[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 33 Introduced in House (IH)]

103d CONGRESS
  1st Session
                                 H. R. 33

 To amend the Public Health Service Act to establish standards for the 
 certification of laboratories engaged in urine drug testing, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 5, 1993

Mr. Dingell (for himself and Mr. Bliley) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to establish standards for the 
 certification of laboratories engaged in urine drug testing, and for 
                            other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Drug Testing Quality Act''.

SEC. 2. STANDARDS FOR CERTIFICATION OF LABORATORIES ENGAGED IN DRUG 
              TESTING.

    Title V of the Public Health Service Act is amended by adding at 
the end the following:

                         ``PART F--DRUG TESTING

``SEC. 571. CERTIFICATION PROGRAM.

    ``(a) In General.--Not later than one year after the date of 
enactment of this part, the Secretary shall, by regulation, establish a 
program (hereinafter referred to in this part as the `certification 
program') for the certification of laboratories for the performance of 
toxicological urinalysis conducted for drug testing programs. The 
certification program shall, except as provided in subsection (b), 
conform, to the maximum extent practicable, to subpart C of the 
mandatory guidelines for Federal workplace drug testing programs 
published on April 11, 1988, by the Department of Health and Human 
Services at 53 Fed. Reg. 11979 and any amendments to such guidelines 
(hereinafter referred to in this part as the `HHS guidelines').
    ``(b) Specific Provision.--The certification program established by 
the Secretary under subsection (a) shall, with respect to laboratory 
inspection, the monitoring of laboratory performance, and the conduct 
of quality control and performance testing programs, be consistent with 
the consensus of expert scientific and medical opinion on such matters 
as determined by the Secretary.
    ``(c) Additional Regulations.--
            ``(1) The certification program established by the 
        Secretary under subsection (a) shall, in addition to the 
        requirements of subsections (a) and (b)--
                    ``(A) provide that the Secretary shall, in 
                considering applications for certification under the 
                certification program, consider whether the applicant 
                has, directly or indirectly, owned or operated a 
                laboratory which has had its certification suspended or 
                revoked under the program, and
                    ``(B)(i) include criteria for recognition by the 
                Secretary of--
                            ``(I) State agencies and private nonprofit 
                        accrediting bodies to certify laboratories in 
                        accordance with the requirements of this 
                        section if such agencies and bodies meet such 
                        criteria, and
                            ``(II) State agencies and private nonprofit 
                        accrediting bodies to act on the Secretary's 
                        behalf in certifying laboratories in accordance 
                        with the requirements of this section if such 
                        agencies and bodies meet such criteria,
                    ``(ii) provide that the Secretary shall oversee and 
                review the performance of any agency or accrediting 
                body recognized by the Secretary as meeting the 
                criteria described in clause (i) to ensure its 
                compliance with the requirements of the certification 
                program, and
                    ``(iii) provide that the Secretary shall have the 
                right to obtain from an agency or accrediting body 
                described in clause (ii) and from any laboratory that 
                may be certified by such an agency or accrediting body 
                all records and materials that are necessary in the 
                Secretary's judgment for the oversight and review 
                required by clause (ii).
            ``(2) A laboratory may not be certified to perform drug 
        testing under the certification program established under 
        subsection (a) unless the laboratory is certified under section 
        353, except that a laboratory which only performs toxicological 
        urinalyses is not required to be certified under section 353 to 
        be certified under the certification program.
            ``(3)(A) A laboratory may not be certified to perform drug 
        testing under the certification program established under 
        subsection (a) unless it demonstrates to the Secretary its 
        competence to perform toxicological urinalyses in accordance 
        with the requirements of this section and section 572 for the 
        following drugs and drug classes;
                    ``(i) the drugs and drug classes for which test 
                methods and cutoff levels are provided under subpart B 
                of the HHS guidelines;
                    ``(ii) barbiturates listed in schedules I and II 
                under the Controlled Substances Act (21 U.S.C. 801 et 
                seq.); and
                    ``(iii) oxazepam and alprazolam.
            ``(B) Notwithstanding subparagraph (A), a laboratory 
        certified under subpart C of the HHS guidelines prior to the 
        date the Secretary establishes the certification program under 
        subsection (a) shall be deemed by the Secretary to be competent 
        to perform toxicological urinalyses for the drugs and drug 
        classes described in subparagraph (A) and shall be certified by 
        the Secretary to do so for drug testing programs as of such 
        date.
            ``(4) A laboratory certified to perform drug testing under 
        the certification program established under subsection (a), 
        shall, in order to retain such certification, require its 
        scientific, technical, and analytical personnel involved in 
        such drug testing to participate in continuing education 
        programs of a nature and at a frequency (not less than 
        annually) specified by the Secretary in regulations.
    ``(d) Revision.--The Secretary shall, in accordance with section 
553 of title 5, United States Code, revise the requirements of the 
certification program as necessary to reflect improvements in drug 
testing methods for the purpose of ensuring the full reliability and 
accuracy of drug testing, the accurate reporting of full results, and 
the integrity and efficacy of drug testing programs.

