**Mammography Facility Inspections**

**Table of Contents**

You can click on any location on the following list of parts and
attachments to taken directly to the listed page:

**Parts Page**

> [Cover Page (corrected 4/4/2006) 2](#COVER)
>
> [Part I -- Background 5](#PARTI)
>
> [Part II -- Implementation 9](#PARTII)
>
> [Part III -- Inspections 16](#PARTIII)
>
> Part IV -- Analytical (blank) 27
>
> [Part V -- Regulatory / Administrative Strategy 28](#PARTV)
>
> [Part VI - References, Attachments and Program Contacts 40](#PARTVI)
>
> [Part VII - Center Responsibilities 42](#PARTVII)

**Attachments Page**

A.  [List of CDRH personnel (inspection, compliance, audits, and
    workplans) 43](#ATTACHMENTA)

```{=html}
<!-- -->
```
A.  [List of CDRH personnel (computer support and testing equipment)
    44](#ATTACHMENTB)

```{=html}
<!-- -->
```
A.  [List of MQSA Auditors 45](#ATTACHMENTC)

B.  [Form FDA 2766 Claim for Damage to an Electronic Product
    46](#ATTACHMENTD)

C.  [Observation Statements for MQSA Inspections 47](#ATTACHMENTE)

D.  [Guidance for Evaluating a Facility Response 60](#ATTACHMENTF)

E.  [Guidance for an Additional Mammography Review (AMR)
    62](#attachment-g)

F.  [Flowchart - Follow-Up for MQSA Inspections 64](#ATTACHMENTH)

G.  [Warning Letter 65](#ATTACHMENTI)

H.  [Adequate Response Letter to Facility 71](#ATTACHMENTJ)

I.  [Example of MQSA Facility Inspection Report 72](#ATTACHMENTK)

J.  [Important Information about Your MQSA Inspection 75](#attachment-l)

K.  [Sample MQSA Inspection Confirmation (5 days prior to inspection)
    78](#ATTACHMENTM)

+--------------------------------+-----------------+-------------------+
| []{#COVER .anchor}SUBJECT:     |                 | IMPLEMENTATION    |
|                                |                 | DATE              |
| Mammography Facility           |                 |                   |
| Inspections                    |                 | July 18, 2005     |
+--------------------------------+-----------------+-------------------+
|                                |                 | COMPLETION DATE   |
|                                |                 |                   |
|                                |                 | September 30,     |
|                                |                 | 2008              |
+--------------------------------+-----------------+-------------------+
| **DATA REPORTING**             |                 |                   |
+--------------------------------+-----------------+-------------------+
| **PRODUCT CODES**              | **PROGRAM       |                   |
|                                | ASSIGNMENT      |                   |
|                                | CODES**         |                   |
+--------------------------------+-----------------+-------------------+
| Product Codes:                 | 85014 Routine   |                   |
|                                | Inspections     |                   |
| 90I_ZH -- screen/film          |                 |                   |
| mammography system             | 85014A Quality  |                   |
|                                | Assurance       |                   |
| > 90M_UE -- full-field digital | Audits          |                   |
| > mammography system           |                 |                   |
| >                              | 85014C          |                   |
| > Establishment Type E         | Compliance      |                   |
|                                | (Coord./Tech.   |                   |
|                                | Asst.)          |                   |
|                                |                 |                   |
|                                | 85014F          |                   |
|                                | Follow‑up       |                   |
|                                | Inspections     |                   |
|                                |                 |                   |
|                                | 85S001 State    |                   |
|                                | Inspections     |                   |
+--------------------------------+-----------------+-------------------+

# Field Reporting {#field-reporting .unnumbered}

**A. Mammography Program Reporting and Information System (MPRIS)**

> [Routine Inspections]{.underline} - Inspectors should record all data
> and observations during an inspection into the Field Inspection
> Support System (FISS) software, using the laptop computer provided by
> the Food and Drug Administration\'s (FDA) Center for Devices and
> Radiological Health (CDRH). They should then upload the inspection
> (computer data) into the MPRIS within five working days after the
> inspection. The inspector would usually print a report of the
> inspection observations from the computer and give this to the
> facility at the conclusion of the inspection. This report is titled
> "MQSA Facility Inspection Report," but may also be referred to as the
> "post-inspection report." The inspector should date and sign the
> report. In some instances, State inspectors will mail the report back
> to the facility, following review by his or her supervisor. Where
> serious violations are found (Level 1, Repeat Level 1, and/or repeat
> Level 2), FDA may do a follow-up inspection or send a Warning Letter
> to the facility. In cases where a Warning Letter is sent, a compliance
> inspection should be done within two to three months after the Warning
> Letter.
>
> FDA field offices may keep printed copies of the post-inspection and
> inspection detail reports in the corresponding FDA district file for
> the facility. Likewise, the States may print out the inspection
> reports for their records. In those cases where FDA inspectors inspect
> non-federal facilities, the State should be copied on the inspection
> report and other correspondence.

### **B. FACTS Reporting** {#b.-facts-reporting .unnumbered}

> FDA MQSA inspectors should report all MQSA-related operations
> (investigations, audits of inspectors, coordination and technical
> assistance, training, etc.), into the Field Accomplishments and
> Compliance Tracking System (FACTS). FACTS data entry for inspections
> isn't needed, since the inspection time is transferred to FACTS from
> inspections uploaded into FISS by FDA inspectors.
>
>  
>
> **Special Instructions Concerning Audits**. MQSA auditors should audit
> FDA and State MQSA inspectors to ensure they are following FDA
> procedures and guidance for MQSA inspections. The majority of audit
> inspections are expected to be joint inspections during an annual
> inspection. Districts should refer to the MQSA Auditors Guide for more
> information regarding audits.  **When an inspector uploads an audit
> inspection, it is automatically entered into FACTS as an audit so
> there is no need for a separate entry into FACTS for these audits.
> When you are an auditor on a Joint Audit inspection, your time for the
> audit will be transferred to FACTS as an Operation 13-Domestic
> Investigation with a Status Code of "Completed."**
>
>  
>
> **Joint Audit Inspection:** An audit performed by an MQSA auditor
> simultaneously with an annual inspection by a State or FDA inspector.
>
>  
>
> **Independent Audit**: A visit to a facility by an MQSA auditor on a
> date subsequent to an inspection conducted by a State or FDA
> inspector.  Your time should transfer over to FACTS in the same manner
> as for a joint audit inspection.
>
> ** **
>
> **Note: When entering investigations or other operations in FACTS for
> a specific mammography facility, you should enter the MQSA facility ID
> number in the cross reference block.**
>
> ** **
>
> **Mentored inspections**: When you are the mentor on a Mentored
> inspection your time will be transferred to FACTS as Operation
> 83-Training Given by FDA with a Status Code of "Completed."

## **C. SPECIAL** {#c.-special .unnumbered}

> **Correspondence with Facilities** -- You should send copies of
> Warning Letters to the State, the facility's accreditation body, and
> Division of Compliance Management and Operations (HFC-210). You should
> provide copies of all correspondence of regulatory significance (e.g.,
> minutes of meetings, follow-up letters to facility) to the appropriate
> state officials.
>
> **New or Uncertified Facilities** -- FDA field personnel and State
> agencies that receive information that a mammography facility is
> suspected of performing mammography while uncertified should send an
> electronic mail message to Division of Mammography Quality and
> Radiation Programs (DMQRP) as soon as possible (see compliance
> contacts in Attachment A), with a copy to the Regional Radiological
> Health Representative (RRHR).
>
> **Compliance Information** - The Facility Noncompliance Tracking and
> Management System (FaNTMS), part of MPRIS, is designed to track
> corrective actions for inspection observations. Each district
> designates personnel to update FaNTMS, which would normally include
> FDA MQSA auditors and inspectors as well as compliance personnel. For
> inspections where the facility is requested to respond (see Part V,
> A.1.a.), FaNTMS should be updated. Districts should enter data
> regarding all correspondence with the facility, including Warning
> Letters and the receipt of facility response letters. This system
> should be updated no later than 15 business days after the letter is
> sent or received.
>
> FaNTMS users usually include MQSA auditors and inspectors, compliance
> officers, and compliance technicians. Only authorized users may update
> FaNTMS. To get an account set up for a new user, districts should
> contact MPRIS Computer Support via telephone or e-mail (301-827-4330
> or computersupport@cdrh.fda.gov).

## **D. FACILITIES** {#d.-facilities .unnumbered}

> All facilities that have been entered into the MPRIS database should
> also appear in the FACTS Firm File, with identifying Central Files
> Numbers (CFNs) or Firm Establishment Identifiers (FEIs). However,
> FACTS users should also enter the facility's MQSA ID number into FACTS
> as a cross-reference.

[]{#PARTI .anchor}**PART I - BACKGROUND**

Breast cancer is a leading cause of cancer death among women and is most
treatable in the early stages. Research indicates that, with widespread
use of high‑quality mammography, breast cancer mortality could be
significantly reduced through the identification of early cancerous
lesions and early implementation of treatment. However, the quality of
mammography at some facilities has been found to be inadequate,
resulting in missed diagnosis of early lesions, delayed treatment, and
otherwise avoidable increases in mortality. Concerns about mammography
quality and breast cancer prompted the establishment of various private,
State, and Federal programs for ensuring quality mammography.

Disadvantages of such programs were that they were either voluntary,
such as the Mammography Accreditation Program of the American College of
Radiology (ACR), or were mandatory but did not apply to all facilities
in the United States, such as State programs and programs administered
by the Centers for Medicare and Medicaid (CMS) (formerly Health Care
Financing Administration (HCFA)). Also, most of these programs lacked
important mammography quality evaluation criteria or oversight
mechanisms, such as clinical image review and on‑site inspections of
facilities. Therefore, on a nationwide level, there were no universal
mandatory standards for providing safe, accurate, and reliable
mammography services.

Congress passed the Mammography Quality Standards Act (MQSA) to set
uniform, national quality standards for mammography. The MQSA amended
part F of Title III of the Public Health Service Act (the MQSA) (42
U.S.C. 262 et seq.) by adding new section 354 (42 U.S.C. 263b) to
require certification and inspection of all mammography facilities by
the Department of Health and Human Services. Under the MQSA, only
certified facilities that are in compliance with uniform Federal
standards for safe, high‑quality mammography services may lawfully
continue operation after October 1, 1994. Performing mammography after
this date requires an MQSA certificate. The requirements under MQSA
apply to all facilities producing, processing, or interpreting
mammograms for screening or diagnostic purposes, except for facilities
of the Department of Veterans Affairs.

FDA was given interim rule authority to establish regulations
implementing provisions of section 354(b), (c), (d), (e), and (f) of the
MQSA pertaining to certification procedures and quality standards for
mammography on December 21, 1993. A more detailed legislative history
and rationale for these regulations are provided in the preamble for the
accreditation regulations published on December 21, 1993 (58 F.R.
67558).

**MQSA Requirements**

> 1\. A National Mammography Quality Assurance Advisory Committee. Among
> other things, the advisory committee will advise the Secretary on the
> appropriate quality standards for the mammography facilities and the
> accreditation bodies (section 354(n) of the MQSA (42 U.S.C. 263b(n)).
>
> 2\. Standards for interpreting physicians, radiologic technologists,
> medical physicists, and mammography facility inspectors (section
> 354(f), (g) of the MQSA (42 U.S.C. 263b(f), (g)).
>
> 3\. Designation of boards or organizations eligible to certify the
> adequacy of training and experience of particular mammography
> personnel (section 354(f)(2) of the MQSA (42 U.S.C. 263b(f)(2)).
>
> 4\. Establishment of quality standards for mammography equipment and
> practices, including quality assurance and quality control programs
> (section 354(f) of the MQSA (42 U.S.C. 263b(f)).
>
> 5\. Establishment of standards governing record keeping for mammograms
> (images and paper records), requirements concerning mammography
> reporting, and notification of results to patients (section
> 354(f)(1)(G) of the MQSA (42 U.S.C. 263b(f)(1)G)).
>
> 6\. Annual physics survey, consultation, and evaluation of mammography
> facilities performed by a certified or State‑licensed/approved medical
> physicist (section 354(f)(1)(E) of the MQSA (42 U.S.C. 263b(f)(1)(E));
> 21 CFR 900.12(e)(9)).
>
> 7\. Accreditation of mammography facilities by private, nonprofit
> organizations or State agencies which have met the standards
> established by the Secretary for accreditation bodies and has been
> approved by the Secretary. It also requires that, as a part of the
> overall accreditation process, clinical mammograms from each facility
> be evaluated for quality (section 354(d)(1)(A)(iv), (e)(1)(B)(i) of
> the MQSA (42 U.S.C. 263b(d)(1)(A)(iv), (e)(1)(B)(i)).
>
> 8\. Annual inspection of mammography facilities, to be performed by
> Federally‑certified inspectors. The MQSA also requires a Federal audit
> of inspections conducted by States (section 354(g)(1), (3) of the MQSA
> (42 U.S.C. 263b(g)(1), (3)).

After October 1, 1994, no mammography facility, whether in a hospital,
doctor\'s office, mobile van, military base, or any other public or
private enterprise may operate legally, unless the facility is:

Accredited by an approved accreditation body (currently, the American
College of Radiology and the States of Arkansas, Iowa, and Texas) and

Certified by FDA or a State approved by FDA (currently the States of
Illinois, Iowa, and South Carolina).

**Reauthorization**

On October 9, 1998, the president signed into law the Mammography
Quality Standards Reauthorization Act of 1998 (Public Law 105-248). The
following is a summarized list of the major changes to MQSA from this
law:

1.  Changes to the requirements for retention of medical records.

```{=html}
<!-- -->
```
1.  Requiring that all women receive notification of the results of
    their mammogram.

2.  Authorizing FDA to inspect all facilities, including facilities
    performing mammography without a certificate, and to inspect
    uncertified facilities to document illegal activity.

3.  Authorizing FDA to conduct a demonstration program to inspect
    certain facilities less often than annually.

4.  Allowing FDA to contract with local, as well as State governments,
    to conduct annual inspections.

5.  Authorizing FDA to require facilities to notify patients when the
    quality of mammography presents a significant risk to individual or
    public health.

6.  Changes to the Civil Money Penalties requirements to include failure
    to notify patients when required.

**Final Regulations**

On April 28, 1999, the current MQSA facility regulations went into
effect (21 CFR Part 900). Prior to this date, facilities were covered by
interim regulations that took effect on October 1, 1994 (21 CFR
900.2(t)).

**Exceptions**

**Veterans Health Administration (VHA):** Mammography facilities in the
Department of Veteran Affairs are exempt from MQSA. However, VHA has
established internal standards equivalent to the MQSA standards. Under
an interagency agreement (IAG) with VHA, FDA conducts inspections of VHA
facilities. VHA facilities are evaluated against the same requirements
as FDA certified facilities. The inspections are conducted using the
same procedures and software as certified facilities. FDA provides the
inspection reports to the VHA who is responsible for assuring compliance
of their facilities with VHA standards. Under the IAG, VHA reimburses
FDA for the costs for these inspections.

**Interventional Mammography:** Facilities using mammography equipment
exclusively for the purpose of interventional procedures (procedures
such as stereotactic breast biopsy, needle localization, fine needle
aspiration, or galactography) currently are not required to be
accredited or certified and should not be inspected. The exemption for
equipment used exclusively for interventional procedures took effect on
September 30, 1994 (21 CFR 900.2(aa)(1)).

**Investigational Mammography Equipment:** There is an exemption in
effect for mammography performed as part of a scientific study to
evaluate an experimental mammography device conducted in accordance with
FDA's investigational device exemption regulations under 21 CFR 812 (21
CFR 900.2(aa)(2)).

**Fees**

Once facilities are inspected, they are usually charged a fee for the
inspection (section 354(r) of the MQSA (42 U.S.C. 263b(r)). Facilities
that qualify as government entities (federal, state, and local) are
exempt from inspection fees. Fees are usually collected for annual
inspections and follow-up inspections. The total fee for an annual
inspection should be based on the FDA's cost for an inspection for a
facility. Since follow-up inspections do not usually cover all aspects
of the facility\'s operation, the fee is lower than for the annual
inspection. Independent audit and compliance inspections are not charged
to the facility (see section A of Part III for an explanation of
inspection types). For information on the current fee structure, go to
<http://www.fda.gov/CDRH/MAMMOGRAPHY/inspection_fees.html>.

[]{#PARTII .anchor}**PART II - IMPLEMENTATION**

# A. Objective {#a.-objective .unnumbered}

> This compliance program provides guidance for:
>
> 1\. Inspections and investigations of mammography facilities under
> MQSA.

2\. Actions that FDA may take to ensure that mammography facilities are
in compliance with MQSA.

