DEPARTMENT: Governmental Operations
Support / Billing Compliance Support
PAGE: 1 of 5
APPROVED: December 7, 1999
EFFECTIVE DATE: April 1, 2000
POLICY DESCRIPTION: Laboratory - Marketing
Practices
REPLACES POLICY DATED: Jan. 21, 1998,
April 16, 1999
RETIRED:
REFERENCE NUMBER: GOS.LAB.023
SCOPE: All Company affiliated facilities performing and/or billing laboratory services. Specifically,
the following departments:
Business Office
Admitting/Registration
Medical Staff
Revenue Integrity
Administration
Allied Health Practitioners
Medicare Service Center
Marketing
Laboratory
Health Information Management
Physician Office Staff
Reimbursement
Revenue Service Center
PURPOSE: To ensure the marketing of laboratory services is honest, straightforward, informative,
compliant with legal requirements, and not deceptive.
POLICY: It is the responsibility of the Laboratory to ensure Clients (as defined below) fully
understand the services offered, the services that will be provided when tests are ordered, and the
financial consequences for the tests ordered.
Definitions:
Client: A Client may be: a physician, employer, reference, or other laboratory to whom laboratory
services are provided as requested and billed on a monthly basis.
Fair Market Value: Fair market value is the value of a service in arm’s-length transactions, consistent
with the general market value. In other words, there is no inappropriate and/or undue influence on
either party.
PROCEDURE: Laboratory personnel must educate all physicians and their associates responsible for
ordering and utilizing laboratory services on the contents of this policy.
IMPLEMENTATION AND ANNUAL REVIEW
Refer to the following guidelines when developing a laboratory marketing plan:
1. Test Orders & Requisitions:
 Requisition forms may be provided to all Clients at no charge.
 Requisitions will allow ordering of HCFA-approved panels only as well as single tests.
 All test orders must include all of the elements defined in the Orders for Outpatient Tests
DEPARTMENT: Governmental Operations
Support / Billing Compliance Support
PAGE: 2 of 5
APPROVED: December 7, 1999
EFFECTIVE DATE: April 1, 2000
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POLICY DESCRIPTION: Laboratory - Marketing
Practices
REPLACES POLICY DATED: Jan. 21, 1998,
April 16, 1999
RETIRED:
REFERENCE NUMBER: GOS.LAB.023
and Services Policy, GOS.GEN.004.
Verbal orders must be authenticated as specified in accordance with the facility’s medical
staff bylaws and/or state rules and regulations. Written confirmation must be requested
within 24 hours.
Standing orders must be reviewed and renewed every 6 months as specified in the Standing
Orders Policy, GOS.GEN.005.
Reflex testing must be specifically requested by the ordering physician or performed as a
result of approved reflex criteria when abnormal results exist. Reflex testing guidelines must
be approved annually by the medical staff as specified in the Reflex Orders Policy,
GOS.LAB.010.
Critical pathway laboratory testing must have annual medical staff approval for acceptable
use as specified in the Critical Pathway Order Sets Policy, GOS.GEN.006.
Requisition forms will be reviewed for billing compliance and updated as needed. As this
occurs, new or revised forms will be sent to all Clients with instructions to discard the
outdated forms.
2. Test/Pricing Information:
Laboratory personnel must review and ensure applicable revisions are made to the chargemaster
and related laboratory and order entry masterfiles/dictionaries to ensure each charge associated
with a procedure is priced no less than the fair market value and cost. The following
documentation should be maintained:
 Supporting calculations for arriving at cost per procedure;
 Procedure price which should reflect any discounts, if applicable;
 Price list documenting current fair market value; and
 Effective date the procedure price was implemented in the chargemaster.
All Clients will be provided with a complete listing of laboratory services which includes:
laboratory name and address, Medical Director name and phone number, laboratory phone &
fax numbers, test name, CPT/HCPCS code, pricing structure, and other information (such as
specimen requirements).
Clients must not be charged less than fair market value and cost since an inference may be made
that the lower price is offered to induce referral business.
Laboratory services must never be provided to any customer free of charge or as a professional
courtesy in order to induce referrals.
DEPARTMENT: Governmental Operations
Support / Billing Compliance Support
PAGE: 3 of 5
APPROVED: December 7, 1999
EFFECTIVE DATE: April 1, 2000
POLICY DESCRIPTION: Laboratory - Marketing
Practices
REPLACES POLICY DATED: Jan. 21, 1998,
April 16, 1999
RETIRED:
REFERENCE NUMBER: GOS.LAB.023
Clients will be billed on a monthly basis and the bill must include at a minimum: patient name,
date of service, test(s) performed and fee charged.
