HomeMy WebLinkAbout980091.tiff RESOLUTION
RE: APPROVE CONTRACT FOR HIV COUNSELING AND TESTING SERVICES 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 Contract for HIV Counseling and
Testing Services between the County of Weld, State of Colorado, by and through the Board of
County Commissioners of Weld County, on behalf of the Health Department, and the Colorado
Department of Public Health and Environment, commencing January 1, 1998, and ending
December 31, 1998, with further terms and conditions being as stated in said contract, and
WHEREAS, after review, the Board deems it advisable to approve said contract, 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 Contract for HIV Counseling and Testing Services between the
County of Weld, State of Colorado, by and through the Board of County Commissioners of
Weld County, on behalf of the Health Department, 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 contract.
The above and foregoing Resolution was, on motion duly made and seconded, adopted
by the following vote on the 21st day of January, A.D., 1998, nunc pro tunc January 1, 1998.
BOARD OF COUNTY COMMISSIONERS
WELD COUNTY, COLORADO
ATTEST:
.„ Constance L. Ha§bert, Chair
Weld Co Jet i `.0 r�, tUJdi2
�f
W. W bster, Pro-Ten
ey
BY:
Deputy s ll� wf! t e re
George E."Baxter
APP D AS T ORM: EXCUSED
Dale2( HGGall
q' 44iL
Barbara J. Kirkmeyer III
980091
CSC //G53[ HL0024
DEPARTMENT OR AGENCY NUMBER
FHA
CONTRACT ROUTING NUMBER
9807870
CONTRACT
THIS CONTRACT,made this_1st-day of January, 1998,by and between the State of Colorado for the use
and benefit of the Department of Public Health and Environment,4300 Cherry Creek Drive South,Denver,
Colorado 80222-1530 hereinafter referred to as the State, and Weld County Health Department. 1517 16th
Avenue Court Greeley CO 80631 hereinafter referred to as the contractor.
WHEREAS,authority exists in the Law and Funds have been budgeted,appropriated and otherwise
made available and a sufficient unencumbered balance thereof remains available for payment in Fund
Number 100 , APPR code 365 , Contract Encumbrance Number FHA 5OD9807870; and
WHEREAS, the State has formulated comprehensive plans relative to the statewide control of
Sexually Transmitted Disease (STD) and Human Immunodeficiency Virus (HIV) Infection; and
WHEREAS, in order to implement said comprehensive plan, the State has established provisions
by which to provide supplementary support to various local health departments and community based
service organizations; and
WHEREAS,theColoradoGeneralAssemblyhasrecognizedtheprovisionofconfidentialcounseling
and testing services as the preferred screening service for the detection of HIV infection; and
WHEREAS, the State has established an anonymous counseling and testing program at select
contracted local county health departments' Counseling and Testing Sites(CTS)for persons considered
to be at high risk for HIV infection; and
WHEREAS, the Contractor has chosen to provide confidential counseling and testing services for
antibody to HIV.
WHEREAS,the Contractor,a County Health Department(CHD), is considered by the State to be an
appropriate agency to provide the services as herein set forth,
NOW THEREFORE, it is hereby agreed that for and in consideration of their mutual promises to each other,
hereinafter stated, the parties hereto agree as follows:
1. The Contractor agrees to provide HIV risk-reduction counseling and antibody testing services
according to the terms outlined in this contract;
Page I of 10 Pages
980091
a. Funds will support two basic types of testing programs; Provider Initiated testing and
Patient Initiated testing. Provider Initiated testing will consist of testing at facilities that
provide routine risk assessment and ongoing medical care (family planning (FP) clinics, sexually
transmitted disease(STD)clinics, substance abuse treatment centers (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 agrees that counseling and testing services for each individual will include the
following: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) drawing blood sample for laboratory processing, e)
transportation of blood to laboratory, f) informing clients of test results, g) explaining the
significance of both positive and negative test results to the client, h) making every effort to ensure
that all clients who test HIV antibody positive receive posttest counseling, i) referring clients who
test positive for follow-up medical and counseling services as appropriate, j) referring clients who
test negative and are engaging in high risk behaviors for follow-up counseling services as appropriate,
k)ensuring that those positive clients who do not return for results are referred to the CDPHE Disease
Intervention Specialists for posttest counseling and sex and needle-share partner referral;
a. The Contractor agrees that screening services for each individual will include the
following:a)the administration of Colorado Department of Public Health and Environment(CDPHE)
specified informed consent forms (samples attached and by this reference made part hereof as
Attachments A and B, respectively), or approved equivalent, b) a client-centered risk
assessment, c) drawing blood sample for laboratory processing, d) transportation of blood to
laboratory, e) informing clients of test results, 0 making every effort to ensure that all
clients who test HIV antibody positive receive posttest counseling, g) ensuring that those
positive clients who do not return for results or are lost for follow-up are referred to the
CDPHE, and h) ensuring that all positive clients are referred to CDPHE Disease Control
Specialists for sex and needle-share partner referral.
3. The Contractor further agrees that this contract amount will be based on client risk.
"High/increased risk" clients have a history since 1978 of one or more of the following: 1) injection
drug use,2)sex with a person with HIV/Acquired Immune Deficiency Syndrome(AIDS),3)sex with a man who
has sex with men,4)sex with an injection drug user, 5)an STD, 6)receiving money or drugs for sex. All
other persons would be considered low/no risk;
4. The Contractor agrees to 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"(sample attached and by this
reference made part hereof as Attachment C and D, respectively).
Pagc 2 of 10 Pages
980091
5. Contractors may (but are 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 CDPHE as
sex/needle-share partners of HIV infected persons or persons who are at high/increased risk for HIV
infection, as described in paragraph three of this contract, will not be denied services because of
inability to pay;
6. 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 continuing education course;
a. Any counselor providing HD/screening services through the FP clinic or SATC only is not
required to attend the training outlined in paragraph six of this contract.
b. Any counselor providing HIV posttest counseling must have successfully completed the
training outlined in paragraph six of this contract.
7. The Contractor agrees to maintain internal medical and administrative records (labslips,
counseling session notes) in a manner which ensures confidentiality and security and is consistent with
procedures for clinical services;
8. Contractors shall designate an HIV Counseling and Testing Coordinator and provide the name of
this person,to the State within thirty 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;
9. All counselors providing counseling and testing will be evaluated annually by the HIV
Coordinator,his/her designee, State staff and/or their designee. This evaluation will include counselor
observation or role-play of a counseling session, depending on clinic staffing at the time of the
scheduled evaluation. The evaluation tool will be provided by the State prior to the scheduled
evaluation. Copies of completed evaluations conducted by parties other than the State will be submitted
to the State for review ;
10. The Contractor agrees to an annual collaborative agency review conducted by the State and a
member of a Peer Evaluation Team if possible.The Peer Evaluation Team is comprised of the State contract
contact person and one or more members from other contracted agencies. This review can include:
counselor observations, chart reviews, a review of testing data and individual interviews with the HIV
Counseling and Testing Coordinator and/or line-staff counselors.
