Order Denying Plaintiffs' Motion for Class Certification, Defendants Response in Opposition to Plaintiffs' Motion for Class Certification
Public Court Documents
November 23, 1992
102 pages
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Case Files, Thompson v. Raiford Hardbacks. Order Denying Plaintiffs' Motion for Class Certification, Defendants Response in Opposition to Plaintiffs' Motion for Class Certification, 1992. cd88697d-5c40-f011-b4cb-7c1e5267c7b6. LDF Archives, Thurgood Marshall Institute. https://ldfrecollection.org/archives/archives-search/archives-item/5c9031db-1de2-4710-8c44-f0e22e912cc1/order-denying-plaintiffs-motion-for-class-certification-defendants-response-in-opposition-to-plaintiffs-motion-for-class-certification. Accessed June 17, 2025.
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IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF TEXAS
DALLAS DIVISION
LOIS THOMPSON on behalf of
and as next friend to
to TAYLOR KEONDRA DIXON,
ZACHERY X. WILLIAMS,
CALVIN A. THOMPSON and
PRENTISS LAVELL MULLINS,
Plaintiffs,
CAUSE NO. 3-92-CV1539-R
Ve
BURTON F. RAIFORD, in his
capacity as Commissioner of
the Texas Department of Human
Services,
and
THE UNITED STATES OF AMERICA
Defendants. wn
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ORDER DENYING PLAINTIFFS' MOTION FOR CLASS CERTIFICATION
Before the Court is Defendant Raiford's Response in Opposition
to Plaintiffs' Motion for Class Certification.
Following consideration, the Court is of the opinion that
Plaintiffs' motion should be denied.
SIGNED this the day of ,.:1992,
UNITED STATES DISTRICT JUDGE
-
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4 » pate
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF TEXAS
DALLAS DIVISION
LOIS THOMPSON on behalf of
and as next friend to
to TAYLOR KEONDRA DIXON,
ZACHERY X. WILLIAMS,
CALVIN A. THOMPSON and
PRENTISS LAVELL MULLINS,
Plaintiffs,
CAUSE NO. 3-92-CV1539-R
Ve
BURTON F. RAIFORD, in his
capacity as Commissioner of
the Texas Department of Human
Services,
and
THE UNITED STATES OF AMERICA
Defendants. wn
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DEFENDANT RATIFORD'S RESPONSE IN OPPOSITION TO
PLAINTIFFS' MOTION FOR CLASS CERTIFICATION
TO THE HONORABLE JUDGE OF SAID COURT:
COMES NOW Defendant, Burton F. Raiford, Commissioner of the
Texas Department of Human Services, and files his Response to
Plaintiffs' Motion for Class Certification showing the Court the
following:
Plaintiffs have requested that the Court certify a state-wide
class of all Medicaid-eligible children presently residing in the
State of Texas for the claims against Defendant Raiford.
Plaintiffs' request that such a class be certified pursuant Rule 23
of the Federal Rules of Civil Procedure and Rule 10.2 of the Local
Rules of the Northern District.
Rule 23 (b) of the Federal Rules of Civil Procedure states,
"an action may be maintained as a class action if the
prerequisites of subdivision (a) are satisfied, and in
addition:...
(2) the party opposing the class has acted or refused
to act on grounds generally applicable to the
class, thereby making appropriate final
injunctive relief with respect to the class as a
whole; "
In their brief in support of their Motion for Class Certification,
Plaintiffs contend that "the 23(b) (2) requirement is met by the
fact that Defendant Raiford continues to allow the use of the EP
test for lead poisoning in the Texas EPSDT program..." Plaintiffs’
Brief in Support of Motion for Class Certification pp. 9-10.
However, this is simply not correct. As of October 23, 1992, the
Texas Department of Human Services, under the supervision of
Defendant Raiford, has begun the use of blood lead level testing
for all Texas children who are Medicaid recipients and eliminated
the use of the EP test altogether. See affidavit of Bridget Cook
attached as Exhibit "A",
Plaintiffs also argue that Defendant has failed to comply with
Medicaid requirements by failing to make blood lead level
assessments based on factors other than age. This allegation is
also incorrect. The Texas Department of Human Services is in an
ongoing process of identifying and recognizing high-risk areas for
lead contamination and has always considered environmental factors
important in making decisions about blood lead level assessments.
Since Plaintiffs' contention has no basis in fact, Plaintiffs' can
not meet the requirement of rule 23(b) (2) and failure to satisfy
any one of the mandatory requirements of Rule 23 precludes class
certification. Walker v. City of Houston, 341 F. Supp. 1124, 1131
(S.D. Tex. 1971).
PLAINTIFFS' DEFINITION OF THE PROPOSED CLASS IS OVERBROAD
In defining their requested class Plaintiffs state that the
class should include "all Medicaid-eligible children in the state
of Texas" and cite Thomas v. Johnston, 557 F. Supp. 879, 916 (W.D.
Texas 1983) as authority. However, Plaintiffs have
mischaracterized the class definition in that case. The Court in
Thomas certified a limited class consisting of:
"all Medicaid recipients in the State of Texas who are
residing in community based Levels V and VI ICF-MR
facilities that specialize in the care of children and
that experienced a reduction in their rates of
reimbursement pursuant to the current ICF-MR
reimbursement rates structure ..."
Contrary to the suggestion made by Plaintiffs' counsel, the Thomas
class differs greatly from the general and overbroad group that
Plaintiffs seek to have certified. First, the Thomas class begins
with Medicaid "recipients", as opposed to those who are "Medicaid-
eligible". To be a Medicaid recipient means that they have
completed the process of being certified by the Texas Department of
Human Services and are determined to be entitled to Medicaid
benefits. Without this certification process, the Department has
no way of knowing how many children in the State of Texas are
"eligible" for Medicaid services. Moreover, the Department is not
authorized to provide services to those who are not certified to be
recipients. Additionally, the Thomas class limits those Medicaid
recipients to a subclass of Medicaid recipients who meet very
- specific criteria. Plaintiffs' proposed class is overbroad in
another respect even if one considers the proposed class to only
include Medicaid recipients. It is overbroad because it includes
EPSDT Medicaid recipients who because of their advanced age and the
lack of any environmental exposure to lead are at "low risk" for
blood lead contamination.
NUMEROUSITY
Defendant Raiford does not dispute that a proper class is so
numerous that joinder of all members of such a class is
impractical.
COMMONALITY
Plaintiffs' claim that there are questions of law or fact
common to the requested class pursuant to Rule 23 (a) (2), Fed. R.
Civ. Pp. However, the common question of law that Plaintiff cites
is Defendant's alleged failure to screen Texas-EPSDT children in
accordance with the Medicaid Act by use of a blood lead test as
opposed to an EP test. As discussed earlier and supported by the
attached affidavit of Bridget Cook, Defendant is not in violation
of the Medicaid Act as Plaintiffs' interpret the law and therefore
this question is moot. The Center for Disease Control has issued
guidelines which explain that recipients must receive testing and
treatment which is appropriate for their age and risk factors.
There will be older, as well as younger children in this class, if
certified, and they will all be from environments of varying risk
- levels for lead contamination. Each group will have different
interests in this litigation and the law with regard to how these
children are to be treated with regard to lead contamination is
different. Class representatives must have the "same interest and
suffer the same injury" as other members of the class. East Texas
Motor Frieght v. Rodriquez, 431 U.S. 395, 403 (1977). Plaintiffs,
therefore, cannot represent all members of their proposed class as
there are not common questions of law which pertain to all class
members.
Plaintiffs also cannot show common questions of fact with
other class members as proposed. The named Plaintiffs are from a
high-risk area for lead contamination. If the requested class is
composed of all Medicaid- eligible children in the State of Texas
there could members from low-risk as well as high-risk which have
very different fact situations surrounding them. There would also
be older children as well as younger children. Each of these
groups has particular facts that are unique to their group.
Plaintiffs do not share common questions of facts with all proposed
class members and therefore cannot hold themselves out as
representing all members of the class. Plaintiffs therefore do not
met the criteria established by Rule 23(a) (2).
TYPICALITY
Plaintiffs are required by section (a) (3) of Rule 23 to show
that "the claims or defenses of the representative parties are
typical of the claims or defenses of the class. However, Plaintiffs
claims could be quite different from those which would be
maintained by other members of the proposed class. Plaintiffs are
young children and reside in a high-risk area for lead
contamination. Other members of this class would be older children
as well as younger children that reside in areas which vary in the
levels of risk regarding lead contamination. Each of these factors
must be treated differently because the law requires the state to
treat these persons differently. Plaintiffs' claims, therefore,
are not typical of the claims of all members of the class and a
person cannot represent a class of people of which he is not a
member. Brown v. Sibley, 650 F. 2d 760, 771 (5th Cir. 1981).
ADEQUATE REPRESENTATION
Plaintiffs are required by Rule 23(a) (4) Fed. R. Civ. P. to
show that "the representative parties will fairly and adequately
protect the interests of the class". However, potential members of
this class would come from all areas within the state of Texas. For
example, some areas in Texas are high-risk for lead contamination
while others are low-risk. Individuals from each of these types of
areas would have different interests. Plaintiffs are children from
high-risk areas and cannot adequately or fairly represent the
interests of those from low-risk areas.
According to Plaintiffs' brief in support of their Motion for
Class Certification, page 15, Plaintiffs are restricted from
settling this matter if the settlement does not include reasonable
attorneys' fees and costs for Plaintiffs! attorneys. Such an
- arrangement creates a clear conflict of interest. The interest of
the class could clearly conflict with the interest of Plaintiffs’
attorneys if a settlement was proposed which afforded the
Plaintiffs appropriate relief but did not provide for attorneys’
fees
WHEREFORE PREMISES CONSIDERED, Defendant Raiford respectfully
requests that the Court deny Plaintiffs' Motion for Class
Certification.
Respectfully submitted,
DAN MORALES
Attorney General of Texas
WILL PRYOR
First Assistant Attorney General
MARY F. KELLER
Deputy Assistant Attorney General
for Litigation
JORGE VEGA, Chief
General Litigation Division
Pe Me. /
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EDWIN N. HORNE 7
Assistant/ Attorney General
Texas Bar No. 10008000
General Litigation Division
P. O. Box 12548, Capitol Station
Austin, Texas 78711-2548
TELEPHONE (512) 440-4550
FAX (512) 447-0511
CERTIFICATE OF SERVICE
I certify that a true and correct copy of the foregoing
document has been sent via U.S. Mail, return receipt requested on
this 23rd day of November, 1992 to:
Michael M. Daniel, P.C.
Laura B. Beshara
3301 Elm Street
Dallas, Texas 75226-1637
Edward B. Cloutman, III
Law Office of Edward B. Cloutman, III
3301 Elm Street
Dallas, Texas 75226
(214) 939-9222
Julius L. Chambers
Alice Brown
NAACP Legal Defense & Educational Fund, Inc.
99 Hudson Street, Suite 1600
New York, NY 10013
Bill Lann Lee
Kirsten D. Levingston
NAACP Legal Defense & Educational Fund, Inc.
315 West Ninth Street, Suite 208
Los Angeles, CA 90015
Jane Perkins
National Health Law Program
1815 H Street, N.W.
Suite 705
Washington, DC 20006
Carlene McNulty
North State Legal Services
114 West Corbin Street
Hillsborough, N.C. 27278
Lucy Billings
Marie-Elena Ruffo
AL
Bronx Legal Services ec Ak :
579 Courtlandt Avenue tf ef75 306
Bronx, N.Y. 10451 7 Pa
ws iA <<) 5 a y 2 Fp
EDWIN N./ HORNE z
“SENT BY: TD H S 7311-23-92 ; 3:53PM i ACUTE CARE STRATUM- 512 447 0511:8 2
IN THE UNITED S8TATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF TEXAS
DALLAS DIVISION
LOIS THOMPSON on behalf of
and as next friend to
TAYLOR KEONDRA DIXON,
ZACHERY X. WILLIAMS,
CALVIN A. THOMPSON and
PRENTISS LAVELL MULLINS
Plaintiffs,
CAUSE NO. 3-92-CV1539-R
Ve.
BURTON F. RAIFORD, in his
capacity as Commissioner of
the Texas Department of Human
Services, and THE UNITED
STATES OF AMERICA Wn
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AFFIDAVIT OF BRIDGET COOK
BEFORE ME, the undersigned authority, on this day personally
appeared Bridget Cook, known to me to be the person whose name is
subscribed below, and after being duly sworn by me, stated on oath
as follows:
"My name is Bridget Cook. I am over the age of 18; I have
never been convicted of a felony, and I am fully competent to make
this affidavit. I am employed by the Texas Department of Human
Services as EPSDT Program Director and I am authorized to make this
affidavit as its agent.
"In December 1991, a letter was received from the Texas
Department of Health (TDH), Bureau of Laboratories, (Contractor for
EXHIBIT
"A rv
SENT BY:T D H S $11-23-92 ; 3:54PM ; ACUTE CARE STRATUM- 512 447 0511:% 3
EPSDT Medical Screening Program Laboratory Services) which
discussed the recently released U.S. Centers for Disease Control
(CDC) guidelines for blood lead levels and detecting the new lower
limit of 10 ug/dL. The letter stated that the existing equipment
used for EPSDT laboratory lead testing procedures was inadequate to
meet the new CDC standards and that there was no way to upgrade the
existing equipment to meet these new standards.
"Following receipt of this information the Department
authorized in a letter dated December 13, 1991, the purchase of
three graphite furnace atomic absorption analyzers at a projected
cost of $47,000 per unit to perform blood lead level testing
procedures in accordance with the new CDC standards. This was in
the absence of any resulaticn, guidelines, or directive from the
Health Care Financing Administration mandating the adoption of
CDC's new statement on blood level testing preocedures.
"Due to a subsequent unprojected increase in laboratory
expenditures/workload (number of overall EPSDT specimens received
for testing) and TDH's simultaneous identification of the projected
need for a fourth graphite furnace, the Department negotiated a
contract amendment with TDH in March 1992 to assure the
availability of funds for all four pieces of the new equipment.
The total contract amount was increased from $461,000 to $752,697
effective April 1, 1992. Workload trends continued to increase and
SENT BY:T DH S 7311-23-82 ; 3:54PM i ACUTE CARE STRATUM- 512 447 0511:8 4
3
"TDH purchased one graphite furnace atomic absorption
spectrometer with non-EPSDT/Medicaid dollars to support lead
testing services authorized under Texas House Bill 1621 (72nd
Legislative Session). Due to the poor experience with this first
analyzer purchased, TDH proceeded to survey other blood lead
testing laboratory facilities to find which equipment had been used
with proven reliability. After the survey, it became evident that
Perkin-Elmer Graphite Furnace Systems had established success in
State level Public Health Laboratories in New York, Florida,
Arkansas and in CDC Laboratory facilities. Although there were
competing systems from other vendors that appeared to have
potential, none had proven track records as yet in any major
laboratories.
"Based on this information, TDH laboratory staff gave much
time and consideration to the preparation of the bid specifications
in the state request for purchase of the four new graphite furnaces
in order to assure the acquisition of quality equipment on behalf
of the Department. This purchase request was submitted in May 1992
to TDH Materials Acquisition and Management Division.
"The bids for the equipment were reviewed in July and August
of 1992 by TDH laboratory staff. However, the original purchase
requisition had to be canceled when it became apparent that only
one vendor, Perkin-Elmer, could meet all the specifications.
Because certain specifications were unique to only one vendor, the
SENT BY:T D H S 3111-23-82 | 3:55PM 5 ACUTE CARE STRATUM- 512 447051134 5
4
requisition was then required to have proprietary handling and
justification. The purchase requisition was reprocessed in August
1992 under Section 3.09 ' (Proprietary Purchase) of the State
Purchasing Code. This, in turn, resulted in a formal protest from
another vendor who had underbid Perkin-Elmer. The protest required
subsequent legal review by TDH, who determined there had been no
violation of the state purchasing code.
"TDH Laboratory staff requested emergency purchase handling in an
effort to ‘avoid any further delays. As a result Perkin-Elmer
received the purchase order in late August 1992. In the meantime,
TDH began site preparation which included the relocation of an
existing laboratory section, subsequent installation of additional
high voltage electrical circuits, compressed gas system with flow
lines, and an external ventilation system to handle the fumes
generated during this type of blood analysis. The equipment
arrived and was installed in late September 1992. After arrival,
it took approximately two weeks for the service engineer to install
and complete the checkout procedures on all four instruments.
Following this, an application specialist from Perkin-Elmer came to
the laboratory to verify the blood lead procedure and provide
hands-on training to the TDH laboratory staff. Once validation
procedures were completed, TDH laboratory staff began analyzing all
EPSDT medical screening program blood specimens submitted for lead
testing on the new equipment in accordance with the new CDC
guidelines specifying direct blood lead level measurement down to
SENT BY:T'D H S 7111-23-92 ; 3:55PM ; ACUTE CARE STRATUM- 512 447 0511:# 6
LS
10 ug/dL. Use of this new laboratory analysis procedure is
applicable to all specimens received for blood lead testing on and
after October 23, 1992.
"The facts stated above are within my personal knowledge, and are
true and correct."
Sworn to and subscribed before me, the undersigned authority, on
JRA
this od 5 day of Nr A , 1992, to certify which
witness my hand and seal of office.
A i “ og TO Ret AO
Notary Public in and for
the State of Texas
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF TEXAS
DALLAS DIVISION
LOIS THOMPSON on behalf of and
as next friend to TAYLOR
KEONDRA DIXON, ZACHERY X.
