Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

LESSONS FROM INSPECTIONS OF


MAMMOGRAPHY FACILITIES


JUNE GIBBS BROWN 

Inspector General 

MAY MM 

OEI-05-92-00300 
OFFICE OF INSPECTOR GENERAL 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 

amended, is to protect the integrity of the Department of Health and Human Setices’ (HHS) 

programs as well as the health and welfare of beneficiaries served by those programs. This 

statutory mission is carried out through a nationwide network of audits, investigations, and 

inspections conducted by three OIG operating components: the Office of Audit Sefices, the 

Office of Investigations, and the Office of Evaluation and Inspections. The OIG also informs 

the Secretary of HHS of program and management problems and recommends courses to 

correct them. 

OFFICE OF AUDIT SERVICES 

The OIGS Office of Audit Services (OAS) provides all auditing services for HHS, either by 

conducting audits with its own audit resources or by overseeing audit work done by others. 

Audits examine the performance of HHS programs and/or its grantees and contractors in 

carrying out their respective responsibilities and are intended to provide independent 

assessments of HHS programs and operations in order to reduce waste, abuse, and 

mismanagement and to promote economy and efficiency throughout the Department. 

OFFICE OF INVESTIGATIONS 

The OIGS Office of Investigations (01) conducts criminal, civil, and administrative 

investigations of allegations of wrongdoing in HHS programs or to HHS beneficiaries and of 

unjust enrichment by providers. The investigative efforts of 01 lead to criminal convictions, 

administrative sanctions, or civil money penalties. The 01 also oversees State Medicaid fraud 

control units which investigate and prosecute fraud and patient abuse in the Medicaid program. 

OFFICE OF EVALUATION AND INSPECTIONS 

The OIGS Office of Evaluation and Inspections (OEI) conducts short-term management and 

program evaluations (called inspections) that focus on issues of concern to the Department, 

the Congress, and the public. The findings and recommendations contained in these inspection 

reports generate rapid, accurate, and up-to-date information on the efficiency, vulnerability, 

and effectiveness of departmental programs. 

This inspection was performed under the direction of William Moran, Regional Inspector 

General of Region V, Office of Evaluation and Inspections, and Natalie Coen, Deputy 

Regional Inspector General. Participating in the project were: 

CHICAGO HEADQUARTERS 

Thomas Komaniecki, Project Leader Penny Thompson 

Jean DuFresne Mary Beth Clarke 

Linda Moscoe 

To obtain a copy of this report, call the Chicago Regional Office at (312) 353-4124 
Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

LESSONS FROM INSPECTIONS OF


MAMMOGRAPHY FACILITIES


smJlc4 

$ 

@ “w 

JUNE GIBBS BROWN 

j Inspector General 

c ‘% MAY 1994 %?tia 4 OEI-05-92-00300 
EXECUTIVE SUMMARY


PURPOSE 

This report examines the on-site inspection process of Medicare screening 

mammography facilities. The report also discusses lessons learned from Medicare that 

the Food and Drug Administration (FDA) should consider in the implementation of 

the Mammography Quality Standards Act (MQSA) of 1992. 

BACKGROUND 

There are approximately 11,000 mammography facilities in the United States today. 

Currently, these facilities operate under a patchwork of Federal, State, and voluntary 

programs that monitor the safety and quality of mammography setices they provide. 

Federal regulation of mammography is mainly the responsibility of FDA and the 

Health Care Financing Administration (HCFA). In the past, FDA provided limited 

oversight of mammography by ensuring the proper manufacture and installation of all 

mammography equipment. The HCFA regulates screening mammography by 

requiring facilities meet quality standards in the areas of equipment, personnel 

qualifications, and documentation. There are approximately 6,800 Medicare-certified 

screening mammography facilities. In August 1992, HCFA began conducting on-site 

inspections of mammography facilities through the States’ survey and certification 

agencies. 

In October 1992, Congress passed the Mammqpphy Quality standards Act (MQSA)” 

Whereas Medicare’s regulations only cover those facilities receiving Medicare 

reimbursement and only for screening mammography, MQSA mandates that all 

facilities providing mammography services, whether screening or diagnostic, meet 

minimum quality standards, or run the risk of fines and sanctions including the closure 

of the facility. 

The FDA is responsible for developing the regulations and implementing the new 

legislation which will prohibit any mammography facility without a certificate from 

operating as of October 1, 1994. By October 1, 1994, HCFA plans to amend the 

Medicare screening mammography regulations to cross-reference FDA’s MQSA 

standards. 

METHODOLOGY 

We gathered data from the people responsible for the inspection of mammography 

facilities. We obtained data about: 1) the number of Medicare-certified facilities; 2) 

the length of time and cost of doing on-site inspections; 3) the training the inspectors 

received; and, 4) the results of the inspections. We spoke with personnel from 87 
inspected facilities and analyzed data from HCFA’S Online Sumey and Certification 

and Reporting system entered through August 31, 1993. 

FINDINGS 

States began routine on-site inspection of mammography facilities in September lW, 

by August 1993, States inspected about 44 percent of the certified facilities. 

The HCFA requires that 100 percent of facilities be inspected annually. Some States 

have completed 100 percent of their inspections while other have completed few 

inspections. 

Eighty-six percent of the inspected facilities failed at least one requirement. Less than 

5 percent of the deficiencies were considered serious. Most facilities corrected their 

deficiencies. 

Fifteen facilities have been terminated from the Medicare program, while 228 have 

voluntarily dropped out. Three areas make up 79 percent of facility failures: duties of 

the physician consultant, aspects of quality assurance, and the written report sent to 

the patient and referring physician. 

State inspectors say that facilities’ unkniliarity with Medicare’s regulations is the 

biggest problem encountered during inspections. 

Respondents from 34 States said that the facilities inspected so far were unfamiliar 

with Medicare’s regulations. Thirty-nine of 87 facility respondents said they received 

no information about the inspection before it occurred. 

The HCFA’S experience with the Medicare program provides valuable lessons for 

FDA as they implement the Mammography Quality Standards Act. These lessons 

relate to: 

. The FDA’s plans to implement MQSA by October 1, 1994. 

� The development and dissemination of the regulations for MQSA. 

� The capacity to inspect all mammography facilities on an annual basis. 

� The development of a management information system. 

RECOMMENDATIONS 

In light of our findings, we make recommendations both to HCFA and FDA regarding 

implementation of the Mammography Quality Standards Act. We believe that FDA 

has made significant progress towards the successful implementation of MQS~ 

including a public conference with the mammography community to discuss the 

implementation of MQSA. The FDA published interim final regulations for the 

quality standards and the accrediting bodies in December 1993. In addition to these 

ii 
efforts, we believe that in the interim period before implementation, both HCFA and 

FDA need to coordinate their work to ease the transition for mammography facilities. 

To ensure the smooth implementation of MQS~ HCFA and FDA should: 

�� reach agreement on the role of HCFA’S screening mammography certification 

program in the interim period before full implementation of MQSA. 

The HCFA inspections could be used to educate Medicare certified 

mammography facilities on the new requirements of MQSA. It would 

also allow inspectors to increase their familiarity with the MQSA 

requirements. 

To effectively target current areas of concern while implementing MQS~ FDA 

should. 

�� ensure that facility personnel are aware of and thoroughly trained on MQSAS 

requirements; 

While FDA has begun educating the mammography industry on 

MQSA’S requirements, further efforts might be made to ensure 

that personnel involved in the day to day operation of the 

mammography units are trained on the requirements. For 

example if funds were available, FDA could provide training 

funds to States to educate the provider community on the new 

regulations, or work with private entities like the ACR, medical 

societies, and professional organizations to educate their 

members. 

�� examine ways to perform the most effective and cost-efficient inspections which 

still adequately enforce the regulations (given that the law requires an annual 

on-site inspection of all mammography facilities); 

Potentially, inspections could be prioritized or targeted to ensure that 

the facilities with little prior regulation, or a history of problems, are 

inspected first. Another possibility includes designing streamlined 

inspections for facilities with a proven compliance record. The FDA 

should use current inspector’s experiences in conducting HCFA’S on-site 

inspections to develop FDA’s inspection protocols. 

�� develop a management information system that allows for continuous 

monitoring of State inspections agency performance and facility compliance and 

distinguishes between documentation non-compliance and performance noncompliance. 

...

111 
We understand that FDA has begun developing a management 

information system for MQSA. We believe the system developed must 

be able to distinguish between documentation non-compliance and 

performance non-compliance. 

AGENCY COMMENTS 

We received comments on our draft report from FDA and HCFA. Both FDA and 

HCFA concur or concur in principle with the recommendations presented in our 

report. Many of the recommendations are already being implemented by FDA as part 

of their implementation of MQSA. Each set of comments are presented in Appendix 

c. 

