1988 to regulate physician office laboratories and cannot imagine where to find the funds to
oversee screening. Another obstacle is that some see screening as a great boon to the public
and do not want regulation that would put conscientious, proficient providers out of business.

One of the strongest barriers to regulation is a lack of consensus regarding whether screening
constitutes a clinical diagnostic test or primarily an informational service to the public. In
Michigan and Wisconsin, the State Attorney General has ruled that public cholesterol
screening does not constitute a clinical laboratory test, since it is not ordered by doctors and
providers are not involved in diagnosis and treatment. In Tennessee, while a special task force
unanimously agreed that screening should be fully licensed, legal opinion was split regarding
whether screening constitutes a clinical chemistry diagnostic test under State law. The public
health commissioner is expected to rule shortly on whether screening will be regulated. In
Florida, screening has become highly controversial. The Office of Licensure and Certification
sent cease and desist orders to unlicensed providers some time ago to bring them under
existing State regulation. They then filed an injunction against one provider who ignored the
order. Although the case was recently settled out of court when the provider agreed to comply
with the State’s independent laboratory regulations, other providers continue to operate. State
attorneys apparently have recommended that the State file similar injunctions against them.
Recently, the governor vetoed a bill that would have greatly reduced State regulatory
oversight of public cholesterol screening.

Given these barriers, it appears to many State respondents that regulation will only occur if
federally mandated and funded.

13


A few screening staff remarked that medical experience was not necessary to do screening.
One recommended “a good background in public relations and marketing,” and another
remarked: “Anyone could do this with no problem. The fingerstick is easy and the machine
does the rest!”

Many respondents questioned the qualifications of staff at screenings: “I’ve seen ads in the
paper for people to learn to do cholesterol screening where the main requirement seems to be
that they own a car.” Respondents from two companies who produce analyzers confirmed
that, since their equipment is so easy to operate, people with no medical training could learn to
use it, although they also stressed the importance of staff training and competence.

At many screenings, there is considerable laxity relative to quality assurance.

The NCEP recommendations call for good sample collection techniques and
recommend that screenees remain seated for five minutes prior to giving
blood, to stabilize blood volume.

—_=___T:

° Almost 60 percent of the screenees who gave blood with a fingerstick had their fingers
squeezed, or “milked,” which can affect the accuracy of test results. “Milking” may
dilute the sample by introducing material from between the cells, giving a lower than
normal result. Or it may break down red blood cells, turning the plasma pink; analyzers
that obtain test results based on the color of the sample will get a false result. The
analyzer used in 70 percent of the fingerstick screenings in the field survey uses this
technology.

. Only 13 percent of screenees were advised to sit for 5 minutes prior to sample collection.

Many respondents expressed concern about a lack of quality assurance at screenings. Some
laboratorians believe that for-profit providers short-circuit quality control to minimize
operating costs and maximize profits, or choose equipment based on cost and ease of
operation rather than accuracy. For these reasons, many express concern that “people are
making big decisions about what they are going to do based on what may be a very lousy test
result,” especially given an overly trusting public who “believes that the number coming out
of a machine is carved in stone.”


APPENDIX B CHART OF STATE REGULATION
State Regulation of Public Cholesterol Screening
State jlic.,Reg. |Fees Screening QA Proficiency |OnSite |Patient Exemptions
or Permit Staff Qualif, [Program _ |Testing Inspec, {Follow-up
AZ + ° ° o +
DE Providers who do not market
. ° . ad screening asa lab test
HI Must be sponsored by locally licensed Physician office lab
° o MD, who can be represented by
signed document stating diagnosis.
ID Outside consultation by laboratorian
° + i
‘4 times/yr.
IL" + + +
KY a + o ° ° Special protocol being developed. _| Hospital-sponsored screening
ME ° ° of o ° a Hospitals & physician office labs
MD** recoups
+ costs + + + + +
NV ° ° ° « ° a ¢
NJ Special protocol being developed.
oa ° ° + ° oa ° Must be done under auspices of
licensed MD.
NY fecoups Test must be ordered by licensed Physician office labs
+ cost o ° « MD. Entrepreneurs must be
sponsored by NY licensed clinical lab.
or" Tecoups
° costs ° + ° + o
PA Entrepreneurs must be associated with
e e + : . clinical lab as technical resource &
PAdicensed MD as medical resource
(can be same entity).
RI** Law says screening program “may
° ° aa ° o ¢ be” supervised by clinical or hospital
lab, and/or MD with R.!
WA*" recoups Effective 7/1/90. Law stipulates civil Waiver provision to be defined
° costs + ° ° ° monetary penalty of up to $10,000 per
day per violation of State guidelines.
WY Screening/testing must be ordered
. . . ° . . by WY licensed MD.

"* Regulations are being developed.

Providers are divided into 6 categories, each with a different waiver provision.

B-1



FINDINGS

Public Cholesterol Screening In Many Areas Is Both Prevalent And Growing. Providers Of
All Kinds Are Conducting Screenings.

. According to surveys by NIH and others, the percentage of adults who have had their
cholesterol checked has gone from 35 percent in 1983 to 66 percent in 1989.

° Providers as varied as hospitals, public health departments, health clubs and grocery
stores are conducting public screenings.

. Screening is taking place at shopping malls, pharmacies and many other types of
community settings.