It should be noted that Medicare requires direct billing of outpatient laboratory services
by the laboratory performing the tests unless otherwise permitted by Referred
Laboratory Testing Policy and Procedure, GOS.LAB.009, and SNF Laboratory Services
Policy, GOS.LAB.020.
3. Courier Service:
 Courier service may be provided at no charge to all laboratory Clients provided that
specimens are to be delivered to the facility laboratory.
 Transported specimens must be packaged and handled according to OSHA guidelines.
4. Equipment & Supplies:
 Equipment provided to Clients must be used exclusively in conjunction with ordering and
testing of laboratory services provided by the facility laboratory.
 Provision of equipment and supplies must be in accordance with federal and state laws and
regulations.
 Supplies, such as needles and tubes, associated with specimen collection may be provided at
no charge as long as the specimen(s) are referred to the facility laboratory providing the
supplies.
5. Contracts & Agreements:
 Laboratory testing requested for patients whose insurance requires testing to be performed
by a contracted reference laboratory other than the facility laboratory must be submitted to
the facility laboratory using the appropriate reference laboratory requisition. Test samples
will be sent to the reference laboratory specified on the laboratory requisition.
 All Clients doing business with the facility laboratory must sign a written agreement.
Attachment A of this policy provides a template for such a written agreement. Prior to
contracting with physicians or other individuals authorized to order tests, a review of the
OIG Program Exclusions list should be conducted. Contracts are not to be entered into with
individuals that have been excluded from Medicare participation and listed on the OIG’s
Program Exclusion list.
 The Skilled Nursing Facility Prospective Payment System (SNF PPS) and Consolidated
Billing rules require that the SNF bill for virtually all services provided to it’s SNF patients.
DEPARTMENT: Governmental Operations
Support / Billing Compliance Support
PAGE: 4 of 5
APPROVED: December 7, 1999
EFFECTIVE DATE: April 1, 2000
POLICY DESCRIPTION: Laboratory - Marketing
Practices
REPLACES POLICY DATED: Jan. 21, 1998,
April 16, 1999
RETIRED:
REFERENCE NUMBER: GOS.LAB.023
It is recommended that a written agreement as defined in this policy exist between your
facility and SNFs in your community to which you will be providing services. However,
some SNFs may refuse to enter into such contractual arrangements. If services are provided
to residents of a SNF that does not have a written agreement with the facility, the SNF is
obligated to pay billed charges to the facility pursuant to the Skilled Nursing Facility
Prospective Payment System and Consolidated Billing rules
 All written agreements must outline the services offered, including courier services,
provision of equipment, fee schedules, and billing practices.
 All contracts must be reviewed by the facility’s operations counsel.
 All contracts must be retained as described in the Laboratory Outpatient Records Policy,
GOS.LAB.016.
6. Education & Communication:
 Annual written notification of and/or training on the following policies and guidelines will
be made available to Clients and medical staff:
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Orders for Outpatient Tests and Services (GOS.GEN.004)
Medical Necessity Guidelines & Local Medical Review Policy
Medical Necessity Policy (GOS. GEN.002)
ABN Form and Policy (GOS. GEN.003)
Organ & Disease Policy (GOS.LAB.004)
Custom Profiles Policy (GOS.LAB.007)
Reflex Testing Policy (GOS.LAB.010)
Standing Orders Policy (GOS. GEN.005)
Critical Pathway Order Sets Policy (GOS.GEN.006)
Three-day Window Policy (GOS.BILL.001)
Laboratory – Marketing Practices Policy (GOS.LAB.023)
Ordering physicians and their office staff must be contacted when ordering information is
incomplete.
The Medical Director or Clinical Consultant is available for consultation regarding
laboratory orders and results.
Updated Local Medical Review guidelines will be sent to Clients/medical staff as
applicable.
DEPARTMENT: Governmental Operations
Support / Billing Compliance Support
PAGE: 5 of 5
APPROVED: December 7, 1999
EFFECTIVE DATE: April 1, 2000
POLICY DESCRIPTION: Laboratory - Marketing
Practices
REPLACES POLICY DATED: Jan. 21, 1998,
April 16, 1999
RETIRED:
REFERENCE NUMBER: GOS.LAB.023
7. Annual Review:
 The Facility Billing Compliance Committee must review the requirements and
implementation of this policy on an annual basis. Deviations from this policy should be
documented and resolved in accordance with the Billing – Audit & Monitoring Policy,
GOS.GEN.001.
