VA Health Care: Purchases of Safer Devices Should Be Based on Risk of
Injury (Letter Report, 11/17/94, GAO/HEHS-95-12).

Every day health care workers suffer cuts, punctures, nicks, and gashes
from needles and other sharp instruments used in taking care of
patients.  These injuries can result in transmission of the hepatitis-B
virus, human immunodeficiency virus (HIV), and other blood-borne
diseases.  Safer needles and sharp devices are being marketed by
companies claiming that their products can reduce the number of
accidental injuries.  Such devices eliminate the need for a needle,
maintain a protective cover over a needle, provide an alternative to
resheathing a needle after use, or use some other safety mechanism.
This report discusses (1) the incidence of needle and sharp instrument
injuries among health care workers in the Department of Veterans Affairs
(VA); (2) the extent to which VA health care workers have tested
positive for hepatitis B or HIV after a needle or sharp instrument
injury; (3) the safety procedures and devices now used to minimize these
injuries; (4) the extent to which VA is adopting new, safer technologies
to prevent needle and sharp instrument injuries; and (5) the cost of
screening and treating personnel who have received needle and sharp
instrument injuries.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  HEHS-95-12
     TITLE:  VA Health Care: Purchases of Safer Devices Should Be Based 
             on Risk of Injury
      DATE:  11/17/94
   SUBJECT:  Medical equipment
             Veterans hospitals
             Accident prevention
             Occupational safety
             Health care personnel
             Infectious diseases
             Health resources utilization
             Information dissemination operations
             Safety standards
             Acquired immunodeficiency syndrome
IDENTIFIER:  VA 1992 Annual Infection Control Survey
             AIDS
             
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Cover
================================================================ COVER


Report to the Chairman, Subcommittee on Regulation, Business
Opportunities, and Technology, Committee on Small Business, House of
Representatives

November 1994

VA HEALTH CARE - PURCHASES OF
SAFER DEVICES SHOULD BE BASED ON
RISK OF INJURY

GAO/HEHS-95-12

VA Health Care


Abbreviations
=============================================================== ABBREV

  AIDS - acquired immunodeficiency syndrome
  CDC - Centers for Disease Control and Prevention
  FDA - Food and Drug Administration
  HIV - human immunodeficiency virus
  IV - intravenous
  NCCC - National Center for Cost Containment
  OSHA - Occupational Safety and Health Administration
  SPD - Supply, Processing, and Distribution
  UD - University Drive
  VA - Department of Veterans Affairs

Letter
=============================================================== LETTER


B-252786

November 17, 1994

The Honorable Ron Wyden
Chairman, Subcommittee on Regulation,
 Business Opportunities, and Technology
Committee on Small Business
House of Representatives

Dear Mr.  Chairman: 

Each day health care workers suffer cuts, punctures, nicks, and
gashes from needles and other sharp instruments they use in taking
care of patients.  These injuries can result in transmission of the
hepatitis B virus,\1 human immunodeficiency virus (HIV),\2 and other
bloodborne disease.  Safer needle and sharps devices are being
marketed by companies claiming that their products can reduce the
number of accidental injuries.  Such devices eliminate the need for a
needle, maintain a protective cover over a needle, provide an
alternative to resheathing a needle after use, or use some other
safety mechanism. 

In February 1993, you asked us to determine the effect safer needle
and sharps devices can have on the working environment of health care
workers in the Department of Veterans Affairs (VA).  You expressed
specific interest in knowing (1) the incidence of needle and sharps
injuries; (2) the extent to which VA health care workers have tested
positive for hepatitis B or HIV after a needle or sharps injury; (3)
the safety procedures and devices currently used to minimize these
injuries; (4) the extent to which VA is adopting new, safer
technologies to prevent needle and sharps injuries; and (5) the cost
of screening and treating personnel who have received needle and
sharps injuries.  This report addresses each of your concerns. 

