NOTICE OF SOLICITATION
SERIAL #: PH RFP 12-023
REQUEST FOR PROPOSAL FOR:
BREAST AND CERVICAL CANCER EARLY DETECTION
SCREENING, DIAGNOSTIC, & TREATMENT SERVICES
Notice is hereby given that sealed proposals will be received by the Maricopa County Department of Public Health,
4041 N. Central Avenue, #1400, Phoenix, AZ 85012, until 2:00 P.M. Arizona time on FEBRUARY 24, 2012 for
the furnishing of the following services for Maricopa County. Proposals will be opened by the Public Health
Procurement Officer (or designated representative) at an open, public meeting at the above time and place.
To participate in this solicitation process, vendors shall register through BidSync.com. To register with BidSync,
please go to www.BidSync.com and click on the orange ‘Register’ link. Registration has no cost, and will allow you
to access all of the proposal information, proposal documents, and receive proposal notifications.
For assistance with registration, please contact BidSync Vendor Support Department via phone or email, during
regular business hours: 1-800-990-9339 or agencysupport@BidSync.com
All Proposals must be signed, sealed and addressed to the Maricopa County Department of Public Health, 4041 N.
Central Avenue, #1400, Phoenix, AZ 85012, and marked “SERIAL #: PH RFP 12-023 REQUEST FOR
PROPOSAL FOR: BREAST AND CERVICAL CANCER EARLY DETECTION SCREENING,
DIAGNOSTIC, & TREATMENT SERVICES.”
The Maricopa County Procurement Code (“The Code”) governs this procurement and is incorporated by this
reference. Any protest concerning this Request for Proposal must be filed with the Procurement Officer in
accordance with Section MC1-905 of the Code.
ALL ADMINISTRATIVE INFORMATION CONCERNING THIS REQUEST FOR PROPOSAL CAN BE
LOCATED AT http://www.maricopa.gov/materials
ANY ADDENDA TO THIS REQUEST FOR PROPOSAL WILL BE POSTED THROUGH THE
MARICOPA COUNTY MATERIALS MANAGEMENT WEB SITE AS WELL AS ONLINE AT
WWW.BIDSYNC.COM.
PROPOSAL ENVELOPES WITH INSUFFICIENT POSTAGE WILL NOT BE ACCEPTED BY THE
MARICOPA COUNTY DEPARTMENT OF PUBLIC HEALTH
DIRECT ALL INQUIRIES TO:
CHERYL RENTSCHELER
PROCUREMENT OFFICER
TELEPHONE: (602) 506-6886
EMAIL: cherylrentscheler@mail.maricopa.gov
NOTE: MARICOPA COUNTY PUBLISHES ITS SOLICITATIONS ONLINE AND THEY ARE AVAILABLE
FOR VIEWING AND/OR DOWNLOADING AT THE FOLLOWING INTERNET ADDRESS:
http://www.maricopa.gov/Materials/solicitation.aspx
Page 1 of 73
SERIAL #: PH RFP 12-023
TABLE OF CONTENTS
NOTICE
TABLE OF CONTENTS
SECTIONS:
1.0
INTENT
2.0
BACKGROUND
3.0
WWHP ELIGIBILITY
4.0
SCOPE OF WORK
5.0
SPECIAL TERMS & CONDITIONS
ATTACHMENTS:
ATTACHMENT A
PRICING
ATTACHMENT B
AGREEMENT/SIGNATURE PAGE
ATTACHMENT C
REFERENCES
EXHIBITS:
EXHIBIT 1
VENDOR REGISTRATION PROCEDURES
EXHIBIT 2
LETTER OF TRANSMITTAL SAMPLE
EXHIBIT 3
WWHP CLINICAL GUIDELINES
EXHIBIT 4
SCHEDULE A
Page 2 of 73
SERIAL #: PH RFP 12-023
REQUEST FOR PROPOSAL FOR:
1.0
BREAST AND CERVICAL CANCER EARLY DETECTION
SCREENING, DIAGNOSTIC, & TREATMENT SERVICES
INTENT:
The Maricopa County Department of Public Health’s (MCDPH), Well Woman Healthcheck Program
(WWHP) is seeking proposals from qualified primary health care providers and/or institutions (private
practices, multi-specialty practices, hospitals, and other health care provider institutions) with a history of,
or capability of, providing breast and cervical cancer screening, diagnostic, and treatment services to
women 40 years of age and older who are either uninsured or underinsured and whose household income
falls at or below 250% of the Federal Poverty Level Guidelines. Successful candidates will provide breast
and cervical cancer screening exams, including clinical breast exams, screening mammography, breast selfexam education, pelvic exams, and pap smears, and diagnostic services, in accordance with their
capabilities, as well as completion of all program forms. Those with the capacity shall also provide
treatment services. Multiple contracts with successful candidates may be awarded.
Other governmental entities under agreement with the County may have access to services provided
hereunder (see also Section 4.4 below).
The County reserves the right to add additional contractors, at the County’s sole discretion, in cases where
the currently listed contractors are of an insufficient number or skill-set to satisfy the County’s needs or to
ensure adequate competition on any project or task order work.
2.0
BACKGROUND:
The Arizona Department of Health Services, Bureau of Health Systems Development, is funded through a
cooperative agreement with Centers for Disease Control and Prevention (CDC) and the State of Arizona to
provide a statewide breast and cervical cancer screening program, known locally as Well Woman
HealthCheck (WWHP). The WWHP is part of the National Breast and Cervical Cancer Early Detection
Program (NBCCEDP), which was authorized when the U.S. Congress passed the Breast and Cervical
Cancer Mortality Prevention Act of 1990, Public Law 101-354. The Act not only established CDC’s
NBCCEDP; it also provided the foundation of the NBCCEDP’s policies and requirements in regard to the
program eligibility and operations. The Breast and Cervical Cancer Mortality and Prevention Act of 1990
strictly prohibit the use of NBCCEDP funds for cancer treatment. In October 2000, U.S Congress passed
the Breast and Cervical Cancer Prevention and Treatment Act of 2000, Public Law 106-354; this law gives
states the authority to provide optional Medicaid coverage to certain breast and cervical cancer patients. In
the spring of 2001, the Arizona Legislature passed H.B. 2194 that authorizes the Arizona Health Care Cost
Containment System (AHCCCS), effective January 1, 2002, to provide certain women diagnosed through
the WWHP with breast, pre-cancerous cervical lesions and cervical cancer with cancer treatment. To be
eligible for treatment, women must be screened through the Well Woman HealthCheck Program on or after
April 1, 2001, under the age of 65, a resident of Arizona, have no credible health insurance coverage, and
be a U.S. citizen or qualified alien.
3.0
WWHP ELIGIBILITY:
3.1
3.2
To be eligible for breast and cervical cancer screening and diagnostic services under the Well
Woman HealthCheck Program all women regardless of age, must be between 101% and 250% of
the Federal Poverty Level guidelines; a resident of Arizona for at least one-day with the intention
of establishing permanent residence in Arizona; and be uninsured or under-insured. Under-insured
is defined as health insurance that does not cover preventative healthcare, or the co pay exceeds
$100.00. The women enrolled in the WWHP must mirror the racial/ethnic demographics of the
county in which the program resides.
Women 65 years of age or older: Women 65 years of age or older who do not have Medicare Part
B may be enrolled. Women with an intact cervix or history of cervical neoplasia are eligible to
receive a Pap test screening in accordance to the WWHP cervical screening policy. The annual
clinical breast examination and pelvic examination are included in the office visit reimbursement,
an allowable expense that may be included in the Contractor’s Expense Report. However, if
diagnosed with cancer this population of women are not eligible to receive treatment services
under the Breast and Cervical Cancer Prevention and Treatment Act 2000. These women, when
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SERIAL #: PH RFP 12-023
3.3
3.4
3.5
possible, should be referred to healthcare organizations or agencies providing benefits provided
under Medicare Parts A and B. If a client is unable to pay Medicare premiums, she may be eligible
for assistance under AHCCCS.
Women 50-64 years of age: Women 50-64 years of age are the priority population for
mammography screening services. Women 50 years of age and older must account for 75% of the
mammography services utilizing funding provided to WWHP contractors. The focus for this
priority population includes screening with initial program Pap tests who have rarely (within the
past 3 years) or never been screened for cervical cancer.
Women 40-49 years of age: Mammography services, utilizing State funding, will be provided to
women 40-49 years of age. Women with an intact cervix or history of cervical neoplasia are
eligible to receive Pap test screening in accordance with the WWHP cervical screening policy.
The annual clinical breast examination and pelvic examination are included in the office visit
reimbursement.