**B. Program Management Instruction**

> **1. Resource Instruction**
>
> MPRIS is a vital part of the program. It allows immediate access to
> and update of information on mammography facilities. All MQSA
> inspectors and compliance officers, who work with violative MQSA
> facilities, should have access to MPRIS, including exchange of
> information and updating capabilities. MPRIS also provides electronic
> mail capability for inspectors. State inspectors also have access to
> their State's inspections.
>
> The FDA\'s RRHRs, along with the Division of Mammography Quality and
> Radiation Programs (DMQRP) and the Division of Human Resource
> Development in ORA, are responsible for training and oversight of FDA
> and State inspectors. These and other functions are described in Part
> VII A. (DMQRP responsibilities). DMQRP staff will train MQSA
> inspectors. Only certified MQSA inspectors can perform MQSA
> inspections (see section 354(g)(1)(D) of the MQSA (42 U.S.C.
> 263b(g)(1)(D)).
>
> FDA districts without a certified FDA MQSA inspector should work with
> their RRHR to arrange for a certified inspector or MQSA auditor from
> the regional office or other districts to perform MQSA inspections and
> audit functions.
>
> All MQSA inspectors should follow FDA inspection procedures provided
> by DMQRP (MQSA Inspection Procedures, version 4.52 or later). FDA
> inspectors should wear personnel dosimeters (radiation badges)
> distributed by the Field Health Physicist at WEAC if they perform
> inspections or accompany an inspector. State contract inspectors
> should wear the personnel dosimeter normally provided by the State.
> All FDA and State inspectors must present identification (provided
> only to MQSA-certified inspectors) to facility personnel prior to the
> start of each inspection. This identification is required by MQSA
> (section 354(g)(1)(B) of the MQSA (42 U.S.C. 263b(g)(1)(B)).
> Credentials issued to FDA investigators should not be used as a
> substitute.

**2. Planning Instructions**

> Each District (or Regional Radiological Staff, where appropriate)
> should develop a strategy:
>
> a\. To work with the RRHR to have State Radiation Programs inspect
> certified facilities annually under the terms of its contract, and
>
> b\. To encourage voluntary compliance of facilities and, where
> necessary, send Warning Letters, conduct follow-up or compliance
> inspections, or recommend regulatory actions to bring violative
> facilities into compliance.
>
> District Office or Regional Radiological Staff should work through the
> RRHR to assure that State contract inspections are done in accordance
> with FDA policy and contract requirements (Refer to Part II B.9. -
> RRHR Management Activities).
>
> **3. States as Certifiers (SAC) Program**
>
> FDA may approve States to certify mammography facilities under MQSA.
> Under section 354(q) of the MQSA (42 U.S.C. 263b(q)), FDA may
> authorize a State to carry out specific responsibilities, which
> include:
>
> a\. Issuing MQSA certificates to mammography facilities
>
> b\. Conducting inspections of mammography facilities
>
> c\. Sending letters and evaluating responses from mammography
> facilities in violation of MQSA standards and regulations
>
> d\. Taking regulatory actions under MQSA, where appropriate, against
> mammography facilities
>
> This authorization does **not** allow States to carry out the
> following responsibilities under MQSA, which must be carried out by
> FDA:
>
> e\. Conducting MQSA inspection audits of State inspectors

f.  Developing MQSA facility standards

> States approved as a SAC State would perform most of the functions
> currently performed by FDA field offices for facilities in their
> State. An exception would be inspection audits, which would still be
> performed by approved FDA auditors. Also, while the Act allows the
> State to take regulatory action against facilities, FDA still has the
> authority to also take action, when necessary (section 354(q)(3)(B) of
> the MQSA (42 U.S.C. 263b(q)(3)(B)).
>
> FDA final regulations for State certification became effective on May
> 7, 2002 (21 CFR 900.20 through 900.25). Go to
> <http://www.fda.gov/CDRH/MAMMOGRAPHY/facilities-rev.html#1> for a
> current list of SAC States.
>
> **Field Office Guidance:** With the exception of inspection audits and
> SAC oversight functions, field offices will not normally be
> responsible for assessing compliance of mammography facilities in SAC
> States. There are several exceptions. The first is where FDA and the
> State decide to work together to bring a facility into compliance.
> Another exception is that FDA certifies and inspects federal
> facilities in SAC States.
>
> **4. Veterans Health Administration (VHA) Inspections**
>
> Mammography facilities operated by VHA, which is part of the U.S.
> Department of Veterans Affairs, are exempt from the requirements of
> MQSA (see 354(a)(3)(A) of the MQSA (42 U.S.C. 263b(a)(3)(A)). The law
> does not require that these facilities be certified or inspected by
> FDA. However, to assure that the quality of mammography at their
> facilities is equivalent to certified facilities, VHA requires all
> their mammography facilities be accredited by the American College of
> Radiology and meet VHA standards that are equivalent to FDA standards.
>
> Under an interagency agreement (IAG) with VHA, FDA inspects VHA
> facilities. Their facilities are evaluated against the same
> requirements as FDA certified facilities. FDA inspects these
> facilities using the same procedures and software as certified
> facilities. FDA provides the inspection reports to the VHA which is
> responsible for assuring compliance of their facilities with VHA
> standards. Under the IAG, VHA reimburses FDA for the costs for these
> inspections.

**5. Inspection Demonstration Program**

> In May of 2002, as part of the 1998 reauthorization of MQSA, FDA began
> a demonstration program to inspect, less frequently, those facilities
> that had excellent inspection records (substantially free of
> inspection violations) (section 354(g)(6) of the MQSA (42 U.S.C.
> 263b(g)(6)). The facilities in this demonstration will skip at least
> one annual inspection and, depending on the results, may be inspected
> in the future every other year. The program consists of study and
> control groups of 160 facilities located in 14 States. Results of this
> program are expected in late 2004 and will be analyzed in 2005.
>
> **6. Inspection Follow-up and Regulatory Action**
>
> Facilities should be informed of adverse observations during the
> inspections in one of several ways. The most common method is for the
> inspector to leave a printed inspection report at the close of the
> inspection (some States may mail this report to the facility after
> State supervisory review).
>
> FDA may use various regulatory actions against a facility that fails
> to comply with the standards and regulations under MQSA. These
> include:

a.  [Warning Letter]{.underline} -- formal notification to the facility
    regarding serious violations that could result in regulatory action,
    if not corrected.

```{=html}
<!-- -->
```
a.  [Additional Mammography Review (AMR)]{.underline} -- under 21 CFR
    900.12(j)(1), FDA may require additional mammography review to
    investigate whether violative conditions at a facility may have
    seriously affected the quality of mammography. Should this AMR shows
    that the quality of mammography represents a serious risk to human
    health, FDA may require patient and physician notification, as well
    as other regulatory actions. An AMR may consist of a review of
    mammograms to assess the clinical image quality of mammography at a
    facility. In some instances, the review could include mammography
    reports to assess the quality of mammographic interpretations.

b.  [Directed Plan of Correction]{.underline} -- a specific set of
    requirements imposed to assure that the facility performs
    mammography in compliance with MQSA and allows monitoring of the
    facility's continued compliance (section 354(h)(1)(A) of the MQSA
    (42 U.S.C. 263b(h)(1)(A)).

c.  [Civil Money Penalties]{.underline} -- fines imposed for violations
    of MQSA (section 354(h)(3) of the MQSA (42 U.S.C. 263b(h)(3)).

d.  [Patient and Physician Notification]{.underline} (wording in MQSA is
    "Patient Information") -- FDA required notification for patients and
    physicians when the mammography at the facility has been found to be
    a serious risk to human health (section 354(h)(2) of the MQSA (42
    U.S.C. 263b(h)(2)).

e.  [Suspension or revocation]{.underline} (of the facility's MQSA
    certificate) -- action taken to stop a facility from performing
    mammography in violation of MQSA (section 354(i) of the MQSA (42
    U.S.C. 263b(i)).

f.  [Action under 21 CFR 900.13(a) (certificate determined to be no
    longer in effect)]{.underline} -- if a facility's accreditation has
    been revoked by its accreditation body, FDA may determine that its
    certificate is no longer in effect. This action is equivalent to
    suspension of the facility's certificate prior to a hearing. A
    facility whose certificate is no longer in effect must stop
    performing mammography.

g.  [Injunction]{.underline} - court order which stops a facility from
    performing mammography where continued operation may represent a
    serious risk to human health or when a facility continues to perform
    mammography without a certificate (section 354(j) of the MQSA (42
    U.S.C. 263b(j)).

> **7. Scheduling Inspections**
>
> In most cases, a facility gets its 6 month provisional certificate and
> then goes on to get its full 3 year certificate. This facility should
> be inspected within 10-14 months of its initial provisional
> certification date and then every 10-14 months from its most recent
> inspection. However, there are exceptions to this general policy that
> can be found under section [2.1.2 Routine Annual Facility
> Inspections - When should a facility be inspected?]{.underline} in the
> MQSA inspection procedures.
>
> **8. Inspection Priorities**
>
> a\. **Highest Priority**
>
> 1\) Immediate inspections to investigate allegations of serious risk
> to human health, performing mammography without a certificate,
> continuing serious violations, or fraud
>
> 2\) Follow-up inspections for facilities with a history of serious
> violations (facility failed to respond or provided inadequate response
> after violative inspection, facilities under Directed Plans of
> Correction, facilities considered for regulatory actions with no
> recent inspection)
>
> 3\) Compliance inspections (inspections to follow up on a Warning
> Letter)
>
> b\. **Moderate Priority** - Inspections under moderate priority should
> be scheduled ahead of facilities with lesser problems, but still
> within 10 to 14 months after the previous inspection. The scheduling
> of these inspections should also take into account the location of the
> facility, as well as travel costs, availability of personnel, and
> other constraints.
>
> 1\) Inspections of facilities with a history of violations not serious
> enough for highest priority (example: Level 1 and/or repeat Level 2
> observations, but response to last annual inspection was adequate)
>
> 2\) Inspections of facilities with violations under State regulations
> that parallel MQSA requirements, but not serious enough for highest
> priority
>
> 3\) Facilities that have complaints against them concerning quality
> standards (including complaints from accreditation bodies), but not
> serious enough for highest priority
>
> 4\) Facilities that have "reinstated for accreditation" and have never
> been inspected (section [2.1.2 Routine Annual Facility Inspections -
> When should a facility be inspected?]{.underline} in the MQSA
> inspection procedures for more information about when to inspect
> reinstated facilities)
>
> **Note: Reinstatement for accreditation is a process that allows
> facilities that are no longer accredited and certified to apply for
> accreditation to have the certificate reinstated. This facility may
> then be considered a new facility and eligible for a provisional
> certificate.  Reinstatement applies to any facility that:**

1.  **let its certificate expire**

```{=html}
<!-- -->
```
1.  **withdrew its accreditation**

2.  **was denied accreditation or reaccreditation**

3.  **had its accreditation suspended or revoked**

4.  **had its certificate suspended**

> **In situations 3-5 above, the facility must have corrected its
> problems to the satisfaction of the accreditation body before being
> reinstated (see 21 CFR 900.11(c)(1)(iii)).  After receiving the
> provisional certificate, the facility may resume performing
> mammography while completing the requirements for certification (21
> CFR 900.11(c)(3)).**
>
> c\. **Normal Priority --** see section 7 of this Part for further
> information on scheduling these inspections.
>
> d\. **Low Priority** - new provisionally certified facilities
> (inspection of these facilities should be delayed, if possible, until
> 10-14 months after their initial provisional certification date. The
> only time a new provisionally certified facility should be high
> priority is when serious MQSA violations and/or mammography quality
> problems are suspected).
>
> **9. RRHR Management Activities**
>
> The RRHR should coordinate and supervise agency contracts with States
> performing MQSA inspections, including the following:
>
> a\. Work with contract States to have each facility within the State
> inspected following the guidance under sections 7 and 8 of this Part
> and to expedite submission of the inspection results for those
> facilities to the MPRIS to ensure timely follow-up action by FDA.
>
> b\. Monitor annual inspection audits of State and FDA personnel by
> qualified MQSA auditors to ensure that proper procedures and
> techniques are used during inspections.
>
> c\. Administer tests and practical examinations to inspectors who are
> training for MQSA inspector certification.
>
> d\. Monitor State and FDA inspection workload and manpower resources
> and give periodic assessments to DMQRP/CDRH.
>
> e\. Coordinate and supervise MQSA inspection contracts with States.
>
> f\. Coordinate with States for the performance of special inspections
> (e.g., follow‑up inspections, special assignment inspections).
>
> g\. Authorize a State to inspect a facility without prior
> notification.
>
> h\. Authorize a State to release information regarding an MQSA
> facility inspection (unless information is required to be released
> under State law).
>
> **RRHRs should be copied on all correspondence with State programs,
> including State inspectors, as well as all facility correspondence.**

[]{#PARTIII .anchor}**PART III - INSPECTIONS**

# A. Facility Inspections {#a.-facility-inspections .unnumbered}

> **Note: Only FDA and State inspectors who have been certified by FDA
> may perform MQSA inspections (including follow-up inspections) (see
> Section 354(g)(1)(D) of the MQSA (42 U.S.C. 263b(g)(1)(D)).**

A facility inspection may consist of equipment testing (x‑ray equipment
and film processors), a review of quality assurance and quality control
records, medical physicist reports, medical audit and outcomes analysis
records, personnel records, and medical records. Both test data and
inspection observations should be included in each inspection report.
Unlike most FDA inspections, the facility should generally be given at
least five days notice before the start of the inspection. This
notification enables the facility to reschedule patients (see Attachment
M for a sample confirmation note).

> **Note: A Notice of Inspection (form FDA 482) is not required for an
> MQSA inspection.**

Under some circumstances, where the continued performance of mammography
may threaten the public health (mammographic quality is seriously
substandard) or where fraud may be suspected (for example, where there
is concern that quality control records had been falsified), districts
may decide to conduct an unannounced inspection. In the event that
districts decide to conduct an unannounced inspection, the inspector
should place a memorandum in the facility's establishment file with the
reasons why he or she conducted an unannounced inspection. States must
get clearance from the RRHR prior to conducting unannounced MQSA
inspections (States may conduct unannounced State inspections without
FDA authorization when operating under State law).

> FDA MQSA inspectors should inspect all federal facilities, including
> military. This would include federal facilities in SAC States and
> military facilities in United States territories and foreign
> countries.
>
> The following are the inspection types that can be selected in the
> FISS software used for inspections:
>
> **Annual Inspection:** The most common type of inspection, which is
> done 10-14 months after the previous inspection. Inspection fee
> applies (go to
> <http://www.fda.gov/CDRH/MAMMOGRAPHY/inspection_fees.html> for
> inspection fee information).
>
> **Follow-Up Inspection:** An inspection conducted to verify corrective
> action identified from a facility response or to document ongoing
> violations prior to taking regulatory action or sending a Warning
> Letter. Follow-up inspections usually are limited to areas found
> noncompliant during the previous inspection. Inspection fee applies
> (go to <http://www.fda.gov/CDRH/MAMMOGRAPHY/inspection_fees.html> for
> inspection fee information).
>
> **Compliance Inspection:** An inspection conducted as a follow up to a
> Warning Letter to determine if violations continue. No inspection fee.
>
> **Headquarters-Initiated Inspection:** Any inspection requested by
> CDRH or initiated by a district to investigate complaints about a
> facility. No inspection fee.
>
> **Joint Audit Inspection:** An audit performed by an MQSA auditor
> simultaneously with an annual inspection by a State or FDA inspector.
> Since this is an annual inspection, it has an inspection fee (see
> section C of this Part for more information about audits).

**Independent Audit**: A visit to a facility by an MQSA auditor on a
date subsequent to an inspection conducted by a State or FDA inspector
(see section C of this Part for more information about audits). No
inspection fee.

