CHAPTER 2 - GENERAL PROVISIONS
2-1. Applicability (§493.3)
a. Basic rule. Except as specified in subparagraph b below, a laboratory
will be cited as out of compliance with these Regulations unless it has
a current, unrevoked or unsuspended DoD certificate of minimal complexity,
a DoD certificate of registration, a DoD certificate of compliance, a DoD
certificate of provider-performed microscopy (PPM), or a DoD certificate
of accreditation issued by the Service's Surgeon General (TSG) under the
authority of the Office of Assistant Secretary of Defense (Health Affairs)
(OASD(HA)) applicable to the category of examinations or procedures performed
by the laboratory. These rules are applicable to laboratories located outside
of the United States except where modified by Status of Forces agreements.
b. Exception. These rules do not apply to components or functions:
(1) Any facility or component of a facility that only performs testing for forensic purposes;
(2) Research laboratories that test human specimens but do not report patient specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients;
(3) Laboratories that are regulated by Department of Defense Instruction (DoDI) 1010.1, or are certified by the National Laboratory Certification Program of the Substance Abuse and Mental Health (SAMHSA) division of Health and Human Services (HHS) in which drug testing is performed which meets HHS guidelines and Regulations. However, all other testing conducted by a NLCP-certified laboratory, or one governed by DoDI 1010.1, is subject to this rule.
(4) Medical laboratories assigned to field medical units that may perform limited human testing in a field environment for military training purposes.
c. Laboratories under DoD jurisdiction are subject to the rules of this
Program, except, after consultation with HHS, as modified by OASD(HA). DoD
shall be responsible for the implementation of, and compliance with, the
rules (as modified) with respect to the laboratories under DoD jurisdiction.
(1) During declared or undeclared wars, or when under a period of mobilization, OASD(HA), the Service's Surgeons General (TSG), or subordinate medical commanders may temporarily modify these rules as required.
(2) OASD(HA) or TSG may modify these rules as required for laboratories which are components of deployable operational forces.
2-2. Categories of tests by complexity (§493.5)
a. Laboratory tests are categorized as one of the following:
(1) Minimal complexity (Waived).
(2) Tests of moderate complexity, including the subcategory of Provider-Performed Microscopy (PPM)procedures.
(3) High complexity.
b. A laboratory may perform only minimally complex tests, only PPM tests,
only tests of moderate complexity, only tests of high complexity, or any
combination depending upon the laboratory's CLIP certificate.
c. Each laboratory must possess one of the following, as defined in this
document:
(1) Certificate of registration
(2) Certificate for minimal complexity testing
(3) Certificate for provider-performed microscopy
(4) Certificate of compliance
(5) Certificate of accreditation.
2-3. Laboratories performing minimally complex tests (§493.15)
a. Tests for certificate of minimal complexity must meet the descriptive
criteria specified in subparagraph b below.
b. Test systems are simple laboratory examinations and procedures which:
(1) Are cleared by Food and Drug Administration (FDA) for home use;
(2) Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or
(3) Pose minimal risk of harm to the patient if the test is performed incorrectly.
c. A laboratory may qualify for a certificate to perform tests of minimal
complexity under CLIP if it restricts the tests that it performs to one
or more of the following tests or examinations (or additional tests added
to this list as provided under paragraph d) and no others:
(1) Dipstick or Tablet Reagent Urinalysis (nonautomated) for the following:
(a) Bilirubin;
(b) Glucose;
(c) Hemoglobin;
(d) Ketone;
(e) Leukocytes;
(f) Nitrite;
(g) pH;
(h) Protein;
(i) Specific gravity; and
(j) Urobilinogen.
(2) Fecal occult blood;
(3) Ovulation tests - visual color comparison tests for human luteinizing hormone;
(4) Urine pregnancy tests - visual color comparison tests;
(5) Erythrocyte sedimentation rate - non-automated;
(6) Hemoglobin - copper sulfate - non-automated;
(7) Blood glucose by monitoring devices cleared by the FDA specifically for home use;
(8) Spun microhematocrit; and
(9) Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout.
(10) Chemtrac single analyte cholesterol accumeter.
(11) HemoCue B-Glucose Analyzer
(12) Serim Pyloritek Test Kit for Helicobacter pylori
(13) Quidel QuickVue In-Line One-Step Strep A Test (streptococcus group A)
(14) Cholestech LDX System (total cholesterol, HDL cholesterol, triglyceride and glucose)
d. HHS will determine whether a laboratory test meets the criteria listed
under paragraph b of this section for a waived test. Revisions to the list
of waived tests approved by HHS will be published in the FEDERAL REGISTER
in a notice with opportunity for comment. The DoD Clinical Laboratory Improvement
Advisory Committee, as defined in Chapter 15, will conduct reviews and make
recommendations to OASD(HA).
e. Laboratories eligible for a certificate of minimal complexity must:
(1) Follow manufacturers' instructions for performing the test
(2) Meet the requirements in Chapter 3, Certificate for Minimal Complexity
(3) Analyze and document the results of controls for the tests as recommended by the test manufacturer;and
(4) Ensure that training to properly perform the test(s) is documented for each employee.
2-4. Test categorization (§493.17)
a. Notices will be published in the FEDERAL REGISTER which list each specific
test system, assay, and examination categorized by complexity which will
be adopted with, or without, modification by OASD(HA). Modification will
not reduce the level of complexity.OASD(HA) will coordinate with/notify
HCFA for all modifications made to CLIA regulations.
b. For test systems, assays, or examinations not commercially available,
DoD laboratories may submit a written request for categorization through
TSG and DoD to the Public Health Service (PHS).
