HomeMy WebLinkAbout20003173.tiff RESOLUTION
RE: APPROVE TASK ORDER FOR HIV COUNSELING AND TESTING AND AUTHORIZE
CHAIR TO SIGN
WHEREAS, the Board of County Commissioners of Weld County, Colorado, pursuant to
Colorado statute and the Weld County Home Rule Charter, is vested with the authority of
administering the affairs of Weld County, Colorado, and
WHEREAS, the Board has been presented with a Task Order for HIV Counseling and
Testing between the County of Weld, State of Colorado, by and through the Board of County
Commissioners of Weld County, on behalf of the Weld County Department of Public Health and
Environment, and the Colorado Department of Public Health and Environment, commencing
January 1, 2001, and ending December 31, 2001, with further terms and conditions being as
stated in said task order, and
WHEREAS, after review, the Board deems it advisable to approve said task order, a
copy of which is attached hereto and incorporated herein by reference.
NOW, THEREFORE, BE IT RESOLVED by the Board of County Commissioners of
Weld County, Colorado, that the Task Order for HIV Counseling and Testing between the
County of Weld, State of Colorado, by and through the Board of County Commissioners of
Weld County, on behalf of the Weld County Department of Public Health and Environment, and
the Colorado Department of Public Health and Environment be, and hereby is, approved.
BE IT FURTHER RESOLVED by the Board that the Chair be, and hereby is, authorized
to sign said task order.
The above and foregoing Resolution was, on motion duly made and seconded, adopted
by the following vote on the 18th day of December, A.D., 2000.
BOARD OF COUNTY COMMISSIONERS
WELD COUNTY, COLO(RA O
d
ATTEST: Ij� � •,�/,. 1;.��/� S! h-lf(L/,f,L J cf.'t�r' zi�-
►�..: .
rBarbara irkmeyer, Chair
Weld County Clerk to the Bo
rz, �0e� /// , g/J ,
�i�►►�� .� M. J. ile, Pro-Tem //
// J
Deputy Clerk to the .. /' n
/ ` U S ' eorge t. Baxter
APPROVED AS tQF7RM: .
/j Zz_ Dale K. Hah� � G I
my Attorney .,,calm
Glenn V at T---
2000-3173
HL0027
Department or Agency Name
COLORADO DEPARTMENT OF PUBLIC
HEALTH AND ENVIRONMENT
Department or Agency Number
FHA
Contract Routing Number
01-00112
TASK ORDER
This TASK ORDER is made this 22nd day of November.2000, by and between: the State of Colorado,for the use
and benefit of the COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT,whose
address or principal place of business is 4300 Cherry Creek Drive South,Denver,Colorado 80246,hereinafter
referred to as "the State";and,the BOARD OF COUNTY COMMISSIONERS OF WELD COUNTY (a
political subdivision of the state of Colorado),whose address or principal place of business is 915 10th Street
3rd Floor,Greeley,Colorado 80631,for the use and benefit of the Weld County Department of Public Health
and Environment, whose address or principal place of business is 1555 North 17th Avenue,Greeley, Colorado
80631,hereinafter referred to as "the Contractor".
WHEREAS,section 29-1-201, 8 C.R.S. as amended,encourages govemments to make the most efficient and
effective use of their powers and responsibilities by cooperating and contracting with each other to the fullest extent
possible to provide any function, service, or facility lawfully authorized to each of the cooperating or contracting
entities,and to this end all State contracts with its political subdivisions are exempt from the State's personnel rules
and the State procurement code;
WHEREAS,the State has formulated a comprehensive State plan,with associated budgets,relative to the State's
programs and services which allocates funds to local health agencies in order to provide certain purchased services
to the people of Colorado;
WHEREAS, such funding is to be allocated through task order contracts with local health agencies;
WHEREAS, as to the State,authority exists in the Law and Funds have been budgeted,appropriated, and otherwise
made available,and a sufficient uncommitted balance thereof remains available for subsequent encumbering and
payment in Fund Number(s) 100,Organizational Unit Code(s)3830 Appropriation Code(s)377,Program Code(s)
Z,and Object Code(s)5420 under Master Contract Routing Number 00 FAA 00008 and Contract Encumbrance
Number PO FHA SOD0100112;
WHEREAS,the State, in order: to carry out its lawful powers,duties,and responsibilities under Section
25-4-1401,g1 seq., 8 C.R.S.,as amended;and,to effectively utilize legislative appropriations made and provided
therefore, in coordination with like powers,duties,and responsibilities of the Contractor, has determined that public
health services are desirable in Weld County, Colorado;
Page I of 9
WHEREAS,pursuant to 25-4-1401, 8 C.R.S.,as amended,the general assembly declares that infection with
human immunodeficiency virus(HIV),the virus which causes acquired immune deficiency syndrome(AIDS), is an
infectious and communicable disease that endangers the population of this state;
WHEREAS,pursuant to 25-4-1405, 8 C.R.S.,as amended, it is the duty of state and local health officers to
investigate sources of HIV infection and to use every proper means to prevent the spread of the disease;
WHEREAS,pursuant to 25-4-1405, 8 C.R.S., as amended, it is the duty of state and local health officers, as part of
disease control efforts,to provide confidential voluntary HIV testing and counseling services;
WHEREAS,the State has established an anonymous HIV counseling and testing program at local county health
departments'Counseling and Testing Sites(CTS)for persons considered to be at high risk for HIV infection;
WHEREAS,the Contractor has chosen to provide confidential and anonymous counseling and testing services for
antibody to HIV;
WHEREAS,pursuant to the Catalog of Federal Domestic Assistance(CFDA)Number 93.940,the State has been
awarded monies by the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention
(CDC)for Human Acquired Immunodeficiency Syndrome(AIDS)detection by means of counseling and testing
services;
WHEREAS,the State and the Contractor agree that the most efficient and effective way of providing these services
is at the local level;
WHEREAS,all required approvals,clearances,and coordination have been accomplished from and with all
appropriate agencies.
NOW THEREFORE, in consideration of their mutual promises to each other, stated below,the parties hereto
agree as follows:
A. PERIOD OF PERFORMANCE AND CONTRACT TERMINATION. The effective date of this Task
Order is January 1.2001,or on the date this Task Order is approved by the State Controller,whichever is
later. The term of this Task Order shall commence on January 1,2001, and continue through and
including December 31,2001,unless sooner terminated by the parties pursuant to the terms and conditions
of the Master Contract.
Page 2 of 9
SCOPE OF WORK.
The Contractor shall provide HIV risk-reduction counseling and antibody testing services
according to the terms outlined in this contract;
a. Funds will support two basic types of testing programs; Provider Initiated testing and
Patient Initiated testine. Provider Initiated testing will consist of testing at facilities that
provide routine risk assessment and ongoing medical care(family planning clinics,
sexually transmitted disease(STD)clinic,substance abuse treatment center(SATC)).
Patient Initiated testing consists of testing at Counseling and Testing Sites (CTS)and
CTS outreach where clients go to receive HIV testing services only;
2. The Contractor shall include the following HIVcounseling and testing services for each
individual:
a. the administration of a Colorado Department of Public Health and Environment
(CDPHE)specified informed consent form(sample attached and by this reference made
part hereof as Attachments A and B), or approved equivalent,
b. a client-centered risk assessment,
c. a discussion and development of a risk-reduction plan for the client,
d. collecting specimen sample for laboratory processing conducted by staff trained in
various specimen collection technologies(OraSure, venipuncture),
e. transportation of specimen to laboratory,
f. informing clients of test results,
g. making every effort to ensure that all clients who test HIV antibody positive receive
posttest counseling,
h. referring clients who test positive for follow-up medical and counseling services as
appropriate,
referring clients who test negative and are engaging in high risk behaviors for follow-up
counseling services as appropriate,
j. ensuring that those positive clients who do not return for results or are lost for follow-up
are referred to the CDPHE;
k. ensuring that all positive clients are referred to CDPHE Disease Control Specialist for sex
and needle-share partner referral.
3. The Contractor understands that the reimbursement amount for HIV counseling and testing will be
based on client risk. "High/increased risk" for HIV includes clients who have a history since
1978 of one or more of the following:
• injection drug use,
• sex with a person with HIV/Acquired Immune Deficiency Syndrome(AIDS),
• sex with a man who has sex with men,
• sex with an injection drug user,
• an STD,
• exchanging money or drugs for sex.