You also expressed concern that the Food and Drug Administration
(FDA) may be taking too long to review and approve needle and sharps
devices designed to protect health care workers from injury and
exposure to bloodborne infections.  In a February 2, 1994, letter, we
discussed FDA's process for review and approval of such devices.\3

To learn how VA policies and procedures concerning needle and sharps
injuries were being implemented, we visited VA's Central Office in
Washington, D.C., and medical centers in Philadelphia and
Coatesville, Pennsylvania; Chicago (Hines); and San Francisco.  To
determine how private hospitals dealt with needle and sharps
injuries, we interviewed personnel at the Thomas Jefferson University
Hospital in Philadelphia and the San Francisco General Hospital.  We
also discussed the importance of reducing the numbers of needle and
sharps injuries with officials at the Department of Health and Human
Services' Centers for Disease Control and Prevention (CDC), the
National Institute of Occupational Safety and Health, the Service
Employees International Union, and other health care experts around
the country. 

We identified 41 safer needle and sharps devices that FDA approved
from January 1, 1990, to May 31, 1993, for use in the United States
and asked VA's Central Office to provide us with data on the extent
to which each of these devices was procured in 1993 by VA medical
centers.  In conjunction with CDC, we established a method to
determine the threat to VA health care workers of contracting a
serious infection from a needle injury.  This methodology is more
fully discussed in appendix I. 

Our review was conducted from February 1993 through August 1994 in
accordance with generally accepted government auditing standards. 


--------------------
\1 Hepatitis B is caused by a virus that can be transmitted through
blood and other body fluids.  It causes a number of conditions,
ranging from fever and jaundice to more serious conditions such as
inflammation of the liver, cirrhosis of the liver, and liver cancer. 
There are other forms of hepatitis such as hepatitis A and C. 

\2 HIV is a virus that attacks a certain type of white blood cell,
the T-cell, which plays an important part in the body's immune
system.  As the virus slowly destroys the T-cells, the body becomes
increasingly unable to fight the virus and other infections.  HIV
eventually leads to acquired immunodeficiency syndrome (AIDS)
disease, which causes death. 

\3 FDA Safety Devices (GAO/HEHS-94-90R, Feb.  2, 1994). 


   BACKGROUND
------------------------------------------------------------ Letter :1

VA employs over 238,337 health care workers in 158 medical centers.\4
During the course of performing their normal daily activities many of
VA's health care workers come in contact with needles or sharps
devices such as lancets, scalpels, and knives.  Thus, the danger of
receiving a percutaneous injury\5 while working with these devices is
an ever-present occupational hazard.  This is not unique to health
care workers in VA.  Health care workers in every hospital setting
have always been subject to such an injury.  However, with the rapid
spread of HIV and hepatitis viruses, increasing attention is being
paid to ways in which such injuries can be reduced and ultimately
prevented.  Until recently, hospitals have tried to reduce health
care workers' percutaneous injuries through education.  Now, the
emphasis is on reducing percutaneous injuries using safer needle and
sharps devices. 


--------------------
\4 VA has defined 130 of these medical centers as acute care centers. 
The remaining medical centers are psychiatric, long-term care, and
nonacute general medical and surgical medical centers. 

\5 Percutaneous means effected or performed through the skin. 
Percutaneous injuries include needle and sharps injuries, and we will
refer to both needle and sharps injuries as percutaneous injuries. 
Needle injuries are injuries caused by needled devices such as
syringes or intravenous (IV) lines.  Sharps injuries are caused by
other sharp objects such as scalpels, lancets, and broken glass. 


   RESULTS IN BRIEF
------------------------------------------------------------ Letter :2

VA medical centers are individually responsible for acquiring medical
devices they need to perform their work, including safer needle and
sharps devices.  While some medical centers are acquiring safer
devices, insufficient data are available within these centers to
demonstrate (1) the extent to which safer devices are needed and (2)
whether the devices will reduce the number of percutaneous injuries. 

In fiscal year 1993, VA's 130 acute care medical centers reported
4,791 needle injuries, about a 19-percent decrease from 5,933 in
fiscal year 1992.  VA officials do not know to what extent this
decrease can be attributed to better use of universal precautions,
safer devices, or underreporting of needle injuries.  But infection
control personnel in VA and clinical staff at the private hospitals
we visited told us that percutaneous injuries regularly go
unreported.  In fact, medical research has found that percutaneous
injuries in both public and private hospitals could be understated by
as much as 75 percent because of underreporting. 

