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fter contact with blood or other poentially infectious materials. This ystem shall specify the methods for ocumenting facility compliance with he infection control procedures estabshed and shall: (i) Comply with all applicable Fedral, State, and local regulations peraining to infection control; and (ii) Comply with the manufacturer's ?commended procedures for the cleanig and disinfection of the mammogzphy equipment used in the facility; r (iii) If adequate manufacturer's recmmendations are not available, comly with generally accepted guidance n infection control, until such recmmendations become available. (f) Quality assurance-mammography edical outcomes audit. Each facility hall establish and maintain a mamiography medical outcomes audit pro

to followup positive mammoraphic assessments and to correlate athology results with the interpreting hysician's findings. This program hall be designed to ensure the relibility, clarity, and accuracy of the inerpretation of mammograms. (1) General requirements. Each facility hall establish a system to collect and eview outcome data for all mammorams performed, including followup in the disposition of all positive mamnograms and correlation of pathology esults with the interpreting physiian's mammography report. Analysis if these outcome data shall be made inlividually and collectively for all inerpreting physicians at the facility. In ddition, any cases of breast cancer imong women imaged at the facility hat subsequently become known to he facility shall prompt the facility to nitiate followup on surgical and/or paihology results and review of the mammograms taken prior to the diagnosis of a malignancy.

(2) Frequency of audit analysis. The facility's first audit analysis shall be initiated no later than 12 months after the date the facility becomes certified, or 12 months after April 28, 1999, whichever date is the latest. This audit analysis shall be completed within an additional 12 months to permit completion of diagnostic procedures and data collection. Subsequent audit analyses will

be conducted at least once every 12 months.

(3) Audit interpreting physician. Each facility shall designate at least one interpreting physician to review the medical outcomes audit data at least once every 12 months. This individual shall record the dates of the audit period(s) and shall be responsible for analyzing results based on this audit. This individual shall also be responsible for documenting the results and for notifying other interpreting physicians of their results and the facility aggregate results. If followup actions are taken, the audit interpreting physician shall also be responsible for documenting the nature of the followup.

(g) Mammographic procedure and techniques for mammography of patients with breast implants. (1) Each facility shall have a procedure to inquire whether or not the patient has breast implants prior to the actual mammographic exam.

(2) Except where contraindicated, or unless modified by a physician's directions, patients with breast implants. undergoing mammography shall have mammographic views to maximize the visualization of breast tissue.

(h) Consumer complaint mechanism. Each facility shall:

(1) Establish a written and documented system for collecting and resolving consumer complaints;

(2) Maintain a record of each serious complaint received by the facility for at least 3 years from the date the complaint was received;

(3) Provide the consumer with adequate directions for filing serious complaints with the facility's accreditation body if the facility is unable to resolve a serious complaint to the consumer's satisfaction;

(4) Report unresolved serious complaints to the accreditation body in a manner and timeframe specified by the accreditation body.

(i) Clinical image quality. Clinical images produced by any certified facility must continue to comply with the standards for clinical image quality established by that facility's accreditation body.

(j) Additional mammography review and patient notification. (1) If FDA believes that mammography quality at a

facility has been compromised and may (b) Withdrawal of FDA approval of an present a serious risk to human health, accreditation body. (1) If FDA withdrans the facility shall provide clinical im- approval of an accreditation body ages and other relevant information, as under $900.6, the certificates of facilispecified by FDA, for review by the ac- ties previously accredited by such body creditation body or other entity des- shall remain in effect for up to 1 year ignated by FDA. This additional mam- from the date of the withdrawal of apmography review will help the agency proval, unless FDA determines, in to determine whether the facility is in order to protect human health or becompliance with this section and, if cause the accreditation body fraudunot, whether there is a need to notify lently accredited facilities, that the affected patients, their physicians, or certificates of some or all of the facilithe public that the reliability, clarity, ties should be revoked or suspended or and accuracy of interpretation of mam- that a shorter time period should be esmograms has been compromised.