All other persons would be considered low/no risk for HIV;
Page 3 of 9
4. The Contractor shall submit all collected specimens to the State Laboratory for analysis. The
Contractor shall fully and legibly complete the HIV 1 Serology lab slip(Attachment C) for each
person tested for HCV or HIV. All lab slips must specify the source of the client services(where
they were tested)along with the provider. Specific codes used to indicate the source of the client
services are as follows:
Source Code
CTS 0214
STD 0114
FP 1213
5. The Contractor shall, for each client posttest counseled, fully and legibly complete the Counseling
Follow-up form on the reverse side of the HIV 1 Serology lab slip provided by the State. The
completed Counseling Follow-up forms shall be submitted to the State within forty-five days after
the date of pretest counseling. The State shall provide to the Contractor a quarterly Testing Site
Activity Report within sixty days following the end of the quarter.
6. If the Contractor elects to use the OraSure oral fluid collection method,the Contractor must
adhere to the requirements outlined in Attachment D.
7. All counselors providing counseling and testing services must have successfully completed the
Centers for Disease Control and Prevention(CDC)course"HIV Prevention Counseling" or an
approved equivalent. All counselors providing ten or more pre or posttest counseling sessions per
calendar quarter(every 3 months)are required to attend one State approved continuing education
course per year. Those Contractors which do not have any counselors providing ten or more pre
or posttest counseling sessions per calendar quarter are required to have a minimum of one
counselor per year attend a State approved HIV continuing education course.
8. All counselors providing counseling and testing must be evaluated annually by the HIV
Coordinator,his/her designee, State staff and/or their designee. This evaluation will include
counselor self-assessments,observation or role-play of a counseling session. The evaluation tools
will be provided by the State.
9. The Contractor shall designate an HIV Counseling and Testing Coordinator and provide the name
of this person to the State within thirSy days of the effective date of this contract. The Coordinator
will serve as the contact person with State staff to resolve operational issues. Such issues will
include but not be limited to: laboratory report form completion, billing and reimbursement,
counselor training,evaluation and modification of counseling services.
10. The Contractor shall maintain internal medical and administrative records(including,but not
limited to, labslips and counseling session notes) in a manner which ensures the confidentiality
and security of those records in accordance with all applicable statutes including, but not limited
to,25-1-107 C.R.S. et seq(Named reporting of certain diseases and conditions B access to
medical records B confidentiality of reports and records)and 18-4-412 C.R.S. et seq(medical
records). Further,the Contractor shall abide by the current policy regarding the retention of HIV
testing records as outlined in the "Colorado Department of Public Health and Environment
Retention of HIV Negative and Positive Tests Results" and the "Rules and Regulations Pertaining
to the Reporting, Prevention,and Control of AIDS, HIV Related Illness, and HIV Infection" (6
CCR-1009-9,Colorado Board of Health), attached hereto and by this reference made part hereof
as Attachment E and F,respectively.
Page 4 of 9
1 1. The Contractor may(but is not required to)charge clients. Contractors choosing to collect fees
may do so by the method they find most appropriate(sliding scale, flat administrative fee,
donation,etc.). A fee waiver is left to the Contractor's discretion. Clients who are referred by the
State as sex/needle-share partners of HIV infected persons or persons who are at high/increased
risk for HIV infection, as described in Part B, paragraph three of this contract,will not be denied
services because of inability to pay.
12. The Contractor agrees to an annual agency review of counseling sessions to be conducted by the
State. This review can include: observations,chart reviews, and individual interviews with the
HIV Counseling and Testing Coordinator and/or line-staff counselors.
a. If the annual agency evaluation indicates problems in the quality of HIV prevention
counseling services being provided,the Contractor agrees to develop with the State an
agency-centered quality improvement plan. The terms of this plan will be determined at
that time by the Contractor and the State.
b. If the terms of the quality improvement plan are not met within the agreed upon time
period without just cause for the delay,the State may exercise its remedies in the Master
Contract.
13. Additionally,the Contractor shall comply with ACompetence Regarding Culture, Disability and
Other Diversity@ as set forth in ADefinitions for HIV Prevention Interventions and Standards of
Practice,@ as approved on May 24, 1999 by the Core Planning Group of Coloradans Working
Together: Preventing HIV/AIDS, incorporated herein by this reference and made a part hereof as
Attachment G.
14. The State has projected that during the term of this Contract the Contractor will perform one
hundred twelve(112)HIV risk reduction counseling and testing sessions with individuals who
report having engaged in high/increased risk behavior for HIV infection as defined in Part B. 3. of
this Contract.The Contractor is expected to perform an average of twenty-eight(28)of the above
described sessions each calendar quarter.
DUTIES AND OBLIGATIONS OF THE STATE.
1. The State shall, in consideration of those services satisfactorily and timely performed by the
Contractor under this Task Order,cause to be paid to the Contractor a sum not to exceed ONE
THOUSAND FOUR HUNDRED TWENTY EIGHT DOLLARS,($1.428.00). Of this total
amount,$1,428.00 are identified as attributable to a funding source of the federal govemment and,
$0.00 are identified as attributable to a funding source of the state of Colorado.
D. PAYMENT MECHANISM.
I. Notwithstanding Paragraph E.2. of the Master Contract,the State shall provide to the Contractor
via facsimile a quarterly statement by the fifteenth working day of the end of the quarter for which
reimbursement is to be provided. This quarterly statement shall reflect the number of test, pretest
and posttest counseling sessions by risk for that quarter. In order to be reimbursed under the
terms of this Contract,the Contractor shall review,verify and sign this statement and return
Page 5 of 9
it to the State within twenty-one calendar days following receipt of the statement. Failure to
notify the State of any discrepancies or to verify this statement by signature within this time
period shall result in a forfeit of reimbursement eligibility for that quarter.
a. Reimbursement HIV risk reduction counseling and testing services shall be made in four
equal payments of Three Hundred Fifty Seven Dollars($357.00)minus laboratory
processing fees described in D.2 below for family planning clients and following receipt
of the verified quarterly statement described in Part D.I of this Contract.
2. The State shall provide free laboratory services for all persons accepting HIV antibody testing
through the CTS and those clients testing through family planning clinic who report having
engaged in high/increased risk behavior for HIV infection as described in Part B.3 of this
Contract.
a. The State shall reduce quarterly reimbursements by a rate not to exceed five dollars
($5.00)for each individual tested through a family planning clinic who does not report
having participated in high/increased risk behavior(no/low risk client)as defined B.3 of
this Contract. The total amount of the reduction will be transferred to the State
Laboratory to pay the fees for laboratory processing services for no/low risk clients.
3. The State may prospectively increase or decrease the amount payable under this Task Order
through a"Task Order Change Order Letter",a sample of which is incorporated herein by this
reference, made a part hereof,and attached hereto as "Attachment H". To be effective,the Task
Order Change Order Letter must be: signed by the State and the Contractor; and, approved by the
State Controller or an authorized designee thereof. Additionally,the Task Order Change Order
Letter shall include the following information:
a. Identification of the related Master Contract and this Task Order by their respective
contract routing numbers and affected paragraph number(s);
b. The type(s)of service(s)or program(s)increased or decreased and the new level of each
service or program;
c. The amount of the increase or decrease in the level of funding for each service or
program and the new total financial obligation;
d. The intended effective date of the funding change;and,
e. A provision stating that the Task Order Change Order Letter shall not be valid until
approved by the State Controller or such assistant as he may designate.
Upon proper execution and approval,the Task Order Change Order Letter shall become an
amendment to this Task Order. Except for the General and Special Provisions of the Master
Contract,the Task Order Change Order Letter shall supersede this Task Order in the event of a
conflict between the two. It is expressly understood and agreed to by the parties that the task
order change order letter process may be used only for increased or decreased levels of funding,
corresponding adjustments to service or program levels,and any related budget line items. Any
other changes to this Task Order, other than those authorized by the task order renewal letter
process described below,shall be made by a formal amendment to this Task Order executed in
Page 6 of 9
accordance with the Fiscal Rules of the state of Colorado.
If the Contractor agrees to and accepts the proposed change,then the Contractor shall execute and
return the Task Order Change Order Letter to the State by the date indicated in the Task Order
Change Order Letter. If the Contractor does not agree to and accept the proposed change,or fails
to timely return the partially executed Task Order Change Order Letter by the date indicated in the
Task Order Change Order Letter,then the State may, upon written notice to the Contractor,
terminate this Task Order twenty(20)calendar days after the return date indicated in the Task
Order Change Order Letter has passed. This written notice shall specify the effective date of
termination of this Task Order. If this Task Order is terminated under this clause, then the parties
shall not be relieved of their respective duties and obligations under this Task Order until the
effective date of termination has passed.