``SEC. 572. PROVISIONS TO ENSURE INTEGRITY OF TOXICOLOGICAL URINALYSIS.

    ``(a) In General.--Not later than 1 year after the date of 
enactment of this part, the Secretary shall issue regulations to ensure 
the integrity of toxicological urinalysis which shall, except as 
provided in subsection (b), conform to the maximum extent practicable 
to subpart B of the HHS guidelines.
    ``(b) Specific Provisions.--The regulations issued under subsection 
(a) shall--
            ``(1) except as otherwise provided in this subsection, 
        treat any person conducting a drug testing program in the same 
        manner as subpart B of the HHS guidelines treats the Federal 
        agencies to which it is applicable,
            ``(2) expand the list of drugs and drug classes for which 
        test methods and cutoff levels are provided under subpart B of 
        the HHS guidelines to include barbiturates listed in schedules 
        I and II under the Controlled Substances Act, oxazepam and 
        alprazolam, anabolic steroids, and such other drugs or drug 
        classes as the Secretary determines under subsection (c) may be 
        appropriate,
            ``(3)(A) neither require nor prohibit the establishment of 
        a drug testing program by any person, and
            ``(B) neither require any person to test nor prohibit any 
        person from testing for any particular drug or class of drugs 
        described in paragraph (2) or subpart B of the HHS guidelines,
            ``(4) provide no specimen collection procedures other than 
        those necessary to establish and maintain a proper chain of 
        custody and to provide for transportation of specimens to the 
        laboratory,
            ``(5) consistent with the consensus of expert medical and 
        scientific opinion as determined by the Secretary, establish 
        appropriate cutoff levels for each drug or class of drugs 
        described in paragraph (2) or subpart B of the HHS guidelines 
        for both initial and confirmatory tests,
            ``(6)(A) establish requirements to ensure the integrity and 
        validity of blind performance testing of laboratories certified 
        under the certification program established under section 571, 
        including a number or percentage of specimens (or both) to be 
        submitted to a laboratory by a drug testing program for blind 
        performance testing, set at the lowest level consistent with 
        the consensus of expert medical and scientific opinion as 
        determined by the Secretary and with the need to ensure 
        accuracy, integrity, and protection of the interests of test 
        subjects, and
            ``(B) establish procedures for drug testing programs to 
        notify the Secretary of any false positive results discovered 
        in blind performance testing or by a medical review officer and 
        for the Secretary to take appropriate action on the basis of 
        such notification,
            ``(7) provide no interim certification procedures, and
            ``(8) allow access by any test subject or any test 
        subject's authorized representative, upon written request, to 
        any record relevant to the results of such subject's drug test 
        and to any record relating to the result of any relevant 
        certification, review, suspension, or revocation of 
        certification proceeding, and require a copy of such record to 
        be provided to such test subject or representative upon written 
        request.
Paragraphs (3) and (4) shall not be construed to affect the 
applicability of the requirements of subpart B of the HHS guidelines to 
drug testing programs conducted by Federal agencies under Executive 
Order 12564.
    ``(c) Additional Drugs.--
            ``(1)(A) Any person may file with the Secretary a petition 
        proposing the issuance of a regulation under subsection (b)(2) 
        prescribing test methods and cutoff levels for any drug or 
        class of drugs for which such test methods and cutoff levels 
        have not been previously prescribed. Notice of the regulation 
        proposed by a petitioner shall be published in the Federal 
        Register within 30 days after filing.
            ``(B) Twelve months following the issuance of regulations 
        under subsection (a), and every 24 months thereafter, the 
        Secretary shall publish in the Federal Register a request for 
        public comment on the advisability of and need for including 
        test methods and cutoff levels in such regulations for drugs or 
        classes of drugs for which such test methods and cutoff levels 
        have not been previously prescribed.
            ``(C) A petitioner or commenter under this paragraph shall 