We have made a number of changes to the report based on the agencies’ comments. 

We also have provided additional information which FDA requested. 

iv 
TABLE OF CONTENTS


PAGE 

EXECUTIVE suMMARY 

mODU~ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ’......1 

FINDINGS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..6 

.	 Statesbeganroutine on-sitehspectionofmarnm FPw 

tkilities in September 1- by August 1993 Statesinspected 

about 44 percentofthecetid facilities. . . . . . . . . . . . . . . . . . . . . . . . . . 6 

.Eighty-sixpercent oftheinspected facilitiexfaikd 

atkastonerequirement Lessthan5perc4mt of the 

deficiencies were ccmsidered~riom. Mostfacilitks 

comecttheir deficiency=. . . . . . . . . . . . . . . . . . . . . . .....~......”.7”””.7 

.Stateinqectors Saidthatfacilitid mfamikity 

with Medicare’s regulationswas the biggest problem 

encountered duringinspedions. . . . . . . . . . . . . . . . . . . . . . . . . . . ..”” . ..”10 

.The HCFA’S experience in implementing the Medicare 

prqpm pfida valuablelessonsfor FDA as it 

attempts to effectively implement the M-OPPh 

Quditystandards ACL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..ll 

WCO=~A~ONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..”. .””””~b 

APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...”.””””””””””””””’”” 

A List of States and how they perform inspections of 

screening mammography fatihties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. A-1 

B: Number of facilities out of compliance with one or 

more conditions or standards under the 

Screening Mammography re/@ations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1 

c Agency Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. O. . . .. C”l. C-l 
INTRODUCTION


PURPOSE 

This report examines the on-site inspection process of Medicare screening 

mammography facilities. The report also discusies lessons learned from Medicare that 

the Food and Drug Administration (FDA) should consider in the implementation of 

the Mammography Quality Standards Act (MQSA) of 1992. 

BACKGROUND 

There are approximately 11,000 mammography facilities in the United States today. 

Currently, these facilities operate under a patchwork of Federal, State, and voluntary 

programs which monitor the safety and quality of mammography services. 

State Standanh and VohntaryAccreditation 

Most States monitor the radiation safety of all X-ray imaging equipment including 

mammography units. Additionally, at least 10 States” have their own quality 

assurance standards for mammography. Although these standards are not identical, 

most set minimum quality standards in areas of radiation exposure, equipment 

specifications, quality control programs and personnel qualifications. 

Since 1987, the American College of Radiology (ACR) has operated a voluntary 

accreditation program for screening and diagnostic mammography providers. As of 

April 4, 1994, ACR had accredited 6,184 facilities and had pending accreditation for 

2,572 facilities. The accreditation process takes about 6 months to complete and 

occurs entirely by mail. The ACR has begun an on-site inspection audit of a sample 

of their accredited facilities. 

Fed&al Rob? m iUammowPbJ 

Various Federal agencies are involved in mammography issues. The National


Institutes of Health perform and fund research on breast cancer as well as access to


mammography semices. The Centers for Disease Control and Prevention (CDC)


provides grants to States for breast and cervical cancer screenings for low-income


women. Facilities approved for CDC grant money must have Medicare certification as


well as ACR accreditation. In addition, CDC has provided training for inspectors of


“Georgia, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, North 

Carolina, Utah, and Vermont - as reported in the Committee on Labor and Human 

Resources Senate Report 102-448 on the Mammography Quality Standards Act of 

1992. 

1 
mammography facilities. The Agency for Health Care Policy and Research is 

currently developing clinical guidelines for the provision of mammography. 

Federal regulation of mammography is mainly the responsibility of FDA and the 

Health Care Financing Administration (HCFA). In the past, FDA provided limited 

oversight of mammography by ensuring the proper manufacture and installation of all 

new mammography equipment. The FDA did not routinely monitor the subsequent 

use of the equipment although FDA has obtained information from the Conference of 

Radiation Control Program Directors (CRCPD) concerning mammography use. 

Individual States, using CRCPD’S Nationwide Evaluation of X-ray Trends survey 

protocols have measured patient radiation exposures and assessed phantom image 

quality. 

The HCFA regulates facilities performing screening mammographies for Medicare 

patients. Screening mammography facilities must meet minimum quality standards to 

receive Medicare reimbursement. These minimum quality standards do not, however, 

apply to facilities performing diagnostic mammography. 

The HCFA published interim final regulations on December 30, 1990, about 10 weeks 

after the passage of the legislation. The HCFA has not yet published final regulations 

for screening mammography for several reasons including Departmental concerns over 

Medicare’s regulation concerning xerography equipment, and the enactment of 

MQSA. 

According to the Medicare quality standards, facilities must use personnel who meet 

criteria on education, experience and certification. Mammography equipment must be 

dedicated (specifically designed for mammography), and meet other technical 

specifications. Film processing equipment must also meet certain standards, and be 

monitored daily. Facilities must also carry out an internal quality assurance program, 

which includes periodic testing of equipment, annual review by a qualified medical 

physicist, continuing education for personnel, and record keeping. Facilities must 

document that they meet all the requirements. 

To receive reimbursement for screening mammograms after January 1, 1991, facilities 

had to meet Medicare’s quality standards. To expedite the process of certi&ing 

facilities, HCFA allowed facilities to attest in writing that they met Medicare’s 

standards. From January 1991 to September 1992, about 6,500 facilities attested that 

they met Medicare’s quality standards. On-site inspections were only done in cases 

where a complaint was filed against a facility. 

In August 1992, HCFA eliminated the attestation process and began conducting onsite inspections of mammography facilities through the States’ sumey and certification 

agencies. Because of the technical component of these inspections, HCFA 

encouraged the agencies to contract (or develop memorandums of agreement) with 

the radiation control units in their States to do all or some of the inspections. 

2

In July and October 1992, HCFA provided a 1 week training course for the States on 

the inspection process. The FDA provided training on the technical aspects of testing 

mammography x-ray equipment. The HCFA trained attendees on the review of 

credentials and documentation. Training was also provided in May 1993 in 

cooperation with the Conference of Radiation Control Program Directors (CRCPD.) 

lhe Mammography Qua&yStati Act of 1992 

In October 1992, Congress passed the Mammography Quality Standards Act. 

Congress felt that the current patch work of Federal, State, and voluntary programs 

did not ensure quality mammography to all women. Whereas Medicare’s regulations 

only cover those facilities receiving Medicare reimbursement, and only for screening 

mammography, and whereas the ACR program only covers facilities that voluntarily 

apply for accreditation, MQSA mandates that all facilities providing mammography 

services, screening or diagnostic, meet minimum quality standards, or run the risk of 

fines and sanctions including the closure of the facility. The legislation also requires 

that all facilities be inspected by qualified inspectors. 

The Senate Committee on Labor and Human Resources Report strongly suggested 

that responsibility for the new legislation be given to the Public Health Service. The 

FDA is responsible for developing the regulations and implementing the new 

legislation which will prohibit any mammography facility without a certificate from 

operating as of October 1, 1994. 

By October 1, 1994, HCFA plans to amend the Medicare screening mammography 

regulations to cross-reference FDA’s MQSA standards. Therefore, facilities that meet 

the mandatory MQSA standards will automatically be qualified to participate in the 

Medicare screening mammography program. 

METHODOLOGY 

lbinspection 

In designing this study, we spoke with staff from HCF~ FDA CDC, the General 

Accounting Office, the National Cancer Institute and the Assistant Secretary for 

Planning and Evaluation. In addition, we spoke with representatives from ACR, the 

CRCPD, the National Electronic Manufacturing Association, the American Cancer 

Society, the American Hospital Association, the Joint Commission for Accreditation of 

Health Organizations, a mammography machine manufacturer and a screening 

mammography provider. We attended mammography sessions at the Radiological 

Society of North America’s national convention. We visited the State of Maryland and 

contacted the State of Illinois to discuss their Medicare inspection process. We 

reviewed literature about reimbursement, quality, and access for screening and 

diagnostic mammography. We also reviewed legislation involving the Medicare 

screening benefit and MQSA. 

3

Data Cbflection 

We gathered preliminary information from the 50 States, the Commonwealth of 

Puerto Rico and the District of Columbia (all referred to as States) about their 

Medicare mammography inspections. After that initial contact, we formally 

interviewed personnel responsible for the inspection of mammography facilities in 48 

States -45 by telephone and 3 on-site. We did not formally intewiew suwey and 

certification agencies in four States because they had not yet done any inspections. 