Increases or decreases in the level of contractual funding made through this task order change
order letter process during the initial, or renewal,term of this Task Order may only be made under
the following circumstances:
f. If necessary to fully utilize appropriations of the state of Colorado and/or non-
appropriated federal grant awards;
g. Adjustments to reflect current year expenditures;
h. Supplemental appropriations, or non-appropriated federal funding changes resulting in an
increase or decrease in the amounts originally budgeted and available for the purposes of
this Task Order;
Closure of programs and/or termination of related contracts or task orders;
Delay or difficulty in implementing new programs or services;and,
k. Other special circumstances as deemed appropriate by the State.
4. The State may renew this Task Order through a"Task Order Renewal Letter",a sample of which
is incorporated herein by this reference,made a part hereof, and attached hereto as"Attachment
I". To be effective,the Task Order Renewal Letter must be: signed by the State and the
Contractor; and,approved by the State Controller or an authorized designee thereof. Additionally,
the Task Order Renewal Letter shall include the following information:
a. Identification of this Task Order by its contract routing number and affected paragraph
number(s);
b. The type(s)of service(s)or program(s), if any, increased or decreased and the new level
of each service or program for the renewal term;
Page 7 of 9
c. The amount of the increase or decrease, if any, in the level of funding for each service or
program and the new total financial obligation;
d. The intended effective date of the renewal;and,
e. A provision stating that the Task Order Renewal Letter shall not be valid until approved
by the State Controller or such assistant as he may designate.
Upon proper execution and approval,the Task Order Renewal Letter shall become an amendment
to this Task Order. Except for the General and Special Provisions of the Master Contract, the
Task Order Renewal Letter shall supersede this Task Order in the event of a conflict between the
two. It is expressly understood and agreed to by the parties that the task order renewal letter
process may be used only to: renew this Task Order; increase or decrease levels of funding related
to that renewal;make corresponding adjustments to service or program levels,and, adjust any
related budget line items. Any other changes to this Task Order, other than those authorized by
the task order change order letter process described above,shall be made by a formal amendment
to this Task Order executed in accordance with the Fiscal Rules of the state of Colorado.
If the Contractor agrees to and accepts the proposed renewal term,then the Contractor shall
execute and return the Task Order Renewal Letter to the State by the date indicated in the Task
Order Renewal Letter. If the Contractor does not agree to and accept the proposed renewal term,
or fails to timely return the partially executed Task Order Renewal Letter by the date indicated in
the Task Order Renewal Letter,then the State may,upon written notice to the Contractor,
terminate this Task Order twenty(20)calendar days after the return date indicated in the Task
Order Renewal Letter has passed. This written notice shall specify the effective date of
termination of this Task Order. If the Task Order is terminated under this clause,then the parties
shall not be relieved of their respective duties and obligations under this Task Order until the
effective date of termination has passed.
E. ATTACHMENTS. All attachments to this Task Order are incorporated herein by this reference and made
a part hereof as if fully set forth herein. In the event of any conflict or inconsistency between the terms and
conditions of this Task Order and those of any attachment hereto,the terms and conditions of this Task
Order shall control.
Page 8 of 9
IN WITNESS WHEREOF,the parties hereto have executed this Task Order as of the day first above written.
CONTRACTOR: STATE:
BOARD OF COUNTY COMMISSIONERS STATE OF COLORADO
OF WELD COUNTY Bill Owens,Governor
(a political subdivision of the state of Colorado)
71
'r/,(�,ULL' t .J,1 �,r if�/nXt '1— By:
9 ��
By:
Na Barbara J. Kirkmey'2r For he Executive • ctor
Title: Chair (12/18/2000) Department of ublic
FEIN: 84-6000813 Health and Environment
AT ST: ' �� PROGRAM APPROVAL:
act ? roW
.•�►
Okr
eIncellUnIt '* >^ ric Scl eiger, Fiscal leer
metiontesexterax
Deputy Clerk to t '` a
PROVALS:
COLORADO DEPARTMENT OF LAW COLORADO DEPARTMENT OF PERSONNEL
OFFICE OF THE ATTORNEY GENERAL OFFICE OF THE STATE CONTROLLER
Ken Salazar,Attor ne tieperal Arthur L. Barnhart,State Controller
er /" By. v . L-C,iltit Ct 1 Ck ICE-
By:
I
WELD COUNTY DEPARTMENT OF
PUBLIC HEALTH AND ENVIRONMENT
BY: itr��x)al C
Mark E. Wallace, MD, MPH-Director
Page 9 of 9
•
ATTACHMENT A
HIV ANTIBODY TEST CONSENT FORM - CTS
(What is an HIV test?
This test looks for antibodies to Human Immunodeficiency Virus, the virus that causes AIDS.
Your body makes antibodies to fight HIV, so if the test finds the antibodies, it means you have
the virus. If you are infected you can give HIV to someone else through sex or sharing needles,
or to your baby, even if you look and feel fine.
This test is voluntary. You should understand the good and bad things about testing before you
decide to take the test.
'Why you might want to be tested: I
• If you have HIV you can get medicine to help you stay healthy.
• If you test positive for the virus,you can learn how to keep from giving it to your
partners.
• If you are pregnant now or might get pregnant,and you learn that you have HIV, there is
medicine you can take so that your baby probably won't get HIV.
• If you find out you have HIV you can get help to tell past partners; they can get tested
without knowing any information about you.
• If you don't have HIV right now,the counselor can help you make a plan so you don't
get it.• Whether you have HIV or not,you can help your friends and your community by finding
out how to keep the vims from spreading.
4
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L/L/SI .���),f , i6t!�i iCotl/ i�.�aC �., , ,
• If you fmd out you have HIV,it can cause worry about getting sick,or dying.
• The process of getting tested may be embarrassing or frightening•
• There is a very small risk of medical problems from having your blood drawn.
• If you test positive,your name is kept at the state health department and/or the local
health department. In some cases,they can give your name to other people.
• The law may change again in the future,allowing your name to be released in other
circumstances.
HIV Antibody Test Consent Form-COUNSELING&TESTING SITE OVER
•
Confidentiality & Privacy:
Colorado law does not allow your records to be released except in the following situations:
• If your counselor suspects that a child has been abused or neglected, the counselor may
have to report the information for investigation, even if you decide not to get tested for
HIV.
If this test is positive, the record of your result is kept here and at the state health
department. Your test result can be released in some cases:
• If the director of the state or local health department has good information that you are a
danger to the public health, he can require you to get counseling. If you continue to
expose other people, he can get court orders for evaluation and more counseling, and
eventually, can order you taken into custody.
• Your test result can be released to a medical worker in order to protect your own life or
health if you have a medical emergency.
• When a public safety worker,emergency medical service provider, staff member of a
detention facility, health care provider, or a custodial employee of the department of
corrections or department of institutions has been exposed to your blood or other body
fluids, your name and test result can be given to these people and their doctors.
• If you are bound over for a sexual offense involving vaginal or anal penetration and you
test positive for HIV,the district attorney will contact the health department to find out if
you had been told that you tested positive before the date of the crime. If you did know,
and you are convicted or plead guilty,the judge must sentence you to three times the
maximum for that offense.
Some places in Colorado can test you for HIV without using your name. lfyou are worried
about giving your name, ask the counselor if this site offers testing without names. If it does not,
. you can ask the counselor for a list of places that do offer testing without having to give your
name. Ask for more information on the parts of this consent form you have questions about.
After all your questions are answered,please sign your name below.
I have read these pages and have had a chance to have my questions answered. I
understand the information on this form and give my consent to have a blood or oral
sample taken from me and tested for the HIV antibody.
Signature or Unique Identifier& Date
U.ips Yrifa 1ST IM Yard=Bat uSa mom I ST!St law of(WWI
tom..e..IST W.r tidier mom Ion Ivddi.M loam Tr dIYtk t w)
HIV Antibody Test Consent Form-COUNSELING&TESTING SITE
f
ATTACHMENT B
HIV ANTIBODY TEST CONSENT FORM - OCS
What is an HIV test?
This test looks for antibodies to Human Immunodeficiency Virus, the virus that causes AIDS.
Your body makes antibodies to fight HIV, so if the test finds the antibodies, it means you have
the virus. If you are infected you can give HIV to someone else through sex or sharing needles,
or to your baby, even if you look and feel fine.
