REGS.LAB.023 - HCA Ethics & Compliance

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DEPARTMENT: Regulatory Compliance
Support
PAGE: 1 of 6
POLICY DESCRIPTION: Laboratory – Client
Billing Practices
REPLACES POLICY DATED: 1/21/98, 4/16/99,
1/1/00, 1/1/02, 12/15/02, 8/1/03, 11/30/04 (GOS.LAB.023),
3/6/06, 11/15/06, 6/1/07; 5/1/08; 7/1/09
EFFECTIVE DATE: February 1, 2011
REFERENCE NUMBER: REGS.LAB.023
APPROVED BY: Ethics and Compliance Policy Committee
SCOPE: All Company-affiliated hospitals performing and/or billing laboratory services. Specifically,
the following departments:
Business Office
Admitting/Registration
Medical Staff
Revenue Integrity
Administration
Allied Health Practitioners
Shared Services Centers
Marketing
Laboratory
Health Information Management
Physician Office Staff
Reimbursement
PURPOSE: To establish guidelines for the billing and marketing of laboratory services to Clients (as
defined below) in an honest, straightforward, informative, compliant, and non-deceptive manner.
POLICY: It is the responsibility of the Laboratory to verify that Clients 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 which 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 CMS-approved panels only as well as single tests.
 All test orders must include all of the elements defined in the Orders for Outpatient Tests
and Services Policy, REGS.GEN.004.
12/2010
DEPARTMENT: Regulatory Compliance
Support
PAGE: 2 of 6
POLICY DESCRIPTION: Laboratory – Client
Billing Practices
REPLACES POLICY DATED: 1/21/98, 4/16/99,
1/1/00, 1/1/02, 12/15/02, 8/1/03, 11/30/04 (GOS.LAB.023),
3/6/06, 11/15/06, 6/1/07; 5/1/08; 7/1/09
EFFECTIVE DATE: February 1, 2011
REFERENCE NUMBER: REGS.LAB.023
APPROVED BY: Ethics and Compliance Policy Committee
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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.
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,
REGS.LAB.010.
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:
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 and fax
numbers, test name, CPT/HCPCS code, pricing structure, and other information (such as specimen
requirements).
Pricing must not be an inducement for physicians to refer other business to the Laboratory or to
another HCA affiliated facility and must not be based on referral patterns.
Clients must not be charged less than fair market value (FMV) and cost for each procedure unless
the client’s account overall yields a profit for the hospital laboratory. If a client is charged less than
FMV and cost for a procedure and the account does not make a profit, then an inference may be
made that the lower price is offered to induce referral business.
In determining whether a procedure is priced below cost, look at the total of all laboratory costs. At
a minimum, the following items must be included in the laboratory costs:
 Laboratory salaries and benefits;
 Costs per reportable result expenses (HPG contract for reagents, equipment leases, etc.);
 Laboratory supply costs (Office supplies, controls, calibrators, pipettes, gloves,
specimen containers, needles, etc.);
 Professional fees (Laboratory Medical Director fees);
 Contract services (Reference lab testing, lab coat cleaning, etc.);
 Maintenance fees (Laboratory equipment or facility repairs);
 Rents and leases (Laboratory locations);
 Utility expense (Laboratory locations);
 Postage and transportation (Freight, postage, courier services related to laboratory
12/2010
DEPARTMENT: Regulatory Compliance
Support
PAGE: 3 of 6
POLICY DESCRIPTION: Laboratory – Client
Billing Practices
REPLACES POLICY DATED: 1/21/98, 4/16/99,
1/1/00, 1/1/02, 12/15/02, 8/1/03, 11/30/04 (GOS.LAB.023),
3/6/06, 11/15/06, 6/1/07; 5/1/08; 7/1/09
EFFECTIVE DATE: February 1, 2011
REFERENCE NUMBER: REGS.LAB.023
APPROVED BY: Ethics and Compliance Policy Committee
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services);
Travel and entertainment (Laboratory meetings, entertainment, lab celebrations);
Dues and subscriptions (Laboratory professional organizations, compliance and
professional subscriptions);
Depreciation (For all assets in the lab that have a remaining depreciable life);
Service center billing costs as they relate to client billing; and
Any other laboratory expenses.
