§900.3. Application for approval as an accreditation body. — Inbound Citations

(i) Meet the requirements specified in § 900.12(a)(3) or alternative requirements established by the accreditation body and approved by FDA in accordance with § 900.3 or paragraph (a)(8) of this section;

(iii) This information shall be placed on the image in a position near the axilla. Standardized codes specified by the accreditation body and approved by FDA in accordance with § 900.3(b) or § 900.4(a)(8) shall be used to identify view and laterality.

(3) The accreditation body shall use a system for scoring phantom images that has been approved by FDA in accordance with § 900.3(b) and (d) or paragraph (a)(8) of this section.

(3) The applicant shall furnish to FDA, at the address in § 900.3(b)(1), three copies of an application containing the following information, materials, and supporting documentation:

(i) Name, address, and phone number of the applicant and, if the applicant is not a State agency, evidence of nonprofit status (i.e., of fulfilling Internal Revenue Service requirements as a nonprofit organization);

(ii) Detailed description of the accreditation standards the applicant will require facilities to meet and a discussion substantiating their equivalence to FDA standards required under § 900.12;

(A) Procedures for performing accreditation and reaccreditation clinical image review in accordance with § 900.4(c), random clinical image reviews in accordance with § 900.4(f), and additional mammography review in accordance with § 900.12(j);

(B) Procedures for performing phantom image review;

(C) Procedures for assessing mammography equipment evaluations and surveys;

(D) Procedures for initiating and performing onsite visits to facilities;

(E) Procedures for assessing facility personnel qualifications;

(F) Copies of the accreditation application forms, guidelines, instructions, and other materials the applicant will send to facilities during the accreditation process, including an accreditation history form that requires each facility to provide a complete history of prior accreditation activities and a statement that all information and data submitted in the application is true and accurate, and that no material fact has been omitted;

(G) Policies and procedures for notifying facilities of deficiencies;

(H) Procedures for monitoring corrections of deficiencies by facilities;

(I) Policies and procedures for suspending or revoking a facility's accreditation;

(J) Policies and procedures that will ensure processing of accreditation applications and renewals within a timeframe approved by FDA and assurances that the body will adhere to such policies and procedures; and

(K) A description of the applicant's appeals process for facilities contesting adverse accreditation status decisions.

(iv) Education, experience, and training requirements for the applicant's professional staff, including reviewers of clinical or phantom images;

(v) Description of the applicant's electronic data management and analysis system with respect to accreditation review and decision processes and the applicant's ability to provide electronic data in a format compatible with FDA data systems;

(vi) Resource analysis that demonstrates that the applicant's staffing, funding, and other resources are adequate to perform the required accreditation activities;

(vii) Fee schedules with supporting cost data;

(viii) Statement of policies and procedures established to avoid conflicts of interest or the appearance of conflicts of interest by the applicant's board members, commissioners, professional personnel (including reviewers of clinical and phantom images), consultants, administrative personnel, and other representatives of the applicant;

(ix) Statement of policies and procedures established to protect confidential information the applicant will collect or receive in its role as an accreditation body;

(x) Disclosure of any specific brand of imaging system or component, measuring device, software package, or other commercial product used in mammography that the applicant develops, sells, or distributes;

(xi) Description of the applicant's consumer complaint mechanism;

(xii) Satisfactory assurances that the applicant shall comply with the requirements of § 900.4; and

(xiii) Any other information as may be required by FDA.

(f) The accreditation body shall conduct onsite visits and random clinical image reviews of a sample of facilities to monitor and assess their compliance with standards established by the body for accreditation. The accreditation body shall submit annually to FDA, at the address given in § 900.3(b)(1), 3 copies of a summary report describing all facility assessments the body conducted under the provisions of this section for the year being reported.

(i) Annually, each accreditation body shall visit at least 5 percent of the facilities it accredits. However, a minimum of 5 facilities shall be visited, and visits to no more than 50 facilities are required, unless problems identified in paragraph (f)(1)(i)(B) of this section indicate a need to visit more than 50 facilities.

(A) At least 50 percent of the facilities visited shall be selected randomly.

(B) Other facilities visited shall be selected based on problems identified through State or FDA inspections, serious complaints received from consumers or others, a previous history of noncompliance, or any other information in the possession of the accreditation body, inspectors, or FDA.

(C) Before, during, or after any facility visit, the accreditation body may require that the facility submit to the body for review clinical images, phantom images, or any other information relevant to applicable standards in this subpart and in subpart B of this part.