        be required to demonstrate in such person's petition or 
        comment, as applicable, that--
                    ``(i) widespread or otherwise significant abuse of 
                such drug or class in the United States or any region 
                of the United States poses a serious threat to public 
                health or safety,
                    ``(ii) there exists a well-documented and reliable 
                method for toxicological urinalysis of such drug or 
                class and for establishing cutoff levels applicable to 
                such drug or class,
                    ``(iii) such test methods and cutoff levels provide 
                specificity and protection of the interests of test 
                subjects equal to or greater than that provided with 
                respect to the drugs or classes for which test methods 
                and cutoff levels have been previously prescribed by 
                the Secretary, and
                    ``(iv) at least one laboratory certified under 
                section 571 has an interest in providing toxicological 
                urinalysis for the drug or class described in the 
                petition or comment and is competent to do so.
        A petitioner or commenter shall also furnish to the Secretary 
        such additional explanatory and supporting data as the 
        Secretary may require.
            ``(2)(A) Commencing 90 days following publication in the 
        Federal Register of the request for public comment described in 
        paragraph (1)(B), and every 24 months thereafter, the Secretary 
        shall review all petitions received and pending under paragraph 
        (1)(A) and all comments received and pending under paragraph 
        (1)(B), together with additional explanatory and supporting 
        data submitted by petitioners and commenters and shall, with 
        respect to each drug or class of drugs which is the subject of 
        a petition or comment, determine whether the petitioner or 
        commenter has made the demonstration required by paragraph 
        (1)(C) and whether other facts, circumstances, or 
        considerations outweigh the need to prescribe test methods and 
        cutoff levels for such drug or class.
            ``(B)(i) If the Secretary determines under subparagraph (A) 
        that a petitioner or commenter has made the demonstration 
        required by paragraph (1)(C) and that no other facts, 
        circumstances, or considerations outweigh the need to prescribe 
        test methods and cutoff levels for such drug or class, the 
        Secretary shall by order issue a regulation prescribing test 
        methods and cutoff levels for such drug or class.
            ``(ii) If the Secretary determines that a petitioner has 
        failed to make the demonstration required by paragraph (1)(C) 
        and that other facts, circumstances, or considerations outweigh 
        the need to prescribe test methods and cutoff levels as 
        requested in the petition, the Secretary shall by order deny 
        the petition and within 30 days thereafter notify the 
        petitioner of such order and of the reasons for such action.
            ``(C) The order required by subparagraph (B) shall be 
        issued within 90 days after review by the Secretary commences 
        under paragraph (2)(A), except that the Secretary may (prior to 
        such 90th day), by written notice to a petitioner in the case 
        of a petition or publication in the Federal Register in the 
        case of a comment, extend such 90-day period to such time (not 
        more than 180 days after commencement of such review) as the 
        Secretary deems necessary to permit appropriate study and 
        investigation.
    ``(d) Amateur Athletics.--In issuing regulations under subsection 
(a), the Secretary shall take into consideration any special factors or 
circumstances applicable to the testing of participants in--
            ``(1) organized interscholastic or intercollegiate athletic 
        competition, or
            ``(2) organized athletic competition conducted under the 
        auspices of or sanctioned by the United States Olympic 
        Committee or any member thereof,
that warrant separate or different treatment of such testing under the 
regulations.
    ``(e) Revision.--The Secretary shall, in accordance with section 
553 of title 5, United States Code, revise the regulations issued under 
subsection (a) as necessary to reflect improvements in drug testing 
methods for the purpose of ensuring the full reliability and accuracy 
of drug testing, the accurate reporting of results, and the integrity 
and efficacy of drug testing programs.