WILLIAMS, CALVIN A. THOMPSON No. 3-92 CV 1539-R
and PRENTISS LAVELL MULLINS,
Plaintiffs Civil Action
Vv. Class Action
BURTON F. RAIFORD, in his
capacity as Commissioner of
the Texas Department of Human
Services,
and
THE UNITED STATES OF AMERICA,
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Defendants.
DECLARATION OF DR. MICHAEL J. NICAR
I, Michael J. Nicar, Ph.D, am the Assistant Director of
the Baylor University Medical Center Pathology Department's Core
Laboratory (which includes Toxicology). I am responsible for all
lead testing at Baylor University Medical Center, 3500 Gaston
Avenue, Dallas, Texas 75246. Part of my responsibilities include
choosing the reference laboratories to which blood lead samples
will be sent for analysis. I have participated in research on
the subject of lead and have work experience on the subject. The
following facts are true and correct to the best of my knowledge:
Attachment 1 to this declaration is a sampling of reference
laboratories that measure lead in blood.Z2 All of these labora-
tories do a nation-wide business. A reference laboratory is a
national laboratory that has satellite branches of laboratories
across the country. When a blood sample is drawn at a drawing
station (i.e., at any place where a doctor or clinic takes a
blood sample), a courier from one of these reference laboratories
Or an express mail serivce will come and pick up the sample. The
sample is then taken to one of the reference laboratories or one
of the branches for blood lead measurement. The results are then
sent back to the doctor or clinic.
All of these laboratories listed will send a representative
to speak to the hospital or whomever is requesting their service
to provide bids and other information on their laboratories and
blood lead testing analysis. It is a very competitive market,
and the laboratories are eager for the business.
Attachment 1 to this declaration is a sample listing of
national reference laboratories for blood lead determination that
I compiled. These are some of the reference laboratories that
Baylor uses for its blood lead testing. Attachment 2 to this
declaration is the same list as Attachment 1 but with notes next
to the laboratories that are based on my experience. The notes
to the side of the laboratories state the type of metal tube used
by that laboratory and the approximate price for a blood lead
sample analysis and the turnaround date for getting the results
* The attached list is a sampling of national reference
laboratories that do blood lead testing and is not intended to be
all inclusive.
back. Many of these laboratories will reduce the price if the
hospital or other entity uses their laboratory in volume.
Attachment 3 to this declaration is a listing of one of the
largest national reference laboratories that performs blood lead
testing, SmithKline Beecham Clinical Laboratories, and its
branches across the country. Attachment 3 is taken from the
pages of the SmithKline Beecham brochure.
Attachment 4 to this declaration is from the same SmithKline
Beecham brochure and are a list of the SmithKline Beecham patient
service centers/draw stations available across the country in
thirty states that offer specimen collection services. A patient
need not be in a city with one of these collection centers in
order to receive a blood lead test. The doctor or clinician may
take the sample and can send the sample via express mail service
to the national reference laboratory for analysis.
I, Michael J. Nicar, declare under penalty of perjury that
the above facts are true and correct to the best of my knowledge.
etfotod foln
Michael J BENieay/
Respectfully submitted,
MICHAEL M. DANIEL, P.C.
3301 Elm Street
Dallas, Texas 75226-1637
(214) 939-9230
Michael M. Daniel
State Bar No. 05360500
By: Buia A. Began
Laura B. Beshara
State Bar No. 02261750
ATTORNEYS FOR PLAINTIFFS
CERTIFICATE OF SERVICE
I certify that a true and correct copy of the above document
served upon counsel for defendants by U.S. Mail on this the
was
R=day of November, 1992.
Kuna 8. Behan
Laura B. Beshara
REFERENCE LABORATORIES FOR LEAD DETERMINATION
AM LABORATORIES /METWEST CLINICAL LABORATORIES
4004 WORTH STREET
DALLAS, TX 75246
800-442-9963
214-827-4970
ASSOCIATED REGIONAL & UNIVERSITY PATHOLOGISTS
(ARUP)
500 CHIPETA WAY
SALT LAKE CITY, UT 84108
800-242-2787
801-583-2787
DAMON CLINICAL LABORATORIES
8300 ESTERS BLVD
DALLAS, TX
214-621-8040
MAYO MEDICAL LABORATORIES
200 FIRST STREBT SW
ROCHESTER, MN 55905
800-533-1710
NATIONAL HEALTH LABS
7777 FOREST LN
DALLAS, TX 75230
214-661-7500
NICHOLS INSTITUTE
33608 ORTEGA HWY
SAN JUAN CAPISTRANO, CA 92690-6130
800-NICHOLS
800-553-5445
ROCHE BIOMEDICAL
2621 W AIRPORT FRWY
IRVING, TX
800-324-4444
214-257-0110
SMITHKLINE BEECHAM CLINICAL LABORATORIES
8000 SOVEREIGN ROW
DALLAS, TX 75247
214-638~1301
800-442-2102
Attachment 1
Breer Leno
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; op NA Heparin AM LABORATORIES /METWEST CLINICAL LABORATORIES
(or TAN METAL BREE ) 4004 WORTH STREET
Price. SLA0 Lier DALLAS, TX 75246
800-442-9963
TURNAROUND + 2-3 DAYS 214-827-4970
eyes 20047 : ASSOCIATED REGIONAL & UNIVERSITY PATHOLOGISTS
Vice © Bo00 LisT 500 CHIPETA WAY
. SALT LAKE CITY, UT 84108
[UCNACOUND run ~- MYo FRI. ann 240 2707 Bil peices AE plist
|-2 DAY TUENAROUND 801-583-2787
Tar! b : :
“ER SE pl, DAMON CLINICAL LABORATORIES THE prICE Will Ho
8300 ESTERS BLVD
Peicer 43.00 DALLAS, TX DOWN | F you AE
ueNAROUNDT FY HR TupaAR. 214-621-8040 SenDiNY sor of
(est: SOI Re
2oyAL BLE EDTA - 2.0 mL MAYO MEDICAL LABORATORIES Speci
: ; LisT 200 FIRST STREET SW
Price: 35:90 "Cri serwp ROCHESTER, MN 55905
TURNAROUND: |-2 PAYs TuenN. 800-533-1710
Test: 834-9 : : 2
Royal BME EDTA - JO mL NATIONAL HEALTH LABS Must BE @OLLEGTED
bd i ae 7777 FOREST LN OT
Fricc: UNAVAILABLE DALLAS, TX 75230 INR REAL. Fred
Tuedpeount: 34 ya (1-2 pays) 214-661-7500 BES
Test: UIE)
RoyAL BLUE EDTA - 2.0m
NICHOLS INSTITUTE
33608 ORTEGA HWY
al SAN JUAN CAPISTRANO, CA 92690-6130 a ED Tr ST ’s
Pry OTe RT 800-NICHOLS
uernapunvy 2-4 Days 800-553-5445
Test: M1635
RoyAL BUAE EDTA - Jo mL
ROCHE BIOMEDICAL
2621 W AIRPORT FRWY
DreicC 23,00 LST IRVING, TX
PRict 800-324-4444
TURNAROUND. 2-4 DAYS 214-257-0110
fest: 5992
ran METAL FREE Sovium Heparin SMITHKLINE BEECHAM CLINICAL LABORATORIES
CitorioN TBE 8000 SOVEREIGN ROW
ice! 3.15 DALLAS, TX 75247
; 214-638-1301
[epttomd:. 2 ~5 Days 800-442-2102
/
TeST > TEST COPE
Types of meat fee TEES ( Depends on which LA= Von WEEY.
TAN oR BROWN TOP TUBE CONTAINING SODIUM Heparin,
RoyAL BLUE Top TAGE SONI LAY EDTA.
EEE
—Attachment 2
MAJOR LABO@ATORY LOCATIONS® SMITHKLINE
Atlanta
1777 Mantrea! Circle
Tucker, GA 30064
(404) 834-9208
~ (800) 877-8805
Drugs of Abuse Testing
3175 Prasidantial Drive
Atlanta, GA 30340
(800) 720-6432
Baltimore
11425 Cronhill Drive
Owings Mills, MD 21117
(301) 581-2400
(800) 729-7625
Boston
343 Winter Street
Waltham, MA 02154
(817) 890-8181
(800) 669-4566
Chicago
506 East State Parkway
Schaumburg, IL 60173
(708) 885-2010
(800) 669-6995
Cleveland
6180 Halle Drive
Valley View, OH 44125
(218) 328-7500
(800) 854-1774 (Ohie Only)
Dallas
8000 Soversign Row
Dallas, TX 75247
(214) 636-1301
(800) 442-2102
Detroit
24469 Indoplex Circle
Farmington Hills, Ml 48335
(313) 478-4414
(800) 356-2142
Hawall
4400 Kalanlanole Highway
Honolulu, HI 96821
(808) 735-9855
Houston
8933 Interchange Drive
Houston, TX 77054
(713) 667-5829
(800) 669-8605
Lexington
2277 Charleston Drive
Lexington, KY 40505
(606) 269-3866
(800) 366-7522
Los Angeles
7600 Tyrone Avenue
Van Nuys, California 81408
(818) 989-2520
(800) 877-2520
Loulaville
2307 Greene Way
Louisville, KY 40220
(502) 491-3484
(800) 877-8570
Miaml
5601 Northwest 158th Street
Hlaleah, FL 33014
(305) 620-0850
(800) 745-7225 (Florida Only)
Minneapolis
600 W. County Road D
New Brighton, MN 55112
(612) 835-1500
(800) 882-7012
Nashvlile
2545 Park Plaza
Nashville, TN 37203
(615) 327-1855
800) 342-2113 (In Tennessee)
800) 261.2633 (Outside Tennesses)
New Orleans
4648 S. I-10 Service Road West
Metslrla, LA 70001
(504) 889-2307
(800) 452-7669
New York City
575 Underhill Blvd,
Syosset, New York 11791
518) 677-3800
800) 877-7630
Philadelphia
400 Egypt Road
Norristown, PA 19403
(215) 831-4200
(800) 523-5447
Phoenix
2727 West Baseline, #8 and #9
Temps, AZ 85283
(802) 438-8477
(800) 829-7225 (Arizona Only)
General Sarvices
EEE
Attachment 3 -
LMM No
San Antonio
601 North Frio Street
San Antonlo, TX 78207
(512) 225-5101
(800) 282-7486
San Diego
9530 Padgett Strast, #101
San Diego, CA 92128
(619) 536-1338
(800) 479-2121 (within San Diago County)
San Francisco
8511 Golden Gate Drive
Dublin, CA 84568
(415) 828-2500
(800) 228-3008 (Northern California)
Seattle
1737 Airport Way South
Sulte 200
Seattle, WA 08134
(208) 623-8100
(800) 877-0061
St, Louis
11838 Administration Drive
St. Louls, MO 83148
(314) 6687-3806
(800) 869-7825
(800) 860-8077 (Cliant Rasponse)
Tallahansae
1892 Prolessional Park Circle
Taliahassee, FL 32308
(804) 877-5171
Tampa
4225 East Fowler Avenue
Tampa, FL 33617
(813) 972-7100
(800) 282-8813 (Florida Only)
Blo-Sclence Laboratory
76800 Tyrone Avenus
Van Nuys, CA 91405
(213) 989-2520
(800) 877-2520
8 General Services
INTERNATIONAL LABORATORIES
Edmonton, Canada
14940 123rd Avenue
Edmonton, Alberta
Canada T6V 1B4
(403) 451-3702
Ottawa, Canada
1095 Carling Avenue, Sulte 500
Ottawa, Ontarlo
Canada K1Y 4P6
(813) 729-0200
AFFILIATED LABORATORIES
Scripps Immunology Reference Laboratory
11107 Roselle Street
Suite A
San Diego, CA 92121
(818) 453-7155
® »
PATIENT SERVICE CENTERS/DRAW STATIONS
Patient Service Centers are SmithKline Beecham
Clinical Laboratories (SBCL) facilities that
provide complete specimen collection services in
addition to a limited test menu (including some
STAT services) and Client Response capabilities.
Additionally, SBCL maintains draw stations which
offer complete specimen collection services for
your patients.
Please refer to the following list for the location
nearest you. Call the appropriate number for
information on specific services.