The Accuracy And Usefulness Of Public Cholesterol Screening Are Compromised By Poor
Quality Assurance, Inadequate On-site Counseling, And Lack Of Referral To A Physician
When Appropriate.

. The qualifications and training of staff conducting screening in the field survey varied
widely, including persons both with and without health care experience.

. The basic rules of hygiene were frequently disregarded, raising concerns about the
safety of public screening for staff and screenees alike.

. Staff conducting screenings frequently wore no gloves, or only one glove, yet handled
money and collected blood. Many squeezed or “milked” screenees’ fingers, which can
affect the accuracy of test results by diluting the sample with material from between the
cells, or by breaking down red blood cells.

. Education, counseling, and physician referral of screenees were often lacking.

° Researchers believe that portable analyzers used in public screenings can produce
accurate results given adequate operator training, quality control, and attention to detail.
However they question whether these conditions exist at most public screenings.

Current State And Federal Regulation Of Public Cholesterol Screening Is Minimal.

. Public cholesterol screening will be federally regulated, to some extent, under CLIA of
1988. However, many respondents are concerned that it will be determined to meet the
waiver provisions, which would exempt providers from the performance standards and
inspection provisions of the law.

. Sixteen States regulate public cholesterol screening, but the type and extent of
regulation vary widely. In many other States, the need for regulation is being debated.


Se

RECOMMENDATIONS

STN

The Department Should Discourage Public Cholesterol Screening Which Does Not Meet
NCEP Guidelines.

We found numerous shortcomings which compromise the safety and effectiveness of public
screenings across the country. The public in general is not aware of these shortcomings, and
does not know what to look for in safe, high-quality public screening programs. In addition,
screening staff may be placing themselves as well as screenees at risk due to marginal
observation of the basic rules of hygiene and infection control procedures.

For these reasons, we believe that the Department should publicly discourage public
cholesterol screenings that are unregulated, and lack strong education, counseling and referral
components as recommended by the NCEP.

HCFA Should Not Apply The CLIA of 1988 Waiver Provision To Public Cholesterol
Screening.

We believe that CLIA of 1988 is the appropriate mechanism to federally regulate public
cholesterol screening, since providers of public screening appropriately fall under the
definition of “laboratory” or “clinical laboratory” in the law. We do not believe that screening
meets the waiver provisions of the law. Even if it did, however, we recommend that the
waiver not be applied, since Federal regulation of public screening is clearly called for in
order to safeguard the public.

Regulation under CLIA of 1988 will ensure that screening providers are those with the best
experience and qualifications to produce accurate and reliable test results. Furthermore, all
providers will have to register and disclose their activities, comply with performance
standards set forth by the Secretary, conduct proficiency testing, and permit periodic
inspections.

The majority of respondents in this study, as well as the NCEP, say that effective screening
programs must provide education, counseling and referral. To ensure that providers
incorporate these elements in their programs, we recommend that the Department consider
using the NCEP public screening guidelines as a starting point to establish regulatory
standards under CLIA of 1988.

14


Non-Compliance With NCEP Guidelines in Field Survey

Lo Good Sample Collection Techniques %
Should Be Used i
Finger “milked” to obtain blood 58
Screenees not advised to sit 5 minutes 87

There Should Be Counseling And %
Physician Referral

Screenees not cautioned that:

Single measurement not a diagnosis 83
m_ Test just an indication of level 68
Screenees with tests over 200 not told to 61

see own physician

List of physicians for referral purposes not 82
available

D-2


EN SRE

APPENDIX A

ERI

Description of Field Survey Methodology

From March through June 1989, OIG’s Office of Analysis and Inspections staff observed and
participated in 71 screenings selected at random in ten States and Washington, D.C. The
States were: New York, Pennsylvania, Georgia, Texas, California, Kansas, Missouri, Illinois,
New Jersey and Massachusetts. In order to ensure that their experiences were those of the
general public, screenees did not identify themselves as OIG employees.

Screenees recorded observations on the screening environment and process using a checklist
developed with the NCEP “Recommendations Regarding Public Screening for Measuring
Blood Cholesterol” as a reference. An assessment of the accuracy of test results themselves
was beyond the scope of this field survey. However we did observe the conditions under
which the tests were administered.

Sites included downtown office buildings, shopping malls, pharmacies, restaurants, libraries,
churches and others. Some screenings were free, but most screenees were charged a few
dollars. At most sites, blood was collected with a fingerstick, analyzed in a matter of minutes
with portable equipment and the results given to screenees immediately. One brand of
portable analyzer was used at 70 percent of these screenings. Eight screenees gave blood via a
venipuncture, the sample was analyzed in a stationary lab and the results sent back a week
later.

Hospitals sponsored a quarter of the screenings, many of them part of Countdown USA, a
special effort on April 26, 1989 where over 400 hospitals belonging to the Voluntary Hospitals
of America screened thousands of Americans in community settings. Pharmacies sponsored
another 25 percent and other sponsors included grocery and health food stores, a church, a
public health department and radio and TV stations. Half of the screenings were conducted by
hospitals or small not-for-profit entities and half by for-profit entities, mostly companies
specializing in screening or diagnostic testing, whether cholesterol screening only or an array
of testing.


Of the six screenees in the high-risk category, two were referred to their doctors and three
were told that their results were “slightly high” or “not bad” and given little or no advice. One
woman was told: “People’s cholesterol rises with age, so 243 isn’t that bad. It would probably
be good to watch what you eat.” A man of 20 with a level of 264 was told that his level was
slightly high but given no advice.

s Screeners should use mail or telephone follow-up to ensure that referral advice Is
followed.

