Free Reply Brief - District Court of Delaware - Delaware

A --- - - -Case 1 :04-cv-01334-KAJ Document 30-2 Filed 01 /09/2006 Page 1 of 2` P "`"`
. Fmsr
Connscrrouu. .
. - Mnnicru.
CHECKLIST FOR HCV TREATMENT
This form must be completed by a Facility Provider for each Hepatitis C positive identified patient, after
completing Work-Up for Abnormal LFTs form, regardless of treatment status.
STEP ONE: ?/ 0
a) Hep C Antibody (Qtest 86803) Date - QA}
b) Hep C confirmation (Qtest# 87522) Date .766)/ mw _
c) Most current A T (must have 3 over past : ’ gp
Date & LevelO§é[Z3 Q 2Dat & Level Date & Level WL I5,] { jim
d) HIV status ositive / ·* egativ (circ e) Date [/7;}/ pt-P t
e) Hep. B. Surface Antigen Positive egati circle one) Date , Kp
f) HCV Genotype Results Date eq W O
STEP TWO:
1) Completed exclusion/inclusion checklist & meets all inclusions:
Affirmative Negative (circle one) Date
2) No exclusions found:
Affirmative Negative (circle one) Date
FTEP THREE
*If answer to 1) is Affirmative and 2) is Aflirmative then:
A.) Completely review with patient and obtain consent/refusal for liver biopsy
and treatment on FCM HCV Consent for Treatment form.
B.) In addition, if consented for Treatment- submit this form for approval,
along with Consult request for liver Biopsy to FCM Delaware Office for Medical Director to complete.
C.) Please give the inmate, along with verbal instruction, a copy of the Inmate
HCV information sheet (please date, sign, and file with this form in the medical record.
STEP FOUR
Regardless of whether the inmate is eligible for treatment or consents/refuses Hepatitis C treatment they
must be offered the following (to be documented on the FCM Inmate TB/Immtmization form):
A.) Hepatitis A vaccine (no serology indicated)
B.) Hepatitis B vaccine series if I-[BsAB (-) and HBSAG (-)
C.) Refusal of vaccine needs to be noted on the FCM refusal of Treatment form.
TO BE COMPLETED BY THE FCM STATE MEDICAL DIRECTOR:
Approval for Hep C Treatment to be initiated Date
Approval! Denial for Liver Biopsy Date
Denial of Hep. C. Tx - Please indicate why
Date
*If answer to 1) is Negative OR 2) is Negative then the patient is ineligible for Treatment. The
_ inmate must be educated as to reasons why they are ineligible, then this documentation and copy
P of Inmate HCV Information sheet must be signed, dated and filed with this form in the chart.
Physician Sis¤¤¢¤r¤ D¤t¤ L
Admin·2007 First Correctional Medical Proprietary information November 2002

( · · e Case 1 :04-cv-01334-KAJ Document 30-2 Filed O1/QQ/2006 ````` " ` ```` ` e gpg; " i`
C oniurcriomu.
- FCM Hepatitis C Exclusion and Inclusion Treatment Criteria Sheet M EDICAL
1. Absolute Exclusion Criteria : YES N 0
a. Age less than 18 or greater than 60. Age: OQ.
b. Failure to have a minimum of 18 months to serve, prior to
parole eligibility or conditional release date, from anticipated l/
initiation of treatment date (Note released date ég 1.
c. History of documented use of illicit drugs or alco ol in preceding
12 months. li
d. Failure (documented) to complete a substance abuse program once
Begun. \/
f. History of epression • r psychosis (or prior suicide attempt) E { - · t
g. History of ma 1gnancy. O Z
h. Clinical signs of decompensated liver disease pf
i. Unstable cardiac disease. if
j. Pregnancy or unwillingness to avoid conception up to K
6 months after therapy. ‘
k. Uncontrolled seizures A I;
l. End stage renal disease on dialysis ;/
. m. Uncontrolled diabetes l/
n. Uncontrolled hypertension.
0. Normal ALT or ALT < 1.5 times normal during 12 month
observation period.
p. History of medical non—compliance I {
I 2. Inclusion Criteria: ·
a. Persistently elevated ALT levels as defined by ALT at least
- 1.5 times normal limit over period of preceding 6 months.
b. Detectable HCV RNA
c. Negative pregnancy test for female inmates. K '
l d. Written consent to antiviral treatment and acknowledgement
of all side effects as below (documented on FCM HCV consent form).
A . 3. Relative Exclusion Criteria:
. a. Chronic steroid use. l/
i b. Hemoglobin less than 12 mg/dl for men or <11mg/dl for women \/
i c. Platelet count < 100,000. 1/
d. Serum Creatinine > 2.0 mg/dl. \/
e. INR > 1.2. »
f. Hepatitis B Surface antigen positive. [/
g. White Blood Cell Count < 3,000.
_ h. Autoimmune disorders. 1/
i. History of thyroid disease/hemoglobinopathies/cytopenia/anemia 1/
j. Serum Albumin < 3.2 mg/dl. L .
k. HIV +
_ Imnate Signature Date
Providers Signature Date Q {%
MR-1087 First Correctional Medical Proprietary information June 2003