42 U.S.C. § 263a — Certification of laboratories

Page 477 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263a (B) information related to development programs for biological products, including biosimilar biological products and inter- changeable biosimilar biological products and relevant clinical considerations for pre- scribers, which may include, as appropriate and applicable, information related to the comparability of such biological products; (C) an explanation of the process for re- porting adverse events for biological prod- ucts, including biosimilar biological prod- ucts and interchangeable biosimilar biologi- cal products; and (D) an explanation of the relationship be- tween biosimilar biological products and interchangeable biosimilar biological prod- ucts licensed under section 262(k) of this title and reference products (as defined in section 262(i) of this title), including the standards for review and licensing of each such type of biological product. (3) Format The educational materials provided under paragraph (1) may be— (A) in formats such as webinars, con- tinuing education modules, videos, fact sheets, infographics, stakeholder toolkits, or other formats as appropriate and applicable; and (B) tailored for the unique needs of health care providers, patients, caregivers, and other audiences, as the Secretary deter- mines appropriate. (4) Other information In addition to the information described in paragraph (2), the Secretary shall continue to publish— (A) the action package of each biological product licensed under subsection (a) or (k) of section 262 of this title; or (B) the summary review of each biological product licensed under subsection (a) or (k) of section 262 of this title. (5) Confidential and trade secret information This subsection does not authorize the dis- closure of any trade secret, confidential com- mercial or financial information, or other matter described in section 552(b) of title 5. (b) Continuing education The Secretary shall advance education and awareness among health care providers regard- ing biological products, including biosimilar bi- ological products and interchangeable bio- similar biological products, as appropriate, in- cluding by developing or improving continuing education programs that advance the education of such providers on the prescribing of, and rel- evant clinical considerations with respect to, bi- ological products, including biosimilar biologi- cal products and interchangeable biosimilar bio- logical products. (July 1, 1944, ch. 373, title III, § 352A, as added Pub. L. 117–8, § 2, Apr. 23, 2021, 135 Stat. 254.) SUBPART 2—CLINICAL LABORATORIES § 263a. Certification of laboratories (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, chem- ical, immuno-hematological, hematological, bio- physical, cytological, pathological, or other ex- amination 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 de- rived from the human body for laboratory exam- ination or other procedure unless there is in ef- fect 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 certifi- cate for a laboratory only if the laboratory meets the requirements of subsection (d). (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 lab- oratory is accredited under subsection (e), the accreditation body which accredited the laboratory submits), an application— (i) in such form and manner as the Sec- retary shall prescribe, (ii) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory in- cluding— (I) the number and types of laboratory examinations and other procedures per- formed, (II) the methodologies for laboratory examinations and other procedures em- ployed, and (III) the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the lab- oratory examinations and other proce- dures, and (iii) that contains such other informa- tion as the Secretary may require to deter- mine compliance with this section, and the laboratory agrees to provide to the Sec- retary (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 Sec- retary— (i) with satisfactory assurances that the laboratory will be operated in accordance with standards issued by the Secretary under subsection (f), or (ii) with proof of accreditation under subsection (e), Page 478 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263a 1 So in original. Probably should be ‘‘by the’’. (C) the laboratory agrees to permit inspec- tions by the Secretary under subsection (g), (D) the laboratory agrees to make records available and submit reports to the Sec- retary as the Secretary may reasonably re- quire, and (E) the laboratory agrees to treat pro- ficiency testing samples in the same manner as it treats materials derived from the human body referred to it for laboratory ex- aminations or other procedures in the ordi- nary course of business, except that no pro- ficiency testing sample shall be referred to another laboratory for analysis as prohibited under subsection (i)(4). (2) Requirements for certificates of waiver (A) In general A laboratory which only performs labora- tory examinations and procedures described in paragraph (3) shall be issued a certificate of waiver or have its