# United States Code/Title 42/Chapter 6a/Section 263a

[Laws in effect as of January 5, 1999]
[CITE: 42USC263a]
  TITLE 42 - THE PUBLIC HEALTH AND WELFARE  CHAPTER 6A - PUBLIC HEALTH SERVICE  SUBCHAPTER II - GENERAL POWERS AND DUTIES  Part F - Licensing of Biological Products and Clinical Laboratories  subpart 2 - clinical laboratories  .   -HEAD-  subpart 2 - clinical laboratories   -CITE-  42 USC Sec. 263a 01/05/99   -EXPCITE-  TITLE 42 - THE PUBLIC HEALTH AND WELFARE  CHAPTER 6A - PUBLIC HEALTH SERVICE  SUBCHAPTER II - GENERAL POWERS AND DUTIES  Part F - Licensing of Biological Products and Clinical Laboratories  subpart 2 - clinical laboratories   -HEAD-  Sec. 263a. Certification of laboratories   -STATUTE-  (a) "Laboratory" or "clinical laboratory" defined  As used in this section, the term "laboratory" or "clinical  laboratory" means 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.  (b) Certificate requirement  No person may solicit or accept materials derived from the human  body for laboratory examination or other procedure unless there is  in effect for the laboratory a certificate issued by the Secretary  under this section applicable to the category of examinations or  procedures which includes such examination or procedure.  (c) Issuance and renewal of certificates  (1) In general  The Secretary may issue or renew a certificate for a laboratory  only if the laboratory meets the requirements of subsection (d)  of this section.  (2) Term  A certificate issued under this section shall be valid for a  period of 2 years or such shorter period as the Secretary may  establish.  (d) Requirements for certificates  (1) In general  A laboratory may be issued a certificate or have its  certificate renewed if -  (A) the laboratory submits (or if the laboratory is  accredited under subsection (e) of this section, the  accreditation body which accredited the laboratory submits), an  application -  (i) in such form and manner as the Secretary shall  prescribe,  (ii) that describes the characteristics of the laboratory  examinations and other procedures performed by the laboratory  including -  (I) the number and types of laboratory examinations and  other procedures performed,  (II) the methodologies for laboratory examinations and  other procedures employed, and  (III) the qualifications (educational background,  training, and experience) of the personnel directing and  supervising the laboratory and performing the laboratory  examinations and other procedures, and  (iii) that contains such other information as the Secretary  may require to determine compliance with this section, and  the laboratory agrees to provide to the Secretary (or if the  laboratory is accredited, to the accreditation body which  accredited it) a description of any change in the information  submitted under clause (ii) not later than 6 months after the  change was put into effect,  (B) the laboratory provides the Secretary -  (i) with satisfactory assurances that the laboratory will  be operated in accordance with standards issued by the  Secretary under subsection (f) of this section, or  (ii) with proof of accreditation under subsection (e) of  this section,  (C) the laboratory agrees to permit inspections by the  Secretary under subsection (g) of this section,  (D) the laboratory agrees to make records available and  submit reports to the Secretary as the Secretary may reasonably  require, and  (E) the laboratory agrees to treat proficiency testing  samples in the same manner as it treats materials derived from  the human body referred to it for laboratory examinations or  other procedures in the ordinary course of business.  (2) Requirements for certificates of waiver  (A) In general  A laboratory which only performs laboratory examinations and  procedures described in paragraph (3) shall be issued a  certificate of waiver or have its certificate of waiver renewed  if -  (i) the laboratory submits an application -  (I) in such form and manner as the Secretary shall  prescribe,  (II) that describes the characteristics of the laboratory  examinations and other procedures performed by the  laboratory, including the number and types of laboratory  examinations and other procedures performed, the  methodologies for laboratory examinations and other  procedures employed, and the qualifications (educational  background, training, and experience) of the personnel  directing and supervising the laboratory and performing the  laboratory examinations and other procedures, and  (III) that contains such other information as the  Secretary may reasonably require to determine compliance  with this section, and  (ii) the laboratory agrees to make records available and  submit reports to the Secretary as the Secretary may require.  (B) Changes  If a laboratory makes changes in the examinations and other  procedures performed by it only with respect to examinations  and procedures which are described in paragraph (3), the  laboratory shall report such changes to the Secretary not later  than 6 months after the change has been put into effect. If a  laboratory proposes to make changes in the examinations and  procedures performed by it such that the laboratory will  perform an examination or procedure not described in paragraph  (3), the laboratory shall report such change to the Secretary  before the change takes effect.  (C) Effect  Subsections (f) and (g) of this section shall not apply to a  laboratory to which has been issued a certificate of waiver.  (3) Examinations and procedures  The examinations and procedures identified in paragraph (2) are  laboratory examinations and procedures that have been approved by  the Food and Drug Administration for home use or that, as  determined by the Secretary, are simple laboratory examinations  and procedures that have an insignificant risk of an erroneous  result, including those that -  (A) employ methodologies that are so simple and accurate as  to render the likelihood of erroneous results by the user  negligible, or  (B) the Secretary has determined pose no unreasonable risk of  harm to the patient if performed incorrectly.  (4) "Certificate" defined  As used in this section, the term "certificate" includes a  certificate of waiver issued under paragraph (2).  (e) Accreditation  (1) In general  A laboratory may be accredited for purposes of obtaining a  certificate if the laboratory -  (A) meets the standards of an approved accreditation body,  and  (B) authorizes the accreditation body to submit to the  Secretary (or such State agency as the Secretary may designate)  such records or other information as the Secretary may require.  (2) Approval of accreditation bodies  (A) In general  The Secretary may approve a private nonprofit organization to  be an accreditation body for the accreditation of laboratories  if -  (i) using inspectors qualified to evaluate the  methodologies used by the laboratories in performing  laboratory examinations and other procedures, the  accreditation body agrees to inspect a laboratory for  purposes of accreditation with such frequency as determined  by (FOOTNOTE 1) Secretary,  (FOOTNOTE 1) So in original. Probably should be "by the".  (ii) the standards applied by the body in determining  whether or not to accredit a laboratory are equal to or more  stringent than the standards issued by the Secretary under  subsection (f) of this section,  (iii) there is adequate provision for assuring that the  standards of the accreditation body continue to be met by the  laboratory,  (iv) in the case of any laboratory accredited by the body  which has had its accreditation denied, suspended, withdrawn,  or revoked or which has had any other action taken against it  by the accrediting body, the accrediting body agrees to  submit to the Secretary the name of such laboratory within 30  days of the action taken,  (v) the accreditation body agrees to notify the Secretary  at least 30 days before it changes its standards, and  (vi) if the accreditation body has its approval withdrawn  by the Secretary, the body agrees to notify each laboratory  accredited by the body of the withdrawal within 10 days of  the withdrawal.  (B) Criteria and procedures  The Secretary shall promulgate criteria and procedures for  approving an accreditation body and for withdrawing such  approval if the Secretary determines that the accreditation  body does not meet the requirements of subparagraph (A).  (C) Effect of withdrawal of approval  If the Secretary withdraws the approval of an accreditation  body under subparagraph (B), the certificate of any laboratory  accredited by the body shall continue in effect for 60 days  after the laboratory receives notification of the withdrawal of  the approval, except that the Secretary may extend such period  for a laboratory if it determines that the laboratory submitted  an application for accreditation or a certificate in a timely  manner after receipt of the notification of the withdrawal of  approval. If an accreditation body withdraws or revokes the  accreditation of a laboratory, the certificate of the  laboratory shall continue in effect -  (i) for 45 days after the laboratory receives notice of the  withdrawal or revocation of the accreditation, or  (ii) until the effective date of any action taken by the  Secretary under subsection (i) of this section.  (D) Evaluations  The Secretary shall evaluate annually the performance of each  approved accreditation body by -  (i) inspecting under subsection (g) of this section a  sufficient number of the laboratories accredited by such body  to allow a reasonable estimate of the performance of such  body, and  (ii) such other means as the Secretary determines  appropriate.  (3) Report  The Secretary shall annually prepare and submit, to the  Committee on Energy and Commerce of the House of Representatives  and the Committee on Labor and Human Resources of the Senate, a  report that describes the results of the evaluation conducted  under paragraph (2)(D).  (f) Standards  (1) In general  The Secretary shall issue standards to assure consistent  performance by laboratories issued a certificate under this  section of valid and reliable laboratory examinations and other  procedures. Such standards shall require each laboratory issued  a certificate under this section -  (A) to maintain a quality assurance and quality control  program adequate and appropriate for the validity and  reliability of the laboratory examinations and other procedures  of the laboratory and to meet requirements relating to the  proper collection, transportation, and storage of specimens and  the reporting of results,  (B) to maintain records, equipment, and facilities necessary  for the proper and effective operation of the laboratory,  (C) in performing and carrying out its laboratory  examinations and other procedures, to use only personnel  meeting such qualifications as the Secretary may establish for  the direction, supervision, and performance of examinations and  procedures within the laboratory, which qualifications shall  take into consideration competency, training, experience, job  performance, and education and which qualifications shall, as  appropriate, be different on the basis of the type of  examinations and procedures being performed by the laboratory  and the risks and consequences of erroneous results associated  with such examinations and procedures,  (D) to qualify under a proficiency testing program meeting  the standards established by the Secretary under paragraph (3),  and  (E) to meet such other requirements as the Secretary  determines necessary to assure consistent performance by such  laboratories of accurate and reliable laboratory examinations  and procedures.  (2) Considerations  In developing the standards to be issued under paragraph (1),  the Secretary shall, within the flexibility provided under  subparagraphs (A) through (E) of paragraph (1), take into  consideration -  (A) the examinations and procedures performed and the  methodologies employed,  (B) the degree of independent judgment involved,  (C) the amount of interpretation involved,  (D) the difficulty of the calculations involved,  (E) the calibration and quality control requirements of the  instruments used,  (F) the type of training required to operate the instruments  used in the methodology, and  (G) such other factors as the Secretary considers relevant.  (3) Proficiency testing program  (A) In general  The Secretary shall establish standards for the proficiency  testing programs for laboratories issued a certificate under  this section which are conducted by the Secretary, conducted by  an organization approved under subparagraph (C), or conducted  by an approved accrediting body. The standards shall require  that a laboratory issued a certificate under this section be  tested for each examination and procedure conducted within a  category of examinations or procedures for which it has  received a certificate, except for examinations and procedures  for which the Secretary has determined that a proficiency test  cannot reasonably be developed. The testing shall be conducted  on a quarterly basis, except where the Secretary determines for  technical and scientific reasons that a particular examination  or procedure may be tested less frequently (but not less often  than twice per year).  (B) Criteria  The standards established under subparagraph (A) shall  include uniform criteria for acceptable performance under a  proficiency testing program, based on the available technology  and the clinical relevance of the laboratory examination or  other procedure subject to such program. The criteria shall be  established for all examinations and procedures and shall be  uniform for each examination and procedure. The standards  shall also include a system for grading proficiency testing  performance to determine whether a laboratory has performed  acceptably for a particular quarter and acceptably for a  particular examination or procedure or category of examination  or procedure over a period of successive quarters.  (C) Approved proficiency testing programs  For the purpose of administering proficiency testing programs  which meet the standards established under subparagraph (A),  the Secretary shall approve a proficiency testing program  offered by a private nonprofit organization or a State if the  program meets the standards established under subparagraph (A)  and the organization or State provides technical assistance to  laboratories seeking to qualify under the program. The  Secretary shall evaluate each program approved under this  subparagraph annually to determine if the program continues to  meet the standards established under subparagraph (A) and shall  withdraw the approval of any program that no longer meets such  standards.  (D) Onsite testing  The Secretary shall perform, or shall direct a program  approved under subparagraph (C) to perform, onsite proficiency  testing to assure compliance with the requirements of  subsection (d)(5) of this section. The Secretary shall  perform, on an onsite or other basis, proficiency testing to  evaluate the performance of a proficiency testing program  approved under subparagraph (C) and to assure quality  performance by a laboratory.  (E) Training, technical assistance, and enhanced proficiency  testing  The Secretary may, in lieu of or in addition to actions  authorized under subsection (h), (i), or (j) of this section,  require any laboratory which fails to perform acceptably on an  individual examination and procedure or a category of  examination and procedures -  (i) to undertake training and to obtain the necessary  technical assistance to meet the requirements of the  proficency (FOOTNOTE 2) testing program,  (FOOTNOTE 2) So in original. Probably should be  "proficiency".  (ii) to enroll in a program of enhanced proficiency  testing, or  (iii) to undertake any combination of the training,  technical assistance, or testing described in clauses (i) and  (ii).  (F) Testing results  The Secretary shall establish a system to make the results of  the proficiency testing programs subject to the standards  established by the Secretary under subparagraph (A) available,  on a reasonable basis, upon request of any person. The  Secretary shall include with results made available under this  subparagraph such explanatory information as may be appropriate  to assist in the interpretation of such results.  (4) National standards for quality assurance in cytology services  (A) Establishment  The Secretary shall establish national standards for quality  assurance in cytology services designed to assure consistent  performance by laboratories of valid and reliable cytological  services.  (B) Standards  The standards established under subparagraph (A) shall  include -  (i) the maximum number of cytology slides that any  individual may screen in a 24-hour period,  (ii) requirements that a clinical laboratory maintain a  record of (I) the number of cytology slides screened during  each 24-hour period by each individual who examines cytology  slides for the laboratory, and (II) the number of hours  devoted during each 24-hour period to screening cytology  slides by such individual,  (iii) criteria for requiring rescreening of cytological  preparations, such as (I) random rescreening of cytology  specimens determined to be in the benign category, (II)  focused rescreening of such preparations in high risk groups,  and (III) for each abnormal cytological result, rescreening  of all prior cytological specimens for the patient, if  available,  (iv) periodic confirmation and evaluation of the  proficiency of individuals involved in screening or  interpreting cytological preparations, including announced  and unannounced on-site proficiency testing of such  individuals, with such testing to take place, to the extent  practicable, under normal working conditions,  (v) procedures for detecting inadequately prepared slides,  for assuring that no cytological diagnosis is rendered on  such slides, and for notifying referring physicians of such  slides,  (vi) requirements that all cytological screening be done on  the premises of a laboratory that is certified under this  section,  (vii) requirements for the retention of cytology slides by  laboratories for such periods of time as the Secretary  considers appropriate, and  (viii) standards requiring periodic inspection of cytology  services by persons capable of evaluating the quality of  cytology services.  (g) Inspections  (1) In general  The Secretary may, on an announced or unannounced basis, enter  and inspect, during regular hours of operation, laboratories  which have been issued a certificate under this section. In  conducting such inspections the Secretary shall have access to  all facilities, equipment, materials, records, and information  that the Secretary determines have a bearing on whether the  laboratory is being operated in accordance with this section. As  part of such an inspection the Secretary may copy any such  material or require to it (FOOTNOTE 3) be submitted to the  Secretary. An inspection under this paragraph may be made only  upon presenting identification to the owner, operator, or agent  in charge of the laboratory being inspected.  (FOOTNOTE 3) So in original. Probably should be "require it  to".  (2) Compliance with requirements and standards  The Secretary shall conduct inspections of laboratories under  paragraph (1) to determine their compliance with the requirements  of subsection (d) of this section and the standards issued under  subsection (f) of this section. Inspections of laboratories not  accredited under subsection (e) of this section shall be  conducted on a biennial basis or with such other frequency as the  Secretary determines to be necessary to assure compliance with  such requirements and standards. Inspections of laboratories  accredited under subsection (e) of this section shall be  conducted on such basis as the Secretary determines is necessary  to assure compliance with such requirements and standards.  (h) Intermediate sanctions  (1) In general  If the Secretary determines that a laboratory which has been  issued a certificate under this section no longer substantially  meets the requirements for the issuance of a certificate, the  Secretary may impose intermediate sanctions in lieu of the  actions authorized by subsection (i) of this section.  (2) Types of sanctions  The intermediate sanctions which may be imposed under paragraph  (1) shall consist of -  (A) directed plans of correction,  (B) civil money penalties in an amount not to exceed $10,000  for each violation listed in subsection (i)(1) of this section  or for each day of substantial noncompliance with the  requirements of this section,  (C) payment for the costs of onsite monitoring, or  (D) any combination of the actions described in subparagraphs  (A), (B), and (C).  (3) Procedures  The Secretary shall develop and implement procedures with  respect to when and how each of the intermediate sanctions is to  be imposed under paragraph (1). Such procedures shall provide for  notice to the laboratory and a reasonable opportunity to respond  to the proposed sanction and appropriate procedures for appealing  determinations relating to the imposition of intermediate  sanctions (FOOTNOTE 4)  (FOOTNOTE 4) So in original. Probably should be followed by a  period.  (i) Suspension, revocation, and limitation  (1) In general  Except as provided in paragraph (2), the certificate of a  laboratory issued under this section may be suspended, revoked,  or limited if the Secretary finds, after reasonable notice and  opportunity for hearing to the owner or operator of the  laboratory, that such owner or operator or any employee of the  laboratory -  (A) has been guilty of misrepresentation in obtaining the  certificate,  (B) has performed or represented the laboratory as entitled  to perform a laboratory examination or other procedure which is  not within a category of laboratory examinations or other  procedures authorized in the certificate,  (C) has failed to comply with the requirements of subsection  (d) of this section or the standards prescribed by the  Secretary under subsection (f) of this section,  (D) has failed to comply with reasonable requests of the  Secretary for -  (i) any information or materials, or  (ii) work on materials,  that the Secretary concludes is necessary to determine the  laboratory's continued eligibility for its certificate or  continued compliance with the Secretary's standards under  subsection (f) of this section,  (E) has refused a reasonable request of the Secretary, or any  Federal officer or employee duly designated by the Secretary,  for permission to inspect the laboratory and its operations and  pertinent records during the hours the laboratory is in  operation,  (F) has violated or aided and abetted in the violation of any  provisions of this section or of any regulation promulgated  thereunder, or  (G) has not complied with an intermediate sanction imposed  under subsection (h) of this section.  (2) Action before a hearing  If the Secretary determines that -  (A) the failure of a laboratory to comply with the standards  of the Secretary under subsection (f) of this section presents  an imminent and serious risk to human health, or  (B) a laboratory has engaged in an action described in  subparagraph (D) or (E) of paragraph (1),  the Secretary may suspend or limit the certificate of the  laboratory before holding a hearing under paragraph (1) regarding  such failure or refusal. The opportunity for a hearing shall be  provided no later than 60 days from the effective date of the  suspension or limitation. A suspension or limitation under this  paragraph shall stay in effect until the decision of the  Secretary made after the hearing under paragraph (1).  (3) Ineligibility to own or operate laboratories after revocation  No person who has owned or operated a laboratory which has had  its certificate revoked may, within 2 years of the revocation of  the certificate, own or operate a laboratory for which a  certificate has been issued under this section. The certificate  of a laboratory which has been excluded from participation under  the medicare program under title XVIII of the Social Security Act  (42 U.S.C. 1395 et seq.) because of actions relating to the  quality of the laboratory shall be suspended for the period the  laboratory is so excluded.  (4) Improper referrals  Any laboratory that the Secretary determines intentionally  refers its proficiency testing samples to another laboratory for  analysis shall have its certificate revoked for at least one year  and shall be subject to appropriate fines and penalties as  provided for in subsection (h) of this section.  (j) Injunctions  Whenever the Secretary has reason to believe that continuation of  any activity by a laboratory would constitute a significant hazard  to the public health the Secretary may bring suit in the district  court of the United States for the district in which such  laboratory is situated to enjoin continuation of such activity.  Upon proper showing, a temporary injunction or restraining order  against continuation of such activity pending issuance of a final  order under this subsection shall be granted without bond by such  court.  (k) Judicial review  (1) Petition  Any laboratory which has had an intermediate sanction imposed  under subsection (h) of this section or has had its certificate  suspended, revoked, or limited under subsection (i) of this  section may, at any time within 60 days after the date the action  of the Secretary under subsection (i) or (h) of this section  becomes final, file a petition with the United States court of  appeals for the circuit wherein the laboratory has its principal  place of business for judicial review of such action. As soon as  practicable after receipt of the petition, the clerk of the court  shall transmit a copy of the petition to the Secretary or other  officer designated by the Secretary for that purpose. As soon as  practicable after receipt of the copy, the Secretary shall file  in the court the record on which the action of the Secretary is  based, as provided in section 2112 of title 28.  (2) Additional evidence  If the petitioner applies to the court for leave to adduce  additional evidence, and shows to the satisfaction of the court  that such additional evidence is material and that there were  reasonable grounds for the failure to adduce such evidence in the  proceeding before the Secretary, the court may order such  additional evidence (and evidence in rebuttal of such additional  evidence) to be taken before the Secretary, and to be adduced  upon the hearing in such manner and upon such terms and  conditions as the court may deem proper. The Secretary may  modify the findings of the Secretary as to the facts, or make new  findings, by reason of the additional evidence so taken, and the  Secretary shall file such modified or new findings, and the  recommendations of the Secretary, if any, for the modification or  setting aside of his original action, with the return of such  additional evidence.  (3) Judgment of court  Upon the filing of the petition referred to in paragraph (1),  the court shall have jurisdiction to affirm the action, or to set  it aside in whole or in part, temporarily or permanently. The  findings of the Secretary as to the facts, if supported by  substantial evidence, shall be conclusive.  (4) Finality of judgment  The judgment of the court affirming or setting aside, in whole  or in part, any such action of the Secretary shall be final,  subject to review by the Supreme Court of the United States upon  certiorari or certification as provided in section 1254 of title  28.  (l) Sanctions  Any person who intentionally violates any requirement of this  section or any regulation promulgated thereunder shall be  imprisoned for not more than one year or fined under title 18, or  both, except that if the conviction is for a second or subsequent  violation of such a requirement such person shall be imprisoned for  not more than 3 years or fined in accordance with title 18, or  both.  (m) Fees  (1) Certificate fees  The Secretary shall require payment of fees for the issuance  and renewal of certificates, except that the Secretary shall only  require a nominal fee for the issuance and renewal of  certificates of waiver.  (2) Additional fees  The Secretary shall require the payment of fees for inspections  of laboratories which are not accredited and for the cost of  performing proficiency testing on laboratories which do not  participate in proficiency testing programs approved under  subsection (f)(3)(C) of this section.  (3) Criteria  (A) Fees under paragraph (1)  Fees imposed under paragraph (1) shall be sufficient to cover  the general costs of administering this section, including  evaluating and monitoring proficiency testing programs approved  under subsection (f) of this section and accrediting bodies and  implementing and monitoring compliance with the requirements of  this section.  (B) Fees under paragraph (2)  Fees imposed under paragraph (2) shall be sufficient to cover  the cost of the Secretary in carrying out the inspections and  proficiency testing described in paragraph (2).  (C) Fees imposed under paragraphs (1) and (2)  Fees imposed under paragraphs (1) and (2) shall vary by group  or classification of laboratory, based on such considerations  as the Secretary determines are relevant, which may include the  dollar volume and scope of the testing being performed by the  laboratories.  (n) Information  On April 1, 1990 and annually thereafter, the Secretary shall  compile and make available to physicians and the general public  information, based on the previous calendar year, which the  Secretary determines is useful in evaluating the performance of a  laboratory, including -  (1) a list of laboratories which have been convicted under  Federal or State laws relating to fraud and abuse, false  billings, or kickbacks,  (2) a list of laboratories -  (A) which have had their certificates revoked, suspended, or  limited under subsection (i) of this section, or  (B) which have been the subject of a sanction under  subsection (l) of this section,  together with a statement of the reasons for the revocation,  suspension, limitation, or sanction,  (3) a list of laboratories subject to intermediate sanctions  under subsection (h) of this section together with a statement of  the reasons for the sanctions,  (4) a list of laboratories whose accreditation has been  withdrawn or revoked together with a statement of the reasons for  the withdrawal or revocation,  (5) a list of laboratories against which the Secretary has  taken action under subsection (j) of this section together with a  statement of the reasons for such action, and  (6) a list of laboratories which have been excluded from  participation under title XVIII or XIX of the Social Security Act  (42 U.S.C. 1395 et seq., 1396 et seq.).  The information to be compiled under paragraphs (1) through (6)  shall be information for the calendar year preceding the date the  information is to be made available to the public and shall be  accompanied by such explanatory information as may be appropriate  to assist in the interpretation of the information compiled under  such paragraphs.  (o) Delegation  In carrying out this section, the Secretary may, pursuant to  agreement, use the services or facilities of any Federal or State  or local public agency or nonprofit private organization, and may  pay therefor in advance or by way of reimbursement, and in such  installments, as the Secretary may determine.  (p) State laws  (1) Except as provided in paragraph (2), nothing in this section  shall be construed as affecting the power of any State to enact and  enforce laws relating to the matters covered by this section to the  extent that such laws are not inconsistent with this section or  with the regulations issued under this section.  (2) If a State enacts laws relating to matters covered by this  section which provide for requirements equal to or more stringent  than the requirements of this section or than the regulations  issued under this section, the Secretary may exempt clinical  laboratories in that State from compliance with this section.  (q) Consultations  In carrying out this section, the Secretary shall consult with  appropriate private organizations and public agencies.   -SOURCE-  (July 1, 1944, ch. 373, title III, Sec. 353, as added Pub. L.  90-174, Sec. 5(a), Dec. 5, 1967, 81 Stat. 536; amended Pub. L.  100-578, Sec. 2, Oct. 31, 1988, 102 Stat. 2903; Pub. L. 105-115,  title I, Sec. 123(h), Nov. 21, 1997, 111 Stat. 2324.)   -REFTEXT-  REFERENCES IN TEXT  The Social Security Act, referred to in subsecs. (i)(3) and  (n)(6), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended.  Titles XVIII and XIX of the Social Security Act are classified  generally to subchapters XVIII (Sec. 1395 et seq.) and XIX (Sec.  1396 et seq.), respectively, of chapter 7 of this title. For  complete classification of this Act to the Code, see section 1305  of this title and Tables.   -MISC2-  AMENDMENTS  1997 - Subsec. (d)(3). Pub. L. 105-115 amended heading and text  of par. (3) generally. Prior to amendment, text read as follows:  "The examinations and procedures identified in paragraph (2) are  simple laboratory examinations and procedures which, as determined  by the Secretary, have an insignificant risk of an erroneous  result, including those which -  "(A) have been approved by the Food and Drug Administration  for home use,  "(B) employ methodologies that are so simple and accurate as  to render the likelihood of erroneous results negligible, or  "(C) the Secretary has determined pose no reasonable risk of  harm to the patient if performed incorrectly."  1988 - Pub. L. 100-578 substituted "Certification of  laboratories" for "Licensing of laboratories" in section  catchline, and amended text generally, revising and restating as  subsecs. (a) to (q) provisions of former subsecs. (a) to (l).   -CHANGE-  CHANGE OF NAME  Committee on Energy and Commerce of House of Representatives  treated as referring to Committee on Commerce of House of  Representatives by section 1(a) of Pub. L. 104-14, set out as a  note preceding section 21 of Title 2, The Congress.   -MISC4-  EFFECTIVE DATE OF 1997 AMENDMENT  Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,  1997, except as otherwise provided, see section 501 of Pub. L.  105-115, set out as a note under section 321 of Title 21, Food and  Drugs.  EFFECTIVE DATE OF 1988 AMENDMENT; EXCEPTIONS; CONTINUING  APPLICABILITY  Section 3 of Pub. L. 100-578 provided that: "Subsections (g)(1),  (h), (i), (j), (k), (l), and (m) of section 353 of the Public  Health Service Act (this section), as amended by section 101  (probably means section 2 of Pub. L. 100-578), shall take effect  January 1, 1989, except that any reference in such subsections to  the standards established under subsection (f) shall be considered  a reference to the standards established under subsection (d) of  such section 353, as in effect on December 31, 1988. During the  period beginning January 1, 1989, and ending December 31, 1989,  subsections (a) through (d) and subsection (i) through (l) of such  section 353 as in effect on December 31, 1988, shall continue to  apply to clinical laboratories. The remaining subsections of such  section 353, as so amended, shall take effect January 1, 1990,  except that subsections (f)(1)(C) and (g)(2) shall take effect July  1, 1991, with respect to laboratories which were not subject to the  requirements of such section 353 as in effect on December 31,  1988."  EFFECTIVE DATE  Section 5(b) of Pub. L. 90-174 provided that: "The amendment  made by subsection (a) (enacting this section) shall become  effective on the first day of the thirteenth month after the month  (December 1967) in which it is enacted, except that the Secretary  of Health, Education, and Welfare may postpone such effective date  for such additional period as he finds necessary, but not beyond  the first day of the 19th month after such month (December 1967) in  which the amendment is enacted."  SHORT TITLE  Section 5(c) of Pub. L. 90-174 provided that: "This section  (enacting this section and provisions set out as a note under this  section) may be cited as the 'Clinical Laboratories Improvement Act  of 1967.' "  STUDIES  Section 4 of Pub. L. 100-578 directed Secretary to conduct  studies and submit report to Congress, not later than May 1, 1990,  relating to the reliability and quality control procedures of  clinical laboratory testing programs and the effect of errors in  the testing procedures and results on the diagnosis and treatment  of patients.   -SECREF-  SECTION REFERRED TO IN OTHER SECTIONS  This section is referred to in sections 263a-2, 300aa-2, 1395x,  1395aa of this title; title 35 section 287.