> Guidelines for facility inspections:
>
> 1\. Inspectors should follow the MQSA inspection procedures (Reference
> A.5. in Part VI).
>
> 2\. Districts and contract States should select facilities for
> inspection based on priority (see Inspection Scheduling and Priority
> in Part II, B.7. and B.8.).
>
> 3\. Inspectors should contact the facility by telephone at least five
> days before the inspection and follow up with a fax notice (the laptop
> computer may be used for this purpose). If the facility does not have
> a fax system, then the inspector should mail a notice to the facility.
> The facility person contacted by phone and notified by fax or letter
> should be a person in authority and not a clerical employee. Examples
> of contact individuals would be the chief technologist, lead or other
> interpreting physician, and quality control technologist. Inspectors
> should also explain that personnel critical to mammography quality
> assurance should be notified regarding the time and date of the
> inspection and be available during the inspection.
>
> **Note: On occasion, when FDA, the State, or an accreditation body is
> informed of possible serious violations or a risk to health at a
> facility inspected less than 10 months previously, FDA may need to
> inspect as soon as possible. For these inspections, the inspector
> should select an inspection type of "Headquarters Initiated" at
> download. This inspection type should also be used for other special
> inspections that aren't annual, follow-up, or independent audits.
> Inspections uploaded with this inspection type wouldn't normally be
> billed for an inspection fee.**
>
> 4\. At the facility, the inspector should:
>
> a\. Wear a personnel radiation dosimeter (thermoluminescent detector
> (TLD) or film badge) provided either by FDA or the appropriate State
> Agency when performing the x-ray system testing.
>
> b\. Discuss the inspection with facility personnel about what is
> involved, prior to conducting any equipment testing or review of
> facility records, unless this was covered on the telephone prior to
> the inspection.
>
> c\. During the inspection, enter inspection data into the laptop
> computer. The inspector should upload the data to MPRIS within five
> working days after the inspection.
>
> d\. Provide the facility with the MQSA Facility Inspection Report
> (indicated as "post-inspection report" in the inspection software
> program), which contains test results and inspection observations
> (some States may mail this printout to the facility after State
> supervisory review). The inspector should discuss these observations
> with the most responsible person at the facility, even when the
> inspection report is mailed to the facility at a later time. The
> inspector should also record in the inspection report if the report is
> left at facility during the inspection or mailed, as well as the
> person who received or was mailed the report. If the person who was
> mailed the report is different from the most responsible person at the
> facility, the most responsible person should also be mailed a copy of
> the inspection report. When the report is mailed, the date it is
> mailed should be recorded in the inspection report. It is very
> important that the inspector make management at the facility aware of
> the inspection observations and what they need to do in response to
> these observations. The inspector should identify areas of
> noncompliance, especially any Level 1 and/or repeat observations. See
> the MQSA Inspection Procedures for more information on discussing
> inspection observations with management.
>
> In addition to the MQSA Facility Inspection Report, the facility
> should receive a document entitled *Important Information about Your
> MQSA Inspection*, which contains guidance to the facility as to how to
> interpret its inspection report (see Attachment L). This identifies
> the different levels of inspection observations and how the facility
> should respond to FDA, based on the highest level of observation. A
> check box is present on the form for the inspector to indicate which
> information pertains to the facility's inspection.
>
> e\. Document any x-ray system damage (real or claimed) due to the
> testing of the x-ray unit or any other facility equipment on FDA form
> 2766, Claim for Damage to an Electronic Product (refer to Attachment
> D). Forward this form immediately through the RRHR to DMQRP (without
> delaying submission or attempting to refute the alleged damages).
>
> **Note: State contract personnel should immediately report any damage
> to an x-ray system to the RRHR. The RRHR should determine what follow
> up is required (use of FDA form 2766 is not required for State
> inspections). Under the Federal Tort Claims Act, FDA is not
> responsible for any damage to facility equipment by State contract
> employees.**

f.  **Documentation**: FDA may need documentation or other evidence for
    a regulatory action (Directed Plan of Correction, Civil Money
    Penalties, suspension or revocation, or injunction). Regarding
    records reviewed during the inspection, **the inspector should
    collect copies of records that show why he or she made a specific
    inspection observation. This would apply for any Level 1, 2, or
    repeat Level 3 observation.** Copies of records should also be
    collected when numerous problems with records may result in a
    Warning Letter being sent, although no Level 1 observations are
    present. If in doubt, the inspector should collect copies of
    records.

> **Note: Since FDA jurisdiction depends upon a facility performing
> mammography when the violations occurred, the inspector should copy
> records showing that mammography was being performed at the time of
> the violations. Since the facility can be charged with violating MQSA
> for each mammogram done while failing to comply, you should document
> as many mammograms as possible that are associated with specific
> violations. If it is not possible to document every mammogram, the
> inspector should record the number of mammograms performed during the
> time period when the facility was in violation of MQSA regulations.
> FDA inspectors should also prepare an affidavit tying all records
> copied to the violations observed and the mammograms done when the
> violations took place.**
>
> Examples of records that could be collected during an inspection
> include:

1)  medical physicist reports,

```{=html}
<!-- -->
```
1)  mammography reports or patient letters (patient names and
    identification must be purged for State inspections; for FDA
    inspections, names and identification should be purged unless
    records were copied to support regulatory action),

2)  records concerning personnel qualifications, and

3)  quality control records for film processing, phantom images, and
    other tests.

> When films such as phantom images, STEP, and FOG tests are produced as
> part of the equipment testing, these films should remain with the
> office that conducted the inspection (either the contract State, the
> FDA district, or FDA regional office), unless specifically requested
> by the FDA district (or regional office, where appropriate) or DMQRP
> to be transferred to another location. The inspector should identify
> records collected with:

1)  name and facility ID number of the facility,

```{=html}
<!-- -->
```
1)  date of the inspection, and

2)  name or initials of the inspector.

> The inspector should forward to the appropriate district or regional
> office copies of records collected during State inspections for Level
> 1, 2, or repeat Level 3 observations (see Attachment E). The State
> should retain films produced during inspections that show minor or no
> observations. For Level 1 phantom image failures, States may need to
> send phantom films to the MQSA auditor to confirm the Level 1 score.
>
> **Note: No documentation of interstate commerce is necessary for MQSA
> inspections.**

f.  **Patient Records:** Inspectors may need to collect copies of
    records, such as mammography reports, mammography logbooks, or
    letters to patients about mammography results. FDA MQSA inspectors
    will most likely collect these records when visiting facilities as
    part of investigations or follow-up inspections, though records may
    be copied during routine inspections to document medical record
    violations under 21 CFR 900.12(c).

> In general, whenever an inspector needs to copy a record containing
> patient names or other identifying information, he or she also needs
> to protect patient confidentiality. All inspectors bear a legal and
> ethical responsibility to prevent unauthorized disclosure of this
> information. However, FDA also should have accurate documentation of
> serious violations under MQSA. FDA may need patient names to establish
> that a violation has occurred, to follow up specific complaints, or to
> prove that a copy of a record made during an inspection or
> investigation is a true copy of the original record. The inspector
> should not purge the copy made during the inspection, if this copy is
> going to be used as evidence for a potential compliance case **(this
> only applies to FDA inspectors, since FDA contracts with States
> prohibit State inspectors from making copies without removing patient
> names or other identifying information**). As with any confidential
> FDA document, the inspector should not disclose these records outside
> of the FDA or State. The inspector should only share unpurged records
> containing patient identifiers with other agency or State employees on
> a "need to know" basis, in accordance with 21 CFR Parts 20 and 21. In
> addition, FDA advises that if copies of these records are required for
> use by authorized personnel, inspectors and/or compliance officers
> should purge additional copies of all patient identifiers whenever
> there is no need for that particular information to be shared. Patient
> identifiers would include names, hospital identification numbers,
> social security numbers, or any other name or code related to a
> specific patient.

g.  **Written Inspection Reports**: For inspections or follow-up
    inspections that reveal serious violations that may result in
    regulatory action, FDA inspectors should prepare, in addition to the
    MQSA Inspection computer data that is uploaded to MPRIS, a complete
    Establishment Inspection Report (see Investigations Operations
    Manual (IOM), Section 593).

h.  **Inspection refusal:** In the event that a facility refuses to
    allow an inspection, the district should contact the Division of
    Compliance Management and Operations (HFC-210) about getting an
    inspection warrant (see Regulatory Procedures Manual, Chapter 6).
    When State inspectors are refused, the inspector or their State
    supervisor should contact the RRHR.

**B. Compliance Follow-Up for Inspections**

> The District Office (or Regional Radiological staff, where
> appropriate) should:
>
> 1\. Thoroughly review compliance activity for any facility where
> regulatory action is being considered. The district's review should
> include the evaluation of all of the following factors:
>
> a\) Inspection data from MPRIS and copies of facility records
>
> b\) Responses to Warning Letters and copies of any other
> correspondence with the facility
>
> c\) The results of an Additional Mammography Review (AMR) for a
> facility (see 21 CFR 900.12(j)(1))
>
> d\) State actions against the facility, under State laws and
> regulations
>
> e\) Equipment maintenance schedules and service records
>
> f\) Medical physicist reports
>
> g\) Written consumer (patient) complaints, employee complaints, or
> medical physicist complaints
>
> h\) Written comments or concerns from the inspector

2\. Ensure that whenever corrective actions are evaluated, the FaNTMS
database is updated to reflect the compliance status of a facility.

3\. Monitor inspection results, responses to inspection observations
(especially those contained in Warning or Directed Plan of Correction
Letters), follow-up inspection data, and identify facilities for
possible regulatory follow up.

> 4\. Prepare and send Warning Letters and perform any follow up
> associated with the letters.

**C. Inspection Quality Assurance Audits**

> 1\. FDA Auditors should audit all FDA and State MQSA inspectors to
> ensure they are following FDA procedures and guidance for MQSA
> inspections. The MQSA Auditor's Guide provides information on how to
> conduct audits.
>
> 2\. Each inspector should be audited at least once for each fiscal
> year. Field Management Directive No. 76 provides general guidance on
> the MQSA audit program. In addition, the MQSA Auditor's Guide, dated
> January 1998, contains procedures and policies pertaining to
> implementation of the audit program. An audit may be either:
>
> **Joint Audit Inspection:** An audit performed by an MQSA auditor
> simultaneously with an annual inspection by a State or FDA inspector.
>
> **Independent Audit:** A visit to a facility by an MQSA auditor on a
> date subsequent to an inspection conducted by a State or FDA
> inspector.
>
> **Note: The majority of audit inspections are expected to be joint
> inspections during an annual inspection. Districts consult with the
> RRHR and follow the MQSA Auditor's Guide before performing an
> independent audit.**

**D. Follow-Up and Compliance Inspections**

> **Note: FDA MQSA inspectors should do all follow-up and compliance
> inspections.**
>
> Facilities will be asked to respond to Level 1 and repeat Level 2
> inspection observations within 15 working days after the inspection
> and Level 2 and repeat Level 3 inspection observations within 30
> working days. Inspectors have been instructed to explain to facility
> management how to respond to the inspection observations and will
> provide them with a revised version of the *Important Information
> about Your MQSA Inspection* document (see Attachment L). If the
> facility management fails to respond or the response is inadequate to
> Level 1 or repeat Level 2 observations, you should send a Warning
> Letter to the most responsible individual at the location and also a
> copy to the most responsible individual, if off site. Typically, this
> Warning Letter is preceded by a follow-up inspection. A compliance
> inspection should be performed two to three months following the
> Warning Letter to ensure that the violations have been corrected. If
> this inspection shows continuing violations, you should consider
> regulatory action, such as a Directed Plan of Correction or Civil
> Money Penalties. These steps are outlined on the flowchart in
> Attachment H.
>
> When using the guidance in the paragraph above, there are several
> things the district should consider:
>
> 1.     If facility management fails to respond within 15 (or 30)
> working days, there may be a reasonable explanation why they haven't
> responded, such as miscommunication within the facility. Before
> sending a Warning Letter for Level 1 or repeat Level 2 observations,
> the district should contact them (may be verbal or written) and ask
> that they respond in writing or come in for a face-to-face meeting. If
> this fails to resolve the violations, the district should proceed with
> the follow-up inspection or Warning Letter.
>
> 2.     If the facility has a violative history, facility management
> may find it difficult to provide convincing evidence that problems are
> permanently corrected. If the facility's response contains promises of
> corrections similar to previous inspections, the district should
> consider it inadequate and schedule a follow-up inspection for Level 1
> or repeat Level 2 observations.
>
> 3.     If FDA previously sent the facility a Warning Letter for an
> MQSA inspection, it probably falls under item two above. If a
> follow-up inspection shows continuing violations, the district should
> consider regulatory action instead of another Warning Letter.
>
> 4.     For certain types of facility problems, such as Level 1
> observations for phantom image testing by the inspector or Level 1
> interpreting physician qualifications, we may require the facility to
> undergo Additional Mammography Review (AMR) under 21 CFR 900.12(j)(1).
> Since the AMR shouldn't be delayed, we may notify the facility about
> the AMR prior to a follow-up inspection. The Director of the Division
> of Mammography Quality and Radiation Programs (DMQRP) would usually
> send an untitled letter to the facility requiring AMR. DMQRP will work
> closely with the district when requesting AMR and will copy it when
> results are provided by the accreditation body or other review entity.
> If the AMR shows that the quality of mammography may represent a
> serious risk to human health, we can require the facility to notify
> patients and physicians under 21 CFR 900.12(j)(2). More information
> about AMR can be found in section A.3. in Part V.
>
> Follow-up and compliance inspections should take priority over
> routine, annual inspections. A fee is usually charged for all
> follow-up inspections, but no fee should be charged for compliance
> inspections which should occur two to three months after the Warning
> Letter was sent.
>
> In violative cases, districts need to obtain adequate documentation of
> the violations. This means that for violative follow-up inspections,
> the inspector should prepare a complete narrative report for the
> inspection (see Investigations Operations Manual (IOM), Section 593),
> in addition to any information or data recorded in the MPRIS
> inspection software.

**E. Uncertified Facilities**

> 1\. **Background**
>
> FDA may learn that a facility may be performing mammography without a
> certificate from several sources. A State radiation control program,
> an accreditation body, consumers, and current or former employees may
> report the facility.
>
> A facility that can be shown to be performing mammography without a
> certificate may be a candidate for regulatory action. However, in most
> cases, FDA would handle these violations like most Level 1
> observations. Examples of facilities performing mammography without a
> certificate could include:

a.  new mammography facilities that fail to apply to an accreditation
    body (this application is required prior to provisional
    certification)

```{=html}
<!-- -->
```
a.  facilities that continue to perform mammography after being notified
    that their certificate has expired, been suspended, been revoked, or
    no longer is in effect

> Facilities can be assessed civil money penalties or enjoined from
> operating if they perform mammography without a certificate and have a
> violative history (see Part V for more information). **If the facility
> performs mammography without a certificate for 90 days or longer, FDA
> may require AMR.**
>
> Since other violations and problems could support regulatory action by
> FDA, the district should inspect against all MQSA requirements, if
> possible.
>
> 2\. **Facility Investigations and Inspections**
>
> a\. If the district becomes aware that a facility may be performing
> mammography without a certificate, it should inspect the facility as
> soon as possible. The district should also contact DMQRP prior to the
> inspection to verify certification status and to obtain any
> documentation it may have regarding the facility's certification
> history.
>
> b\. The inspector should conduct a routine MQSA inspection and also
> document the illegal mammography. The documentation the inspector
> collects to show illegal mammography should consist of copies of
> mammography reports (the more recent, the better). Mammography reports
> are documents that contain the physician\'s interpretation of the
> mammogram and should include the date of the mammogram, the date of
> the interpretation, the facility name, the patient\'s name or some
> identification, physician\'s name, and a written interpretation. For
> records with patient names or identification, all personnel involved
> with MQSA should exercise caution to ensure confidentiality and
> privacy when handling these documents and information (see section
> A.4.g of this Part for information on the handling of patient
> records).
>
> c\. If the mammography reports do not contain sufficient information
> to document that the facility was performing mammography without a
> certificate, inspectors may need to copy mammography film labels.
> Mammography films have either a paper label attached or a label
> imprinted into the film with light. Either of the labels should copy
> easily on a conventional photocopier. The labels should contain the
> patient's name, the facility's name, and the date of the mammogram. If
> the label cannot be photocopied, the inspector may need to photograph
> the label (on the facility's viewbox if the label was imprinted into
> the film). However, unless the mammogram has information that can be
> correlated with the date that the exam was performed, inspectors
> should not copy information from the films.
>
> d\. Inspectors may find that patient logs or schedules are good
> sources of information about patients who had mammograms. However,
> inspectors should make sure that patients listed for mammography on
> logs or schedules actually had mammograms at the facility. Patients on
> these documents may have been scheduled, but may not have had the
> scheduled mammogram. Inspectors may find that the logs or schedules
> provide indications of volume, but should not be used as a substitute
> for copies of mammography reports.
>
> **NOTE: Inspectors should always attempt to get a commitment from the
> uncertified facility to voluntarily stop performing mammography on the
> day of the inspection. If the facility is not willing to voluntarily
> stop performing mammography, FDA may need to enjoin the facility from
> performing mammography without a certificate. In the interim, the
> State should be contacted. It may have independent authority to stop
> the facility from performing mammography and FDA may decide to
> coordinate action with the State against the facility.**

# Possible Criminal Activity at a Facility

#  {#section .unnumbered}

> If the district suspects that a facility may have falsified records,
> has submitted false information to the district, or may have engaged
> in other possible criminal activity, it should contact the appropriate
> Office of Criminal Investigations (OCI) field office. The district
> should coordinate any district follow-up at the facility with this OCI
> office. **However, the district should not delay inspections or
> investigation of serious problems regarding the quality of mammography
> (that is, where a possible serious risk to human health may exist) for
> the purposes of documenting criminal activity, since FDA may need to
> require AMR at the facility.**

**G. Mammography Equipment Problems (Non-MQSA)**

> If the district suspects that a problem with mammography x-ray unit,
> film processor, film, cassettes, image processing computers, or other
> equipment is related to the manufacturer or assembler of the
> equipment, it should notify the Diagnostic X-Ray Devices Branch, OCER,
> CDRH (HFZ-240) and the RRHR. Please refer to CP 7386.003 for guidance
> regarding x-ray equipment problems.

**PART IV - ANALYTICAL**

No laboratory testing will be done under this program.