This test is voluntary. You should understand the good and bad things about testing before you
• decide to take the test.
Why you might wantto be tested:
• If you have HIV you can get medicine to help you stay healthy.
• If you test positive for the virus, you can learn how to keep from giving it to your
partners.
• If you are pregnant now or might get pregnant, and you learn that you have HIV, there is
medicine you can take so that your baby probably won't get HIV.
• If you find out you have HIV you can get help to tell past partners; they can get tested
without knowing any information about you.
• If you don't have HIV right now,the counselor can help you make a plan so you don't
get it.
• Whether you have HIV or not,you can help your friends and your community by finding
out how to keep the virus from spreading.
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CCPiN" ; �a�₹," s'+ i =.
• If you find out you have HIV,it can cause worry about getting sick,or dying.
• The process of getting tested may be embarrassing or frightening.
• There is a very small risk of medical problems from having your blood drawn.
• If you test positive,your name is kept at the state health department and/or the local
health department. In some cases,they can give your name to other people.
• The law may change again in the future,allowing your name to be released in other
circumstances.
HIV Antibody Test Consent Form-ONGOING CARE SITE OVER
Confidentiality & Privacy:
Colorado law does not allow your records to be released except in the following situations:
• If your counselor suspects that a child has been abused or neglected, the counselor may
have to report the information for investigation, even if you decide not to get tested for
HIV.
• Your HIV test and results are part of your medical record at this office. Your test and
result will be included if you request your complete medical record. Your test and result
could also be released as part of a legal action involving your medical records.
If this test is positive, the record of your result is kept here and at the state health
department. Your test result can be released in some cases:
• If the director of the state or local health department has good information that you are a
danger to the public health, he can require you to get counseling. If you continue to
expose other people, he can get court orders for evaluation and more counseling, and
eventually, can order you taken into custody.
• Your test result can be released to a medical worker in order to protect your own life or
health if you have a medical emergency.
• When a public safety worker,emergency medical service provider, staff member of a
detention facility,health care provider,or a custodial employee of the department of
corrections or department of institutions has been exposed to your blood or other body
fluids, your name and test result can be given to these people and their doctors.
• If you are bound over for a sexual offense involving vaginal or anal penetration and you
test positive for HIV,the district attorney will contact the health department to find out if
you had been told that you tested positive before the date of the crime. If you did know,
and you are convicted or plead guilty,the judge must sentence you to three times the
maximum for that offense.
Some places in Colorado can test you for HIV without using your name. If you are worried
about giving your name, ask the counselor f this site offers testing without names. If it does not,
you can ask the counselor for a list of places that do offer testing without having to give your
name. Ask for more information on the parts of this consent form you have questions about.
After all your questions are answered,please sign your name below.
I have read these pages and have had a chance to have my questions answered. I
understand the information on this form and give my consent to have a blood or oral
sample taken from me and tested for the HIV antibody.
Signature& Date
HIV Antibody Test Consent Form-ONGOING CARE SITE
nvier.- 7— o Bcs 17123 D weer.CO h8021217 I HIV Serology ( ATTACHMENT C
mm none 303692-308S
Nin:Laboratory and Radiation Services
:a •. Arm,/ Phone DATE RECEIVED/SPECIMEN NUMBER
a.
• s. . Address MAB USE ONLY
HIV I HP)2
City State Zip'me EIA; Non Reactive
—se ------ Specimen Collection Repeatedly Reactive
Site Code ---
s - ------ — --- WESTERN Positive
_Month Day Year Test/Type
it _ __ _ _-__a —_— --_ BLOT:
,� Jan. O BLY LICY Negative
—1 Feb. ] -�- Blood Indeterminate
Not Done
� �' a• � ^ March ^ ^ GI ^ Dried blood spot
asst — IICI II - April I I I Oral fluid BANDS: 21 41 120 100
I II r May _ 7 z Urine HCV EIA: Reactive
. , ' l June r , 7 Non Reactive
i�I a a July
Aug _ S/�
. Sept. • I Testing History: L— --_... .._._
..on ! ; ; l Oct. iii,. , a,rn:i a i ❑m•'c; ID NUMBER
s•
! a r .. at , n Nov. ^ ----
Date Last: /
' j •: v , , l lDec., I _ i
l _ . . _. i ._ _-Dec .. ...._ i ma i Results: r. ' it10
In a
immi II)*if confirmatory:imi
saa Are you dealing with any of the following challenges? Race/Ethnicity: (Mark all that apply) I Age i Date of Birth
a. (Mark all that apply)
White.not Hispanic Month I DayTVear
1 asp Physical challenge Blind/visually impaired Black.not Hispanic Jan.
am Learning or thinking challenge Emotional or mental illness Hispanic Feb.
r• Deaf/hard-of-hearing Other Asian/Pacific Iv. i0 o March 0 0 0 0
as. Am.Indian/AK Native
I I April I I t t
o w Cgem'sIVam<(last.First.MU Other
2 2 May 2 2 2 2
• 3 3 June 3 3 3 0
f• 4 4 July s + +
s Address Sex: u F
Transgendered: Its NO s s Aug. s s s
tm 6 6 Sept. 6 6 6
O M City State Zip
7 Op. 2 r r
•Use No.2 pencil,blue or black ink pen. a a Nov I a e 6
No CYent's Phone •Fill ovals completely.
•Make no stray marks on this form. s 9 Dec. I 9 9 s
MS
s•
s. • N last More than 12
O. Sexual Orientation(Client report regardless of behavior) Client History of: 12 months months aa t o M
we iquoscaun. HE IENUSEXUAI BISEXUAL
— kgeeted drug the
mg Number of different partners in past 12 months Receiving blood transfusion/products before 1986
is Syphilis.Gonorrhea.CNamydia.Herpes or Hep B .
a s far sex
aas 0 14 44 7-9 10-19 20+ Occupational
money expos
xe
s>• apoare to body Bads IHCW)
am What types of sex do you have?(mark all that apply) Sexual abuse or assauk
am Oral NO YES Suspected perinatal Section - YES N
NO YES Is Ns a child of an HIV+woman?s Vaginal NO
sue Anal NO YES Sexual Exposure with Mn):
Male
sOf the last 10 times you've had anal or vaginal sex. Fanak
ow how many times did you use a condom? Person known to have HIV/AIDS
MN 0 t 2 3 4 s 6 r At es Man who has sex with men •
sr Section drag arse
,., Did you use a condom the last time you had sex? Person paid money a drugs for sat
INN NO YES During p counseling,was a NO t
sae specific risk reduction plan developed?
a The last time you had sex without■ During pretest counseling,what Services
s• condom were you drunk or high? . . . . Nu r s referrals did the counselor Not Not mi im Are you currently pregnant? NO YES uux
make to specific agencies? In AxWdak Insist
-
f _----- STD clinic
Local Use Only Family Planning Substance Abuse Treatment •, _ '
ATTACHMENT D
EPITOPE .•
Dear Doctor,
"Thank you for deciding to use the OraSure® HIV-1 Oral Specimen Collection device. OraSure 111V-I
provides a non-invasive way to collect specimens to be tested for antibodies to the HIV-1 virus, and we
think that it can be a valuable tool in your practice. By purchasing this device, you are agreeing to abide
by the following requirements for the use of the OraSure device:
1. You arc responsible to insure that OraSure HIV-I is made available for use only to trained individuals
who have been trained to administer the device in accordance with the device labeling and training
materials provided.
2. You are responsible to insure that test results obtained on OraSure HIV-1 specimens will be reported
to you or someone under your supervision.
3. You are responsible to insure that OraSure HIV-1 specimen collection and testing arc done in
accordance with applicable laws and regulations concerning informed consent and confidentiality.
We have designed a training program to help you in training OraSure HIV-1 collectors. The training
program consists of a videotape, a videotape script, a quiz and written materials provided with the device,
the package insert, and the "Subject Information" pamphlet. We will give a brief overview of each of
these.
The package insert for the device contains warnings and precautions,restricti'ns on the use of the device,
and information about how the device works, how to use the device, transportation and shipping of
OraSure HiV-1 specimens, interpretation of results, and limitations of the procedure. The "Subject
Information" pamphlet provides subjects with information about the limitations of the OraSure IIIV-I
device and the meaning of a positive, negative, or indeterminate test result on an OraSure HIV-1
specimen,as well as general information about HIV&AIDS.