REFERENCES:
OIG Model Compliance Plan for Clinical Laboratories, March 1997, Federal Register Vol. 62, No. 41
Stark Self Referral Prohibitions, 42 U.S.C., 1395nn.
Medicare Anti-Kickback Statute 42 U.S.C., 1320a-7b.
The Office of Inspector General’s Compliance Program Guidance For Clinical Laboratories (August
1998) Med-Manual, Med-Guide 10,285.03, Independent Laboratory Services
Med-Law, Med-Guide, SS Act Section 1861, Definitions of Services, Institutions, ETC. 42 U.S.C.
Med-Law, Med-Guide, SS Act Section 1833, Payment of Benefits, Subse (h), Clinical Diagnostic
Laboratory Tests
CLINICAL LABORATORY SERVICES AGREEMENT
THIS
CLINICAL
LABORATORY
SERVICES
by
and
between
_______________________________,
with a business
address at
(hereinafter referred
to as “GROUP”), and
, whose address is
_____________________________________________ (hereinafter referred to as “LAB”).
AGREEMENT
1. Services
The parties agree that LAB is to provide only clinical laboratory services for the patients of
the GROUP under the terms and conditions of this Agreement and in accordance with all
applicable requirements of federal, state or local laws, rules, and/or regulations, third party
reimbursement sources (public or private), or other reimbursement sources covering LAB
services. Clinical Lab services may include, but are not limited to: microbiology, virology,
mycology, serology, chemistry, urinalysis, hematology, or immunology testing performed on
samples to provide information for the diagnosis, prevention, or treatment of a disease or
assessment of a medical condition. LAB shall provide service twenty-four hours per day,
seven days per week to GROUP. LAB agrees to render clinical laboratory services for the
patients of GROUP in accordance with orders given by the physicians of said patients. Every
endeavor shall be made to complete STAT tests within ______ hours of the request for said
tests by GROUP. The parties agree that any laboratory services ordered as STAT tests by a
physician shall be considered emergency procedures*. Most routine tests will be performed
and reported within ______ hours, unless the test is esoteric or a microbiology test which
requires longer turnaround.
*It is understood that in some isolated instances it may not be realistic to complete these tests
within this time frame (examples would include such things as STAT cultures and/or tests
referred to an independent reference laboratory). Needed documentation to substantiate this
delay shall be provided by LAB upon GROUP’s request.
2. Term & Termination
A. Term. This Agreement shall remain in effect for a term beginning on
and
ending at midnight on
, unless otherwise terminated as provided
herein.
B. Termination. Notwithstanding anything herein to the contrary, this Agreement may be
terminated at any time as follows:
B.1.
Whenever GROUP and LAB shall mutually agree to the termination in writing; or
B.2.
Except as provided elsewhere in this Agreement, with cause by either party upon
the default by the other party of any term, covenant or condition of this
Attachment to GOS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
Agreement, where such default continues for a period of ten (10) business days
after the defaulting party receives written notice thereof from the other party
specifying the existence of such default; or
B.3.
Without cause by either party upon at least thirty (30) days prior written notice to
the other party in which case the Agreement shall terminate on the future date
specified in such notice, except that no such termination without cause shall take
effect prior to the first annual anniversary of the Agreement; or
B.4.
Upon the filing of voluntary or involuntary bankruptcy by either GROUP or LAB;
or
B.5.
Upon either party’s loss of license, accreditation or certification.
3. Compensation & Billing
A. Procedures for Billing GROUP. GROUP may order or request LAB services to be
provided directly to GROUP (and not to or on behalf of a particular patient or GROUP
employee) where such services will be paid for directly by GROUP. Under such
circumstances, GROUP will give LAB written notice of those services for which GROUP
will pay LAB directly for the provision of services to GROUP except as otherwise
prohibited in section B below.
For the provision of such services, LAB will bill GROUP monthly, and GROUP agrees to
reimburse LAB at the rate set forth in Exhibit “A” as the current fees to be charged to
GROUP for services rendered hereunder. Any amendments or changes to the scheduled
fees, Exhibit “A”, shall be effective forty-five (45) days following the date upon which
LAB has notified GROUP in writing, at which time the amended schedule will become
part of this Agreement. No tests or services will be priced below the fair market value as
required by law.