Women under 40 years of age: Women less than 40 years of age may only be enrolled for breast
cancer screening and diagnostic services if they exhibit clinically confirmed symptoms of breast
cancer. Breast Cancer symptoms include:
 Painless lump or mass
 Spontaneous, unilateral, serous or serosanguinous nipple discharge
 Spontaneous, unilateral, bloody nipple discharge
 Dermatitis of nipple/areola
 Change in contour of breast
 Dimpling of the breast skin
 Nipple retraction (this does not include women with a history of inverted nipples)
 Fixation of a mass to the chest wall or adjacent tissue
 Edema and erythema of breast skin
 Axillary adenopathy
Once the client’s abnormality has been resolved and the recommendation is to return to routine
screening intervals the client should be removed from WWHP rolls and referred t the local Title V
(Maternal and Child Health Service Block Grant) or Title X (Arizona Family Planning) program.
Women 21-64 years of age may be screened for cervical cancer.
4.0
SCOPE OF WORK:
4.1
SERVICE REQUIREMENTS:
4.1.1
SCREENING SERVICES: The Contractor shall provide the following breast and cervical
cancer screening services: Breast - annual clinical breast examination (CBE) and
screening mammography; Cervical - pelvic examination and Pap smear. All services shall
be completed in accordance with the WWHP Clinical Guidelines (Exhibit 3).
4.1.2
DIAGNOSTIC SERVICES: The Contractor shall provide the following diagnostic
services, as appropriate, using the recommendations provided in the WWHP Clinical
Guidelines, for women with abnormal screening results: diagnostic mammography;
breast ultrasound, fine needle aspiration biopsy, excisional biopsy, surgical consultation,
colposcopy, colposcopy-directed biopsy, endocervical curettage (ECC), endometrial
biopsy (EMB), cold knife conization (CKC), and diagnostic LEEP. If the Contractor does
not have the capacity to perform diagnostic services, the Contractor shall maintain a
contract with another provider who will provide the necessary diagnostic services.
4.1.3
The Contractor shall submit a request to the MCWWHP case manager for authorization
prior to obtaining a surgical consultation or performing advanced diagnostic procedures,
including breast biopsy, endometrial biopsy, cold knife conization CKC) or LEEP.The
contractor may perform diagnostic mammogram, breast ultrasound, colposcopy, ECC, or
cervical biopsy without prior authorization from the MCWWHP case manager.
4.1.4
TREATMENT SERVICES: The Contractor shall provide treatment services, such as
radiation, chemotherapy, lumpectomy, mastectomy, or LEEP, in accordance with the
Contractor’s capacity to do so.
4.1.5
Treatment is covered for eligible legal citizens of the United States and qualified aliens
by the Breast and Cervical Cancer Treatment Program (BCCTP), through the Arizona
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SERIAL #: PH RFP 12-023
4.1.6
4.1.7
4.1.8
4.1.9
4.1.10
4.1.11
4.1.12
4.1.13
4.1.14
4.1.15
Health Care Cost Containment System (AHCCCS). For clients diagnosed with
abnormalities of the breast or cervix, who are not eligible for BCCTP, contractors are
responsible for entering into a sliding fee scale agreement based on the woman’s income
and ability to pay or making appropriate referrals to other providers willing to donate or
enter into a sliding scale agreement with clients.
The Contractor must be an AHCCCS registered provider. In the event that a woman’s
diagnostic work-up is positive for cancer or pre-cancerous cervical lesions, and the client
has been approved for BCCTP through AHCCCS, AHCCCS will cover the cost of
treatment and diagnostic procedures and can pay AHCCCS registered providers directly
for services rendered.
The Contractor shall use an effective system to schedule client appointments in a timely
manner and notify them about test results and when follow-up appointments are
necessary.
The Contractor shall provide client test results to MCWWHP case managers in a timely
manner and collaborate with them to provide appropriate and timely follow-up to clients
with abnormal screening results. To assure quality and meet CDC requirements, the
Contractor shall comply with the following:
4.1.8.1 The time from screening to diagnosis, or a recommendation to return to routine
screening, shall be 60 or less calendar days. If this time frame is not met,
services will not be reimbursed.
4.1.8.2 The time from diagnosis to treatment start for breast cancer and invasive
cervical cancer shall be 60 or less calendar days. The time from diagnosis to
treatment start for cervical lesions requiring treatment shall be 90 or less
calendar days. If this time frame is not met, services will not be reimbursed.
The Contractor shall submit to the WWHP manager complete, accurate, and legible
copies of all data requirements and program forms within 30 days from the completion of
the screening and/or diagnostic follow-up and/or treatment procedure/exam. The
Contractor shall respond to all requests for missing or incomplete data within 48 hours
after the request has been made.
The contract amount is not a guaranteed amount. Each Contractor will be given a funding
amount at the beginning of the fiscal year which is their actual budgeted amount.
Contractors are responsible for tracking expenditures from their funding amount on an
ongoing basis. Contractors may request an increase to their funding amount anytime
throughout the year prior to reaching their funding limit, by emailing a request to the
MCWWHP program manager. Requests will be reviewed and may be approved if funds
are available. Contractors will not be reimbursed for services that exceed their funding
amount.
The Contractor shall attend required MCDPH WWHP meetings.
The Contractor shall maintain an ongoing tracking of “in-kind match.” “In-kind match” is
defined as non-federally funded, materials, services, and time that directly support
WWHP activities. “In-kind match” is NOT TO INCLUDE treatment services. Completed
“in-kind match” contribution information needs to be submitted quarterly in October (for
July-September), January (for October-December), April (for January-March) and
August (for the April-June).
Contractors must be willing to accept compensation for each enrollee on a fee for service
basis, based on Medicare Part B allowable costs. Women enrolled in WWHP shall not be
charged for covered services. Reimbursement rates are formulated annually by the CDC
(Exhibit 4). An updated schedule of maximum reimbursement rates will be provided to
the Contractor after the rates are received by MCDPH from the CDC in April.
If a woman needs a diagnostic or treatment service that is not a covered service under this
program, the Contractor will provide services applying the AHCCCS rate.
The Contractor shall submit to annual audits of provider performance and implement
plans to ensure that quality standards are followed for mammography and cytology
procedures, as well as for program policy and procedures. Quality standards shall
include:
4.1.15.1 The Contractor will obtain and maintain the following current documents:
license(s) or certification(s), and liability insurance. This information may be
requested as expiration dates occur.
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SERIAL #: PH RFP 12-023
4.1.16
4.1.17
4.2
4.1.15.2 Personnel: If Physicians are providing services under this contract they shall be
either an M.D. or D.O. and be currently licensed under the provisions of the
Arizona Revised Statutes, Title 32, Chapter 13 or 17. Midlevel personnel
providing services shall be registered, licensed or board certified in Arizona in
their respective fields, as applicable under the provisions of the Arizona Revised
Statues, Title 32, Chapter 15 (nurse practitioners) or Chapter 25 (physician’s
assistants).
4.1.15.3 Facility: (1) All mammography facilities used by the contractor and its
subcontractors shall be certified by the Food and Drug Administration in
compliance with the Mammography Quality Standards Acts of 1992, maintain
annual American College of Radiology (ACR) accreditation, and be inspected
annually by the Arizona Radiation Regulatory Agency in accordance with
Arizona State Statute. To be approved for payment by the Office/WWHP, all
reports must be submitted using the language of the ACR lexicon, also known as
BI-RADS™. (2) All laboratory facilities used by the contractor and its
subcontractors shall adhere to the standards of the Clinical Laboratory
Improvement Act (CLIA) (1988), and maintain the appropriate CLIA
certification. To be approved for payment by the MCWWHP, all Pap test reports
must be submitted using the Bethesda System (TBS) of reporting.
The Contractor shall respond within 48 hours to communications concerning quality
assurance issues.
Special consideration will be given to facilities with a history of outreach and service
delivery to the target population and women’s health care programs. Preference will be
given to those providers targeting uninsured or underinsured women, women at or below
250% of the Federal Poverty Level, those who do not qualify for other programs, those
who are 40 years of age or older, and to facilities that are located to best provide
geographic coverage to Maricopa County. Preference will also be given to facilities that
have bilingual (English/Spanish or English/Asian language) staff persons.