The training video, a script of which is enclosed for you to distribute to your collectors,puts all of this
together. It discusses the materials needed for testing, including those that we at Epitope provide and
those that we don't It also discusses the stops leading up to specimen collection, especially providing
information to the subject about OraSure HIV-I oral fluid testing,HIV,and confidentiality,and obtaining
the subject's infonned consent. It next discusses the steps in specimen collection, and then the steps
necessary for handling the specimens in the field.
You will,of course,want to review all of these materials yourself.You should have each collector trainee
read all of the written materials, and watch the video. You should also provide a copy of the package
Insert to each collector trainee to retain.The enclosed quiz can be wed to test the trainee's mastery of the
material.
We at Epitope are committed to helping each physician make OraSure HIV-1 the valuable tool in his or
her practice that we believe it con be. If you need additional free copies of our training materials (all of
which, including the video,you are also welcome to copy yourself),or if you have any questions,please
call us toll-fret at 1-800-234-3786.
Sine y, qG ' r'�-
1 f•
a. ft-
Richard George,Ph.D.
Chief Scientific Officer
• ATTACHMENT E
Colorado Department of Public Health and Environment
Retention of HIV Negative and Positive Tests Results
Revised May 17, 1995
Because of public discussion about the Colorado Department of Public Health and
Environment (CDPHE) maintaining records on persons who test negative for HIV in the State
Laboratory, the Department reviewed state law concerning the protection of confidentiality of HD/
negative records and reassessed its need to keep records of and statistical data on HIV negative
tests. The findings are presented in parts I and II. Part III of this document describes changes in
policy and records management that can assure the public that the HIV negative information will
be used only for legitimate disease control, epidemiologic, and medical-legal requirements. Part
III was revised as of May 17, 1995, to reflect a Colorado Board of Health review of the policy in
effect since May 1, 1993.
I. Current Status
A. Records of HIV antibody tests kept by state and local departments of health are at
follows: positive tests reported by any laboratory or physician and negative tests
performed at the State Laboratory. Local health departments may also have
records of HIV tests performed under research protocols in laboratories other than
the State Laboratory. Records of HIV negative tests performed at the State
Laboratory are kept at both the CDPHE and the test site, i.e., counseling and
testing site (CTS), tuberculosis clinic, STD clinic, drug treatment center, family
planning clinic, etc.
B. HIV negative tests submitted from state-funded NW counseling and testing
programs and performed at the State Laboratory have the same level of
confidentiality protection, physical and legal, as do HIV positive tests. Records
resulting from compliance with CRS 25-4-1405(1) ['it is the duty of state and local
health officers to investigate sources of HIV infection and use every proper means
to prevent the spread of the disease] are protected under CRS 25-4-1404(1).
• Since CRS 25-4-1405(2)states that "it is the duty of state and local health officers,
as part of disease control efforts, to provide...confidential voluntary testing and
counseling,' the Department considers all tests performed at state-ftmded HIV
• counseling and testing programs to be a proper means of preventing the spread of
HIV. Hence, records of all tests at these sites are confidential, and the Department
will treat them confidentially. This view is supported by the Attorney General's
office.
There have been no breaches of confidentiality of either HIV positive or negative
tests held by state or local health departments.
C. State-funded HIV counseling and testing began in July 1985, and every person
tested at a counseling and testing program has signed a written consent form which
tiwp:,mauwa..w 1
•
•
states that the results will be kept in locked files at the CDPHE and the test site.
Greater than 100,000 confidential tests have been conducted in the past 6 3/4
years.
D. The CDPHE has no lists or secret files of HIV negative persons with certain risk
behaviors.
E. In a survey recently conducted by the Governor's AIDS Council, 5 of 10 states
with some form of named HIV reporting [including Colorado] kept results of HIV
negative tests. The states keeping HIV negative test records were Missouri,
Oklahoma, Kentucky, Idaho, and Colorado; states not keeping such records were
Minnesota, Arizona, South Carolina, New Jersey, and Oregon. Reasons why
states did or did not retain HD/ negative test records were not collected.
II. The Value of HIV Negative Test Records to State and Local Health Departments
A. The standard of practice in all laboratories, public and private, hospital or office,
is to maintain records of all tests performed, whatever the results. This is useful
to the client if he/she wants to verify the date and result of a test. It is important
for the laboratory, if case results are questioned at a future date or tests on a single
patient from,multiple providers give conflicting results; the State Laboratory would ".
have records of its work and could perform repeat assays of serum as necessary.
Federal laboratory regulations (42 CFR Part 74 et al., Subpart J—Patient Test
Management) require that:
Records of test requisitions must be maintained for at least two years. The
laboratory must assure that the requisition includes—(1) The patient's name
or other method of specimen identification to assure accurate reporting of
results;
•
The laboratory mint maintain a system to ensure reliable specimen
identification, and must"document each step in processing, testing, and
reporting patient specimens to assure accurate test results are reported.
• A legally reproduced record of each test result, including preliminary
reports, must be preserved'by the testing laboratory for a period of at least
two years after the date of reporting.
B. HP/ negative tests prevent wasting limited state resources for partner notification
and avoid unnecessary intrusion into partner's lives.
Examples:
I. If an infected Demon has a prior ive HIV test: A person is found to be
N.ydoua n'..ans 2
positive on November 20, 1991. He had a negative test on September 1, 1991.
• The earliest date of infection would be 6 months prior to August 31, 1991, i.e.
February 28, 1991 (because it may take up to 6 months to seroconvert from
negative to positive after infection). Disease control specialists normally interview
an infected person about his/her sexual and/or needle sharing partners during the
one year prior to the positive test result and then attempt to notify these partners.
In this example, it would not be necessary to notify partners prior to February 28,
1991.
2. If a partner has a negative HIV test: If a partner has a negative HIV test in
October 1991 and last had sex with an infected person in March 1991, there is no
need to notify the partner that s/he had been exposed to HP/.
These examples happen approximately 600 times per year, and having a record of
a negative HIV test conserves $30,000 per year in state expenditures for partner
notification. In addition, the HIV negative test records prevent unnecessary
intrusion and anxiety caused by informing a person they were potentially exposed
to HIV when they were not.
•
C. HIV negative tests may be useful for research purposes. Researchers at Denver
•
Disease Control use HIV negative tests as part of their study to measure the
• incidence of HIV infection. Research on the differences in behavior between FM'
negative and HIV positive persons is important for determining which preven.ic.r
strategies work.
D. Statistical analyses of proportion of persons tested positive by various risk factors
are rcrntial for epidemiologic monitoring of the spread of the H1V epidemic
ar'_
for evaluating use of publicly-funded test sites. Such analyses are performed
•
throughout the United States.
•
•
•
III. Revised CDPHE Policy Concerning HIV Negative Tests
A. Computer and hard copies of HIV negative test records with patient names and risk
' factors held by the CDPHE,with a blood collection date more than two years old
have been destroyed by purging and supervised shredding, respectively.
B. CDPHE computer files of HIV negative test records, dated more than 120 days
after the blood specimen was collected, have been permanently altered to create
two tmlinlable files: the name file and the risk file. The name file contains name,
personal identifiers, locating information, date of birth, demographic information,
provider information, testing history, symptom data, ID number, date
(month/day/year), and test result and posttest information. The risk file contains
demographic information, risk factors, provider information, testing history,
symptom data,date (month/year), and test result and posttest information. See
ec.Daxu,s►swae.r+ 3
Attachment A for detailed data items.
C. On an ongoing basis the computer file of the HIV negative test held by the
CDPHE will have the name unlinked from risk factor information as soon as the
testing site reports whether the person returned for post-test counseling and after
the CDPHE has reviewed the test report for quality assurance of data entry. This
process will take no longer than 120 days after the blood specimen is collected.
Hard copies will be shredded at that time.
D. The CDPHE requires that its Confidential Counseling and Testing Site (CTS)
contractors, i.e., local health department CTS which provide only HIV counseling
and testing services, develop and adhere to an HIV record retention policy. This
policy must be adopted by the local board of health with the opportunity for public
comment and input through an open public forum conducted at least every two
years. Other mechanisms for input into the record retention policy and the need for
an anonymous testing option in that area must be available in addition to the public
forum, including anonymous testimony in writing or through an organization. The
CDPHE recommends, but does not require, that local health departments adopt the
CDPHE HIV record retention policy. Any alternative policy must address the
following areas: 1) linkage of personal identifiers, behavioral risk information and
results; time frames, if any for delinkage, (The CDPHE strongly encourages that
any alternative record retention policy include the delinldng of personal identifying
information from risk information 120 days from the date of testing.), 2) the
availability of anonymous testing, 3) time frames for destruction of records, 4)
method and supervision for destruction of records, 5) approval of record retention
policy by the Colorado State Archivist, 6)procedures for hard (paper) records and
electronic (computer) records, '7) procedures for records of negative results and
positive results and 8) inclusion of record retention information in the client
consent form.