certificate of waiver re- newed if— (i) the laboratory submits an applica- tion— (I) in such form and manner as the Sec- retary shall prescribe, (II) that describes the characteristics of the laboratory examinations and other procedures performed by the lab- oratory, including the number and types of laboratory examinations and other procedures performed, the methodologies for laboratory examinations and other procedures employed, and the qualifica- tions (educational background, training, and experience) of the personnel direct- ing and supervising the laboratory and performing the laboratory examinations and other procedures, and (III) that contains such other informa- tion as the Secretary may reasonably re- quire 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 re- quire. (B) Changes If a laboratory makes changes in the ex- aminations 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) shall not apply to a laboratory to which has been issued a cer- tificate 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 sim- ple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that— (A) employ methodologies that are so sim- ple 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 ‘‘certifi- cate’’ 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 ac- creditation body, and (B) authorizes the accreditation body to submit to the Secretary (or such State agen- cy as the Secretary may designate) such records or other information as the Sec- retary may require. (2) Approval of accreditation bodies (A) In general The Secretary may approve a private non- profit 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 fre- quency as determined by 1 Secretary, (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), (iii) there is adequate provision for as- suring that the standards of the accredita- tion body continue to be met by the lab- oratory, (iv) in the case of any laboratory accred- ited by the body which has had its accredi- tation denied, suspended, withdrawn, or re- voked 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 no- tify the Secretary at least 30 days before it changes its standards, and (vi) if the accreditation body has its ap- proval withdrawn by the Secretary, the body agrees to notify each laboratory ac- credited by the body of the withdrawal within 10 days of the withdrawal. Page 479 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263a (B) Criteria and procedures The Secretary shall promulgate criteria and procedures for approving an accredita- tion body and for withdrawing such approval if the Secretary determines that the accredi- tation 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 accred- ited by the body shall continue in effect for 60 days after the laboratory receives notifi- cation of the withdrawal of the approval, ex- cept that the Secretary may extend such pe- riod 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 accredita- tion body withdraws or revokes the accredi- tation of a laboratory, the certificate of the laboratory shall continue in effect— (i) for 45 days after the laboratory re- ceives notice of the withdrawal or revoca- tion of the accreditation, or (ii) until the effective date of any action taken by the Secretary under subsection (i). (D) Evaluations The Secretary shall evaluate annually the performance of each approved accreditation body by— (i) inspecting under subsection (g) a suf- ficient number of the laboratories accred- ited by such body to allow a reasonable es- timate of the performance of such body, and (ii) such other means as the Secretary determines appropriate. (3) Omitted (f) Standards (1) In general The Secretary shall issue standards to as- sure 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 appro- priate for the validity and reliability of the laboratory examinations and other proce- dures of the laboratory and to meet require- ments 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 effec- tive operation of the laboratory, (C) in performing and carrying out its lab- oratory examinations and other procedures, to use only personnel meeting such quali- fications 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, ex- perience, job performance, and education and which qualifications shall, as appro- priate, be different on the basis of the type of examinations and procedures being per- formed 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 examina- tions and procedures. (2) Considerations In developing the standards to be issued under paragraph (1), the Secretary shall, with- in the flexibility provided under subpara- graphs (A) through (E) of paragraph (1), take into consideration— (A) the examinations and procedures per- formed and the methodologies employed, (B) the degree of independent judgment in- volved, (C) the amount of interpretation involved, (D) the difficulty of the calculations in- volved, (E) the calibration and quality control re- quirements 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 labora- tories issued a certificate under this section which are conducted by the Secretary, con- ducted by an organization approved under subparagraph (C), or conducted by an ap- proved