Page 3 of 10 Pages
980091
a. The Contractor agrees meet with the State following the annual evaluation to develop a
quality improvement action plan. The terms of this plan will be determined at that time
by the Contractor and the State;
11. The Contractor agrees to fully and legibly complete the HIV 1 Serology lab slip for each person
tested. 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
12. The Contractor further agrees, for each client posttest counseled, to 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;
13. The State shall provide free laboratory services for all persons accepting HIV antibody testing
through the CTS and those clients through FP and Si]) who report having participated in high/increased
risk behavior as defined in paragraph three of this contract;
14. The Contractor agrees that the contract amount for testing services will be based on testing
volume at this agency during the previous year and the following budgetary criteria;
a. Pretest counseling for all persons with higb/increased risk accepting HIV antibody
testing at the CTS, at twenty dollars ($20.00) per client.
b. Pretest counseling for all persons with bigh/increased risk accepting HIV antibody
testing at the STD Clinic at sixteen dollars ($16.00) per client.
c. Posttest counseling for all persons with high/increased risk accepting HIV antibody
testing at the CTS or STD Clinic, at six dollars ($6.00) per client.
d. HIV screening sessions for all persons with high/increased risk accepting HIV antibody
testing at the family planning clinic or SATC, at ten dollars ($10.00) per client.
e. Posttest counseling for all persons testing HIV antibody positive at the family
planning clinic or SATC at seventeen dollars ($17.00) per client.
f. Second posttest counseling for all persons testing HIV antibody positive at the family
Page 4 of 10 Pages
380091
planning clinic, CTS, STD Clinic, or SATC, at twenty dollars ($20.00) per client.
15. The State will, in consideration of all services outlined in this contract, cause to be paid to
the Contractor a sum not to exceed Two Thousand Eight Hundred Ten Dollars($2.810.00)for the period
beginning January 1, 1998, and continuing through December 31, 1998, subject to change based upon
differences between estimated and actual funding appropriations and legislative approval, and
conditioned upon affirmation by the State that services were rendered in accordance with this contract
as follows:
a. The State will provide via facsimile quarterly statements by the eleventh working day
of the end of the quarter for which reimbursement is to be provided. The four quarterly
statements will be: 1) the reimbursement report which states the number of pretest and posttest
counseling sessions, 2) a return rate report, 3) a referral rates report, and 4) a hierarchical
risk report. All reports will reflect activity for that quarter. The Contractor will have 21
days following receipt of these statements in which to review and verify these statements by
signing and returning the reimbursement report or inform the State of any discrepancies.
Failure to notify the State of any discrepancies or to return the signed reimbursement report
within 21 days following receipt of the statement may result in a forfeit of reimbursement
eligibility for that quarter;
b. The awarded dollar amount of this contract is based on the average performance of twenty
eight(28)high/increased HIV tests per calendar quarter(every 3 mos). If testing volume falls
20% below this average and it appears that funds will not be utilized for HIV testing services,
the Contractor agrees that they may be subject to a corresponding reduction in the contract
amount based on the reduction in testing;
16. The following budget shall govern the expenditure of funds by the Contractor, as well as
subsequent reimbursement by the State:
a. Reimbursement will be made in four equal payments of Seven Hundred Two Dollars and
Fifty Cents ($702.50) minus laboratory processing fees described in part(b)below for
the FP and STD clients and following receipt of the verified quarterly statements
described in paragraph 15 (a) of this contract.
b. The State shall reduce quarterly reimbursement rates by a rate not to exceed five dollars
($5.00) for each individual testing through the FP and STD clinic who does not report
having participated in high/increased risk behavior (no/low risk client) as defined in
paragraph three of this contract. The total amount of the reduction will be transferred
to the State Laboratory to cover the laboratory processing services for no/low risk
clients;
c. The contractor may choose to charge clients as outlined in paragraph five of this
contract.
Page 5 of 10 Pages
980091
17. Changes in total reimbursement amounts for above named services in consideration of increased
or decreased levels of utilization in the original contract due to conditions described in paragraph 15
(b)or other reasons deemed appropriate by the State shall be made by a mutually signed Change Order
Letter approved by the State Controller or his designee in the form attached hereto as Attachment E,
subject to the following conditions:
a. Identification of contract by contract number and number of affected paragraph;
b. Amount of increase or decrease in funding and amount of change in number of clients
served;
c. Intended effective date of funding change;
d. Authorized signatures of the Contractor, the Program, the Health Department and the
State Controller or an approved designee. It is understood that no change except funding
amounts and the resulting change in client numbers,may be made through the Change Order
Letter. Any other changes will be made by an amendment to this contract;
e. A provision stating that the change shall not be deemed valid until approved by the State
Controller or such assistant as he may designate. Upon proper execution and approval,
such Letter shall become an amendment to this Contract and, except for the General and
Special Provisions in the Contract, the Letter shall supersede the Contract in the event
of a conflict between the two.
18. The State and Contractor agree that additional funds may be awarded to expand or extend
activities. Should such funds become available, they will be awarded by an amendment to this contract;
19. The term of this contract is beginning January 1, 1998, and continuing through December 31,
1998.
Page 6 of 10 Pages
980091
COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT-hereinafter,under the General Contract Provisions,
referred to as"CDPHE".
GENERAL CONTRACT PROVISIONS--page 1 of 2 pages
I. THE CONTRACTOR SHALL PERFORM ITS DUTIES HEREUNDER AS AN INDEPENDENT CONTRACTOR AND
NOT AS AN EMPLOYEE. NEITHER THE CONTRACTOR NOR ANY AGENT OR EMPLOYEE OF THE CONTRACTOR
SHALL BE OR SHALL BE DEEMED TO BE AN AGENT OR EMPLOYEE OF THE STATE. CONTRACTOR SHALL PAY
WHEN DUE ALL REQUIRED EMPLOYMENT TAXES AND INCOME TAX AND LOCAL HEAD TAX ON ANY MONIES
PAID PURSUANT TO THIS CONTRACT. CONTRACTOR ACKNOWLEDGES THAT THE CONTRACTOR AND ITS
EMPLOYEES ARE NOT ENTITLED TO UNEMPLOYMENT INSURANCE BENEFITS UNLESS THE CONTRACTOR OR
A THIRD PARTY PROVIDES SUCH COVERAGE AND THAT THE STATE DOES NOT PAY FOR OR OTHERWISE
PROVIDE SUCH COVERAGE. CONTRACTOR SHALL HAVE NO AUTHORIZATION,EXPRESS OR IMPLIED,TO BIND
THE STATE TO ANY AGREEMENTS,LIABILITY,OR UNDERSTANDING EXCEPT AS EXPRESSLY SET FORTH HEREIN.