Two persons screened by hospitals received letters advertising special classes or programs,
and another received a phone call asking if she had seen a physician as advised.

Respondents in this study stress that, while counseling and physician referral should be key
elements of public screenings, they are lacking at many screenings: “Most people seem to just
get a piece of paper with ranges on it.” This disturbs them because “numbers in a vacuum are
not a complete service.” Some fear that screenees at risk will self-diagnose and treat rather
than seeing a physician. In this sense, one pointed out, “a little knowledge is a dangerous
thing.”

Current State And Federal Regulation Of Public Cholesterol Screening Is Minimal.
Screening will, to some extent, be federally regulated under CLIA of 1988 when it is fully

implemented in 1990-91. However, many respondents are concerned that screening will be
determined to meet the waiver provisions of the law.

In October 1988, Congress enacted the Clinical Laboratory Improvement Amendments, for
the first time bringing all clinical laboratories under Federal regulation. The law requires all
clinical laboratories, regardless of the number of tests they perform, to meet several
requirements in order to obtain a certificate, or license, in order to operate. The law provides a
waiver provision, however. Laboratories employing “methodologies that are so simple and
accurate as to render the likelihood of erroneous results negligible,” or which “the Secretary
has determined pose no reasonable risk of harm to the patient if performed incorrectly,” may
be issued a certificate of waiver exempting them from meeting specific performance standards
outlined under the law.

Three-quarters of State respondents believe that public cholesterol screening will be covered
under CLIA of 1988. However, many are unsure of how the Department will interpret or
define public screening under the law. They believe that screening may be determined to meet
the waiver provisions, which they say would be a “mistake.” Many experts and laboratorians
agree. Laboratorians, especially, favor regulation under CLIA of 1988 as the only way to
ensure quality testing.

ll


policy recommendations on the role of public screening in the national cholesterol education
effort.

Private organizations and groups, especially within the medical community, have also become
increasingly involved in the issue of cholesterol screening. For example, the American
Medical Association, which endorses physician screening, recently launched a Campaign
Against Cholesterol to increase public awareness of cholesterol and educate the public
regarding methods for controlling cholesterol through diet. National sponsors of the
Campaign include Kellogg Company, Boyle-Midway Household Products, Inc., and Merck,
Sharp & Dohme. And the Voluntary Hospitals of America sponsored a special program on
April 26, 1989 called Countdown USA, where over 400 hospitals screened thousands of
Americans in community settings.

SCOPE AND METHODOLOGY

Information was gathered through an extensive literature review, telephone interviews, and a
special field survey in which we observed and participated in 71 public cholesterol screenings
across the country. Appendix A describes the survey methodology.

The literature reviewed consisted of Federal and State laws, regulations and guidelines,
research papers, studies, reports, and newspaper articles.

Discussions were held with nearly 250 persons, including:

. Department of Health and Human Services officials, especially in the Public Health
Service and Health Care Financing Administration (HCFA);

° persons from the Office of Technology Assessment and the General Accounting Office;

. persons in all 50 States and Washington, D.C. responsible for oversight of clinical or
physiological health services;

. representatives of professional associations, State hospital associations and State
consumer fraud agencies;

. experts with special perspectives on the issue; and

. equipment manufacturers.

When this report refers to respondents, it is discussing opinions expressed in these interviews.


SSR

TABLE OF CONTENTS

_eoheatenaenanenee

EXECUTIVE SUMMARY
INTRODUCTION 0.00.00 c cc nee ene tte ene nee ]
FINDINGS 0.0.0... ccc cece ene ene enter e nee eens 4

Public cholesterol screening in many areas Is both prevalent and
growing: Providers of all kinds are conducting screenings ..........+55 4

The accuracy and usefulness of public cholesterol screening are
compromised by poor quality assurance, inadequate on-site

counseling, and lack of referral to a physician when appropriate. ...... 5

Current State and Federal regulation of public cholesterol

screening is MINIMAL. 6.6. nent ee eens V
RECOMMENDATIONS ........ 000 cece ee eee ene tee nee eee 14

APPENDIX A: Description of Field Survey Methodology .........--.++: A
APPENDIX B: Chart of State Regulation»... 6... cece eee eens B.
APPENDIX C: Description of State Regulation .... 6... see e eee eee C-
APPENDIX D: Non-Compliance with NCEP Guidelines in Field Survey ...D:

iv


Some argue that screening is not a clinical laboratory test, and that it therefore does not
need to be regulated.

RECOMMENDATIONS

The Department Should Discourage Public Cholesterol Screening Which Does Not Meet
NCEP Guidelines.

We found numerous shortcomings which compromise the safety and effectiveness of public
screening. The public, in general, is not aware of these shortcomings and does not know what
to look for in safe, high-quality screenings. In addition, screening staff may be placing
themselves, as well as screenees, at risk due to marginal observation of the basic rules of
hygiene and infection control procedures. We therefore recommend that the Department
publicly discourage screenings which are unregulated, and lack the education, counseling and
referral components recommended by the NCEP.

The HCFA Should Not Apply The CLIA of 1988 Waiver Provision To Public Cholesterol
Screening.

