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

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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  Medicares  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  FDAs  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  HCFAS 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 Medicares  regulations  is the 
biggest problem  encountered  during inspections. 
Respondents  from  34 States  said that  the  facilities  inspected  so far were  unfamiliar 
with Medicares  regulations.  Thirty-nine  of 87 facility respondents  said they  received 
no information  about  the  inspection  before  it occurred. 
The  HCFAS experience  with the Medicare  program provides valuable  lessons  for 
FDA  as they implement  the Mammography  Quality Standards Act.  These  lessons 
relate  to: 
.  The FDAs  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 HCFAS 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 
MQSAS 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  inspectors  experiences  in conducting  HCFAS 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  non-
compliance. 
...
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 Medicares  regulationswas  the biggest problem 
encountered  duringinspedions.  . . . . . . . . . . . . . . . . . . . . . . . . . . ..  . ..10 
.The  HCFAS 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. . . ..  Cl.  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. 
StateStandanh 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 CRCPDS 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 
Medicares  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  Medicares  quality  standards.  To  expedite  the  process  of certi&ing 
facilities,  HCFA  allowed  facilities  to attest  in writing  that  they  met  Medicares 
standards.  From  January  1991 to September  1992, about  6,500 facilities  attested  that 
they  met  Medicares  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  on-
site 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  MammographyQua&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  Medicares  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  FDAs  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  Americas  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  HCFAS 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 
HCFAS 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  Presidents  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  HCFAS 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 facilitys

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 HCFAS 
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  HCFAS 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 manufacturers 
specified  developer  temperature)  and  10 percent  failed  safety  standards.  This 
accounted  for just  under  1.5 percent  of all conditional  level  deficiencies. 
According  to HCFAS 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 
consultants  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  technicians  positioning  and  technique. 
Typical  of the  comments  we heard  was one  facilitys 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 Tabars 
Level  3 course,  and  even  those  of us who  have  taken  that  course  are  not  qualified  to 
critique  our  technologists  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  mammographys  results  to the  patients  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 physicians

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

HCFAS requirement  that  a written  statement  be  given to the  patient.

Some  facility respondents  were  concerned  that  the written  statement  may interfere

with the  patients  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  radiologists  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 
HCFAS 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 Medicares  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  facilitys 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 HCFAS 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  FDAs  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  Medicares  requirements  for physician  consultant  duties.

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

technicians  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

Medicares  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  technicians  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 Medicares  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  HCFAS 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  everybodys  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 States  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, 
FDAs  Commissioner  Kessler  spoke  at the  Radiological  Society  of North  Americas 
annual  conference,  and  the  FDA  presented  other  materials  there  to many  interested 
people  and  groups  in the  radiology  community.  The  FDAs  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 MQSAS 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  HCFAS 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  HCFAS 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  operators 
initials  on the  patients  record,  as opposed  to the  operators  full name.  The  OSCAR 
system  does  not  capture  the  fact  that  the  operator  is identified  on the  patients  record 
but  failed  to record  their  full name.  The  FDAs  management  information  system 
should  capture  such differences.  The  HCFAS  experience  with  inspections  and  with 
OSCAR  could  provide  valuable  information  in helping  to design  FDAs  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 HCFAS 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 MQSAS 
requirements; 
While  FDA  has begun  educating  the  mammography  industry  on 
MQSAS 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  inspectors  experiences  in conducting  HCFAS 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  non-
compliance. 
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 HCFAS screening  mammography  program.  Instructions  on ensuring  a smooth 
transition  from  HCFAS management  of the  screening  mammography  program  to 
FDAs  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. 
Facilities  out  Percent  out  of 
Regulation  of compliance  compliance 
General  - Must meet  all the conditions in the  I  I 
I

Consultation with a qualified physician.  123  8% 
Qualifications  for the Dhvsician consultant.  195  12% 
Interpretation  of the results of screening 
mammography procedures.  99  6% 
Board  certification  of interpreting  physician.  232  14% 
I 1 
Qualifications  of operators  of screening 
mammography  equipment.  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 
of compliance  compliance 
Regulation  .....................,,,:,  ......................... .........,;,. 
387  24% 
-q  assurm=* 
423  26% 
Responsibility  for the  quality  assurance  progam. 
770 
119 
Calibration  of equipment. 
684  42V0 
Performance  monitoring. 
378  23% 
Evaluation  of monitofig  results. 
13% 
218 
Retake  analysis. 
Responsl%le  personnel  for  monitofig  must  be  29% 
476 
assigned. 
*  More  than  one  tag number  was rolled  up  into  these  conditional  level  requirements. 
B-4	 APPENDIX  C 
AGENCY  CO~ 
c-1  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

To  Inspector General, OS

Attached are the PuMic  Health Semite  comments on the subject 
draft  report.  We concur  fully  or  in  principle  with  the 
reports  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  . Lee, M.D.

_- 
  c- .
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

OIGS 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 Administrations

(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 facilitys medical physicist.

91G Recommendation

1.	 The HCFA  and  FDA  should  have  a  written  agreement  on  the 
role  of  HCFAS  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 OIGs first recommendation: 
To ensure  the  smooth  implementation  of MQSA, HCFA 
and FDA should ~  X  agreement on the 
rele of HCFAs 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 MQSAS 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, FDAs  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 Coxmnen
t

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)  -P~a ei  a~h 5:  MQSAS 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&cares  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 MQSAS 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  x-
ray  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  publish-
analyses  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 
HCFAS 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

c-7
 6

National Mammography Quality Assurance Mvisory  Committee.

11)  paae  12,  naraaraph  ~:  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. 
C-8 
	 . 
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. 
, 
c-9  w 
/-% L-
4 DEPARTMENT OFHEALTH& HUMAN SERVICES 
; *   Fmncing  Admtmstration
; 
Memorandum 
 
Date

~     ~#( 
From	 Bruce  C. Vladecfl 
Administrator 
w  Office  of Inspector  General  (OIG) DraftReport LessonsF rom Inspedionosf

MammographyFacilit(iOeEsI
 -05-92-00300)

To 
JuneGibbsBrown

InspectoGre
neral

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 HCFAS 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 HCFAS management  of the 
screening  mammography  program  to FDAs  management  of the MQSA  HCFA  will 
ako  ksue  a regulation  to accept  FDAs  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 
C-10	 ~1 
ontheOfficoef lnsne ctorG eneral(sO
 IG)DraftRmort:

%essonFsr om InseDc tionosf
 MammographyFacilities

[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 secondfindinogf thereporitn cludeass tatementth
atmammography 
facilidteyf iciencwieerse notseriousT.h e basifso rthisf indinagp pearstobe

onpage7,whereitstatetsh athxsthan5percenotf alldeficiencfioeusn
 di

thefacilitaireesf orconditionlaelv e(lc onsiderseedr iousd)e
ficiencies.

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. 
8  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. 
C-n  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 
Medicares  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 sentenc-e-The reporstt atetsh
 atHCFA basedthescreening 
mammographyregulatioonnst heportablxe- rayr egulatiotnhsa trequirteh
 ata
physiciasnu pervisoovre rseteh ex-rapyr ocess.We  suggestth attheStiternebnet
 

revisetdo
 readasfollows:

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. 
C-12