—Attachment 4
General Services 9
ALABAMA
Birmingham
3928 Montclair Road
Birmingham, AL 35213
(205) 879-3950
Montgomery
2119 East South Bivd.
Suite 110
Montgomery, AL 36116
(205) 281-9070
ALASKA
Anchorage
4120 Laurel Street, #104
Anchorage, AK 99508
(907) 563-3170
2211 E. North Lights, #210
Anchorage, AK 99508
(907) 272-5475
ARKANSAS
Little Rock
500 S. University, #709
Little Rock, AR 72205
(501) 661-9706
CALIFORNIA
Alamo
Alamo Medical Group Laboratory
1505 St. Alphonsus
Alamo, CA 94583
(415) 837-4225
Anaheim Hills
500 South Anaheim Hills Road, Suite 146
Anaheim Hills, CA 92805
(714) 974-7191
Apple Valley
15982 Quantico Road
Suite G
Apple Valley, CA 92307
(619) 946-0801
Barstow
112 East Williams Street
Suite C
Barstow, CA 92311
(619) 256-5619
Berkeley
Oslerwelch Laboratories
3021 Telegraph Avenue
Suite A
Berkeley, CA 94705
(415) 841-3866
Burlingame
45 Adrian Ct.
Burlingame, CA 94010
(415) 828-2500
10 General Services
Carmichael
6620 Coyle Avenue, #120
Carmichael, CA 95608
(916) 961-4833
Chico
Medlab Services
183 East 8th Avenue
Chico, CA 95926
(800) 424-4448
(916) 891-0416
Chula Vista
450 4th Avenue, #100
Chula Vista, CA 92010
(619) 427-2824
Clovis
255 West Bullard, #107
Clovis, CA 93612
(209) 299-3157
Concord
2485 High School Avenue, #120
Concord, CA 94520
(415) 825-5033
Clinova Laboratory
2425 East Street, #6
Concord, CA 94520
(415) 798-9181
Clinova Laboratory
2580 Park Avenue
Concord, CA 94520
(415) 685-2114
Corning
MedLab Services
155 Solano Street
Corning, CA 96021
(916) 824-4663
Costa Mesa
722 Baker Street
Costa Mesa, CA 92625
(714) 557-8800
Escondido
925 E. Pennsylvania
Escondido, CA 92025
(619) 747-7027
Fairfield
~ 1900 Pennsylvania
Suite D
Fairfield, CA 94533
(707) 428-6242
Fair Oaks
7529 Sunset Avenue, #C
Fair Oaks, CA 95628
(916) 863-7928
Fountain Valley
11420 Warner Avenue
Fountain Valley, CA 92708
(714) 433-3152
Fremont
2147 Mowry Avenue, A-1
Fremont, CA 94538
(415) 797-6525
2557 Mowry Avenue, #10
Fremont, CA 94538
(415) 797-5342
Washington Internal Medical
Group Laboratory
2557 Mowry Avenue, #12
Fremont, CA 94538
(415) 792-1672
Fresno
1191 East Herndon Avenue, Suite 103
Fresno, CA 93710
(209) 435-0907
Glendale
CPPMG
716 W. Broadway
Glendale, CA 91204
(818) 547-7117
Hayward
22455 Maple Court, #301
Hayward CA 94541
(415) 538-5932
Hesperia
Desert Medical Laboratory
17151 Main Street, Suite 1
Hesperia, CA 92345
(619) 244-8902
Lodi
845 South Fairmont Avenue
Lodi, CA 95240
(209) 368-7185
Loma Linda
Faculty Medical Laboratory
11370 Anderson, Suite 2900
Loma Linda, CA 92354
(714) 796-4816
Long Beach
2850 Long Beach Boulevard, #161
Long Beach, CA 90806
(213) 424-3039
3815 Woodruff
Long Beach, CA 90808
(213) 420-8666
Los Angeles
8635 West 3rd Street, Suite 150W
Los Angeles, CA 90048
(213) 659-0814
1400 S. Grand Avenue
Los Angeles, CA 90015
1025 W. Olympic Blvd.
Los Angeles, CA 90015
(213) 623-2318
CPPMG
3800 East First Street
Los Angeles, CA 90063
(213) 261-7520
Mission Viejo
23512 Madero
Mission Viejo, CA 92691
(714) 583-1600
Modesto
1524 McHenry Avenue, #235
Modesto, CA 95350
(209) 578-1551
Memorial Hospital
1401 Spanos Court
Suite 107
Modesto, CA 95355
(209) 525-3148
Montebello
CPPMG
2601 Via Campo
Montebello, CA 90640
(213) 720-1144
Moreno Valley
13050 Heacock Blvd.
Moreno Valley, CA 92388
(714) 656-1213
Mountain View
Oslerwelch Laboratories
105 South Drive
Suite E
Mountain View, CA 94040
(415) 969-0200
Newhall
23206 West Lyons
Suite 112
Newhall, CA 91321
(805) 259-8358
Oakland
373 9th Street
Suite 306
Oakland, CA 94607
(415) 839-3177
Oslerwelch Laboratories
2647 East 14th Street, #108
Oakland, CA 94601
(415) 533-0818
General Services 11
Oslerwelch Laboratories
2929 Summit Street, #103
Oakland, CA 94609
(415) 835-8293
Palo Alto
Oslerwelch Laboratories
900 Welch Road, #101
Palo Alto, CA 94304
(415) 326-3239
Paradise
Medlab Services
771 Bushmann Road
Paradise, CA 95969
(916) 877-9770
Petaluma
200 Fourth Street
Suite B
Petaluma, CA 94952
(707) 763-6831
108 Lynch Creek Way, #6
Petaluma, CA 94952
(707) 778-6466
Pleasanton
1439 Cedarwood
Building 6, Suite C
Pleasanton, Ca 94566
(415) 462-7465
Redwood City
Oslerwelch Laboratories
2946 Broadway
Redwood City, CA 94062
(415) 366-5813
Riverside
3900 Sherman, #I
Riverside, CA 92503
(714) 688-5661
Roseville
729 Sunrise Avenue, #600
Roseville, CA 95661
(916) 786-2068
Salinas
505 East Romie Lane
Suite H
Salinas, CA 93901
(408) 424-1955
1326 Natividad Road
Suite C
Salinas, CA 93906
(408) 754-1593
San Diego
6475 Alvarado Road, #132
San Diego, CA 92129
(619) 286-8671
12 General Services
7910 Frost Street, #103
San Diego, CA 921283
(619) 560-7655
3444 Kearny Villa Road, #103
San Diego, CA 92123
(619) 542-0752
2850 Sixth Avenue, #223
San Diego, CA 92103
(619) 294-4888
939 University Avenue
San Diego, CA 92103
(619) 543-0479
San Francisco
Oslerwelch Laboratories
22 Battery Street, #900
San Francisco, CA 94111
(415) 391-2075
595 Buckingham Way, #222
San Francisco, CA 94132
(415) 731-6343
2460 Mission Street #104
San Francisco, CA 94110
(415) 282-3158
490 Post Street, #419
San Francisco, CA 94102
(415) 788-7140
450 Sutter Street, #511
San Francisco, CA 94108
(415) 362-7167
Oslerwelch Laboratories
450 Sutter Street, #911
San Francisco, CA 94108
(415) 391-6139
Oslerwelch Laboratories
2340 Sutter Street, #101
San Francisco, CA 94115
(415) 921-1304
3480 A Sacramento Street
San Francisco, CA 94118
(415) 441-0304
3905 Sacramento Street
San Francisco, CA 94118
(415) 441-0304
2000 Van Ness, #215
San Francisco, CA 94109
(415) 474-8687
San Jose
2577 Samaritan Drive, #730
San Jose, CA 95124
(408) 356-3161
2100 Forest Avenue, #107
San Jose, CA 95128
(408) 298-9645
San Leandro
433 Estudillo Avenue, #203
San Leandro, CA 94577
(415) 352-9804
San Mateo
101 South San Mateo Drive, #107
San Mateo, CA 94401
(415) 348-5221
San Pablo
Bay Laboratory
2089 Vale Road, #14
San Pablo, CA 94806
(415) 234-4210
Santa Ana
720 Tustin, #104
Santa Ana, CA 92705
(714) 541-5728
Santa Cruz
1505 Soquel Drive, #4
Santa Cruz, CA 95065
(408) 475-5043
Santa Fe Springs
11861 East Telegraph Road
Santa Fe Springs, CA 90670
(800) 423-5883 (In California)
Santa Monica
Parkside Medical Center
2336 Santa Monica Boulevard, Suite 205
Santa Monica, CA 90404
(213) 453-7909
Sonoma
368 Perkins Street
Sonoma, CA 95476
(707) 935-7365
Stockton
2291 March Lane
Building F
Stockton, CA 95207
(209) 951-5831
2420 N. California, #21
Stockton, CA 95204
(209) 946-0951
2800 N. California Street, # 2
Stockton, CA 95204
(209) 464-8323
Sun City
Faculty Medical Laboratory
27990 Sherman Road
Sun City, CA 92381
(714) 672-1931
Faculty Medical Laboratory
28115 Bradley Road
Sun City, CA 92381
(714) 679-1167
Tarzana
5525 Etiwanda Avenue, #320
Tarzana, CA 91356
(818) 609-0985
Vacaville
991 Nut Tree Road
2nd Floor
Vacaville, CA 95687
(707) 447-5278
Van Nuys
15243 Vanowen Street, Suite 101
Van Nuys, CA 91405
(818) 786-3180
Victorville
15366 11th Street, Suite A
Victorville, CA 92392
(619) 241-1986
West Hills/Canoga Park
23101 Sherman Place, #110
West Hills, CA 91304
(818) 347-8715
Whittier
9209 South Colima Road, #2300
Whittier, CA 90605
(213) 696-7115
Yuba City
Medlab Services
1007 Live Oak Blvd., A-3
Yuba City, CA 95991
(916) 674-9104
COLORADO
Denver
Denver SARD Office
1546 Williams Street, Suite 102
Denver, CO 80218
(303) 399-3772
DELAWARE
Kelway Plaza
314 E. Main Street
Suite 1
Newark, DE 19711
(302) 737-5430
Trolley Square
13B Trolley Square
Delaware Avenue
Wilmington, DE 19806
(302) 575-1119
General Services 13
Silverside
2502 Silverside Road
Suite1
Wilmington, DE 19810
(302) 479-5530
FLORIDA
Bradenton
2703 19th Street, Court E
Bradenton, FL 34208
(813) 746-8156
Cape Coral
603 Del Prado Bivd., #A
Cape Coral, FL 33904
(813) 574-4248
Clearwater
611 Druid Road East
Building 500, Suite 510
Clearwater, FL 34616
(813) 461-3449
Delray Beach
6642 West Atlantic Avenue
Delray Beach, FL 33446
(407) 495-1959
Fort Lauderdale
2040 NE 49th Street
Fort Lauderdale, FL 33308
(305) 776-0147
Fort Myers
3900 Broadway, Bldg. D, Suite 11
Fort Myers, FL 33901
(813) 936-4855
9371 Cypress Lake Drive, Unit #3
Fort Myers, FL 33919
(813) 482-1127
Gainesville
409 SW 8th Street
Gainesville, FL 32605
(904) 372-0609
Hialeah
777 East 25th Street
Suite 220
Hialeah, FL 33013
(305) 691-7856
5601 NW 159th Street
Hialeah, FL 33014
(305) 620-0650
Jacksonville
1045 Riverside Avenue
Suite G-45
Jacksonville, FL 32204
(904) 354-6866
3599 University Blvd. South
Suite 104
Jacksonville, FL 32204
(904) 739-1626
14 General Services
Miami
1150 NW 14th Street
Suite 214
Miami, FL 33136
(305) 547-2121
9090 SW 87th Court
Miami, FL 33176
(305) 279-7275
New Port Richey
Newporter Medical Mall, Suite 10
150 Sunset Blvd
New Port Richey, FL 33552
(813) 848-1073
Ocala
1500 S. Magnolia Extension, Suite 103
Ocala, FL 32670
(904) 732-3060
Orlando
3100 Clay Avenue, Suite 159
Orlando, FL 32804
(407) 896-1793
85 W. Miller
Orlando, FL 32804
(407) 423-1420
Pensacola
4700 Bayou Boulevard, #2C
Pensacola, FL 32504
(904) 476-7135
Port Charlotte
4054 Beaver Lane
Port Charlotte, FL 33952
(813) 625-7278
St. Petersburg
5712 5th Avenue North
St. Petersburg, FL 33710
(813) 384-3663
Sarasota
106 Medical Arts Building
1950 Arlington Street
Sarasota, FL 34239
(813) 365-4474
Doctor's Hospital Medical Complex
2650 Bahia Vista Street, Suite 105
Sarasota, FL 34239
(813) 365-4474
1775 Arlington St.
Suite 2
Sarasota, FL 34239
(813) 951-0852
Tallahassee
1892 Professional Park Circle
Tallahassee, FL 32308
(904) 877-5171
1623 Medical Drive
Tallahassee, FL 32308
(904) 656-1416
Tampa
4225 E. Fowler Avenue
Tampa, FL 33617
(813) 972-7100
4710 N. Habana Avenue
Tampa, FL 33614
(813) 872-5619
13550 N. 31st Street, #140
Tampa, FL 33613
(813) 971-1400
Venice
400 S. Tamiami Trail
Suite 150
Venice, FL 34295
(813) 484-4624
West Palm Beach
Metro Centre
2478 Metro Centre Boulevard
West Palm Beach, FL 33407
(407) 689-6485
GEORGIA
Atlanta
Medical Quarters
Suite 270
5555 Peachtree Dunwoody Road
Atlanta, GA 30342
(404) 843-3010
Midtown
730 Peachtree Street NE, Suite 1020
Atlanta, GA 30308
(404) 607-7403
Northside Hospital Doctors Building
Suite 135
960 Johnson Ferry Road
Atlanta, GA 30342
(404) 252-7472
Northside Professional Center
Suite 360, Building D
993 Johnson Ferry Road
Atlanta, GA 30342
(404) 252-7842
Sheffield Building
Suite 102
1938 Peachtree Road NW
Atlanta, GA 30309
(404) 355-5500
Austell
1791 Mulkey Road, Suite 102
Austell, GA 30001
(404) 941-0483
Columbus
633 W. 19th Street
Columbus, GA 31901
(404) 323-6567
(800) 733-3020
Decatur
Northeast Medical Arts Building
Suite 333
2801 North Decatur Road
Decatur, GA 30033
(404) 299-3994
North Professional Building
755 Commerce Drive, Suite 402
Decatur, GA 30030
(404) 373-0184
Snapfinger
Suite 200
5040 Snapfinger Woods Drive
Decatur, GA 30035
(404) 593-0855
Winn Medical Center
Suite A-120
497 Winn Way
Decatur, GA 30033
(404) 292-7227
East Point
South Fulton Medical Arts Center
1136 Cleveland Avenue
Suite 314
East Point, GA 30344
(404) 767-0579
Macon
1021 Daisy Park
Macon, GA 31201
(912) 745-8576
(800) 733-3080
Savannah
Sterling Square Building
601 East 66th Street
Savannah, GA 31405
(912) 354-0664
Snellville
Gwinnett Community Professional
Professional Complex
2151 Fountain Drive, Suite 101-A
Snellville, GA 30278
(404) 979-8377
Tucker
Montreal Medical Center
Suite 305
1462 Montreal Road
Tucker, GA 30084
(404) 491-1140
General Services 15
HAWAII
Aiea
Aiea Medical Building
99-128 Aiea Heights Drive, #306
Aiea, HI 96701
(808) 487-3921
Honolulu
Ala Moana
1441 Kapiolani Boulevard, #504
Honolulu, HI 96826
(808) 945-3124
Kaheka Professional Center
1481 S. King Street
Ground Floor
Honolulu, HI 96814
(808) 949-8909
Kalihi
A.Y. Wong Building
1507 S. King Street, #105
Honolulu, HI 96814
(808) 955-1596
Kalihi Medical Center
2055 North King Street
Honolulu, HI 96819
(808) 841-4507
Medical Arts Building
1010 South King Street, #217
Honolulu, HI 96814
(808) 521-1537
Moiliili Medical Building
2525 South King Street, #301
Honolulu, HI 96826
(808) 944-9993
Queen Emma
1270 Queen Emma Street, #106
Honolulu, HI 96813
(808) 524-3996
Waialae-Kahala
4400 Kalanianaole Highway
Honolulu, HI 96821
(808) 735-9855
Kailua
Kailua Medical Arts Building
407 Uluniu Street
Kailua, HI 96734
(808) 262-6961
Kauai
Kuhio Medical Clinic
3-3295 Kuhio Highway
Lihue, Hl 96766
(808) 245-7130
16 General Services
Waipahu
Depot Center Building
94-239 Waipahu Depot Street, #204
Waipahu, HI 96797
(808) 671-5510
IDAHO
Pocatello
Eastern Idaho Clinical
Pathology Lab
1950 East Clark, Suite F
Pocatello, ID 83201
(208) 323-6740
Idaho Falls
EICP - Idaho Falls
1740 East 17th Avenue
Idaho Falls, ID 83401
(208) 523-0401
ILLINOIS
Belleville
920 A South 59th Street
Belleville, IL 62223
(618) 234-0501
Chicago
4211 N. Cicero Avenue, 1st Floor
Chicago, IL 60641
(312) 794-8943)