We believe that CLIA of 1988 is the appropriate mechanism to federally regulate public cholesterol
screening and that the waiver provision should not be applied. Regulation of screening under
CLIA of 1988 will ensure that screening providers are qualified and experienced. It will also
require providers to register, disclose their activities, comply with Departmental performance
standards, conduct proficiency testing and permit periodic inspections.

The majority of respondents in this study, as well as the NCEP, say that effective screening
programs must provide education, counseling and referral of screenees. To ensure that providers
include these elements in their programs, we recommend that the Department consider using the
NCEP guidelines as a starting point to establish regulatory standards under CLIA of 1988.

COMMENTS

Regarding our first recommendation, we believe we are in agreement with PHS that the NCEP
guidelines must be followed. However, based on what we found in our study, we are unable
to accomodate the word changes suggested by PHS to encourage public cholesterol screening.
We will be able to determine if we are in full agreement with the PHS when we receive their
action plan for enforcing use of the NCEP guidelines.

Since the release of our draft report in November 1989, HCFA has stated that public
cholesterol screening will be regulated under CLIA of 1988. Furthermore, the HCFA
Administrator, in testimony before the Senate Committee on Labor and Human Resources and
the Senate Subcommittee on Oversite of Government Management, indicated that public
cholesterol screening would not be waived. This means that laboratories or sponsors of public
screenings must meet specific performance and other requirements before being certified to
conduct public testing. These requirements are currently being developed within the
Department and should be issued shortly.

tii


Sixteen States regulate public cholesterol screening, but the type and extent of regulation vary
widely.

State respondents often express mixed feelings about regulation. However, over 80 percent
favor some type of regulation to ensure minimum standards for quality control, staff training,
and follow-up.

Sixteen States regulate screening, although four of them only recently passed legislation and
their regulations have not yet been implemented. Some regulate under existing statutes and
others through legislation specifically addressing screening. The extent and type of regulation
varies widely, from paper compliance via submission of a special protocol to full licensure
under a State’s clinical laboratory statute. Appendices B and C summarize existing State
regulation.

Screening poses special problems relative to regulation.

No matter what type of regulation, State respondents often described problems identifying
providers in order to bring them into compliance: “By the time we hear about them, they’re
gone.” Some likened themselves to detectives in trying to track down providers, relying on
advertisements, word of mouth, complaints from other providers, or just plain “serendipity” to
find them.

Some States reported being overwhelmed by both unlicensed providers operating illegally and
the large number of providers applying for a license. Unprepared for the extra workload, they
are still trying to catch up. Five respondents believe that their State regulations have been
effective in curbing screenings by unlicensed providers. Two think that they are now aware of
all screening providers operating in the State. One State limited the number of private
entrepreneurs, that is, those who are not health professionals. They reported that now,
screening done by physicians outside their offices, which is not regulated, has become very
prevalent.

In many States, regulation is being debated.

Many States are just becoming aware of public cholesterol screening. While most State
respondents favor regulation as a means to protect the public from inaccurate testing,
misleading information and unscrupulous providers, there are a number of barriers to
regulation, and opinion among groups both within and outside State Government is often split
with regard to the need for regulation.

The most common barrier to regulation is lack of funding and staff. One State respondent
said, for example that, “if screening were regulated, we would need to at least quadruple our
staff.” Many report that they are scrambling to come up with the funds needed under CLIA of

12


informed about the role of high cholesterol in CHD, and that high blood cholesterol be
aggressively treated. They advised all adult Americans to obtain a blood cholesterol
measurement and recommended physician screening, as a part of routine health examinations,
as the best way to identify persons with elevated cholesterol.

In 1985, NIH launched the National Cholesterol Education Program (NCEP) to implement
these recommendations. The NCEP is a consortium of practitioners, public health
professionals, voluntary health organizations, and government agencies coordinated by the
National Heart, Lung, and Blood Institute. Its mandate is to educate health professionals and
the public in order to identify and treat all adults whose high blood cholesterol places them at
tisk for CHD.

In 1987, an NCEP Adult Treatment Panel established guidelines on the detection, evaluation,
and treatment of high blood cholesterol. They advised all adult Americans to “Know your

<200 mg/dL * Desirable blood cholesterol
200-239 mg/dL Borderline high blood cholesterol
>240 mg/dL High blood cholesterol

* milligrams per deciliter

cholesterol number” and established cutpoints for the classification of blood cholesterol:

The guidelines call for physician screening and emphasize the importance of clinical judgment
and patient management. They designate dietary therapy as the comerstone of treatment for
high blood cholesterol.

In 1988, stressing the need for accurate, standardized cholesterol measurement, an NCEP
Laboratory Standardization Panel recommended that: (1) all laboratories achieve cholesterol
measurement no greater than five percent from true value; (2) all cholesterol measurement in
the country be standardized; (3) all laboratories adopt the NCEP cutpoints for identifying
persons at high risk; and (4) portable analyzers be further evaluated before being adopted for
routine use with patients. The Panel stressed the importance of quality control and operator
training with such instruments.

While the NCEP continues to endorse only physician screening, it recognizes that public
screening is widespread and recently issued formal recommendations regarding the conduct of
public screening which will be discussed in this report. Later this year, NCEP will issue


APPENDIX C

Description of State Regulation

Licensure/Registration: In 15 States, providers must be licensed or register, either by site or
provider. Hawaii is an exception, and Illinois exempts not-for-profit providers, who need only
submit a protocol. Fourteen States charge a fee, which may be based on volume of business,
number of staff or the provider’s gross earnings. Only four States (NY, MD, OR and WA)
calculate fees in order to recoup the costs of administering the program.