From the personnel responsible for the inspections, we obtained demographic 

information about the number of certified facilities, the length of time and cost of 

doing the inspections, information about the training the inspectors received, results of 

the inspections, the inspectors’ impressions of the inspected facilities, and suggestions 

on areas of improvement. 

We also requested complete data on the mammography facilities inspected including 

whether the facility originally attested to the Medicare reqwrements, name of a 

contact person and any conditions out of compliance. Not all the information received 

was complete. One State chose not to return this information. 

We also contacted the radiation control agencies in the States and interviewed 

representatives in these agencies about their involvement with Medicare inspections, 

other mammography related inspections in the State, and the implementation of 

MQSA One State did not have a radiation control agency. 

We intetiewed personnel in two inspected mammography facilities in each State 

where inspections were ongoing. In a few States, only one inspection had occurred 

and we contacted that one facility. We contacted a total of 87 facilities in 47 States. 

Fiftyone percent of these facilities were ACR accredited, 32 percent were in the ACR 

accreditation process and 7 percent were planning to apply for ACR accreditation. 

Ten percent of the facilities were not planning to apply for ACR accreditation. We 

spoke mainly with technicians and mammography y administrative personnel - those 

staff who had the most contact with the sumeyors at the time of the inspection. 

* 

We visited Georgia, Louisiana and Michigan. Where applicable, we intemiewed staff 

at the State survey and certification agencies and at the radiation control agencies. 

We accompanied an inspector on an inspect Ion of a mammography facility in each 

State. We conducted interviews at two inspected facilities in each State. 

We also obtained screening mammography inspection data from HCFA’S Online 

Survey and Certification and Reporting (OSCAR) system entered through August 31, 

1993. This system allows for online data entry by State agencies and HCFA regional 

offices. The States are allowed up to 60 days after the inspection to input data in 

OSCAR. To check the OSCAR reliability, we randomly compared data collected 

directly from the States to OSCAR data. Our testsof the data revealed minor 

inconsistencies, omissions or other errors. However, when these data are viewed in 

4 
context with other available evidence, we believe the findings and recommendations in 

this report are valid. 

SCOPE 

This report discusses issues of the on-site inspection of mammography facilities under 

HCFA’S Medicare screening quality standards. In addition, this report discusses issues 

that FDA must address to implement MQSA. 

This report does not discuss what constitutes a quality mammogram, nor the 

appropriate cost of a mammogram. 

This study was conducted in accordance with the QualityStandardsfor Inspections 

issued by the President’s Council on Integrity and Efficiency in March 1993. 

5

FINDINGS —


States began routine on-site inspection of mammography facilities in September 1~, 

by August 1993, States inspected about 44 percent of the certified facilities. 

Before September 1992, States only inspected facilities for HCFA in the case of a


complaint. The HCFA now requires that inspections be performed annually at all


facilities. By August 1993, States inspected about 44 percent (3,000/6,791) of


Medicare certified mammography facilities. States conducted inspections ranging from


a low of 2 percent to a high of 100 percent of their facilities. The reasons for this


wide range vary. Some States were already conducting comprehensive reviews of


mammography so enacting the Medicare surveys took little extra effort. Other States


had never conducted extensive mammography reviews, had other surveys to conduct


that competed with the mammography inspections, and/or experienced difficulty


contracting with technical staff to conduct parts of the inspection.


In an August 1992 guidance to States, HCFA encouraged State survey and


certification agencies to seek help from the radiation control agencies to conduct the


inspections. Thirty-three States conduct inspections using a combination of staff from


survey and certification and radiation control agencies. The sumey and certification


agency conducts the non-technical (documentation review) while the radiation control


agency conducts the technical portion (machine review). The inspection is either


completed as a joint review or as two separate reviews. For the remainder of the


States, either the entire inspection process has been contracted to the radiation control


agency or the survey and certification agency has hired or contracted with a


radiological physicist. (See Appendix A.)


Most States choose facilities to inspect based on their geographic location. For


example, they will inspect all the facilities within a given area, such as a county, or the


northern region of their State. Originally per HCFA’S instructions, inspections were


unamounced. However, HCFA revised its policy, allowing up to 2 days notice


because of complaints that unannounced inspections disrupted patient schedules.


Some States will only amounce the technical portion of the inspection and still


conduct the non-technical portion unannounced.


During the technical portion of the inspection, the inspector measures radiation


dosage, takes phantom images, and may perform other tests for the State that make


the machine unavailable for patient use for at least 1 hour and up to 4 hours. In


addition, the inspector reviews the quality control logs and manuals for the imaging


equipment and the film processor. The inspector also reviews the policy and


procedure manuals, staff credentials, and all other pertinent documents. A facility’s


mammography technician generally accompanies the inspector during these reviews.


According to our facility respondents, there is a great deal of interaction between the


technician and the inspector during the on-site inspection, which averages 7 hours.


6

The average for an overall inspection, which includes follow-up visits and paperwork, 

is 25 hours. The cost of an inspection averaged $950 with a range of $200 to $2,800. 

Few facility respondents expressed problems with the actual inspection. Furthermore, 

61 facility respondents said the inspection helped their facility do some things better, 

such as preparing a policy and procedures manual. However, some complained that 

inspections interrupted patient care. In a few cases, unannounced visits were chaotic 

because the lead mammography technician was not in the facility that day. 

Eighty-six percent of the inspected facilities failed at least one requirement Less than 

5 percent of the deficiencies were considered serious. Most facilities corrected their 

deficiencies. 

Eighty-six percent of the inspected facilities failed to meet one or more of HCFA’S 

requirements, with an average of 13 deficiencies per facility.”* Less than 5 percent of 

all deficiencies found in the facilities are for conditional level (considered serious) 

deficiencies. The great majority of facilities correct their deficiencies and continue to 

supply screening mammography to Medicare beneficiaries. 

According to recent HCFA information, 15 facilities have been terminated from the 

Medicare screening program, while 228 facilities have voluntarily dropped out because 

they could not correct their deficiencies or for other reasons. These facilities are still 

eligible to receive Medicare reimbursement for diagnostic mammography. Although 

as of October 1, 1994, all mammography facilities will be subject to quality standards 

regardless of reimbursement. 

Few facilities are failing to meet HCFA’S mammography requirements for safety and 

equipment specifications. Only two State respondents said that the common use of 

non-dedicated or unsafe imaging equipment was a problem. Overall, 20 percent of 

facilities failed to meet equipment standards, (most for not adhering to manufacturer’s 

specified developer temperature) and 10 percent failed safety standards. This 

accounted for just under 1.5 percent of all conditional level deficiencies. 

According to HCFA’S OSCAR data, three areas in particular accounted for 79 percent 

of facility deficiencies. These were duties of a physician consultant, the written report 

sent to the patient and referring physician, and aspects of quality assurance. Each are 

explained below. (See Appendix B for a list of regulations and number of facilities out 

of compliance with a condition or standard.) 

““	 We based our analysis of deficiencies on information contained in OSCAR. As 

of August 31, 1993, 1,394 facilities had at least one deficiency out of 1,615 

facilities input into OSCAR. States are allowed up to 60 days after the 

inspection to input data into OSCAR. 

7 
Duties of the PhysicianConsultant 

Sixty-three percent of inspected facilities in some way failed the physician consultant 

requirement. The HCFA requires that a screening mammography facility employ or 

contract with a physician consultant to oversee the entire mammography process. Six 

States reported that many facilities in their States were unaware of the physician 

consultant’s responsibilities. 

Among various duties, HCFA requires that the physician consultant observe the 

technicians’ technique and positioning of a patient on a monthly basis. At 53 percent 

(859 facilities), this is the requirement most often failed. Thirty percent of our facility 

respondents told us they failed the physician consultant requirement because the 

physician consultant did not obsexve a technician on a monthly basis to evaluate their 

positioning and technique. In some cases, facilities reported that a physician 

consultant was observing the technician on a monthly basis but it was not documented 

in the procedures manual. 

Some State and facility respondents thought there was little value added to the quality 

of a screening mammogram by having the physician consultant obseme the technician. 

Some of these respondents said that the physician consultant was not sufficiently 

trained to comment on the technician’s positioning and technique. 

Typical of the comments we heard was one facility’s letter to a State in which they 

wrote, “A radiologist is trained to interpret images and to evaluate the quality of the 

images based on the images themselves. The only current formal training available to 

a radiologist that allows actual hands-on position training for mammography is Tabar’s 

Level 3 course, and even those of us who have taken that course are not qualified to 

critique our technologist’s positioning technique except by review of the images 

themselves.” Other facility respondents stated that many women feel uncomfortable 

having another person present while a technician performs a mammogram. 