accrediting body. The standards shall require that a laboratory issued a certificate under this section be tested for each exam- ination 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 pro- ficiency test cannot reasonably be devel- oped. The testing shall be conducted on a quarterly basis, except where the Secretary determines for technical and scientific rea- sons that a particular examination or proce- dure may be tested less frequently (but not less often than twice per year). (B) Criteria The standards established under subpara- graph (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 pro- cedures and shall be uniform for each exam- Page 480 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263a 2 So in original. Probably should be ‘‘proficiency’’. 3 So in original. Probably should be ‘‘require it to’’. ination 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 par- ticular examination or procedure or cat- egory of examination or procedure over a pe- riod of successive quarters. (C) Approved proficiency testing programs For the purpose of administering pro- ficiency testing programs which meet the standards established under subparagraph (A), the Secretary shall approve a pro- ficiency testing program offered by a private nonprofit organization or a State if the pro- gram meets the standards established under subparagraph (A) and the organization or State provides technical assistance to lab- oratories seeking to qualify under the pro- gram. The Secretary shall evaluate each program approved under this subparagraph annually to determine if the program con- tinues 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 di- rect a program approved under subparagraph (C) to perform, onsite proficiency testing to assure compliance with the requirements of subsection (d)(5). The Secretary shall per- form, on an onsite or other basis, proficiency testing to evaluate the performance of a pro- ficiency testing program approved under subparagraph (C) and to assure quality per- formance by a laboratory. (E) Training, technical assistance, and en- hanced proficiency testing The Secretary may, in lieu of or in addi- tion to actions authorized under subsection (h), (i), or (j), 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 2 test- ing program, (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 estab- lished by the Secretary under subparagraph (A) available, on a reasonable basis, upon re- quest of any person. The Secretary shall in- clude with results made available under this subparagraph such explanatory information as may be appropriate to assist in the inter- pretation 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 per- formance by laboratories of valid and reli- able cytological services. (B) Standards The standards established under subpara- graph (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 labora- tory maintain a record of (I) the number of cytology slides screened during each 24- hour period by each individual who exam- ines 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) ran- dom rescreening of cytology specimens de- termined to be in the benign category, (II) focused rescreening of such preparations in high risk groups, and (III) for each abnor- mal cytological result, rescreening of all prior cytological specimens for the pa- tient, if available, (iv) periodic confirmation and evaluation of the proficiency of individuals involved in screening or interpreting cytological preparations, including announced and un- announced on-site proficiency testing of such individuals, with such testing to take place, to the extent practicable, under nor- mal working conditions, (v) procedures for detecting inadequately prepared slides, for assuring that no cytological diagnosis is rendered on such slides, and for notifying referring physi- cians of such slides, (vi) requirements that all cytological screening be done on the premises of a lab- oratory that is certified under this section, (vii) requirements for the retention of cytology slides by laboratories for such pe- riods of time as the Secretary considers appropriate, and (viii) standards requiring periodic in- spection of cytology services by persons capable of evaluating the quality of cytol- ogy services. (g) Inspections (1) In general The Secretary may, on an announced or un- announced basis, enter and inspect, during regular hours of operation, laboratories which have been issued a certificate under this sec- tion. In conducting such inspections the Sec- retary shall have access to all facilities, equip- ment, 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 3 be submitted to Page 481 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263a 4 So in original. Probably should be followed by a period. the Secretary. An inspection under this para- graph may be made only upon presenting iden- tification to the owner, operator, or agent in charge of the laboratory being inspected. (2) Compliance with requirements and stand- ards The Secretary shall conduct inspections of laboratories under paragraph (1) to determine their compliance with the requirements of subsection (d) and the