(ii) The accreditation body shall conduct facility onsite visits according to a visit plan that has been approved by FDA in accordance with § 900.3(d) or paragraph (a)(8) of this section, unless otherwise directed by FDA in particular circumstances. At a minimum, such a plan shall provide for:

(A) Assessment of overall clinical image QA activities of the facility;

(B) Review of facility documentation to determine if appropriate mammography reports are sent to patients and providers as required;

(C) Clinical images shall be selected in a manner specified by the accreditation body and approved by FDA that does not compromise care of the patient as a result of the absence of the selected images from the facility;

(D) Verification that the facility has a medical audit system in place and is correlating films and pathology reports for positive cases;

(E) Verification that personnel specified by the facility are the ones actually performing designated personnel functions;

(F) Verification that equipment specified by the facility is the equipment that is actually being used to perform designated equipment functions;

(G) Verification that a consumer complaint mechanism is in place and that the facility is following its procedures; and

(H) Review of all factors related to previously identified concerns or concerns identified during that visit.

(i) In addition to conducting clinical image reviews for accreditation and reaccreditation for all facilities, the accreditation body shall conduct clinical image reviews annually for a randomly selected sample as specified by FDA, but to include at least 3 percent of the facilities the body accredits. Accreditation bodies may count toward this random sample requirement all facilities selected randomly for the onsite visits described in paragraph (f)(1)(i)(A) of this section. Accreditation bodies shall not count toward the random sample requirement any facilities described in paragraph (f)(1)(i)(B) of this section that were selected for a visit because of previously identified concerns.

(ii) In performing clinical image reviews of the random sample of facilities, accreditation bodies shall evaluate the same attributes as those in paragraph (c) of this section for review of clinical images for accreditation and reaccreditation.

(iii) Accreditation bodies should not schedule random clinical image reviews at facilities that have received notification of the need to begin the accreditation renewal process or that have completed the accreditation renewal process within the previous 6 months.

(iv) Clinical images shall be selected in a manner, specified by the accreditation body and approved by FDA under § 900.3(d) or paragraph (a)(8) of this section, that does not compromise care of the patient as a result of the absence of the selected images from the facility.

(2) FDA will notify the applicant of the relevant information, materials, and supporting documentation required under § 900.3(b)(3) that the applicant shall submit as part of the renewal procedure.

(4) If deficiencies cannot be corrected to ensure compliance with standards or if a facility is unwilling to take corrective actions, the accreditation body shall immediately so notify FDA, and shall suspend or revoke the facility's accreditation in accordance with the policies and procedures described under § 900.3(b)(3)(iii)(I).

(4) No later than July 28, 1998, any accreditation body approved under the interim regulations published in the Federal Register of December 21, 1993 (58 FR 67558), that desires to continue to serve as an accreditation body under the final regulations shall apply for renewal of approval in accordance with the procedures set forth in paragraphs (c)(1) through (c)(3) of this section.

(3) At least 6 months before the date of expiration of a body's approval, the applicant shall furnish to FDA, at the address in § 900.3(b)(1), three copies of a renewal application containing the information, materials, and supporting documentation requested by FDA in accordance with § 900.3(c)(2).

(4) No later than July 28, 1998, any accreditation body approved under the interim regulations published in the Federal Register of December 21, 1993 (58 FR 67558), that desires to continue to serve as an accreditation body under the final regulations shall apply for renewal of approval in accordance with the procedures set forth in paragraphs (c)(1) through (c)(3) of this section.

(iii) The phantom image shall achieve at least the minimum score established by the accreditation body and accepted by FDA in accordance with § 900.3(d) or § 900.4(a)(8).

(a) or body means an entity that has been approved by FDA under § 900.3(d) to accredit mammography facilities.

(3) The accreditation body shall establish and administer a quality assurance (QA) program that has been approved by FDA in accordance with § 900.3(d) or paragraph (a)(8) of this section. Such quality assurance program shall:

(i) Include requirements for clinical image review and phantom image review;

(ii) Ensure that clinical and phantom images are evaluated consistently and accurately; and

(iii) Specify the methods and frequency of training and evaluation for clinical and phantom image reviewers, and the bases and procedures for removal of such reviewers.

(b) A facility that has been denied accreditation is entitled to an appeals process from the accreditation body. The appeals process shall be specified in writing by the accreditation body and shall have been approved by FDA in accordance with § 900.3(d) or § 900.4(a)(8).