COMPENSATION/FEES:
Compensation shall be on a fee for service basis as determined by Medicare’s allowable
compensation costs for annual breast and cervical screening services (Exhibit 4). No minimum
number of clients is guaranteed. Payment will occur after all required data and program forms are
submitted and approved within the required 30 day timeframe. The following is a list of typical
services:
4.2.1
Clinical breast examination
4.2.2
Pelvic examination
4.2.3
Unilateral Mammogram
4.2.4
Bilateral Mammogram
4.2.5
Breast ultrasound
4.2.6
Aspiration of cysts of breast
4.2.7
Biopsy of breast, needle core (surgical procedure only) and pathology
4.2.8
Incisional biopsy of breast and pathology
4.2.9
Excisional breast biopsy
4.2.10 Fine Needle Aspiration with/without preparation of smears and pathology
4.2.11 Pap smear, reported in Bethesda
4.2.12 Colposcopy without biopsy
4.2.13 Colposcopy with biopsy and/or endocervical curettage surgical procedure only and
Pathology
4.2.14 Endocervical Curettage (ECC)
4.2.15 Endometrial biopsy (EMB)
4.2.16 Cold Knife Conization (CKC)
4.2.17 Diagnostic LEEP (loop electrode excision procedure)
4.2.18 Consultation visit – 20 minutes face to face with patient
4.2.19 Appropriate referral for treatment, as needed, to providers willing to donate or enter into
a sliding scale agreement with clients.
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SERIAL #: PH RFP 12-023
4.3
INVOICES AND PAYMENTS:
4.3.1
The Contractor shall submit completed minimum data elements (MDE)s along with
supporting documentation such as lab reports, progress/diagnostic work-up notes, and/or
pathology reports within 30 days following services. Reimbursement will be denied for
services billed after 45 days of the date of service.
4.3.2
The Contractor is solely responsible for its own corporate medical direction, promotion,
advertising, revenue disbursement, information systems, oversight, personnel/human
resources, administrative services, and any and all tasks, duties, and expenses related to
or associated with their corporate operation.
4.3.3
The Contractor shall be responsible for any and all taxes, permit, or authorizations that
may be required by laws of the federal, state, or local government.
4.3.4
The Respondent shall submit two (2) legible copies of their detailed invoice before
payment(s) can be made. At a minimum, the invoice must provide the following
information:

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
4.4
Company name, address and contact
County bill-to name and contact information
Contract Serial Number
County purchase order number
Invoice number and date
Payment terms
Date of service or delivery
Quantity
Contract Item number(s)
Description of Purchase (services)
Pricing per unit of service
Extended price
Total Amount Due
4.3.5
Problems regarding billing or invoicing shall be directed to the using agency as listed on
the Purchase Order
4.3.6
Payment shall be made to the Contractor by Accounts Payable through the Maricopa
County Vendor Express Payment Program. This is an Electronic Funds Transfer (EFT)
process. After Contract Award the Contractor shall complete the Vendor Registration
Form located on the County Department of Finance Vendor Registration Web Site
(http://www.maricopa.gov/finance/vendors).
4.3.7
EFT payments to the routing and account numbers designated by the Contractor will
include the details on the specific invoices that the payment covers. The Contractor is
required to discuss remittance delivery capabilities with their designated financial
institution for access to those details.
TAX: (SERVICES)
No tax shall be levied against labor. It is the responsibility of the Contractor to determine any and
all taxes and include the same in proposal price.
4.5
STRATEGIC ALLIANCE for VOLUME EXPENDITURES ($AVE):
The County is a member of the $AVE cooperative purchasing group. $AVE includes the State of
Arizona, many Phoenix metropolitan area municipalities, and many K-12 unified school districts.
Under the $AVE Cooperative Purchasing Agreement, and with the concurrence of the successful
Respondent under this solicitation, a member of $AVE may access a contract resulting from a
solicitation issued by the County. If you do not want to grant such access to a member of $AVE,
please so state in your proposal. In the absence of a statement to the contrary, the County will
Page 7 of 73
SERIAL #: PH RFP 12-023
assume that you do wish to grant access to any contract that may result from this Request for
Proposal.
5.0
SPECIAL TERMS & CONDITIONS:
5.1
CONTRACT TERM:
This Request for Proposal is for awarding a service contract to cover a three (3) year term.
5.2
OPTION TO RENEW CONTRACT:
The County may, at its option and with the approval of the Contractor, renew the term of this
Contract up to a maximum of two (2) additional years, or other specified length options, (or at the
County’s sole discretion, extend the contract on a month to month basis for a maximum of six (6)
months after expiration). The Contractor shall be notified in writing by the Materials Management
Department of the County’s intention to extend the contract term at least thirty (30) calendar days
prior to the expiration of the original contract term.
5.3
5.4
INDEMNIFICATION:
5.3.1
To the fullest extent permitted by law, Contractor shall defend, indemnify, and hold
harmless County, its agents, representatives, officers, directors, officials, and employees
from and against all claims, damages, losses and expenses, including, but not limited to,
attorney fees, court costs, expert witness fees, and the cost of appellate proceedings,
relating to, arising out of, or alleged to have resulted from the negligent acts, errors,
omissions, mistakes or malfeasance relating to the performance of this Contract.
Contractor’s duty to defend, indemnify and hold harmless County, its agents,
representatives, officers, directors, officials, and employees shall arise in connection with
any claim, damage, loss or expense that is caused by any negligent acts, errors, omissions
or mistakes in the performance of this Contract by the Contractor, as well as any person
or entity for whose acts, errors, omissions, mistakes or malfeasance Contractor may be
legally liable.
5.3.2
The amount and type of insurance coverage requirements set forth herein will in no way
be construed as limiting the scope of the indemnity in this paragraph.
5.3.3
The scope of this indemnification does not extend to the sole negligence of County.
INSURANCE REQUIREMENTS:
5.4.1
Contractor, at Contactor’s own expense, shall purchase and maintain the herein stipulated
minimum insurance from a company or companies duly licensed by the State of Arizona
and possessing a current A.M. Best, Inc. rating of A-, VII or higher. In lieu of State of
Arizona licensing, the stipulated insurance may be purchased from a company or
companies, which are authorized to do business in the State of Arizona, provided that
said insurance companies meet the approval of County. The form of any insurance
policies and forms must be acceptable to County.
5.4.2
All insurance required herein shall be maintained in full force and effect until all work or
service required to be performed under the terms of the Contract is satisfactorily
completed and formally accepted. Failure to do so may, at the sole discretion of County,
constitute a material breach of this Contract.
5.4.3
Contractor’s insurance shall be primary insurance as respects County, and any insurance
or self-insurance maintained by County shall not contribute to it.
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5.4.4
Any failure to comply with the claim reporting provisions of the insurance policies or any
breach of an insurance policy warranty shall not affect the County’s right to coverage
afforded under the insurance policies.
5.4.5
The insurance policies may provide coverage that contains deductibles or self-insured
retentions. Such deductible and/or self-insured retentions shall not be applicable with
respect to the coverage provided to County under such policies. Contactor shall be solely
responsible for the deductible and/or self-insured retention and County, at its option, may
require Contractor to secure payment of such deductibles or self-insured retentions by a
surety bond or an irrevocable and unconditional letter of credit.
5.4.6
County reserves the right to request and to receive, within 10 working days, certified
copies of any or all of the herein required insurance certificates. County shall not be
obligated to review policies and/or endorsements or to advise Contractor of any
deficiencies in such policies and endorsements, and such receipt shall not relieve
Contractor from, or be deemed a waiver of County’s right to insist on strict fulfillment of
Contractor’s obligations under this Contract.
5.4.7
The insurance policies required by this Contract, except Workers’ Compensation, and
Errors and Omissions, shall name County, its agents, representatives, officers, directors,
officials and employees as Additional Insureds.
5.4.8
The policies required hereunder, except Workers’ Compensation, and Errors and
Omissions, shall contain a waiver of transfer of rights of recovery (subrogation) against
County, its agents, representatives, officers, directors, officials and employees for any
claims arising out of Contractor’s work or service.
5.4.9
Commercial General Liability.
Commercial General Liability insurance and, if necessary, Commercial Umbrella
insurance with a limit of not less than $1,000,000 for each occurrence, $2,000,000
Products/Completed Operations Aggregate, and $2,000,000 General Aggregate Limit.
The policy shall include coverage for bodily injury, broad form property damage,
personal injury, products and completed operations and blanket contractual coverage, and
shall not contain any provision which would serve to limit third party action over claims.
There shall be no endorsement or modification of the CGL limiting the scope of coverage
for liability arising from explosion, collapse, or underground property damage.
5.4.10
Automobile Liability.
Commercial/Business Automobile Liability insurance and, if necessary, Commercial
Umbrella insurance with a combined single limit for bodily injury and property damage
of not less than $1,000,000 each occurrence with respect to any of the Contractor’s
owned, hired, and non-owned vehicles assigned to or used in performance of the
Contractor’s work or services under this Contract.