Health care workers are sometimes reluctant to report these injuries
for a variety of reasons, including lack of severity (for example, if
the needle was not contaminated by blood) and concern about
maintaining confidentiality (for example, if a worker does not want
it known that he or she was exposed to a potential infection). 
However, a current surveillance study conducted by three private
hospitals and the VA medical center in San Francisco indicates that
the reporting of percutaneous injuries can be substantially improved
when immediate, confidential counseling and follow-up are available
to the injured workers. 

VA health care workers are at risk of incurring life-threatening
diseases from a percutaneous injury involving HIV- or hepatitis-
infected blood from patients in VA medical centers.  The risk of
becoming HIV positive after a percutaneous injury is small, about
one-third of 1 percent.  In fact, as of September 1994, there were no
documented cases of VA health care workers being infected with HIV as
the result of such an injury.  However, we estimated that in fiscal
year 1993, VA health care workers had 71 injuries involving needles
contaminated with HIV-infected blood.  This number may, in fact, be
understated because it is based on data of questionable accuracy. 

The risk of acquiring hepatitis B from a percutaneous injury is
between 6 and 30 percent.  However, VA's Central Office does not know
how many of its health care workers have contracted hepatitis as a
result of a percutaneous injury because no records are maintained on
this type of occurrence. 

To combat the danger of infection, VA has implemented standards and
procedures in each of its medical centers to protect health care
workers from percutaneous injuries.  It also conducts training
programs that emphasize the importance of a safe work environment. 
However, acquisition of safer devices to prevent percutaneous
injuries varies by medical center, and the type of information needed
to make informed procurement decisions is not always available. 

In fiscal year 1993, 90 VA acute and nonacute medical centers spent
about $1.1 million to purchase 33 types of new safer devices that FDA
approved from January 1990 through May 1993 for marketing in the
United States.  The total dollar value of individual medical center
purchases of these safer devices ranged from $10 to $103,000. 
Several of the medical centers that did not purchase safer devices
are in areas with high numbers of people who are HIV positive or have
already acquired AIDS. 

The VA medical centers that we visited did not have financial
accounting systems that allow collection of precise information on
the cost of screening and treating personnel who have received a
percutaneous injury.  As a result, we were only able to obtain
estimates of such costs. 


   VA NEEDLE INJURIES MAY BE
   UNDERSTATED
------------------------------------------------------------ Letter :3

The number of needle injuries that occur in VA medical centers may be
understated because they are not being reported by health care
workers.  In fiscal year 1993, VA's 130 acute care medical centers
reported 4,791 needle injuries, a 19-percent decrease from the 5,933
reported in fiscal year 1992.  The number of needle injuries per
medical center in fiscal year 1993 ranged from a low of 3 in Fort
Harrison, Montana, to a high of 115 in Boston.  (See app.  II for a
complete listing of needle injuries reported by acute care VA medical
centers.)

VA officials do not know to what extent the 19-percent decrease in
the number of reported needle injuries is attributable to the better
use of universal precautions, acquisition of safer devices,
underreporting of injuries, or a combination of these factors. 
However, infection control personnel at two of the medical centers we
visited told us that percutaneous injuries regularly go unreported. 
Furthermore, medical research has found that percutaneous injuries in
both public and private hospitals could be understated by as much as
75 percent because of underreporting.\6

VA officials told us that the reasons percutaneous injuries go
unreported include the lack of severity of the injury (for example,
if the needle was not contaminated by blood), concern about
maintaining confidentiality (for example, if a worker does not want
it known that he or she was exposed to a potential infection), and
the current lack of effective treatment for HIV.  The threat of
disciplinary action is also a deterrent to reporting injuries.  For
example, an official at one VA medical center said that a hospital
service at the facility was telling employees that they would receive
bad ratings if they had too many percutaneous injuries. 

VA's Central Office collects information on needle injuries for each
medical center, but it does not collect similar information on sharps
injuries although this information is available at some medical
centers.  Both of the two private hospitals we visited collected
information on the number of percutaneous injuries to their
employees.  One of these hospitals had 219 needle injuries in fiscal
year 1991/1992, 28 of which involved HIV-infected patients.  The
other hospital had 213 percutaneous injuries in 1992.  But officials
at both hospitals told us that their employees underreport such
injuries. 