tablished for the certificates to rema:) (2) If FDA determines that the qual- in effect. ity of mammography performed by a

(2) After 1 year from the date of withfacility, whether or not certified under

drawal of approval of an accreditation $ 900.11, was so inconsistent with the

body, or within any shorter period of quality standards established in this

time established by the agency, the afsection as to present a significant risk

fected facilities must obtain accreditato individual or public health, FDA

tion from another accreditation bods. may require such facility to notify pa

or from another entity designated by tients who received mammograms at

FDA. such facility, and their referring physicians, of the deficiencies presenting

$ 900.14 Suspension or revocation of such risk, the potential harm result- certificates. ing, appropriate remedial measures, and such other relevant information as

(a) Except as provided in paragraph

(b) of this section, FDA may suspend or FDA may require. Such notification

revoke a certificate if FDA finds, after shall occur within a timeframe and in

providing the owner or operator of the a manner specified by FDA.

facility with notice and opportunity (62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. for an informal hearing in accordance 10, 1997, as amended at 63 FR 56558, Oct. 22,

with part 16 of this chapter, that the 1998; 64 FR 18333, Apr. 14, 1999; 64 FR 32408,

owner, operator, or any employee of June 17, 1999; 65 FR 43690, July 14, 2000]

the facility: $ 900.13 Revocation of accreditation

(1) Has been guilty of misrepresentaand revocation of accreditation tion in obtaining the certificate; body approval.

(2) Has failed to comply with the (a) FDA action following revocation of standards of $ 900.12; accreditation. If a facility's accredita- (3) Has failed to comply with reasontion is revoked by an accreditation

able requests of the agency or the acbody, the agency may conduct an in

creditation body for records, informavestigation into the reasons for the tion, reports, or materials that FDA revocation. Following such investiga

believes are necessary to determine the tion, the agency may determine that continued eligibility of the facility for the facility's certificate shall no longer

a certificate or continued compliance be in effect or the agency may take

with the standards of $ 900.12; whatever other action or combination (4) Has refused a reasonable request of actions will best protect the public of a duly designated FDA inspector, health, including the establishment State inspector, or accreditation body and implementation of a corrective representative for permission to inplan of action that will permit the cer- spect the facility or the operations and tificate to continue in effect while the pertinent records of the facility; facility seeks reaccreditation. A facil- (5) Has violated or aided and abetted ity whose certificate is no longer in ef- in the violation of any provision of or fect because it has lost its accredita- regulation promulgated pursuant to 42 tion may not practice mammography. U.S.C. 263b; or



(6) Has failed to comply with prior inctions imposed by the agency under U.S.C. 263b(h). (b) FDA may suspend the certificate a facility before holding a hearing if DA makes a finding described in paraaph (a) of this section and also deterines that; (1) The failure to comply with retired standards presents a serious sk to human health; (2) The refusal to permit inspection akes immediate suspension necsary; or (3) There is reason to believe that the olation or aiding and abetting of the olation was intentional or associated ith fraud. (c) If FDA suspends a certificate in cordance with paragraph (b) of this ction: (1) The agency shall provide the facily with an opportunity for an informal earing under part 16 of this chapter ot later than 60 days from the effecve date of this suspension; (2) The suspension shall remain in efct until the agency determines that: (i) Allegations of violations or misonduct were not substantiated; (ii) Violations of required standards ave been corrected to the agency's atisfaction; or (iii) The facility's certificate is reoked in accordance with paragraph (d) f this section; (d) After providing a hearing in acordance with paragraph (c)(1) of this ection, the agency may revoke the faility's certificate if the agency deternines that the facility: (1) Is unwilling or unable to correct violations that were the basis for susension; or

(2) Has engaged in fraudulent activty to obtain or continue certification.