Staff Qualifications: State requirements vary widely. Some impose no requirements. Others
mandate that staff be graduates of accredited laboratory programs. Some States set no staff
requirements but mandate that a State-licensed independent clinical laboratory, hospital
laboratory or physician be responsible for ensuring that staff are properly trained at all
screenings. Others mandate that providers have a laboratory director or “qualified person”
with certain degrees or experience. Illinois is unique in setting no requirements for
not-for-profit providers, but requiring that staff of for-profit providers be technicians or
laboratory assistants.

Quality Assurance Program: Fourteen States require that a quality assurance program be in
place.

Proficiency Testing: Twelve States require that providers enroll in a nationally recognized
proficiency testing program. Idaho even offers its own program.

On-site Inspection: Eleven States will conduct on-site inspections, although provisions vary
all the way from an annual inspection at each site or selected sites; biennial inspection;
inspection at the discretion of the State; inspection of randomly selected sites; or inspection
following a failed proficiency test.

Patient Follow-Up: Nine States mandate that providers have patient follow-up provisions in
their programs to ensure proper counseling and physician referral, although five are just now
drafting regulations or guidelines (MD, OR, RI, KY, NJ). Pennsylvania also requires that the
physician in charge contact patients within six weeks to stress the need for follow-up.

Provider Exemptions: Seven States exempt certain kinds of providers, including physician
office laboratories (HI, NY); hospitals (KY); hospital and physician (ME); or a provider who
does not market screening as a lab test (DE). Illinois has six categories of providers, each
with different waiver or exemption provisions. Washington State is still developing waiver
criteria.


VICES,
“Us
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3
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%,

Larva:

OFFICE OF INSPECTOR GENERAL

OFFICE OF EVALUATION AND INSPECTIONS

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MAY1990


Many hospitals sponsor and conduct screenings, often for public relations or marketing
purposes. Hight out of 10 respondents from State hospital associations estimated that at least
half of the hospitals in their States conduct some screening, especially larger hospitals in
urban areas. A physician said that his hospital screened 11,000 people in 3 days at malls. A
State respondent described another hospital-sponsored program that screened 22,000 people in
4 days.

Pharmacies also appear to be heavily involved in screening. A survey of the top 100
pharmacy chains conducted by Drug Store News showed that: (1) four times as many chains
were offering screening in 1988 as in 1986; (2) on average, 111 customers were screened per
day per store; (3) half the respondents said they did screening to contribute to their health care
image and “build traffic”; (4) nearly half said they offer screening four or more times a year;
and (5) over half said they collaborate with an outside group to provide screening. Most
respondents reported charging a fee (with the average just over $6), usually to cover costs
rather than make a profit.

The Accuracy And Usefulness Of Public Cholesterol Screening Are Compromised By Poor
Quality Assurance, Inadequate On-site Counseling, And Lack Of Referral To A Physician
When Appropriate.

Many respondents, including 80 percent of the State respondents, believe that the
effectiveness of public screening is often compromised by serious shortcomings relative to
both the screening environment and process. To complement discussions with respondents,
OIG staff conducted a special field survey in which they observed and participated in 71
public screenings across the country. A checklist which was developed with the NCEP
“Recommendations Regarding Public Screening for Measuring Blood Cholesterol” as a
reference, was used to record observations. The methodology used in the field survey is
described in appendix A.

At screenings everywhere, staff are subject to considerable distraction and there is a notable
lack of privacy.

The NCEP recommends that screening environments provide (1) privacy for
blood sampling, confidentiality of results, and discussions between participants
and staff; and (2) adequate staffing and equipment to minimize a “stressed,
hurried environment that is associated with poor quality.” They recommend
that the analyzer used “optimally should provide hard copy readout,” both to
minimize transcription errors and maximize screenee privacy.

Se aera
a DESEO nOnes anes

Screenees described the environment at numerous screenings in the field survey as “highly
public,” with little or no privacy. Blood was almost always collected in full view of other


ee

FINDINGS

sae oe

Public Cholesterol Screening In Many Areas Is Both Prevalent And Growing. Providers Of
All Kinds Are Conducting Screenings

“Cholesterol testing has leapfrogged beyond anything that has been done in
portable testing in terms of rapid growth. Tests are easy, cheap, and practically
public policy”

Numerous comments such as this from respondents attest to both the prevalence and growth
of public cholesterol screening. While there are no reliable national statistics on prevalence,
surveys by NJH and others reflect that the percentage of adults who have had their blood
cholesterol checked, whether in a physician’s office or in a public setting, has gone from 35
percent in 1983 to an estimated 66 percent in 1989. In early 1987, a Wall Street Journal
article reported that about 100 million cholesterol tests were performed in the U.S. in 1986, at
a cost to patients and insurers of between $1 billion and $1.5 billion.

A wide variety of public and private providers, with or without health care experience, are
conducting screenings at sites as diverse as shopping malls, pharmacies, health clubs and
village halls. Hospitals and other health care providers, public health departments, private
agencies and organizations, employers, and businesses such as pharmacies and grocery stores
all sponsor screenings. State respondents who oversee clinical laboratories, especially,
confirm that providers of all types are conducting screenings.

All State respondents report that screening is occurring in their States, and 60 percent say that
it is very prevalent. Early this year, the National Intelligence Report stated that one company
alone in Florida was screening 25,000-30,000 people a month at $7 each.