7350 W. College Drive
Palos Heights, IL 60463
(708) 361-3070
6200 N. Western
Chicago, IL 60659
(312) 989-1255
676 N. St. Clair
Suite 2140
Chicago, IL 60651
(312) 664-5400
Cahokia
4041 Mississippi Avenue
Cahokia, IL 62206
(618) 332-2573
Lombard
2340 N. Highland
Lombard, IL 60148
(708) 932-2175
Moline
1302 Seventh Street
Moline, IL 61265
(309) 764-1215
Springfield
520 N. Fourth Street
Springfield, IL 62702
(217) 544-0878
INDIANA
Evansville
600 N. Weinbach
Suite 710
Evansville, IN 47711
(812) 473-9985
Wichita
3333 E. Central #701
Wichita, KS 67208
(316) 685-5185
KENTUCKY
Lexington
2277 Charleston Drive
P.O. Box 11750
Lexington, KY 40577
(606) 299-3866
Medical Heights
2370 Nicholasville Road
Suite 105
Lexington, KY 40503
(606) 276-2548
Physicians Mall
1725 Harrodsburg Road, E2
Lexington, KY 40504
(606) 278-3810
Professional Arts Center
135 East Maxwell Street
Suite 103
Lexington, KY 40508
(606) 255-7183
Louisville
2307 Greene Way
Louisville, KY 40202
(502) 491-3484
(800) 877-8570
Professional Towers
4010 DuPont Circle
Suite 380
Louisville, KY 40207
(502) 895-2481
1169 Eastern Parkway
Suite 3311
Louisville, KY 40217
(502) 452-1561
250 Liberty, Suite B-2
Louisville, KY 40202
(502) 587-8744
LOUISIANA
Bossier City
1514 Doctors Drive, Suite 104
Bossier City, LA 71111
(318) 746-5112
Covington
Highland Park Plaza, #202
Covington, LA 70433
(504) 893-0077
Metairie
4648 S. 1-10 Service Road W.
Metairie, LA 70001
(504) 889-2307
3601 Houma Blvd., #201A
Metairie, LA 70005
(504) 454-5493
New Orleans
4400 General Meyer Ave., #307
New Orleans, LA 70131
(504) 454-5495
2025 Gravier Street
New Orleans, LA 70112
(504) 525-3964
3715 Prytania Street
New Orleans, LA 70115
(504) 896-3260
4335 Elysian Fields Avenue
Suite 302
New Orleans, LA 70122
(504) 288-4717
Shreveport
1534 Elizabeth Street, #115
Shreveport, LA 71101
(318) 221-5060
803 Jordan Street
Shreveport, LA 71101
(318) 221-5060
: MARYLAND
Baltimore
207 Ridgely Avenue
Annapolis, MD 21401
(301) 263-0908
1205 York Road, Suite 15
Lutherville, MD 21093
(301) 321-8339
224 Washington Heights
Medical Center
Westminster, MD 21152
(301) 857-0201
MASSACHUSETTS
Brighton
697 Cambridge Street
Brighton, MA 02135
(508) 783-5550
General Services 17
Brockton
225 Quincy Avenue
Brockton, MA 02402
(617) 586-5955
Brookline
1101 Beacon Street
Brookline, MA 02146
(617) 566-2810
Danvers
Liberty Tree Mall
140 Commonwealth Avenue
Danvers, MA 01923
(508) 777-6060
Framingham
Wonder Shopping Center
444 Franklin Street
Framingham, MA 01701
(508) 875-7434
Marshfield
435 Furnace Street
Marshfield, MA 02050
(617) 834-0321
Plymouth
110 Long Pond Road
Plymouth, MA 02360
(508) 746-2926
Scituate
7 Driftway Medical Bldg.
Scituate, MA 02040
(617) 545-9437
Stoughton
966 Park Street
Stoughton, MA 02072
(617) 344-2248
Waltham
32 South Street
Waltham, MA 02154
(617) 899-7310
Watertown
521 Mt. Auburn Street
Watertown, MA 02172
(617) 926-1270
(617) 926-1271
Worcester
385 Grove Street
Worcester, MA 01605
(508) 757-8397
MICHIGAN
Farmington Hills
28595 Orchard Lake Road
Suite 103
Farmington Hills, Ml 48334
(313) 553-2565
18 General Services
Garden City
6033 Middlebelt Road
Garden City, Ml 48135
(313) 522-1588
Westland
35150 Nankin Blvd.
Suite 101
Westland, MI 48185
(313) 458-2010
MINNESOTA
Burnsville
Ridgepoint Medical Center, Suite 312
14050 Nicollet Avenue South
Burnsville, MN 55337
(612) 892-6929
Edina
Centennial Lakes Medical Building, Suite 410
7373 France Avenue South
Edina, MN 55435
(612) 831-4547
Southdale Medical Building, Suite 200
6545 France Avenue S
Edina, MN 55435
(612) 927-7941
Minneapolis
Medical Arts Building, Suite 450
825 Nicollet Mall
Minneapolis, MN 55402
(612) 333-6521 x76
Metropolitan Medical Offices Building
825 S. Eighth Street, Suite LL14
Minneapolis, MN 55404
(612) 333-6521 x77
New Brighton
600 W. County Road D
New Brighton, MN 55112
(612) 635-1500
MISSOURI
Ballwin
15421 Clayton Road, Suite G-3
Ballwin, MO 63011
(314) 256-3898
Clayton
950 Francis Place, Suite 307
St. Louis, MO 63105
(314) 721-1903
Creve Coeur
777 S. New Ballas Road
St. Louis, MO 63141
(314) 872-7500
420 N. New Ballas Road
St. Louis, MO 63141
(314) 567-3840
Festus
Medical Village Industrial Bivd., #104
Festus, MO 63028
(314) 937-6717
Florissant
11115 New Halls Ferry Road
Florissant, MO 63033
(314) 837-0077
Kansas City
6724 Troost
Kansas City, MO 64131
(816) 361-4646
Kirkwood
325 N. Kirkwood Road, Suite 103
St. Louis, MO 63122
(314) 965-8763
Richmond Heights
1035 Bellevue #101
St. Louis, MO 63117
(814) 645-2822
St. Charles
2730 Highway 94 South
St. Charles, MO 63303
(314) 441-7120
St. Louis
6651 Chippewa Street, Suite 316
St. Louis, MO 63109
(314) 781-8964
100 N. Euclid at West Pine
St. Louis, MO 63108
(314) 367-3133
South St. Louis County
13131 Tesson Ferry Road
St. Louis, MO 63128
(314) 842-3693
Town & Country
2821 N. Ballas Road, Suite C-55
St. Louis, MO 63131
(314) 569-3203
NEW JERSEY
Bricktown
457 Jack Martin Blvd.
Bricktown, NJ 08723
(201) 840-4030
Montclair
127 Pine Street
Room 12
Montclair, NJ 07042
(201) 783-0455
Toms River
1163 Route 37
Suite C3
Toms River, NJ 08755
(201) 286-4903
NEW YORK
Brockport
80 West Avenue, Suite 208
Brockport, NY 14420
(716) 637-4740
Brooklyn
5527 New Utrecht Avenue
Boro Park, Brooklyn, NY 11219
(718) 871-6969
370 Bay Ridge Parkway
Brooklyn, NY 11209
(718) 680-2801
Lancaster
450 Central Avenue
Lancaster, NY 14086
(716) 681-8242
Liverpool
8132 B Oswego Road
Route 57
Liverpool, NY 13090
(315) 652-0025
Manhattan
Manhattan STAT Lab
30 E. 60th Street
New York, NY 10022
(212) 826-9620
Nanuet
36 College Avenue
Nanuet, NY 10954
(914) 623-8220
Nassau
Island Diagnostic
872 Atlantic Avenue
Baldwin, NY 11510
(516) 379-9591
2001 Marcus Avenue
Suite S150
Lake Success, NY 11042
(516) 437-3887
575 Underhill Blvd.
Syosset, NY 11791
(516) 677-3800
(800) 877-7530
222 Station Plaza
Suite 200
Mineola, NY 11501
(516) 741-0270
230 Hilton Avenue
Hempstead, NY 11550
(516) 489-6060
Queens
140-04 58 Road
Flushing, NY 11355
(718) 762-4766
General Services 19
Rochester
1160 Chili Avenue, Suite 104
Rochester, NY 14624
(716) 235-2360
31 Erie Canal Drive, Suite G
Rochester, NY 14626
(716) 225-6630
1400 Portland Avenue, Suite 1
Rochester, NY 14621
(716) 266-0410
919 Westfall Road, Building B-140
Rochester, NY 14618
(716) 461-8450
Rockland
36 College Avenue
Nanuet, NY 10954
(914) 623-8220
Schenectady
2546 Balltown Road, Suite 104
Schenectady, NY 12309
(518) 372-0162
Staten Island
2285 Victory Blvd.
Staten Island, NY 10314
(718) 494-4660
Suffolk
350 E Main Street
Bayshore, NY 11706
(516) 665-1595
118 North Country Road
Port Jefferson, NY 11777
(516) 473-5292
238 Old Town Road
Southampton, NY 11968
(516) 287-1280
25 Sunset Avenue
West Hampton, NY 11978
(516) 288-4084
Patchogue East End Lab
250 Yaphank Road
East Patchogue, NY 11772
(516) 654-2211
59 Ponquogue Avenue
Hampton Bays, NY 11946
(516) 728-0032
Syracuse
1000 E. Genesee Street, Suite 304
Syracuse, NY 13210
(315) 474-2997
20 General Services
Westchester
Putnam Valley Medical Center
Oregon Corners
Peekskill Hollow Road
Putnam Valley, NY 10579
(914) 528-2232
12 Green Ridge Avenue
White Plains, NY 10605
(914) 428-8692
NEVADA
Carson City
Medlab Services
1200 North Mountain
Carson City, NV 89703
(702) 883-1141
Incline Village
North Tahoe Diagnostic Laboratory
889 Alder # 103
Incline Villiage, NV 89451
(702) 832-1013
Reno
85 Kirman
Reno, NV 89502
(702) 322-1364
NORTH CAROLINA
Asheville
N-2 Doctors Building
Doctors Drive
Asheville, NC 28801
(704) 252-0706
(800) 733-3078
Charlotte
1900 Randolph Road, #300
Charlotte, NC 28207
(704) 334-3026
(800) 733-3693
OHIO
Beachwood
3619 Park East, Suite 213
Beachwood, OH 44122
(216) 464-4224
Lakewood
14650 Detroit Avenue, Suite 105
Lakewood, OH 44107
(216) 228-9161
Mayfield Heights
6801 Mayfield Road
Mayfield Heights, OH 44124
(216) 449-8626
Middleburg Heights
7155 Pearl Road
Phase Il Building
Middleburg Heights, OH 44129
(216) 843-5830
4
Oregon
2730 Navarre, Suite E
Oregon, OH 43616
(419) 693-6121
Parma
6681 Ridge Road, Suite 110
Parma, OH 44129
(216) 842-0415
6789 Ridge Road, Suite 101
Parma, OH 44129
(216) 886-3855
Parma Heights
6363 York Road, Suite 206
Parma Heights, OH 44130
(216) 842-0401
Tallmadge
33 North Avenue, #208
Tallmadge, OH 44278
(216) 633-9300
Toledo
2914 S. Republic Blvd.
Toledo, OH 43615
(419) 531-4414
1544 S. Byrne
Toledo, OH 43614
(419) 382-5192
3900 Sunforest Court, Suite 120
Toledo, OH 43623
(419) 473-3431
OKLAHOMA
Enid
330 S. Fifth Street
Enid, OK 73101
(405) 233-2611
620 S. Madison
Enid, OK 73101
(405) 233-2616
615 E. Oklahoma
Enid, OK 73101
(405) 233-2615
Oklahoma City
3433 N.W. 56th Street, #370
Oklahoma City, OK 73112
(405) 945-4488
1044 SW 44th, #108
Oklahoma City, OK 73109
(405) 632-0187
Tulsa
1145 S. Utica, #163
Tulsa, OK 74104
(918) 749-5016
OREGON
Portland
Portland-South West
9370 Southwest Greenburg Road, Suite M
Portland, OR 97223
(503) 244-6207
PENNSYLVANIA
Allentown
Springtree Professional Bldg.
1575 Pond Road, Suite 204
Allentown, PA 18104
Bethlehem
Gateway Professional Center
Suite 301
2045 Westgate Drive
Bethlehem, PA 18017
(215) 868-8722
Broadheadsville
Pleasant Valley Plaza
Route 209
Broadheadsville, PA 18322
(717) 992-6654
Chadds Ford
201 Route 202
Glen Mills, PA 19342
(215) 558-2695
Greenville
4 Fourth Avenue
Greenville, PA 16125
(412) 588-0352
Norristown
400 Egypt Road
Norristown, PA 19403
(215) 631-4518
Oxford Valley’
Penn Square
402 Middletown Blvd., Suite 208
Langhorne, PA 19047
(215) 741-1550
Philadelphia
Northeast Medical Center, Suite 20
Welsh Road & Roosevelt Blvd.
Philadelphia, PA 19114
(215) 464-4590
General Services 21
Pittsburgh
5231 Penn Avenue
Pittsburgh, PA 15224
(412) 361-8015
Mellon Pavilion
4815 Liberty Avenue
Suite 239
Pittsburgh, PA 15224
(412) 681-1560
Sellersville
Upper Bucks Medical Arts Bldg., Suite 8
817 Lawn Avenue
Sellersville, PA 18960
(215) 257-2201
RHODE ISLAND
Providence
189 Governor Street
Providence, RI 02907
(401) 351-4900
TENNESSEE
Bristol
245 Midway Street, Suite 202
Bristol, TN 37620
(615) 968-9557
Chattanooga
1042 E. 3rd Street
Chattanooga, TN 37402
(615) 267-1640
Jackson
1804 US-45 Bypass
Jackson, TN 38305
(901) 664-1801
Johnson City
411 Princeton Road, Suite 101
Johnson City, TN 37601
(615) 283-4342
Knoxville
9303 Park West Blvd.
Knoxville, TN 37923
(615) 690-3382
Lawrenceburg
323 Brink Street
Lawrenceburg, TN 38464
(615) 762-3712
Lebanon
404 East Spring Street
Lebanon, TN 37087
(615) 449-2371
22 General Services
Memphis
2713 Colony Park
Memphis, TN 38131
(901) 345-1660
Murfreesboro
503 A Highland Terrace
Murfreesboro, TN 37130
(615) 890-3633
Nashville
2545 Park Plaza
Nashville, TN 37203
(615) 327-1855
TEXAS
Allen
400 N. Allen Drive, #107
Allen, TX 75002
(214) 727-6551
Austin
2906 Medical Arts Street
Austin, TX 78705
(512) 320-1658
Beaumont
3155 Stagg Drive, #129
Beaumont, TX 77701
(409) 835-2554
Corpus Christi
2601 Hospital Blvd., #102
Corpus Christi, TX 78405
(512) 884-1948
1415 Third Street
Corpus Christi, TX 78404
(512) 884-3584
3612 Reid Drive
Corpus Christi, TX 78404
(512) 855-4351
Dallas
8325 Walnut Hill Lane, #105
Dallas, TX 75231
(214) 363-6549
8000 Sovereign Row
Dallas, TX 75247
(214) 638-1301
122 W. Colorado, #311
Dallas, TX 75208
(214) 942-8454
8160 Walnut Hill Lane, #202
Dallas, TX 75231
(214) 750-0623
Fort Worth
1108 West Rosedale
Fort Worth, TX 76104
(817) 336-4069
Houston
1200 Binz, #590
Houston, TX 77004
(713) 667-5829
7515 S. Main, #160
Houston, TX 77030
(713) 790-1465
Lancaster
2700 W. Pleasant Run
Lancaster, TX 75146
(214) 223-0020
Longview
402 N. Fifth Street
Longview, TX 75601
(214) 758-9967
San Antonio
601 North Frio Street
San Antonio, TX 78207
(512) 225-5101
730 North Main, #207
San Antonio, TX 78205
(512) 225-5101 ext. 561
8711 Village Drive, #103
San Antonio, TX 78217
(512) 225-5101 ext. 574
7210 Louis Pasteur, #110
San Antonio, TX 78229
(512) 225-5101 ext. 504
Waco
2112 Washington
Waco, TX 76702
(817) 756-7225
Weslaco
1210 E. Eighth Street, #3
Weslaco, TX 78596
(512) 969-2501
Sait Lake City
Aspen SmithKline
5770 South 250 East
Suite 24
Salt Lake City, UT 84107
(801) 261-2967
WASHINGTON
Burien
14213 Ambaum Boulevard Southwest
Seattle, WA 98166
(206) 246-3883
Everett
General Hospital Medical Center
Office Building
1330 Rockefeller, Suite 110
Everett, WA 98201
(206) 258-6624
Federal Way
Capital Square Laboratory
720 South 320th
Federal Way, WA 98003
(206) 927-8535
Torquay Laboratory
34616-11th Place South
Federal Way, WA 98003
(206) 927-7655
Gig Harbor
Harbor Park Laboratory :
5122 Olympic Drive Northwest, #102
Gig Harbor, WA 98335
(206) 851-9910
Puyallup
Valley Clinic
1322 3rd Street Southeast, #350
Puyallup, WA 98371
(206) 845-6529
Seattle
Medical Dental Building
509 Olive Way, Room 1005
Seattle, WA 98101
(206) 623-4354
Tacoma
Allenmore Medical Center Laboratory
1901 South Union
Suite B3005
Tacoma, WA 98405
(206) 572-4331
Bridgeport Medical Laboratory
7424 Bridgeport Way West
Tacoma, WA 98467
(206) 582-6372
12911 120th Avenue NE, #F-280
Kirkland, WA 98034
(206) 823-2016
General Services 23
Lakes Medical Plaza
11311 Bridgeport Way SW
Tacoma, WA 98499
(206) 588-6812
Lakewood Village Laboratory
5900-100th SW, #13
Tacoma, WA 98499
(206) 588-4477
1102 South | Street
Tacoma, WA 98405
(206) 627-8988
WEST VIRGINIA
Huntington
2828 First Avenue
Suite 103
Huntington, WV 25702
(304) 522-0450
WISCONSIN
Milwaukee
8909 N. Port Washington Road
Milwaukee, WI
(414) 352-2011
24 General Services
» NORTHERN DISTRICT ¢
¥ 1
IN THE UNITED STATES DISTRICT COURT | [oy 29
FOR THE NORTHERN DISTRICT OF TEXAS ;
DALLAS DIVISION
LOIS THOMPSON on behalf of and
as next friend to TAYLOR
KEONDRA DIXON, ZACHERY X.
WILLIAMS, CALVIN A. THOMPSON
and PRENTISS LAVELL MULLINS,
No. 3-92 CV 1539-R
Plaintiffs Civil Action
Vv. Class Action
BURTON F. RAIFORD, in his
capacity as Commissioner of
the Texas Department of Human
Services,
and
THE UNITED STATES OF AMERICA,
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Defendants.
DECLARATION OF LAURA B. BESHARA
IN OPPOSITION TO DEFENDANT USA’S MOTION
TO DISMISS OR IN THE ALTERNATIVE FOR SUMMARY JUDGMENT
My name is Laura B. Beshara and I am one of the attorneys
for plaintiffs in this case. Plaintiffs’ Response to Defendant
USA’s Motion for Summary Judgment and Plaintiffs’ Memorandum in
Support of Plaintiffs’ Response and in Opposition to Defendant
USA's Motion to Dismiss or in the Alternative for Summary Judg-
ment contain quotes from the listed studies, reports, and plsne
authored by agencies of the United States government. The quotes
are accurate. The sections of the documents containing the
quotes are attached as exhibits to this declaration.
#1. Excerpts from HHS, "Strategic Plan For the Elimination
of Childhood Lead Poisoning", February 1991.
#2. Excerpts from HHS, "The Nature and Extent of Lead
Poisoning in Children in the United States: A Report to
1
Congress", 1988.
#3. HCFA State Medicaid Manual - 9/19/92 Revisions
The following listed and attached documents are true and
correct copies of what they purport to be.
#4. Donald L. Kelley, Texas State Medicaid Director, July
9, 1992 letter in response to an Open Records Act
request
#5. Excerpts from HCFA’s Medicaid Oversight Report of the
Texas EPSDT Program, July 21, 1991
#6. "Evaluation of the Erythrocyte Protoporphyrin Test as a
Screen for Elevated Blood Lead Levels", Ocotber 1991,
Journal of Pediatrics, pp.548-550 by: Michael D.
McElvaine, DVM, MPH, Hyman G. Orbach, PhD., Sue Binder,
MD, Lorry A. Blanksma, PhD., Edmond F. Maes, PhD., and
Richard M. Krieg, PhD.
Reference is made in plaintiffs’ response and memorandum to
the Centers for Disease Control (CDC) Statement, "Preventing Lead
Poisoning in Young Children", 1991. The CDC Statement is at-
tached to Defendant USA’s motion.
Reference is also made in plaintiffs’ response and memoran-
dum to the affidavit of John F. Rosem. M.D. That affidavit is
attached to the amicus brief of the plaintiff-interveners.
This Declaration is also being made pursuant to Rule 56 (f)
of the Fed. R. Civ. Proc. to show that for the following reasons
discovery is needed on certain issues raised by defendant USA’s
motion for summary judgment in order to completely respond to
defendant USA’s motion for summary judgment.
First, the USA alleges several facts surrounding the process
by which the new HCFA guidelines were developed. Plaintiffs
believe that these facts are irrelevant to the issues before the
2
Court. The USA's allegations involve allegations of input and
consultation that plaintiffs have no ready access to or means of
confirming. The USA’s facts on consultation and input are
completely within the control of the federal agencies involved.
It is unlikely that any federal employee would even be willing to
give an affidavit which did not corroborate the USA’s position.
The USA’s motion was filed while plaintiffs are prohibited from
obtaining merits discovery by the Local Rules. If the Court
believes these allegations are relevant, plaintiffs request that
the Court either refuse the application or order a continuance
for plaintiffs to conduct discovery on these allegations.
Secondly, the USA alleges that there is a lack of "capacity"
in some unspecified states which lack supports the continued use
of the EP test. The USA furnishes no single specific instance of
a state without the capacity. The facts upon which the USA
relies are completely within the control of the USA. There has
not been enough time to even attempt to obtain affidavits from
each of the 50 states on the issue of capacity. Affidavits are
not likely to be a good source of reliable evidence since each
state will have a vested financial interest in at least under-
stating its capacity for administration of blood lead tests.
Plaintiffs have not been able to do any discovery on this issue
because of the stage of the case and the Local Rule prohibiting
merits discovery while the class motion is pending. While plain-
tiffs believe that the declarations of Rosen and Nicar put into
dispute the factual issue of "capacity", plaintiffs request the
Court to either refuse the application for judgment or order a
continuance and allow plaintiffs the opportunity to conduct
discovery on the USA’s lack of capacity allegations.
Finally, the USA makes the factual allegation that the
federal Centers for Disease Control [CDC], as an agency, believes
that the new HCFA guidelines are consistent with the CDC’s 1991
Statement. The only factual support for the allegation is the
single statement by Sue Binder, MD., and employee of CDC. Dr.