``SEC. 573. SPECIMEN COLLECTION PROCEDURES.

    ``(a) In General.--Not later than 1 year after the date of 
enactment of this part, the Secretary shall issue model specimen 
collection procedures for the guidance of drug testing programs other 
than those conducted by Federal agencies under Executive Order 12564. 
Such model procedures shall include provisions for designation of a 
collection site, security, personnel access, and privacy in the 
collection process, and precautions to ensure the integrity and 
identity of specimens. In issuing such model procedures, the Secretary 
may recommend alternatives to address appropriate particularized needs 
or circumstances, including those applicable to athletic competition, 
and may provide technical assistance to drug testing programs adopting 
or considering adoption of such model procedures.
    ``(b) Savings Provision.--Subsection (a) shall not be construed to 
affect the applicability of the specimen collection procedures in 
subpart B of the HHS guidelines to drug testing programs conducted by 
Federal agencies under Executive Order 12564.

``SEC. 574. PROHIBITIONS.

    ``(a) Certification Requirement.--(1) No person may perform any 
toxicological urinalysis in connection with any drug testing program 
unless that person is a laboratory which is certified under the 
certification program established under section 571.
    ``(2) It shall be unlawful for any laboratory certified to perform 
toxicological urinalysis under the certification program established 
under section 571 to perform toxicological urinalyses in connection 
with any drug testing program for any drug or drug class other than 
those listed in section 571(c)(3)(A) unless--
            ``(A) in a case where such other drug or drug class is one 
        for which the Secretary has prescribed test methods and cutoff 
        levels under section 572(b)(2) or 572(c), such laboratory is 
        certified by the Secretary to perform toxicological urinalyses 
        for such other drug or drug class, or
            ``(B) in the case of any other drug or drug class, such 
        drug testing program provides the laboratory with a statement 
        signed by the test subject acknowledging that disclosure of a 
        test for such other drug or drug class has been made and 
        consenting to the performance of such test.
    ``(b) Other Violations.--It shall be unlawful for any person--
            ``(1) who is a test subject to knowingly disclose the 
        results of a toxicological urinalysis in connection with any 
        drug testing program which was not performed on such person,
            ``(2) who is not a test subject and who has been directly 
        or indirectly involved in a drug testing program or a 
        toxicological urinalysis under such a program, to knowingly 
        disclose the results of any toxicological urinalysis in 
        connection with any drug testing program, except--
                    ``(A) as provided in the regulations issued under 
                section 572,
                    ``(B) that if the person is authorized to 
                represent--
                            ``(i) an educational institution in which a 
                        participant described in section 572(d) is 
                        enrolled,
                            ``(ii) an organized interscholastic or 
                        intercollegiate athletic team, league, or 
                        association, or
                            ``(iii) an organization that conducts 
                        organized athletic competition under the 
                        auspices of or sanctioned by the United States 
                        Olympic Committee or any member thereof,
                such person may disclose the results of a toxicological 
                urinalysis performed on a participant described in 
                section 572(d) in connection with a drug testing 
                program, and
                    ``(C) that if the person is authorized to represent 
                a team, league, or association which conducts a drug 
                testing program in which participants in athletic 
                competitions who are paid for their performance are 
                test subjects, such person may disclose the results of 
                a toxicological urinalysis performed on such 
                participant in connection with a drug testing program,
        ``(3) to knowingly--
                    ``(A) alter or falsely report the results of a 
                toxicological urinalysis, or
                    ``(B) adulterate any urine specimen (other than a 
                specimen spiked for use in performance testing),
        in connection with any drug testing program or performance 
        testing,
            ``(4) except in connection with epidemiological, 
        biomedical, or other medical research in which the identity of 
        the person providing the urine specimen is unknown, to 
        knowingly perform or cause to be performed on a urine specimen 
        a test for any medical condition or any substance, other than 
        alcohol or a drug or drug class for which the Secretary has 
        prescribed test methods and cutoff levels under section 572(a) 
        or 562(b)(2), without the consent of the person providing the 
        urine specimen following disclosure to such person of the 
        medical condition or substance for which testing will be 
        performed,
            ``(5) if the consent of a person providing a urine specimen 
        is required under paragraph (4) before the specimen may be 
        tested, to take any adverse action against such person for 
        refusing to give such consent, unless such person is a 
        participant described in section 572(d) or is a participant in 
        athletic competition who is paid for the participant's 
        performance,
            ``(6) in the case of a toxicological urinalysis, to take 
        any adverse action against any test subject based, in whole or 
        in part, upon a positive result that has not been confirmed by 
        a test--
                    ``(A) which uses gas chromatography/mass 
                spectrometry (or, in the case of alprazolam, which uses 
                high-performance liquid chromatography), or
                    ``(B) which, after the establishment of the 
                certification program under section 571, is performed 
                in accordance with the requirements of such program,
            ``(7) in the case of a toxicological urinalysis, where a 
        confirmed positive result has not been verified by a medical 
        review officer because there exists a legitimate medical 
        explanation for the result consistent with legal drug use, 
        including use of a drug pursuant to and in accordance with a 
        valid prescription, or because the result is scientifically 
        insufficient for further action, to take any adverse action 
        against any test subject based in whole or in part upon such 
        result, except that, in the case of a drug testing program 
        conducted in connection with athletic competition, a medical 
        review officer may verify a confirmed positive result for any 
        drug described in subsection (a)(2)(B) notwithstanding the 
        existence of a legitimate medical explanation for the result, 
        and adverse action may be taken against any participant in 
        athletic competition based upon such result, or
            ``(8) to knowingly fail to administer or conduct any 
        toxicological urinalysis or drug testing program in accordance 
        with the requirements of the certification program established 
        under section 571 or the regulations issued under section 572.
As used in paragraph (4), the term `any medical condition or any 
substance' does not include creatinine, pH, or specific gravity.