(b) Upon learning that a facility has failed to become accredited accredited, FDA will notify the facility that the agency is unable to certify that facility without proof of accreditation.

(c) A facility that has been denied accreditation or reaccreditation is entitled to an appeals process from the accreditation body, in accordance with $900.7. A facility must avail itself of the accreditation body's appeal process before requesting reconsideration from FDA.

(d) A facility that cannot achieve satisfactory resolution of an adverse accreditation decision through the accreditation body's appeal process is entitled to further appeal in accordance with procedures set forth in this section and in regulations published in 42 CFR part 498.

(1) References to the Health Care Financing Administration (HCFA) in 42 CFR part 498 should be read as the Division of Mammography Quality and Radiation Programs (DMQRP), Center for Devices and Radiological Health, Food and Drug Administration.

(2) References to the Appeals Council of the Social Security Administration in 42 CFR part 498 should be read as references to the Departmental Appeals Board.

(3) In accordance with the procedures set forth in subpart B of 42 CFR part 498, a facility that has been denied accreditation following appeal to the accreditation body may request reconsideration of that adverse decision from DMQRP.

(i) A facility must request reconsideration by DMQRP within 60 days of the accreditation body's adverse appeals decision, at the following address: Division of Mammography Quality and Radiation Programs (HFZ-240), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, Attn: Facility Accreditation Review Committee.

(ii) The request for reconsideration shall include three copies of the following records:

(A) The accreditation body's original denial of accreditation.

900.15 Appeals of adverse accredita

tion or reaccreditation decisions that preclude certification or recertification. (a) The appeals procedures described in this section are available only for adverse accreditation or reaccreditation decisions that preclude certification or recertification by FDA. Agency decisions to suspend or revoke certificates that are already in effect will be handled in accordance with $900.14.

8 900.17 [Reserved]

(B) All information the facility submitted to the accreditation body as part of the appeals process;

(C) A copy of the accreditation body's adverse appeals decision; and

(D) A statement of the basis for the facility's disagreement with the accreditation body's decision.

(iii) DMQRP will conduct its reconsideration in accordance with the procedures set forth in subpart B of 42 CFR part 498.

(4) A facility that is dissatisfied with DMQRP's decision following reconsideration is entitled to a formal hearing in accordance with procedures set forth in subpart D of 42 CFR part 498.

(5) Either the facility or FDA may request review of the hearing officer's decision. Such review will be conducted by the Departmental Appeals Board in accordance with subpart E of 42 CFR part 498.

(6) A facility cannot perform mammography services while an adverse accreditation decision is being appealed. $ 900.16 Appeals of denials of certifi.

cation. (a) The appeals procedures described in this section are available only to facilities that are denied certification by FDA after they have been accredited by an approved accreditation body. Appeals for facilities that have failed to become accredited are governed by the procedures set forth in 8 900.15.

(b) FDA may deny the application if the agency has reason to believe that:

(1) The facility will not be operated in accordance with standards established under $900.12;

(2) The facility will not permit inspections or provide access to records or information in a timely fashion; or

(3) The facility has been guilty of misrepresentation in obtaining the accreditation.

(C)(1) If FDA denies an application for certification by a faciity that has received accreditation from an approved accreditation body, FDA shall provide the facility with a statement of the grounds on which the denial is based.

(2) A facility that has been denied accreditation may request reconsideration and appeal of FDA's determination in accordance with the applicable provisions of $ 900.15(d).

8 900.18 Alternative requirements for

$ 900.12 quality standards. (a) Criteria for approval of alternative standards. Upon application by a qualified party as defined in paragraph (b) of this section, FDA may approve an alternative to a quality standard under $ 900.12, when the agency determines that:

(1) The proposed alternative standard will be at least as effective in assuring quality mammography as the standard it proposes to replace, and

(2) The proposed alternative:

(i) Is too limited in its applicability to justify an amendment to the standard; or

(ii) Offers an expected benefit human health that is so great that the time required for amending the standard would present an unjustifiable risk to the human health; and

(3) The granting of the alternative in keeping with the purposes of 42 U.S.C. 263b.