To determine the cost of a laboratory procedure, either:
(a) Divide the total of all laboratory costs by the total number of laboratory tests; or
(b) Utilize the Medicare Cost Report Overhead Allocation (step down) to approximate the cost
of laboratory services using Medicare’s Ratio of Cost to Charges (RCC) calculation.
Multiply the hospital’s charge for a specific laboratory test by the RCC to determine the cost
per procedure.
The following documentation related to client pricing must be maintained at the facility:
 Supporting calculations for arriving at cost;
 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.
To determine FMV, the hospital or market may use one of a number of methods, including
engaging an independent appraiser to conduct a fair market value analysis; or reviewing at least
30 of the most frequently performed tests and comparing its prices to the price charged by other
laboratories offering the same tests in the same general locality, to the extent such laboratory
pricing information is publicly available.
Hospital laboratories may have multiple Client pricing tiers to accommodate arrangements with
other HCA owned entities. Arrangements with other HCA owned entities may be priced at cost
only.
Laboratory services must never be provided to any customer free of charge or as a professional
courtesy in order to induce referrals.
Laboratory services should not be provided as part of the client agreement if the client is sixty or
more days past due in paying its bills. The relationship with the client does not have to be
terminated, but should be suspended until the client account is no longer past due.
12/2010
DEPARTMENT: Regulatory Compliance
Support
PAGE: 4 of 6
POLICY DESCRIPTION: Laboratory – Client
Billing Practices
REPLACES POLICY DATED: 1/21/98, 4/16/99,
1/1/00, 1/1/02, 12/15/02, 8/1/03, 11/30/04 (GOS.LAB.023),
3/6/06, 11/15/06, 6/1/07; 5/1/08; 7/1/09
EFFECTIVE DATE: February 1, 2011
REFERENCE NUMBER: REGS.LAB.023
APPROVED BY: Ethics and Compliance Policy Committee
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 the Referred Laboratory
Testing Policy, REGS.LAB.009 and Technical Component of Anatomical Pathology
Services for Inpatients and Outpatients Policy, REGS.LAB.015.
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 at no charge or below fair market value must be used
exclusively in conjunction with ordering and testing of laboratory services provided by the
facility laboratory.
 Reusable items that can be of value in the Client’s operations separate and apart from the
clinical laboratory work to be provided by the facility laboratory cannot be provided at no
charge or below fair market value.
 Examples of permissible items that can be provided at no charge or below fair market
value are: specimen tubes, urine cups, venipuncture needles, and specimen pick-up
boxes.
 Examples of prohibited items that cannot be provided at no charge or below fair market
value are: general office supplies, gloves, tourniquets, injection needles, snares, biopsy
needles, syringes, phlebotomy chairs, and refrigerators.
 Provision of equipment and supplies must be in accordance with federal and state laws and
regulations. If you have any questions concerning what equipment and supplies may and
may not be provided at no charge or below fair market value to Clients, consult with your
assigned operations counsel.
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
must be sent to the reference laboratory specified on the laboratory requisition.
12/2010
DEPARTMENT: Regulatory Compliance
Support
PAGE: 5 of 6
POLICY DESCRIPTION: Laboratory – Client
Billing Practices
REPLACES POLICY DATED: 1/21/98, 4/16/99,
1/1/00, 1/1/02, 12/15/02, 8/1/03, 11/30/04 (GOS.LAB.023),
3/6/06, 11/15/06, 6/1/07; 5/1/08; 7/1/09
EFFECTIVE DATE: February 1, 2011
REFERENCE NUMBER: REGS.LAB.023
APPROVED BY: Ethics and Compliance Policy Committee
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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 must 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 its SNF patients.
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 SNF PPS and Consolidated
Billing rules.
 All written agreements must outline the services offered, including courier services,
provision of equipment, fee schedules, and billing practices.
 Any changes to the attached form agreement must be reviewed and approved in advance by
the facility’s operations counsel.