[]{#PARTV .anchor}**PART V -- REGULATORY / ADMINISTRATIVE**

**STRATEGY**

# A. Regulatory Philosophy and Strategy {#a.-regulatory-philosophy-and-strategy .unnumbered}

**1. Inspection Observations**

> There are three levels of observations, from Level 1, which is the
> most severe, to Level 3 (see Attachment E). The type of follow-up
> should depend on the level of the noncompliance. The post inspection
> printout, called the "MQSA Facility Inspection Report" should identify
> all of the inspection observations.
>
> **a. Levels of Inspection Observations**

+------------------------------+---------------------------------------+
| **Highest Level of           | **Action by Facility**                |
| Observation**                |                                       |
+------------------------------+---------------------------------------+
| ### Level 1 -- repe          | Response from facility within 15      |
| at observation {#level-1-rep | working days                          |
| eat-observation .unnumbered} |                                       |
+------------------------------+---------------------------------------+
| ### Le                       | ### Response from facility within 15  |
| vel 1 {#level-1 .unnumbered} |  working days {#response-from-facilit |
|                              | y-within-15-working-days .unnumbered} |
+------------------------------+---------------------------------------+
| Level 2 -- repeat            | Response from facility within 15      |
| observation                  | working days                          |
+------------------------------+---------------------------------------+
| Level 2                      | Response from facility within 30      |
|                              | working days                          |
+------------------------------+---------------------------------------+
| Level 3 -- repeat            | Response from facility within 30      |
| observation                  | working days                          |
+------------------------------+---------------------------------------+
| Level 3                      | Follow up during next annual          |
|                              | inspection                            |
+------------------------------+---------------------------------------+

> **b. Repeat Inspection Observations**
>
> The following list identifies characteristics pertaining to repeat
> inspection observations:

1.  Uncorrected from previous inspection or has recurred

```{=html}
<!-- -->
```
1.  Generates the same standard statement from the inspection software
    as for the previous inspection

2.  Can be for a different individual in a facility within the same
    professional category (physician, technologist, or physicist), a
    different x-ray system, or a different film processor

3.  Response from the facility should include how it intends to correct
    all repeat observations, regardless of level

> **c. Facility Responses**
>
> Facilities should send all responses to inspection observations to the
> district office (or Regional Radiological Staff, where appropriate).
> It does not matter whether the inspection was conducted by a State or
> an FDA MQSA inspector. Facilities should be directed, however, to send
> a copy of letters they send FDA to the State. FDA recommends that
> contract States be consulted on the adequacy of facility responses,
> since State inspectors usually conduct MQSA inspections and have
> useful information about the facility and the inspection. In addition,
> the district should copy the State program for all letters sent to
> facilities, as well as minutes of meetings with facilities. Attachment
> F contains guidance on reviewing responses.
>
> Before reviewing a facility response, the district should read
> Attachment F for guidance. If a facility doesn't respond to Level 1 or
> repeat Level 2 inspection observations when requested or doesn't
> respond adequately, the district should consider a follow-up
> inspection or Warning Letter. The district should review section D
> under Part III before scheduling the follow-up inspection or sending a
> Warning Letter.
>
> DMQRP has provided access to all district and regional offices to the
> FaNTMS, a part of MPRIS. FaNTMS contains information on facility
> inspection data, results, and compliance information. The district
> should update FaNTMS when the response to the letter has been
> evaluated. A letter should be sent to the facility when the responses
> are found to be adequate (see Attachment J) and no follow-up
> inspection or further action is indicated.

**2. Warning Letters**

> Facilities will be asked to respond to Level 1 and repeat Level 2
> inspection observations within 15 working days after the inspection
> and Level 2 and repeat Level 3 inspection observations within 30
> working days. Inspectors have been instructed to explain to facility
> management how to respond to the inspection observations and will
> provide them with a revised version of the *Important Information
> about Your MQSA Inspection* document (see Attachment L). If the
> facility adequately responds to inspection observations, the District
> should send a close-out letter to the facility. If the facility fails
> to respond within the appropriate time frame or the response is
> inadequate, the District should communicate with the facility to
> remind it of its obligations and encourage an adequate response to the
> observations within a reasonable timeframe.
>
> If, after communicating with the District, a facility, with Level 1 or
> repeat Level 2 inspection observations, still fails to respond, or its
> response is inadequate, the district should send a Warning Letter. If
> the District finds that the facility's proposed corrections appear
> adequate, but based on the facility's past history and capabilities
> require further verification, the district should conduct a follow-up
> (fee based) inspection (rather than a Warning Letter). If similar
> violations are again found during the follow-up (fee based)
> inspection, the District should send a Warning Letter.
>
> Note: Districts retain direct reference authority to send Warning
> Letters for Level 1 and/or Repeat Level 2 observations. When sending
> Warning Letters, Districts must follow their standard procedures,
> including the need for OCC clearance. CDRH concurrence is required for
> Warning Letters where the most significant observation is either Level
> 2 or Repeat Level 3.
>
> If, after communicating with the District, a facility with Level 2 or
> repeat Level 3 inspection observations still fails to respond, or its
> response is inadequate, the District should conduct a follow-up
> inspection. If similar violations are again identified during the
> follow-up (fee based) inspection, the District should send a Warning
> Letter.

In all cases Warning Letters should be sent to the most responsible
individuals, not necessarily the contact people at the locations. The
district should copy all contract states for all Warning Letters sent to
facilities located in their states and to the facility's accreditation
body (for a list of the current accreditation bodies, go to
<http://www.fda.gov/CDRH/MAMMOGRAPHY/accreditation.html> ), in addition
to the normal distribution.

**3. Additional Mammography Review (AMR)**

> If the district suspects that the mammography quality at a facility
> has been compromised and may present a serious risk to human health,
> it should recommend that the facility undergo AMR. Under an AMR, the
> facility must provide clinical images and other relevant information
> (which may include mammography reports), for review by the facility's
> accreditation body or by an interpreting physician not associated with
> the facility (21 CFR 900.12(j)(1)). The AMR review will help FDA
> determine whether there is a need to notify affected patients, their
> physicians, or the public that the reliability, clarity, and accuracy
> of interpretation of mammograms has been compromised.
>
> FDA has written guidance defining situations where AMR may be needed,
> as well as procedures to follow for AMR. FDA may request AMR even if
> it does not have evidence of violations for a Warning Letter. Several
> complaints from other facilities about mammographic quality would be
> an example of this type of situation.

### **a. Information the district should include with an AMR recommendation** {#a.-information-the-district-should-include-with-an-amr-recommendation .unnumbered}

> Submit the following documents (by e-mail or fax; if you submit films,
> use overnight carrier) to the Division of Mammography Quality and
> Radiation Programs (DMQRP):

1.  Recommendation memorandum summarizing facts

```{=html}
<!-- -->
```
1.  Establishment Inspection Report (EIR), if one is written

2.  Documentation, copies of correspondence, exhibits, and other
    materials

> **Note: Level 1 observations (either the phantom image test or the
> qualifications of the interpreting physician), by themselves, may
> warrant an AMR recommendation. For most inspections, you may only have
> a State inspection. If FDA did not conduct the inspection and you
> don't need a follow-up inspection to further document facility
> problems, just submit the memorandum. In this case, you can reference
> the Facility ID and the date of the uploaded inspection in the
> memorandum.**
>
> **b. Checklist for inspection documentation:**

1.  Level 1 phantom image scores from inspection confirmed through a
    second review by the MQSA auditor or an FDA MQSA inspector (or by
    the State, if the State has a thorough phantom image quality
    assurance (QA) program in place)

```{=html}
<!-- -->
```
1.  Inspector has re-scored the facility's QC phantom images and
    recorded any failed scores in inspection record (including dates of
    failed facility images to help determine AMR time frame)

2.  Medical physicist survey phantom image scores recorded by inspector

3.  Time frame for interpreting physician's reading and interpretation
    of mammograms documented by inspector

4.  Actual qualifications of interpreting physician documented (or
    facility could not document physician's qualification)

> **Note: The district should not consider recommending an AMR for a
> lack of qualifications for an interpreting physician unless it has
> made reasonable attempts to assure that the physician truly lacks
> these qualifications. In many cases, documentation may have been
> missing at the time of the inspection and missing documents may have
> caused the inspector to cite the facility. At a later date, the
> facility submitted the documents that indicated that the physician was
> qualified at the time of the inspection. When the inspection
> observation is a documentation issue, the district should not consider
> recommending an AMR for the facility.**
>
> **c. AMRs and regulatory actions**
>
> When districts find violations significant enough to consider
> regulatory action, it should also consider recommending AMR. The
> recommendation for AMR may be included in the recommendation for
> regulatory action, rather than as a separate memorandum.

### **d. How AMR recommendations are approved** {#d.-how-amr-recommendations-are-approved .unnumbered}

> DMQRP approves all requests for AMRs, regardless of the type of
> problem(s) that resulted in the recommendation to request an AMR from
> the facility. DMQRP must also approve the plan for the AMR, including
> the selection of the reviewing interpreting physician(s) (if not
> selected by the accreditation body) and the number and timeframe of
> the exams reviewed. DMQRP will use the results of the AMR to determine
> whether to require Patient and Physician Notification by the facility.
> DMQRP will update the district of the status of AMRs.

**4. Regulatory Actions under MQSA**

> **a. General sanctions information**
>
> **Note: Whenever the district finds serious conditions at a facility
> where the reliability, clarity, and accuracy of interpretation of
> mammograms may be suspect, it should consider AMR for the facility, in
> addition to considering a regulatory action. It should not delay an
> AMR while considering regulatory action.**
>
> Generally, the district should have at least repeat Level 1, Level 1,
> and/or repeat Level 2 observations from the most recent inspection and
> have prior notice before considering regulatory action for a facility
> (usually a Warning Letter; see Chapter 10 of the Regulatory Procedures
> Manual for other examples of prior notice). Before considering
> regulatory action, the district should usually have done a follow-up
> or compliance inspection to document current problems. While a single
> inspection may indicate the need for some type of regulatory action,
> it would be a rare situation.
>
> **Factors to consider prior to recommendations for regulatory action**

1.  **Prior Notice**: FDA may take regulatory action without prior
    notice if the situation presents a danger to health or constitutes
    intentional, gross, or flagrant violations. When the district finds
    the above conditions, it should contact DMQRP and the RRHR to
    discuss options for regulatory action.

```{=html}
<!-- -->
```
1.  **Corrections and History:** The district should also consider the
    facility's commitment to correct the problems, including corrections
    made during the inspection, and the inspection history of the
    facility. The district should review all relevant information and
    evidence, including any information and recommendations from the
    inspector.

2.  **Follow-Up and Compliance Inspections:** The district should
    consider a follow-up or compliance inspection by an FDA MQSA
    inspector before recommending regulatory action. In most cases, you
    should conduct an inspection to show that violations continue and to
    gather sufficient documentation.

> There are a variety of sanctions or regulatory actions that FDA may
> impose under MQSA, including Directed Plan of Correction (DPC),
> Patient and Physician Notification (PPN), Civil Money Penalties (CMP),
> and suspension or revocation of a facility certificate. FDA may also
> seek injunctions against facilities in federal district court. Of
> these actions, the DPC, PPN, and suspension can be implemented fairly
> quickly.
>
> **b. Directed Plan of Correction (DPC)**
>
> Under section 354(h)(1)(A) of the MQSA (42 U.S.C. 263b(h)(1)(A)), FDA
> may impose "Directed plans of correction which afford a facility an
> opportunity to correct violations in a timely manner." FDA is not
> limited to the problems or types of violations the DPC can address,
> nor is FDA restricted by MQSA for what a DPC may require of a
> facility. FDA, therefore, has options we can require of the facility
> to correct problems.
>
> The district may decide that the DPC works best for many situations,
> since it can prevent continued use of specific personnel, procedures,
> or equipment, without FDA suspending their certificate. FDA may limit
> the DPC to address a particular problem at a facility. An effective
> DPC would require a facility to immediately address significant
> observations and allow FDA to monitor corrections under the plan.
>
> The following are examples of conditions or requirements the district
> may include in a DPC:

1.  The facility would cease using a mammographic x-ray system with poor
    performance until the system repairs showed acceptable improvement
    in image quality.

```{=html}
<!-- -->
```
1.  The facility would have a qualified medical physicist evaluate
    specific problems with a follow-up report to FDA.

2.  The facility could not use unqualified interpreting physicians to
    read and interpret mammograms or radiologic technologists to perform
    mammograms. FDA can maintain this prohibition until the personnel
    meet the MQSA requirements (21 CFR 900.12).

3.  The facility would have to undergo AMR.

> If FDA requires a facility to discontinue use of specific equipment or
> personnel as part of a DPC, the facility need not stop performing
> mammography. A facility may have only one x-ray system or employ one
> interpreting physician, but the facility may bring in a mobile unit or
> temporary personnel. In this manner, they can continue to operate
> until they correct problems.
>
> FDA should require monitoring of the facility under DPC. The district
> will be responsible for monitoring compliance with the DPC. Monitoring
> under a DPC could include, but is not limited to, the following:

1.  Submission of copies of records to the district office, such as
    quality control (QC) charts, on a regular schedule to demonstrate
    appropriate record keeping.

```{=html}
<!-- -->
```
1.  A survey by a qualified medical physicist, regardless of whether the
    facility is due for its annual survey.

2.  Follow-up inspections by FDA or the State.

3.  A site visit to the facility by the accreditation body.

####### **c. Payment for the Cost of On-Site Monitoring** {#c.-payment-for-the-cost-of-on-site-monitoring .unnumbered}

> Under section 354(h)(1)(B) of the MQSA (42 U.S.C. 263b(h)(1)(B)), FDA
> may require the facility to pay for on-site monitoring of the
> facility.
>
> Monitoring could include routine inspections by FDA or State MQSA
> inspectors to monitor continued compliance by the facility. FDA would
> choose an inspection frequency based on how often we may need to check
> on facility compliance. FDA could adjust the frequency of the
> inspections, based on the results of previous inspections.
>
> **d. Patient and Physician Notification (PPN)**
>
> FDA has authority to require PPN when the quality of mammography at a
> facility represents a significant risk to individual or public health.
> This authority can be found under 21 CFR  900.12(j)(2) and 354(h)(2)
> of the MQSA (42 U.S.C. 263b(h)(2)) (wording in the Act is "Patient
> Information").
>
> FDA would usually consider PPN after finding serious problems with
> mammographic quality at a facility through an AMR. The notification to
> the patients and/or their referring physicians may be that the quality
> of the mammograms was inadequate, the interpretation of the mammogram
> by the interpreting physician was inadequate, or both.
>
> **e. Civil Money Penalties (CMP)**

A CMP is a fine levied against the facility and/or individuals by the
FDA for violations of MQSA after FDA has given the facility an
opportunity for an administrative hearing. The most likely situations
where FDA might want to assess CMP would be where violations were
serious, but were not continuing. As an example, we may find that a
facility is performing mammography without a certificate, but agrees to
stop when discovered. We may decide to assess CMP in this situation.

> A facility may be subject to CMP up to \$10,000 for failure to obtain
> a certificate (section 354(h)(3)(A) of the MQSA
> (42 U.S.C. 263b(h)(3)(A)) and up to \$10,000 for failure to notify a
> patient of risk (section 354(h)(3)(C) of the MQSA
> (42 U.S.C. 263b(h)(3)(C)). Other violations may also be subject to CMP
> (354(h)(3)(B), (D) of the MQSA (42 U.S.C. 263b(h)(3)(B), (D)).
>
> Before assessing a CMP, FDA would notify the facility by letter of our
> intent to assess a penalty and provide instructions for requesting a
> hearing. FDA has specific regulations for CMP hearing procedures at 21
> CFR Part 17.
>
> **f. Suspension**
>
> Suspension of the facility's certificate prevents them from performing
> mammography (section 354(i) of the MQSA (42 U.S.C. 263b(i)). For this
> reason, FDA normally would not consider this sanction, unless one or
> more of the following conditions are present:

1.  Lesser sanctions, such as a DPC, have failed to bring the facility
    into compliance.

```{=html}
<!-- -->
```
1.  The facility has refused to permit inspection.

2.  The conditions at the facility represent a serious risk to human
    health.

3.  Violations at the facility were intentional.

> FDA has two different ways in which suspension could occur:

1.  FDA would notify the facility by letter that we intend to suspend
    the facility's certificate and that they may request a hearing. Only
    after the facility waives their right to a hearing, or after a
    hearing, would we suspend the certificate.

```{=html}
<!-- -->
```
1.  FDA would notify the facility by letter that we have suspended their
    certificate and that they may request a hearing. Either conditions 3
    or 4 above would be required to suspend a certificate prior to a
    hearing. We would normally hold a hearing to allow the facility to
    contest the suspension or present their views on whether we should
    lift the suspension.

######### FDA may employ one or more of the following factors in deciding whether to suspend a facility's certificate prior to holding a hearing:

1.  Failure to comply with the required standards presents a serious
    risk to human health.

```{=html}
<!-- -->
```
1.  The refusal to permit inspection makes immediate suspension
    necessary.

2.  There is reason to believe that the violative acts were intentional
    or otherwise rise to a level that presents a threat to public
    health.