For HIV negative tests performed in tuberculosis, STD, drug treatment facilities,
and other facilities which provide ongoing medical care, the test is considered part
of the medical record of the treating clinic. For HIV negative tests collected at
these locations, the CDPHE will follow the procedures of III A-C, but will not
require the contracting clinic to follow these procedures.
E. The CDPHE revised consent forms advise clients of both contracted CTS and sites
providing ongoing medical care of how HIV negative test records will be handled.
If a CTS chooses to adopt an alternative record retention policy, the consent form
must include information on how records are retained both at the site and at
CDPHE. Alternative consent forms must be approved by CDPHE.
If negative, the al client will be informed that
1. the test results become part of the record kept by the gland how
uryaxu,snwa,.ae,t 4
those records are retained;
2. test results held by the CDPHE:
a. the identifying information will be linked to risk factor
information for no more than 120 days after the blood
specimen collection date;
b. the risk factor and test result information will be used for
statistical purposes without the identifying information
provided by the client; and
c. records consisting of the client's identifying information
and test results will be kept by the CDPHE for two years.
If negative, the client of a contracted site providing ongoing care :
1. the test becomes part of the medical record kept by the clinic,
protected by medical record laws;
2. for test records held by the CDPHE:
a. the identifying information will be linked to risk factor
information for no more than 120 days after the blooc
specimen collection date;
b. the risk factor and test result information will be used for
statistical purposes without the identifying information
provided by the client; and
c. records consisting of the client's identifying information
• and test results will be kept by the CDPHE for two years.
Consent forms must inform all counseling and testing clients that they are
encouraged, but not obligated, to answer questions on the laboratory submission
form regarding demographic and risk factors.
IV. CDPHE Policy Concerning HIV Positive Tests
A: HIV positive test records held by the CDPHE will not be delinked and will be
retained indefinitely. Local health department CTS which provide only HIV
counseling and testing services must develop and adhere to a HIV record retention
policy. See III D above.
B. HIV positive test records held by CDPHE contacted tuberculosis, STD, drug
LWydo auasm u 5
IC • `
treatment facilities, and other facilities which provide ongoing medical care are
protected by medical laws.
C. The CDPHE revised consent forms advise both contracted CTS and sites providing
ongoing care of how positive test records will be handled. If a CTS chooses to
adopt an alternative record retention policy, the consent form must include
information on how records are retained both at the site and at CDPHE.
Alternative consent forms must be approved by CDPHE.
•
LL.reerneec+sm SS 6
Attachment •
Data Items Collected on the HIV 1 Serology Lab Slip
Items retained for specimens with negative results:items retained in each database are indicated by an x. All
data items for specimens testing indeterminate or positive are retained.
Data Items Name File Risk File
Pretest ID Number x
ELISA Results x x
Western Blot Results x x
Date Collected M/D/Yr M/Yr
Pretest Counselor Initials x
Testing History x x
Date Last Test x x
Results Last Test x x
Symptoms of HIV x x
Provider Name x x
Provider Code x x
Provider Address, City, State, Zip x
•
Patient Name x
Patient Address x
Patient City, State, Zip x x
Patient Phone •x
•
Patient DOB x
xr
Patient Age •
x
Patient Race x x
Patient Sex x x
Patient Sex Preference/Orientation x
Number Sex Partners in Last Year x
Greatest Number Sex Partners x
Influence of Drugs/Alcohol x
Type of Sex/Condom Use x
LAeldo aaer+sA+Raa+ 7
Data Items Name File Risk Ale •
Patient Hx Since '78 all items x
Patient Sex Exposure Since '78 all items x
Referral to Specific Agency x x
Posttest Provider Code x x
Posttest ID Number x
Posttest Counselor Initials x
Date of Posttest Counseling x x
Referred to CDH, Date Referred x x
Data item in shaded area no longer collected (effective 4/8/921.
in five-year aggregate
•
• Liontestgaranai 8
ATTACHMENT F
6 CCR-1009-9 effective 6/30/97
STATE OF COLORADO
COLORADO BOARD OF HEALTH
RULES AND REGULATIONS
PERTAINING TO THE REPORTING, PREVENTION, AND CONTROL OF
AIDS, HIV RELATED ILLNESS, AND HIV INFECTION
Colorado has a comprehensive public health AIDS/HIV control law: Colorado Revised Statutes
Title 25, Article 4, Sections 1401 et seq. These regulations are intended to provide detail and
clarification for selected parts of the above cited statute. The statute covers subject matters not included
in these regulations.
C.R.S. 25-4-1405.5 (2) (a) (I) requires the Colorado Department of Public Health and
Environment (CDPHE) to conduct an anonymous counseling and testing program for persons considered
to be at high risk for infection with HIV. The provision of confidential counseling and testing for HIV is
the preferred screening service for detection of HIV infection. Local boards of health who provide lii
counseling and testing through a contractual agreement with the CDPHE must consider the need for an
anonymous HIV testing option in their jurisdiction. The consideration of this option must provide an
opportunity for public comment in a public forum at a minimum of every two years. Other mechanisms
for input into the need for an anonymous testing option in that jurisdiction must be available in addition to
the public forum, including anonymous testimony in writing or through an organization. Local Boards of
Health must document the following: notification of interested parties and the public, time allowed
between notification and the public forum, accessibility in both location and time of the public forum, and
the response to public comment in the decision process. Local boards of health electing to provide
confidential HIV testing with an anonymous option must do so in conjunction with counseling and testing
sites (CTS); i.e., CDPHE designated sites which screen individuals for HIV infection without providing
on-going health care. This will be done through a contractual agreement with the CDPHE. Local boards
of health may elect, at the time of contract renewal,to provide confidential testing with an anonymous
option.
Per C.R.S. 254-1405.5 (2)(a)(II), Regulations 6-8 are the performance standards for
confidential and anonymous HIV CTS and the CDPHE staff.
Regulation 1. Reporting By Physicians, Health Care Providers, Hospitals, And Others
Diagnosed cases of AIDS, HIV-related illness, and HIV infection, regardless of whether
confirmed by laboratory tests, shall be reported to the state or local health department or health agency
within 7 days of diagnosis by physicians, health care providers, hospitals, or any other person providing
1
1^LOMppJN,eya,gNlliA.M
•
•
ATTACHMENT F
treatment to a person with HIV infection. When hospitals and laboratories transmit disease reports
electronically using systems and protocols developed by the department that ensure protection of
confidentiality, such reporting is acceptable and is considered good faith reporting.
All cases are to be reported with the patient's name, date of birth, sex, address (including city
and county), name and address of the reporting physician or agency; and such other information as is
needed to locate the patient for follow-up. For cases reported from a public anonymous testing site as
provided by C.R.S. 25-4-1405.5, the patient's name and address and the name and address of the
reporting physician are not required.
Reports on hospitalized patients may be made part of a report by the hospital as a whole.
Research activities of persons performing clinical research on persons with AIDS, HIV-related
illness, or HIV infection whose research activity:
1. involves the study of HIV treatment or vaccine effectiveness or is basic biomedical
research into the cellular mechanisms causing HIV infection or HIV-related disease;
2. meets the research exemption criteria of C.R.S. 25-4-1402.5(3); and
3. has been approved by the Board of Health pursuant to C.R.S. 25-4-1402.5(2)
shall be exempt from meeting the reporting requirements for AIDS, HIV-related illness, and HIV
infection.
Regulation 2. Reporting by Laboratories
Laboratories shall report every test result that is diagnostic of or highly correlated with or
indicates HIV infection. The report shall include the name, date of birth, sex and address of the
individual from whom the specimen was submitted. Such test results shall be reported by all in-state
laboratories and by out-of-state laboratories that maintain an office or collection facility in Colorado or
arrange for collection of specimens in Colorado. Results must be reported by the laboratory which
performs the test, but an in-state laboratory which sends specimens to an out-of-state referral laboratory
is also responsible for reporting the results. The laboratory shall also report the name and address of the
attending physician and any other person or agency referring such specimen for testing.