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:
 Orders for Outpatient Tests and Services (REGS.GEN.004)
 Advance Beneficiary Notice of Noncoverage – Outpatient Services Policy
(REGS.GEN.003)
 Medicare – Hospital Issued Notice of Non-Coverage Policy (REGS.GEN.010)
 Medicare – National and Local Coverage Determinations Policy
(REGS.GEN.011)
 Organ & Disease Panels Policy (REGS.LAB.004)
 Billing - Custom Profiles Policy (REGS.LAB.007)
 Laboratory - Reflex Orders Policy (REGS.LAB.010)
 Outpatient Services and Medicare Three Day Window Policy (REGS.GEN.009)
 Laboratory – Client Billing Practices Policy (REGS.LAB.023)
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12/2010
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
DEPARTMENT: Regulatory Compliance
Support
PAGE: 6 of 6
POLICY DESCRIPTION: Laboratory – Client
Billing Practices
REPLACES POLICY DATED: 1/21/98, 4/16/99,
1/1/00, 1/1/02, 12/15/02, 8/1/03, 11/30/04 (GOS.LAB.023),
3/6/06, 11/15/06, 6/1/07; 5/1/08; 7/1/09
EFFECTIVE DATE: February 1, 2011
REFERENCE NUMBER: REGS.LAB.023
APPROVED BY: Ethics and Compliance Policy Committee
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laboratory orders and results.
Updated Local Coverage Determinations and National Coverage Determinations will be
sent to Clients/medical staff as applicable.
7. Annual Review:
The Facility Ethics and Compliance Committee must review the requirements and implementation
of this policy on an annual basis.
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
OIG Advisory Opinion No. 99-13, November 30, 1999
12/2010
CLINICAL LABORATORY SERVICES AGREEMENT
THIS CLINICAL LABORATORY SERVICES AGREEMENT by and between
_______________________________,
with a business
address at
(hereinafter referred
to as “GROUP”), and
_____
, whose address is
_________________________________________________ (hereinafter referred to as “LAB”).
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 REGS.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.
2
Attachment to REGS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
c) Name of each patient to whom services were provided, the date each service was
provided, the accepted nomenclature of the services provided, and the total charge
for services.
B. Procedures for Billing Other Payers. 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 Payer’s rules, regulations, contractual obligations, or other procedures
pertaining to appropriate billing practices. For each service for which GROUP does not
instruct LAB to bill GROUP (and thus LAB is to bill the patient or a third party),
GROUP hereby represents and warrants to LAB that GROUP is not receiving
compensation for that service from any source including but not limited to a research
grant.
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 Payer’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 Director’s name and phone number
 Tests offered, including: test name, pricing, CPT/HCPCS code, and specimen
requirements.
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Attachment to REGS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
5. Test Orders and Forms
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. Standing orders (also called recurring orders) must be
written, authenticated and renewed in accordance with the LAB’s medical staff by-laws
and/or state rules and regulations.
B. Forms. Requisition, Medicare Secondary Payer and Advance Beneficiary Notice forms
will be provided to all customers at no charge. The LAB’s requisition forms will allow
ordering of CMS 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
A. Record Retention Requirements Compliance. 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. Such records shall include documentation of the determination by
the physician, as required by federal law and regulations, that the services ordered by the
physician are medically necessary for the patient in the event that the patient is a
beneficiary of the Medicare program, and also documentation that the information
submitted with each claim accurately reflects the information received from the physician
who ordered the services.
B. Laboratory Report Timely Delivery and Contents. 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.
C. Books and Records.
4
Attachment to REGS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
1. LAB. 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.
2. Subcontractor. 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 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 and 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:
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Orders for Outpatient Tests and Services policy ;
Advance Beneficiary Notice of Noncoverage – Outpatient Services policy
(ABN);
Medicare – Hospital Issued Notice of Non-Coverage policy
Medicare – National and Local Coverage Determinations policy
Organ & Disease Panel policy;
Custom Profiles policy;
Laboratory Reflex Orders policy;
Outpatient Services and the Medicare Three Day window policy; and,
Laboratory – Client Billing Practices 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
5
Attachment to REGS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
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, CMS’s
Clinical Laboratory Improvement Act, or any other governmental agency responsible for
administering, regulating, or accrediting healthcare facilities or professionals. Lab will
conform to all applicable LAB policies including personnel qualifications established and
maintained to comply with both Medicare and state laws and regulations.
9. Supplies and 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 only specimen collection supplies (specimen tubes,
urine cups, venipuncture needles, and specimen pick-up boxes) 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 Equipment Agreement (a copy
of which is attached hereto as Exhibit “B”). For purposes of this Agreement, GROUP
and LAB agree that the Incidental Equipment Agreement __ will or ____will not [select
one] be required since the LAB __ will or __ will not [select one] be providing equipment
to GROUP. The parties agree that any Incidental Equipment
Agreement executed
between the parties shall be incorporated by reference into this Agreement.