Other physician consultant duties that facilities often fail include: 

. physician consultant signs off on the procedures manual, 39 percent; 

�	 physician consultant verifies that equipment and procedures meet all Federal, 

State, and local regulations, 32 percent, and; 

.	 physician consultant assures that safe operating procedures are used, 30 

percent. 

It is possible that physicians are performing these duties in their facilities. However, 

the documentation did not exist to verify it. Furthermore, although many facility 

respondents expressed frustration with specific required physician consultant duties, 

some of the technicians were pleased that the regulations required that the radiologist 

be involved with quality assurance activities in the facility. 

8

Wiiitenkm Sent to Patientand Rejkmkg Physician 

Fifty-eight percent of facilities failed to meet the condition of interpretation of


screening mammography results. A facility could fail to meet this requirement


because: 1) the interpreting radiologist was not board certified or could not provide


the board certificate, 14 percen$ 2) the interpreting radiologist did not have enough


continuing education or did not properly document their continuing education, 27


percent; and, 3) the interpreting radiologist did not provide a written interpretation of


the mammography results to the referring physician and the patient, 46 percent. In


particular, 31 percent of inspected facilities were cited for not providing a written


statement to the patient.


Within a typical mammography practice, a radiologist provides a written interpretation


of the mammography’s results to the patient’s referring physician. Rarely does a


patient directly receive a written interpretation of the results. However, because a


patient may receive a screening mammogram through Medicare without a physician’s


referral, the Medicare regulations require that in addition to the usual written


interpretation for the referring physician, the radiologist must also provide a statement


to the patient explaining the findings of the mammogram in lay terms. This statement


may be sent directly to the patient or through the referring physician. Seventeen State


respondents said that at the time of the inspection, many facilities were unaware of


HCFA’S requirement that a written statement be given to the patient.


Some facility respondents were concerned that the written statement may interfere


with the patient’s relationship to her referring physician. These facility respondents


said many referring physicians prefer to discuss the findings with their patient without


the direct interpretation of the radiologist. Furthermore, many State respondents


believe enforcing this requirement is difficult because they do not review whether the


referring physicians are giving the radiologist’s written statement to the patient.


~@’ ~xe (QA) Monitotig


Sixty-two percent of inspected facilities were cited for quality assurance requirements.


Most of the failures (42 percent) occurred because facilities were not routinely


monitoring such things as automatic exposure (212 facilities), darkroom integrity (137),


output reproducibility (133), and film storage adequacy (104).


Other failures in the quality assurance area include:


�	 direct assignment of quality assurance activities to responsible personnel (such 

as a technician), 29 percent; 

�	 responsibility of overall quality assurance program to a qualified physicist 

(including an annual review), 26 percent, and; 

� evaluation of monitoring results, 23 percent. 

9 
Unfortunately, it is difficult to determine if the number of quality assurance failures in 

HCFA’S OSCAR data reflect a substantive problem in this crucial area of 

mammography. Few State inspectors told us that they saw actual problems with 

quality assurance in the facilities they had inspected. 

It is possible that many of these procedures are being performed, but are not properly 

documented. fie Medicare regulations, andthus the OSCMdata, does not make 

that distinction. Nevertheless, documentation of such activities are often the only way 

that inspectors have of determining the presence of quality assurance activities. 

Furthermore, a lack of documentation of QA process measurements prevents trend 

analysis which is essential to a QA program. The high number of deficiencies in this 

area warrants additional study. 

State inspectors said that facilities’ unfamiliarity with Medicare’s regulations is the 

biggest problem encountered during inspections. 

Thirty-four State respondents said inspected facilities were unfamiliar with the 

Medicare regulations before the inspection. Nineteen State respondents specifically 

said the reason for the unfamiliarity was that the radiologist or technician in charge of 

the mammography unit did not see the regulations or interpretive guidelines before 

the inspection. In many cases, these inspectors thought the attestation statement was 

signed by financial or administrative personnel but the attached regulations were never 

forwarded to the radiologist or technician in charge. 

During two inspections we observed, the facility persomel were flustered and 

apparently unaware of the Medicare regulations. At one of the facilities, the State 

inspector gave the mammography technician a copy of the facility’s attestation 

statement. The technician said it had been signed by someone in accounting. At the 

other facility, the State inspector gave a copy of the regulations and interpretive 

guidelines to the technician and radiologist who also claimed they had not seen them. 

In this case, the facility had many deficiencies that led to a denial of their initial 

application for Medicare certification. 

Sixty-three percent of the facility respondents were aware that the State would inspect 

them for compliance with Medicare regulations. However, 45 percent of facility 

respondents (who were primarily mammography technicians and supervisors) said they 

had not received information about the regulations. 

In addition, seven State inspectors said facilities were often confused and thought 

Medicare requirements were the same as ACR requirements. Many mammography 

facilities are freestanding clinics or doctors’ offices that have never been regulated or 

undergone any kind of inspection. 

Two State respondents said that special educational efforts by their States, such as 

seminars for the facilities, ensured that the facilities were prepared for the inspection. 

10

These educational efforts took place after the first few inspections in their States 

showed that facilities were unprepared for a HCFA sumey. 

The facilities’ initial unfamiliarity with Medicare requirements contributed to 

unnecessary noncompliance by the facilities. This in turn required that the State 

inspectors spend additional time and effort filling out paper work and conducting 

follow-up visits. 

The HCFA’S experience with the Medicare program provides wduable lessons for 

FDA as they implement the Mammography Quality StidU* Ad 

l%e FDA!r pkl~ to hlpih@lt MQS2i by October 1, 1~. 

. What are FDA’s current activities to implement MQSA? 

The FDA was not given the authority to implement MQSA until June 1993. Since


then, FDA has formed the Division of Mammography Quality and Radiation Programs


within the Center for Devices and Radiological Health. In September, FDA


sponsored a public conference on MQSA. The many issues discussed at this


conference serve to illustrate the complexity of this legislation, and the need for


careful MQSA implementation.


The FDA published interim final regulations for the requirements for accrediting


bodies of mammography facilities and the quality standards and certification


requirements for mammography facilities on December 21, 1993. These regulations


took effect 60 days after their publication. The interim final regulations will be used


as the basis for certifying mammography facilities - and all mammography facilities in


the United States must be certified by October 1, 1994 in order to lawfully operate.


Furthermore, under MQS~ facilities must be accredited by a private non-profit


agency or a State agency which has been approved by the Secretary.


Because the FDA has based their interim regulations on the standards currently used


by ACR, facilities with ACR accreditation automatically quali~ for MQSA


certification. (There are few States which are in a position to accredit facilities in


their State.) Currently, 6,184 facilities have units that have been accredited by ACR


and 2,572 more are in ACR review. However, according to our conversations with


ACR, a thorough accreditation process takes about 6 months to complete. Therefore,


approximately 2,000 or more facilities in the country will need to apply for ACR


accreditation within the next few months and be accredited by October 1, 1994 in


order to be certified under MQSA. This is a substantial challenge for ACR. The


FDA must address how facilities that did not apply to the ACR (or perhaps their


State) for accreditation will be handled after October 1, 1994.


Another issue that FDA faces is that some facilities may not be able to afford ACR or


State accreditation fees and proposed inspection fees, in addition to the operating


costs (which includes medical physicist charges) of providing mammography sewices.


11 

— 
In August 1993, FDA announced the formation of a national mammography advisoxy 

committee. This committee will advise FDA on various issues, including the cost of 

MQSA for facilities, the development of final MQSA quality standards and regulations 

for facilities and an accrediting body, and the development of sanctions. 

Development and diwmination of the reguhtions for MQSA 

� What are the appropriate duties of the interpreting physician, the radiologic 

technician, and the medical physicist in ensuring quality mammography? 

The OSCAR data we analyzed, as well as our interviews with State inspectors and


facility personnel, indicate that HCFA regulations do not completely reflect current


industry practice regarding the duties of the physician consultant. The data shows that


facilities are not meeting Medicare’s requirements for physician consultant duties.


Specifically, our respondents questioned the need for physicians to observe a


technician’s positioning and technique on a monthly basis.


Respondents also questioned the need for a contract between a physician and a facility


which outlines the required specific duties of the physician. They stated that in many


cases physicians do not work on-site at facilities, but have films sent to them.


However, a few mammography technicians we spoke with did express satisfaction with


Medicare’s strict requirements for the physician consultant. They were pleased that


the radiologist finally had to get involved with quality assurance.


Our interviews and on-site observations at several facilities indicated the radiologic


mammography technician has most day-to-day control over the production of clear


images in the facility. These are the people who work with the patients, develop the


film, and conduct the quality assurance monitoring. Facility respondents stressed the


importance of the technician’s qualifications and continuing education in the provision


of mammography.