> In the event that the facility requests a hearing, FDA will use the
> process outlined in 21 CFR Part 16.
>
> **g. Revocation**
>
> Revocation of a certificate is an action taken by the FDA that
> prohibits a facility from operating, with the expectation that it will
> not be operating in the future. We may seek to revoke a facility\'s
> certificate for the same violations mentioned under suspension of a
> certificate. Unlike suspension, if we revoke a facility\'s
> certificate, the owner or operator of the facility may not operate
> that facility or any other facility for two years after the date of
> revocation (section 354(i)(3) of the MQSA (42 U.S.C. 263b(i)(3)). We
> intend suspension to be a temporary action to encourage a facility to
> comply with the quality standards. We would generally revoke a
> certificate of a facility that cannot or will not comply with the
> regulations. We may seek revocation when a facility continues to
> operate after suspension of its certificate. In some circumstances, we
> may suspend a certificate without a prior hearing, but revocation
> actions always require an opportunity for a hearing. We would use the
> same process under 21 CFR Part 16 for hearings that are employed for
> suspension.
>
> **h. Injunction**
>
> An injunction under MQSA is a court order prohibiting a facility from
> continuing any activity related to the provision of mammography that
> would constitute a serious risk to human health or to stop a facility
> from performing mammography without a certificate (section 354(j) of
> the MQSA (42 U.S.C. 263b(j)). Violation of the order can result in
> criminal contempt sanctions. FDA would normally use this mechanism
> when other FDA actions, including other sanctions, have failed to
> bring a facility into compliance or to stop a facility from performing
> mammography without a certificate. Under certain circumstances, where
> continued operation of a facility constitutes a serious hazard to the
> public health, we may choose this as a course of action.

**5. Violations under State Law for Mammography Facilities**

Many States have mammography facility requirements that overlap with
MQSA requirements. In some cases, the State may have different or more
stringent requirements than FDA. States may also decide to take
regulatory action against a facility for violations that would normally
not result in similar action by FDA.

> For these reasons, States should copy FDA on letters they send to
> facilities pertaining to mammography requirements or violations. Under
> State contracts, the State must report to the RRHR or other designated
> field contact any adverse action taken against a facility under State
> authority within ten working days of the event in instances where a
> significant violation has occurred that would result in FDA taking
> action under MQSA.

#  {#section-1 .unnumbered}

# B. Case Guidance {#b.-case-guidance .unnumbered}

1.  **General Information**

> **Preliminary contacts with DMQRP:** When the district finds that
> specific facility problems may be serious enough for regulatory
> action, it should send an e-mail to DMQRP prior to submission of a
> recommendation package. This e-mail should include:

a.  A summary of the facts relating to the facility's violative
    operation, including information obtained from inspections and
    investigations.

```{=html}
<!-- -->
```
a.  A brief history of the facility's prior violations, if present, and
    whether prior notice was given and when.

b.  A description of why this would be a candidate for regulatory
    action, versus trying to get the facility to voluntarily comply.

> After the e-mail is sent, the district may want a conference call with
> DMQRP and other headquarters units to discuss the merits of the case.
>
> **Recommendation package:** After consultation with DMQRP, the
> district may submit a recommendation to DMQRP. The district should
> include the following with the recommendation memorandum:

a.  Establishment Inspection Reports and reports for any investigations.

```{=html}
<!-- -->
```
a.  Exhibits and documentation (affidavits, photographs, copies of
    facility records).

b.  Copies of correspondence, including Warning Letters.

c.  Draft documents for approval (see specific documents mentioned below
    pertaining to specific actions).

> The district should submit all recommendations for regulatory action
> to DMQRP. For any documents or records that are in electronic format,
> please submit these documents by electronic mail or on disc. You do
> not have to submit copies of inspection reports from the inspections
> uploaded into MPRIS, unless the inspection could not be uploaded and
> only a paper report is available.

**2. Directed Plan of Correction (DPC)**

> **Draft documents to submit:** DPC letter
>
> **Approval official:** Director, Division of Mammography Quality and
> Radiation Programs, OCER, CDRH
>
> **FDA headquarters units involved in the review process:** DMQRP
> (review of DPC letter by Office of the Chief Counsel (OCC))
>
> **Appeal process for facility:** 21 CFR 10.75 -- Request for appeal to
> the Director of the Office of Communication, Education, and Radiation
> Programs, CDRH

**3. Civil Money Penalties (CMP)**

> **Draft documents to submit:** Draft Notice of Opportunity of Hearing
> (for CDRH Director's signature) and draft complaint (for OCC
> attorney's signature) (see 21 CFR 17.5)
>
> **Approval official:** Director, CDRH
>
> **FDA headquarters units involved in the review process:** CDRH,
> ORA/OE/DCMO, OCC
>
> **Appeal process for facility:** 21 CFR 17 -- Hearing before FDA
> administrative law judge

**4. Suspension and/or Revocation**

> **Draft documents to submit:** Draft Notice of Intent to Suspend (or
> Revoke) or Notice of Suspension letter (for Office of Communication,
> Education, and Radiation Programs Director's signature)
>
> **Approval official:** Director, Office of Communication, Education,
> and Radiation Programs, CDRH
>
> **FDA headquarters units involved in the review process:** CDRH, OCC
>
> **Appeal process for facility:** 21 CFR 16 -- Regulatory hearing
> before FDA-appointed presiding officer

**5. Injunction**

> **Draft documents to submit:** see Chapter 6 of the Regulatory
> Procedures Manual
>
> **Approval official:** United States District Judge
>
> **FDA headquarters units involved in the review process:** CDRH, OCC
>
> **Appeal process for facility:** Hearing before the United States
> District Judge signing the order

[]{#PARTVI .anchor}PART VI - References, Attachments and Program
Contacts

### **A. REFERENCES**  {#a.-references .unnumbered}

1.  United States Code, Title 42, *Mammography Quality Standards Act of
    1992* (Public Law 102-539)

```{=html}
<!-- -->
```
1.  United States Code, Title 42, *Mammography Quality Standards
    Reauthorization Act*, (Public Law 105-248)

2.  Code of Federal Regulations, Title 21, Part 900

3.  Federal Register, Final Quality Standards for Mammography
    (62 F.R. 55852, Oct. 28, 1997)

4.  MQSA Inspection Procedures (version 4.52 or later)

5.  *Compliance Guidance - The Mammography Quality Standards Act Final
    Regulations* Documents. These can found at
    <http://www.fda.gov/cdrh/mammography/index.html>. New documents
    pertaining to MQSA are posted on this site in draft and final. Once
    issued in final, they are eventually incorporated into the **Policy
    Guidance Help System**, which can be found at
    <http://www.fda.gov/CDRH/MAMMOGRAPHY/robohelp/START.HTM>

6.  Investigations Operations Manual, FDA

7.  Regulatory Procedures Manual, FDA

8.  Federal Register, Interim Quality Standards for Mammography
    (58 F.R. 67558, Dec. 21, 1993)

9.  United States Code, Title 21, [Federal Food, Drug, and Cosmetic Act,
    As Amended]{.underline}

10. Compliance Program 7382.003, Field Compliance Testing of Diagnostic
    (Medical) X-ray Equipment

11. MQSA Auditor's Guide
    (<http://www.fda.gov/ora/inspect_ref/igs/mqsa.html>)

**B. ATTACHMENTS**

List of CDRH personnel to contact on inspection and compliance
procedures, case management, inspection audits, and workplans

A.  List of CDRH personnel to contact on inspection computer support and
    testing equipment

B.  List of MQSA Auditors

C.  Form FDA 2766 Claim for Damage to an Electronic Product

D.  Observation Statements for MQSA Inspections

E.  Guidance for Evaluating a Facility Response

F.  Guidance for an Additional Mammography Review (AMR)

G.  Flowchart - Follow-Up for MQSA Inspections

H.  Warning Letter for inspections with Level 1 and or repeat Level 2
    inspection observations

I.  Adequate Response Letter to Facility

J.  Example of MQSA Facility Inspection Report

K.  [Important Information about Your MQSA Inspection]{.underline}
    (given to facility at the close of the inspection)

L.  Sample MQSA Inspection Confirmation (5 days prior to inspection)

#### C. PROGRAM CONTACTS {#c.-program-contacts .unnumbered}

> 1\. [CDRH Contact]{.underline} - Questions concerning this compliance
> program should be directed to Michael P. Divine, Inspection and
> Compliance Branch, Division of Mammography Quality and Radiation
> Programs, OCER (HFZ-240) (301) 594-3763. Secondary contact may be made
> with the individuals listed on Attachments A through C.
>
> 2\. [ORA Contact]{.underline} - The ORA Headquarters contact for this
> compliance program and state contract issues is Stephen G. Toigo,
> Division of Federal-State Relations ORO (HFC-152), (301) 443-3360.

[]{#PARTVII .anchor}**PART VII - CENTER RESPONSIBILITIES**

**A. CDRH/OCER/DMQRP:**

1.  Provide calibrated test equipment for use by all FDA and State
    inspectors (calibration of x-ray monitors by the Radiation Metrology
    Branch, DECS/OST/CDRH (HFZ-143)).

```{=html}
<!-- -->
```
1.  Review regulatory action recommendations and provide assistance and
    guidance in the preparation of compliance cases, including the
    Directed Plan of Correction. For Civil Money Penalties, suspension,
    revocation, and injunctions under MQSA, DMQRP and the CDRH Office of
    Compliance will work closely together regarding these actions.

2.  Maintain/develop computer software for direct access to MPRIS by
    inspectors, auditors, and RRHR\'s.

3.  Monitor and evaluate inspector performance through FDA audits and
    inspection data analysis.

4.  Recommend specific sites for special inspections when requested.

5.  Develop and revise facility inspection procedures.

6.  Provide training courses for MQSA inspectors and administer MQSA
    inspector certification and quality assurance programs.

7.  Develop regulatory guidance for inspectors and FDA field offices.

B. [Program Review]{.underline} - On a routine basis, but not less often
than annually, this program will be reviewed. This review will be the
results of this program and any needed improvements to increase program
effectiveness. Program changes and recommendations should be submitted
to the Chief, Inspection and Compliance Branch, DMQRP (HFZ-240) for
consideration.

[]{#ATTACHMENTA .anchor}Attachment A

**FDA/CDRH/OCER/DMQRP Personnel to Contact**

**Inspection Procedures and Use of Instrumentation**

1.  Walid G. Mourad 301-594-3778 (Information Management Branch, DMQRP)

```{=html}
<!-- -->
```
1.  Charles R. Gunzburg 301-594-3587 (Inspection and Compliance Branch,
    DMQRP)

2.  Michael P. Divine 301-594-3763 (Inspection and Compliance Branch,
    DMQRP)

**Inspection Field Workplan**

> Ellyce F. Ratskoff 301-827-2980 (Inspection and Compliance Branch,
> DMQRP)

**FDA/CDRH Personnel to Contact for**

**Facility Compliance Issues and Case Management**

1.  Michael P. Divine 301-594-3763 (Inspection and Compliance Branch,
    DMQRP)

```{=html}
<!-- -->
```
1.  Sharon M. Davis 301-827-8772 (Inspection and Compliance Branch,
    DMQRP)

2.  Ellyce Ratskoff 301-827-2980 (Inspection and Compliance Branch,
    DMQRP)

3.  Charles R. Gunzburg 301-594-3587 (Inspection and Compliance Branch,
    DMQRP)

4.  Nancy Wynne 301-594-3534 (Inspection and Compliance Branch, DMQRP)

[]{#ATTACHMENTB .anchor}Attachment B

**Contact Information - Inspection Computer Support and Testing
Equipment**

+-----------------------------------+----------------------------------+
| Computer, Printer, Inspection     | Contact MPRIS Computer Support   |
| Upload/Download, or E-mail Issues | via telephone or e-mail          |
|                                   | (301-827-4330 or                 |
|                                   | <computersupport@cdrh.fda.gov>). |
+-----------------------------------+----------------------------------+
| MDH Test Equipment Issues ONLY    | Contact Jannita Ridgell via      |
|                                   | phone or email (301-443-2536 ext |
| (Issued by the MQSA Program)      | 151 or <jzr@cdrh.fda.gov>).      |
+-----------------------------------+----------------------------------+
| MQSA Issued Inspection Equipment  | Contact Stephanie Belella via    |
| Questions (e.g., film requests;   | phone or email (301-827-3997 or  |
| sensitometer or densitometer      | 301-594-3332 or                  |
| problems; non-MDH calibration     | <swb@cdrh.fda.gov>).             |
| questions; phantom problems; need |                                  |
| for other equipment, including    |                                  |
| magnifying glass, ruler, aluminum |                                  |
| filters, timers, fog folders)     |                                  |
+-----------------------------------+----------------------------------+

**DO NOT** return instruments to headquarters for calibration or repairs
until calling the appropriate individual and thus obtaining instructions
for return.

[]{#ATTACHMENTC .anchor}Attachment C

**MQSA Auditors and RRHRs**

The following list includes Regional Radiological Health Representatives
(RRHRs) who are responsible for oversight of State MQSA contracts and
auditors who are qualified to conduct quality assurance audits of MQSA
inspectors. RRHR responsibilities are outlined in section B.9. of Part
II. For more information on MQSA audits, consult the MQSA Auditors
Guide.

  -------------------- --------------------------------------------------
  **Central Region**   

                       

  Rachel T. Evans      RRHR

  Rachel T. Evans      Chicago District

  R. Terry Bolen       Cincinnati District

  Dennis E. Swartz     Detroit District

  Thomas W. Garvin     Minneapolis District

  Robert E. Davis      Philadelphia District

                       

  **Northeast Region** 

                       

  Ronald Bernacki      RRHR

  Michael J. Leal      New England District

  James R. Wormuth     New York District

                       

  **Pacific Region**   

                       

  Vacant               RRHR

  Beverly A. Thomas    Los Angeles District

                       

  **Southeast Region** 

                       

  Tom Trout            RRHR

  Janeth Caycedo       Florida District

  Karen R. Smallwood   New Orleans District

  Jorge E. Martinez    San Juan District

                       

  **Southwest Region** all Southwest Region auditors are assigned to the
                       regional office, though some are physically
                       located in a district office

                       

  Scotty Hargrave      RRHR

  Robert G. Antonsen   Denver District

  Reggie D. Cope       Kansas City District

  John D. Mays         Southwest Regional Office

  Deborah M. McGee     Southwest Regional Office
  -------------------- --------------------------------------------------

[]{#ATTACHMENTD .anchor}Attachment D

[]{#ATTACHMENTE .anchor}Attachment E

Observation Statements for MQSA Inspections

**Mammography Program Reporting and Information System (MPRIS)**

**Field Inspection Sub-System (FISS)**

The following list of observations (i.e., violations of MQSA) is
generated during mammography facility inspections by the FISS inspection
software. The inspector prints a report (called the MQSA Facility
Inspection Report) from his or her laptop computer. He or she gives the
facility the report at the close of the inspection (some States mail
this report to the facility at a later date). This report contains one
or more of the statements below.

You should consult Part V, under section A.1.a, for guidance on the
appropriate follow up, if any, to different levels of inspection
observations. You should contact personnel in CDRH, listed in
Attachment A, if you have any questions regarding a specific inspection
and the observations involved.

With certain exceptions, you will find the requirements that relate to
these observations in 21 CFR 900.12 (see CFR references in brackets
"\[\]"). Where certain requirements are found elsewhere in 21 CFR, we
have indicated the source of the requirement. Where we have used braces
"{}", this indicates that the FISS software will insert information
specific to a given facility, such as the name of a person at the
facility, a room number, or a location ("site") where interpreting
physicians read the mammograms.

**Inspection Demonstration Program** -- as explain in Part II, B.5., FDA
began a demonstration program to inspect some facilities frequently.
These facilities in this demonstration will skip at least one annual
inspection. Since the inspection of these facilities will cover two
years of facility records, rather than one, some the inspection report
statements below will slightly different wording. These inspections can
be identified by having the inspection type of Biennial Inspection in
the inspection detail report.

**Level 1 Observation**

(**Facility requested to respond within 15 working days**)

##  {#section-2 .unnumbered}

## **Accreditation -- 21 CFR 900.4(a), (b), & (c)(4)** {#accreditation-21-cfr-900.4a-b-c4 .unnumbered}

The x-ray system for unit {unit number}, room {room name or number} has
been used clinically for at least a year and is not accredited.

##  {#section-3 .unnumbered}

## **Certification -- 21 CFR 900.11(a)** {#certification-21-cfr-900.11a .unnumbered}

The facility was performing mammography without a valid certificate.

##  {#section-4 .unnumbered}

## **Personnel - 21 CFR 900.12(a)** {#personnel---21-cfr-900.12a .unnumbered}

Failed to produce documents verifying that the interpreting physician
met the initial requirement of being currently licensed to practice
medicine in a State: {name of physician} \[§900.12(a)(1)(i)(A)\].

Failed to produce documents verifying that the interpreting physician
met the initial requirement of being certified in the appropriate
specialty by an FDA-approved board or having 3 months of initial
training in the interpretation of mammograms: {name of physician}
\[§900.12(a)(1)(i)(B)(1) and (2)\].

> **Note:** physicians may be cited for failure to have certification or
> 2 months of training, which was a requirement under
> §900.12(a)(1)(ii)(A) and (B) of the regulations in effect prior to
> April 28, 1999.

