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

(a) Definitions: In this section, "laboratory" or "clinical laboratory" means a facility that examines material taken from a human body — biologically, microbiologically, chemically, or through similar methods — to help diagnose, prevent, or treat disease, or to assess a person's health. (b) Certificate requirement: No one may solicit or accept human body material for laboratory testing unless the laboratory holds a certificate from the Secretary covering that category of examination or procedure. (c) Issuance and renewal: The Secretary may issue or renew a certificate only if the laboratory meets the requirements of subsection (d). A certificate is valid for 2 years, or a shorter period the Secretary sets. (d) Requirements for certificates: A laboratory (or, if accredited under subsection (e), its accreditation body) can get or renew a certificate if it submits an application, in the Secretary's required form, describing the lab's examinations and procedures — how many and what kinds, the methods used, and the qualifications of the staff who direct, supervise, and perform them — plus any other information the Secretary requires, and agrees to report any change in that information within 6 months; if the lab gives the Secretary either assurance it will follow the standards in subsection (f) or proof of accreditation under subsection (e); if it agrees to inspections under subsection (g); if it agrees to keep records and file reports the Secretary reasonably requires; and if it agrees to treat proficiency-testing samples the same as real patient samples, except that it can't send a proficiency sample to another laboratory for analysis, which subsection (i)(4) bans. A laboratory that performs only the simple, low-risk tests described in paragraph (3) can instead get or renew a "certificate of waiver" by submitting an application describing its tests, methods, and staff qualifications, and by agreeing to keep records and report as the Secretary requires; it must report any change among these simple tests within 6 months, and must report before adding any test outside that list. A lab holding only a certificate of waiver does not have to follow the standards in subsection (f) or the inspection rules in subsection (g). The qualifying simple tests are ones approved by the FDA for home use, or ones the Secretary decides carry an insignificant risk of an erroneous result — for example, because the method is simple and accurate enough that user error is unlikely, or because the Secretary has found the test poses no unreasonable risk of harm even if done wrong. "Certificate" includes a certificate of waiver. (e) Accreditation: A laboratory may become accredited, to help it get a certificate, if it meets an approved accreditation body's standards and authorizes that body to give the Secretary (or a State agency the Secretary designates) any records or information the Secretary requires. The Secretary may approve a private nonprofit organization as an accreditation body if it uses qualified inspectors and agrees to inspect labs as often as the Secretary determines; its standards are at least as strict as the Secretary's own standards under subsection (f); it has adequate ways to ensure labs keep meeting its standards; it agrees to tell the Secretary within 30 days whenever it denies, suspends, withdraws, or revokes a lab's accreditation, or takes other action against a lab; it agrees to give the Secretary at least 30 days' notice before changing its standards; and, if the Secretary withdraws its approval, it agrees to notify each lab it accredited within 10 days. The Secretary must set criteria and procedures for approving accreditation bodies and for withdrawing approval from one that no longer qualifies. If the Secretary withdraws an accreditation body's approval, a laboratory it accredited keeps its certificate for 60 days after being notified (longer if the Secretary decides the lab applied for new accreditation in a timely way). If instead the accreditation body itself withdraws or revokes a laboratory's accreditation, that laboratory's certificate stays valid for 45 days after the laboratory is notified, or until the Secretary takes action under subsection (i), whichever applies. The Secretary must evaluate each approved accreditation body every year, partly by inspecting enough of its accredited laboratories to reasonably judge its performance, and partly by other means the Secretary finds appropriate. (Paragraph (3) of this subsection is marked "Omitted" in the statute.) (f) Standards: The Secretary must issue standards so that certified laboratories consistently produce valid and reliable results. These standards must require each laboratory to run a quality assurance and quality control program suited to its tests, and to properly collect, transport, and store specimens and report results; to keep the records, equipment, and facilities needed to operate properly; to use only staff meeting qualifications the Secretary sets, based on competency, training, experience, job performance, and education, which may vary with the type and risk of the