(b) Applicants for alternatives. (11 Mammography facilities and accreditation bodies may apply for alternatives to the quality standards of $ 900.12.

(2) Federal agencies and State gorernments that are not accreditation bodies may apply for alternatives to the standards of $ 900.12(a).

(3) Manufacturers and assemblers of equipment used for mammography mas apply for alternatives to the standards of $ 900.12(b) and (e).

(c) Applications for approval of an alternative standard. An application for approval of an alternative standard of for an amendment or extension of the alternative standard shall be submitted in an original and two copies to the Director, Division of Mammography Quality and Radiation Programs (HFZ240), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. The application for approval of an alternative standard shall include the following information:

(1) Identification of the original standard for which the alternative standard is being proposed and an explanation of why the applicant is proposing the alternative;


(2) A description of the manner in zich the alternative is proposed to deate from the original standard; (3) A description, supported by data,

the advantages to be derived from ch deviation; 4) An explanation, supported by ta, of how such a deviation would enre equal or greater quality of producon, processing, or interpretation of immograms than the original standd; 5) The suggested period of time that

proposed alternative standard yuld be in effect; and 6) Such other information required

the Director to evaluate ad act on e application. d) Ruling on applications. (1) FDA ay approve or deny, in whole or in rt, a request for approval of an alteritive standard or any amendment or tension thereof, and shall inform the iplicant in writing of this action. The ritten notice shall state the manner

which the requested alternative andard differs from the agency standd and a summary of the reasons for proval or denial of the request. If the quest is approved, the written notice all also include the effective date id the termination date of the ap'oval and a summary of the limitaons and conditions attached to the sproval and any other information lat may be relevant to the approved quest. Each approved alternative andard shall be assigned an identiring number. (2) Notice of an approved request for a alternative standard or any amendlent or extension thereof shall be laced in the public docket file in the ivision of Dockets Management and ay also be in the form of a notice ablished in the FEDERAL REGISTER. he notice shall state the name of the pplicant, a description of the pubshed agency standard, and a descripion of the approved alternative standrd, including limitations and condiions attached to the approval of the Iternative standard. (3) Summaries of the approval of alernative standards, including informaion on their nature and number, shall le provided to the National Mammogaphy Quality Assurance Advisory Committee.

(4) All applications for approval of alternative standards and for amendments and extensions thereof and all correspondence (including written notices of approval) on these applications shall vailable for public disclo re in the Division of Dockets Management, excluding patient identifiers and confidential commercial information.

(e) Amendment or extension of an alternative standard. An application for amending or extending approval of an alternative standard shall include the following information:

(1) The approval number and the expiration date of the alternative standard;

(2) The amendment or extension requested and the basis for the amendment or extension; and

(3) An explanation, supported by data, of how such an amendment or extension would ensure equal or greater quality of production, processing, or interpretation of mammograms than the original standard.

(f) Applicability of the alternative standards. (1) Except as provided in paragraphs (f)(2) and (f)(3) of this section, any approval of an alternative standard, amendment, or extension may be implemented only by the entity to which it was granted and under the terms under which it was granted. Other entities interested in similar or identical approvals must file their own application following the procedures of paragraph (c) of this section.

(2) When an alternative standard is approved for a manufacturer of equipment, any facility using that equipment will also be covered by the alternative standard.

(3) The agency may extend the alternative standard to other entities when FDA determines that expansion of the approval of the alternative standard would be an effective means of promoting the acceptance of measures to improve the quality of mammography. All such determinations will be publicized by appropriate means.

(g) Withdrawal of approval of alternative requirements. FDA shall amend or withdraw approval of an alternative standard whenever the agency determines that this action is necessary to protect the human health or otherwise is justified by $ 900.12. Such action will

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