standards issued under subsection (f). Inspections of laboratories not accredited under subsection (e) shall be con- ducted on a biennial basis or with such other frequency as the Secretary determines to be necessary to assure compliance with such re- quirements and standards. Inspections of lab- oratories accredited under subsection (e) 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 labora- tory 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 sanc- tions in lieu of the actions authorized by sub- section (i). (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) or for each day of substan- tial noncompliance with the requirements of this section, (C) payment for the costs of onsite moni- toring, or (D) any combination of the actions de- scribed 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 rea- sonable opportunity to respond to the pro- posed sanction and appropriate procedures for appealing determinations relating to the im- position of intermediate sanctions 4 (i) Suspension, revocation, and limitation (1) In general Except as provided in paragraph (2), the cer- tificate of a laboratory issued under this sec- tion 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 lab- oratory as entitled to perform a laboratory examination or other procedure which is not within a category of laboratory examina- tions or other procedures authorized in the certificate, (C) has failed to comply with the require- ments of subsection (d) or the standards pre- scribed by the Secretary under subsection (f), (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 eligi- bility for its certificate or continued compli- ance with the Secretary’s standards under subsection (f), (E) has refused a reasonable request of the Secretary, or any Federal officer or em- ployee 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 sec- tion or of any regulation promulgated there- under, or (G) has not complied with an intermediate sanction imposed under subsection (h). (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) presents an imminent and se- rious risk to human health, or (B) a laboratory has engaged in an action described in subparagraph (D) or (E) of para- graph (1), the Secretary may suspend or limit the cer- tificate of the laboratory before holding a hearing under paragraph (1) regarding such failure or refusal. The opportunity for a hear- ing 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 hear- ing under paragraph (1). (3) Ineligibility to own or operate laboratories after revocation No person who has owned or operated a lab- oratory 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, except that if the revocation occurs pursuant to paragraph (4) the Secretary may substitute intermediate sanctions under sub- section (h) instead of the 2-year prohibition against ownership or operation which would otherwise apply under this paragraph. The cer- tificate of a laboratory which has been ex- cluded from participation under the medicare program under title XVIII of the Social Secu- rity Act [42 U.S.C. 1395 et seq.] because of ac- tions relating to the quality of the laboratory shall be suspended for the period the labora- tory is so excluded. Page 482 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263a (4) Improper referrals Any laboratory that the Secretary deter- mines intentionally refers its proficiency test- ing samples to another laboratory for analysis may have its certificate revoked for at least one year and shall be subject to appropriate fines and penalties as provided for in sub- section (h). (j) Injunctions Whenever the Secretary has reason to believe that continuation of any activity by a labora- tory 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 prop- er showing, a temporary injunction or restrain- ing order against continuation of such activity pending issuance of a final order under this sub- section shall be granted without bond by such court. (k) Judicial review (1) Petition Any laboratory which has had an inter- mediate sanction imposed under subsection (h) or has had its certificate suspended, revoked, or limited under subsection (i) may, at any time within 60 days after the date the action of the Secretary under subsection (i) or (h) be- comes final, file a petition with the United States court of appeals for the circuit wherein the laboratory has its principal place of busi- ness 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 des- ignated 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 addi- tional evidence is material and that there were reasonable grounds for the failure to ad- duce such evidence in the proceeding before the Secretary, the court may order such addi- tional 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 find- ings, by reason of the additional evidence so taken, and the Secretary shall file such modi- fied 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 set- ting aside, in whole or in part, any such action of the Secretary shall be final, subject to re- view by the Supreme Court of the United States upon certiorari or certification as pro- vided in section 1254 of title 28. (l) Sanctions Any person who