(1) These requests will be forwarded to the Centers for Disease Control (CDC) for evaluation; CDC will determine complexity category and notify the applicant, Health Care Financing Administration (HCFA), and FDA of the categorization decision. Test categorization will be effective as of the notification to the applicant. In the case of request for a change of category or for previously uncategorized new technology, PHS will receive the request application and forward it to CDC for categorization.
(2) A request for recategorization will be accepted for review if it is based on new information not previously submitted in a request for categorization or recategorization by the same applicant and will not be considered more frequently than once per year.
(3) If a laboratory test system, assay or examination does not appear on the lists of tests in the FEDERAL REGISTER notices, it is considered to be a test of high complexity until PHS, upon request, reviews the matter and notifies the applicant of its decision.
(4) PHS will publish revisions periodically to the list of moderate and high complexity tests in the FEDERAL REGISTER in a notice with opportunity for comment. DoD CLIAC will review these changes and determine whether to incorporate them into Service regulations. They may be incorporated with or without modification. The DoD CLIAC will coordinate with/notify HCFA and CDC for all modifications made to CLIA regulations.
2-5. Provider-performed microscopy procedures (§493.19)
a. Procedures to be categorized as provider-performed microscopy procedures
must meet the criteria specified in paragraph b.
b. Procedures must meet the following specifications:
(1) The examination must be personally performed by one of the following practitioners:
(a) A physician during the patient's visit, on a specimen obtained from his or her own patient or from a patient of a group medical practice of which the physician is a member or an employee.
(b) A midlevel practitioner (nurse practitioner, nurse midwife, or physician assistant) under the supervision of a physician, or in independent practice (only if licensed by the recognized licensing agency of a State,the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands) and credentialed to practice their specialty in a DoD medical treatment facility (MTF), during the patient's visit, on a specimen obtained from his or her own patient or from a patient of a clinic, group medical practice, or other health care provider of which the midlevel practitioner is a member or an employee.
(c) A dentist during the patient's visit, on a specimen obtained from his or her own patient or from a patient of a clinic group medical practice of which the dentist is a member or an employee.
(2) The procedure must be categorized as moderately complex.
(3) The primary instrument for performing the test is the microscope, limited to bright-field or phase-contrast microscopy.
(4) The specimen is labile or delay in performing the test could compromise the accuracy of the test result.
(5) Control materials are not available to monitor the entire testing process.
(6) Limited specimen handling or processing is required.
c. A laboratory may qualify to perform tests under this provision if it
restricts provider-performed microscopy examinations to one or more of the
following procedures, minimally complex and no others (or additional procedures
added to this list as provided at paragraph d below);
(1) All direct wet mount preparations for the presence or absence of bacteria, fungi, parasites, and human cellular elements.
(2) All potassium hydroxide (KOH) preparations
(3) Pinworm examinations
(4) Fern tests
(5) Post-coital direct, qualitative examinations of vaginal or cervical mucous
(6) Urine sediment examinations
(7) Nasal smears for granulocytes
(8) Fecal leukocyte examinations
(9) Qualitative semen analysis (limited to the presence or absence of sperm and detection of motility).
d. Revisions to criteria and the list of provider-performed microscopy procedures.
(1) The Clinical Laboratory Improvement Advisory Committee (CLIAC) will conduct reviews upon request of HHS and recommend to HHS revisions to the criteria for categorization of procedures.
(2) HHS will determine whether a laboratory procedure meets the criteria listed under paragraph b above for a provider-performed microscopy procedure. Revisions to the list of the provider-performed microscopy procedures proposed by HHS will be published in the FEDERAL REGISTER as a Notice with an opportunity for
public comment. The DoD CLIAC, as defined in Chapter 15, will conduct reviews and make recommendations to OASD(HA).
e. Laboratories eligible for test performance under the provider-performed
microscopy examination provision must:
(1) Meet the applicable requirements in Chapters 4, 5, 6, 7, 8, 9, 10, 11, and 12.
(2) Be subject to inspection as specified under Chapter 13.
2-6. Laboratories performing tests of moderate complexity (§493.20)
a. A laboratory may qualify for a certificate to perform tests of moderate
complexity provided that it restricts its test performance to minimally
complex tests or examinations and one or more tests or examinations meeting
criteria for tests of moderate complexity including the subcategory of PPM
procedures.
b. A laboratory that performs tests or examinations of moderate complexity
must meet the applicable requirements in Chapters 4, 5, 6, 7, 8, 9, 10,
11, 12, and 13. Under a registration certificate or certificate of compliance,
laboratories also performing PPM procedures must meet the inspection requirements
at paragraph 13-2.
c. If the laboratory also performs minimal complexity tests listed in paragraph
2-3, compliance with Chapters 3, 6, 7, 8, 9, 10, 11, and 12 are not applicable
to the minimal complexity tests. However, the laboratory must comply with
the requirements in paragraph 2-3e and paragraph 13-1.
2-7. Laboratories performing tests of high complexity (§493.25)
a. A laboratory must obtain a certificate for tests of high complexity if
it performs one or more tests that meet the criteria for tests of high complexity
as specified in paragraph 2-4a.
b. A laboratory performing one or more tests of high complexity must meet
the applicable requirements of Chapters 4, 5, 6, 7, 8, 9, 10, 11, 12, and
13.
c. If the laboratory also performs tests of moderate complexity, the applicable
requirements of Chapters 4, 5,6, 7, 8, 9, 10, 11, 12, and 13 must be met.
Under a registration certificate or certificate of compliance, PPM procedures
must meet the inspection requirements at paragraph 13-2.
d. If the laboratory also performs minimal complexity tests, the requirements
of Chapters 3, 6, 7, 8, 9, 10, 11,and 12 are not applicable for the minimally
complex tests. However, the laboratory must comply with the requirements
in paragraph 2-3e and paragraph 13-1.