Also, some State inspectors and facility personnel were concerned with the lack of


qualified medical physicists to review all mammography facilities. This concern was


further complicated by Medicare’s requirement that overall responsibility for an


equipment quality control program be assigned to a medical physicist. Some medical


physicists thought this made them liable for any problems, and therefore were


reluctant to perform these duties for Medicare-certified facilities.


Although MQSA emphasizes image quality, MQSA also requires standards for


personnel involved in the provision of mammography. The HCFA’S experience


regarding personnel qualifications and duties could provide useful lessons to FDA as


they refine these regulations.


.	 How can FDA minimize the many and/or varied requirements that facilities 

must meet, but still ensure quality mammography? 

12

For the facility respondents who offered an opinion about MQS~ most said that the 

new regulations should complement State and ACR guidelines. Eighteen facility 

respondents expressed current frustration with trying to meet the varied requirements 

of different organizations and agencies. They wanted one requirement that would 

meet everybody’s requirements and thus reduce the amount of needed documentation. 

By modeling the interim final regulations on current ACR standards, the FDA has 

addressed some of the facility respondents’ concerns. The FDA is also familiar with 

various State standards. Because MQSA must set the national standard for 

mammography facilities, there may be some cases where a State’s standards are 

significantly different or more stringent than MQSA. In these cases, the State 

inspectors (and perhaps the consulting physicist) will bear most of the responsibility 

for instructing the facilities in their State on what the facilities must do to meet both 

MQSA and State standards. 

�	 What methods will successfully disseminate appropriate information about 

MQSA to involved groups and individuals? 

The fact that some mammography facilities have experienced regulation and on-site 

inspection under Medicare (and perhaps their State) helped break ground for MQSA. 

Also, FDA has been working to alert facilities about MQSA. In December 1993, 

FDA’s Commissioner Kessler spoke at the Radiological Society of North America’s 

annual conference, and the FDA presented other materials there to many interested 

people and groups in the radiology community. The FDA’s public conference in 

September 1993 also helped to disseminate some initial information. In Februa~ 

1994, FDA sent a quarterly newsletter, entitled “Mammography Matters,” to all known 

mammography facilities to alert them of their need to comply with MQSA. In 

addition, State involvement in educating facilities will increase the effectiveness of 

Federal education efforts. 

However, thirty-eight percent of facility respondents we spoke with either have not 

heard about MQSA or are unfamiliar with its intent. Some confused the Medicare 

regulations and MQSA. In addition, approximately 35 percent of facilities providing 

mammography services in the country have not applied for Medicare certification nor 

undergone an inspection. It is unknown how many of these facilities will apply for 

Medicare certification or undergo an inspection before MQSA is implemented. 

Facilities with minimal State and no previous Federal or ACR monitoring will be 

especially unfamiliar with the regulatory process and inspections under MQSA. 

Although we realize that facilities are ultimately responsible for their compliance with 

MQS~ to avoid similar problems encountered during the Medicare inspections, we 

agree with the 21 State inspectors who said that facilities should be thoroughly trained 

on MQSA’S regulations before the inspection process begins. Ensuring that the 

mammography technicians are well-informed and instructed is especially crucial to 

successful MQSA implementation, not only to the letter but to the intent of the law. 

13

Capacityto inspect all mammographyfacilitia on an annual bask 

�	 What issues must FDA address to inspect all mammography facilities on an 

annual basis? 

The regulations under MQSA will differ from those under HCFA’S program. 

However, both programs require annual on-site inspection of 100 percent of facilities 

in their programs. Even if FDA significantly lowers the on-site and overall inspection 

time currently expended in the Medicare inspections, the additional 4,000 facilities 

covered by MQSA poses a substantial challenge. 

To meet the 100 percent on-site inspection requirement, the FDA must use staff in 

the radiation control agencies in the States. However, these agencies va~ their 

current capacities to fulfill that charge. Until their involvement in the Medicare 

program, some of these agencies only conducted minimal safety inspections of 

radiation equipment in their States once every three years. Even under the Medicare 

program, most of the States radiation control staff still only conduct the machine 

portion inspections. Other States conduct more comprehensive reviews of 

mammography facilities. Furthermore, these agencies must contend with competing 

priorities for inspections of radiological equipment in their States. 

State radiation control personnel in 32 States said they will need additional staff to 

enforce MQSA. Fourteen radiation control respondents said they would need two or 

more additional staff to cover the MQSA inspections, while 12 said they would need 

between one and two additional people. Six said they would need more, but did not 

know how many. In addition, radiation control personnel in 33 States said they would 

need additional equipment. 

Medicare inspection experience and the apparent shortage of qualified staff and 

resources should spark serious discussion over ways to prioritize and streamline the 

inspections while still ensuring quality mammography. The FDA will need to work 

closely with the individual State agencies in order to identifi their current capacity, 

projected workload, and needed staff and equipment resources. 

.	 Will States be able to hire extra inspectors to cover the workload required by 

MQSA inspections? 

Most of the respondents we spoke with in the States’ radiation control agencies said 

they could hire and had room for extra staff as long as the funds were readily available 

for salaries and other expenses. However, there may be a time lag in hiring new staff 

if these States have to wait for funds generated from user fees. 

However, radiation control personnel in 16 States said that there were possible 

constraints to expanding the staff in their agencies. Of these States, half thought that 

a current State hiring freeze would prevent them from expanding their ageney. The 

14

FDA may have to use their own inspectors in those States where additional staff 

cannot be hired or in those States where the inspectors need extensive training. 

. How will FDA train all the inspectors needed to conduct the inspections? 

The MQSA legislation requires that only qualified inspectors conduct on-site 

inspections of mammography facilities. The FDA is currently designing a two-week 

training course for inspectors which includes field training. Furthermore, experienced 

inspectors will be given the opportunity to “test out” of certain portions of the training. 

Some of the State inspectors currently conducting Medicare inspections commented on 

the training they received from HCFA and FDA. Most expressed the need for more 

training in unfamiliar areas. In particular, radiation control personnel wanted more 

practical training on conducting paper reviews. Also, our observation of inspections 

and interviews with inspectors revealed that some inspectors had different ideas about 

their role as inspector - some inspectors viewed themselves as educators in a facility, 

whereas others were more concerned with strict compliance with the regulation. We 

hope the FDA will consider these issues when designing their training curriculum. 

Development of a munagemenl informationsystem 

.	 What data should be collected from MQSA inspections? How could FDA use 

this data to better implement and manage MQSA? 

The MQSA legislation requires that States prepare and submit an annual report on 

the facilities inspected. We believe that such information, if continually collected and 

analyzed, could be highly useful for providing feedback and assistance to State 

inspection agencies and facilities as well as revealing the state of quality in 

mammography facilities. The FDA is currently developing a management information 

system to handle the mass of data which MQSA will generate, as well as help prepare 

the required reports. 

The HCFA’S OSCAR system is an example of such a database. The OSCAR system, 

however, does not always differentiate between a substantive problem as opposed to a 

documentation technicality. To illustrate, facilities were cited for having the operator’s 

initials on the patient’s record, as opposed to the operator’s full name. The OSCAR 

system does not capture the fact that the operator is identified on the patient’s record 

but failed to record their full name. The FDA’s management information system 

should capture such differences. The HCFAS experience with inspections and with 

OSCAR could provide valuable information in helping to design FDA’s system. 

15

RECOMMENDATIONS


In light of our findings, we make recommendations both to HCFA and FDA regarding 

implementation of the Mammography Quality Standards Act. We believe that FDA 

has made significant progress towards the successful implementation of MQS& 

including a public conference with the mammography community to discuss the 

implementation of MQSA. The FDA published interim final regulations for the 

quality standards and the accrediting bodies. In addition to these efforts, we believe 

that in the interim period before implementation, both HCFA and FDA need to 

coordinate their work to ease the transition for mammography facilities. 

To ensure the smooth implementation of MQS~ H~A ~d ~A sho~~ 

�	 reach agreement on the role of HCFA’S screening mammography certification 

program in the interim period before full implementation of MQSA. 

The HCFA inspections could be used to educate Medicare certified 

mammography facilities on the new requirements of MQSA. It would 

also allow inspectors to increase their familiarity with the MQSA 

requirements. 