Currently there are some 25 cholesterol measurement devices on the market. However, three
portable analyzers in particular are being heavily used in public screenings. Many State
respondents report that equipment manufacturers are aggressively marketing and that demand
is high. A manufacturer respondent confirmed that the market is both lucrative and growing.

While manufacturers say that they sell primarily to people with medical qualifications, some
acknowledge that “anyone who has the money” can buy the equipment. For entrepreneurs, there is
money is to be made in public screening. A manufacturer respondent described one woman who
gave up nursing to conduct screenings and grossed over $100,000 in less than 10 months.

While screening is sometimes provided as a public service, more often it serves as a public
relations tool, marketing ploy, or money-maker for the sponsor. For-profit sponsors, such as
retail stores, draw people in with ads and signs in their windows urging people to “Take the
test that could save your life!” or warning: “Cholesterol Kills!”



OA A SR

INTRODUCTION

See

PURPOSE

This report describes the prevalence, conduct and regulation of public screening for
cholesterol. The term public screening refers to screening conducted in public settings, as
opposed to physician offices.

BACKGROUND

This inspection was conducted in response to a request by the Chairman of the House
Subcommittee on Regulation and Business Opportunities, to provide information concerning
mobile health services, that is, services offered outside the traditional settings of a hospital,
clinic, or physician’s office. This is one in a series of reports answering the request.

Public cholesterol screening is the most prevalent and visible type of mobile health service.
According to a recent study conducted by researchers from the Public Health Service, over 60
million American adults may currently have high blood cholesterol, placing them at risk of
heart disease. Demand for screening is increasing significantly. This is due in part to public
awareness of the dangers of high cholesterol. But it also results from expectations of ease,
convenience and low cost of public screening. Also, the development of portable equipment
that uses a fingerstick blood sample has made cholesterol measurement rapid and almost
painless.

Coronary heart disease (CHD) is the major cause of death and disability in the United States.
It accounts for more deaths annually than any other disease, including all forms of cancer
combined. According to the National Center for Health Statistics and the American Heart
Association, over 1.5 million heart attacks occur each year in the United States, and more than
520,000 die from them. Coronary heart disease is estimated to cost over $80 billion a year in
health care costs, lost wages, and productivity.

Thus far, the Federal role relative to cholesterol screening has been one of research and public
education. Screening is not reimbursable under Medicare, although both diagnostic tests and
treatment for high blood cholesterol and coronary heart disease are covered. Screening is not
federally regulated at present. However, when it is fully implemented in 1990-91, Clinical
Laboratory Improvement Amendments of 1988 (CLIA of 1988), which brings all clinical
laboratories under Federal regulation, will apply to screening. The regulations implementing
the law should be issued shortly by HCFA.

In 1984, the Federal Government’s fight against CHD gained momentum. Following the
completion of a major study which linked high blood cholesterol and heart disease, NIH
convened a national conference which recommended that both physicians and the public be


COMMENTS

‘We received comments on the draft of this report from both PHS and HCFA. In responding to
our draft report PHS felt that the first recommendation should be rewritten as follows:

"The Department should encourage public screening for cholesterol when such screening
meets (1) the guidelines established by the National Cholesterol Education Program (NCEP)
and (2) the standards for good laboratory quality control established by the NCEP Laboratory
Standardization Panel."

We are in agreement with PHS that the NCEP guidelines must be followed. However, based
on what we found in our study, we are unable to accomodate the word changes suggested by
PHS to encourage public cholesterol screening. We will be able to determine if we are in full
agreement with the PHS when we receive their action plan for enforcing use of the NCEP
guidelines.

With regard to coverage under CLIA, both HCFA and PHS stated that a decision would have
to be delayed until proper deliberations were made in the context of developing the regulation
to implement CLIA.

Since then, these agencies have been preparing the regulations. While these regulations have
not as yet been released to the public, the HCFA Administrator, in recent testimony before the
Senate Committee on Labor and Human Resources and the Senate Subcommittee on
Oversight of Government Management, indicated that public cholesterol screening would not
be waived under CLIA of 1988. This means that laboratories or other sponsors of public
screenings must meet specific performance and other requirements before being certified to
conduct public cholesterol testing. These requirements are currently being developed within
the Department and should be issued shortly.

We wish to thank those in HCFA and PHS who commented on our report and we are pleased
that our recommendations have been implemented.

15


aE

TIVE SUMMARY

ne

PURPOSE

This inspection was conducted to examine the prevalence, conduct and regulation of public
cholesterol screening. The term public screening refers to screening which is conducted in
public settings, as opposed to physician offices.

METHODOLOGY

Information was gathered through an extensive literature review, telephone interviews, and a
special field survey in which we observed and participated in 71 public cholesterol screenings
across the country. In all, 250 respondents were contacted.

BACKGROUND

According to a recent study by researchers from the Public Health Service, over 60 million
adult Americans may currently have high blood cholesterol, placing them at risk of heart
disease. Demand for screening is increasing significantly. This is due in part to public
awareness of the dangers of high cholesterol. But it also results from expectations of ease,
convenience, and low cost of public screening. Also, portable equipment has been developed
which makes cholesterol measurement rapid and almost painless.