LAB will submit to GROUP on a monthly basis an invoice, which will reflect services
rendered from the first day of the calendar month to the last day of the calendar month,
will be in the form reasonably required by GROUP and will be submitted to GROUP
within 30 days of the end of the calendar month. GROUP agrees to pay LAB within
thirty (30) days of receipt of LAB'S invoice.
Such invoice shall include the following:
a) Name and address of LAB.
b) Name and address of GROUP.
c) Name of each patient to whom supplies, equipment and/or services were
provided, the date each service was provided, the accepted nomenclature of the
2
Attachment to GOS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
supplies, equipment and/or services provided, and the total charge for supplies,
equipment and/or services.
B. Procedures for Billing Other Payors. Except in the circumstances where GROUP
informs LAB to bill GROUP for the services rendered, LAB will be solely responsible for
determining the appropriate party (i.e., Medicare, Medicaid, or a managed care
organization) functioning as the GROUP patient’s third party reimbursement source
(collectively referred to as the "Appropriate Payor"). GROUP will make reasonably
available any information it may have regarding the GROUP patient’s Appropriate Payor,
including such Payor’s rules, regulations, contractual obligations, or other procedures
pertaining to appropriate billing practices.
Notwithstanding GROUP’s instructions to LAB to the contrary, LAB will be
compensated for services rendered to or on behalf of GROUP patients that are Medicare
beneficiaries by directly billing the Medicare system, or as otherwise required by
applicable Medicare billing regulations. LAB will be compensated for services rendered
to or on behalf of all other GROUP patients (not provided for above) by following the
Appropriate Payor’s respective rules, regulations, contractual obligations, or other
procedures pertaining to appropriate billing practices if LAB is requested by GROUP to
direct bill the Appropriate Payor.
GROUP and LAB will work together in good faith to reduce reimbursement denials by
providing adequate documentation, including proper coding for the medical necessity of
laboratory services. GROUP shall be responsible for payment to LAB for services
rendered should the Appropriate Payor deny the LAB’s claim (or should such claim be
deemed invalid) as a result of insufficient information provided by GROUP or lack of
medical necessity at the time of the physician’s order. Except as provided above, in the
event LAB fails to receive payment for a service provided to or on behalf of a GROUP
patient that LAB was directed by GROUP to direct bill, LAB will not look to GROUP for
payment, in whole or in part, and LAB will have no right of recovery against GROUP.
4. Test Information
LAB will provide GROUP with the following test information:
 Laboratory name and address
 Laboratory phone and fax number
 Medical Directors name and phone number
 Tests Offered, including: test name, pricing, CPT/HCPCS code, and specimen
requirements.
5. Test Orders and Forms
3
Attachment to GOS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
A. Orders. All tests ordered by GROUP will be performed by or referred to another
laboratory by LAB. All test orders must be accompanied with a diagnosis, sign, symptom,
and/or ICD-9-CM code associated with the test(s) being ordered. Verbal test orders must
be authenticated as specified in accordance with the LAB’s medical staff by-laws and/or
state rules and regulations. Written confirmation of verbal orders must be received within
twenty-four (24) hours. Standing orders (also called recurring orders) must be written,
authenticated and renewed every six (6) months.
B. Forms. Requisition and Advance Beneficiary Notice forms will be provided to all
customers at no charge. The LAB’s requisition forms will allow ordering of HCFA
approved panels and single tests. Additional space will be provided to order tests not
listed on the requisition. Requisition forms will be reviewed for billing compliance and
updated as needed. As this occurs, new or revised forms will be sent to all Clients with
instructions to discard the outdated forms. Laboratory testing requested for patients
whose insurance requires testing to be performed by a contracted reference laboratory
other than the LAB must be submitted to the LAB using the appropriate reference
laboratory requisition form. Test samples will be sent to the laboratory specified on the
requisition.
6. Records
LAB agrees to keep and maintain any and all records, including but not limited to medical
and financial records, for services rendered by LAB to patients in GROUP as may be required
by federal, state, or local government agency, GROUP policies or other parties to whom
billings for LAB’s services are rendered.
LAB agrees to deliver a copy of the original laboratory report in a timely manner to GROUP.
The laboratory test report will include at a minimum: patient’s name, date of test, test name,
test result, normal values, laboratory name and address. LAB shall report all abnormal and
STAT reports to GROUP or to the patient’s attending physician, as directed by GROUP.
LAB agrees to make all records on GROUP’s patients to whom LAB has rendered service
available for GROUP inspection upon request.