In December 1993, VA's National Center for Cost Containment (NCCC),
at the Milwaukee VA medical center, initiated a project on the use of
safer devices.  In August 1994, at about the same time that a draft
of this report was sent to VA for its comments, the results of this
project were published.  The study, Needle Stick Prevention in the
Department of Veterans Affairs - Monograph I, concluded, among other
things, that (1) needle injuries remain a prevalent problem for the
VA health care system and (2) surveillance and tracking of needle
injuries are not standardized throughout the VA system. 

Efforts are under way to improve the reporting of percutaneous
injuries in both VA and private sector hospitals.  For example, in
January 1992, San Francisco VA medical center joined three private
hospitals in a CDC-initiated percutaneous injury surveillance
project.  The project was designed to collect injury data in
sufficient detail to isolate and understand problem situations,
recommend solutions, and evaluate the effectiveness of prevention
measures. 

A major part of the surveillance project is a confidential 24-hour
telephone hot line that employees use to report percutaneous injuries
as soon as they happen.  The hot line has several benefits. 
Specifically, injured employees receive medical advice, counseling,
and follow-up treatment immediately, and the hospital receives more
accurate and complete reporting of percutaneous injuries.  Before
either employees or the patients whose blood contaminated the
employees (source patients) are tested for HIV, however, VA is
required to obtain written consent from the individuals being tested. 
Preliminary indications are that the project is effective. 

In the 12-month period after the San Francisco VA medical center
implemented the 24-hour hot line, the number of reported percutaneous
injuries nearly doubled from 43 in 1991 to 79 in 1992.  An official
at the medical center told us that, in his opinion, the increase was
due to better reporting of injuries, not to a greater rate of injury. 
At two of the private hospitals involved in this study, the frequency
of reporting percutaneous injuries increased by 54 percent and 60
percent. 

Project researchers found that while the hot line improved the
reporting of injuries, the prevention measures instituted as a result
of the hot line information failed to reduce the number of injuries. 
The project researchers concluded that for health care workers,
behavioral changes alone are not a satisfactory solution.  In their
opinion, primary prevention of occupational exposures to blood must
also embrace the industrial hygiene standard of work place safety,
which emphasizes use of inherently safer devices, administrative
controls, and personal protective equipment. 

Although the San Francisco VA medical center's 24-hour hot line
program is currently in danger of being canceled for lack of funds,
the Chief of Infectious Disease there told us that he will attempt to
continue the hot line with a combination of hospital and research
funding.  The private hospitals participating in the project have
integrated the hot line into their infection control programs and
intend to continue it. 


--------------------
\6 Bruce H.  Harmory, M.D., "Underreporting of needlestick injuries
in a university hospital," American Journal of Infection Control,
October 1983, Vol.  11, No.  5, pp.  174-77. 


   VA DATA ON HEALTH CARE WORKERS
   WITH HIV/AIDS OR HEPATITIS B
   ARE INCOMPLETE
------------------------------------------------------------ Letter :4

As of September 1994, no VA health care worker had been reported to
CDC as having acquired HIV or AIDS because of a percutaneous injury. 
However, VA's Central Office does not know the number of workers who
may have acquired hepatitis B through work-related percutaneous
injuries because it does not routinely collect those data. 

The Public Health Service Act authorizes CDC through the National
Center for Health Statistics to collect information on AIDS cases in
the United States.\7 Although there is no federal requirement that
HIV or AIDS cases be reported to CDC, all states voluntarily report
known AIDS cases and 36 states require reporting of known HIV cases
to CDC.  Also, all states report health care workers infected with
HIV.  CDC receives the AIDS and HIV information from state and local
health departments.  These departments reported that 40 health care
workers were known to have acquired HIV infection in the performance
of their occupational duties through December 1993.  According to
CDC, as of December 1993, 12 of the 40 health care workers had
developed AIDS.  In addition, 83 cases were reported to CDC in which
health care workers were suspected of having acquired HIV from
percutaneous injuries. 

Although no VA health care workers are known to have been infected on
the job, the possibility of infection is very real.  In fiscal year
1993, VA medical centers treated 16,749 patients with HIV or AIDS. 
We estimated that during 1993 at least 71 needle injuries to VA
health care workers involved HIV-infected blood; and during 1992, at
least 99 such injuries occurred.\8 We also estimated that every 5
years at least one VA employee will seroconvert\9 to HIV positive
because of a needle injury.\10 (See app.  I for the methodology we
used.) Unless a cure is found, these HIV-positive health care workers
will ultimately develop AIDS.  Furthermore, given the fact that the
data from which these calculations are made may be understated, HIV
infection and seroconversion rates may be even higher. 