Thus far, the Federal role relative to cholesterol screening has been one of research and public
education through the National Cholesterol Education Program (NCEP), a consortium of
public and private groups created by the National Institutes of Health (NIH). The NCEP is
charged with educating health professionals and the public in order to identify and treat all
adults with high blood cholesterol. They have advised all adult Americans to “Know your
cholesterol number” and endorse screening by a physician as part of an office visit, rather than
screening in public settings. However, later this year, recognizing that public screening is
growing, NCEP plans to issue policy recommendations regarding the role of public screening
in the national cholesterol education effort.

Cholesterol screening is not federally regulated at present. However, the Clinical Laboratory
Improvement Amendments of 1988 (CLIA of 1988), when fully implemented in 1990-91, will
apply to screening. Regulations implementing the law should be issued shortly by the Health
Care Financing Administration (HCFA).


The basic rules of hygiene are frequently disregarded, raising concern about the safety of
public screenings for screenees and staff alike.

The NCEP recommendations state that staff should understand infection
control and prevention techniques.

. Screenees at a few for-profit screenings questioned hygienic conditions, finding
bloodstained tablecloths and gauze, staff wearing bloody gloves, or staff who “just
turned over a bloody mat and didn’t replace it.” Ata pharmacy, staff were observed
inspecting lancets lying on the table because they were afraid they had put a used one
back in with the new ones.

° Some staff who wore no gloves, or only one glove, both handled money and collected
blood samples.

. A third of those collecting blood did not wear gloves, including all who performed
venipuncture. Of those who did wear gloves, only half changed them with each new
screenee.

. At one site, a staff person was observed removing a broken tube with a jagged edge
from a centrifuge with her bare hands, smearing blood all over her fingers in the process.

. Staff used a container marked “biohazardous waste” to dispose of needles and lancets
less than half the time. Common use garbage containers, including a coffee can, were
used for disposal almost 20 percent of the time. However, no needles or lancets were
observed to be reused.

. Some State respondents report having seen dirty or unkempt sites.

Researchers believe that portable analyzers are capable of producing accurate results.
However, they as well as other types of respondents emphasize that operator training, quality
control, and attention to detail are key in achieving reliable results in public screenings.

If the public is to be well served by public screening, equipment must be capable of producing
reliable test results. While an assessment of the accuracy of the portable analyzers most used
in public cholesterol screening is outside the scope of this study, discussions with expert
respondents indicate that they have significant reservations about analyzer performance,
especially in community settings. They are very concerned about the implications of
inaccurate test results; they say that some screenees will be falsely reassured that they are not
at risk, and others will be made unduly anxious, in addition to paying for unnecessary doctors
visits and re-testing.


a Test values should be reported against the NCEP risk levels, on a form containing a
==" Concise statement of follow-up treatment guidelines.

While test results were almost always reported to screenees against the NCEP risk levels,
hospitals were far more likely than for-profit sponsors to provide a concise written summary
of treatment guidelines along with the test results.

Screenees should be told the meaning and limitations of a single test result and
informed of the need for more than one measurement to determine high cholesterol.

Less than 20 percent of screenees were told that screening is only a guide to potential
problems rather than a diagnostic test, and only a third were cautioned about the limitations of
a single cholesterol measurement. While release forms and literature handed out sometimes
contained such information or advised periodic retesting, it was often buried in text or in very
small print, and the impact on screenees is doubtful.

All screenees should receive verbal and printed information on cholesterol, other CHD
tisk factors, diet, and dietary alternatives.

At for-profit screenings, test results were often handed to screenees on a simple flyer or
pamphlet containing brief summary information on cholesterol and diet, and there was
minimal discussion with staff. Hospitals, on the other hand, did a better job of counseling
screenees about nutrition and diet than other providers and sometimes even had nutritionists
and dieticians on staff. Many, though not all, also provided extensive written material.

Ck Sponsors should provide referral to physicians: (1) those in the borderline-risk category
==" should be questioned and referred to a physician if other CHD risk

factors are present, and if not, advised to be retested within a year; (2) those

in the high-risk category should be referred to a physician.

Hospitals more frequently offered and provided physician referral than for-profit screeners,
who rarely even mentioned referral. While literature given out by for-profits sometimes said
that a screenee should consult a physician or be tested periodically, this was often buried in
text and not explicit.

Of the 20 screenees in the borderline-risk category, only four were given the appropriate
advice. Three venipuncture screenees picked up their test results later at a pharmacy, where
the pharmacist handed them their results but provided no counseling or advice. Of the
remaining 13 screenees, two-thirds were either given some printed material on diet and told to
“swatch what you eat,” or told not to worry. One man who tested at 220 was told, “That’s
good.” When he said he thought it should be 200, the screener replied, “You should see some
of the ones in the 300’s we’ve seen. Well, 220 is pretty good.”

10


RICHARD P. KUSSEROW
INSPECTOR GENERAL

OEI-05-89-01330

MAY 1990


eee

oR

RN

APPENDIX D

a SS ES

SRE

Non-Compliance With NCEP Guidelines in Field Survey

Paaalesiet eo Allow Privacy And %
Blood not collected in private 92
Results not kept confidential 73
Discussions not confidential 82
Persons doing analysis subject to distraction 56

Rules of Infection Control Should Be %
Observed
Work area dirty 11
Staff did not wear gloves 35
Staff did not change gloves with each new 50
screenee
Container marked “Biohazardous Waste" not 56

used for disposal of lancets/needles



OFFICE OF INSPECTOR GENERAL

The mission of the Office of Inspector General (OIG) is to promote the efficiency,
effectiveness and integrity of programs in the United States Department of Health and Human
Services (HHS). It does this by developing methods to detect and prevent fraud, waste and
abuse. Created by statute in 1976, the Inspector General keeps both the Secretary and the
Congress fully and currently informed about programs or management problems and
recommends corrective action. The OIG performs its mission by conducting audits,
investigations and inspections with approximately 1,400 staff strategically located around the
country.