CONTRACTOR SHALL PROVIDE AND KEEP IN FORCE WORKERS'COMPENSATION(AND SHOW PROOF OF SUCH
INSURANCE)AND UNEMPLOYMENT COMPENSATION INSURANCE INAMOUNTS REQUIRED BY LAW,AND SHALL
BE SOLELY RESPONSIBLE FOR THE ACTS OF THE CONTRACTOR,ITS EMPLOYEES AND AGENTS.
2. Contractor authorizes CDPHE, or its agents, to perform audits and to make inspections for the purpose of evaluating
performance under this contract
3. Either party shall have the right to terminate this agreement by giving the other party thirty days notice by registered mail,
return receipt requested If notice is so given,this agreement shall terminate on the expiration of the thirty days,and the liability of
the parties hereunder for the further performance of the terms of this agreement shall thereupon cease,but the parties shall not be
relieved of the duty to perform their obligations up to the date of termination.
4. This agreement is intended as the complete integration of all understandings between the parties. No prior or
contemporaneous addition,deletion,or other amendment hereto shall have any force or effect whatsoever,unless embodied herein
in writing. No subsequent novation,renewal, addition,deletion,or other amendment hereto shall have any force or effect unless
embodied in a written contract executed and approved pursuant to the State Fiscal Rules.
5. If this contract involves the expenditure of federal funds,this contract is contingent upon continued availability of federal funds
for payment pursuant to the terms of this agreement Contractor also agrees to fulfill the requirements of:
a) Office of Management and Budget Circulars A-87,A-21 or A-122,and A-102 or A-110,whichever is applicable;
b) the Hatch Act(5 U.S.C.1501-1508)and Public Law 95-454 Section 4728. These statutes state that federal funds cannot
be used for partisan political purposes of any kind by any person or organization involved in the administration of federally-assisted
programs;
c) the Davis-Bacon Act(40 Stat 1494,Mar. 3, 1921, Chap. 411,40 U.S.C. 276A-276A-5). This act requires that all
laborers and mechanics employed by contractors or sub-contractors to work on construction projects financed by federal assistance
must be paid wages not less than those established for the locality of the project by the Secretary of Labor,
d) 42 U.S.C.6101 et seq,42 U.S.C.2000d,29 U.S.C.794. These acts require that no person shall,on the grounds of race,
color,national origin,age,or handicap,be excluded from participation in or be subjected to discrimination in any program or activity
funded,in whole or in part,by federal funds;
Page 7 of 10 Pages
Rev.05/07/97(GEN)
980091
GENERAL CONTRACT PROVISIONS--Page 2 of 2 pages
e) the Americans with Disabilities Act(Public Law 101-336;42 U.S.C. 12101, 12102, 12111 - 12117, 12131 - 12134,
12141 - 12150, 12161 - 12165, 12181 - 12159, 12201 - 12213 and 47 U.S.C. 225 and 47 U.S.C. 611;
f) if the contractor is acquiring real property and displacing households or businesses in the performance of this contract,the
contractor is in compliance with the Uniform Relocation Assistance and Real Property Acquisition Policies Act,as amended(Public
Law 91-646,as amended and Public Law 100-17, 101 Stat.246-256);and
g) when applicable,the contractor is in compliance with the provisions of the"Uniform Administrative Requirements for
Grants and Cooperative Agreements to State and Local Governments"(Common Rule).
6. By signing and submitting this contract the contractor states that:
a) the contractor is in compliance with the requirements of the Drug-Free Workplace Act(Public Law 100-690 Tide V,
Subtitle D,41 U.S.C.701 et seq.);
b) the contractor is not presently debarred,suspended,proposed for debarment,declared ineligible,or voluntarily excluded
from covered transactions by any federal department or agency.
7. To be considered for payment,billings for payment pursuant to this contract must be received within 60 days after the period
for which payment is being requested and final billings on the contract must be received by CDPHE within 60 days after the end of
the contract term.
8. If applicable,J(rat Match is to be submitted on the monthly payment statements,in the column provided,as required by the
funding source.
9. If contractor receives federal funds in an aggregate amount per year from CDPHE which exceeds the applicable threshold
dollar amount specified in the Office of Management and Budget Circulars A-128 or A-133,contractor agrees to have an annual audit,
by an independent certified public accountant,which meets the requirements of Office of Management and Budget Circular A-128
or A-133,whichever applies.If contractor is required to submit an annual indirect cost proposal to CDPHE for review and approval,
contractor's auditor will audit the proposal in accordance with the requirements of OMB Circular A-87,A-21 or A-122. Contractor
agrees to furnish one copy of the audit reports to the CDPHE Department Accounting Office within 30 days of their issuance,but not
later than nine months after the end of contractor's fiscal year.Contractor agrees to take appropriate corrective action within six months
of the report's issuance in instances of noncompliance with federal laws and regulations. Contractor agrees to permit CDPHE or its
agents to have access to its records and financial statements as necessary, and further agrees to retain such records and financial
statements fora period of three years after the date of issuance of the audit report This contract(DOES/DOES NOT)contain federal
funds as of the date it is signed This requirement is in addition to any other audit requirements contained in other paragraphs within
this contract
10. Contractor agrees to not use federal funds to caticify federal cost sharing and matching requirements unless approved in writing
by the appropriate federal agency.
Page 8 of 10 Pages
Rev.05/07/97 (GEN)
380091
in accordance therewith,sod such other sanctions as may be imposed and remedies as may be invoked as provided in Executive Order,Equal Opportunity and
Affirmative Action of April 16,1975,or by rules,regulations,or orders promulgated in accordance therewith,or as otherwise provided by law.less(h)The contractor will include the provisions of paragraphs(a)through)in
every
sub-contract
Action d subcontractorf t 7 so purchase et order
provisions exemptedwill be binding
regulations,or orders issued pursuant to Executive Order,Equal Opportunity
upon each subcontractor or vendor. The contractor will take such action with respect to any
ing or purchase
the event rd the r becomes agency
may
direct as a means of enforcing such provisions,including sanctions for non-compliance;provided, the State
in,or is threatened with,litigation,with the subcontractor or vendor as a result of such direction by the contracting agency,the contractor may request
of Colorado to enter into such litigation to protect the interest of the State of Colorado.