When accnciated with other clinical or laboratory evidence of HIV infection, the Board of Health
defines a CD4 test result of either CD4 count <500 mm'or CD4% <29% as a primary immunologic
measure indicating severe HIV infection and, when the count is <200 mm', as defining AIDS.
Laboratories shall report CD4 counts <500 mm'OR CD4% <29%. The Department shall destroy
personal identifying information on all persons with CD4 results in the reportable range if investigation
subsequent to the report finds no evidence of HP/infection. Laboratories may fulfill the requirement to
report CD4 counts <500 nun'or CD4%<29% by allowing authorized personnel of the Department of
Public Health and Environment an-nc to such records.
tKamoai..rcr.a.ox..ti«, 2
C
ATTACHMENT F
Laboratories shall follow the same procedures for reporting as are required of other reporting
sources in Regulation 1.
Report of test results by a laboratory does not relieve the attending physician of his/her
obligation to report the case or diagnosis, nor does report by the physician relieve the laboratory of its
obligation.
Regulation 3. Information Sharing
Information concerning cases of AIDS, HIV-related illness, or HIV infection shall be shared
between the appropriate local health department or health agency and the state health department, as
provided by C.R.S. 254-1404 (1)(B), and in a timely manner, usually within the timeframe for reporting
in Regulation 1.
These requirements shall not apply if the state and local health agencies mutually agree not to
share information on reported cases.
Regulation 4. Confidentiality
All public health reports and records held by the state or local health department in complia^
with these regulations shall be confidential information subject to C.R.S. 254-1404. The public health
reports and records referred to in C.R.S. 25-4-1404 shall include, but not be limited to, the forms and
records designated by the CDPHE for institutions and agencies which screen individuals for HIV
infection without providing ongoing health care, such as a public HIV counseling and testing site.
Reasonable efforts shall be made by the department to consult with the attending physician or
medical facility caring for the patient prior to any further follow-up by state or local health departments
or health agencies.
Regulation 5. Investigations To Confirm The Diagnosis And Source Of HIV Infection And
To Prevent HIV Transmission
It is the duty of state and local health officers to conduct investigations to confirm the diagnosis and
sources of HP/infection and to prevent transmission of HIV. Such investigations shall be considered
official duties of the health department or health agency. Such investigations may include,but are not
limited to:
1. review of pertinent, relevant medical records by authorized personnel if necessary to
confirm the diagnosis, to investigate possible sources of infection, to determine objects and
materials potentially contaminated with HIV and persons potentially exposed to HIV. Such
3
ATTACHMENT F
review of records may occur without patient consent and shall be conducted at reasonable
times and with such notice as is reasonable under the circumstances;
2. performing follow-up interview(s) with the case or persons knowledgeable about the case to
collect pertinent and relevant information about the sources of HIV infection, materials and
objects potentially contaminated with HIV, and persons who may have been exposed to
HIV.
Regulation 6. Objective Standards
A. Training
1. All persons providing HIV pre and posttest prevention and risk-reduction
counseling at a CTS will have completed the HIV Serologic Test Counseling course
or an equivalent of not less than 16 hours of training, approved by the CDPHE
STD/AIDS Program.
2. All persons providing HIV pre and posttest prevention and risk-reduction
counseling at a CTS will have a minimum of 8 hours of relevant HIV/STD or
allied health services continuing education annually, approved by the CDPHE
STD/AIDS Program.
3. All persons performing partner notification interviews will have completed courses
concerning introduction to sexually transmitted disease interviewing and partner
notification, as specified by the CDPHE.
B. Notification of Results
1. Of all HIV tests performed at a CTS, 90% of those persons testing HIV positive
will receive results and posttest risk-reduction counseling.
2. Of all HIV tests performed at a CTS, 80% of those persons testing HIV negative
will receive results and posttest prevention and risk-reduction counseling.
C. Partner Notification
If CDPHE staff provide partner notification for a CTS, then the following standards do not
apply to the CTS.
1. Of the 90% of HIV positive individuals receiving results and posttest counseling,
100% will be assigned for partner notification interview. A minimum of 75% of
those assigned for a partner notification interview will receive an interview.
Agencies providing partner notification services (CDPHE and local health
departments)will have a partner index(defined as the number of unsafe partners
identified for whom identifying information was sufficient to initiate notification,
divided by the number of interviewed HIV positive persons with unsafe behavior in
the past year)of 0.8. Effective January 1, 1995, the acceptable partner index will
ATTACHMENT F
be 1.0. Documentation of this activity will be provided to the CDPHE through use
of a CDPHE specified form.
A contact is defined as a person named by an infected person as having been an
unsafe sex partner/needle share partner of that infected person. If sufficient
locating information (name, age, sex, phone number, recent address, work address)
is obtained to conduct an investigation, such a contact is defined as an initiated
contact.
2. Of all in-state initiated contacts, 60% must be located and offered HIV prevention
and risk-reduction counseling and/or testing as documented by the results of the
investigation on the CDPHE specified form. Documentation of investigation
outcomes will include disposition codes as specified by the CDPHE, dates and
location of counseling, and dates and location of testing (if done).
Regulation 7. Operational Standards
A. Counseling
1. All counselors at a CTS performing HIV pretest prevention and risk-reduction
counseling will: a)conduct a risk assessment, b)discuss and develop a risk-
reduction plan, i.e., identify with the client specific behaviors that can❑,: istically
be changed to reduce risk, c) fully and legibly complete for each person tested the
HIV 1 Serology lab slip.
2. All counselors at a CTS performing HIV posttest prevention and risk-reduction
counseling will: a) inform clients in person of test results, b) explain the
significance of both positive and negative test results, c)discuss and/or modify the
risk-reduction plan, d) refer clients who test positive for follow-up medical and
counseling services.
B. Consent Form
1. A consent form specified by the CDPHE or an approved equivalent must be used at
all CTS.
C. Testing Parameters
1. CTS will not provide anonymous testing to any person 12 years of age or younger.
2. If a counselor judges that a client is unable to understand either counseling or the
testing process, e.g., because the client is under the influence of drugs or alcohol,
the counselor may defer testing.
D. Written Results
5
11CalI4UY W O�aMMH I W 1.M
ATTACHMENT F
1. CTS may only provide written results to persons testing confidentially. To receive
written results, the CTS must be presented with photo identification from the
person requesting written results at the time of posttest.
2. Contracting agencies may not give written results to any person testing
anonymously.
E. Confidentiality and Record Maintenance
1. Contracting agencies must have and adhere to an HIV record retention policy.
Any record retention policy must be adopted by the local board of health with the
opportunity for public comment and input through an open public forum conducted
at least every two years. Other mechanisms for input into the record retention
policy must be available in addition to the public forum, including anonymous
testimony in writing or through an organization.
Any policy must address the following areas:
a) linkage of personal identifiers, behavioral risk information and results;
time frames, if any for delinkage, (The CDPHE encourages that any
record retention policy include the delinking of identifying information
from risk information 120 days from the date of testing.),
b) the availability of anonymous testing,
c) time frames for destruction of records,
d) method and supervision for destruction of records,
e) approval of record retention policy by the Colorado State Archivist,
f) procedures for hard(paper) records and electronic(computer) records,
g) procedures for records of negative results and positive results
h) inclusion of record retention information in the client consent form
2. Per C.R.S. 254-1404.5 (2) (a)(II), a person may provide personal identifying
information after counseling, if the person volunteers to do so. Contracting
agencies must document this information when volunteered, and provide this
information to the CDPHE on the posttest reimbursement form submitted to the
CDPHE within 30 days of the date the blood specimen was collected.
Regulation 8. Evaluation Standards and Penalties
A. Each CTS's compliance with these standards will be evaluated by the following:
1. A semi-annual analysis by the CDPHE staff of the number of persons receiving
HIV antibody testing and the proportion of persons testing receiving results per
contracted agency.
2. A minimum of one on-site observation conducted annually by the CDPHE staff.
1. Cali..____OH....», 6
ATTACHMENT F
This on-site observation will include observation of counselors at each CTS
performing HIV pre and posttest prevention and risk-reduction counseling.
3. A semi-annual analysis of testing trends (anonymous vs. confidential) conducted by
CDPHE staff.
4. A semi-annual review of counseling and partner notification forms for completion
and accuracy conducted by CDPHE staff.
5. A minimum of one annual audit of charts for all contracting agencies, conducted by
CDPHE staff.