The fear of contracting AIDS has overshadowed the dangers of
acquiring hepatitis B.  According to CDC, about 12,000 health care
workers contract the hepatitis B virus annually, and about 250
infected individuals die from the disease.  The risk of acquiring
hepatitis B from a percutaneous injury involving hepatitis B-infected
blood is between 6 and 30 percent.  By comparison, the risk of
becoming HIV positive from a percutaneous injury is about one-third
of 1 percent.  Given that in 1992, 3,083 VA patients tested positive
for hepatitis B and 6,613 tested positive for hepatitis C,\11 VA
health care workers are at obvious risk of acquiring the disease. 
Although a vaccine is available that provides active immunization
against hepatitis B infection, no such vaccine exists for hepatitis
C. 


--------------------
\7 The Public Health Service Act, 42 U.S.C.  242b and 242k. 

\8 The decrease in estimated needle injuries involving HIV-infected
blood reflects the decrease in reported needle injuries and the
decrease in the estimated patient HIV seroprevalence percentage in
fiscal year 1993.  Seroprevalence means the number of cases of viral
infection in a population. 

\9 Seroconvert means to indicate the development of antibodies in the
blood in response to an infection. 

\10 These estimates were calculated only for VA medical centers.  The
methodology we used has not been applied to other federal or private
sector medical facilities. 

\11 According to VA's 1992 Annual Infection Control Survey. 


   VA HAS IMPLEMENTED SAFETY
   PROCEDURES AND ACTIVITIES
   DESIGNED TO PROTECT HEALTH CARE
   WORKERS
------------------------------------------------------------ Letter :5

VA has adopted and implemented CDC's recommended universal
precautions that are designed to protect health care workers from
accidental injury and infection.  Under universal precautions, all
health care workers are expected to use gloves, gowns, masks, and
protective eyewear when exposure to blood and other potentially
infectious body fluids is reasonably anticipated.  These measures are
also to be applied consistently for all patients no matter what the
circumstances.  Universal precautions also require disposal of needle
and sharps devices in puncture-resistant containers located as close
as possible to the use area to minimize the workers' exposure to
injury. 

VA has also adopted the Occupational Safety and Health
Administration's (OSHA) bloodborne pathogen standard.  This standard,
published in December 1991, requires health care institutions to
provide adequate and appropriate protection for all health care
workers potentially exposed to patient blood and body fluids.  The
standard is designed to minimize or eliminate percutaneous injuries
by using a combination of engineering and work practice controls,
personal protective clothing and equipment, training, medical
surveillance, hepatitis B vaccination, signs, labels, and other
provisions.  A key provision of the standard is the requirement that
all employers develop an exposure control plan that identifies
individuals who will receive training, protective equipment,
vaccinations, and other benefits.  All of the VA medical centers we
visited were implementing exposure control plans that follow the
direction of the OSHA standard.  In addition, for all health care
workers who are exposed to HIV-infected blood, VA has established a
policy for follow-up, treatment, and care. 

VA conducts training, education, and other activities to facilitate
health care worker safety.  Some labor-saving initiatives have also
resulted in a safer work environment.  For example, in an effort to
reduce the workload of physician residents, VA encourages medical
centers, where appropriate, to establish special teams of skilled
staff to insert IV lines in patients.  Intravenous teams can reduce
the number of needle injuries because they are specially trained and
are skilled in performing such procedures.  Intravenous teams have
been established in 57 VA medical centers, but VA does not know to
what extent these teams have reduced needle injuries. 

Another approach taken by the Philadelphia and San Francisco VA
medical centers is the use of phlebotomy teams.  These teams are
composed of members whose primary job is to draw blood from patients
for testing and analysis.  Medical center personnel at these
facilities believe the introduction of phlebotomy teams has helped to
decrease the incidence of needle injuries. 

Individual medical center personnel can also play a significant role
in making the work environment safer.  For example, the Supply,
Processing, and Distribution (SPD) Chief at the Philadelphia VA
medical center developed a bloodborne pathogen report using fiscal
year 1991 and 1992 percutaneous injury information to determine who
was injured and when and how the injuries occurred.  This was a
self-initiated report and not part of VA's standard reporting
process.  The SPD Chief estimated it took 500 to 800 hours to analyze
the data and write the report.  The report findings included the
following: 

The nursing service was at the most risk for injuries. 