``SEC. 575. SANCTIONS AND REMEDIES.

    ``(a) Criminal Penalty.--A person who violates section 574(a) shall 
be subject to imprisonment for not more than 3 years, or a fine under 
title 18, United States Code, or both.
    ``(b) Administrative Remedies.--
            ``(1) A laboratory performing any toxicological urinalysis 
        in connection with any drug testing program that violates any 
        regulation issued under section 572 shall be subject to 
        assessment by the Secretary of a civil penalty of not less than 
        $1,000 or more than $10,000, taking into account the previous 
        record of the laboratory under sections 571 and 572 and the 
        gravity of the violation.
            ``(2) If the Secretary discovers a violation of any 
        regulation issued under section 572 by any person other than a 
        laboratory, the Secretary shall refer the matter to the 
        Attorney General for further investigation and appropriate 
        action.
    ``(c) Injunction.--The Secretary or the Attorney General, as 
appropriate, or any aggrieved person, may bring an action to restrain 
violations of section 574(a) or any regulation issued under section 
572. In any action brought under this subsection, the district courts 
of the United States shall have jurisdiction for cause shown, to issue 
declaratory relief, temporary restraining orders, and preliminary and 
permanent injunctions to require compliance with such provisions.
    ``(d) Civil Action.--Any test subject who is tested, or whose test 
results are handled, in violation of, or is deprived of rights because 
of a violation under, subsection (a) or paragraphs (1) through (7) of 
subsection (b) of section 574, or who is adversely affected by a 
material breach in an applicable chain of custody under section 572, 
may institute a civil action in any district court of the United States 
of competent jurisdiction for appropriate legal and equitable relief, 
including employment, reinstatement, promotion, the payment of lost 
wages and benefits, and damages. The costs of suit, including a 
reasonable attorney's fee, shall be allowed to a prevailing party. Such 
an attorney's fee shall be allowed in the manner in which attorney's 
fees are allowed under the last sentence of section 722 of the Revised 
Statutes (42 U.S.C. 1988). It shall not be a defense to such an action 
that the plaintiff has waived the rights or protections provided for in 
this section or has otherwise consented to a violation, deprivation, or 
breach. No action may be instituted under this subsection after the 
expiration of 2 years from the date the person discovers the violation, 
deprivation, or breach.
    ``(e) Indemnification and Contribution.--Any person conducting a 
drug testing program who takes any adverse action against any test 
subject based, in whole or in part, upon a report by a laboratory of a 
positive test result which is thereafter found to have been a false 
positive result and who consequently is held liable under subsection 
(d) for damages or other sums may institute a civil action against such 
laboratory for indemnification or contribution, as appropriate, in any 
district court of the United States of competent jurisdiction. No 
action may be instituted under this subsection after the expiration of 
one year from the date on which a judgment under subsection (d) becomes 
final.

``SEC. 576. CONSTRUCTIONS.

    ``(a) In General.--Nothing in this part limits the authority--
            ``(1) of the Secretary under section 571(c)(1)(B)(i) to 
        permit an agency or accrediting body described in section 
        571(c)(1)(B)(ii) to maintain, or
            ``(2) of any test subject or duly authorized representative 
        of a test subject to contract for,
standards, procedures, or requirements more protective of test subjects 
than those provided by the certification program established under 
section 571 or the regulations issued under section 572.
    ``(b) Limitation.--Notwithstanding subsection (a)(1), the Secretary 
shall not permit an agency or accrediting body described in section 
571(c)(1)(B)(ii) to deny certification under section 571 to any 
laboratory complying with the standards, procedures, and requirements 
established by the Secretary under section 571.
    ``(c) Certification.--To the extent that this part imposes a more 
protective standard, procedure, or requirement on--
            ``(1) the Secretary,
            ``(2) laboratories performing toxicological urinalysis, or
            ``(3) a person conducting a drug testing program, such 
        standard, procedure, or requirement shall supersede and replace 
        that provided by the HHS guidelines and by any statute, rule, 
        regulation, Executive order, or other law in effect on the date 
        on which such standard, procedure, or requirement becomes 
        effective.