Binder is not the head of CDC, and her statement does not set out
the authority she has to make such a statement on behalf of the
agency. Given that CDC is an agency of the USA, it is unlikely
that plaintiffs will be able to obtain voluntary and candid
affidavits setting out the facts underlying Dr. Binder’s state-
ment from other federal employees. Given the explicit contradic-
tions between major parts of the HCFA guidelines and the CDC 1991
Statement on the use of the EP test, discovery of documents and
depositions of witnesses are necessary to develop the issue of
CDC’s position on the issue. Plaintiffs have not been able to do
such discovery because of the stage of the case and the Local
Rule prohibiting merits discovery until the class questions are
resolved. Plaintiffs request the Court to either refuse the
application for judgment or order a continuance to allow plain-
tiffs the opportunity to conduct discovery on the issue.
I declare, under penalty of perjury that the statements in
this declaration are true and correct. Executed thes day of
November, 1992.
ura bh _Beshara
‘Laura B. Beshara
Respectfully Submitted,
MICHAEL M. DANIEL, P.C.
3301 Elm Street
Dallas, Texas 75226-1637
(214) 939-9230
(214) 939-9229 (telecopier)
ste hl ah op
Michael M. Daniel
State Bar No. 05360500
By: Cua. Fh
Laura B. Beshara
State Bar No. 02261750
ATTORNEYS FOR PLAINTIFFS
CERTIFICATE OF SERVICE
I certify that a true and correct copy of the above document
255 served upon counsel for defendants by U.S. Mail on this the
day of November, 1992.
“Laura B. Beshara
ONIN
Developed for the Risk Management Subcommittee, Committee
to Coordinate Environmental Health and Related Programs,
U.S. Department of Health and Human Services.
|
]
February 1991
ERVIC,
ph SERVICES,
U.S. DEPARTMENT OF HEALTH
AND HUMAN SERVICES
<°
5
=
i] Public Health Service
wv,
ke) Centers for Disease Control
‘ gm
] Exhibit 1
AUTHORS, CONTRIBUTORS, PEER REVIEWERS, AND ACKNOWLEDGEMENTS
PRINCIPAL AUTHORS
Sue Binder, M.D.
Centers for Disease Control
Center for Environmental Health and Injury Control
1600 Clifton Road, NE
Atlanta, Georgia 30333
Henry Falk, M.D., M.P.H.
Centers for Disease Control
Center for Environmental Health and Injury Control
1600 Clifton Road, NE
Atlanta, Georgia 30333
CONTRIBUTORS
FEDERAL
Max Lum, E.D.
Agency for Toxic Substances and Disease Registry
Division of Health Education
1600 Clifton Road, NE
Atlanta, Georgia 30333
Susanne Simon
Agency for Toxic Substances and Disease Registry
Division of Health Education
3 1600 Clifton Road, NE
§ Atlanta, Georgia 30333
James L. Pirkle, M.D., Ph.D.
Centers for Disease Control
5 Center for Environmental Health and Injury Control
1600 Clifton Road, NE
Atlanta, Georgia 30333
Joel Schwartz, Ph.D.
Environmental Protection Agency
401 M Street, SW, PM-221
Washington, D.C. 20460
iv
The CDC Categorical Grant Program was authorized by the Lead Contamination
Control Act of 1988. This program provides for childhood lead screening by State and
local agencies, referral of children with elevated blood lead levels for treatment and
environmental interventions, and education about childhood lead poisoning prevention.
Money for this program was first appropriated in FY 1990. The President’s budget for
FY 1992 contains $14.95 million for this program, an increase of $7.16 million from FY
1991.
Other govermnment-funded child health programs also conduct some childhood lead
screening. These programs include Medicaid’s Early and Periodic Screening, Diagnostic,
and Treatment Program (EPSDT); the Supplemental Food Program for Women, Infants,
and Children (WIC); and Head Start.
EPSDT is a comprehensive prevention and treatment program available to
Medicaid-eligible persons under 21 years of age. In 1989, of the 10 million eligible
persons, more than 4 million received initial or periodic screening health examinations.
These are provided at a variety of sites (for example, physician offices, public health
clinics, and community health centers) by private or public sector providers. Screening
services, defined by statute, must include a blood lead assessment "where age and risk
factors indicate it is medically appropriate." (The requirements for a blood lead
assessment are not further defined.) In addition, the EP test is recommended for
children ages 1 to 5 years to screen for iron deficiency. Because this test is also useful in
identifying children with blood lead levels > 25 ug/dL, many children being screened for
iron deficiency are screened for lead poisoning at the same time. The guidelines for
States indicate that environmental investigations for lead-poisoned children are covered
under EPSDT, although abatement is not. However, specific criteria for screening and
the determination of what Medicaid will cover are decided on a State-by-State basis.
Thus, many States do not conduct much screening or do not pay for environmental
investigations for poisoned children. National data are not available on the numbers of
children screened for lead poisoning through EPSDT, since State-reported Medicaid
performance and fiscal data are not broken down to such specific elements.
The U.S. Department of Agriculture’s WIC program serves pregnant and postpartum
women and children under 5 years of age in low-income households. Program benefits
include supplemental food, nutrition education, and encouragement and coordination for
the use of other existing health services. As of March 1988, an estimated 1.63 million
children ages 1 to 4 years were participating in WIC. Although children must undergo a
medical or nutritional assessment or both to be certified to receive benefits, Federal
WIC regulations permit States to establish their own requirements for WIC certification
examinations. These regulations permit the use of an EP test for certification and define
lead poisoning as a nutritionally-related medical condition that can be the basis of
certifying a child to receive WIC benefits. Most WIC programs that perform EP tests
use them to screen for iron deficiency, although hematocrit or hemoglobin measurements
are most commonly used for this purpose. The nutritional education and supplemental
food provided by WIC are undoubtedly important in reducing lead absorption in many
children and pregnant women.
Page 18
The expansion of screening programs will result in a demand for training programs on
childhood lead screening and the investigation of environmental sources. The Louisville,
Kentucky, training program can serve as a model for other such programs. This program
provides methods for assessing lead poisoning in high-risk populations and demonstrates
the integration of lead screening with basic child health services and the technical and
management skills needed for an effective and efficient childhood lead poisoning
prevention program.
In addition, increased screening will lead to a demand for increased laboratory services.
In 1991 CDC will likely issue new recommendations suggesting that screening programs
attempt to identify children with blood lead levels below 25 ug/dL. This change will
mean that blood lead measurements must be used for childhood lead screening instead
of EP measurements. When this happens, the demand for increased blood lead testing
will far exceed current capacity. In addition, cheaper, easier to use, and portable
instrumentation for blood lead testing will need to be developed. Furthermore, existing
programs for proficiency testing and certification of laboratories will have to be
expanded. With concem about: health effects at low blood lead levels, laboratories will
be called upon to do better measurements in the 4 to 5 ug/dL range. As a result, major
efforts will be needed to improve laboratory quality assurance and control at these lower
levels. Reference materials for laboratories performing blood lead measurements and
technical assistance will be required to improve laboratory quality.
Page 23
Studies should be conducted on the cost-effectiveness of different strategies for
childhood lead screening. These strategies include screening in inner-city emergency
rooms to reach children who have no ongoing source of care and "cluster testing” of all
children in multiple dwelling units where cases of childhood lead poisoning have been
identified. The usefulness of screening in day care centers and nursery schools should
also be evaluated. In addition, Federal programs now funding childhood lead screening
should be evaluated to see how they can work together for a most efficient use of
resources.
At present it is much cheaper and easier to perform an EP test than a blood lead
measurement; however, the EP test is not a useful screening test for blood lead levels
below 25 ug/dL. Both because of the expected increase in screening and because of the
concen about the health effects of lower blood lead levels, the demand for blood lead
testing is likely to increase. The development of portable, easy-to-use, cheaper
instrumentation for blood lead measurement is extremely important.
Because capillary (or fingerstick) blood samples may be easily contaminated with lead on
the skin, venous blood must be used to confirm lead poisoning in children. Several
capillary blood collection devices now on the market purport to collect blood free of
surface finger contamination from lead. These devices should be evaluated for ease of
use and ability to collect an uncontaminated sample.
The education of families about lead poisoning by childhood lead poisoning prevention
programs often includes information about the importance of nutrition. Because of our
growing concem about the adverse effects of low blood lead levels, nutritional
interventions are likely to be recommended for more children. A number of nutritional
factors have been shown experimentally to influence the absorption of lead and its
concentrations in tissues. Intervention studies or clinical trials should be conducted to
establish that increasing the regularity of meals and ensuring adequate dietary intake of
iron and calcium can reduce blood lead levels.
Educational strategies for increasing medical care provider and public awareness of lead
poisoning should also be evaluated for their efficacy in reducing children’s blood lead
levels and preventing lead poisoning.
Page 40
The Nature and Extent of
Lead Poisoning in Children
in the United States:
A Report to Congress
N
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51
13
Effects monitoring for exposure in general and lead exposure in particular has drawbacks (Friberg, 1985). Effects monitoring is most usefuy] when the
the other.
An elevated Pb-B level] and, consequently, increased lead absorption may exist even when the EP value is within normal limits, now £35 micrograms (ug) EP/deciliter (d1) of whole blood. We might expect that in high-risk, low socioeconomic status (SES), nutrient (including iron)-deficient children in urban areas, chronic Pb-B elevation would invariably accompany persistent EP
time of NHANES II), 47% had EP levels at or below 30 pg/dl, and 58% (Annest and Mahaffey, 1984) had EP levels less than the current EP cutoff value of 35 ug/dl (coc, 1985). This means that reliance on EP level for initial screening
3. Environmental Sources of Lead in the United States with Reference to Young Children and Other Risk Groups
As graphically depicted in Figure II-1, several environmental sources of lead exposure pose a risk for young children and fetuses. Many sources not
IT-9
State Medicaid Manual
Part 5 - Early and Periodic Screening
Diagnosis, and Treatment (EPSDT)
HCFA Pub 45-5
09-92
Rev. 5
Retrieval Title: R5.SM5
REVISED MATERIAL REVISED PAGES REPLACED PAGES
Sec. 5123.2 (Cont.)5-13 - 5-16.1 (5 pp.) 5-13 - 5-16 (4 pp.)
CHANGED IMPLEMENTING INSTRUCTIONS--EFFECTIVE DATE: 09/19/92
Section 5123.2, Screening Service Content.--Part D of this
section, Appropriate Laboratory Tests, has been revised to update
HCFA policies and provide guidance to States for lead toxicity
screening through the Early and Periodic Screening, Diagnosis and
Treatment (EPSDT) program after considering the October 1991
statement of the Centers for Disease Control (CDC), Public Health
Service, Preventing Lead Poisoning in Young Children. The CDC
statement lowered the blood lead level threshold at which followup
and iriterventions are recommended for children from 25 micrograms
per deciliter (ug/dL) of whole blood to 10 ug/dL.
Given the current state of the art of lead poisoning-related
technology instrumentation and the limitations in resources
available to States for lead poisoning prevention and treatment
efforts, HCFA is issuing this first phase of guidance. In many
States, the public health agency is leading the effort to
implement the new CDC guidelines. HCFA intends to provide enough
flexibility in the screening guidelines to allow State Medicaid
agencies to function within the overall plan of their State health
department. :
While HCFA wants to stress that blood lead testing is the
screening test of choice, HCFA acknowledges that it will take some
time for States to make a transition to blood lead testing. The
erythrocyte protoporphyrin (EP) test is not sensitive for blood
lead levels below 25 ug/dL. However, HCFA recognizes that the
capacity may not exist in every community for analyzing blood lead
for every Medicaid eligible child. States continue to have the
option to use the EP test as the initial screening blood test.
However, elevated EP tests must be confirmed with a blood lead
test, Additionally, while HCFA recommends venous blood lead
tests, HCFA understands the hesitation of some practitioners to
perform venous blood tests on small children. In these
circumstances, a capillary specimen may be used for the initial
blood lead test to be followed, if necessary, with a venous blood
lead test. HCFA will consider guidelines for a next phase based
on State or community laboratory testing capacities and any
further revisions to CDC's statement.
BE RE iY
Exhibit 3 -
A change has been made to Part C, Appropriate Immunizations, by
listing two additional immunizations which should be provided when
medically necessary and appropriate.
EARLY AND PERIODIC SCREENING,
09-92 DIAGNOSTIC AND TREATMENT SERVICES 5123.2 (Cont.)
o In screening for developmental assessment, the
examiner incorporates and reviews this information in conjunction
with other information gathered during the physical examination
and makes an objective professional judgement whether the child
is within the expected ranges. Review developmental progress, not
in isolation, but as a component of overall health and well-being,
given the child's age and culture.
o Developmental assessment should be culturally
sensitive and valid. Do not dismiss or excuse improperly
potential problems on grounds of culturally appropriate behavior.
Do not initiate referrals improperly for factors associated with
cultural heritage.
o Programs should not result in a label or
premature diagnosis of a child. Providers should report only that
a condition was referred or that a type of diagnostic or treatment
service is needed. Results of initial screening should not be
accepted as conclusions and do not represent a diagnosis.
o Refer to appropriate child development resources
for additional assessment, diagnosis, treatment or follow-up when
concerns or questions remain after the screening process.
2. Assessment of Nutritional Status.--This is accomplished
in the basic examination through:
o Questions about dietary practices to identify unusual
eating habits (such as pica or extended use of bottle feedings)
or diets which are deficient or excessive in one or more
nutrients.
o A complete physical examination including an oral
dental examination. Pay special attention to such general features
as pallor, apathy and irritability.
o Accurate measurements of height and weight are among
the most important indices of nutritional status.
o A laboratory test to screen for iron deficiency.
HCFA and PHS recommend that the erythrocyte protoporphyrin (EP)
test be utilized when possible for children ages 1-5. It is a
simple, cost effective tool for screening for iron deficiency.
Where the EP test is not available, use hemoglobin concentration
or hematocrit.
o If feasible, screen children over 1 year of age for
serum cholesterol determination, especially those with a family
history of heart disease and/or hypertension and stroke.
If information suggests dietary inadequacy, obesity or other
nutritional problems, further assessment is indicated, including:
o Family, socioeconomic or any community factors,
Rev. 5 5-13
EARLY AND PERIODIC SCREENING,
5123.2 (Cont.) DIAGNOSTIC AND TREATMENT SERVICES 09-92
: o Determining quality and quantity of individual diets
(e.g., dietary intake, food acceptance, meal patterns, methods of
food preparation and preservation, and utilization of food
assistance programs),
o Further physical and laboratory examinations, and
0 Preventive, treatment and follow-up services,
including dietary counseling and nutrition education.
B. Comprehensive Unclothed Physical Examination: --This
includes the following:
1. Physical Growth.--Record and compare the child's height
and weight with those considered normal for that age. (In the
first year of life, head circumference measurements are
important). Use a graphic recording sheet to chart height and
weight over time.
2. Unclothed Physical Inspection.--Check the general
appearance of the child to determine overall health status. This
process can pick up obvious physical defects, including orthopedic
disorders, hernia, skin disease, and genital abnormalities.
Physical inspection includes an examination of all organ systems
such as pulmonary, cardiac, and gastrointestinal.
C. Appropriate Immunizations.--Assess whether the child has
been immunized against diphtheria, pertussis, tetanus, polio,
measles, rubella, mumps, Haemophilus b Conjugate (HIB) and
hepatitis B and whether booster shots are needed. The child's
immunization record should be available to the provider. When an
immunization or an Qupdating is medically necessary and
appropriate, provide it and so inform the child's health
supervision provider.
Provide immunizations as recommended by the American Academy of
Pediatrics (AAP) and/or local health departments.
D. Appropriate Laboratory Tests.--Identify, as statewide
screening requirements, the minimum laboratory tests or analyses
to be performed by medical providers for particular age or
population groups. Physicians providing screening/assessment
‘services under the EPSDT program use their medical judgement in
determining the applicability of the laboratory tests or analyses
to be performed. 1f any laboratory tests or analyses are medically
contraindicated at the time of screening/assessment, provide them
when no longer medically contraindicated. As appropriate, conduct
the following laboratory tests:
1. Lead Toxicity Screening.--All children ages 6 months to
72 months are considered at risk and must be screened for lead
poisoning. Complete lead screening consists of both a verbal risk
assessment and blood test(s). Each State establishes its own
periodicity schedule after consultation with medical organizations
involved in child health. These periodicity schedules and any
other associated office visits must be used as an opportunity for
anticipatory guidance and risk assessment for lead poisoning. As
part of the nutritional assessment conducted at each periodic
screening, an EP blood test may be done to test for iron
deficiency. This blood test may also be used as the initial
screening blood test for lead toxicity.
a. Risk Assessment. All children from 6 to 72 months
of age are considered at risk and must be screened, unless it can
be shown that the community in which the children live does not
have a childhood lead poisoning problem. Only an official State
or local health authority can declare that a
5-14
Rev. 5
EARLY AND PERIODIC SCREENING,
09-92 DIAGNOSTIC AND TREATMENT SERVICES 5123.2
{Cont.)
geographic community, or part of a community, does not have a
problem. However, all children moving into a "lead-free
community" must be screened. Regardless of their risk, all
families must be given detailed lead poisoning prevention
counselling as part of the anticipatory guidance during the
screening visit.
Beginning at six months of age and at each visit thereafter, the
provider must discuss with the child's parent or guardian
childhood lead poisoning interventions and assess the child's risk
for exposure. Ask the following types of questions at a minimum.
o Does your child live in or regularly visit an old house
built before 1960? was your child's day care
center/preschool/babysitter’s home built before 19607? Does the
house have peeling or chipping paint?
o Does your child live in a house built before 1960 with
recent, ongoing or planned renovation or remodeling?
o Have any of your children or their playmates had lead
poisoning?
;
o Does your child frequently come in contact with an adult
who works with lead? Examples are construction, welding, pottery,
or other trades practiced in your community.
o Does your child live near a lead smelter, battery recycling
plant, or other industry likely to release lead such as (give
examples in your community)?
o Do you give your child any home or folk remedies which may
contain lead?
o Does your child live near a heavily travelled major highway
where soil and dust may be contaminated with lead? :
o Does your home's plumbing have lead pipes or copper with
lead solder joints?