Failed to produce documents verifying that the radiologic technologist
met the initial requirement of being currently licensed in a State or
certified by an FDA-approved body: {name of technologist}
\[§900.12(a)(2)(i)(A) and (B)\].

Failed to produce documents verifying that the medical physicist met the
initial requirement of being currently licensed or approved by a State,
or certified by an FDA-approved body to perform physics surveys: {name
of physicist} \[§900.12(a)(3)(i)(A)\].

Failed to produce documents verifying that the medical physicist met the
initial requirement of having a masters degree or higher in a physical
science with at least 20 semester hours of physics: {name of physicist}
\[§900.12(a)(3)(i)(B)\].

Failed to produce documents verifying that the medical physicist met the
initial requirement of being currently licensed or approved by a State,
or certified by an FDA-approved body to perform physics surveys: {name
of physicist} \[§900.12(a)(3)(ii)(A)\].

Failed to produce documents verifying that the medical physicist met the
requirement of having a bachelor\'s degree or higher in a physical
science prior to April 28, 1999: {name of physicist}
\[§900.12(a)(3)(ii)(B)(1)\].

**Equipment - 21 CFR 900.12(b)**

The x-ray system for unit {unit number}, room {room name or number} is
not specifically designed for mammography \[§900.12(b)(2)\].

**Medical Records and Mammography Reports - 21 CFR 900.12(c)**

The system to communicate results is not adequate for {name of site}
because:

-   there is no system in place to provide timely medical reports
    \[§900.12(c)(2)(i) and (3)(i)\].

-   there is no system in place to provide timely lay summaries
    \[§900.12(c)(2)\].

-   there is no system in place to communicate serious or highly
    suggestive cases as soon as possible \[§900.12(c)(3)(ii)\].

    **Quality Assurance---Equipment - 21 CFR 900.12(e)**

Processor QC records were missing {number of days} consecutive days for
processor {name of processor}, room {room name or number} at site {name
of site} \[§900.12(e)(1)\].

**Note:** If the number of consecutive days missing is five or greater,
this is a Level 1 observation.

Processor QC records were missing {number of days} out of {number of
days} days of operation in month {name of month}. Processor QC records
missing {percentage}%, for processor {name of processor}, room {room
name or number} at site {name of site} \[§900.12(e)(1)\].

**Note:** If percentage is equal to or greater than 30 for the worst
month, this is a Level 1 observation.

The processing speed (using the S.T.E.P. procedure) is less than 65 for
standard processing: processor {name of processor}, room {room name or
number} at site {name of site} \[§900.12(e)(1)\].

The processing speed (using the S.T.E.P. procedure) is less than 85 for
extended processing: processor {name of processor}, room {room name or
number} at site {name of site} \[§900.12(e)(1)\].

Mammograms were processed in processor {name of processor}, room {room
name or number} at site {name of site}, when it was out of limits on
{number of days} days \[§900.12(e)(1)(i), (ii), and/or (iii)\].

**Note:** If the number of days out of limits is five or greater, this
is a Level 1 observation.

Phantom QC records were missing for {number of weeks} weeks for unit
{unit number}, room {room name or number} \[§900.12(e)(2)\].

**Note:** If the number of weeks missing is four or greater out of 12,
this is a Level 1 observation.

The phantom image score (using an FDA- approved mammography phantom) is
less than 3 fibers for unit {unit number}, room {room name or number}
\[§900.12(e)(2)(iii)\].

The phantom image score (using an FDA- approved mammography phantom) is
less than 2 masses for unit {unit number}, room {room name or number}
\[§900.12(e)(2)(iii)\].

The phantom image score (using an FDA-approved mammography phantom) is
less than 2 speck groups for unit {unit number}, room {room name or
number} \[§900.12(e)(2)(iii)\].

The average glandular dose (using an FDA-approved mammography phantom)
is 350 mrad or greater (film-screen systems) for unit {unit number},
room {room name or number} \[§900.12(e)(5)(vi)\].

Physicist survey for x-ray unit {unit number}, room {room name or
number} was not conducted in over two years \[§900.12(e)(9)(i)\].

#### Level 2 Observation {#level-2-observation .unnumbered}

(**Facility requested to respond within 30 working days; if repeat, 15
days**)

**Accreditation -- 21 CFR 900.4(a), (b), & (c)(4)**

The x-ray system for unit {unit number}, room {room name or number} is
not accredited.

**Note:** if the x-ray unit has been used for less than one year and is
not accredited, this is a Level 2 observation.

**Personnel - 21 CFR 900.12(a)**

Failed to produce documents verifying that the interpreting physician
met the initial requirement of having 60 hours of medical education in
mammography: {name of physician} \[§900.12(a)(1)(i)(C)\].

**Note:** physicians may be cited for failure to have 40 CME credit
hours of initial training in mammography, which was a requirement under
§900.12(a)(1)(ii)(C) of the regulations in effect prior to April 28,
1999.

Failed to produce documents verifying that the interpreting physician
met the initial experience requirement of having interpreted or
multi-read 240 mammograms in 6 months: {name of physician}
\[§900.12(a)(1)(i)(D)\].

Failed to produce documents verifying that the interpreting physician
met the continuing experience requirement of having interpreted or
multi-read 960 mammograms in 24 months: {name of physician}
\[§900.12(a)(1)(ii)(A)\].

Failed to produce documents verifying that the interpreting physician
met the continuing education requirement of having taught or completed
at least 15 category 1 continuing education units in mammography in 36
months: {name of physician} \[§900.12(a)(1)(ii)(B)\].

Failed to produce documents verifying that the interpreting physician
met the requirement of having 8 hours of training in the new
mammographic modality: {name of physician} \[§900.12(a)(1)(ii)(C)\].

Failed to produce documents verifying that the radiologic technologist
met the initial requirement of having 40 contact hours training specific
to mammography: {name of technologist} \[§900.12(a)(2)(ii)\].

**Note:** technologists may be cited for failure to have specific
mammography training, which was a requirement under
§900.12(a)(2)(iii)(A) of the regulations in effect prior to April 28,
1999.

Failed to produce documents verifying that the radiologic technologist
met the continuing education requirement of having taught or completed
at least 15 continuing education units in mammography in 36 months:
{name of technologist} \[§900.12(a)(2)(iii)(A)\].

Failed to produce documents verifying that the radiologic technologist
met the requirement of having 8 hours of training in each mammographic
modality: {name of technologist} \[§900.12(a)(2)(iii)(E)\].

Failed to produce documents verifying that the radiologic technologist
met the continuing experience requirement of having performed 200
mammography examinations in 24 months: {name of technologist}
\[§900.12(a)(2)(iv)(A)\].

**Note:** radiologic technologists will not be evaluated for this until
4/28/2001, when 24 months have passed since this requirement took
effect.

Failed to produce documents verifying that the medical physicist met the
initial requirement of having 20 contact hours of documented specialized
training in conducting surveys of mammography facilities: {name of
physicist} \[§900.12(a)(3)(i)(B)(2)\].

Failed to produce documents verifying that the medical physicist met the
initial requirement of having the experience of conducting surveys of at
least 1 mammography facility and a total of at least 10 mammography
units: {name of physicist} \[§900.12(a)(3)(i)(B)(3)\].

Failed to produce documents verifying that the medical physicist met the
alternative initial requirement of having, prior to April 28, 1999 and
after fulfilling the degree requirement, 40 contact hours of documented
specialized training in conducting surveys of mammography facilities:
{name of physicist} \[§900.12(a)(3)(ii)(B)(2)\].

Failed to produce documents verifying that the medical physicist met the
alternative initial requirement of having, prior to April 28, 1999, and
after fulfilling the degree requirement, the experience of conducting
surveys of at least 1 mammography facility and a total of at least 20
mammography units: {name of physicist} \[§900.12(a)(3)(ii)(B)(3)\].

Failed to produce documents verifying that the medical physicist met the
continuing education requirement of having taught or completed at least
15 continuing education units in mammography in 36 months: {name of
physicist} \[§900.12(a)(3)(iii)(A)\].

Failed to produce documents verifying that the medical physicist met the
continuing experience requirement of having surveyed at least 2
mammography facilities and a total of at least 6 mammography units in 24
months: {name of physicist} \[§900.12(a)(3)(iii)(B)\].

**Note:** medical physicists will not be evaluated for this until
4/28/2001, when 24 months have passed since this requirement took
effect.

Failed to produce documents verifying that the medical physicist met the
requirement of having 8 hours of training in surveying units of the new
mammographic modality: {name of physicist} \[§900.12(a)(3)(iii)(C)\].

**Equipment - 21 CFR 900.12(b)**

The x-ray system for unit {unit number}, room {room name or number} does
not include the following:

-   Image receptors for 2 sizes \[§900.12(b)(4)(i)\].

-   Moving grids for 2 sizes \[§900.12(b)(4)(ii)\].

-   Post-exposure display in AEC mode (for focal spot)
    \[§900.12(b)(7)(iii)\].

-   Post-exposure display in AEC mode (for target material)
    \[§900.12(b)(7)(iii)\].

-   Compression paddles for 2 sizes \[§900.12(b)(8)(ii)(A)\].

    **Medical Records and Mammography Reports - 21 CFR 900.12(c)**

{any number up to 10} of {5 or 10} random reports reviewed did not have
identification of a qualified interpreting physician for site {name of
site} \[§900.12(c)(1)(iii)\].

> **Note:** Any number from one to the maximum reviewed without an
> identification of a qualified interpreting physician is a Level 2
> observation.

{any number up to 10} of {5 or 10} random reports reviewed did not
contain an assessment category for site {name of site}
\[§900.12(c)(1)(iv)\].

> **Note:** Any number from one to the maximum reviewed without an
> assessment category is a Level 2 observation.

**Quality Assurance---Equipment - 21 CFR 900.12(e)**

Processor QC records were missing {number of days} consecutive days for
processor {name of processor}, room {room name or number} at site {name
of site} \[§900.12(e)(1)\].

**Note:** If the number of consecutive days missing is two, three, or
four, this is a Level 2 observation.

Processor QC records were missing {number of days} out of {number of
days} days of operation in month {name of month}. Processor QC records
missing {percentage}%, for processor {name of processor}, room {room
name or number} at site {name of site} \[§900.12(e)(1)\].

**Note:** If percentage is less than 30, but greater than or equal to 10
for the worst month, this is a Level 2 observation.

The processing speed (using the S.T.E.P. procedure) is greater than or
equal to 65, but less than 80 standard processing: processor {name of
processor}, room {room name or number} at site {name of site}
\[§900.12(e)(1)\].

The processing speed (using the S.T.E.P. procedure) is greater than or
equal to 85, but less than 100 for extended processing: processor {name
of processor}, room {room name or number} at site {name of site}
\[§900.12(e)(1)\].

Mammograms were processed in processor {name of processor}, room {room
name or number} at site {name of site}, when it was out of limits on
{number of days} days \[§900.12(e)(1)(i), (ii), and/or (iii)\].

**Note:** If the number of days out of limits is two, three, or four,
this is a Level 2 observation.

Corrective actions for processor QC failures were not documented at
least once for processor {name of processor}, room {room name or number}
at site {name of site} \[§900.12(e)(8)(ii) with reference to
§900.12(e)(1)(i), (ii), and/or (iii)\].

Phantom QC records were missing for {number of weeks} weeks for unit
{unit number}, room {room name or number} \[§900.12(e)(2)\].

**Note:** If the number of weeks missing is two or three out of 12, this
is a Level 2 observation.

The phantom QC is not adequate for unit {unit number}, room {room name
or number} because:

-   The image was not taken at clinical setting \[§900.12(e)(2)(i)\].

-   The background density was \< 1.20 \[§900.12(e)(2)(i)\].

Corrective action for a failing image score (before further exams) was
not documented for unit {unit number}, room {room name or number}
\[§900.12(e)(8)(ii) with reference to §900.12(e)(2)(iii)\].

The measured fog density is equal to {darkroom fog density} for darkroom
{room name or number} at site {name of site} \[§900.12(e)(4)(i)\].

**Note:** If the darkroom fog density is equal to or greater than 0.10,
this is a Level 2 observation.

The medical physicist\'s survey for x-ray unit {unit number}, room {room
name or number} is incomplete because the following tests were not done:

-   No AEC performance capability \[§900.12(e)(5)(i)\]

```{=html}
<!-- -->
```
-   Test not done for 2, 4, and 6 cm phantom thicknesses at typical
    kVp(s) \[§900.12(e)(5)(i)(A)\]

-   Numerical results were not given \[§900.12(e)(9)(ii)\]

```{=html}
<!-- -->
```
-   No focal spot size/resolution measurement \[§900.12(e)(5)(iii)\]

```{=html}
<!-- -->
```
-   Test not done for all clinically used focal spots
    \[§900.12(e)(5)(iii)\].

```{=html}
<!-- -->
```
-   Numerical results were not given \[§900.12(e)(9)(ii)\].

```{=html}
<!-- -->
```
-   No AEC performance -- Reproducibility \[§900.12(e)(5)(v)\]

```{=html}
<!-- -->
```
-   Numerical results were not given \[§900.12(e)(9)(ii)\].

```{=html}
<!-- -->
```
-   Average glandular dose \[§900.12(e)(5)(vi)\]

```{=html}
<!-- -->
```
-   Exp. & HVL measurements at same clinical kVp \[§900.12(e)(5)(vi)\].

-   Did not use an FDA-approved phantom (or equivalent) dose
    \[§900.12(e)(5)(vi)\].

```{=html}
<!-- -->
```
-   Numerical results were not given \[§900.12(e)(9)(ii)\]

```{=html}
<!-- -->
```
-   No artifact evaluation \[§900.12(e)(5)(ix)\].

-   No phantom image \[§900.12(e)(9)(i) with reference to
    §900.12(e)(2)\]

```{=html}
<!-- -->
```
-   Test not done at the kVp normally used clinically \[§900.12(e)(9)(i)
    with reference to §900.12(e)(2)(i)\].

-   Did not use an FDA-approved phantom (or equivalent)
    \[§900.12(e)(9)(i) with reference to §900.12(e)(2)\].

-   Less than 3 object scores were given \[§900.12(e)(9)(i) with
    reference to §900.12(e)(2)(iii)\].

```{=html}
<!-- -->
```
-   No QC test - new modalities \[§900.12(e)(9)(i) with reference to §
    900.12(e)(6)\].

Manufacturer recommended QC procedures were not followed for digital
unit {unit number}, room {room name or number} \[§900.12(e)(6)\].

Monitor QC was not done per manufacturer\'s recommendation for digital
unit {unit number}, room {room name or number} \[§900.12(e)(6)\].

Manufacturer recommended procedures for laser film or other display
method were not used for digital unit {unit number}, room {room name or
number} \[§900.12(e)(6)\].

Performance verification test was not conducted after each move for
mobile unit {unit number}, room {room name or number} \[§900.12(e)(7)\].

Physicist survey report for x-ray unit {unit number} in room {room name
or number} was not conducted within 14 months \[§900.12(e)(9)(i)\].

The time period between the previous and current surveys for x-ray unit
{unit number} exceeds 14 months \[§900.12(e)(9)(i)\].

The person who conducted or supervised the survey for x-ray unit {unit
number}, room {room name or number} is not identified in the report
\[§900.12(e)(9)(v)\].

The mammography equipment evaluation (by a medical physicist) for unit
{unit number}, room {room name or number} or related processor was not
done \[§900.12(e)(10)\].

There is no written procedure for infection control at site {name of
site} \[§900.12(e)(13)\].

### **Quality Assurance-Mammography Medical Outcomes Audit -- 21 CFR 900.12(f)** {#quality-assurance-mammography-medical-outcomes-audit-21-cfr-900.12f .unnumbered}

There were no examples of nor attempts to get biopsy results for site
{name of site} \[§900.12(f)(1)\].

Not all positive mammograms were entered in the tracking system for site
{name of site} \[§900.12(f)(1)\].

There was no designated reviewing interpreting physician for site {name
of site} \[§900.12(f)(3)\].

Medical audit and outcome analysis was not done for the facility as a
whole at site {name of site} \[§900.12(f)(1)\]

Medical audit and outcome analysis was not done separately for each
individual at site {name of site} \[§900.12(f)(2)\]

Medical audit and outcome analysis was not performed annually at site
{name of site} \[§900.12(f)(2)\]

**Consumer Complaint Mechanism -- 21 CFR 900.12(h)**

There is no written procedure for handling consumer complaints at site
{name of site} \[§900.12(h)(3)\].

#### Level 3 Observation {#level-3-observation .unnumbered}

(**No response requested. Will be checked at next inspection;**

**except for repeat Level 3 -- response within 30 working days)**

**Display of Certificate - 42 USC 263b(b)(1)(A)(iii)** -- this is a
statutory requirement. There is no specific regulation for the display
of the certificate.

The MQSA certificate was not displayed.

**Personnel - 21 CFR 900.12(a)**

The required personnel qualification documents were unavailable during
the inspection \[§900.12(a)(4)\].