COLORADO LABOR PREFERENCE
6a. Provisions of CRS 8-17-101&102 for prefrece of Colorado labor are applicable to this contract if public works within the State are undertaken hereunder
and are financed in whole or in part by State funds.
b. When a construction contract for a public project is to be awarded to a bidder,a resident bidder shall be allowed a preference against a non-resident bidder
from a state or foreign county equal to the preference given or required by the state or foreign country in which the non-resident bidder is a resident If it is
determined by the officer responsible for awarding the bid that compliance with the subsection.06 may cause denial of federal funds which would otherwise
be available or would otherwise be inconsistent with requirements of Federal law,this subsection shall be suspended but only to the extent nrwaary to prevent
denial of the moneys or to eliminate the inconsistency with Federal requirements(CRS 8-19-101 and 102).
GENERAL
7. The laws of the State of Colorado and rules and regulations issued pursuant thereto shall be applied in the interpretation,execution,and enforcement ofthn is
contract Any provision of this contract whether or not incorporated herein by reference which provides for arbitration by any extra-judicial body or peed herein
o
which is otherwise is conflict with said laws,rules,and regulations shall be considered null and void. Nothing contained in any provision
by reference which purports to negate this or any other special provision in whole or in part shall be valid or enforceable or available in any action at law whether
by way of complaint defense,or otherwise. Any provision rendered null and void by the operation of this provision will not invalidate the remainder of this
contract to the extent that the contract is capable of execution.
8. At all times during the performance of this contract the Contractor shall strictly adhere to all applicable federal and state laws,rules,and regulations that
have been or may hereafter be established.
9. Pursuant to CRS 24-30-202A(as amended),the state controller may withhold debts owed to state agencies under the vendor offset intercept system for(a)
unpaid child support debt of child support arrearages;(b)unpaid balance of tax,accrued interest,or other charges specified in Article 22,Title 39,CRS;(c)
unpaid loans due a the student loan dowing
ton of the department any of higher education;
thetamount of which is found to uints oired to be paid to be owing as a result of final agency detemrin ation
e unemployment compensation
Ind;and(e) other unpaid debts owing to the state or any agency
or reduced to judgment as certified by the controller.
10. The signatories aver that they are farmliar with h CRS 18-8-301,et seq.,(Bribery and Corrupt Influences)and CRS 18-8401,et seq.,(Abuse of Public Office),
and that no violation of such provisions is present
11. The signatories aver that to their knowledge,no state employee has any personal or beneficial interest whatsoever in the service or property described herein.
IN WITNESS WHEREOF,the parties hereto have executed this Contract on the day first above written.
Contractor. State of Colorado
(Full Name) WELD COUNTY BOA OF COMMISSIONERS ROY ROMER,GOVERNOR
,,
,,
By �Q .r�,Position(Title) Constance L. Harbert. Chair By '� at.l/ - T
(01/21/98) J
846000813
Social Security Numvll7?•rv,. �'rnaba of Department PUBLIC HEALTH AND ENVIRONMENT
IAE11,
v a1' �.
If Corporation or
To Jet V / PROGRAM APPROVAL:
L.A. les . In.Fiscal Officer
�7r 1t � t�'rli /'/%
Atteat(Affixseal) i )r WE C0U T EPARTMEIILT
qa� err D• Z�C
i./fi a r. �r�
By•. V',�a+7r:;; . A!!! Clark to the Board
APPROVALS S. PICKLE, M.S.E.H.
' DIRECTOR
ATTORNEY GENERAL 'ft:I Alptiera, CONTROLLER
{ By APPROVALS:
By Clifford W.Hall LLER
GaleANorton fit
C_ Rinhatrt P nington CLIF
which is the last of 10 pages j Q�}
Form 6-AC-02C(GF.NOa019'/)Revised �nt cinch GgtY@m. BY: �v}
State Se C .-";n,
a ,
ATTACHMENT D
1 5/95
2 STATE OF COLORADO
3 COLORADO BOARD OF HEALTH
4
5 RULES AND REGULATIONS
6 PERTAINING TO THE REPORTING, PREVENTION, AND CONTROL OF
7 AIDS, HIV RELATED ILLNESS, AND HIV INFECTION
8
9
10 Colorado has a comprehensive public health AIDS/HIV control law: Colorado
11 Revised Statutes Title 25, Article 4, Sections 1401 et seq. These regulations are
12 intended to provide detail and clarification for selected parts of the above cited
13 statute. The statute covers subject matters not included in these regulations.
14 •
15
16 C.R.S. 25-4-1405.5 (2) (a) (I) requires the Colorado Department of Public
17 Health and Environment (CDPHE) to conduct an anonymous counseling and testing
18 program for persons considered to be at high risk for infection with HIV. The
19 provision of confidential counseling and testing for HIV is the preferred screening
20 service for detection of HIV infection. Local boards of health who provide HIV
21 counseling and testing through a contractual agreement with the CDPHE must
22 consider the need for an anonymous HIV testing option in their jurisdiction. The
23 consideration of this option must provide an opportunity for public comment in a
24 public forum at a minimum of every two years. Other mechanisms for input into the
25 need for an anonymous testing option in that jurisdiction must be available in addition
26 to the public forum, including anonymous testimony in writing or through.an
27 organization. Local Boards of Health must document the following: notification of
28 interested parties and the public, time allowed between notification and the public
29 forum, accessibility in both location and time of the public forum, and the response to
30 public comment in the decision process. Local boards of health electing to provide
31 confidential HIV testing with an anonymous option must do so in conjunction with
32 counseling and testing sites (CTS); i.e., CDPHE designated sites which screen
33 individuals for HIV infection without providing on-going health care. This will be
34 done through a contractual agreement with the CDPHE. Local boards of health may
35 elect, at the time of contract renewal, to provide confidential testing with an
36 anonymous option.