5.4.11
Workers’ Compensation.
5.4.11.1 Workers’ Compensation insurance to cover obligations imposed by federal and
state statutes having jurisdiction of Contractor’s employees engaged in the
performance of the work or services under this Contract; and Employer’s
Liability insurance of not less than $100,000 for each accident, $100,000 disease
for each employee, and $500,000 disease policy limit.
5.4.11.2 Contractor waives all rights against County and its agents, officers, directors and
employees for recovery of damages to the extent these damages are covered by
the Workers’ Compensation and Employer’s Liability or commercial umbrella
liability insurance obtained by Contractor pursuant to this Contract.
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5.4.12
Errors and Omissions Insurance.
Errors and Omissions insurance and, if necessary, Commercial Umbrella insurance,
which will insure and provide coverage for errors or omissions of the Contractor, with
limits of no less than $1,000,000 for each claim.
5.4.13
Certificates of Insurance.
5.4.13.1 Prior to commencing work or services under this Contract, Contractor shall have
insurance in effect as required by the Contract in the form provided by the
County, issued by Contractor’s insurer(s), as evidence that policies providing the
required coverage, conditions and limits required by this Contract are in full
force and effect. Such certificates shall be made available to the County upon
48 hours notice.
BY SIGNING THE AGREEMENT PAGE THE
CONTRACTOR AGREES TO THIS REQUIREMENT AND FAILURE TO
MEET THIS REQUIREMENT WILL RESULT IN CANCELLATION OF
CONTRACT.
5.4.13.1.1 In the event any insurance policy (ies) required by this contract is
(are) written on a “claims made” basis, coverage shall extend for two
years past completion and acceptance of Contractor’s work or
services and as evidenced by annual Certificates of Insurance.
5.4.13.1.2 If a policy does expire during the life of the Contract, a renewal
certificate must be sent to County fifteen (15) days prior to the
expiration date.
5.4.14
Cancellation and Expiration Notice.
Insurance required herein shall not be permitted to expire, be canceled, or materially
changed without thirty (30) days prior written notice to the County.
5.5
LICENSURE/CERTIFICATION
5.5.1
5.5.2
5.5.3
5.6
Contractor shall comply with all applicable provisions of law and other rules and
regulations of any and all governmental, accrediting and/or regulatory authorities relating
to the licensure and regulation of health care providers and physicians.
Upon request, Contractor agrees to allow County, to the extent permitted by law, access
to credentials of Qualified Physicians and Qualified Providers who are providing services
to Department under the terms and conditions of this Contract.
Contractor expressly agrees that it shall comply with all rules, regulations, orders, standards
and interpretations promulgated pursuant to the Occupational Safety and Health Act of
1970 (and to the Occupational and Safety Health Act of the State of Arizona), including but
not limited to training, provision of personal protective equipment, provision of postexposure prophylaxis, adherence to appropriate lock out/tag out procedures, and providing
all notices, material safety data sheets, labels, etc. required by the right-to-know-standard.
ACCESS TO AND RETENTION OF RECORDS FOR THE PURPOSE OF AUDIT AND/OR
OTHER REVIEW:
5.6.1
In accordance with section MCI 367 of the Maricopa County Procurement Code the
Contractor agrees to retain all books, records, accounts, statements, reports, files, and
other records and back-up documentation relevant to this Contract for six (6) years after
final payment or until after the resolution of any audit questions which could be more
than six (6) years, whichever is latest. The County, Federal or State auditors and any
other persons duly authorized by the Department shall have full access to, and the right to
examine, copy, and make use of, any and all said materials.
Page 10 of 73
SERIAL #: PH RFP 12-023
5.6.2
5.7
5.8
If the Contractor’s books, records , accounts, statements, reports, files, and other records
and back-up documentation relevant to this Contract are not sufficient to support and
document that requested services were provided, the Contractor shall reimburse Maricopa
County for the services not so adequately supported and documented.
SUBCONTRACTING:
5.7.1
The Contractor may not assign a Contract or Subcontract to another party for
performance of the terms and conditions hereof without the written consent of the
County. All correspondence authorizing subcontracting must reference the Bid Serial
Number and identify the job project.
5.7.2
The Subcontractor’s rate for the job shall not exceed that of the Prime Contractor’s rate,
as bid in the pricing section, unless the Prime Contractor is willing to absorb any higher
rates. The Subcontractor’s invoice shall be invoiced directly to the Prime Contractor,
who in turn shall pass-through the costs to the County, without mark-up. A copy of the
Subcontractor’s invoice must accompany the Prime Contractor’s invoice.
SCHEDULE OF EVENTS:
Request for Proposals Issued:
January 27, 2012
Deadline for written questions is February 13, 2012. Questions will not be responded to after the
deadline has elapsed. All questions and answers shall be posted to www.bidsync.com under the
Q&A’s tab for the solicitation and must be received by 2:00 PM Arizona time.
Proposals Opening Date:
February 24, 2012
Deadline for submission of proposals is 2:00 P.M., Arizona Time, on FEBRUARY 24, 2012. All
proposals must be received before 2:00 P.M., Arizona Time, on the above date at the Maricopa
County Department of Public Health, 4041 N. Central Avenue, #1400, Phoenix, AZ 85012.
Proposed review of Proposals and short list decision:
February 24 – March 2, 2012
Proposed selection and negotiation:
March 2 – March 9, 2012
Proposed Best & Final (if required)
March 9 – March 16, 2012
Proposed award of Contract:
April 11, 2012
All responses to this Request for Proposal become the property of Maricopa County and (other
than pricing) will be held confidential, to the extent permissible by law. The County will not be
held accountable if material from proposal responses is obtained without the written consent of the
Respondent by parties other than the County.
5.9
INQUIRIES AND NOTICES:
All inquiries concerning information herein shall be addressed to:
Maricopa County
Department of Public Health
Attn: Cheryl Rentscheler
4041 N. Central Avenue, #1400
Phoenix, AZ 85012
Administrative telephone inquiries shall be addressed to:
Cheryl Rentscheler, Procurement Officer, 602.506.6886
Page 11 of 73
SERIAL #: PH RFP 12-023
(cherylrentscheler@mail.maricopa.gov)
Inquiries may be submitted by telephone but must be followed up in writing.
communication is binding on Maricopa County.
5.10
No oral
INSTRUCTIONS FOR PREPARING AND SUBMITTING PROPOSALS:
Respondents shall provide their proposals in accordance with Section 5.13 as follows:
5.10.1
One (1) original hardcopy of all proposal documents.
5.10.2
One (1) CD or flash drive providing all proposal documents in their original version
(Word, Excel, etc.) as well as all proposal documents in PDF format.
5.10.3
Five (5) CD’s or flash drives providing the entire proposal in PDF format only.
5.10.4
Respondents shall address proposals identified with return address, serial number and
title in the following manner:
Maricopa County
Department of Public Health
Attn: Cheryl Rentscheler
4041 N. Central Avenue, #1400
Phoenix, AZ 85012
SERIAL #: PH RFP 12-023, BREAST AND CERVICAL CANCER EARLY
DETECTION SCREENING, DIAGNOSTIC, & TREATMENT SERVICES
5.10.5
5.11
Proposals shall be signed by an owner, partner or corporate official who has been
authorized to make such commitments. All prices shall be held firm for a period of one
hundred fifty (150) days after the RFP closing date.
EXCEPTIONS TO THE SOLICITATION:
The Respondent shall identify and list all exceptions taken to all sections of PH RFP 12-023 and
list these exceptions referencing the section (paragraph) where the exception exists and identify
the exceptions and the proposed wording for the Respondent’s exception under the heading,
“Exception to the PROPOSAL Solicitation, SERIAL #: PH RFP 12-023.” Exceptions that
surface elsewhere and that do not also appear under the heading, “Exceptions to the
PROPOSAL Solicitation, SERIAL #: PH RFP 12-023,” shall be considered invalid and void
and of no contractual significance.
The County reserves the right to reject, determine the proposal non-responsive, enter into
negotiation on any of the Respondent exceptions, or accept them outright.
5.12
5.13
GENERAL CONTENT:
5.12.1
The Proposal should be specific and complete in every detail. It should be practical and
provide a straightforward, concise delineation of capabilities to satisfactorily perform the
Contract being sought.
5.12.2
The Respondent should not necessarily limit the proposal to the performance of the
services in accordance with this Request for Proposal but should outline any additional
services and their costs if the Respondent deems them necessary to accomplish the
program.