OFFICE OF EVALUATION AND INSPECTIONS

This report is produced by the Office of Evaluation and Inspections (OE]), one of the three
major offices within the OIG. The other two are the Office of Audit Services and the Office of
Investigations. The OEI conducts inspections which are typically short-term studies designed
to determine program effectiveness, efficiency and vulnerability to fraud or abuse.

This study was conducted to provide information regarding the prevalence, conduct and
regulation of public cholesterol screening.

The report was prepared under the direction of William C. Moran, Regional Inspector
General, and Natalie A. Coen, Deputy Regional Inspector General, Office of Analysis and
Inspections, Region V. Participating in this project were the following people:

REGION V HEADQUARTERS
Barbara Butz, Project Leader Suzanne Murrin
Suzanne Johnson

Phillip Onofrio

Staff from all regional offices and headquarters participated in the field survey.


screenees. Only 25 percent of the screenees said that test results were kept confidential:
“Names and numbers were called out for all to hear.” Few screenees reported that their
discussions of test results with staff were kept confidential. Almost no one received a hard
copy readout of test results. In fact, an analyzer with only a digital readout was used in over
two-thirds of the fingerstick screenings.

There were plenty of distractions. Screenings attended by hundreds were often described as
“a major production” or even “frenetic.” At others, screening was conducted in cramped
quarters such as the aisles of stores or pharmacies, in full view of customers, often with only
one or two staff to handle everything. Over half the screenees reported that staff were subject
to distraction while performing analysis. One man at a table by the revolving doors in a lobby
was running three analyzers, handing out test results and counseling screenees. Distracted by
passing traffic and screenees requesting their “number,” he became confused about whose
results came from which machine and broke off discussion in mid-sentence with a woman
who had a high test result.

Hospitals passed out literature on their services, advertised take-home meals and conducted a
drawing for a gift certificate. In one instance, local politicians dropped in to campaign. Stores
offered money-off coupons and sold fish oil and oat bran. A surgicenter gathered screenees
for a sales pitch, and a nurses association and school recruited students. Screenees were urged
to pay for special health assessment questionnaires or take extra tests such as a
“comprehensive blood test panel” or body composition analysis. A screening company and an
equipment manufacturer handed out marketing material.

The qualifications and training of staff conducting screening vary widely.

The NCEP recommends that staff be appropriately trained and stresses the
importance of professional appearance and conduct.

.r,rrCO®COCOR

Screenees informally questioned staff who took blood and performed analysis about their
qualifications. Staff varied widely, from health professionals such as nurses and medical
technologists, to people with no professional experience and minimal training from the
screening company, like the “Certified Screening Technician” with no medical background
who had just come to town and learned about the job in the paper.

At for-profit screenings, many screenees reported that staff were uncommunicative, acted
defensive about their background, or appeared “nervous” or “disorganized.” At a pharmacy,
the man collecting the sample appeared nervous. After fumbling with the lancet, gauze and
blood tube, he remarked to the other staff person: “Well, I’m sorry, I really messed that one
up.” They discarded the sample.


While most researchers believe that portable analyzers are capable of producing accurate
results, they describe special problems related to their use in public settings. Temperature and
humidity fluctuations, movement, and vibration can affect accuracy. Improper blood
collection techniques can affect the integrity of the sample. Operators must be well trained.
In short, researchers caution that “you must pay attention to everything.”

One analyzer in particular is well known by many respondents and appears to be the most
prevalent in public screening due to its relatively low cost, portability, and ease of operation.
It was used in 70 percent of the fingerstick screenings in the field study. While the
manufacturer deems it “absolutely perfect for screening,” laboratorian respondents,
particularly, expressed concern about its performance in community settings.

Manufacturers say that their equipment meets the NCEP standards for accuracy. They say that
when their equipment gives inaccurate results, it is because operators are careless, do not
follow the manufacturer’s instructions, or “are not doing calibrations because it costs too
much.” All of them provide operator training and are participating with NIH and others in the
development of a national training package for equipment operators. Some manufacturers
will also help prospective screening providers find trained operators if needed.

In the field survey, we did not attempt to verify the accuracy of the test results, themselves,
which screenees received. However, screenees did ask staff, “How accurate is my result?”
Responses varied widely, including: within 2 points, 3 points, or 10 points either way; 95, 96,
and 97 to 99 percent accurate; “very” or “fairly” accurate, or just “it’s accurate.” Some got
different answers from different staff at the same site. A few who questioned their results
were simply reassured, “‘it’s accurate” or told that it “must be” accurate, since no one else had
questioned their results.

Education, counseling and referral of screenees are frequently lacking, although hospitals are
more likely to provide better quality educational material and physician referral.

The NCEP emphasizes that education of all screenees, and referral of those Ee
with high cholesterol to medical follow-up, are key elements of successful a
public screening, and further, that “receipt of only a cholesterol number by a be
participant is not sufficient ina screening program.” They make several
specific recommendations in this regard.