Sunday, March 15, 2009

Zero Gravity Mammography

When You Gotta Go...
There's a scene in 2001 a Space Odyssey, when Dr. David Bowman, the ship commander, has to use the most simple of devices, the crapper.
Unfortunately, poor Dr. Bowman is going to have to wait until he reads and deciphers the instructions for the Zero Gravity Toilet before he gets to go...
Posted below, are the Zero Gravity Toilet Instructions for Mammography-- provided by Congress as the Mammograpthy Quality Standards Act (MQSA)--just in case you thought I was exaggerating in my previous posts here and here, describing the only federal law that regulates a specific medical practice or procedure.
There are no such guidelines for brain surgery or giving chemotherapy to children or even pulling bullets out of mafia hit men in the ER; only mammography -- the most basic of all basic radiological exams -- warrants its own set of rules, assessments and penalties, provided by its own law.

Now, provided for your bathroom perusal, are the MQSA guidelines that every mammography center is compelled to abide by -- through the force of law. Think of what it costs to do this (and you'll begin to understand why women's centers are shutting down at the rate of 20 per month!)...then think about what the situation will be when we have laws for all the things we do in health care (called nationalized health care or single payor system).
Then even Ted Kennedy might be stymied!

MQSA Regulations Overview

Quality Standards
Personnel. Interpreting physicians, radiologic technologists, and medical physicists must meet initial and continuing requirements. Documentation of these requirements must be available for inspection.
Equipment. Only equipment designed specifically for mammography qualifies for certification.
Medical Records and Mammography Reports. Summary data written in lay terms must be sent directly to all patients as soon as possible. Mammography films and reports must be retained for at least 5 years and up to 10 years, and labeled according to Food and Drug Administration (FDA) regulation.
Quality Assurance. Quality control testing protocols must be used and maintained by each facility, including mammography equipment evaluations and an annual physics survey. Documentation of daily, weekly, quarterly, semiannual, and annual quality control tests must be retained for FDA inspections
Mammography Medical Outcomes Audit. An interpreting physician must annually review the medical outcomes audit data.
Consumer Complaint Mechanism. Facilities must establish a written and documented system for collecting consumer complaints.

Current Accreditation Bodies. American College of Radiology (ACR), Iowa, Arkansas, and Texas.
Responsibilities of Accreditation Bodies. Accreditation bodies must monitor facility compliance with quality standards, review clinical and phantom images from each facility at least once every 3 years, conduct annual onsite visits of at least 5 percent of the facilities it accredits, and maintain a consumer complaint system.
Accreditation Body Audit. FDA will evaluate the performance of each accreditation body annually.
Facility Accreditation. Facilities must submit verification that personnel, equipment, and practices conform to established quality standards to be eligible for accreditation.

Current Certification Bodies. FDA, Iowa, Illinois, and South Carolina.
Responsibilities of Certification Bodies. Certification bodies must issue Mammography Quality Standards Act (MQSA) certificates allowing accredited facilities to operate lawfully, and must perform annual inspections of each certified facility.
Facility Certification. Accredited facilities are eligible for certification. Certificates are valid for 3 years, and are renewable.

General. Facilities must undergo annual inspections.
Inspectors. Facilities may be inspected by FDA inspectors, state or local agency inspectors under FDA contract, or inspectors from states that are certifying agencies. Federal facilities can be inspected only by FDA inspectors.
Inspector Audit. Annual assessment of state performance is carried out by FDA auditors.
Fees. The facility undergoing inspection is responsible for all inspection fees. As of October 1, 2003, a fee of $1,749 is charged for the first mammography unit inspected, and $204 for every unit thereafter. Follow-up inspection fees are $991.

Compliance and Enforcement
Levels of Noncompliance
Level 1: Failure to meet a key MQSA requirement that may seriously compromise mammography quality. The facility is given 15 days to respond with corrective actions.
Level 2: All critical MQSA requirements met, yet a significant mammography quality item overlooked. The facility is given 30 days to respond,
Level 3: A minor deviation from MQSA standards. The facility is given until next annual inspection to address the problem, although it is advised to correct it as soon as possible,

FDA may impose one or more of the following sanctions:
Directed Plan of Correction, allowing facility to correct violations in a timely manner, while being monitored by FDA.
Patient and Physician Notification, requiring facilities to inform those that may be at risk due to unacceptable image quality or other conditions that could cause significant negative impact on patient health. Follow-up Inspection.
Certificate Revocation or Suspension.

Civil Money Penalties of up to $10,000 per examination or per violation per day may be applied to facilities performing mammography services without proper certification or for other significant violations.

Advisory Committee
Title. The establishment of a National Mammography Quality Assurance Advisory Committee (NMQAAC) was mandated by MQSA.
Members. FDA appoints members from the community of physicians, health professionals, consumer organizations, and industry representatives.
Responsibilities. The NMQAAC advises FDA on appropriate quality standards, assists in the development of sanctions, designs a method to investigate consumer complaints, reports on new developments in breast imaging, determines whether a shortage of health professionals exists, and measures the costs and benefits of MQSA compliance.

SOURCE: Mammography Quality Standards Act, 42 U.S.C. § 263b (2003). 21 C.F.R. § 900.1 (2003).


Bard-Parker said...

Actually it was Heywood Floyd who had to use the toilet..

Dr.T said...


You be as old as me. Sure looks like Keir Dullea in the picture....