FORMAT AND CONTENT:
Page 12 of 73
SERIAL #: PH RFP 12-023
To aid in the evaluation, it is desired that all proposals follow the same general format. The
proposal hardcopy must be submitted in binders and have sections tabbed as below: (Responses
are limited to 20 pages, single sided, 10 point font type).
5.14
5.13.1
Table of Contents
5.13.2
Letter of Transmittal
5.13.3
Qualifications and Experience – This section shall describe the respondent’s ability and
experience related to the programs and services proposed. All project personnel, as
applicable, shall be listed including a description of assignments and responsibilities, a
resume of professional experience, an estimate of the time each would devote to this
program, and other pertinent information. Copies of licenses, accreditation certification,
evidence of status as an AHCCCS registered provider, and other pertinent documents
shall also be included. Include prior history or capability of providing breast and cervical
cancer screening, and diagnostic services, especially those provider institutions with
established women’s health and outreach programs.
5.13.4
Services to Be Provided - This section should contain a statement of all of the services
proposed, Identify the breast and cervical cancer screening services you intend to
provide as well as which diagnostic services you intend to provide. If you will be
contracting diagnostic services through another provider, identify the provider and the
services they will provide. Specify the number of women for annual and diagnostic
services your organization is able and willing to handle on a weekly/annual basis. If
applicable, also identify the treatment services that you have the capacity to provide. If
you do not have the capacity to provide treatment services, please identify the provider or
agency to whom you will refer women for treatment.
5.13.5
Approach – This section shall contain an outline of the general approach you shall utilize.
Fully explain your established ability or plan to reach the target population of whom 75%
are 50 years of age or older. Include detailed plans for tracking and retaining enrollees
over a 12-month period so as to have them return for an annual exam to include all the
above mentioned services. Describe strategies for scheduling client appointments in a
timely manner. Explain plan for providing test results to WWHP case managers in a
timely manner. Describe process for ensuring timely follow-up of women with abnormal
results to ensure that CDC timeframe requirements for screening to diagnosis and
diagnosis to treatment are met. Describe plan for submitting completed program forms,
and results within 30 days after screening and diagnostic procedures/exams.
5.13.6
Proposal exceptions
5.13.7
Attachment A (Pricing)
5.13.8
Attachment B (Agreement Page)
5.13.9
Attachment C (References)
EVALUATION OF PROPOSAL – SELECTION FACTORS:
A Proposal Evaluation Committee shall be appointed, chaired by the Procurement Officer to evaluate
each Proposal. At the County’s option, Respondents may be invited to make presentations to the
Evaluation Committee. Best and Final Offers and/or Negotiations may be conducted, as needed, with
the highest rated Respondent(s). Proposals will be evaluated on the following criteria which are listed
descending order of importance:
5.14.1
5.14.2
Qualifications and Experience
Approach
Page 13 of 73
SERIAL #: PH RFP 12-023
5.14.3
Services to be provided – preference will be given to providers in the following zip
codes: 85021, 85032, 85050, 85254, 85260, 85331, 85335, 85370, 85374, 85379 and
surrounding areas. Preference will also be given to providers who are able to perform
treatment services or have a well-established network for treatment referrals.
5.15
CERTIFICATION REGARDING DEBARMENT AND SUSPENSION:
5.15.1 The undersigned (authorized official signing for the Contractor) certifies to the best of his
or her knowledge and belief, that the Contractor, defined as the primary participant in
accordance with 45 CFR Part 76, and its principals:
5.15.1.1 are not presently debarred, suspended, proposed for debarment, declared
ineligible, or voluntarily excluded from covered transactions by any Federal
Department or agency;
5.15.1.2 have not within 3-year period preceding this Contract been convicted of or had a
civil judgment rendered against them for commission of fraud or a criminal
offense in connection with obtaining, attempting to obtain, or performing a
public (Federal, State or local) transaction or contract under a public transaction;
violation of Federal or State antitrust statues or commission of embezzlement,
theft, forgery, bribery, falsification or destruction of records, making false
statements, or receiving stolen property;
5.15.1.3 are not presently indicted or otherwise criminally or civilly charged by a
government entity (Federal, State or local) with commission of any of the
offenses enumerated in paragraph (2) of this certification; and
5.15.1.4 have not within a 3-year period preceding this Contract had one or more public
transaction (Federal, State or local) terminated for cause of default.
5.15.2 Should the Contractor not be able to provide this certification, an explanation as to why
should be attached to the Contact.
5.15.3 The Contractor agrees to include, without modification, this clause in all lower tier
covered transactions (i.e. transactions with subcontractors) and in all solicitations for
lower tier covered transactions related to this Contract.
5.16
VERIFICATION REGARDING COMPLIANCE WITH ARIZONA REVISED STATUTES §414401 AND FEDERAL IMMIGRATION LAWS AND REGULATIONS:
5.16.1 By entering into the Contract, the Contractor warrants compliance with the Immigration
and Nationality Act (INA using e-verify) and all other federal immigration laws and
regulations related to the immigration status of its employees and A.R.S. §23-214(A). The
contractor shall obtain statements from its subcontractors certifying compliance and shall
furnish the statements to the Procurement Officer upon request. These warranties shall
remain in effect through the term of the Contract. The Contractor and its subcontractors
shall also maintain Employment Eligibility Verification forms (I-9) as required by the
Immigration Reform and Control Act of 1986, as amended from time to time, for all
employees performing work under the Contract and verify employee compliance using the
E-verify system and shall keep a record of the verification for the duration of the
employee’s employment or at least three years, whichever is longer. I-9 forms are available
for download at USCIS.GOV.
5.16.2 The County retains the legal right to inspect contractor and subcontractor employee
documents performing work under this Contract to verify compliance with paragraph 5.16.1
of this Section. Contractor and subcontractor shall be given reasonable notice of the
County’s intent to inspect and shall make the documents available at the time and date
specified. Should the County suspect or find that the Contractor or any of its subcontractors
are not in compliance, the County will consider this a material breach of the contract and
may pursue any and all remedies allowed by law, including, but not limited to: suspension
of work, termination of the Contract for default, and suspension and/or debarment of the
Contractor. All costs necessary to verify compliance are the responsibility of the
Contractor.
5.17
VERIFICATION REGARDING COMPLIANCE WITH ARIZONA REVISED STATUTES
§§35-391.06 AND 35-393.06 BUSINESS RELATIONS WITH SUDAN AND IRAN:
Page 14 of 73
SERIAL #: PH RFP 12-023
5.17.1
5.17.2
By entering into the Contract, the Contractor certifies it does not have scrutinized business
operations in Sudan or Iran. The contractor shall obtain statements from its subcontractors
certifying compliance and shall furnish the statements to the Procurement Officer upon
request. These warranties shall remain in effect through the term of the Contract.
The County may request verification of compliance for any contractor or subcontractor
performing work under the Contract. Should the County suspect or find that the Contractor
or any of its subcontractors are not in compliance, the County may pursue any and all
remedies allowed by law, including, but not limited to: suspension of work, termination of
the Contract for default, and suspension and/or debarment of the Contractor. All costs
necessary to verify compliance are the responsibility of the Contractor.
5.18
CONTRACTOR LICENSE REQUIREMENT:
5.18.1 The Respondent shall procure all permits, insurance, licenses and pay the charges and
fees necessary and incidental to the lawful conduct of his/her business, and as necessary
complete any required certification requirements, required by any and all governmental
or non-governmental entities as mandated to maintain compliance with and in good
standing for all permits and/or licenses. The Respondent shall keep fully informed of
existing and future trade or industry requirements, Federal, State and Local laws,
ordinances, and regulations which in any manner affect the fulfillment of a Contract and
shall comply with the same. Contractor shall immediately notify both Materials
Management and the using agency of any and all changes concerning permits, insurance
or licenses.
5.18.2 Respondents furnishing finished products, materials or articles of merchandise that will
require installation or attachment as part of the Contract, shall possess any licenses
required. A Respondent is not relieved of its obligation to posses the required licenses by
subcontracting of the labor portion of the Contract. Respondents are advised to contact
the Arizona Registrar of Contractors, Chief of Licensing, at (602) 542-1502 to ascertain
licensing requirements for a particular contract. Respondents shall identify which
license(s), if any, the Registrar of Contractors requires for performance of the Contract.
5.19
INFLUENCE:
As prescribed in MC1-1202 of the Maricopa County Procurement Code, any effort to influence an
employee or agent to breach the Maricopa County Ethical Code of Conduct or any ethical conduct,
may be grounds for Disbarment or Suspension under MC1-902.