If applicable, pursuant to Section 1395X(V)(1)(I) of Title 42 of the United States Code, until
the expiration of four (4) years after the termination of this contract, LAB shall make
available, upon written request to the Secretary of the United States Department of Health
and Human Services, or upon request to the Comptroller General of the United States
General Accounting Office, or any of their duly authorized representatives, a copy of this
contract and such books, documents and records as are necessary to certify the nature and
extent of costs of the services provided by LAB under this Agreement.
LAB further agrees that in the event LAB carries out any of the duties under this Agreement
through a subcontract, with a value of cost of Ten Thousand Dollars ($10,000) or more over a
twelve month period, with a related organization, such a contract shall contain a clause to the
effect that until the expiration of four (4) years after the furnishing of such services pursuant
4
Attachment to GOS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
to such subcontract, the related organization shall make available, upon written request to the
Secretary of the United States Department of Health and Human Services, or upon request to
the Comptroller General of the United States General Accounting Office, or any of their duly
authorized representatives, a copy of such subcontract and such books, documents and
records of such organization as are necessary to verify the nature and extent of such costs.
7. Education, Communication & Consultation
A. Education. LAB will provide laboratory test ordering education to GROUP and will
make appropriate recommendations to the administration of lab ordering to GROUP,
assist in implementation of such recommendations and maintain an on-going assessment
of progress to facilitate compliance by GROUP with all governmental and third party
rules, regulations, and policies. LAB will advise and participate in GROUP’s in-service
educational training program. Annual written notification and/or training will be provided
to GROUP by LAB on the following policies and procedures:
 Laboratory test ordering
 Medical necessity guidelines
 Advance Beneficiary Notice (ABN)
 Organ & Disease Panel policy
 Custom profiles policy
 Reflex testing policy
 Standing orders policy
 Critical pathway orders policy
 Three-day window policy
 Laboratory marketing policy
B. Communication. LAB will answer questions, arrange for special tests, and communicate
new regulations and processes to GROUP. Written reports will be submitted by LAB as
may from time to time be required by GROUP, including quarterly reports which may be
required.
C. Consultation. LAB will provide a clinical consultant as needed for consultation
regarding appropriate test ordering and diagnostic evaluation.
8. Laboratory Qualifications
LAB shall provide GROUP with proof that LAB is approved by Medicare CLIA ID number
____________ to provide laboratory services and is licensed or registered, where and as
applicable, by the State of _______________________.
LAB will provide copies of
licensure and certification to GROUP as requested. LAB warrants that their laboratory staff
is duly licensed to provide services if required by state. LAB will perform all tests in
compliance with any standard, ruling, or regulation of the Joint Commission on Accreditation
of Healthcare Organizations, the State Department of Health and Human Services, HCFA’s
Clinical Laboratory Improvement Act, or any other governmental agency responsible for
administering, regulating, or accrediting healthcare facilities or professionals. Lab will
5
Attachment to GOS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
conform to all applicable LAB policies including personnel qualifications established and
maintained to comply with both Medicare and state laws and regulations.
9. Supplies & Equipment
All supplies and equipment essential to LAB’s execution of its duties under this Agreement
shall be the responsibility of LAB.
A. Supplies. LAB agrees to furnish specimen collection supplies at no charge to GROUP
for the sole purpose of specimen collection for samples sent to LAB for testing. GROUP
agrees to follow test-specific collection protocol when collecting laboratory specimens.
B. Equipment. Equipment provided by LAB to the GROUP free of charge must be used
exclusively in conjunction with ordering and testing of laboratory services provided by
LAB. Computer hardware and software may be provided free of charge for the sole
purpose of reporting laboratory results from LAB. All equipment provided to GROUP by
LAB must be documented and tracked using the Incidental Agreement form in Exhibit
“B”.
10. Specimen Transport & Courier Service
A. Transport. Under normal conditions, LAB will be responsible for transport of all
specimens. Transported specimens must be packaged and handled by GROUP and LAB
according to OSHA guidelines.