Ask any additional questions that may be specific to situatiohs
which exist in a particular community.
b. Determining Risk.--Risk is determined from thé
response to the questions which your State requires for verbal
risk assessment.
o 1f the answers to all questions are negative, a child is
considered low risk for high doses of lead exposure, but must
receive blood lead screening by EP or blood lead test at 12 months
of age. :
o If the answer to any question is positive, a child is
considered high risk for high doses of lead exposure. A blood
lead test must be obtained at the time a child is determined to
be high risk.
Subsequent verbal risk assessments can change a child's risk
category. Any information suggesting increased lead exposure for
previously low risk children must be followed up with a blood lead
test.
Rev. 5 : 5-15
EARLY AND PERIODIC SCREENING,
5123.2 (Cont.) DIAGNOSTIC AND TREATMENT SERVICES 09-92
Ca Screening Blood Tests.--The term screening blood
tests refers to blood tests for children who have not previously
been tested for lead with either the EP or blood lead test or who
have been previously tested and found not to have an elevated EP
or blood lead level. If a child is determined by the verbal risk
assessment to be at:
(1) Low Risk.--A screening EP test or a blood lead
test is required at 12 months and a second EP test or a blood lead
test at 24 months.
(2) High Risk.--A blood lead test is required when
a child is identified as being high risk, beginning at six months
of age. If the initial blood lead test results are less than (<)
10 micrograms per deciliter (ug/dL), a screening EP test or blood
lead test is required at every visit prescribed in your EPSDT
periodicity schedule through 72 months of age.
If a child between the ages of 24 months and 72 months has not
received a screening blood test, then that child must receive it
immediately, regardless of being determined at low or high risk.
An elevated EP test must be confirmed with a blood lead test. A
blood lead test result equal to or greater than (>) 10 ug/dL
obtained by capillary specimen (fingerstick) must be confirmed
using a venous blood sample.
d. Diagnosis, Treatment and Follow-up.--If a child is
found to have blood lead levels equal to or >10 ug/dL, providers
are to use their professional judgment, with reference to CDC
guidelines covering patient management and treatment, including
follow up blood tests and initiating investigations to the source
of lead, where indicated. Determining the source of lead may be
reimbursable by Medicaid.
e. Coordination With Other Agencies. Coordination with
WIC, Head Start, and other private and public resources enables
elimination of duplicate testing and ensure comprehensive
diagnosis and treatment. Also, public health agencies' Childhood
Lead Poisoning Prevention Programs may be available. These
agencies may have the authority and ability to investigate a lead-
poisoned child's environment and to require remediation.
2. Anemia Test.--The most easily administered test for
anemia is a microhematocrit determination from venous blood or a
fingerstick.
3. Sickle Cell Test.--Diagnosis for sickle cell trait may
be done with sickle cell preparation or a hemoglobin solubility
test. If a child has been properly tested once for sickle cell
EARLY AND PERIODIC SCREENING,
09-92 DIAGNOSTIC AND TREATMENT SERVICES 5123.2
{Cont.)
(or guardians) and children is required and is designed to assist
in understanding what to expect in terms of the child's
development and to provide information about the benefits of
healthy lifestyles and practices as well as accident and disease
prevention.
F. Vision and Hearing Screens.--Vision and hearing services
are subject to their own periodicity schedules (as described in
§5140). However, where the periodicity schedules coincide with
the schedule for screening services (defined in §5122A), you may
include vision and hearing screens as a part of the required
minimum screening services.
1. Appropriate Vision Screen.--Administer an age-
appropriate vision assessment. Consultation by ophthalmologists
and optometrists can help determine the type of procedures to use
and the criteria for determining when a child is referred for
diagnostic examination.
2. Appropriate Hearing Screen.--Administer an age-
appropriate hearing assessment. Obtain consultation and suitable
procedures for screening and methods of administering them from
audiologists, or from State health or education departments.
G. Dental Screening Services.--Although an oral screening may
be part of a physical examination, it does not substitute for
examination through direct referral to a dentist. A direct dental
referral is required for every child in accordance with your
periodicity schedule and at other intervals as medically
necessary. Prior to enactment of OBRA 1989, HCFA in consultation
with the American Dental Association, the American Academy of
Pediatrics and the American Academy of Family Practice, among
other organizations, required direct referral to a dentist
beginning at age 3 or at an earlier age if determined medically
necessary. The law as amended by OBRA 1989 requires that dental
services (including initial direct referral to a dentist) conform
to your periodicity schedule which must be established after
consultation with recognized dental organizations involved in
child health care.
Especially in older children, the periodicity schedule for dental
examinations is not governed by the schedule for medical
examinations. Dental examinations of older children should occur
with greater frequency than is the case with physical
examinations. The referral must be for an encounter with a
dentist, or a professional dental hygienist under the supervision
of a dentist, for diagnosis and treatment. However, where any
screening, even as early as the neonatal examination, indicates
that dental services are needed at an earlier age, provide the
needed dental services.
The requirement of a direct referral to a dentist can be met in
settings other than a dentist's office. The necessary element is
that the child be examined by a dentist or other dental
professional under the supervision of a dentist. In an area where
dentists are scarce or not easy to reach, dental examinations in
a clinic or group setting may make the service more appealing to
recipients while meeting the dental periodicity schedule. 1f
continuing care providers have dentists on their staff, the direct
referral to a dentist requirement is met. Dental
paraprofessionals under direct supervision of a dentist may
perform routine services when in compliance with State practice
acts.
Determine whether the screening provider or the agency does the
direct referral to a dentist. You are ultimately responsible for.
assuring that the direct referral is made and that the child gets
to the dentist's office in a timely manner. : :
Rev. 5 5=16.1
Texas )
Department
Human” Services
JUL | 6 1990
INTERIM BOARD MEMBERS
COMMISSIONER
;
Cassandra C. Carr
Burton F. Railord Chairman, Austin
David Herndon
Vice Chairman, Austin
July 9, 1992 Bob Geyer
El Paso
Yava D. Scott
Houston
; Paula S. Gomez
Susan Finkelstein Brownsville
Attorney at Law ; Karen M. Heltzel
Texas Rural Legal Aid, Inc. Dallas
405 North St. Mary's Street, Suite 910
San Antonio, TX 78205
Dear Ms. Finkelstein:
This is in response to your Open Records Act request of May 26,
1992, regarding lead blood screening in children and receipt of
your reimbursement of $15.70 for same.
Request |
Studies that the Department has reviewed concerning blood lead
levels in children in Texas.
Response
To my knowledge, the Department has not reviewed any studies
related to your request.
Request
Description of the Department's arrangements with the Texas
Department of Health (TDH) concerning blood lead testing, i.e.,
whereby TDH provides laboratory supplies to health care providers,
conducts testing, and reports test results to health care
providers.
Response
See the enclosed booklet entitled Laboratory Screening Services.
This document is in the process of being updated to reflect changes
since 1985.
Request
The Department's proposals, whether implemented or not, for the
past five fiscal years coricerning testing and treatment of lead
blood poisoning in children in Texas.
Response
The Department has made no’ such proposals.
John H. Winters Human Services Center ® 701 West 51st Street
Central Office Mailing Address P.O. Box 149030 * Austin, Texas 78714 -90.
Telephone (512) 450-3011 « Call your local DHS office for assistance. — Exhibit 4
Susan Finkelstein
July 9, 1992
Page 2
Request :
For Texas and for each county in Texas, the number of lead blood
screens performed on children for the past five fiscal years.
Response
We have this data available only on an aggregated state level from
fiscal year 1990 to date. To obtain a more detailed level of data
would involve a recipient-by-providers manual compilation and such
a task is prohibitive for us to perform. The data (see attachment
on Lead Blood Tests) presented are for both erythrocyte
protoporphyrin (EP) tests and lead tests. Those with abnormal EP
test results receive lead tests; therefore, both totals are shown
for FY '90, FY '91, and year-to-date FY '92.
Request
For Texas and for each county in Texas, the number of children who
have received follow-up treatment for lead blood poisoning. If
possible, please include information about the type of treatment
received.
Response
At present, the Department does not have an automated program to
provide the information requested.
Request
Copies of all HCFA Form 416s prepared since the April/September
1990 Form.
Response
Enclosed April 1 - September 30, 1990, and October 1, 1990 -
September 30, 1991.
Sincerely,
rll ES
Donald L. Kelley, M.D., F.A.C.
State Medicaid Director
i i
DLK: srs
Enclosures
DEPARTHENT OF HEALTH AND HUMAN SERVICES
Form Approved
HEALTH CARE FINANCING ADHINISTRATION
OMB No. 0938-0291
ANNUAL EPSDT PARTICIPATION REPORT
State TEXAS FY 1990 * ° Cat.
Age Groups
Total 1-3 6-14 15-20
Number of individuals
eligible for EPSDT:
CN 764,937 304,087 254,697 111,427
HN 35,014 9,658 17,814 5,009
799,951 313,745 272,511 116,436
Number of eligibles
enrolled in continuing
care arrangements:
Number of eligibles
receiving screening
services:
Total number of eligibles
provided child health
screening supervision .
(Line 2 + Line 3):
79,773
3,455
83,228
PARTICIPANT RATIO
(Line 4 + Line 1)
10.43%
9.87%
10.40%
Total number of screening
(examination) services:
96,036
3,985
100,021
SCREENING RATIO
(Line 6 + Line 1)
12.55%
11.38%
12.50%
Number of eligibles
referred for corrective:
treatment:
34,455 -
1,539
35,994
Number of eligibles
receiving vision services:
63,798
6,892
68,690
Number of eligibles
receiving preventive
dental services:
71,387
6,182
77,569
11. Number of eligibles
receiving hearing services:
CN | 29,310
MN 1,580
Total 30,890 3,640 15,929
Form TCFAL18 (5-50)
NOTE: "CN"-Categorically Needy, "HK"-— Medically Needy
* April 1 - September 30, 1990
revised 06/07/91
@® ibladant iain bi
DEPARTMENT OF HEALTH AND HUMAN SERVICES
HEALTH CARE FINANCING ADMINISTRATION
Form Approved
OMB No. 0938-0291
ANNUAL EPSDT PARTICIPATION REPORT
\
Age Groups
State _Texas FY 19.91 * Cat.
Total <1 1-5 6-14 15-20
CN 999,309 126,074 418,925 322,165 132,145
1. Number of individuals
eligible for EPSDT: mw 30,467 976 4,964 19,012 9,519
Total 1,029,776 127,050 423,889 341,177 137,660
CN 0 0 0 0 0
2. Number of eligibles
enrolled fn continuing MN 0 0 0 0 0
care arrangements: Pe
Total 0 0 0 0 0
CN 179,340 54,2640 99,265 22,003 3,832
3. Number of eligibles FF
receiving screening MN 4,476 S77 1,936 1,667 296
services:
Total 183,816 54,817 101,201 23,670 4,128
A. Total nuber of eligibles CN 179,340 54,260 99,265 22,003 3,832
provided child health MN 4,476 577 1,936 1,667 296
screening supervision
(Line 2 + Line 3): Total 183,816 54,817 101, 201 23,670 4,128
CN. 17.9% 43% 23.7% 6.83% 2.9%
S. PARTICIPANT RATIO
(Line & + Line 1) MN 16.7% 59.1% 39% 8.77% 5.37%
Total 17.85% 43.15% 23.87% 6.96% 3%
CN 335,701 167,965 140,327 23,317 4,092
6. Tots\ mnber of scresning MN 5,792 1,066 2,762 1,686 298
(examination) services:
Total 341,493 169,031 143,069 25,003 4,390
CN 33.6% 133.2% 33.5% 7.26% 3.1%
7. SCREENING RATIO
(Line 6 + Line 1) MN 19% 109.2% 55.2% 8.87% 5.6%
Total 33.2% 133% 33.75% 7.31% 3.2%
CN 81,706 | 20,728 47,993 10,993 1,990
8. Number of eligibles EE
referred for corrective MN 2,180 266 974 807 153
treatment:
-
Hs
Total 83,884 20,974 48,967 11,800 2,143
CN 141,548 2,901 25,034 78,218 35,395
9. Number of eligibles MN 11.245 39 679 7,978 2,549
receiving vision services:
.
re
Total 152,793 2,940 25,713 86,196 37,9644
CN 159,607 [A] 42,582 88,917 28,062
10. Number of eligibles
receiving preventive MN 12,407 1 1,190 9,070 2,146
dental services:
Total 172,014 47 43,772 97,987 30,208
CN 68,016 5,060 39,375 18,266 | 5,335
17. Number of eligibles MN 2.651 22 856 1,454 269
receiving hearing services:
——
Total 70,667 5,132 40,231 19,700 | 5,606
Form HCFA-6416 (5-90)
NOTE: wcN"—Categorically Needy,
vMN"— Medically Needy
LEAD BLOOD TESTS*
Fiscal Year EP Lead Elevated Lead Level
'90 16,520 2,413 78
'91 25,010 4,158 70
'92 42,731 7,696 137
sTests based on specimens submitted during EPSDT medical
screenings.
Texas Department of Human Services
EPSDT Services, Policy and Program Development
prepared 6/10/92
MEDICAID OVERSIGHT REPORT
TEXAS MEDICAID PROGRAM
EARLY AND PERIODIC SCREENING, DIAGNOSIS, AND TREATMENT
(EPSDT) PROGRAM
DATES OF REVIEW: JUNE 3-7, 1991
NAMES OF REVIEWERS:
Shirley Duncan
Pat Lawton
Report Prepared July 12, 1991
Exhibit 5
For those Medicaid eligible children who are also eligible for Head
Start, Day Care or Foster Care, Texas allows categorical
"exceptions" to the Medicaid periodicity schedule because those
programs require more frequent medical examinations than does the
Medicaid periodicity schedule.
Texas pays the EPSDT screening provider $27 for performing all of
the screens: i.e. medical, vision, hearing, and dental referral. This $27 includes any immunizations needed and the drawing of samples for laboratory testing. Then, the provider sends all laboratory testing, except urinalysis and TB testing, to the Texas Department of Health for processing. The Department of Health returns the results of the laboratory tests to the EPSDT screener. EPSDT screening providers are supplied with vacu-tainers, needles,
and postage-paid mailing containers for this purpose. The Texas Department of Health furnishes immunization materials free of charge to EPSDT providers, including private providers.
The State has delegated its provider recruitment/training responsibilities to its health insuring agent, National Heritage
Insurance Corporation (NHIC). For approximately one year, NHIC has dedicated one full time equivalent staff position to the EPSDT provider recruitment/training effort. : This staff person, a registered nurse, conducts EPSDT provider workshops and responds to EPSDT provider inquiries.
aN
The EPSDT review was accomplished by a review of claims, provider
manuals, procedure manuals, and other supporting implementing
materials, and by interviews with staff from the Texas Department
of Human Services staff and from its health insuring agent.
FINDINGS AND RECOMMENDATIONS
FINDING T1-EP-B/Cl - BLOOD LEAD LEVEL TESTING
The State has not established risk factors (other than age) to
assist providers in determining whether it is appropriate to
perform a blood lead level test. It has established an age factor
(i.e. it requires that lead level testing be done between the ages
of 6 months and 3 years); however, according to Section 5123.2.D.1
of the State Medicaid Manual, States should also consider
environmental aspects when establishing risk factors.
RECOMMENDATION Le py
The State should require that high blood lead level areas be taken
into consideration when determining risk factors and it should
furnish EPSDT screening providers with a list of these high risk
zones.
FINDING T1-EP-B/C2 - HEALTH EDUCATION
The EPSDT screening schedule contained on page 134 of the State's
Medicaid Provider Procedures Manual does not reflect that health
education is a mandatory element of the screening package. Page
136 of the same manual does indicate in a narrative fashion that
health education is a mandatory component of the medical screening
but this information has not been merged into the EPSDT screening
chart.
RECOMMENDATION
The State should revise the EPSDT screening schedule on page 134
of the provider manual to clearly indicate that health education
is a required element of the screening package.
"FINDING P1-Er-B/C3(1) _- PERIODICITY SCHEDULE
The State's periodicity schedule allows for only 11 screens, 9 less
than is recommended by the American Academy of Pediatrics.
While the statute permits a state to establish jts own periodicity
schedule, the legislative history indicates that in drafting these
provisions the House Committee on Energy and Commerce preferred
that these health examinations be provided at intervals that are
no greater than those established by the American Academy of
Pediatrics.
RECOMMENDATION
The State should consider adopting the periodicity schedule
recommended by the American Academy of Pediatrics. A policy
inquiry is pending in HCFA's Central Office to determine whether
the language in the legislative history serves as a mandate that
states adopt the AAP periodicity schedule. The State will be
advised further if this is the case.
FINDING T1-EP-B/C3(2) = DISTINCT SCHEDULES FOR HEARING, VISION,
AND DENTAL SCREENS
while the State has established distinct intervals for hearing,
vision, and dental screenings, it has not established separate
reimbursement rates to accommodate the screening provider that only
A
Q |
MEDICAID OVERSIGHT REPORT
TEXAS MEDICAID PROGRAM
EARLY AND PERIODIC SCREENING, DIAGNOSIS, AND TREATMENT
(EPSDT) PROGRAM
DATES OF REVIEW: June 3 - 7, 1991)
RESPONSE
August 29, 1991
9... ®
Medicaid Oversight Report - Response
August 29, 1991
Page 1
Background
As discussed with the reviewers, an EPSDT Medical Screening Ad Hoc
Committee was formed this year for the purpose of reviewing the
program and providing professional consultation/recommendations on
the periodicity schedule, screening standards, and the claim form.