10. Specimen Transport & Courier Service
6
Attachment to REGS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
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’s office at no charge if
provided exclusively in conjunction with ordering and testing of laboratory services
provided by LAB. LAB may also 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
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.
7
Attachment to REGS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
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.
D. HIPAA Requirements. Both parties agree to comply with the applicable provisions of
the Health Information Technology for Economic and Clinical Health Act of 2009 (the
"HITECH Act"), the Administrative Simplification section of the Health Insurance
Portability and Accountability Act of 1996, as codified at 42 U.S.C. §1320d through d-8,
as amended from time to time (“HIPAA”), and the requirements of any regulations
promulgated under either the HITECH Act or HIPAA, including, without limitation, the
federal privacy regulations as contained in 45 CFR Parts 160 and 164 (the “Federal
Privacy Regulations”), the federal security standards as contained in 45 CFR Parts 160,
162 and 164 (the “Federal Security Regulations”), and the federal standards for electronic
transactions contained in 45 C.F.R. Parts 160 and 162 (the "Federal Electronic
Transactions Regulations"), all as may be amended from time to time, and all collectively
referred to herein as "HIPAA Requirements." Both parties acknowledge that each party
constitutes a “covered entity,” as that term is defined at 45 CFR §164.103, and both
parties are engaged in “covered functions,” as that term is defined at 45 CFR §164.501.
Both parties agree not to use or further disclose any “protected health information,” as
defined at 45 CFR §164.504, or “individually identifiable health information,” as defined
at 42 U.S.C. §1320d (collectively, the “Protected Health Information”), concerning a
patient other than as permitted by the provisions of this Agreement and the requirements
of HIPAA and the regulations promulgated pursuant to HIPAA, including without
limitation the Federal Privacy Regulations and the Federal Security Regulations. Both
8
Attachment to REGS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
parties shall implement appropriate safeguards to prevent the use or disclosure of
protected health information other than as provided for by this Agreement. Either party
shall promptly report to the other party any use or disclosure of protected health
information not in accordance with this Agreement or in violation of HIPAA
Requirements of which that party becomes aware. In the event either party, with the prior
approval of the other party in writing, contracts with any other parties or agents to whom
the party furnishes protected health information received from the party, that party shall
include provisions in such agreements whereby that party and the other party or agent
agree to the same restrictions and conditions that apply to that party with respect to such
protected health information. Either party shall return to the other party or properly
dispose of any protected health information in accordance with federal and state law and
regulations after the expiration or termination of this Agreement. Either party shall make
its internal practices, books, and records relating to the use and disclosure of protected
health information available to the Secretary of Health and Human Services to the extent
required for determining compliance with HIPAA Requirements. Notwithstanding the
foregoing, no attorney-client, accountant-client, or other legal privilege shall be deemed
waived by either party by virtue of this paragraph. Any breach of this paragraph shall
constitute a material breach upon which termination of this Agreement may be based.
13.
Insurance
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
.
9
Attachment to REGS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
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.
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.
10
Attachment to REGS.LAB.023
Attachment A
Clinical Laboratory Services 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.
O. Not Excluded from Federal Health Care Programs. Each party represents and
warrants to the other that it (i) is not currently excluded, debarred, or otherwise ineligible
to participate in the federal health care programs as defined in 42 U.S.C. §1320a-7b(f)
(the “federal health care programs”); (ii) is not convicted of a criminal offense related to
the provision of health care items or services and has not been excluded, debarred or
otherwise declared ineligible to participate in the federal health care programs; and, (iii)
is not under investigation or otherwise aware of any circumstances that may result in it
being excluded from participation in the federal health care programs. This shall be an
ongoing representation and warranty during the term of the Agreement. Either party shall
immediately notify the other of any change in the status of the representation and
warranty set forth in this Addendum. Any breach of this Addendum shall give the other
party the right to terminate the Agreement immediately for cause.
15.
Notice
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
11
Attachment to REGS.LAB.023
Attachment A
Clinical Laboratory Services Agreement
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:
Date: _______________________________
Date: _______________________________
12
Attachment to REGS.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 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.
13
Attachment to REGS.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.
14
Attachment to REGS.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:_________________________________
Date: _______________________________
Hospital Address:
_____________________________________
_____________________________________
_____________________________________
Physician:
Physician Address:
_____________________________________
_____________________________________
_____________________________________
15
Attachment to REGS.LAB.023
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