6. Accuracy and completion of the posttest counseling reimbursement form submitted
to the CDPHE.
B. Failure of a CTS to comply with and meet these standards may result in one or more of the
following action(s):
1. The CTS may meet with the CDPHE to develop a plan for improving performance
in specified areas.
2. The CTS may be given a probationary period to comply and meet the standards.
3. The CTS may be reevaluated by the end of the probationary period.
4. Failure to meet and comply with the standards may result in contract termination.
7
ATTACHMENT G
Chapter 2
Competence Regarding Culture, Disability and Other Diversity
Three separate decision items have been passed by Coloradans Working Together that promote
competence/proficiency in regard to culture and other diversity. The first decision item deals specifically
with culture and communities of color; the second deals with disability status; the third deals with other
diversity issues(age, gender, substance use, socioeconomic status, sexual orientation, linguistics,
disabilities, and geographic settings including migrant, seasonal or resort workers).
CWT Decision Item regarding cultural competence/proficiency
Organizations must adhere to and demonstrate a philosophy of cultural competence and proficiency as
characterized by acceptance of and respect for difference,continuing self-assessment regarding culture,
careful attention to the dynamics of difference,continuous expansion of cultural knowledge and resources,
and adaptations of service models in order to better meet the needs of communities of color. These agencies
provide support for staff to become comfortable working in cross-cultural situations. Further,culturally
competent agencies understand the interplay between policy and practice,are committed to policies that
enhance services to diverse clientele and to move the agency to a position of cultural proficiency.
Culturally proficient agencies are characterized by holdmg culture in high esteem and seek to add to the
knowledge base of culturally-competent practice by including but not limited to such areas as research,
developing new therapeutic approaches based on culture,and publishing and disseminating the results of
demonstration projects. Attitudes,policies,and practices are the three major areas wherein development
can and must occur if agencies are to move toward cultural proficiency.
CWT Decision Item regarding people with disabilities,who are deaf,or hard-of-hearing
All CDPHE funded HIV prevention contractors should adhere to the following:
1) Each funded organization should develop a written access plan for people with disabilities(other than
AIDS-defined disabilities)based on the services they will be providing. For example an agency would
have a reasonable plan for accommodating people who use wheelchairs,qualified interpreters would be
provided upon request,etc. with
2) The organization should collaborate with other agencies whose primary mission is to serve people
disabilities(other than AIDS-defined disabilities),which might include obtaining necessary
training/technical assistance/consultation. with
3) Agencies are encouraged to recruit and hire a culturally diverse work force including people
disabilities.
•
CWT Decision Item regarding diversity
CWT has addressed the issue of providing competent/proficient services to communities of color. We have
addressed the issue of access and respectful services to the deaf/hard-of-hearing and disabled communities.
These issues are essential for effective my prevention programs. With this decision item we acknowledge
Definition for HIV Prevention Interventions&Standards of Practice-page 4
•
yet a third component necessary to provide comprehensive effective.programming. It is incumbent upon
organizations providing HIV prevention service to demonstrate this competency/proficiency in addressing
the diverse needs of the populations they serve in terms of age,gender,substance use,socioeconomic status,
sexual orientation, linguistics,disabilities,and geographic settings including migrant,seasonal or resort
workers.These Agencies acknowledge that such a philosophy will be evident in their attitudes,policies, and
practices, and that such competency/proficiency is necessary to provide effective, respectful/service to their
clientele.
Assessment of competence regarding culture and other diversity
• To make meaningful progress in achieving the types of competence and proficiency voiced in these decision
items, providers of HIV prevention service will be systematically assessed. Through the assessment,
providers will become more aware of the strengths of their current programs and areas in need of
strengthening. Capacity building activities will be directed to building on these strengths and making
progress in areas needing attention. Key areas to be assessed are:
a. Client demographics
b. Background of agency staff and management
c. Involvement of target populations in developing and implementing policies and procedures
d. HIV program language capacity
e. Training and other capacity building activities
• f. Efforts to assess and improve programs
g. Challenges faced in doing HIV prevention work
1 Definitions for HIV Prevention Interventions&Standards of Practice-pope 6
Attachment H
[Date] Sample Task Order Change Order Letter
State Fiscal Year 2000-2001,Task Order Change Order Letter Number**,Contract Routing Number*******
Pursuant to Part F.3.of the Master Contract with contract routing number******* and paragraph ** of the Task
Order with contract routing number**-***** and contract encumbrance number***********,(as amended by
Task Order Renewal Letter**,contract routing number**-*****,and/or Task Order Change Order Letter**,
contract routing number **-*****, if any),hereinafter referred to as the"Original Task Order"(a copy of which is
attached hereto and by this reference incorporated herein and made a part hereof)between the State of Colorado,
Department of Public Health and Environment and Contractor's Legal Name, for the term from ********* **
****,through********* **.**** the parties agree that the maximum amount payable by the State for the eligible
services referenced in paragraph** of the Original Task Order is increased/decreased by dollar amount
DOLLARS,($*.**)for a new total financial obligation of the State of dollar amount DOLLARS,( *). The
revised Scope of Work,which is attached hereto as"Attachment I",and the revised budget,which is attached
hereto as "Attachment 2",are incorporated herein by this reference and made a part hereof. The first sentence in
paragraph**of the Original Task Order is hereby modified accordingly. All other terms and conditions of the
Original Task Order are hereby reaffirmed. This amendment to the Original Task Order is intended to be effective
as of********* ** **** However, in no event shall this amendment be deemed valid until it shall have been
approved by the State Controller or such assistant as he may designate.
Please sign,date,and return all ** originals of this Task Order Change Order Letter by********* **,****,to the
attention of: Lisa Ellis,Colorado Department of Public Health and Environment,4300 Cherry Creek Drive
South,Denver,Colorado 80246, Mail Code: DCEED-A3. One original of this Task Order Change Order Letter
will be returned to you when fully approved.
Contractor's Legal Name STATE OF COLORADO
(legal type of entity) Bill Owens,Governor
By: By:
For the Executive Director
Print Name: DEPARTMENT OF PUBLIC HEALTH
AND ENVIRONMENT
Title:
FEIN:
APPROVALS:
FOR THE STATE CONTROLLER PROGRAM:
Arthur L.Barnhart,State Controller
By: By:
Eric Schleiger,Fiscal Officer
Attachment I
[Date] Sample Task Order Renewal Letter
State Fiscal Year 19** -"*,
Task Order Renewal Letter Number**, Contract Routing Number**-*****
Pursuant to Part F.5. of the Master Contract with contract routing number******* and paragraph** of the Task Order with
** ***** ***********,(as amended by Task Order Change
contract routing number - and contract encumbrance number ** *******
Order Letter**,contract routing number**-*****,and/or Task Order Renewal Letter ,contract routing number ,
if any),hereinafter referred to as the"Original Task Order"(a copy of which is attached hereto and by this reference
incorporated herein and made a part hereof)between the State of Colorado, Department of Public Health and Environment
and Contractor's Legal Name,for the renewal term from ********* **•****,through ********* **•****,the parties
agree that the maximum amount payable by the State for the eligible services referenced in paragraph** of the Original Task
Order is increased/decreased by dollar amount DOLLARS,($*.**)for a new total financial obligation of the State of dollar
amount DOLLARS, (S*.**). The Scope of Work,which is attached hereto as"Attachment 1",and the budget,which is
attached hereto as"Attachment 2",are incorporated herein by this reference and made a part hereof. The first sentence in
paragraph** of the Original Task Order is hereby modified accordingly. All other terms and conditions of the Original Task
Order are hereby reaffirmed. This amendment to the Original Task Order is intended to be effective as of********* **
****. However,in no event shall this amendment he deemed valid until it shall have been approved by the State Controller or
such assistant as he may designate.
Please sign,date, and return all** originals of this Task Order Renewal Letter by********* **•****,to the attention of:
************ ************,Colorado Department of Public Health and Environment,4300 Cherry Creek Drive
South,Denver,Colorado 80246,Mail Code: *****-**. One original of this Task Order Letter will be returned to you when
fully approved.
Contractor's Legal Name STATE OF COLORADO
(legal type of entity) Bill Owens,Governor
By: By:
For the Executive Director
Print Name: DEPARTMENT OF PUBLIC HEALTH
AND ENVIRONMENT
Title:
FEIN:
APPROVALS:
FOR THE STATE CONTROLLER: PROGRAM:
Arthur L.Barnhart, State Controller
By: By:
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