**Quality Assurance \-- General - 21 CFR 900.12(d)**

The QA program is inadequate. For {name of site} the missing or
incomplete item(s) are listed below:

-   Personnel responsibilities \[§900.12(d)(2)\].

-   QC test procedures \[§900.12(d)(2)\].

-   Current technique tables/charts \[§900.12(d)(2)\].

    **Quality Assurance---Equipment - 21 CFR 900.12(e)**

The fixer retention QC is not adequate for {name of processor}, room
{room name or number} at site {name of site}. The missing or incomplete
item(s) are listed below:

-   The fixer retention QC records were not done at the required
    frequency \[§900.12(e)(3)(i)\].

-   Corrective action was not documented at least once
    \[§900.12(e)(8)(ii) with reference to §900.12(e)(3)(i)\].

The repeat analysis QC is not adequate for site {name of site} because:

-   QC was not done at the required frequency \[§900.12(e)(3)(ii)\].

-   There was no evaluation done when the number of repeats/rejects
    exceeded 2% (either plus or minus) \[§900.12(e)(3)(ii)\].

-   Corrective action within 30 days was not documented
    \[§900.12(e)(8)(ii) with reference to §900.12(e)(3)(ii)\].

The measured fog density is equal to {darkroom fog density} for darkroom
{room name or number} at site {name of site} \[§900.12(e)(4)(i)\].

**Note:** If the darkroom fog density is 0.07, 0.08, or 0.09, this is a
Level 3 observation.

The darkroom fog QC is not adequate for darkroom {room name or number}
at site {name of site} because:

-   The QC records were not done at the required frequency
    \[§900.12(e)(4)(i)\].

-   The background density was \< 1.20 \[§900.12(e)(4)(i)\].

-   Corrective action (before using the failed darkroom for further
    exams) was not documented at least once \[§900.12(e)(8)(ii) with
    reference to §900.12(e)(4)(i)\].

The screen-film contact QC is not adequate for site {name of site}
because:

-   QC was not done at the required frequency \[§900.12(e)(4)(ii)\].

-   Not all mammography cassettes in use were tested
    \[§900.12(e)(4)(ii)\].

-   The 40-mesh copper test tool was not used \[§900.12(e)(4)(ii)\].

-   Corrective action (before using the failed cassette(s) for further
    exams) was not documented at least once \[§900.12(e)(8)(ii) with
    reference to §900.12(e)(4)(ii)\].

Compression device QC is not adequate for unit {unit number}, room {room
name or number} because:

-   QC was not done at the required frequency \[§900.12(e)(4)(iii)\].

-   Corrective action (before further exams) was not documented at least
    once \[§900.12(e)(8)(ii) with reference to §900.12(e)(4)(iii)\].

The half value layer (HVL) of the x-ray beam (in units of mm Al) is less
than {value based on selected kVp value divided by 100} for unit {unit
number}, room {room name or number} \[§900.12(e)(5)(iv)\].

The coefficient of variation (COV) for exposure reproducibility is
greater than 0.05 for unit {unit number}, room {room name or number}
\[§900.12(e)(5)(v)\].

The x-ray field does not extend to the edge of the image receptor on the
chest wall side for unit {unit number}, room {room name or number}
\[§900.12(e)(5)(vii)(A)\].

The chest wall side of the x-ray field extends beyond the chest wall
edge of the image receptor by more than 2% of the SID for unit {unit
number}, room {room name or number} \[§900.12(e)(5)(vii)(A)\].

The {right/left/nipple} side of the x-ray field extends beyond the
{right/left/nipple} edge of the image receptor by more than 2% of the
SID for unit {unit number}, room {room name or number}
\[§900.12(e)(5)(vii)(A)\].

The chest wall edge of the compression paddle is visible on the test
image for unit {unit number}, room {room name or number}
\[§900.12(e)(5)(vii)(C)\].

The chest wall edge of the compression paddle extends beyond the chest
wall edge of the image receptor by more than 1% of SID for unit {unit
number}, room {room name or number} \[§900.12(e)(5)(vii)(C)\].

The medical physicist\'s survey for x-ray unit {unit number}, room {room
name or number} is incomplete because the following tests were not done
(§900.12(e)(9)):

-   No kVp accuracy \[§900.12(e)(5)(ii)(A)\]

```{=html}
<!-- -->
```
-   Test not done at all clinically important kVp\'s
    \[§900.12(e)(5)(ii)(A)\].

-   Numerical results were not given \[§900.12(e)(9)(ii) \].

```{=html}
<!-- -->
```
-   No kVp Reproducibility \[§900.12(e)(5)(ii)(B)\]

```{=html}
<!-- -->
```
-   Test were not done at the kVp normally used clinically
    \[§900.12(e)(5)(ii)(B)\].

-   Numerical results were not given \[§900.12(e)(9)(ii)\].

```{=html}
<!-- -->
```
-   No beam quality (HVL) measurement \[§900.12(e)(5)(iv)\]

```{=html}
<!-- -->
```
-   Test not done at the kVp normally used clinically
    \[§900.12(e)(5)(iv)\].

```{=html}
<!-- -->
```
-   Numerical results were not given \[§900.12(e)(9)(ii)\].

```{=html}
<!-- -->
```
-   No collimation \[§900.12(e)(5)(vii)\]

```{=html}
<!-- -->
```
-   No x-ray field - image receptor alignment \[§900.12(e)(5)(vii)(A)\].

-   No x-ray field - light field alignment \[§900.12(e)(5)(vii)(B)\].

-   No compression device edge alignment \[§900.12(e)(5)(vii)(C)\].

```{=html}
<!-- -->
```
-   No uniformity of screen speed \[§900.12(e)(5)(viii)\]

```{=html}
<!-- -->
```
-   Numerical results were not given \[§900.12(e)(9)(ii)\].

```{=html}
<!-- -->
```
-   No radiation output \[§900.12(e)(5)(x)\].

-   No decompression \[§900.12(e)(5)(xi)\].

-   No evaluation of the Technologist\'s QC tests \[§900.12(e)(9)(ii)\]

```{=html}
<!-- -->
```
-   No processor QC \[§900.12(e)(9)(ii) with reference to
    §900.12(e)(1)\].

-   No phantom images \[§900.12(e)(9)(ii) with reference to
    §900.12(e)(2)\].

-   No analysis of fixer retention \[§900.12(e)(9)(ii) with reference to
    §900.12(e)(3)(i)\].

-   No repeat analysis \[§900.12(e)(9)(ii) with reference to
    §900.12(e)(3)(ii)\].

-   No darkroom fog \[§900.12(e)(9)(ii) with reference to
    §900.12(e)(4)(i)\].

-   No screen-film contact \[§900.12(e)(9)(ii) with reference to
    §900.12(e)(4)(ii)\].

-   No compression \[§900.12(e)(9)(ii) with reference to
    §900.12(e)(4)(iii)\].

```{=html}
<!-- -->
```
-   No pass/fail list \[§900.12(e)(9)(iii)\].

-   No recommendations for failed items were given
    \[§900.12(e)(9)(iii)\].

Corrective action was not taken when called for in the medical
physicist\'s survey report for unit {unit number}, room {room name or
number} \[§900.12(e)(8)(ii)\].

[]{#ATTACHMENTF .anchor}Attachment F

**GUIDANCE FOR EVALUATING**

**A FACILITY RESPONSE**

**Facility Responses and Follow-Up Inspections**

You will find additional guidance on facility responses is provided in
section A. 1. c. of Part V. Since the adequacy of the facility response
may trigger a Warning Letter or follow-up inspection, you should also
review section A. 2. in Part V on Warning Letters and section B. in Part
III on compliance and follow-up inspections.

**Evaluating a Facility Response**

You will find that most facilities will respond to the inspections
observations and provide adequate information. In those cases where
information is missing, a phone call or follow-up letter may resolve the
situation.

A facility response should include all of the following items:

1.  How the facility has corrected or plans to correct the problems
    observed

```{=html}
<!-- -->
```
1.  The date(s) corrections will take place, if the facility hasn't
    corrected all of the problems when it responds

2.  How the facility will prevent recurrence of the problems

3.  For problems involving equipment, equipment test results, including
    equipment settings and technique factors, raw test data, and
    calculated final results

4.  If the observations relate to quality control or other records,
    sample records showing compliant recordkeeping (patient names or
    identification should be omitted from any copies of records
    submitted)

5.  For personnel qualifications, one of the following:

    a.  documentation that the personnel meet the requirements,

    b.  an indication that the personnel are no longer providing
        mammography services at the facility (services would be defined
        as interpreting physicians reading and interpreting mammograms,
        radiologic technologists performing mammography, or medical
        physicists conducting medical physicist surveys)

    c.  an indication that personnel have been placed under the direct
        supervision of a qualified physician, technologist, or
        physicist, as appropriate.

```{=html}
<!-- -->
```
1.  For Level 1 observations for a mammography x-ray unit, it needs to
    be brought into compliance before it can be used for mammograms. For
    a film processor, it must be brought into compliance before
    mammograms are processed. For Level 2 observations under
    21 CFR 900.12(b), the facility does not have to stop using the
    equipment immediately, but needs to correct the problem in a timely
    manner. "In a timely manner" might mean within 30 days, but longer
    if parts must be ordered or a new x-ray unit or processor must be
    installed. For Level 2 observations under 21 CFR 900.12(e), consult
    §900.12(e)(8)(ii) for additional information on when the facility
    must take corrective action.

> **NOTE: If the x-ray system noncompliance is a manufacturer or
> assembly problem, refer to CP 7382.003.**

**Facility Responses from Facilities with Violative Histories**

If the facility has a violative history, facility management may find it
difficult to provide convincing evidence that problems are permanently
corrected. If the facility's response contains promises of corrections
similar to previous inspections, you should consider it inadequate and
schedule a follow-up inspection before sending a Warning Letter.

**Inspection Observations Disputed by Facility**

If a facility disputes inspection observations and believes that the
inspection report is incorrect, the district should work with the
inspector to resolve the dispute. If the inspector works with the State,
the district should consult with the RRHR. For guidance on disputed
observations, go the Policy Guidance Help System at
<http://www.fda.gov/CDRH/MAMMOGRAPHY/robohelp/START.HTM> (check under
Inspection/Report/Inspection Findings Disputed by Facilities).

**Assistance with Facility Responses**

If the district would like assistance when evaluating facility
responses, it should refer to Attachment A for contacts.

## Attachment G {#attachment-g .unnumbered}

## **Guidance for Additional Mammography Review (AMR)** {#guidance-for-additional-mammography-review-amr .unnumbered}

#  {#section-5 .unnumbered}

FDA may require AMR to see if the mammography quality at a facility may
present a "serious risk to human health" (21 CFR 900.12(j)) The term
"mammography quality" encompasses all aspects of quality related to the
production and interpretation of a mammogram. This may include aspects
of the clinical image quality as well as other issues related to
quality. Examples of reasons to require an AMR are:

1.  **Inspection observations**

```{=html}
<!-- -->
```
A.  Level 1 phantom image failure

####  B. Interpreting physician {#b.-interpreting-physician .unnumbered}

1\. Medical license: never licensed to practice medicine in a State

2\. Does not have board certification or the required initial
mammography training (2 or 3 months)

**Note: For guidance on items A and B above, go to the Policy Guidance
Help System at**
<http://www.fda.gov/CDRH/MAMMOGRAPHY/robohelp/START.HTM>**.**

C. A combination of inspection observations, which results in a
reasonable probability that mammography quality has been seriously
compromised and may represent a serious risk to human health.

1.  **Other**

```{=html}
<!-- -->
```
A.  A combination of observations from various sources (inspections,
    complaints, interpreting physicians, etc.) which results in a
    reasonable probability that mammography quality has been seriously
    compromised and may represent a serious risk to human health.

B. Investigations of allegations or complaints that indicate a
reasonable probability exists that mammography quality has been
seriously compromised and may represent a serious risk to human health.
Under this category, FDA can require AMR without documented violations
of MQSA.

###### C. Uncertified facility {#c.-uncertified-facility .unnumbered}

If a facility had performed mammography without a certificate for at
least 90 days, FDA may require AMR.

D.  Clinical image review by an accreditation body

> If an accreditation body, during a review of mammograms for
> accreditation, reaccreditation, or for any other reason, finds that
> the quality of mammography may represent a serious risk to human
> health, this body should notify FDA within two working days. Based on
> this information, FDA may require AMR.

**Note: An AMR may be performed regardless of whether a regulatory
action will or will not be taken by the agency.**

[]{#ATTACHMENTH .anchor}Attachment H

> **Follow-Up for MQSA Inspections**
>
> ![](media/image2.wmf)
>
> []{#ATTACHMENTI .anchor}Attachment I

**(MQSA Inspection Violations Letter**)

### WARNING LETTER {#warning-letter .unnumbered}

{Date}

**Certified Mail {or Overnight Mail}**

**Return Receipt Requested**

Re: MQSA Inspection ID \# \_\_\_\_\_\_\_\_\_\_\_\_\_

> FEI# \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ {optional}

Name of responsible individual

Name of facility

Address

Dear \_\_\_\_\_\_\_:

On \_\_\_\_\_\_\_\_, a representative of the State/Commonwealth of
\_\_\_\_\_\_\_, acting on behalf of the Food and Drug Administration
(FDA) {or, if the inspection is conducted by FDA, replace with "a
representative of the Food and Drug Administration (FDA)"} inspected
your facility. This inspection revealed a serious problem involving the
conduct of mammography at your facility. Under the Mammography Quality
Standards Act of 1992 ("MQSA"), which is codified in Section 263b of
Title 42 of the United States Code (USC)**,** your facility must meet
specific requirements to practice mammography. These requirements help
protect the health of women by assuring that a facility can perform
quality mammography.

The inspection revealed a violation(s) of the MQSA at your facility.
This violation was {These violations were} noted on the MQSA Facility
Inspection Report and the document *"Important Information about Your
MQSA Inspection"* that the inspector {left with {Name of Person} at your
facility at the close of the inspection {on date (if different from
inspection date) or mailed to your facility on {Date}}. The violation(s)
is/are again identified below.

**{List here 1) repeat Level 1 observations; 2) Level 1 observations; 3)
repeat Level 2 observations; 4) Level 2 observations; and 5) other less
serious violations you believe should be noted. Each violation should
include the parallel statement from the MQSA Facility Inspection Report
and a specific citation to the appropriate part of 21 CFR Part 900}**

> *Example***: Level 1:** Processor Quality Control records were missing
> for \[number of days\] consecutive days from {start date for missing
> days} to {end date for missing days} for {name of} processor, room
> {name or number}, at {name of site}. \[See 21 CFR 900.12(e)(1)\].
>
> *Example***: Level 1:** The system to communicate results is not
> adequate for {name of site} because there is no system in place to
> communicate cases that are "suspicious" or "highly suggestive of
> malignancy" to the relevant health care provider(s) as soon as
> possible \[see 21 CFR 900.12(c)(3)(ii))\]
>
> *Example***: Level 2:** Failed to produce documents verifying that the
> interpreting physician met the continuing education requirement of
> having taught or completed at least 15 category 1 continuing education
> units in mammography in 36 months: {name of physician} \[see 21 CFR
> 900.12(a)(1)(ii)(B)\].
>
> *Example***: Level 2:** The x-ray system for unit {**unit number**},
> room {**room name or number**} does not include different sized
> compression paddles that match the size of all full-field image
> receptors provided for the system. \[see 21 CFR 900.12(b)(8)(ii)(A)\].

**{Insert one of the following two paragraphs, as appropriate:}** You
have failed to respond to the MQSA Facility Inspection Report as
requested in the document "Important Information about your MQSA
Inspection" and failed to respond to additional communication attempts
by our office on {Dates}. **OR** On **{date}** we received your response
to the MQSA Facility Inspection Report. Your response was inadequate in
that **{insert explanation, at least in general terms, of why response
is considered inadequate}.** Subsequent communication with our office on
{Dates} failed to resolve the violation(s).

**{Insert highlighted section if a follow-up inspection was
performed:}** On \_\_\_\_\_\_\_\_, a representative of the Food and Drug
Administration (FDA) performed an MQSA follow-up inspection of your
facility. This MQSA follow-up inspection revealed that your facility
failed to correct the violation(s) identified below.

> **{List here 1) repeat Level 1 observations; 2) Level 1 observations;
> 3) repeat Level 2 observations; 4) Level 2 observations; and 5) other
> less serious violations you believe should be noted. Each violation
> should include the parallel statement from the MQSA Facility
> Inspection Report and a specific citation to the appropriate part of
> 21 CFR Part 900}**
>
> *Example***: Level 1:** Processor Quality Control records were missing
> for \[number of days\] consecutive days from {start date for missing
> days} to {end date for missing days} for {name of} processor, room
> {name or number}, at {name of site}. \[See 21 CFR 900.12(e)(1)\].
>
> *Example***: Level 1:** The system to communicate results is not
> adequate for {name of site} because there is no system in place to
> communicate cases that are "suspicious" or "highly suggestive of
> malignancy" to the relevant health care provider(s) as soon as
> possible \[see 21 CFR 900.12(c)(3)(ii))\]
>
> *Example***: Level 2:** Failed to produce documents verifying that the
> interpreting physician met the continuing education requirement of
> having taught or completed at least 15 category 1 continuing education
> units in mammography in 36 months: {name of physician} \[see 21 CFR
> 900.12(a)(1)(ii)(B)\].