tests performed; to pass a proficiency testing program under paragraph (3); and to meet any other requirement the Secretary decides is necessary for accurate, reliable results. In writing these standards, the Secretary must consider the tests and methods used, how much independent judgment and interpretation is involved, how difficult the calculations are, the calibration and quality-control needs of the instruments used, the training needed to operate them, and other relevant factors. On proficiency testing, the Secretary must set standards for testing programs run by the Secretary, by an approved organization, or by an approved accreditation body. A certified laboratory must be tested for each examination or procedure within its certified category, unless the Secretary decides a proficiency test cannot reasonably be developed for it. Testing happens quarterly, unless the Secretary allows less frequent testing for technical or scientific reasons — but never less than twice a year. The standards must set uniform criteria for acceptable performance, based on available technology and clinical relevance, applied the same way to every examination and procedure, and must grade a laboratory's performance for each quarter and over successive quarters. The Secretary must approve testing programs offered by private nonprofits or States that meet these standards and provide technical help to laboratories, must evaluate each approved program annually, and must withdraw approval from any program that no longer qualifies. The Secretary must perform, or direct an approved program to perform, onsite testing to check compliance with subsection (d)(5), and must also test the performance of the approved testing programs themselves. If a laboratory fails to perform acceptably on an examination or category of examinations, the Secretary may — instead of, or along with, the actions in subsections (h), (i), or (j) — require the laboratory to get training and technical assistance, enroll in enhanced proficiency testing, or do some combination of these. The Secretary must set up a system making proficiency testing results available to anyone who asks, along with explanatory information to help interpret them. The Secretary must also set national standards for cytology (cell-screening) services, including: the maximum number of slides one person may screen in 24 hours; requirements that laboratories record how many slides each screener examines and how many hours they spend screening each day; criteria for rescreening slides, such as random rechecking of slides classified as benign, extra rechecking for high-risk groups, and rechecking all of a patient's earlier slides whenever a new result is abnormal; periodic testing of screeners' proficiency, including announced and unannounced onsite tests, done where practical under normal working conditions; procedures for catching badly prepared slides, preventing diagnoses from being made on them, and notifying the referring doctor; a requirement that all cytology screening happen at a laboratory certified under this section; rules on how long laboratories must keep slides; and standards for periodic outside inspection of cytology services. (g) Inspections: The Secretary may enter and inspect certified laboratories, announced or unannounced, during regular operating hours, with access to all facilities, equipment, materials, records, and information bearing on whether the laboratory follows this section, including copying material or requiring it be submitted. An inspection may happen only after the inspector presents identification to the laboratory's owner, operator, or agent in charge. The Secretary must inspect laboratories to check compliance with subsection (d)'s requirements and subsection (f)'s standards: laboratories not accredited under subsection (e) are inspected at least every two years, or more often if needed; accredited laboratories are inspected as often as the Secretary determines necessary. (h) Intermediate sanctions: If the Secretary finds that a certified laboratory no longer substantially meets certification requirements, the Secretary may impose lighter sanctions instead of the harsher actions in subsection (i). These sanctions are: directed correction plans; civil fines of up to $10,000 for each violation listed in subsection (i)(1), or for each day the laboratory remains substantially out of compliance; requiring the laboratory to pay for onsite monitoring; or any combination of these. The Secretary must develop procedures for when and how to impose each sanction, including notice to the laboratory, a reasonable chance to respond, and a way to appeal. (i) Suspension, revocation, and limitation: Except as paragraph (2) allows, the Secretary may suspend, revoke, or limit a laboratory's certificate — after reasonable notice and an opportunity for a hearing for the owner or operator — if the owner, operator, or any employee: lied to obtain the certificate; performed or claimed authority to perform an examination or procedure outside the certificate's category; failed to comply with subsection (d)'s requirements or subsection (f)'s standards; ignored