``SEC. 577. PREEMPTION.

    ``(a) In General.--No State or local government may adopt or 
enforce any law, rule, regulation, ordinance, standard, or order 
relating to--
            ``(1) the certification of laboratories which perform drug 
        testing, or
            ``(2) requirements for the conduct of drug testing under 
        the certification program established under this part,
which is different from such certification program.
    ``(b) Prohibition.--No State or local government may adopt or 
enforce any law, rule, regulation, ordinance, standard, or order that 
permits or requires any act prohibited by section 574.

``SEC. 578. FEES.

    ``The Secretary shall require the payment of fees by a laboratory 
for certification and recertification in such amounts as the Secretary 
may, from time to time, determine are necessary to recover the cost of 
granting or denying such certification or recertification under the 
certification program established under section 571. The Secretary 
shall also require the payment thereafter of annual fees by certified 
laboratories in such amounts as the Secretary may, from time to time, 
determine are necessary to recover the cost of ongoing testing, 
inspection, investigation, enforcement, and other supervisory 
activities with respect to certified laboratories under this part and 
such certification program. Subject to appropriation Acts, the 
Secretary may use fees collected under this section to administer the 
certification program under section 571 and to carry out the activities 
described in the preceding sentence.

``SEC. 579. DEFINITIONS.

    ``As used in this part--
            ``(1) the term `blank specimen' means a urine specimen 
        containing no drug,
            ``(2) the term `controlled substance' has the meaning given 
        to it in section 102(b) of the Controlled Substances Act (21 
        U.S.C. 802(6)),
            ``(3) the term `drug' means any controlled substance and 
        any metabolite of a controlled substance,
            ``(4) the term `drug testing program' means any program or 
        policy under which 2 or more individuals are, or can reasonably 
        be expected to be, required or requested to submit urine 
        specimens for toxicological urinalysis, but such term does not 
        include--
                    ``(A) any program for toxicological urinalysis--
                            ``(i) administered by the armed forces (as 
                        defined in section 2101(2) of title 5, United 
                        States Code) or the intelligence community (as 
                        defined in Executive Order 12333 of December 4, 
                        1981), or
                            ``(ii) involving the testing of arrestees, 
                        detainees, probationers, incarcerated persons, 
                        or parolees in the criminal justice system, and
                    ``(B) the submission to a laboratory of any urine 
                specimen by an individual's physician if the testing by 
                the laboratory of the specimen is to be conducted as 
                part of the regular course of diagnosis or treatment 
                prescribed by the physician,
            ``(5) the term `false positive result' means a report in 
        connection with any toxicological urinalysis of the presence of 
        a drug in a urine specimen in which that drug is not in fact 
        present at or above the cutoff level for that drug established 
        by the Secretary,
            ``(6) the term `medical review officer' has the meaning 
        given such term in subpart A of the HHS guidelines,
            ``(7) the term `person' includes the Federal Government, a 
        State or local government, or any agency of such a government,
            ``(8) the term `performance testing' means testing of a 
        laboratory's ability--
                    ``(A) to identify correctly whether a urine 
                specimen contains a quantity of a drug, and
                    ``(B) in the case of a spiked specimen, to identify 
                correctly the amount of any drug in that specimen 
                within qualitative threshold levels and quantitative 
                ranges established by the regulations issued under 
                section 572,
            ``(9) the term `spiked specimen' means a urine specimen 
        into which a quantity of a drug or drugs has intentionally been 
        placed for use in performance testing,
            ``(10) the term `test subject' means an individual who has 
        been required or requested to submit a urine specimen for 
        toxicological urinalysis in connection with a drug testing 
        program, and
            ``(11) the term `toxicological urinalysis' means the 
        performance of any analytical procedure or set of procedures on 
        a urine specimen to identify the presence in that specimen of 
        any drug and the amount thereof.''.

SEC. 3. EFFECTIVE DATE.

    Part F of title V of the Public Health Service Act, added by 
section 2, shall take effect on the date of the enactment of this Act, 
except that subsections (a), (b)(2), and (b)(8) of section 574 of such 
part shall take effect one year after the date the Secretary of Health 
and Human Services establishes the laboratory certification program 
under section 571 of such part.

                                 <all>

HR 33 IH----2