Any program changes. were deferred pending completion of the
committee's work and recommendations which were presented as an
information item to the Department's Medical Care Advisory
Committee (MCAC) on July 6, 1991. The report was very well
received by the MCAC as reflected by the motion (Attachment TI)
which passed the committee. These recommendations will
subsequently be presented to the MCAC as an action item at the next
meeting on September 6, 1991, at which time the MCAC will be asked
to formally approve the proposed changes. It is the plan of the
Department to coordinate implementation of all the new changes
effective in November 1991, via a special EPSDT medical screening:
supplement to the Medicaid Provider Procedures Manual. This
reflects the time required for both the Department and the National
Heritage Insurance Company (NHIC) to make all the necessary
computer program changes, new claim form designs, and printing,
etc. This will explain our frequent reference to & November
timetable in our comments to follow. >
FINDING T1-EP-B/C1 — BLOOD LEAD LEVEL TESTING
Recommendation
The State should require that high blood lead level areas be taken into consideration when
determining risk factors and it should furnish EPSDT screening providers with a list of these high
risk zones.
Response:
We agree with the finding. Effective November 1991, laboratory
lead screening will be required on each screen for ages six months
through 20 years if not previously performed by the provider. The
Texas Department of Health (TDH) Environmental Division is also
being requested to provide us with any available environmental
information that can be passed on to providers in the Medicaid
Provider Procedures Manual and/or provider bulletins to assist in
identifying children at xisk.
Evaluation of the erythrocyte
protoporphyrin test as a screen for
elevated blood lead levels
Michael D. McElvaine, bvMm, MPH, Hyman G. Orbach, phD, Sue Binder, MD,
Lorry A. Blanksma, phD, Edmond F. Maes, phD, and Richard M. Krieg, PhD
From the Division of Environmental Hazards and Health Effects, Center for Environmental Health
and Injury Control, Centers for Disease Control, Atlanta, Georgia, and the City of Chicago De-
partment of Health, Chicago, Illinois
To study the effect of lowering the definition of an elevated blood lead level on
the performance of the erythrocyte protoporphyrin screening test and the num-
ber of children who would require follow-up, we collected laboratory data from
a screening program. The estimated sensitivity of an erythrocyte protoporphy-
rin level =35 pg/dl for identifying children with elevated blood lead levels was
73% when we used 1985 Centers for Disease Control guidelines (elevated blood
lead level =25 ug/dl). Eight percent of the tests showed positive results. When
we redefined an elevated blood lead level as >=15 ug/dl, the sensitivity estimate
was reduced to 37% and the number of positive test results increased fourfold.
(J PEDIATR 1991;449:548-50)
The most recent statement of the Centers for Disease Con- ond National Health and Nutrition Examination Survey,
trol (CDC), published in 1985,! defined an elevated blood
lead level in children as =25 pg/dl (1.21 wumol/L), a
threshold exceeded by an estimated 250,000 children in
1984.2 The 1985 CDC statement recommended screening
for elevated BPb levels by measuring erythrocyte protopor-
phyrin levels and considering an EP level of =35 ug/dl
(0.62 umol/L) as a positive screening test result. EP is a
precursor of heme that accumulates when lead interferes
with normal heme synthesis.
Few data are available on how well the EP test, with a
positive test result defined as =35 ug/dl, would perform in
identifying children with BPb levels of =25 ug/dl in ac-
tual clinic screenings. Among children tested in the Sec-
Presented in part at the 1990 Epidemic Intelligence Service Con-
ference, April 23-27, 1990, Atlanta, Ga.
The authors of this article are solely responsible for all analysis and
interpretation of the data presented here.
Submitted for publication April 3, 1991; accepted June 20, 1991.
Reprint requests: Michael D. McElvaine, DVM, MPH, Division of
Environmental Hazards and Health Effects, Center for Environ-
mental Health and Injury Control, Centers for Disease Control,
Mal Stop F-2X%,1600 Clifton Rd. NE, Atlanta, GA 30333.
9 0 Muy?
Can
the sensitivity of the EP test in detecting elevated BPb lev-
els was 26% (unpublished data). For low-income black
children in NHANES II who lived in the central city (i.e.,
were at high risk for lead poisoning), the sensitivity estimate
was 42%. A more recent survey of urban children in a com-
munity with characteristics associated with high rates of
lead poisoning, Oakland, Calif., yielded a sensitivity esti-
mate of 50%.
BPb Blood lead
EP Erythrocyte protoporphyrin
NHANES Il Second National Health and
Nutrition Examination Survey
Recent research has shown that significant adverse
effects result from BPb levels of 10 to 15 ug/dl or even
lower,2 4 and the CDC is reconsidering its definition of an
elevated BPb level. There is poor correlation between BPb
and EP when BPb levels are less than 18 to 20 ug/dl.>®
Accordingly, to assess how lowering the definition of an el-
evated BPb level would affect EP test performance and the
numbers of children needing follow-up care, we analyzed
laboratory data from a childhood lead poisoning prevention
— Exhibit 6
Volume 119
Number 4
Performance of screening test for lead poisoning 549
Table I. Population blood lead and erythrocyte protoporphyrin values by age group, Chicago, I11., 1988-1989
Age group
(yr) (ng/dl)
Mean BPb (range)
Children with
Mean EP (range) BPb =25 nug/di
(ug/dl) (%)
<2 12.1 (3-83)
2.3 14.8 (2-49)
4-5 13.4 (3-50)
TOTAL 13.4 (2-83)
program that screens children at high risk for lead poison-
ing.
METHODS
The City of Chicago Department of Health Division of
Laboratories measures EP and BPb levels in about 50,000
venous blood samples each year. The EP level is measured
by hematofluorometry.” The BPb level is measured by
atomic absorption spectrophotometry? or by anodic strip-
ping voltammetry. This laboratory is one of six reference
laboratories used by the proficiency testing program run
jointly by the CDC, the Health Resources and Services
Administration, and the University of Wisconsin to estab-
lish target values for BPb testing and is also a regular par-
ticipant in the proficiency testing program for EP.
The population that we studied consisted of children who
visited city-run clinics that operate in low-income neigh-
borhoods. Every child received lead screening as part of the
routine health program. In addition, the city also provided
mobile screening services to underserved areas.
Laboratory and demographic data were abstracted from
a 2%systematicsampleof laboratory test records (n = 1057)
for the period of Sept. 1, 1988, through Aug. 31, 1989. A
two-digit random number was used as a starting point; then
every fiftieth record was selected. From this sample, we in-
cluded all children from 6 months through § years of age
who were tested at the city’s screening centers. For the four
children who appeared twice in the sample, only the first set
of results was used. A total of 577 records met these crite-
ria and were included for analysis.
RESULTS
The study population was 53% male. The ethnic distri-
bution was 68% black, 29% Hispanic, and 3% other. The
highest mean BPb and EP levels were in the 2- and 3-year-
old age group (Table I).
Performance of the EP test to identify various levels of
BPb elevation is shown in Table 1. Twenty-three percent of
the EP tests were =35 ug/dl. Using the 1985 CDC defini-
tion of an elevated BPb level, we estimated the sensitivity
to be 73%. If an elevated BPb level was redefined as = 15
29.8 (2-146) 4
31.8 (1-234) 12
28.1 (4-214) 8
30.1 (1-234) 8
Table Il. Performance of the erythrocyte protoporphyrin
test to identify samples with elevated blood lead levels,
with an EP level =35 ug/dl used as a screening cutoff
point, Chicago, 111., 1988-1989
Children with
Definition of elevated BPb Sensitivity Specificity
elevated BPb (n = 577)
(kg/dl) (%)
(%)
(95% Cl)
(%)
(95% CI)
8
13
32
66
73 (60-86)
49 (39-60)
37 (30-44)
26 (21-30)
81 (78-85)
82 (78-85)
84 (80-87)
82 (77-88)
C1. 95% Confidence intervals for estimated values.
ug/dl, the proportion of samples with elevated BPb levels
increased four times and the sensitivity of the EP screen was
reduced by half to 37%. When a definition of = 10 ug/dl was
used, the proportion with elevated BPb levels increased to
66% and the sensitivity decreased further. For this sample
population, the EP test (at =>35 ng/dl) identified all
subjects with BPb levels of 35 ug/dl or greater.
DISCUSSION
The results show that the sensitivity of the EP test in this
high-risk population (73%) is higher than that found from
NHANES II overall (26%), from a high-risk subset of
NHANES II (42%) and in Oakland, Calif. (50%).> The
higher sensitivity estimates seen in the Chicago data may be
the result of several factors. Among subjects with elevated
BPD levels, those levels were relatively higher in Chicago
than in the other populations. In NHANES 11, 55% of the
children with elevated BPb levels had levels in the 25 to 29
ug/dl range. In Chicago, of the tests showing elevated BPb
levels 67% showed levels of >30 ug/dl. Because EP
increases exponentially with increasing BPb values, sensi-
tivity is greater for children with higher BPb levels.5 ©
Iron deficiency also can cause an increase in the EP level
in children.® 1° The apparent sensitivity of the EP test for
identifying elevated BPb levels should be greater in a pop-
ulation in which iron deficiency is more prevalent. Iron de-
ficiency and lead poisoning often coexist.® The prevalence
IN THE UNITED STATES DISTRICT COURT] NV 293
FOR THE NORTHERN DISTRICT OF TEXAS | »
DALLAS DIVISION
LOIS THOMPSON on behalf of and
as next friend to TAYLOR
KEONDRA DIXON, ZACHERY X.
WILLIAMS, CALVIN A. THOMPSON
and PRENTISS LAVELL MULLINS,
Plaintiffs
Vv.
BURTON F. RAIFORD, in his
capacity as Commissioner of
the Texas Department of Human
Services,
and
THE UNITED STATES OF AMERICA,
Defendants. ¥
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No. 3-92 CV 1539-R
Civil Action
Class Action
MEMORANDUM IN SUPPORT OF PLAINTIFFS’ RESPONSE AND IN
OPPOSITION TO DEFENDANT USA’S MOTION TO DISMISS
OR IN THE ALTERNATIVE FOR SUMMARY JUDGMENT
V1.
TABLE OF CONTENTS
The Medicaid Statute Prohibits any use of the EP test
Lack of Capacity is not a Meritorious Argument
Standing Arguments
HCFA guidelines and CDC
The Status Quo is Blood Lead Level Test
Summary Judgment is Not Appropriate
12
15
TABLE OF AUTHORITIES
Cases: Page:
Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986) 15,16
Barker v. Norman, 651 F.2d 1107 (5th Cir. 1981) 15
Burlington Northern R. Co. v. Oklahoma Tax Comm'n,
481 U.S. 454 (1987) 2,4
Canal Authority of State of Florida v. Callaway,
489 P.24 567 {5th Cir. 1974) 14
Castillo v. Bowles, 687 F. Supp. 277 (N.D. Tex. 1988) 15
County of Riverside v. McLaughlin, U.S. a
114 L.Ed.2d 49 (1991) 11
Demarest v. Manspeaker, = U.S. 184, =, 112 L.E4.24
608 (1991) 2
District 50, United Mine Workers of America v.
Int'l Union, United Mine Workers of America,
412 F.24 165 (D.C. Cir. 1969) 13
Griffin v. Oceanic Contractors, Inc., 458 U.S. 564
(1982) 3
Iselin v. United States, 270 U.S. 245 (1926) 5
Liegl v. Webb, 802 F.2d 623 (2nd Cir. 1986) 9
Mississippi Power & Light Co. v. United Gas ;
Pipe Line Co., 609 F.Supp. 333 (D.C. Miss. 1984) 14
Mitchell v. Johnston, 701 F.24 337 (5th Cir. 1983) 7,8
Morgan v. Fletcher, 518 F.2d 236 (5th Cir. 1975) 13
Porter v. Califano, 592 F.2d 770 (5th Cir. 1979) 15
Public Employees Retirement System of Ohio v. Betts,
oo U.8. “106 L.,B4d.24 134 (1959) 2
Rubin v. United States, 449 U.S. 424 (1981) 2
“ii
Cases:
Washington Capitols Basketball Club, Inc. v. Barry,
419 F.24 472 (9th Cir. 1969)
West Virginia Univ. Hospitals, Inc. v. Casey,
_U.8. , 113 L.Ed.2d 68 (1991)
Yeargin Const. Co., Inc. v. Parsons & Whittemore
Alabama Machinery & Services, Corp., 609 F.2d 829
(5th Cir. 1980)
Statutes:
42 U.S.C. § 1396d4(r)
OBRA '89 § 6403, now 42 U.S.C. § 1396d(r)
Reports:
Report of the House Budget Committee, Explanation of
the Energy and Commerce and Ways and Means Committees
Affecting Medicare-Medicaid Programs, 101 Cong.
lst. Sess., p. 398 (September 20, 1989)
"The Nature and Extent of Lead Poisoning in Children
in the United States," by the U.S. Dept. of Health
and Human Services Agency for Toxic Substances
and Disease Registry
Guidelines:
HCFA 9/19/92 guidelines
Rules:
Ped. R. Evid. 801(4){2)
Ped.R. Clv. Proc. 56(e)
Fed.R. Civ. Proc. 56(f)
-3ii-
13
throughout
4
15
16
Plaintiffs oppose defendant USA’s Motion to Dismiss or in
the Alternative for Summary Judgment.
This case is not as difficult as the USA would like the
Court to believe. While plaintiffs are challenging the USA’s
continued use of an ineffectual laboratory test, EP, as a screen-
ing tool for childhood lead poisoning, there is really much more
at stake. The real issue in this case is whether the federal
government can intentionally and knowingly be allowed to overlook
hundreds of thousands of impoverished children at risk for
childhood lead poisoning who will go untreated without proper
diagnosis. Can the federal government, after it enacts wideswe-
eping legislation and policy calling for an end to childhood lead
poisoning, then be permitted to invidiously remove millions of
poor, minority children from the reach of that legislation
through the simple expedient of using a test that does not
measure the condition?
I. The Medicaid Statute Prohibits any use of the EP test
The Medicaid Act requires "lead blood level assessment
appropriate for age and risk factors" for children who are
screened under the EPSDT program. 42 U.S.C. § 1396d(r)(1l)(B) (iv).
The statute’s plain and unambiguous language requires the
use of "lead blood level assessment." No where in the statute or
in the legislative history does Congress express an intention for
the states to use the Erythrocyte Protoporphyrin (EP) test. As
plaintiffs’ response indicates and as defendant USA admits, the
EP test does not measure the lead in a child’s blood at all.
The USA’s policy argument is that the states should be
allowed to use the EP test as a device for lead poisoning screen-
ing for the poor children of our country until some unknown
future date. The policy argument of the USA acting through HCFA
must be rejected. Administrative interpretation of a statute
contrary to the plain language of the statute is not entitled to
deference by the courts. Demarest v. Manspeaker, = U.S. 184, _ ,
112 L.Ed.2d 608, 616 (1991); see Public Employees Retirement
System of Ohio v. Betts, U.S. , 106 L.Ed.2d 134, 150-151
(1989). If Congress had wanted to the states to use a test that
did not detect for levels of lead in the blood Congress could
have said so in the statute. Congress did not choose to do that.
Instead, Congress made a policy decision to have EPSDT children
screened with a blood lead level test. The policy decision has
been made by Congress and defendant USA should not be allowed to
change it.
When the language of the statute is unambiguous, judicial
inquiry is complete except in rare and unusual circumstances.
Demarest v. Manspeaker, @ U.S. , 112 L.Ed.2d 608, 616 (1991);
Burlington Northern R. Co. v. Oklahoma Tax Comm’n, 481 U.S. 454,
461 (1987); Rubin v. United States, 449 U.S. 424, 430 (1981).
The language of the Medicaid Act is unambiguous. It states that
"laboratory tests (including lead blood level assessment appro-
priate for age and risk factors)" are required for EPSDT chil-
dren. 42 U.S.C. § 1396d(r)(1)(B)(iv). From the face of the
statute, a laboratory test that detects levels of lead in the
blood is required and not a test that does not even detect levels
of lead such as the EP test.
The USA contends that EP is "appropriate for age and risk"
and that it therefore is consistent with the statute. The record
of the EP test, as set out in plaintiffs’ response, shows that it
is not an appropriate test for any person at risk. There is more
to the statute than that selective phrase. The entire statute
states that EPSDT screening must provide for "laboratory tests
(including lead blood level assessment appropriate for age and
risk factors)." 42 U.S.C. § 1396d(r)(1)(B)(iv). The entire
statute makes it clear that blood lead tests are required.
This is not one of those rare circumstances as in Griffin v.
Oceanic Contractors, Inc., 458 U.S.564, 571 (1982), where the
literal or usual meaning of the statute would thwart the purpose
of the statute. The literal or usual meaning of the statute at
issue here would require a blood lead level assessment that would
detect the level of lead in a child’s blood in order to determine
if that child had lead poisoning.? The purpose of the EPSDT
statute and the 1989 amendments is to provide health care to poor
children. 42 U.S.C. §§ 1396d(r); Report of the House Budget
Committee, Explanation of the Energy and Commerce and Ways and
Means Committees Affecting Medicare-Medicaid Programs, 101 Cong.
lst. Sess., p. 398 (September 20, 1989). The literal or usual
1 The definition of lead poisoning has been recently changed
by the Centers for Disease Control (CDC). The new level of
concern is 10 ug/dL of lead in the blood for even at this low
level adverse health effects can occur in young children.