To effectivdy target current areas of concern wme irnplemen~gMQS4 ~A


should. 

c	 ensure that facility personnel are aware of and thoroughly trained on MQSA’S 

requirements; 

While FDA has begun educating the mammography industry on 

MQSA’S requirements, further efforts might be made to en&re 

that personnel involved in the day to day operation of the 

mammography units are trained on the requirements. For 

example if funds were available, FDA could provide training 

funds to States to educate the provider community on the new 

regulations, or work with private entities like the ACR, medical 

societies, and professional organizations to educate their 

members. 

c	 examine ways to perform the most effective and cost-efficient inspections which 

still adequately enforce the regulations (given that the law requires an annual 

on-site inspection of all mammography facilities); 

Potentially, inspections could be prioritized or targeted to ensure that 

the facilities with little prior regulation, or a history of problems, are 

inspected first. Another possibility includes designing streamlined 

inspections for facilities with a proven compliance record. The FDA 

16 

—-
should use current inspector’s experiences in conducting HCFA’S on-site 

inspections to develop FDAs inspection protocols. 

�	 develop a management information system that allows for continuous 

monitoring of State inspections agency performance and facility compliance and 

distinguishes between documentation non-compliance and performance noncompliance. 

We understand that FDA has begun developing a management 

information system for MQSA. We believe the system developed must 

be able to distinguish between documentation non-compliance and 

performance non-compliance. 

AGENCY COMMENTS 

We received comments on our draft report from both HCFA and FDA. The HCFA 

agrees with our recommendation that they reach an agreement with FDA on the role 

of HCFA’S screening mammography program. Instructions on ensuring a smooth 

transition from HCFA’S management of the screening mammography program to 

FDA’s management of MQSA will be sent out shortly to HCFA regional offices, 

Medicare State agencies and State radiation control agencies. 

The FDA concurs fully or in principle with our recommendations. As part of the 

implementation of MQS~ FDA is already implementing or in the process of 

implementing our recommendations. They have held public meetings to discuss the 

quality standards of MQS~ provided initial training to some State inspectors, have 

reached an agreement with CRCPD for the States’ input into the inspection process 

and have plans to develop a management information system. Each set of comments 

are presented in fill in Appendix C. 

We also have made a number of changes to the report based on the agencies’ 

comments. The FDA requested additional information on some areas of our report; 

we have provided that information separately to FDA. 

17

APPENDIX A 

LIST OF STA~ AND HOW THEY PERFON INSPE~ONS OF 

sCREENING MAMMOGRAPHY FA~ 

--ri---
STATE COMBINED RADIATION SURVEY & 

AGENCY CONTROL CERTIFICATION 

AGENCY AGENCY 

Arkansas x	

Arizona x	

Alabama x	

Alaska x	

California x	

Colorado x	

Connecticut x	

District of	

Columbia x	

Delaware x	

Florida x	

Georgia x	

Hawaii x	

Iowa x	

Idaho x	

Illinois x	

Indiana x	

Kansas x	

Kentucky	

Louisiana x	

Massachusetts x	

Maryland x	

Maine x	

Michigan x	

Minnesota x	

Missouri x	

Mississippi x	

A-2	
STATE COMBINED RADIATION SURVEY & 

AGENCY CONTROL CERTIFICATION 

AGENCY AGENCY 

Montana x	

North	

Carolina x	

North Dakota x	

Nebraska x	

New x	

Hampshire	

New Jersey x	

New Mexico x	

Nevada x	

New York x	

Ohio x	

Oklahoma 

Oregon x	

Pennsylvania x	

Puerto Rico x	

Rhode Island x	

South Carolina x	

South	

Dakota x	

Tennessee x	

Texas x	

Utah x	

Virginia x	

Vermont x	

Washington x	

Wisconsin x	

West Virginia x	

Wyoming x	

A-3 
APPENDIX B 

NUMBER OF FACILKIES OUT OF COMPLIANCE WITH ONE OR MORE 

CONIXTIONS OR STANDARDS UNDER THE KREENING MAMMOGRAPHY 

REGULATIONS. 

B-1 

—— ——. 
We obtained data from OSCAR on the results of all inspections entered through 

August 31, 1993. A total of 1,615 inspected screening mammography facilities were 

entered. Inspectors found deficiencies in 1,394 facilities. The following table breaks 

out the number of mammography facilities failing one or more standards or conditions 

after their initial inspection. Conditional level requirements are bolded. 

The HCFA assigns identification numbers for data input (known as tag numbers) to 

various conditions and standards. The HCFA can assign more than one tag number 

to a standard or condition. For example, the standard for personnel orientation has 

12 different tag numbers assigned for various portions of the standard. We chose to 

combine the tag numbers under a standard or condition. The facilities out of 

compliance represent a unique count of facilities failing one or more of these tags 

under a standard or condition. Conditions are in bold text, while standards are in 

normal text. 

Regulation 

General - Must meet all the conditions in the 

Consultation with a qualified physician. 

Qualifications for the Dhvsician consultant. 

Interpretation of the results of screening 

mammography procedures. 

Board certification of interpreting physician. 

Qualifications of operators of screening 

mammography equipment. 

Facilities out Percent out of 

of compliance compliance 

I I 

I


123 8% 

195 12% 

99 6% 

232 14% 

I 1 

233 14% 

B-2	
.,.,.,.,.,.,.,.,.,.,:.:.:.. ,,.,.,.,,,,::.:.,.,.: .,,,. ......... ...................... .......... .................................................... .... ....................................:,:,:,; ......................,,,.,,. ..........,,., .....,,...........,,,,,,,, .,..,,.,,,,,,,, .... ............,,,., ..,,, ...... ,,, .,,, ....,,, .,,, ....,, .....,, ......,....... ....... ,,,,,...., ..................,.,,..,. .. .......... .....................................................................

.................. .........

.............. .........:.:.,.:,::.:.,,,. ,.,. .. ................................

Facilities out ‘ Percent out of 

Regulation of compliance compliance 

Personnel orientation for mammography	

operators. 621 38%	

Qualifications of individuals furnishing diagnostic	

X-ray physics support. 162 10%	

Maintenance of employee records. 119 7% ., ,:.:,,,,. ,,, ,., .:,.,., ,,,,, ...,:,,.,, .,,.:. ,.:,::.:.:.: .,, .... ..:.:.:.:.,.::,:,:::.:,,,:,::

:: ....... ... ,., .......... .., . . ... . . ,,,...,,,.. .,.,.,.,., .:,::,,,,,,,, ,,,,, ,,,.,,..,,,,,., ,,, .,.,.,., ,,,,,,, . .,,..,...,,.,, . . . ,,,, 

Obtaining and presening records. 108 7%


Records of screening mammography services


performed by the supplier. 660 41%


Equipment specifically designed for 

mammography. 2 .1% 

FDA standards for x-ray system. 26 2% 

Image receptor systems designed appropriately for 

mammography. 

DeveloDer temperature. 

kV-target-filter combinations. 38 2% 

Focal spot size. 23 1% 

Devices to immobilize and compress the breast. 43 3% 

Standard: Anti-scatter grids. 15 1% 

Automatic exposure control. 9 1% 

Control panel indicators. 17 1% 

Recalibration of mobile units after each 

relocation. 24 1% . -.,.,.= .,.:......

.,,,.

.

;,.,. . .=.. .,,..:,::::>::::

Safety standards. 11 1% 

Safety precautions. 58 4% 

Exposure badges to measure radiation exposure. 27 2% 

Equipment inspection. 75 5% 

Protection against electrical hazards. 43 3% 

B-3 
................. .................. .. .. .......

Facilities out percent out Of 

Regulation of compliance .,,,:, 

compliance . . . . .,; ,. 

387 24% 

-q assurm=* 

423 26% 

Responsibility 

119 770 

Calibration of equipment. 

684 42V0 

Performance monitoring. 

378 23% 

Evaluation of monitofig results. 

Retake analysis. 

218 13% 

for the quality assurance progam. 

Responsl%le personnel for monitofig must be 476 29% 

assigned. 

* More than one tag number was rolled up into these conditional level requirements. 

B-4	
APPENDIX C 

AGENCY CO~ 

c-1 
To 

DEPARTMENTOF HEALTH 8LWW SUWICES mtllkmti 

Memorandum 

.APR Io S94


Assistant Secretary for Health 

Office of Inspector General (OIG) Draft Report “Lessons From


Inspections of Mammography Facilities,” 0EI-05-92-O0300


Inspector General, OS


Attached are the PuMic Health Semite comments on the subject 

draft report. We concur fully or in principle with the 

report’s reconnnendations and our comments describe the actions 

taken or planned to implement these recommendations. We also 

offer a seri.ea of tec~ical comments for your consideration. 

ffJj+&L � Philin _—-——— c- . Lee, . M.D.


Attachment


C-2 

— 
-. 