intentionally violates any re- quirement of this section or any regulation pro- mulgated 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 sec- ond or subsequent violation of such a require- ment 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 pro- grams approved under subsection (f)(3)(C). (3) Criteria (A) Fees under paragraph (1) Fees imposed under paragraph (1) shall be sufficient to cover the general costs of ad- ministering this section, including evalu- ating and monitoring proficiency testing programs approved under subsection (f) and accrediting bodies and implementing and monitoring compliance with the require- ments 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 pro- ficiency 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 lab- oratory, 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 labora- tories. (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 Page 483 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263a to fraud and abuse, false billings, or kick- backs, (2) a list of laboratories— (A) which have had their certificates re- voked, suspended, or limited under sub- section (i), or (B) which have been the subject of a sanc- tion under subsection (l), together with a statement of the reasons for the revocation, suspension, limitation, or sanction, (3) a list of laboratories subject to inter- mediate sanctions under subsection (h) to- gether 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) together with a statement of the reasons for such action, and (6) a list of laboratories which have been ex- cluded 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 para- graphs (1) through (6) shall be information for the calendar year preceding the date the infor- mation is to be made available to the public and shall be accompanied by such explanatory infor- mation 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 reim- bursement, and in such installments, as the Sec- retary may determine. (p) State laws (1) Except as provided in paragraph (2), noth- ing in this section shall be construed as affect- ing the power of any State to enact and enforce laws relating to the matters covered by this sec- tion to the extent that such laws are not incon- sistent 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 re- quirements equal to or more stringent than the requirements of this section or than the regula- tions 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 organiza- tions and public agencies. (July 1, 1944, ch. 373, title III, § 353, as added Pub. L. 90–174, § 5(a), Dec. 5, 1967, 81 Stat. 536; amended Pub. L. 100–578, § 2, Oct. 31, 1988, 102 Stat. 2903; Pub. L. 105–115, title I, § 123(h), Nov. 21, 1997, 111 Stat. 2324; Pub. L. 112–202, § 2, Dec. 4, 2012, 126 Stat. 1483.) Editorial Notes 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. Ti- tles XVIII and XIX of the Social Security Act are clas- sified generally to subchapters XVIII (§ 1395 et seq.) and XIX (§ 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. CODIFICATION Subsec. (e)(3) of this section, which required the Sec- retary to annually prepare and submit to certain com- mittees of Congress a report describing the results of the evaluation conducted under subsec. (e)(2)(D) of this section, terminated, effective May 15, 2000, pursuant to section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31, Money and Finance. See, also, page 96 of House Document No. 103–7. AMENDMENTS 2012—Subsec. (d)(1)(E). Pub. L. 112–202, § 2(1), inserted ‘‘, except that no proficiency testing sample shall be referred to another laboratory for analysis as prohib- ited under subsection (i)(4)’’ before period at end. Subsec. (i)(3). Pub. L. 112–202, § 2(2)(A), inserted ‘‘, except that if the revocation occurs pursuant to paragraph (4) the Secretary may substitute inter- mediate sanctions under subsection (h) instead of the 2- year prohibition against ownership or operation which would otherwise apply under this paragraph’’ after ‘‘issued under this section’’. Subsec. (i)(4). Pub. L. 112–202, § 2(2)(B), substituted ‘‘may have its certificate revoked’’ for ‘‘shall have its certificate revoked’’. 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 exami- nations 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 Ad- ministration for home use, ‘‘(B) employ methodologies that are so simple and accurate as to render the likelihood of erroneous re- sults negligible, or ‘‘(C) the Secretary has determined pose no reason- able risk of harm to the patient if performed incor- rectly.’’ 1988—Pub. L. 100–578 substituted ‘‘Certification of lab- oratories’’ for ‘‘Licensing of laboratories’’ in section catchline, and amended text generally, revising and re- stating as subsecs. (a) to (q) provisions of former sub- secs. (a) to (l). Statutory Notes and Related Subsidiaries 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 Pub. L. 100–578, § 3, Oct. 31, 1988, 102 Stat. 2914, pro- vided that: ‘‘Subsections (g)(1), (h), (i), (j), (k), (l), and (m) of section 353 of the Public Health Service Act [42 U.S.C. 263a], 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) Page 484 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263a–1 1 See References in Text note below. through (d) and subsection (i) through (l) of such sec- tion 353 as in effect on December 31, 1988, shall continue to apply to clinical laboratories. The remaining sub- sections 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 require- ments of such section 353 as in effect on December 31, 1988.’’ EFFECTIVE DATE Pub. L. 90–174, § 5(b), Dec. 5, 1967, 81 Stat. 539, provided that: ‘‘The amendment made by subsection (a) [enact- ing 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 nec- essary, but not beyond the first day of the 19th month after such month [December 1967] in which the amend- ment is enacted.’’ CLIA WAIVER IMPROVEMENTS Pub. L. 114–255, div. A, title III, § 3057, Dec. 13, 2016, 130 Stat. 1128, provided that: ‘‘(a) DRAFT REVISED GUIDANCE.—Not later than 1 year after the date of the enactment of this Act [Dec. 13, 2016], the Secretary of Health and Human Services, act- ing through the Commissioner of Food and Drugs, shall publish a draft guidance that— ‘‘(1) revises ‘Section V. Demonstrating Insignificant Risk of an Erroneous Result – Accuracy’ of the guid- ance entitled ‘Recommendations for Clinical Labora- tory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diag- nostic Devices’ and dated January 30, 2008; and ‘‘(2) includes the appropriate use of comparable per- formance between a waived user and a moderately complex laboratory user to demonstrate accuracy. ‘‘(b) FINAL REVISED GUIDANCE.—The Secretary of Health and Human Services, acting through the Com- missioner of Food and Drugs, shall finalize the draft guidance published under subsection (a) not later than 1 year after the comment period for such draft guidance closes.’’ STUDIES Pub. L. 100–578, § 4, Oct. 31, 1988, 102 Stat. 2914, di- rected 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. § 263a–1. Assisted reproductive technology pro- grams (a) In general Effective 2 years after October 24, 1992, each assisted reproductive technology (as defined in section 263a–7 1 of this title) program shall annu- ally report to the Secretary through the Centers for Disease Control— (1) pregnancy success rates achieved by such program through each assisted reproductive technology, and (2) the identity of each embryo laboratory (as defined in section 263a–7 1 of this title) used by such program and whether the laboratory is certified under section 263a–2 of this title or has applied for such certification. (b) Pregnancy success rates (1) In general For purposes of subsection (a)(1), the Sec- retary shall, in consultation with the organi- zations referenced in subsection (c), define pregnancy success rates and shall make public any proposed definition in such manner as to facilitate comment from any person (including any Federal or other public agency) during its development. (2) Definition In developing the definition of pregnancy success rates, the Secretary shall take into ac- count the effect on success rates of age, diag- nosis, and other significant factors and shall include in such rates— (A) the basic live birth rate calculated for each assisted reproductive technology per- formed by an assisted reproductive tech- nology program by dividing the number of pregnancies which result in live births by the number of ovarian stimulation proce- dures attempted by such program, and (B) the live birth rate per successful oo- cyte retrieval procedure calculated for each assisted reproductive technology performed by an assisted reproductive technology pro- gram by dividing the number of pregnancies which result in live births by the number of successful oocyte retrieval procedures per- formed by such program. (c) Consultation In developing the definition under subsection (b), the Secretary shall consult with appropriate consumer and professional organizations with expertise in using, providing, and evaluating professional services and embryo laboratories associated with assisted reproductive tech- nologies. (Pub. L. 102–493, § 2, Oct. 24, 1992, 106 Stat. 3146.) Editorial Notes REFERENCES IN TEXT Section 263a–7 of this title, referred to in subsec. (a), was in the original ‘‘section 7’’ meaning section 7 of Pub. L. 102–493, which was translated as reading section 8 to reflect the probable intent of Congress, because definitions are contained in section 8 instead of section 7. CODIFICATION Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter. Statutory Notes and Related Subsidiaries CHANGE OF NAME Centers for Disease Control changed to Centers for Disease Control and Prevention by Pub. L. 102–531, title III, § 312, Oct. 27, 1992, 106 Stat. 3504. EFFECTIVE DATE Pub. L. 102–493, § 9, Oct. 24, 1992, 106 Stat. 3152, pro- vided that: ‘‘This Act [enacting this section, sections 263a–2 to 263a–7 of this title, and provisions set out as a note under section 201 of this title] shall take effect upon the expiration of 2 years after the date of the en- actment of this Act [Oct. 24, 1992].’’ § 263a–2. Certification of embryo laboratories (a) In general (1) Development Not later than 2 years after October 24, 1992, the Secretary, through the Centers for Disease