3
meaning of the statute is consistent with that purpose and would
require a blood lead test that could detect levels of lead so
that poor children with lead poisoning could be diagnosed and
treated. The EP test is inappropriate with the overall purpose
of the Medicaid Act and the EPSDT scheme. The EP test does not
detect levels of lead in the body and as is evident through
defendant’s many admissions, is a useless screening test for
childhood lead poisoning.
The USA contends that since the legislative history of the
Medicaid Act is silent on the issue of whether a blood lead test
or EP should be required then this silence supports its argument
that the USA can allow the use of the EP test by the states.
Legislative history, however, is irrelevant where the language of
the statute is plain. While "legislative history can be a
legitimate guide to a statutory purpose obscured by ambiguity, in
the absence of a clearly expressed legislative intention to the
contrary, the language of the statute itself must ordinarily be
regarded as conclusive." Burlington Northern R. Co. v. Oklahoma
Tax Comm’n, 481 U.S. 454, 461 (1987). Lack of legislative
history does not prevent the Court from applying the plain
language of the statute and requiring the USA to support a blood
lead test for EPSDT children.
Congress enacted amendments to the Medicaid Act in 1989.
Those amendments included the addition of blood lead testing for
EPSDT children. OBRA ’89 § 6403, now 42 U.S.C. § 1396d(r). The
addition of a "lead blood level assessment" was made after the
1998 Report to Congress, "The Nature and Extent of Lead Poisoning
in Children in the United States," by the U.S. Dept. of Health
and Human Services Agency for Toxic Substances and Disease
Registry, which indicated that EP was not a useful screening
device for detecting levels of lead in the blood of children.
The USA now argues that the statute does not have the "narrow,
technical meaning" of a blood lead test in spite of the plain
words of the statute. The USA would like to ignore the plain
language of the 1989 amendment in favor of the earlier version of
the statute that does not have the language requiring "lead blood
level assessment." It is not the function of the courts,
however, to decide whether or not the amendment is better. The
plain language of the statute controls. West Virginia Univ.
Hospitals, Inc. v. Casey, U.S. 113 L.E4.2d 68, 84 (1991).
As Justice Brandeis has explained, the expansion of a
statute beyond its plain language is not a role for the courts:
[The statute’s] language is plain and unambiguous. What the
Government asks is not a construction of a statute, but, in
effect, an enlargement of it by the court, so that what was
omitted, presumably by inadvertence, may be included within
its scope. To supply omissions transcends the judicial
function.
Iselin v. United States, 270 U.S. 245, 250-51 (1926). The USA
should not be allowed to expand the clear language of the statute
requiring a blood lead test to include a useless test that does
not detect lead.
II. Lack of Capacity is not a Meritorious Argument
The lack of capacity argument by the USA is both a factual
argument and a legal argument. The USA argues that there are
5
states that do not have the capacity to perform blood lead
testing. The argument never proceeds beyond the statement of the
ultimate conclusion. The USA provides no particulars. The USA
names no specific states without "capacity." The USA does not
explain why any state cannot or does not have this "capacity."
This bald, unsupported general allegation does not prove, or tend
to prove, any facts.
The USA’s legal argument is not made but must rather be
implied from the factual argument. Assume that there are,
somewhere, states without the capacity to draw small amounts of
blood from little children, put it in a tube, and deliver it to a
laboratory inside or outside the state. The USA must be arguing
that this lack of capacity excuses performance from the statute.
It is a lame excuse for noncompliance with the statute. The
U.S. Congress, in 1989, told each state that if it was going to
participate in the federal Medicaid/EPSDT program that it had to
provide such blood lead testing in return for the federal funds
necessary to do the testing. 42 U.S.C. § 1396d(r)(1)(B)(iv). A
state’s refusal to provide the capacity to collect and analyze
blood samples for lead content should not be a defense to a clear
violation of the statute. This is the last decade of the twenti-
eth century. We have put persons on the moon. The USA is not a
third world country which needs to import United Nations medical
teams to test its children for lead poisoning.
Unwillingness or self-imposed inability to provide a re-
quired service does not excuse a state from compliance with the
Medicaid statute. "Texas, like most states, has taken a bite out
of the carrot of cooperative federalism and is, accordingly,
subject to the federal stick -- the minimum mandatory require-
ments set forth in the Medicaid legislation." Mitchell v. Johnst-
on, 701 F.2d 337, 340 (5th Cir. 1983) (state could not limit
EPSDT dental care to checkups every three years).
The lack of capacity argument also fails as an argument
against plaintiffs having standing. The USA argues that if the
requested relief is granted (blood lead tests for all regardless
of high or low risk) then the lack of capacity means that high
risk kids will be delayed in getting the blood lead tests because
they may be behind low risk kids waiting for the tests. The lack
of capacity argument really boils down to the USA not wanting to
follow the statute.
If the USA wanted poor children to have the benefit of a
blood lead test then there are several national laboratories
willing and available to do such analysis. See Declaration of Dr.
Michael J. Nicar; affidavit of Dr. Rosen. The lack of capacity
is a camouflage for the federal government’s real interest in
promoting the use of the EP test -- saving money. See Dr. Bind-
er’s article [copy attached to Beshara declaration].
The capacity argument, if accepted, would also negate the
other part of the USA’s argument -- the states must use blood
lead testing for high risk children. If a state lacks capacity
to perform blood lead tests for low risk children and that lack
is excused, the same lack of capacity would prevent the use for
high risk children and would also be excused. The USA should not
be allowed to hide behind the ambiguities of the word "capacity"
to avoid the statute’s mandate.
III. Standing Arguments
The USA argues that the named plaintiffs are at high risk
and therefore do not suffer the same injury as those children
that are at low risk. Unfortunately, the USA misconstrues the
injury to the plaintiffs. Being subjected to the EP test and the
attendant probability of a misdiagnosis is the injury and is the
same injury whether the child is "high risk" or "low risk."
The State of Texas defendant made the same argument in
another EPSDT case that the plaintiffs did not possess the same
interest as the other class members. The Fifth Circuit rejected
that argument in that case and stated that the named plaintiffs’
injuries were directly and seriously caused defendant’s actions
in reducing EPSDT benefits and were also representative generally
of the injuries caused by defendant. Mitchell v. Johnston, 701
F.2d 337, 345 (5th Cir. 1983). The Fifth Circuit stated that the
named plaintiffs’ injury was reflective of the type of injury
that could occur from defendant’s reduction in EPSDT benefits.
Id. at 345-46.
The named plaintiffs in this case have been subjected to the
EP test in violation of the statute and were misdiagnosed as a
result. The youngest named plaintiff will not receive a blood
lead test even now under the new HCFA guidelines that continue to
allow states to use EP on high risk children.
The USA’s statement that under the new HCFA guidelines the
children that are at high risk will receive screening only with
blood lead tests is wrong. See HCFA 9/19/92 guidelines. Plain-
tiffs’ response clearly indicates that the guidelines are confus-
ing at best and not a straightforward indication of what is
required. The guidelines do allow the states to continue to use
EP as a screening test for childhood lead poisoning despite the
Medicaid statute to the contrary.
More importantly, even if the guidelines mean to say that
all high risk children should be given a blood lead test, they
mean nothing to the youngest named plaintiff Taylor Keondra
Dixon. Her initial blood lead test showed she had only 9 ug/dL.
She was only 5 months old at the time. As plaintiffs’ response
shows, under the guidelines, she will now be tested using only
the EP test. She has not moved from West Dallas. The environ-
ment has not been cleaned up. The known point sources of lead
contamination continue to operate. She is still at high risk.
She still will not receive a blood lead test.
Furthermore, the 9/19/92 HCFA guidelines and the "Action
Transmittal" by which the guidelines were distributed to the
states are not mandatory or otherwise binding on the states.
Liegl v. Webb, 802 F.2d 623, 626 (2nd Cir. 1986) - specific
discussion of HCFA "Action Transmittals." The USA’s arguments
are based on a notion that plaintiffs are challenging the HCFA
guidelines. It is clear from a cursory reading of the complaint
that plaintiffs are challenging more than the HCFA guidelines. In
fact, the plaintiffs are not challenging all of the 9/19/92
2 The plaintiffs, instead, seek remedy for the guidelines.
federal government’s continued support, financing and encourage-
ment to the states for the use of the EP test as a screening
device for childhood lead poisoning. The USA does not say that
any state has changed their policy based on the new HCFA guide-
lines or changed from using the EP test. The USA does not deny
anywhere in its brief that the federal government continues to
pay the states for performing EP tests on EPSDT children.
The USA makes the argument that granting the relief request-
ed by plaintiffs, allowing the use of a blood lead test, would
not redress injuries or offer any relief not provided by the
guidelines. This is incorrect. The relief sought would immedi-
ately end federal financial support for the use of the EP test as
a screening procedure for childhood lead poisoning. The State of
Texas, and every other state, would be forced, in order to
receive compensation, to discontinue the use of the EP test. 42
U.S.C. § 1396d(r)(5) (state must cover necessary health care for
EPSDT children "whether or not such services are covered under
the State plan.") Plaintiffs and class members would receive the
blood lead level screening the statute mandates.
In footnote 13, page 26 of its’ brief, defendant USA makes
the argument that plaintiffs lack standing because the HCFA
guidelines went into effect on 9/19/92 and as of that point
2 For example, the plaintiffs agree that the new level of
concern for childhood lead poisoning is now 10 ug/dL.
10
plaintiffs, as high risk children, would be eligible for a blood
lead test under the guidelines. The USA’s argument continues
that no new class representatives may be chosen because these
named plaintiffs lack standing, and thus, the Court lacks juris-
diction over the case.
The sequence of events in this case makes clear, as de-
scribed in plaintiffs’ response, that the HCFA guidelines have
had no effect on the named plaintiffs to date. All of the EPSDT
children in the State of Texas are still subject to the use of
the EP test even after the effective date of the HCFA guidelines.
The state defendant’s October 9, 1992 answer to the Second
Amended Complaint admits the allegation in plaintiffs’ q 50.
"Only if a child tests higher than 35 on the EP test is a blood
lead level test administered." Even if the State of Texas
follows the HCFA guidelines the youngest named plaintiff, and
others in the same situation, will not receive a blood lead test.
If at some point in the future, the name plaintiffs receive
the proper blood lead level assessment and the past effects of
being screened with EP are remedied, then the case may be moot
for these named plaintiffs. However, new class representatives
may be chosen at that point to represent the members of the
class. Cases collected at County of Riverside v. McLaughlin,
v.83. , 114 L.Pd.2d 49, 60 (1991).
IV. HCFA quidelines and CDC
The United States says in its brief that the delay in the
HCFA guidelines for a "transition" period for the states to
11
change over to blood lead testing is consistent with the October
1991 CDC statement.
Plaintiffs have a simple reply. To the extent that the
October 1991 CDC statement calls for a transition period then the
CDC statement is inconsistent with the Medicaid statute. The
statute mentions nothing about a transition period. 42 U.S.C. §
1396d(r)(1)(B)(iv). The statute mentions nothing about allowing
a transition period for these poor children because this would be
a good area for the federal government and the states to save
some money by using a useless screening test. The CDC statement
is an official publication of defendant United States. The
extent to which the CDC statement is inconsistent with the
statute is simply more evidence that the United States continues
to harm the plaintiffs and the class.
V. The Status Quo is Blood Lead Level Test
Defendant USA argues that the status quo for purposes of
preliminary injunctive relief is HCFA’s current (9/19/92) EPSDT
lead screening guidelines that continue to allow the states to
use the EP test for screening childhood lead poisoning. Defen-
dant USA applies an incorrect definition of the status quo and
confuses the issue in its brief.
The federal defendant in this lawsuit is the United States
of America and not the Health Care Financing Administration. As
mentioned earlier, the HCFA guidelines are not the subject of the
lawsuit. The USA’s actions in continuing to support, finance,
and encourage the use of the EP test are the actions about which
12
plaintiffs complain.
The Medicaid Act clearly requires a "lead blood level
assessment" for EPSDT children. As indicated in plaintiffs’
response, defendant United States of America has made numerous
statements and issued policy statements that blood lead level
tests should be used to screen children for childhood lead
poisoning. Those admissions are offered against defendant USA and
are binding as admissions by a party-opponent. Fed. R. Evid.
801(d) (2). The United States would like to ignore those admis-
sions when it comes to the health of the impoverished children of
the country. Only when poor, minority children are involved does
the United States seek to use a useless test, the EP test, for
screening indigent children.
The relevant status quo is the condition mandated by the
statute requiring a blood lead level assessment. 42 U.S.C. §
1396d(r) (1) (B) (iv). The statute has been in effect since the
beginning of 1990. HCFA’s new guidelines that continue to allow
states to use the EP test are contrary to the status quo of the
blood lead test. Plaintiffs seek to maintain the status quo of
the statute and to receive the blood lead test that they deserve
and that defendant is required by law to give them. Morgan v.
Fletcher, 518 F.2d 236, 239 (5th Cir. 1975) (preliminary injunc-
tion granted to preserve status quo); Yeargin Const. Co., Inc. Vv.
Parsons & Whittemore Alabama Machinery & Services, Corp., 609
F.2d 829, 831 (5th Cir. 1980).
Preliminary injunctions should also be granted when it is
13
necessary to compel defendant to correct injury already inflicted
upon plaintiffs. Washington Capitols Basketball Club, Inc. v.
Barry, 419 F.2d 472 (9th Cir. 1969). In those instances, the
status quo is defined as "the last peaceable uncontested status"
existing between the parties before the dispute developed. Canal
Authority of State of Florida v. Callaway, 489 F.2d 567, 576 (5th
Cir. 1974); District 50, United Mine Workers of America v. Int’l
Union, United Mine Workers of America, 412 F.2d 165, 168 (D.C.
Cir. 1969); Mississippi Power & Light Co. v. United Gas Pipe Line
Co., 609 F.Supp. 333, 343 (D.C. Miss. 1984). Indeed, there is no
particular magic to the phrase "status quo" because the "purpose
to a preliminary injunction is always to prevent irreparable
injury so as to preserve the court’s ability to render a meaning-
ful decision on the merits." Canal Authority, 489 F.2d at 576.
The Medicaid Act requires blood lead level assessments to be
performed as do the many admissions of the defendant USA. The
last uncontested status is 42 U.S.C. § 1396d(r)(1)(B) (iv) which
requires a blood lead level test.
Even more importantly, the plaintiffs continue to suffer
irreparable harm which is the relevant inquiry for the granting
of a preliminary injunction. Canal Authority, 489 F.2d at 576.
In order to obtain a "meaningful decision on the merits" the
Court should grant the preliminary injunction and order the USA
to require the states to use the blood lead test for EPSDT
children. Assuming that the plaintiffs ultimately prevail on the
merits of this case and the preliminary relief is not granted,
14
the Court will not be able to provide meaningful relief to the
entire class. Without implementation of a blood lead test,
hundreds of millions of children will go undiagnosed and untreat-
ed with lead poisoning.
VI. Summary Judgment is Not Appropriate
The Court should deny defendant USA’s motion for summary
judgment because there are genuine and material issues of fact to
be determined in this case. Anderson v. Liberty Lobby, Inc., 477
U.S. 242, 248 (1986). Plaintiffs set out the disputed facts and
additional facts in opposition in their response. In particular,
the lack of capacity of the states to comply with the mandates of
the Medicaid Act and perform blood lead tests on children is a
contested issue of fact.
The bald assertions in the declarations of Dr. Sue Binder
and William McC. Hiscock that states lack the capacity perform
blood lead tests are unsupported and are not based on any facts.
The USA conveniently fails to give the particulars of its "lack
of capacity" argument and tries to hide behind affidavits with
conclusory statements. General, conclusory statements in affida-
vits will not support a motion for summary judgment. Porter v.
Califano, 592 F.2d 770, 778 (5th Cir. 1979).
The facts set out in affidavits must also be within the
affiant’s personal knowledge. Fed.R. Civ. Proc. 56(e); Barker v.
Norman, 651 ¥.2d 1107, 1123 (5th Cir. 1981); Castillo v. Bowles,
687 F. Supp. 277, 280 (N.D. Tex. 1988). Clearly, the lack of
capacity of the fifty states is not within the personal knowledge
15
of any of the USA’s affiants.
A Declaration of Laura B. Beshara is being filed along with
plaintiffs’ response and this memorandum. The declaration is
made pursuant to Rule 56(f) of the Fed. R. Civ. Proc. to show the
need for more discovery on the issue of lack of capacity. The
USA furnishes no single specific instance of a state without the
capacity. Plaintiffs have not been able to do any discovery on
this issue because of the stage of the case and the Local Rule
prohibiting merits discovery while the class motion is pending.
Plaintiffs request the opportunity to conduct discovery on the
issue of capacity as well as on the issue, if relevant, of the
process by which the new HCFA guidelines were developed.
In a motion for summary judgment, "the evidence of the
nonmovant is to be believed and all justifiable inferences are to
be drawn in his favor." Anderson v. Liberty Lobby, Inc., 477
U.S. 242, 255 (1986). Plaintiffs have presented sufficient evi-
dence and issues of fact in their response to deny defendant
USA’s motion for summary judgment. Plaintiffs request that
defendant USA’s motion for summary judgment be denied.
16
Respectfully Submitted,
MICHAEL M. DANIEL, P.C.
3301 Elm Street
Dallas, Texas 75226-1637
(214) 939-9230
oT 939-9229 (telecopier)
ML M. Daniel
State Bar No. 05360500
By: aha (A. Beha a
~~ Laura B. Beshara
State Bar No. 02261750
ATTORNEYS FOR PLAINTIFFS
CERTIFICATE OF SERVICE
I certify that a true and correct copy of the above document
vas, served upon counsel for defendants by U.S. Mail on this the
R32 daay of November, 1992.
UNA BS Rosh)
Laura B. Beshara
17