Syringes were involved in 49 percent of the injuries in fiscal year
1992. 

Lancets were the second leading cause of injury in both fiscal year
1991 and 1992. 

The SPD Chief recommended that the nursing service be targeted for
all available safety training and devices, that a needleless IV
system and safety lancets be procured, and that only phlebotomy and
IV team personnel perform phlebotomies and IV insertions,
respectively.  In fiscal year 1993, the Philadelphia VA medical
center implemented all the recommendations in the report.  As a
result, through July 1994, there were no IV injuries after the
introduction of the needleless IV system in February 1994 and no
lancet injuries after the introduction of the safety lancets in
January 1993.  The SPD Chief was waiting until the end of fiscal year
1994 to analyze the results of the implemented recommendations. 


   MEDICAL CENTERS' ACQUISITION OF
   SAFER NEEDLE AND SHARPS DEVICES
   VARIES WIDELY
------------------------------------------------------------ Letter :6

VA medical center purchases of safer needle and sharps devices are
not necessarily based on risk data.  Under VA's decentralized
management philosophy, VA medical centers decide when, and to what
extent, they will acquire safer devices.  However, we found that
medical centers are purchasing safer devices, in varying degrees,
without regard to data that can be collected at each of the medical
centers on the extent and cause of percutaneous injuries.  As a
result, purchases of safer devices are being made, but they may not
be resolving the injury problems.  Conversely, some medical centers
that should be considering acquisition of safer devices are not doing
so. 

In fiscal year 1993, 90 VA medical centers spent between $10 and
$103,000 to purchase safer devices that FDA approved from January
1990 through May 1993 for marketing in the United States.  In total,
these 90 medical centers spent about $1.1 million on 33 types of
devices.  (See app.  III for purchases by individual medical centers
in fiscal year 1993.) Whether these variations in procurement amounts
are justified is unknown.  However, of the top 10 VA medical center
purchasers of safer devices in fiscal year 1993

2 medical centers (Portland, Oregon; and Cleveland) were among those
with the highest needle injuries in fiscal year 1992;

4 medical centers (Miami; New York; Atlanta; and East Orange, New
Jersey) had high patient HIV seroprevalence percentage estimates in
fiscal year 1992; and

3 medical centers (Miami; Portland, Oregon; and Atlanta) had high
health care worker HIV seroconversion estimates in fiscal year 1992. 

Conversely several medical centers (Los Angeles, San Diego, Puerto
Rico) with high seroprevalence or seroconversion estimates in fiscal
year 1992 purchased no safer devices in fiscal year 1993. 
Nonetheless, in each of these facilities, the number of reported
needle injuries dropped from fiscal year 1992 to fiscal year 1993. 

Safer devices can be 2 to 3 times more expensive than their standard
counterparts.  For example, a safer 22-gauge, 1-inch, IV catheter
costs approximately $1.76; the same standard IV catheter costs
approximately 62 cents.  Considering that a typical hospital could
use hundreds of these and other safer devices in a year, the total
annual cost differential could be substantial.  Thus, the cost should
be balanced against the safer devices' ability to reduce the number
of percutaneous injuries. 

Table 1 shows the 10 VA medical centers that spent the most on safer
devices in 1993, the number of needle injuries that occurred in each
facility, and the facilities' relative ranking in terms of patient
HIV seroprevalence percentage and health care worker HIV
seroconversion estimates.  The table is intended to show how
additional pertinent information can be used to facilitate decisions
on the acquisition of safer needle and sharps devices.  For example,
in fiscal year 1993, the Miami VA medical center spent more than any
other medical center on the purchase of safer devices.  Although it
was 49th of the acute medical centers in terms of needle injuries in
fiscal year 1992, the center was second in patient HIV seroprevalence
percentage and third in health care worker HIV seroconversion at
acute medical centers.  These data indicate that careful
consideration should be given to acquisition of safer devices which,
in this instance, occurred. 



                Table 1

 Top 10 VA Purchasers of Safer Medical
Devices and Pertinent Injury and Health
                  Data

