characteristic - a property of a test that is used to describe its quality, e.g., accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference range, etc.

Performance specification - a value or range of values for a performance characteristic, established or verified by the laboratory, that is used to describe the quality of patient test results.

Physician - an individual with a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine degree who is licensed by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and privileged to practice medicine in a DOD medical treatment facility.

Principle Sanctions - limitation, suspension or revocation of a CLIP certificate in response to condition level deficiencies.

Referee laboratory - a laboratory currently in compliance with applicable CLIA requirements, that has had a record of satisfactory proficiency testing performance for all testing events for at least one year for a specific test,
analyte, subspecialty, or specialty and has been designated by an HS-approved proficiency testing program as a referee laboratory for analyzing proficiency testing specimens for the purpose of determining the correct response for the specimens in a testing event for that specific test, analyte, subspecialty, or specialty.

Reference range - the range of test values expected for a designated population of individuals, e.g., 95 percent of individuals that are presumed to be healthy (or normal).

Regulated analyte - Tests or procedures for which proficiency testing is required by Public Law 100-578. The list and minimal performance in proficiency testing events is stated in this document.

Sample (in proficiency testing) - the material contained in a vial, on a slide, or other unit that contains material to be tested by proficiency testing program participants. When possible, samples are of human origin.

Target value for quantitative tests - either the mean of all participant responses after removal of outliers (those responses greater than 3 standard deviations from the original mean) or the mean established by definitive or reference methods acceptable for use in the National Reference System for the Clinical Laboratory (NRSCL) by the National Committee for Clinical Laboratory Standards (NCCLS). In instances where definitive or reference methods are not available or a specific method's results demonstrate bias that is not observed with actual patient specimens, as determined by a defensible scientific protocol, a comparative method or a method group ("peer" group) may be used. If the method group is less than 10 participants, "target value" means the overall mean after outlier removal (as defined above) unless acceptable scientific reasons are available to indicate that such an evaluation is not appropriate.

TSG - the Service's Surgeons General, i.e., the Surgeon General of the Air Force, the Surgeon General of the Army, and the Surgeon General of the Navy.

Unsatisfactory proficiency testing performance - failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for a testing event.

Unsuccessful proficiency testing performance - failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for two consecutive or two of three consecutive testing events.

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