?UBLIC HEALTH SERVICE (PHS) COMMENTS ON THE OFFICE OF , INSPECTOR GENERAL (OIG) D-T REPORT “LESSONS FROM 

INSPECTIONS OF MAMMOGRAPHYFACILITIES,” OEI-05-92-00300


OIG’S recommendations present important “lessons” that the


Food and Drug Administration (FDA) should be aware of as the


Mammography Quality Standards Act (MQSA) of 1992 is


implemented. The Health Care Financing Administration’s


(HCFA) experience in the inspections of Medicare screening 

mammography facilities is important. However, the emphasis on 

providing facilities with sufficient information to understand 

what is required of them prior to the first inspection is a 

tall order. The time frames required of FDA to properly 

certify all facilities prior to the October 1, 1994 deadline? 

and the resources available to accomplish the tasks, will 

require FDA to focus on the certification process rather than 

any extensive facility education program. 

At the same time, FDA recognizes that the intent of the MQSA


is to bring facilities into compliance rather than forcing


mammography facilities out of business. To that end, FDA will 

implement the law fairly. Facilities will be given the 

opportunity to comply fully with the MQSA; however~ if 

facilities refuse or are unable to comply, FDA will enforce 

the law and move to assure that these facilities do not 

operate unlawfully. 

The dilemma identified in this report (the education versus 

enforcement role of the inspector) is one that is always an 

issue for regulatory programs. There is no Westion that 

inspectors must be responsible for the objective, unbiased 

evaluation of the facility. This enforcement role is the xnost 

important. However, it is also possible for these inspectors 

to pxovide some assistance to the facilities to help them 

determine how to come into compliance. When this assistance 

is provided it must be provided in a lawful, fair, uniform 

reamer and the inspector must not provide information that 

could be construed as providing specific details about how to 

comply with the regulations. The regulatory programs in the 

States have historically worked out for their own purposes how 

this issue should generally be handled. FDA will not 

encourage the inspectors to take on responsibilities that


appropriately belong to the facility’s medical physicist.


91G Recommendation


1.	 The HCFA and FDA should have a written agreement on the 

role of HCFA’S screening maracuography certification 

program in the interim period before full implementation 

of MQSA. 

c-3 

..— 
2


ti concur in pa*. The FDA and HCFA are already working to 

provide a muooth transition between the Medicare program and 

the 14QSAprogram. It is our intention to go as far as is 

possible to make these changes through administrative actions. 

However, it is not yet clear that all of the issues can be 

resolved within the Depar@nent. A conforming amendment to the 

Medicare program may still be required to resolve this issue 

completely. If the Department determines that Congressional 

action is necessary to complete the task, all possible lawful 

steps will have been taken within the Department by the 

October deadline.


In this light, FDA suggests,the following alternat~ve language 

for OIG’s first recommendation: 

To ensure the smooth implementation of MQSA, HCFA 

and FDA should ~ X agreement on the 

rele of HCFA’s screening mammography certification 

program in the interim period before full


implementation of MQSA.


91G Rec~ e~dat~m 

2:	 The FDA should ensure that facility persomel are aware 

of and thoroughly trained on MQSA’S requirements. 

PHS Comment


We concur in principle. OIG recommends FDA provide training


funds to States to improve the knowledge of MQSA requirements


among the provider community. Although this approach could be


useful, the suggestion is unrealistic in light of existing


budget constraints. FDA does not have sufficient funds this


year to fully fund the first year of the MQSA inspection


program. Given this constraint, FDA’s highest priority for 

applying the limited available funds is to assure that the 

inspection program is funded as completely as possible. 

However, FDA has worked to alert facilities to the 

requirements. FDA has sent the interim final rules to 

individual facllit2e8, it has worked to alert the professions 

by attending their professional meetings, holding public 

meetings to invite interested parties, and finally, it has


established a quarterly newsletter, entitled ‘_ography


Matters.” The first edition of this newsletter was sent to 

all known mammography facilities in February 1994. Its 

purpose is to alert facilities not only to the need to comply 

with the MQSA, but to answer some additional more involved 

issues, explain the differences between the existing American


c-4 

—._— 
. 

3 

College of Radiology (ACR) and HCFA programs and the MQSA, and


emphasize the need to be accredited by an approved accrediting


body .


In addition, on March 7, 1994 FDA provided a Level II training


for 20 mammography inspectors who are senior staff from the


States.


~ endation 

3.
 The FDA should examine ways to perform the most effective 

and cost-efficient inspections which still adqately 

enforce the regulations (given that the law requires an 

annual on-site inspection of all mammography facilities.) 

PHS Comment 

We concur. The recommendation to utilize the experience of 

the State inspectors in the development of the MQSA inspection 

prwram has been implemented. In February 1994, the 

Conference of Radiation Control Program Directors and FDA 

agreed to a process by which the States will have input in the 

inspection procedures as they are developed. However, the 

tting required to implement the program will limit the


opportunity for an involved iterative process here~


OIG Recommendation


4:	 The FDA should develop a management information system 

that allows for continuous mnitoring of State 

inspections agency performance and facility compliance 

and distinguishes between documentation non-compliance 

and performance non-compliance.


PHS Coxmne
nt


We concur. FDA will develop a management information syst= 

(MIS) that will allow continuous monitoring of State 

inspections.and facility compliance. The MIS will focus on 

facility performance, including documentation necessary to 

assure adequate performance.


Technical Comments


The following comments are related to specific sections of the 

report, as noted. 

1) -~ Paei a~h 5: MQSA’S effective date should be

revised to state that MQSA prohlblts any mammography facility 

from operating after October 1, 1994 without a ce~ificate 

issued by FI)A. The current word~nq suggests that facility 

c-5 

—.——-
. 

4


certification might start after October 1, 1994; should this 

be the case, all mammography facilities would be unlawfully 

providing mammography se=ices since no facillty would have 

the required certificate. Additionally, MQSA dld not replace 

Had&care’s current regulations. The question is whether the 

Department has the authority to modify the approach taken 

under the Ommibus Budget and Reconciliation Act of 1990 (OBW 

’90) to effect the replacement, or whether Congress will have 

to pass a conforming amendment to correct the situation. In 

the =anttie, FDA and HCFA are working to assist facilities in 

the transition. HCFA is working with their contractors in tho 

State health departments to inform facilities inspected under 

the Medicare program that inspection after September 1994 wi~l 

be against MQSA requirements. As MQSA inspection procedures 

are developed, State inspectors can use these methods rather 

than the Medicare su~ey methods and will evaluate facilities 

against MQSA’S interim final regulations where appropriate. 

2) ?~ anh 4$ The report seems to confuse the 

numbers of facilities accredited by ACR with the number of 

x-ray units. This common point of confusion results from one 

of the differences between what ACR has historically done? 

i.e. accredit individual x-ray units, and what is required 

under the statute, that facilities rather than individual xray units be accredited. The number stated in this paragraph 

appears to represent the number of units accredited not the 

number of facilities. This will demonstrate a larger 

difference between those facilities accredited by ACR and the 

total number in the U.S.. AS of February 1994, ACR had 

accredited 7,742 units in 6,029 facilities. 

3) Paae 2 � Da~ZIDh L The wording of this paragraph should 

be modified to reflect he proper ownership of the NEXT 

program. TMs La a program that is conducted by the 

Conference of Radiation Control Program Directors. FDA, under 

the terms of a cooperative agreement covering several areas, 

receives the results of the States’ program and has publishanalyses of the NEXT program results. FDA would prefer the 

following language: “...although FDA has obtained information 

from the Conference of Radiation Control Program Directors 

(CRCPD ) concerning mammography use. Individual States, usiW 

the NEXT protocol, have measured patient radiation exposures 

and assessed phantom image quality . ...” 

4) ~: e2 It is not clear that the reason for 

HCFA’S delay in publishing the final regulations is totally 

related to the xerography issue. We believe there were other 

substantive issues as well, one of which was the enactment of 

MQSA about 22 months after the interim final mammography 

screening rules were published by HCFA. 

C-6

.’O 

5


5) Paae 3, 2nd whole Darac7raDh: See technical comment 

number 1. 

6) Paae 4, paraaradl 1: Information from the 4 States that


had not yet done any inspections muld be helpful to FDA in


its negotiation of inspection contracts with these States.


This information might point to issues that should be


considered before negotiations begin so that if there are
 .	 problems that need to be resolved, FDA will have some 

opportunity to work to that end and assure adequate 

inspectional programs in each State. 

7) Paue 6. Pa auraph 2: AS in Technical Comment number 6,


FDA would likerto have the information the OIG has obtained


regarding the number of inspections performed by each State.


8) paae 7, naraaranh 4: Although the statement is true that 

under OBRA ’90, the Medicare program could reimburse 

facilities for providing diagnostic mammography semices, it


would nevertheless be useful here to reiterate that under MQSA


any facility that does not have an FDA certificate after


October 1, 1994 can not lawfully provide mammography semices


of any type regardless of whether federal reimbursement is 

involved.