37
38 Per C.R.S. 25-4-1405.5 (2) (a) (II), Regulations 6-8 are the performance
39 standards for confidential and anonymous HIV CTS and the CDPHE staff.
t\wpaoc�1bot95ThivMe 51z
3800')1,
1
2 Regulation 1. Reporting By Physicians. Health Care Providers Hospitals And Others
3
4 Diagnosed cases of AIDS, HIV-related illness, and HIV infection, regardless
5 of whether confirmed by laboratory tests, shall be reported to the state or local health
6 department or health agency within 7 days of diagnosis by physicians, health care
7 providers, hospitals, or any other person providing treatment to a person with HIV
8 infection.
9
10 All cases are to be reported with the patient's name, age, sex, address
11 (including city and county), e and address of responsible
cian; and such
12 other information as is needed olocate the patpatient forfollow upst. For cases reported
13 from a public anonymous testing site as provided by C.R.S. 25-4-1405.5, The
14 patient's name and address and the name and address of the responsible physician are
15 not required.
16
17 Reports on hospitalized patients may be made part of a report by the hospital
18 as a whole.
19
20 Research activities of persons performing clinical research on persons with
21 AIDS, HIV-related illness, or HIV infection whose research activity:
22 1. involves the study of HIV treatment or vaccine effectiveness or is basic
23 biomedical research into the cellular mechanisms causing HIV infection
24 or HIV-related disease;
25 2. meets the research exemption criteria of C.R.S. 25-4-1402.5(3); and
26 3. has been approved by the Board of Health pursuant to C.R.S. 25-4-
27 1402.5(2) •
28 - shall be exempt from meeting the reporting requirements for AIDS, HIV-related
29 illness, and HIV infection.
30
31
32 Regulation 2. Reporting by Laboratories
33
34 Cases of AIDS, HIV-related illness, and HIV infection shall also be reported
35 with the information required in Regulation 1 by laboratories whether or not
36 associated with a hospital, and by out of state laboratories that maintain an office or
37 collection facility in Colorado or arrange for collection of specimens in Colorado.
38 Laboratories shall report:
39 1. Any of the following positive serologic tests: (a) repeatedly reactive
Borpeoa16oh951Liv,We.ln2
98005)1
1 All public health reports and records held by the state or local health
2 department in compliance with these regulations shall be confidential information
3 subject to C.R.S. 25-4-1404. The public health reports and records referred to in
4 C.R.S. 25-4-1404 shall include, but not be limited to, the forms and records
5 designated by the CDPHE for institutions and agencies which screen individuals for
6 HIV infection without providing ongoing health care, such as a public HIV counseling
7 and testing site.
8
9 Reasonable efforts shall be made by the department to consult with the
10 attending physician or medical facility caring for the patient prior to any further
11 follow-up by state or local health departments or health agencies.
12
13
14 • Regulation 5. Investigations To Confirm The Diagnosis And Source Of HIV
15 Infection And To Prevent HIV Transmission
16
17 Investigations may be conducted pursuant to C.R.S. 25-4-1405 et seq. to confirm
18 the diagnosis and sources of HIV infection and to prevent transmission of HIV and
19 shall be considered official duties of the health department or health agency. Such
20 investigations may include, but are not limited to:
21 1. review of pertinent, relevant medical records by authorized personnel if
22 nerecsary to confirm the diagnosis, to investigate possible sources of
23 infection, to determine objects and materials potentially contaminated with
24 HIV and persons potentially exposed to HIV. Such review of records may
25 occur without patient consent and shall be conducted at reasonable times
26 and with such notice as is reasonable under the-circumstances;
27 2. performing follow-up interview(s) with the case or persons knowledgeable
28 about the case to collect pertinent and relevant information about the
29 sources of HIV infection, materials and objects potentially contaminated
30 with HW, and persons who may have been exposed to HIV.
31
32
33 Regulation 6. Objective Standards
34
35 A. Training
36
37 1. All persons providing HIV pre and posttest prevention and risk-
38 reduction counseling at a CTS will have completed the HIV
39 Serologic Test Counseling course or an equivalent of not less than
BwpdocAboh95\hivruk.fn2
980091
1 ELISA test; (b) positive supplementary test such as Western blot; (c)
2 positive test for antigenemia [all of the above according to test
3 manufacturer's directions]; (d) positive polymerase chain reaction test
4 in persons less than 13 years of age; or (e) positive latex agglutination
5 test for HIV.
6 2. _Positive viral culture for HIV.
7 3. CD4 counts < 500 mm' or CD4% <29% regardless of HIV test
8 results.
9
10 When associated with other clinical or laboratory evidence of HIV infection,
11 the Board of Health defines a CD4 test result in the range listed above as the primary
12 immunologic measure indicating severe HIV infection and when less than 200 mm',
13 as defining AIDS. The Department shall destroy personal identifying information on
14 all persons with CD4 results in the reportable range if investigation subsequent to the
15 report finds no evidence of infection. Laboratories may fulfill the requirement to
16 report CD4 counts < 500 mm' or CD4% <29% by allowing authorized personnel of
17 the Department of Public Health and Environment to have access to such records.
18
19 Laboratories shall follow the same procedures for reporting as are required of
20 other reporting sources in Regulation 1.
21
22 Report of test results by a laboratory does not relieve the attending physician
23 of his/her obligation to report the case or diagnosis, nor does report by the physician
24 relieve the laboratory of its obligation.
25
26 •
27 Regulation 3. Information Sharing
28
29 Information concerning cases of AIDS, HIV-related illness, or HIV infection
30 shall be shared between the appropriate local health department or health agency and
31 the state health department, as provided by C.R.S. 25-4-1404, and in a timely
32 manner, usually within the timeframe for reporting in Regulation 1.
33
34 These requirements shall not apply if the state and local health agencies
35 mutually agree not to share information on reported cases.
36
37
38 Regulation 4. Confidentiality
39
tb.•pfoa'bon95 hrcwwe.m2
980091.
1 16 hours of training, approved by the CDPHE STD/AIDS Program.
2 2. All persons providing HIV pre and posttest prevention and risk-
3 reduction counseling at a CTS will have a minimum of 8 hours of
4 relevant HIV/STD or allied health services continuing education
5 annually, approved by the CDPHE STD/AIDS Program.
6 3. All persons performing partner notification interviews will have
7 completed courses concerning introduction to sexually transmitted
8 disease interviewing and partner notification, as specified by the
9 CDPHE.
10
11 B. Notification of Results
12
13 1. Of all HIV tests performed at a CTS, 90% of those persons testing
14 HIV positive will receive results and posttest risk-reduction
15 counseling.
16 2. Of all HIV tests performed at a CTS, 80% of those persons testing
17 HIV negative will receive results and posttest prevention and risk-
18 reduction counseling.