Because the continued failure to resolve this (these) violation(s) may
be indicative of serious underlying problems that could compromise the
quality of mammography at your facility, FDA may take additional
actions, including, but not limited to, the following:

-   requiring your facility to undergo an Additional Mammography Review

-   placing your facility under a Directed Plan of Correction

-   charging your facility for the cost of on-site monitoring

-   requiring your facility to notify patients who received mammograms
    at your facility, and their referring physicians, of the
    deficiencies, the potential harm resulting from such deficiencies,
    appropriate remedial measures, and other relevant information
    **{only include this item if the violation(s) listed in the letter
    satisfy the standard in the statute (42 USC 263b(h)(2)) -- namely
    the "quality of mammography performed by a facility (whether or not
    certified pursuant to subsection (c)) was so inconsistent with the
    quality standards established pursuant to subsection (f) as to
    present a significant risk to individual or human health"}**

-   seeking civil money penalties up to \$10,000 for each failure to
    substantially comply with, or each day of failure to substantially
    comply with, MQSA standards

-   seeking to suspend or revoke your facility's FDA certificate

-   seeking a court injunction against your facility **{only include
    this item if the violation(s) listed in the letter satisfy the
    requirement of the statute (42 USC 263b(j)) -- namely, that
    continued failure to correct it "would constitute a serious risk to
    human health" or if the facility is performing mammography without a
    certificate}**

See 42 USC 263b(h)-(j) and 21 CFR 900.12(j).

FDA may need to perform a Compliance Follow-up Inspection to determine
that each problem at your facility has been corrected.

You should respond in writing to FDA within fifteen (15) working days
from the date you received this letter. Your response should address the
findings listed above and include:

1.  the specific steps you have taken, or will take, to correct all of
    the violations noted in this letter, including projected timeframes
    for implementing those steps;

```{=html}
<!-- -->
```
1.  the specific steps you have taken, or will take, to prevent the
    recurrence of similar violations, including projected timeframes for
    implementing those steps;

2.  {**this item should only be included if one of the observations
    listed above is equipment failure**} equipment settings (including
    technique factors), raw test data, and calculated final results;

3.  {**this item should only be included if one of the observations
    listed above relate to Quality Control or other record problems**}
    sample records that demonstrate proper record keeping procedures;
    {**add the following note if the observations relates to patient
    records**: **Note: Patient names or other information that would
    likely reveal the patient's identity should be deleted from any
    copies of records you submit**}

Please submit your response to this letter to:

> {insert name, address, phone number, and fax number here}

Please send a copy of your response to:

> State of \_\_\_\_\_\_\_\_ {radiation control office}
>
> {street address}
>
> {city, state, zip code}

Finally, you should understand that there are many requirements
pertaining to mammography. This letter pertains only to violations
related to the recent inspection(s) of your facility and does not
necessarily address other obligations you have under the law. You may
obtain general information about all of FDA's requirements for
mammography facilities by contacting the Mammography Quality Assurance
Program, Food and Drug Administration, P.O. Box 6057, Columbia, MD
21045-6057 (1-800-838-7715) or through the Internet at
http://www.fda.gov/cdrh/mammography/index.html.

If you have additional or more specific questions about mammography
facility requirements, or about the content of this letter, please feel
free to contact {name} at {phone number}.

> Sincerely yours,
>
> District Director

cc:

State of \_\_\_\_\_\_\_\_ {radiation control office}

{street address}

{city, state, zip code}

If facility is ACR accredited:

Priscilla F. Butler, M.S., FAAPM

Director, Breast Imaging Accreditation Programs,

American College of Radiology

1891 Preston White Drive

Reston, Virginia 22091

If the facility is accredited by the State of Arkansas:

Jonathon Bibb

Radioactive Materials & Mammography Section

Div. of Radiation Control & Emergency Mgmt.

Arkansas Department of Health

4815 W. Markham, Slot 30

Little Rock, Arkansas 72205-3867

If the facility is accredited by the State of Texas:

Kaye J. Goss-Terry, RT(R)(M)

Mammography Certification and

Accreditation Program Manager

Texas Department of Health

Bureau of Radiation Control

1100 West 49^th^ Street

Austin, Texas 78756-3189

bcc:

HFA-224

HFC-130

HFC-210

HFC-230

HFI-35 (redacted copy for public display)

HFR - (Regional Director)

HFR - (District Director)

HFR - (District Compliance Branch)

Revised -- 7/31/2003

Attachment J []{#ATTACHMENTJ .anchor}

(**Adequate Response Letter to Facility**)

\[Date\]

Name of responsible individual

Name of facility

Address

## Re: MQSA Inspection ID \# \_\_\_\_\_\_\_\_\_\_\_\_\_

Dear [(Addressee)]{.underline} :

Your facility was inspected on [insert date of inspection
here]{.underline} by a representative \[{from the State of [state name
and name of state radiation control program]{.underline} under contract
to the Food and Drug Administration} or {of the Food and Drug
Administration}\]. This inspection revealed that your facility failed to
comply with the Quality Standards for Mammography (Standards) as
specified in 42 U.S.C. 263b(f) and Title 21, [Code of Federal
Regulations]{.underline} (CFR), Section 900.12.

On [insert date of facility response here]{.underline} , you responded
by letter to the noncompliances found during the inspection \[ {for
situations where letters are sent} as referenced in the Warning Letter
dated [date of letter]{.underline} \]. Based on your response, your
facility has now met the annual MQSA inspection requirement. The
corrective action you have implemented will be evaluated during your
next inspection.

Sincerely yours,

\[name and title of district official\]

District Office

cc:

State of \_\_\_\_\_\_\_\_ \[radiation control office\]

\[street address\]

\[city, state, zip code\]

bcc:

HFA-224

(district office)

[]{#ATTACHMENTK .anchor}Attachment K

Sample Inspection Report

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

MQSA Facility Inspection Report

Inspection ID: 1234560009

FEI: 1000514118

Inspection Date: 12/19/2002

Print Date: 12/19/2002 18:08

Facility:

Rockville Radiology, P.C.

5588 Western Hills Road

Suite A

Rockville, NY 13088

Facility Accreditation Contact:

Martin J. Chuzzlewit, M.D.

Phone: (315) 555-2829

Facility Inspection Contact:

Belinda Cratchit, R.T.

Mammo Co-ordinator

Phone: (315) 555-2000

Compliance Contact:

Martin J. Chuzzlewit, M.D.

Director, Radiology Services

Phone: (315) 555-2000

Lead Interpreting Physician: MARTIN CHUZZLEWIT

\[Equipment Test Results\]

Unit number: 2

Room name or number: Mammography Room

X-Ray unit still in use? Yes

Manufacturer - model: Acme Medical Systems Inc. - MARK V

Medical physicist\'s survey date: 06/29/2002

Image receptor type: Film Screen

X-Ray Tests:

Calculated dose (phantom) = 172

Reproducibility coefficient

of variation (3 cassettes) = 0.026

Beam quality: HVL (@ 25 kVp) = 0.353

Phantom Image 1

Number of fibers = 4

Number of speck groups = 3.5

Number of masses = 4

\[Processor STEP Test\]

Processor number: 0000000001 Processing Speed = 99 (Normal)

Manufacturer: Acme Site: Rockville Radiology, P.C.

Model: 2500 Room: Dark Room

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

Post Inspection Report Page 1 Inspection: 1234560009

Printed: 12/19/2002 6:08:28 PM FEI: 1000514238

POST INSPECTION REPORT

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\[Darkroom Fog Test\]

Room: Dark Room Fog OD = 0

Site: Rockville Radiology, P.C.

\[List of Observations\]

Noncompliance Level: 1

Mammograms were processed in processor 0000000001, Acme, 2500, room Dark

Room at site Rockville Radiology, P.C., when it was out of limits on at
least 5

days

Noncompliance Level: 2

> Corrective actions for processor QC failures were not documented at
> least once for processor 0000000001, Acme, 2500, room Dark Room at
> site Rockville Radiology, P.C.
>
> The time period between the previous and current surveys for x-ray
> unit 2, Acme Medical Systems Inc., Mark V exceeds 14 months

Noncompliance Level: 3

The repeat analysis QC is not adequate for site Rockville Radiology,
P.C.

because:

> \- There was no evaluation done when the change in the number of
> repeats/rejects exceeded 2 (either plus or minus)

\[Inspector Remarks\]

1.  Processor Performance QC

> Mammograms were processed on May 11-12 and 15-17 when out of limits
> without corrective action.

4.  Repeat Analysis QC

> The analysis done on 4/5/2002 had 7% repeats while the 7/10/2002
> analysis had 12% repeats. No documented evaluation was done to
> determine cause or any evidence of corrective action.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

Post Inspection Report Page 2 Inspection: 1234560009

Printed: 12/19/2002 6:08:28 PM FEI: 1000514238

POST INSPECTION REPORT

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

Inspection conducted by: SETH PECKSNIFF (I1001)

Name of state or district office: New York

Address:

Telephone: (315) 555-7649

Signature of inspector:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

If your facility is certified by FDA and you have any comments regarding
the

conduct of this inspection or the findings, you may contact FDA\'s
facility

Hotline at 1-800-838-7715. If your facility was issued an MQSA
certificate by

a State government agency, and not the FDA, please contact that State
agency

directly at the telephone number listed on your State MQSA certificate.

Facilities wishing to obtain additional information about the MQSA
program

in general may check the FDA Website at: www.fda.gov/cdrh/mammography.

Facilities wishing to obtain additional information about MQSA
regulations

and guidance may check the Policy Guidance Help System on the FDA
Website

at: www.fda.gov/cdrh/mammography/robohelp/finalregs.htm.

# Attachment L {#attachment-l .unnumbered}

#  {#section-6 .unnumbered}

# U.S. Department of Health and Human Services {#u.s.-department-of-health-and-human-services .unnumbered}

# Food and Drug Administration (FDA) {#food-and-drug-administration-fda .unnumbered}

## Important Information about Your Mammography Quality Standards Act (MQSA) Inspection {#important-information-about-your-mammography-quality-standards-act-mqsa-inspection .unnumbered}

#### The accompanying MQSA Facility Inspection Report (Report) provides the results of your MQSA inspection. This document is to assist you in reviewing the Report. {#the-accompanying-mqsa-facility-inspection-report-report-provides-the-results-of-your-mqsa-inspection.-this-document-is-to-assist-you-in-reviewing-the-report. .unnumbered}

FDA has classified each adverse inspection observation into one of three
category levels. A **Level 1** observation indicates a failure to meet a
key MQSA requirement that may compromise the quality of mammography
performed at the facility. A **Level 2** observation indicates that the
facility meets all key MQSA requirements but fails to meet a significant
mammography quality item. A **Level 3** observation indicates that the
facility meets all major MQSA requirements with only minor problems.
Adverse inspection observations are placed into a category level based
on FDA's assessment of how the observation may affect the quality of
mammography. The category level is also used to determine how the
facility should respond to the observation. Identical observations found
during two consecutive inspections are identified as repeats.

***If your report identified at least one repeat Level 1, Level 1, or
repeat Level 2 as the most serious adverse observation:***

If the Report noted at least one repeat Level 1, Level 1, or repeat
Level 2 adverse observation during your annual inspection, **you should
correct all inspection observations as soon as possible.** Because of
the nature of the observation(s), FDA may issue your facility a Warning
Letter, perform a Follow-up Inspection, and/or take other regulatory
action to determine that each problem at your facility has been
corrected.

The decision to issue a Warning Letter, perform a Follow-up Inspection
and/or take other regulatory action will be based on FDA's review of:

-   your inspection report.

```{=html}
<!-- -->
```
-   all written correspondence we receive from your facility within 15
    working days of you receiving your inspection report, indicating how
    each problem has been corrected.

-   your facility's past history of MQSA violations (if any)

Please note: A fee of \$991 is charged for a follow-up inspection.

We suggest that any correspondence address all adverse observations
listed in the accompanying MQSA Facility Inspection Report and include:

-   Facility ID number (from your FDA certificate).

-   Listing of corrective actions performed or proposed to correct the
    problem(s).

-   Date that each corrective action was or will be completed.

-   Copies of service records and/or other supporting documents showing
    any corrective action already completed.

-   For equipment test items, copies of raw test data and calculated
    final results.

-   For quality control and medical records, copies of records that show
    that the records are in compliance (delete patient names and other
    patient identifiers).

-   For personnel qualification issues, documentation showing that the
    person(s) actually met the requirement(s) or what steps the facility
    has or will take to address the problem.

-   The steps taken to prevent the reoccurrence of the problem(s).

***If your report identified at least one Level 2 or repeat Level 3
adverse observation as the most serious observation:***

If the Report noted at least one Level 2 or repeat Level 3 adverse
observation as the most serious observation during your annual
inspection, **you should correct all inspection observations as soon as
possible.** Because of the nature of the observation(s), FDA may issue
your facility a Warning Letter and/or perform a Follow-up Inspection to
determine that each problem at your facility has been corrected.

The decision to issue a Warning Letter and/or perform a Follow-up
Inspection will be based on FDA's review of:

-   your inspection report.

```{=html}
<!-- -->
```
-   all written correspondence we receive from your facility within 30
    working days of you receiving your inspection report, indicating how
    each problem has been corrected.

-   your facility's past history of MQSA violations (if any)

Please note: A fee of \$991 is charged for a follow-up inspection.

We suggest that any correspondence address all adverse observations
listed in the accompanying MQSA Facility Inspection Report and include:

-   Facility ID number (from your FDA certificate).

-   Listing of corrective actions performed or proposed to correct the
    problem(s).

-   Date that each corrective action was or will be completed.

-   Copies of service records and/or other supporting documents showing
    any corrective action already completed.

-   For equipment test items, copies of raw test data and calculated
    final results.

-   For quality control and medical records, copies of records that show
    that the records are in compliance (delete patient names and other
    patient identifiers).

-   For personnel qualification issues, documentation showing that the
    person(s) actually met the requirement(s) or what steps the facility
    has or will take to address the problem.

-   The steps taken to prevent the reoccurrence of the problem(s).

***If your report identified at least one Level 3 adverse observation as
the most serious observation:***

If the Report noted at least one Level 3 adverse observation as the most
serious observation during your annual inspection, this indicates that
the facility meets all key MQSA requirements but fails to meet a minor
mammography quality item. You do not have to respond in writing to the
FDA regarding any adverse observation, however, **you should correct
each problem as soon as possible**. During your next MQSA inspection, we
will check to ensure that each problem was corrected.

***If no adverse observations were identified:***

If the Report identified no adverse observations at your facility, this
indicates that the facility meets all key MQSA requirements and no
correspondence with FDA regarding your inspection is necessary.

***[Where to Submit Correspondence:]{.underline}***

Submit your written correspondence to:

Food and Drug Administration

\[street address\]

\[city, state, zip code\]

Send a copy to:

\[State radiation control office\]

\[street address\]

\[city, state, zip code\]

For questions about addressing an adverse observation, you may contact
the \[name and title of FDA compliance officer, MQSA auditor, or other
person\] at \[FDA phone number\]. If you have other questions regarding
your inspection, please contact \[inspector name and title\] at
\[inspector phone number\].

***[Additional information:]{.underline}***

Additional information on meeting MQSA requirements may be found at
FDA's mammography Internet site at
<http://www.fda.gov/cdrh/mammography/index.html>. Please note that there
are many FDA requirements pertaining to mammography. The Report you
received pertains only to observations related to your inspection and
does not necessarily address other obligations you have under the law.

[***State Requirements:***]{.underline}

The inspector may have identified observations regarding State
requirements during your inspection or the State may later send a letter
to your facility. Please communicate directly with the State regarding
these observations.

Revised -- 9/29/2003

Attachment M []{#ATTACHMENTM .anchor}

**MQSA**

**Inspection Confirmation**

This notice confirms our telephone conversation of \_\_\_\_\_\_\_\_\_
regarding the scheduled inspection. If you have questions, contact the
inspector at the telephone number below.

Date and time of inspection:

Name and address of facility:

Facility person contacted:

Facility telephone number:

Inspector name:

Inspector office address:

Inspector telephone number: Fax:

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

The MQSA inspection will cover the following areas:

\- Equipment performance (including image quality and dose)

\- Technologist and physicist quality control/quality assurance (QC/QA)
tests and tasks

\- Medical audit and outcome analysis records

\- Medical records (mammography reports and films)

\- Personnel qualification records

Average on-site inspection time: approximately six hours.

Testing for each mammography x-ray unit, darkroom and film processor
combination: approximately one hour

The remainder of the inspector\'s time will be spent reviewing facility
records. We recommend that you schedule a block of time for the testing
of each x-ray unit and film processor combination to help minimize any
inconvenience to patient care from the inspection process. For the
remainder of the inspection time, staff may conduct their usual duties
but should be available to the inspector during the records review
portion, should he or she have questions or need assistance.