An attempt to influence includes, but is not limited to:
5.19.1
5.19.2
A Person offering or providing a gratuity, gift, tip, present, donation, money,
entertainment or educational passes or tickets, or any type valuable contribution or
subsidy,
That is offered or given with the intent to influence a decision, obtain a contract, garner
favorable treatment, or gain favorable consideration of any kind.
If a Person attempts to influence any employee or agent of Maricopa County, the Chief
Procurement Officer, or his designee, reserves the right to seek any remedy provided by the
Maricopa County Procurement Code, any remedy in equity or in the law, or any remedy provided
by this contract.
5.20
POST AWARD MEETING:
The successful Respondent(s) may be required to attend a post-award meeting with the Using Agency
to discuss the terms and conditions of the Contract. This meeting will be coordinated by the
Procurement Officer of the Contract.
NOTE 1:
RESPONDENTS ARE STRONGLY ENCOURAGED TO REVIEW MARICOPA COUNTY’S
PROCUREMENT ADMINISTRATIVE INFORMATION AND SAMPLE CONTRACT
DOCUMENT PRIOR TO SUBMITTING A PROPOSAL. FOR THIS INFORMATION, GO
TO: http://www.maricopa.gov/Materials
Page 15 of 73
SERIAL #: PH RFP 12-023
NOTE 2:
RESPONDENTS ARE REQUIRED TO USE ATTACHED FORMS TO SUBMIT THEIR
PROPOSAL.
Page 16 of 73
SERIAL #: PH RFP 12-023
ATTACHMENT A
PRICING SHEET
BIDDER NAME:
F.I.D./VENDOR #:
BIDDER ADDRESS:
P.O. ADDRESS:
BIDDER PHONE #:
BIDDER FAX #:
COMPANY WEB SITE:
COMPANY CONTACT (REP):
E-MAIL ADDRESS (REP):
PAYMENT TERMS: BIDDER IS REQUIRED TO SELECT ONE OF THE FOLLOWING:
TERMS WILL BE CONSIDERED IN DETERMINING LOW BID.
FAILURE TO CHOOSE A TERM WILL RESULT IN A DEFAULT TO NET 30.
BIDDER MUST INITIAL THE SELECTION BELOW.
NET 10 ____________________
NET 15 ____________________
NET 20 ____________________
NET 30 ____________________
NET 45 ____________________
NET 60 ____________________
NET 90 ____________________
2% 10 DAYS NET 30
____________________
1% 10 DAYS NET 30
____________________
2% 30 DAYS NET 31
____________________
1% 30 DAYS NET 31
____________________
5% 30 DAYS NET 31
____________________
COMPENSATION/FEES:
Procedures as described in Section 4.2
(As defined herein)
RATE
As determined by Medicare’s allowable costs
(Exhibit 4)
Respondent's signature below indicates understanding and agreement to perform the services outlined in the Request
for Proposal indicated above for the total amounts listed above.
Signature (REQUIRED)
Date
Page 17 of 73
SERIAL #: PH RFP 12-023
ATTACHMENT B
AGREEMENT
Respondent hereby certifies that Respondent has read, understands, and agrees that acceptance by Maricopa County of the
Respondent’s Offer will create a binding Contract. Respondent agrees to fully comply with all terms and conditions as set forth in the
Maricopa County Procurement Code, and amendments thereto, together with the specifications and other documentary forms herewith
made a part of this specific procurement.
BY SIGNING THIS PAGE THE SUBMITTING RESPONDENT CERTIFIES THAT RESPONDENT HAS REVIEWED
THE ADMINISTRATIVE INFORMATION AND DRAFT RFP CONTRACT’S TERMS AND CONDITIONS LOCATED AT
http://www.maricopa.gov/materials. AND AGREE TO BE CONTRACTUALLY BOUND TO THEM.
[]
Small Business Enterprise (SBE)
RESPONDENT (FIRM) SUBMITTING PROPOSAL
FEDERAL TAX ID NUMBER
PRINTED NAME AND TITLE
AUTHORIZED SIGNATURE
ADDRESS
TELEPHONE
DUNS #
/
CITY
WEB SITE
STATE
ZIP
FAX #
DATE
EMAIL ADDRESS
Page 18 of 73
SERIAL #: PH RFP 12-023
ATTACHMENT C
RESPONDENT’S REFERENCES
RESPONDENT SUBMITTING PROPOSAL:
1.
COMPANY NAME:
ADDRESS:
CONTACT PERSON:
TELEPHONE:
2.
E-MAIL ADDRESS:
COMPANY NAME:
ADDRESS:
CONTACT PERSON:
TELEPHONE:
3.
E-MAIL ADDRESS:
COMPANY NAME:
ADDRESS:
CONTACT PERSON:
TELEPHONE:
4.
E-MAIL ADDRESS:
COMPANY NAME:
ADDRESS:
CONTACT PERSON:
TELEPHONE:
5.
E-MAIL ADDRESS:
COMPANY NAME:
ADDRESS:
CONTACT PERSON:
TELEPHONE:
E-MAIL ADDRESS:
Page 19 of 73
EXHIBIT 1
VENDOR REGISTRATION PROCEDURES
BidSync.com Registration is FREE and REQUIRED for all vendors.
Register On-line at https://www.bidsync.com/Links/links-learn
Upon completion of your on-line registration, you are responsible for
updating any changes to your information. Please retain your Login
ID and Password for future use.
For assistance, please contact BidSync Vendor Support
Department via phone or email, during regular business hours: 1800-990-9339 or agencysupport@BidSync.com
Page 20 of 73
SERIAL #: PH RFP 12-023
EXHIBIT 2
SAMPLE TRANSMITTAL LETTER
(To be typed on the letterhead of Offeror)
Maricopa County
Department of Public Health
4041 N. Central Avenue, #1400
Phoenix, AZ 85012
Re:
Serial #: PH RFP 12-023, BREAST AND CERVICAL CANCER EARLY DETECTION SCREENING,
DIAGNOSTIC, & TREATMENT SERVICES
To Cheryl Rentscheler:
(NAME OF COMPANY) (Herein referred to as the "RESPONDENT"), hereby submits its response to your Request for
Proposal dated
, and agrees to perform as proposed in their proposal, if awarded the contract. The
Respondent shall thereupon be contractually obligated to carry out its responsibilities respecting the services proposed.
Kindly advise us in writing on or before
if you should desire to accept this proposal.
Very truly yours,
_______________________________
NAME (please print)
_______________________________
SIGNATURE
_______________________________
TITLE (please print)
Page 21 of 73
SERIAL #: PH RFP 12-023
EXHIBIT 3
Breast
& Cervical
Clinical
Guidelines
Page 22 of 73
SERIAL #: PH RFP 12-023
The Well Woman Healthcheck Program wishes to extend its gratitude and appreciation to the past and current Well
Woman Healthcheck Medical Advisory Board members for their work on the initial version, revision and expansion of
this guide.
Notes about the Well Woman Healthcheck Breast and Cervical Clinical Guidelines
This symbol precedes Well Woman Healthcheck policy, which may not necessarily be representative of standard
breast and cervical screening guidelines for the general population.
Page 23 of 73
SECTION ONE - BREAST HEALTH
Screening is the process to assist in the detection of unsuspected disease in asymptomatic patients. Seventy-five percent
of women with newly diagnosed breast cancer have no identifiable risk.
The methods used for early detection of breast cancer by health providers are clinical breast examination (CBE) and
routine screening mammography. The purpose of mammography screening is to improve breast cancer survival rates
by detecting breast cancer before it is palpable. Screening mammography combined with CBE has been found to
significantly decrease breast cancer mortality for women 50 years of age and older. The American Cancer Society and
the National Cancer Institute recommend screening mammography every year for women 40 years of age and older.
Controversy still exists within the medical community concerning the frequency of mammography examination and the
ages for which to start and stop routine mammography screening. Women younger than 40 years of age should have an
annual clinical breast examination, but they should not undergo routine screening mammography, unless of course they
have risk factors for early-onset breast carcinoma and/or are symptomatic.
Symptoms suggestive of breast cancer include:
 Painless lump or mass
 Spontaneous, unilateral, serous or serosanguinous nipple discharge
 Spontaneous, unilateral, bloody nipple discharge
 Dermatitis of nipple/areola
 Change in contour of breast
 Dimpling of the breast skin
 Nipple retraction (this does not include women with a history of inverted nipples)
 Fixation of a mass to the chest wall or adjacent tissue
 Edema and erythema of breast skin
 Axillary adenopathy
Important points to remember about breast cancer screening:




Normal results on a screening examination do not necessarily indicate absence of disease.