19
20 C. Partner Notification
21 If CDPHE staff provide partner notification for a CTS, then the following
22 standards do not apply to the cm.
23
24 1. Of the 90% of HIV positive individuals receiving results and
25 posttest counseling, 100% will be assigned for partner notification
26 interview. A minimum of 75% of those assigned for a partner
27 notification interview will receive an interview. Agencies providing
28 partner notification services (CDPHE and local health departments)
29 will have a partner index (defined as the number of unsafe partners
30 identified for whom identifying information was sufficient to initiate
31 notification, divided by the number of interviewed HIV positive
32 persons with unsafe behavior in the past year) of 0.8. Effective
33 January 1, 1995, the acceptable partner index will be 1.0.
34 Documentation of this activity will be provided to the CDPHE
35 through use of a CDPHE specified form.
36
37 A contact is defined as a person named by an infected person as
38 having been an unsafe sex partner/needle share partner of that
39 infected person. If sufficient locating information (name, age, sex,
L lw-pdoa\boh95Vuv,ulaM2
9800"1
1 phone number, recent address, work address) is obtained to conduct
2 an investigation, such a contact is defined as an initiated contact.
3 2. Of all in-state initiated contacts, 60% must be located and offered
4 HIV prevention and risk-reduction counseling and/or testing as
5 documented by the results of the investigation on the CDPHE
6 specified form. Documentation of investigation outcomes will
7 include disposition codes as specified by the CDPHE, dates and
8 location of counseling, and dates and location of testing (if done).
9
10
11 Regulation 7. Operational Standards
12
13 A. Counseling
14
15 1. All counselors at a CTS performing HIV pretest prevention and
16 risk-reduction counseling will: a) conduct a risk assessment, b)
17 discuss and develop a risk-reduction plan, i.e., identify with the
18 client specific behaviors that can realistically be changed to reduce
19 risk, c) fully and legibly complete for each person tested the HIV 1
20 Serology lab slip.
21 2. All counselors at a CTS performing HIV posttest prevention and
22 risk-reduction counseling will: a) inform clients in person of test
23 results, b) explain the significance of both positive and negative test
24 results, c) discuss and/or modify the risk-reduction plan, d) refer
25 clients who test positive for follow-up medical and counseling
26 services.
27
28 B. Consent Form
29
30 1. A consent form specified by the CDPHE or an approved
31 must be used at all CTS. equivalent
32
33 C. Testing Parameters
34
35 1. CTS will not provide anonymous testin to
36 8 an y person 12 years of
age or younger.
37 2. If a counselor judges that a client is unable to understand either
38 .. counseling or the testing process, e.g., because the client is under
39 the influence of drugs or alcohol, the counselor may defer testing.
cnydoaThohMiv we.m2
980091
1 D. Written Results
2
3 1. CTS may only provide written results to persons testing
4 confidentially. To receive written results, the CTS must be
5 presented with photo identification from the person requesting
6 written results at the time of posttest.
7 2. Contracting agencies may not give written results to any person
8 testing anonymously.
9
10 E. Confidentiality and Record Maintenance
11
12 1. Contracting agencies may develop and adhere to an alternative HIV
13 record retention policy. This policy must be adopted by the local
14 board of health with the opportunity for public comment and input
15 through an open public forum conducted at least every two years.
16 Other mechanisms for input into the record retention policy must be
17 available in addition to the public forum, including anonymous
18 testimony in writing or through an organization.
19 Any policy must address the following areas:
20 a) linkage of personal identifiers, behavioral risk information
21 and results; time frames, if any for delinkage, (The CDPHE
22 encourages that any alternative record retention policy
23 include the delinking of identifying information from risk
24 information 120 days from the date of testing.),
25 b) the availability of anonymous testing,
26 c) time frames for_destruction of records,
27 d) method and supervision for destruction of records,
28 e) approval of record retention policy by the Colorado State
29 Archivist,
30 f) procedures for hard (paper) records and electronic
31 (computer) records,
32 g) procedures for records of negative results and positive
33 results
34 h) inclusion of record retention information in the client consent
35 form
36 2. Per C.R.S. 25-4-1404.5 (2) (a) (II), a person may provide personal
37 identifying information after counseling, if the person volunteers to
38 do so. Contracting agencies must document this information when
39 volunteered, and provide this information to the CDPHE on the
iAwpdoa\boh95'hivruk.tn2
3800”1
1 posttest reimbursement form submitted to the CDPHE within 30
2 days of the date the blood specimen was collected.
3
4
5 Regulation 8. Evaluation Standards and Penalties
6
7 A. Each CTS's compliance with these standards will be evaluated by the
8 following:
9
10 1. A semi-annual analysis by the CDPHE staff of the number of
11 persons receiving HIV antibody testing and the proportion of
12 persons testing receiving results per contracted agency.
13 2. A minimum of one on-site observation conducted annually by the
14 CDPHE staff. This on-site observation will include observation of
15 counselors at each CTS performing HIV pre and posttest prevention
16 and risk-reduction counseling.
17 3. A semi-annual analysis of testing trends (anonymous vs.
18 confidential) conducted by CDPHE staff.
19 4. A semi-annual review of counseling and partner notification forms
20 for completion and accuracy conducted by CDPHE staff.
21 5. A minimum of one annual audit of charts for all contracting
22 agencies, conducted by CDPHE staff.
23 6. Accuracy and completion of the posttest counseling reimbursement
24 form submitted to the CDPHE.
25
26 B. Failure of a CTS to comply with and meet these standards may result in
27 one or more of the following action(s):
28
29 - 1. The CTS may meet with the CDPHE to develop a plan for
30 improving performance in specified areas.
31 2. The CTS may be given a probationary period to comply and meet
32 the standards.
33 3. The CTS may be reevaluated by the end of the probationary period.
34 4. Failure to meet and comply with the standards may result in
35 contract termination.
kbipdo,xwoh95Wn vlo.n2
980091
•
—'k11'ACHMENT E
STATE OF COLORADO
Roy Romer.Governor cow
Patti Shwayder,Acting Executive Director
,�.0c.A c _1
Dedicated to protecting and improving the health and environment of the people of Colorado r o
Main Building Laboratory Building • : '
4300 Cherry Creek Dr.5. 4210 E.11th Avenue '1816 la]6
Denver,Colorado 80222-1530 Denver,Colorado 80220-3716 Colorado Department
Phone(303)692.2000 (303)691-4700 P
of Public Health
Date and Environment
State Fiscal Year 19_-_ Routing Number_-
Change Order Letter No.