B. Courier. Courier service may be provided by LAB to _________________________
GROUP at no charge if provided exclusively in conjunction with ordering and testing of
laboratory services provided by LAB. LAB may provide regular, periodic courier
services to pick up and deliver specimens, reports, and supplies for the
________________________GROUP on schedules determined by LAB.
11. Independent Contractors
In performing the services herein specified, LAB is acting as an independent contractor, and
neither LAB nor any hospital staff shall be considered employees of GROUP. It is agreed
and acknowledged by the parties that, as an independent contractor, LAB retains the right to
contract with and provide its services to facilities and persons other than GROUP and its
patients, and nothing in this Agreement shall be interpreted as limiting or restricting that right
in any way. In no event shall this Agreement be construed as establishing a partnership or
joint venture or similar relationship between the parties hereto, and nothing herein contained
shall be construed to authorize either party to act as agent for the other. LAB shall be liable
for its own debts, obligations, acts and omissions, including with respect to all of LAB’s
employees and contractors (including all hospital staff), the payment of all applicable
compensation, wages, pensions, workers’ compensation, insurance, and all required
withholding, social security and other taxes and benefits. LAB hereby expressly agrees to
provide GROUP with proof of payment of such taxes in the event such is requested of LAB
6
Attachment to GOS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
by federal or state tax authorities. Any such proof will be provided directly to LAB’s counsel
for delivery to tax authorities in order to preserve the confidentiality of such records. Neither
LAB nor any hospital staff shall be subject to any GROUP policies solely applicable to
GROUP’s employees, or be eligible for any employee benefit plan offered by GROUP .
12. Confidentiality
A. Confidential Information. Both parties recognize and acknowledge that, by virtue of
entering into this Agreement and providing services to GROUP hereunder, both parties
may have access to certain information that is confidential and constitutes valuable,
special and unique property of the other party. Both parties warrant and covenant to each
other that neither party will at any time, either during or subsequent to the term of this
Agreement, disclose to others, use, copy or permit to be copied, without the other party’s
express prior written consent, except pursuant to LAB’s or LAB Staff’s duties hereunder,
any confidential or proprietary information of the other party, including, but not limited
to, information which concerns GROUP’s patients, costs, prices and treatment methods at
any time used, developed or made by LAB, and which is not otherwise available to the
public.
B. Terms of this Agreement. Except for disclosure to their legal counsel, accountants or
financial advisors, both parties warrant and covenant to the other party that neither party
shall disclose the terms of this Agreement to any person who is not a party or signatory to
this Agreement, unless disclosure thereof is required by law or otherwise authorized by
this Agreement or consented to by the other party. Unauthorized disclosure of the terms
of this Agreement shall be a material breach of this Agreement and shall provide the nonbreaching party with the option of pursuing remedies for breach or immediate termination
of this Agreement in accordance with Article B.2. hereof.
C. Patient Information. LAB warrants and covenants to GROUP that neither LAB nor any
LAB Staff shall disclose to any third party, except where permitted or required by law or
where such disclosure is expressly approved by GROUP in writing, any patient or
medical record information regarding GROUP patients, and LAB and LAB Staff shall
comply with all federal and state laws and regulations, and all reasonable rules,
regulations, and policies of GROUP and its medical staff, regarding the confidentiality of
such information. LAB acknowledges that in receiving or otherwise dealing with any
records or information from GROUP about GROUP patients receiving treatment for
alcohol or drug abuse, LAB and all LAB Staff are fully bound by the provisions of the
federal regulations governing Confidentiality of Alcohol and Drug Abuse Patient Records
(42 C.F.R. Part 2, as amended from time to time) as well as any State laws that govern
HIV/AIDS and mental health treatment. In addition, LAB warrants and covenants to
GROUP that, if necessary, LAB and all LAB Staff will resist in judicial proceedings any
effort to obtain access to such records or information except such access as is expressly
permitted by the aforementioned federal regulations and/or State law.
13. Insurance
7
Attachment to GOS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
GROUP shall, at its sole cost and expense at all time during the term of this Agreement,
procure and maintain comprehensive general and professional liability insurance (including
personal injury, property damage, products liability, and completed operations liability), in a
minimum amount of One Million Dollars ($1,000,000). GROUP shall cause to be issued to
LAB proper certificates of insurance evidencing the foregoing provisions of this Agreement
have been complied with and said certificates shall provide that prior to any cancellation or
change in the underlying insurance during the policy period, and the insurance carrier will
first give thirty (30) calendar days written notice to LAB.
LAB shall, at its sole cost and expense and at all times during the term of the Agreement,
procure and maintain professional liability insurance (including personal injury, property
damage, products liability) in a minimum amount of One Million Dollars ($1,000,000). LAB
shall cause to be issued to GROUP proper certificates of insurance evidencing the foregoing
provisions of this Agreement have been complied with and said certificates shall provide that
prior to any cancellation or change in the underlying insurance during the policy period, the
insurance carrier will first give thirty (30) calendar days written notice to GROUP.