No screening test is 100% accurate; therefore, some cases of the disease may be unavoidably missed.
Normal results of a screening exam should never rule out the later development of disease, which is why
ongoing regular screening is so strongly recommended.
The detection of an abnormality does not mean the abnormality is cancerous. Only about 20 percent of the
women with abnormal screening results will, after further evaluation, be diagnosed with breast cancer.
PATIENT EDUCATION
Written materials regarding clinical breast examination (CBE), breast-self examination (BSE) and mammography
should be provided to the patient to reinforce staff recommendations. Materials should include information in regard to:
BSE techniques and normal findings; indications for calling provider about signs or symptoms of breast cancer;
importance of age-appropriate screening; an explanation of breast screening and diagnostic procedures; and the
limitations of screening exams.
Page 24 of 73
Instruct clients on the day of their mammography appointment to:
 Wear pants or a skirt because she will have to undress from the waist up.
 Instruct her to avoid the use of deodorants, powders or other topical agents on the breasts or in the underarm
areas, because they may cause artifacts on the mammogram.
Breast-self Examination (BSE)
The benefit of breast-self examination (BSE) in the early detection of breast cancer has not been proven. Breast-self
examination should be taught to patients but not overemphasized. If a patient values the role of breast self examination
in breast cancer screening and is comfortable with its use, the practice should be reinforced and encouraged. A woman
who finds a mass or abnormality during BSE should be seen promptly for appropriate clinical evaluation.
RISK ASSESSMENT AND CLINICAL BREAST EXAMINATION (CBE)
A comprehensive breast examination includes: risk assessment, patient history, and a thorough examination.
Risk assessment: age; family history of breast cancer (mother, sisters, daughters) including the age they developed
breast cancer, bilateral or unilateral involvement; family men who had breast cancer; and family who had ovarian
cancer.
Specific history: previous biopsies and the pathology discovered; diagnosis of previous breast, endometrial, ovarian, or
colon cancer; parity, age at first child; age at menarche and menopause; hormone or contraceptive use; the possibility of
current pregnancy; and potential radiation exposure as a child.
Symptom assessment: lumps, pain, nipple discharge, changes in shape, difference between breasts, cyclic tenderness,
and skin changes.
The CBE should occur prior to the patient's mammography appointment to determine the need for routine screening
or diagnostic imaging.
Clinical Breast Examination: The examination should be conducted in a setting allowing for minimal distraction and
adequate patient privacy. Examination gowns should be adjusted to minimize the unnecessary exposure of the patient
being examined. A complete clinical breast examination should take 5-10 minutes. The CBE should occur:
A.) With the Patient Sitting:
 Inspect the breasts for asymmetry, abnormal superficial vascular patterns, dimpling, nipple retraction, and peau
d'orange.
 Palpation of axillary and supraclavicular/infraclavicular nodes. Note size, location mobility, and consistency of
nodes palpated.
Page 25 of 73
Page 26 of 73
A discrete palpable mass should be documented in the examiners notes with specific notation of the following
elements:
 Location (upper outer quadrant; 1 cm. from the nipple)
 Mobility (fixed, mobile)
 Approximate size (1/2 cm. 1 cm.)
 Consistency and tenderness (lump, rubbery, soft, smooth)
 Bloody or serous nipple discharge
 Nipple or areolar scaliness
 Skin dimpling and retraction (puckering, dimpling, thickening)
MAMMOGRAPHY
Screening Mammography - (CPT Code 76092) Is a bilateral procedure performed to detect unsuspected cancer in
asymptomatic women, it is limited to two images, craniocaudal and mediolateral oblique views.
Diagnostic Mammography: Unilateral- (CPT Code 76090) May also be referred to as "additional" or "supplementary"
mammographic views, such as magnification for calcification and/or a coned compression view. A diagnostic
mammogram requires direct physician supervision and interpretive skills. It is used to further investigate suspicious
masses found on physical examination. A unilateral exam is limited to the symptomatic breast.
Diagnostic Mammography; Bilateral- (CPT Code 76091) May also be referred to as "additional" or "supplementary"
mammographic views, such as magnification for calcification and/or a coned compression view. A diagnostic
mammogram requires direct physician supervision and interpretive skills. It is used to further investigate suspicious
masses found on physical examination. A bilateral exam focuses on both breasts.
Seventy-five percent of the women receiving mammography services in the Well Woman Healthcheck Program must
be 50 years of age and older. Twenty-five percent of the women receiving mammography services through the Well
Woman Healthcheck Program may be younger women.
All Well Woman Healthcheck Program patients must have a CBE within six-weeks prior to their scheduled screening
mammography appointment. A routine screening mammography consists of mediolateral oblique and craniocaudal
projections of both breasts.
 Any women with a positive clinical breast examination should be referred for a diagnostic mammogram. The
CBE results should be well documented and forwarded to the referral mammography facility.
 Scheduling mammography services during a patient's menstrual cycle should be avoided due to increased
breast tenderness.
 Women with breast implants should be referred to a radiologist with experience in performing mammography
on these women.
 If the client has had a previous mammogram, request that her films be sent from last mammogram to the
referral mammography facility.
Page 27 of 73
Mammography Facilities
Effective October 1, 1994, all mammography facilities must be certified by the Food and Drug Administration (FDA)
as providing quality mammography. Certification requirements included in the Mammography Quality Standards Act
(MQSA) discuss personnel, equipment, radiation exposure, quality assurance programs, and record keeping and
reporting issues.
A list of certified mammography facilities can be obtained online from:
www.fda.gov/cdrh/mammography/certified.html
WWHP MAMMOGRAPHY SCREENING GUIDELINES
I. Women less than 40 Years of Age
Women less than 40 years of age must have a clinical breast examination to confirm symptoms prior to receiving
breast follow-up services through the Well Woman Healthcheck Program.
If the CBE confirms suspicious findings then:
 Women 35 years of age or older may be referred for diagnostic mammography;
 Women less than 35 years of age should not be referred for mammography, as results often are equivocal.
Women less than 35 years of age should be referred for breast ultrasound examination.
II. Women 40-49 Years of Age
Since women less than 50 years of age may only account for 25% of the yearly mammograms performed, the clinician
must evaluate the client's risk to determine the patient's future screening interval:
Low risk group -discuss need for every other year (biennial) mammographic screening
High-risk group - may benefit from yearly mammographic screening. This group includes those women with:






Personal history of breast cancer. (Approximately 10% will have a second primary breast cancer during her
lifetime)
Family history of breast cancer, first-degree relative with premenopausal breast cancer. (Risk increased 3-4
times.)
Mother, daughter, or sister with a history of premenopausal bilateral breast cancer. (Risk increased 8-10
times.)
Biopsy-proven moderate or severe atypical epithelial hyperplasia. (Risk increased 3-5 times.)
Personal history of lobular ductal carcinoma-in-situ. (Risk increased 8-10 times.)
Nulliparity or age 30 or older at first live birth. (Risk increased 1-1.5 times.)
III. Women 50 Years of Age and Older
Annual CBE and bilateral screening mammography
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 Well Woman Healthcheck Program's
Mammography Screening Policy Matrix


75% of WWHP mammograms must be provided to women 50 years of age or older.
25% of WWHP mammograms may be provide to women less than 50 years of age.
Age
CBE
Mammography
Under 40
Annual CBE
50+
Annual CBE
Women under 40 years of age may
be eligible for breast screening and
diagnostics if an abnormality is
confirmed by clinical breast exam.
Due to breast density,
mammography is of little value in
this population of women. Women
less than 35 years of age should be
directly referred for an ultrasound
examination of the breast(s).
Annual bilateral mammography
screening.
Page 29 of 73
Mammography Reporting Lexicon
The American College of Radiologists, BI-RADSTM (Breast Imaging Reporting and Data System) reporting system is
the required mammography-reporting lexicon under the MQSA regulations. The mammography report should be
concise and include: (1) a succinct description of the overall breast composition; (2) a clear description of any
significant finding [a] mass [b] calcifications [c] architectural distortion and [d] special cases; and (3) an overall
summary impression as follows:
BI-RADSTM
Category 0
Assessment Incomplete
Category 1
Negative
Category 2
Benign
Finding for which additional imaging
evaluation is needed. A
recommendation for additional imaging
evaluation includes the use of spot
compression, magnifications, special
mammographic views, ultrasounds, etc.
Negative mammogram
There is a negative mammogram but
the interpreter may wish to describe the
finding. Involuting, calcified
fibroadenomas, fat containing lesions,
such as oil cysts, lipomas, etc., all have
characteristic appearances and may be
labeled.