In accordance with Paragraph 4 of routing number_- , of contract number , (copy attached and
by this reference made a part hereof) between the State of Colorado Department of Public Health and
Environment (Disease Control anti Environmental Epidemiology Division) and
covering the period of , 19_ through , 19_ the undersigned agree that the maximum
amount payable by the State for eligible services in Paragraph_ is being increased by $ to a new
total of$ . The first sentence in Paragraph_ is hereby modified accordingly. The terms and
conditions of the original contract shall remain the same.
This amendment to the contract is intended to be effective as of_/ /_, but in no event shall it 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 copies of this letter on or before , 19_ to:
Audrey Christensen
Colorado Department of Public
Health and Environment
DCEED-ADM-A3 .
4300 Cherry Creek Drive South
Denver, Colorado 80222-1530.
A verified copy of this letter will be returned to you when it is fully approved.
State of Colorado:
• Roy Romer, Governor
By: By:
Name Lee Thielen, Assistant Director
Tide For the Executive Director
Colorado Department of Health
APPROVALS:
By: By:
L. A. Koleski, Jr., Fiscal Officer State Controller or
Disease Control and Environmental Authorized Designee
Epidemiology Division
980091
®Printed on Recycled Paper
HIV Antih Test Consent Form - Orr " Care Site ATTACHMENT A
What"is an HIV test?
This test is a test for the HIV (Human Immunodeficiency Virus) antibody. HIV is the virus which can cause AIDS.
This test finds antibody to HIV, not the virus itself. The body makes antibody to try to fight the virus.
AIDS (Acquired ImmunoDeficiency Syndrome) is a serious disease that is caused when HIV damages a part of the
body's immune system (its natural defenses). This makes it hard for the body to fight off diseases.
All persons infected with HIV (even those that are healthy) can give the virus to others through unprotected sex or
shared needles. A woman infected with HIV c,an wive the virus to her baby during pregnancy, during childbirth, or
breastfeeding. Anyone who has the virus can pass it on.
Testing for HIV is voluntary. You should be tested only if you understand the advantages and disadvantages of
testing.
What are the advantages •and disadvantages of being tested?.
Advantages: If you have HIV, there are things you can do that may help you stay healthy and keep you from
developing AIDS.
If you find out you have HIV, you will want to tell your sex partner(s) or people you have shared needles with so
they can get tested too. You will need to learn about 'safer sex" and other ways to protect your partner's health
and to keep yourself from becoming exposed again. If you find out you do not have the virus, your counselor will
talk about ways to keep from getting HIV.
Disadvantages: Finding out that you have HIV can be upsetting. You might become worried about developing
AIDS or infecting others. For this reason it is important to think about who you can trust and talk to and who can
help you when you get your results. Also, there are counselors, volunteers, and support groups to help you with
these feelings.
I-.jj:inEattrla
Y�gani :: cm i c k „a+ > e �ae "�z
What-do es tt mean if my test is negative? What lf'tt a postttve7
A NEGATIVE test means that antibody to HIV cannot be found. This usually means that the person does not have
the virus now. In some cases, however, a person may have become infected too recently for the test to turn
positive, It can take as long as six months after infection for the HIV antibodies to show up.
A POSITIVE test means that a person is infected with HIV and can pass it to others. The test does not tell how
long a person has had HIV or whether a person has AIDS or will develop AIDS. The results of this test are very
good. However, no test is 100% correct. If you think your results are wrong, please request a repeat test.
S .,y.r c t<q r> f a
3 YL 6S L < L
Is1my HlV test confident,al7
•
Yes. This test becomes part of your confidential medical record and will be kept by this clinic. Medical records
can be released with your informed consent and can sometimes be released through legal action.
If your test is positive, a complete record of your test, with all the information on the laboratory form, will be kept
in locked files at the Colorado Department of Public Health and Environment (CDPHE) indefinitely.
(over)
a AwpdoaVommsknnca.95
rev.3/95
980091
If your test is negative, a copy of the test will be kept at the CDPHE in locked files for 120 days. After 120 days
the information is placed into two unsinkable files. One file has your name, age, test results, and address/phone
number, and will be destroyed at the CDPHE after two years. The other file has your risks without your name and
will be used for statistical purposes only.
Colorado law forbids the CDPHE to release the records it holds to any other government agency, person, doctor,
hospital, clinic, employer, or insurance company, even if you give your permission. But if you are concerned that
records may be released or that the law may change, you can be tested at a site that has anonymous testing. If
you test anonymously, no personal identifiers (name, address, phone number, date of birth) will be used. You
cannot be contacted in the future. Please discuss any questions with your counselor.
What will the counseling session be like? •
You will go to a private room where a counselor will talk with you about HIV and AIDS. The counselor will talk
about what you do or have done that put(s) you at risk for HIV infection. Together you will develop a plan to
decrease your risk.
S/he will also talk with you about the HIV test and answer any questions you may have about HIV and AIDS. One
tablespoon of blood will be taken from your arm, with a sterile needle, and sent to the lab for testing.
Your test results will be back in this office in 10-14 days. The results will be given to you only in person, not by
phone or mail. This is done to be sure that the results go only to you.
If your HIV test is positive, there will be many decisions for you to make. One decision is about how to tell your
sexual and/or needle sharing partner(s) that they have been exposed to the virus and that they should get
counseling and testing. A trained specialist will talk to you about telling your partners of their risk of infection.
They need to know; they might be infected too. As always, all information about you and your partners is
completely confidential.
I have read both pages and have had a chance to have my questions answered. I understand the infomtation on
this form and freely give my consent to have my,blood drawn and tested for the HIV antibody.
Signature
Date
Witness
Date
elwpdocNomm,tauca.9 5
r«.7ry5
980091
HIV Antibody T-1t Consent Form - Counserra& Testing Site
ATTACHMENT B
What'is an HIV test? •
•
This test is a test for the HIV (Human Immunodeficiency Virus) antibody. HIV is the virus which can cause AIDS.
This test finds antibody to HIV, not the virus itself. The body makes antibody to try to fight the virus.
AIDS (Acquired ImmunoDeficiency Syndrome) is a serious disease that is caused when HIV damages a part of the
body's immune system (its natural defenses). This makes it hard for the body to fight off diseases.
All persons infected with HIV (even those that are healthy) can give the virus to others through unprotected sex or
shared needles. A woman infected with HIV can give the virus to her baby during pregnancy, during childbirth, or
breastfeeding. Anyone who has the virus can pass it on.
Testing for HIV is voluntary. You should be tested only if you understand the advantages and disadvantages of
testing.