LAB will maintain automobile liability insurance coverage, sufficient to cover the business
activities performed under this Agreement and in accordance with the laws of the state of
__________________ on any vehicle used in the delivery of services under this Agreement.
14. Miscellaneous
A. Governing Law. This Agreement has been made and executed in, and shall be
construed, interpreted and governed by the laws of the State of
.
B. Indemnification. Each party shall protect, indemnify and hold the other party harmless
from and against any and all liability and expense of any kind, arising from injuries or
damages to persons or property in connection with the provision of services by the
indemnifying party hereunder.
C. Assignment. This Agreement and the rights and interests hereunder may be transferred
or assigned by GROUP or LAB only with the prior written consent of the other party.
D. Successors. This Agreement shall inure to the benefit and be binding upon the GROUP
and its successors and assigns and LAB and its successors and assigns.
E. Waiver. The waiver of any breach of any term or condition of this Agreement shall not
be deemed to constitute the waiver of any other breach of the same or any other term or
condition.
F. Section and Other Headings. The article and other headings contained in this
Agreement are for reference purposes only and shall not affect in any way the meaning or
interpretation of this Agreement.
8
Attachment to GOS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
G. Enforceability. In the event any provision of this Agreement is found to be
unenforceable or invalid, such provision shall be severable from this Agreement and shall
not affect the enforceability or validity of any other provision contained in this
Agreement.
H. Entire Agreement. This Agreement contains the entire contractual understanding
between the parties and supersedes and terminates any prior agreement(s) between the
parties hereto. No amendments or additions to this Agreement shall be binding unless
such amendments or additions are in writing and signed by the GROUP and LAB, except
as herein otherwise provided.
I. No Obligation to Make Referrals. The parties acknowledge that nothing contained
herein shall be interpreted to require or obligate GROUP to admit or cause the admittance
of a patient to LAB or affiliated facilities, or to utilize their services. The parties further
acknowledge that none of the benefits granted the parties under this Agreement is
conditioned on any requirement or expected that the parties make referrals to, be in a
position to make or influence referrals to, or otherwise generate business for the other
party. The parties further acknowledge that neither party is restricted from referring any
service to, or otherwise generating any business for any other entity of their choosing.
J. Counterparts. This Agreement may be executed in one or more counterparts, all of
which together shall constitute only one Agreement.
K. Attorney’s Fees. In the event of the commencement of suit to enforce any of the terms
or conditions in this Agreement, each party shall bear financial responsibility for their
own attorney and legal fees regardless of which party prevails.
L. Civil Rights. LAB agrees to comply with Title VI of the Civil Rights Act of 1964 and all
requirements imposed by or pursuant to the regulation of the Department of Health and
Human Services, (45 C.F.R. Part 80) issued pursuant to that Title, to the end that, no
person in the United States shall, on the ground of race, color or national origin, be
excluded from participation, be denied the benefits of, or be otherwise subjected to
discrimination under any program or activity for which federal funds are used in support
of LAB activities.
M. Remedies. In addition to those remedies provided herein, LAB and GROUP shall have
available all remedies provided by law.
N. Amendments. No modifications of or amendment to this Agreement or its attachments
shall be effective or binding on either party unless mutually agreed to in writing signed by
both parties.
15. Notice
9
Attachment to GOS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
Any notice required to be provided to any party to this Agreement shall be in writing and
shall be considered effective as of the date of deposit with the United States Postal Service by
certified or registered mail, postage prepaid, return receipt requested to the parties as follows:
LAB:
cc:
Legal Department
One Park Plaza
Nashville, TN 37203
GROUP:
Any changes in the above addresses for notice shall be provided to the other party to this
Agreement within five (5) days of such change.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement on the day and
year first above written.
GROUP
LAB
____________________________________
____________________________________
By:
By:
Title:
Title:
10
Attachment to GOS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
INCIDENTAL EQUIPMENT AGREEMENT
Exhibit B
THIS AGREEMENT is made and entered into this ______ day of _________________,
______, by and between __________________ d/b/a ___________________________ (herein
referred to as “Hospital”) and ________________________________(herein referred to as
“Physician”).
WITNESSETH:
WHEREAS, the purpose of this Agreement is to state the terms and conditions under which
Hospital will provide Physician certain computer hardware and software in order to facilitate the
efficient and economical delivery of lab results to Physician from Hospital.
NOW, THEREFORE, in consideration of the mutual promises herein contained, Hospital and
Physician agree as follows:
Section 1. Equipment. Hospital will place in Physician’s office without charge to Physician
certain computer hardware and software (which shall remain property of Hospital as hereinafter
more fully provided) for authorized use pursuant to the terms of this Agreement only. Physician
will provide and maintain a compatible working telephone line which can be used to receive lab
results from Hospital via such equipment.