9) Paae 9. section on “Oualitv Assurance !40nitorin~”2 The 

fact that documentation of quality control (QC) practices was 

not available for the State inspector should be considered a 

demonstration that QC practices are not implemented. The 

evaluation of the processes, i.e., making objective 

measurements of the pxocess, and recording those measurements 

is central to any QC program. This is a rather generic 

process whether 4t is used in an industrial setting or a 

nmclical one. The lack of documentation of the process 

measurements would prevent trend analysis which is essential 

to process control. IUthout this essential element, the 

process controls are limited to correcting bad processes


rather than preventing them which is the fundamental goal of a 

quality assurance (QA) program. If measurements are being 

taken but not documented for trends analysis, this should not


be considered a QA program.


10) Paae 11. last naxaaranh: The concern mentioned here 

regarding the cost of accreditation should be placed in 

perspective with the other aspects of the program. If 

facilities cannot afford to pay the accreditation fee, how can


they afford to pay for the annual physics survey rqired bY


MQSA, and, if the inspections are to be self funding through


fees as required by MQSA, these will be new costs to


facilities that they have not previously incurred. These are


among the issues that are assiqned by the statute to the


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6


National Mammography Quality Assurance Mvisory Committee.


11) paae 12, naraa raph ~: The comment in the last line of 

this paragraph regarding the requirement for radiologists to 

“finally get involved with quality assurance” is an 

interesting contrast to the complaints by some facilities 

regarding the need for the physician consultant on page 8~ 

paragraph 1. It appears that the team did find some support 

for the concepts behind physician involvement in establishing 

and monitoring the quality of mammography performed in the


facility. This comment should be strengthened to put the


complaints reported on page 8 into better context.


12) ~~ r x The comments in this paragraph 

regarding the question of sufficient medical physics support 

and the concern of some physicists for liability and the 

speculation that this might cause some to refuse to work under


these conditions is an important issue for the Mvisory


Committee to evaluate. Any specific information the authors


of this report could provide to clarify these issues would be


important for the Mvisory Committee to have available to


them .


13) Paae 13, DaraUraDhS 3 & ~: We are concerned that the OIG


seems to place nearly all of the responsibility on FDA for


alerting facilities to the need to comply with MQSA. The


limited time provided to implement the program severely limits


the opportunities for facilities to fully understand what is


expected of them prior to the compliance deadline. The HCFA


experience suggests that many of the people involved in


mammography facilities do not take these requirements


seriously in the first place. Even the strongly worded letter 

from HCFA warning against false attestations resulted in a 

very high percentage of facilities making attestations of 

compliance without understanding the requirements. Clearly, 

this is a difficult task that will finally be resolved only


during the inspection program.


The FDA has worked to alert facilities to the requirements,


not only by sending the interim final roles to individual


facilities, but has also worked to alert the professions by


attending their professional meetings, holding public meetings


to invite interested parties, and finally~ a Wafierly


newsletter has been established and the first edition sent to


all known mammography facilities in February 1994. This first


newsletter was written to alert facilities not only to the	

need to comply but to answer some additional more involved 

issues, explain the differences between the existing Advisoq 

Committee and HCFA progr~s and this new one~ and mphasize 

the need to be accredited by an approved accrediting body. 

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—	
.’ 

7


The FDA is aware of activities on the part of some States to 

provide information on MQSA to mammography providers (e.g., 

Comecticut recently made such efforts with assistance froxn 

the FDA Regional Radiological Health Representative). State


efforts will clearly increase the effectiveness of federal


educational efforts.


14) Paffes14 & 15, re: inspector training: FDA began the 

training program for inspectors in February 1994. The 

training program will provide inspectors with much more 

extensive training than the llCFA program did, with three 

2-week training sessions interspersed with mentored inspection 

work and culminating with a practical qualification 

examination. Once potential inspectors have been qualified, 

they will be permitted to conduct the MQSA inspections. Then, 

their performance will be monitored through the statutorily 

required audit program. 

, 

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w L-

� DEPARTMENT OFHEALTH& HUMAN SERVICES Fmncing Admtmstration * ; 

; 

“ 

/-%

4 Memorandum 

Date


“~ ‘ “ ~#( 

From	 Bruce C. Vladecfl 

Administrator 

‘w Office of Inspector General (OIG) DraftReport Lessons From Inspedions
 of

Mammography Facilities
 (OEI-05-92-00300)


To 

JuneGibbsBrown


Inspector
 General


We reviewed the subject draft report which describes inspections of mammography 

facilities under the Medicare screening mammography program. The report also 

discusses the implementation of the Mammography Quality Standards Act (MQSA). 

We agree with OIGS recommendation that the Health Care Financing 

Administration (HCFA) and the Food and Drug Administration (FDA) have a 

written agreement on the role of HCFA’S screening mammography certification 

program. HCFA and FDA have agreed on an approach to surveying screening 

mammography facilities between now and the time MQSA becomes effective after 

September 30. This approach will include continued onsite inspections of Medicare 

approved screening mammography facilities through September 30, after which the 

FDA will assume responsibility for all certification activity. Instructions to implement 

the agreement between HCFA and FDA will be sent shortly to the HCFA Regional 

Offices the Medicare State agencies, and the State radiation control agencies. These 

instmctions will ensure a coordinated transition from HCFA’S management of the 

screening mammography program to FDA’s management of the MQSA HCFA will 

ako ksue a regulation to accept FDA’s quality standards for Medicare facilities that 

provide mammography seMces. 

Additional comments are attached for your consideration. Thank you for the 

opportunity to review and comment on this draft repolt Please advise us if you 

would like to discuss our comments at your earIiest convenience. 

Attachment 

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~1 

on theOffice oflnsn ector General’s
 (OIG)DraftRmort:


‘%essons From InsD ections
 ofMammographyFacilities”


[OF1-05-92-00300]


GeneralComments


m
 The report states that it is unknown how the Mammography Quality Standard 

Act (MQSA) till affect the Medicare progr~ and ~sPections” We have 

determined that there is no conflict betsveen the Medicare screening 

mammography law and the interim regulations promulgated by the Food and 

Drug Administration (FDA) on December 21, 1993. A a resul~ we are 

amending the interim final Medicare screening mammography regulations to 

cross-reference the FDA standards by the effective date of those rules 

(October 1). 

m
 The secondfinding ofthereport includes a statement
 thatmammography 

facility deficiencies werenotserious. The basis forthis finding appearstobe

on page7,whereitstates that“hxsthan5 percent ofalldeficiencies
 foundi

thefacilities areforconditional level (considered serious)
 deficiencies.”

Minor deficiencies typically greatly outnumber serious deficiencies in any type 

of quality su~ey, and, thus serious deficiencies as a percentage of all 

deficiencies would typkdly be small. Therefore, we do not believe this k a 

valid analysis or finding and request that it be deleted from the report. 

The last recommendation, addressed to FD& is to develop a system that 

distinguishes behveen “documentation noncompliance” and “performance 

noncompliance.” The report does not provide a further explanation of what 

either condition means, nor does it provide a rationale for this 

recommendation. We suggest that the final report further develop an 

explanation and justification for this recommendation. 

A significant difficulty with this recommendation is that “documentation 

noncompliance and “performance noncompliance” appear to be interhvined. 

For example, if corrective action documentation is missing (“documentation 

noncompliance”) for a problem that may have caused inaccurate test resul~ 

the sumeyor would then check patient records for any unusual test results. 

This examination of patient records may result in the discovery of a 

“performance noncompliance” when in fact the investigation started as a 

‘documentation noncompliance” issue. 

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8 
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Page 2 

Technical Comments 

Page 2,third full paragraph The report states that “HCFA has not yet published 

final regulations for screening mammography because of departmental concerns over 

Medicare’s regulation concerning xerography equipment.” We suggest hat the 

statement be revised to read as follows: 

“HCFA has not published final regulations for screening mammography under 

the Medicare program for a number of reasons including the enactment of 

the Mammography Quality Standards Act (MQSA) of 19Z which the Food 

and Drug Administration is responsible for implementing by October 1, 1994, 

and which HCFA believes will supersede the Medicare standards at that time.” 

Page 7,last sentence The report states
 that“HCFA basedthescreening 

mammographyregulations on theportable x-ray regulations thatrequire
 thata

physician supervisor oversee thex-ray process.” We suggest thattheStiternent
 be


revised
 toreadasfollows:


“HCFA modeled its Medicare screening mammography regdation$ k pan 

after the American College of Radiology Accreditation guidelines and the 

Medicare portable x-ray regulation% both of which require that a physician 

supervisor oversee the x-ray process.” 

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