What are the advantages and disadvantages of'being tested?
Advantages: If you have HIV, there are things you can do that may help you stay healthy and keep you from
developing AIDS.
If you find out you have HIV, you will want to tell your sex partner(s) or people you have shared needles with so
they can get tested too. You will need to learn about "safer sex" and other ways to protect your partner's health
and to keep yourself from becoming exposed again. If you find out you do not have the virus, your counselor will
talk about ways to keep from getting HIV.
Disadvantages: Finding out that you have HIV can be upsetting. You might become worried about developing
AIDS or infecting others. For this reason it is important to think about who you can trust and talk to and who can
help you when you get your results. Also, there are counselors, volunteers, and support groups to help you with
these feelings.
•
What does it thein.-it.MW•teititriegatiiie? Whaf if If is positive?:
A NEGATIVE test means that antibody to HIV cannot be found. This usually means that the person does not have
the virus now. In some cases, however, a person may have become infected too recently for the test to turn
positive. It can take as long as six months after infection for the HIV antibodies to show up.
A POSITIVE test means that a person is infected with HIV and can pass it to others. The test does not tell how
long a person has had HIV or whether a person has AIDS or will develop AIDS. The results of this test are very
good. However, no test is 100% correct. If you think your results are wrong, please request a repeat test.
s my 1 W test confidential?'ri g$ fk.S x k`5 ` s
Yes. All HIV records are kept completely confidential.
If your test is positive, a complete record of your test, with all the information on the laboratory form, will be kept
in locked files at the Colorado Department of Public Health and Environment (CDPHE) and at this Counseling and
Testing Site indefinitely.
(over)
lwpdoaVortnAamsu.9 S pc� /�
rev.-3/9 - 980091
If your test is negative, a copy tie test will be kept in locked files at thr"PHE and at this Counseling and
Testing Site for 120 days. Aft, _0 days the information in each place i_ _.;ed into two unlinkable files. One
file has your name, age, test results, and address/phone number and will be destroyed after two years. The other
file has your risks without your name and will be used for statistical purposes only.
At confidential testing sites, you are asked to give your name, address, birth date and telephone number. This
information is necessary in the event someone at the site needs to contact you. You would be contacted only if
there is a problem with your test and retesting is needed, if you do not return for results, or if new information
about HIV infection becomes available that would be useful to you.
Colorado law forbids the CDPHE and this Counseling and Testing Site to release the records it holds to any other
government agency, person, doctor, hospital, clinic, employer, or insurance company, even if you give your
permission. But if you are concerned that records may be released or that the law may change, you can be tested
at a site that has anonymous testing. If you test anonymously, no personal identifiers (name, address, phone
number, date of birth) will be used. You cannot be contacted in the future. Please discuss any questions with
your counselor.
What will the::counseling session be like?
You will go to a private room where a counselor will talk with you about HIV and AIDS: The counselor will talk
about what you do or have done that put(s) you at risk for HIV infection. Together you will develop a plan to
decrease your risk.
S/he will also talk with you about the HIV test and answer any questions you may have about HIV and AIDS. One
tablespoon of blood will be taken from your arm, with a sterile needle, and sent to the lab for testing.
Your test results will be back in this office in 10-14 days. The results will be given to you only in person, not by
phone or mail. This is done to be sure that the results go only to you.
If your HIV test is positive, there will be many decisions for you to make. One decision is about how to tell your
sexual and/or needle sharing partner(s) that they have been exposed to the virus and that they should get
counseling and testing. A trained specialist will talk to you about telling your partners of their risk of infection.
They need to know; they might be infected too. As always, all information about you and your partners is
completely confidential.
I have read both pages and have had a chance to have my questions answered. I understand the information on
this form and freely give my consent to have my blood drawn and tested for the HIV antibody.
Signature Date
Witness Date
olwpdoa\tonnsbneL.95
row.3/95 980091.
ATTACHMENT C
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 HIV
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.
Current Status
A. Records of HIV antibody tests kept by state and local departments of health are as
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, Si]) clinic, drug treatment center, family
planning clinic, etc.
B. HIV negative tests submitted from state-funded HIV 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-funded 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 connceling and testing began in July 1985, and every person
tested at a counseling and testing program has signed a written consent form which
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
LMpdocs\bob.95\.udrem.6, 1
960091
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 HIV 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 must 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. HIV negative tests prevent wasting limited state resources for partner notification
and avoid unnecessary intrusion into partner's lives.
Examples:
1. If an infected person has a prior negative HIV test: A person is found to be
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
1A.pa«.toe.vsaRmem.rm 2
9800991
• 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 neressary 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 HIV.
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 HIV
negative and HIV positive persons is important for determining which prevention
strategies work.
D. Statistical analyses of proportion of persons tested positive by various risk factors
are essential for epidemiologic monitoring of the spread of the HIV epidemic and
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 unlinkable 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
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
r:t peocAbon.95=* ,.w 3
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I
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. My 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 delinking 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 CTS client will be informed that:
1. the test results become part of the record kept by the CTS and how
those records are retained;
2. test results held by the CDPHE:
4
a. the identifying information will be linked to risk factor
information for no more than 120 days after the blood
specimen collection date;
LIwpden\boh.954cArsm.fS 4
9800"i
•
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 neeative, the client of a contracted site providing oneoine care :
I. 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 identifyine 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.
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 contracted tuberculosis, STD, drug
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.
r:wpdee.toh.954eidnm.fN 5
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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, Zp x
Patient Name x
Patient Address x
Patient City, State, Zip x x
Patient Phone x
Patient DOB x
Patient Age x 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
Patient Hx Since '78 all items x
ctwpdoonboe.ssk aran.w 6
980091
Data Items Name File Risk Ale
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 4/8/92).
in five-year aggregate
L\apdeaWoh.95\re rdrem.IN 7 98005)1
mEmoRAnDum WEELD COMITY
' Constance L. Harbert, Chair (^ rt +"� 9 Pr1 �: t!
COLORADO
To Board of County Commissioners Date January 19, 199
R{
T r n
From i;^.^;1
John Pickle, Director, Health Departm
Subject: HIV Counseling and Testing Contract
Enclosed for Board review and approval is a contract between the Colorado Department of
Public Health and Environment and Weld County Health Department for HIV counseling and
testing services.
This contract is for the time period January 1, 1998 through December 31, 1998 and for an
amount not to exceed $2810.00. This represents a decrease of$1,450 from the 1997 contract and
is a result of federal funding cuts.
I recommend your approval of this contract as it is a critical public health service.
Enclosure
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