Section 2. Computer Equipment. The computer terminal, modem and other hardware and
software (collectively, the “Equipment”) furnished by Hospital to pursuant to this Agreement
shall remain the property of Hospital. Physician shall use the Equipment only to receive lab test
results from Hospital and for no other reason whatsoever. Physician shall take good care of the
Equipment while it is in the possession of Physician, and shall not purport to pledge, encumber
or convey title to any of the Equipment. Physician shall return the Equipment to Hospital
immediately upon termination of that certain Clinical Laboratory Services Agreement between
the parties for any reason.
Section 3. Disclaimer of Warranties. Hospital makes no representation, warranty or guaranty,
express or implied, including (without limitation) any warrant of merchantability or fitness for
particular purpose with regard to the Equipment supplied to Physician pursuant to this
Agreement. Should any of the Equipment fail or be inaccurate, under no circumstance shall
Hospital be liable for any loss of profits to Physician or for special, consequential, or exemplary
damages (all of which are hereby expressly waived by Physician as part of the consideration to
Hospital for this Agreement), even if Hospital has been advised of the possibility of such
damages.
11
Attachment to GOS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
Section 4. No Assignment. This Agreement may not be assigned by Physician without the prior
written consent of Hospital which consent may be withheld in Hospital’s sole discretion.
Section 5. Fees and Expenses. If any action at law or in equity is brought in respect of any
provision of Agreement, the prevailing party shall be entitled to reasonable attorney’s fees, costs
and expenses, in addition to any other remedy or relief to which such party may be entitled.
Section 6. Agreement Term. The term of this Agreement shall commence on the date this
Agreement is signed as indicated below, and shall continue until termination as herein provided.
Termination shall occur (a) upon 30 days written notice from either party to the other, or (b)
immediately by Hospital without notice in the event Physician fails in any way to only use the
Equipment pursuant to the terms of this Agreement only. Physician’s obligation under Section 2
of this Agreement, and the disclaimer and waiver under Section 3 of this Agreement, shall
continue and be unaffected by any such termination.
Section 7. Notices. Any notice required or permitted to be given under this Agreement shall be
in writing and shall be deemed properly addressed and postpaid, to the address specified below
the signature lines for each of the parties, or at such other address as may be specified in writing.
Section 8. Divisions and Headings. The divisions of this Agreement into articles and sections
and the use of captions and headings in connection therewith are solely for convenience and shall
have no legal effect in construing the provisions of the Agreement.
Section 9. Severability. In the event any provision of this Agreement is held to be invalid,
unlawful, or unenforceable for any reason and in any respect, such invalidity, unlawfulness, or
unenforceable shall in no event affect, prejudice or disturb the validity of the remainder of this
Agreement, which shall be and remain in full force and effect, enforceable in accordance with its
terms.
Section 10. Choice of Law: Place of Performance. This Agreement shall be construed in
accordance with laws of the State in which Hospital is located.
12
Attachment to GOS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
Section 11. NO REQUIREMENT TO REFER. NOTHING IN THIS AGREEMENT SHALL BE
CONSTRUED TO REQUIRE PHYSICIAN TO ADMIT PATIENTS TO HOSPITAL OR TO UTILIZE
HOSPITAL TO PROVIDE INPATIENT, OUTPATIENT OR ANY OTHER SERVICES TO
PATIENTS, TO ORDER ANY GOODS OR SERVICES FROM HOSPITAL, OR OTHERWISE
GENERATE BUSINESS FOR HOSPITAL. NOTWITHSTANDING ANY UNANTICIPATED EFFECT
OF ANY PROVISION OF THIS AGREEMENT, NEITHER PARTY WILL KNOWINGLY OR
INTENTIONALLY CONDUCT HIMSELF IN SUCH A MANNER AS TO VIOLATE THE
PROHIBITION AGAINST FRAUD AND ABUSE IN CONNECTION WITH THE MEDICARE AND
MEDICAID PROGRAMS (42 USC SECTION 1320A-7B).
EXECUTED this ________ day of _______________________, ______.
Hospital:
______________________________________
d/b/a__________________________________
By:___________________________________
Name:________________________________
Title:_________________________________
Hospital Address:
_____________________________________
_____________________________________
_____________________________________
Physician:
Physician Address:
_____________________________________
_____________________________________
_____________________________________
13
Attachment to GOS.LAB.023