reasonable requests for information, materials, or work needed to determine the laboratory's continued eligibility or compliance; refused a reasonable request to inspect the laboratory; violated or helped violate this section or its regulations; or failed to comply with an intermediate sanction under subsection (h). Before a hearing, the Secretary may suspend or limit a certificate immediately if either a standards failure poses an imminent, serious risk to health, or the laboratory engaged in the information-refusal or inspection-refusal conduct described above — but the laboratory must get a hearing within 60 days, and the early suspension or limitation stays in effect until the Secretary decides after that hearing. Anyone who owned or operated a laboratory whose certificate was revoked may not own or operate a certified laboratory for 2 years after the revocation, except that for revocations under paragraph (4) (improper referrals), the Secretary may substitute intermediate sanctions for that 2-year ban. A laboratory's certificate is automatically suspended for as long as it is excluded from Medicare over quality-of-testing problems. If the Secretary determines a laboratory intentionally referred its proficiency testing samples to another laboratory for analysis, its certificate may be revoked for at least one year, along with fines and penalties under subsection (h). (j) Injunctions: Whenever the Secretary believes a laboratory's continued activity would seriously endanger public health, the Secretary may sue in the federal district court where the laboratory is located to stop that activity. The court may grant a temporary injunction or restraining order without a bond, once the Secretary makes a proper showing, while a final decision is pending. (k) Judicial review: A laboratory hit with an intermediate sanction, or a suspended, revoked, or limited certificate, may file a petition for review within 60 days after the Secretary's action becomes final, with the federal court of appeals for the circuit where the laboratory is based. The court clerk sends a copy to the Secretary, who must then file the record the decision was based on. If a party asks the court for leave to add new evidence and shows good reason it wasn't offered before, the court may send the case back to the Secretary to take that evidence (and any rebuttal evidence); the Secretary may then revise findings and recommendations based on it. The court may affirm the Secretary's action or set it aside, in whole or in part, temporarily or permanently — but the Secretary's factual findings stand if supported by substantial evidence. The court's judgment is final, subject to review by the Supreme Court. (l) Sanctions: Anyone who intentionally violates this section or its regulations may be imprisoned for up to one year or fined under title 18, or both. A second or later violation raises the maximum to 3 years' imprisonment, with a fine under title 18. (m) Fees: The Secretary must charge fees for issuing and renewing certificates, but only a nominal fee for certificates of waiver. The Secretary must also charge fees for inspecting laboratories that aren't accredited and for proficiency testing of laboratories that don't join an approved testing program. Certificate fees must be enough to cover the general cost of administering this section, including evaluating proficiency testing programs and accrediting bodies and enforcing this section's requirements. Inspection and testing fees must cover the Secretary's cost of performing those inspections and tests. Both kinds of fees may vary by the type or group of laboratory, based on factors like the volume and scope of its testing. (n) Information: Starting April 1, 1990, and every year after, the Secretary must compile and make public, for the prior calendar year, information useful for judging a laboratory's performance, including lists of laboratories: convicted under federal or state fraud, false-billing, or kickback laws; that have had certificates revoked, suspended, or limited, or been hit with a subsection (l) sanction, along with the reasons; under intermediate sanctions, along with the reasons; whose accreditation was withdrawn or revoked, along with the reasons; targeted by action under subsection (j), along with the reasons; and excluded from Medicare or Medicaid. This information must come with explanatory material to help the public interpret it. (o) Delegation: To carry out this section, the Secretary may use, by agreement, the services of any federal, state, or local public agency or nonprofit private organization, paying for them in advance or by reimbursement. (p) State laws: Except as paragraph (2) provides, this section doesn't stop a State from enacting and enforcing its own laws on these matters, as long as they don't conflict with this section or its regulations. If a State's laws impose requirements equal to or stricter than this section's, the Secretary may exempt that State's laboratories from having to also comply with this section. (q) Consultations: In carrying out this section, the Secretary must consult with appropriate private organizations and public agencies.