A finding in this category should have
high probability of being benign. It is
not expected to change over the followup interval but the radiologist would
prefer to establish stability
Biopsy should be considered. These
Category 4
Suspicious Abnormality
are lesions that do not have
characteristic morphologies of breast
cancer but have a definite probability of
being malignant. The radiologist has
sufficient concern to urge a biopsy. If
possible, the relevant probabilities
should be cited so that the patient and
her physician can make the decision on
the ultimate course of action.
Appropriate action should be taken,
Category 5
Highly Suggestive of Malignancy
these lesions have a high probability of
being cancer.
TM
For more information in regard to BI-RADS please visit the American College of Radiologists’ web site at:
www.acr.org
Category 3
Probably Benign
FOLLOW-UP ROUTINE
For normal Screening Examination (both CBE and Mammogram)
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Normal CBE = a finding of "normal" or "benign"
Normal Mammogram = a BI-RADTM 1 or BI-RADTM 2 mammography finding.
Notify the patient of examination findings, including the need for regular ongoing screening examinations and the
procedure for reminding the patient when her next screening examination is due.
For Abnormal Screening Examination (either CBE or Mammogram)
An abnormal clinical breast examination or screening mammogram should generate follow-up diagnostic referrals.
Notify the patient of an abnormal result and the implications within 5 days of receipt of abnormal findings, include:
need for further testing, a choice (if available) of appropriate referrals for definitive diagnostic procedures, and an
explanation that it is her responsibility to obtain follow-up care in a timely manner before the need for treatment can be
established.
Abnormal CBE
An abnormal CBE should be followed by a diagnostic mammogram. If the diagnostic mammogram is negative, a
referral to a surgeon or physician with expertise in breast problems is required.
A normal mammogram does not rule out cancer if a woman has a mass on CBE.
Abnormal Mammogram
An abnormal screening mammogram should be followed with additional mammographic views or ultrasound as
recommended by the radiologist.
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MANAGEMENT OF COMMON BREAST PROBLEMS
Prepared by the Commission on Cancer and the American College of Surgeons and the Society of Surgical Oncology
for the Centers for Disease Control and Prevention (1995).
Thorough communication with patients about the follow-up options, their risks, and all test results, as well as written
documentation of these discussions, is very important to the provision of quality care.
Cyst




Solid




Ultrasound or cyst aspiration is useful to differentiate between solid and cystic mass.
If the mass does not disappear with fine needle aspiration, or if the fluid is bloody, send the fluid specimen
for cytological study and refer the patient to a surgeon. Fluid can otherwise be discarded.
Nonpalpable simple cysts confirmed by ultrasound do not need aspiration except for pain relief. Cysts having
suspicious characteristics need to be biopsied.
Reexamine breast in 6 weeks for recurrence. If cyst recurs, refer to a surgeon. Otherwise, follow routinely.
A patient with a suspicious mass should have a bilateral diagnostic mammogram to screen both breasts for
nonpalpable cancers. A normal mammogram does not eliminate need for further evaluation of a
clinically suspicious mass. However, if a mass is clinically benign on breast examination, and this is
confirmed by cytologic examination and mammography, the patient may be followed by a surgeon every 3
months until biopsy or resolution of problem.
Women younger than 30 years most likely have cyst or fibroadenoma. Ultrasound or fine needle aspiration
may be used to confirm.
Refer patients to a surgeon for a solid, dominant, persistent mass because biopsy is almost always indicated.
If mass persists after 3 months and can be distinguished from remainder of breast tissue, refer to a surgeon.
Vague Nodularitv

If significant doubt exists about the nature of a mass, consider mammogram or ultrasound first and then fine
needle aspiration for cytologic examination. If mass appears benign, slightly lobulated breast tissue, or
poorly defined thickening not matched in opposite breast - recheck bimonthly or quarterly.
Mammographic Abnormality
 For American College of Radiology (ACR) BI-RADTM categories 4 (suspicious abnormality; biopsy should
be considered) and BI-RADTM category 5 (highly suggestive of malignancy), refer to a surgeon.
 For ACR BI-RADTM category 3 (probably benign; short follow-up interval suggested), patient may be
followed with sequential imaging at an interval suggested by the radiologist. Clearly communicate to women
the need for clinical and imaging follow-up.
Page 32 of 73

For ACR BI-RADTM category 0 (assessment is incomplete; additional imaging evaluation needed), obtain
recommended imaging studies to better characterize the abnormality.
Breast Pain
 Perform clinical breast examination and mammography, if age appropriate.
 If examination and mammography are negative, fibrocystic change is most likely. Reassure patient, offer a
trial of a non-narcotic analgesic, and recommend use of a well-supporting brassiere.
 If conservative measures do not relieve pain symptoms, referral to a surgeon is indicated.
Skin/Nipple Change and Nipple Discharge
 Women with skin breakdown on the nipple or areola should be referred to a surgeon.
 Patient with palpable mass and nipple discharge should be referred to a surgeon
 If discharge suggestive of neoplasm (spontaneous; unilateral; confined to single
duct; occurring in older patient; clear, bloody, serous, or serosanguinous) send patient for mammography and
surgical consult.
 Nipple discharge -particularly if bilateral or multiductal; milky, green, gray, or black discharge is not
suggestive of cancer. If milky discharge is profuse, medical work-up for galactorrhea may be indicated.
The Worried Patient with a Negative Work-up
 Refer patient to a surgeon for a second opinion.
Difficult Breast Examinations
 May refer to a surgeon if the woman has had mammoplasty or augmentation implantation, if breasts are very
large or multinodular, or if several biopsies have severely scarred the breasts.
High-Risk Patients
 Consult a breast cancer specialist for a woman with history of breast cancer; strong first-degree family
history; history of atypia; or multiple biopsies
 Such women may need special follow-up regimens.
SPECIAL CONSIDERATIONS
Pregnant or Lactating Women with Breast Masses
 Physical diagnosis of breast cancer may be extremely difficult in these situations, it is important to refer these
patients to a surgeon. Approximately 1 in 2,000 pregnant or lactating women have breast cancer.
Page 33 of 73
BENIGN BREAST CONDITIONS
Fibrocystic disease - Characterized by nodules or cysts in ducts, may be bilateral or unilateral. May be localized or
spread throughout. The patient often presents with pain and tenderness. Varies with monthly hormonal cycle.
Fibroadenoma - Characterized as a firm, round, mobile, non-tender mass.
Intraductal Papilloma - Overgrowth of benign cells lining the ducts. Frequently there is an absence of a palpable
mass. The patient may present with serous, serosanguinous or bloody nipple discharge.
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BREAST ALGORITHMS
Algorithm 1.
Assessment of Risk
Algorithm 2.
New Palpable Mass
Algorithm 3.
Abnormal Screening mammogram with Normal CBE
Algorithm 4.
Spontaneous Unilateral Nipple Discharge
Algorithm 5.
Breast Skin Changes/Nipple Retraction
Algorithm 6.
Breast Pain in Non-Lactating Women
Algorithm 7.
Management of Breast Biopsy Results
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BREAST REFERENCES
American Cancer Society. Clinical Breast Examination, Proficiency Criteria and Guidelines, pp. 1-20, 1998.
American College of Radiology. Breast Imaging Lexicon, Reporting System. Available online at:
http://home.earthlink.net/~rowberg/birads/reporting.htm
Accessed 03/02/2000
California Department of Public Health, cancer Detection Section. Breast Cancer Diagnostic Algorithms for Primary
Care Providers. June, 2011. Available online at: http://qap.sdsu.edu.
Centers for Disease Control and Prevention. Evaluation of Common Breast Problems: A Primer for Primary Care
Providers. Pamphlet, pp. 1-13, 1995.
Centers for Disease Control and Prevention. Follow-up of Abnormal CBE and Mammographic Findings, Manual.
1999.
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SERIAL #: PH RFP 12-023
SECTION TWO - CERVICAL CANCER SCREENING
A cervical Pap test is a cytodiagnostic test primarily for the detection of cervical cancer and precancerous lesions.
Squamous cell carcinoma comprises 90%, and adenocarcinoma comprises approximately 10% of cervical cancers
(NCI, 2002). Although the Pap test can sometimes detect endometrial, vaginal and other cancers, its use as a
screening test is intended for the early detection of cervical dysplasia and cancer (USPHTF, 1996). It should be
noted that a single negative cytodiagnosis, and on occasion multiple negative cytodiagnoses, does not rule out
gynecologic neoplasia. The Pap test false negative rate can be as high as 50% in cases of invasive cervical cancer
(NCI, 2002).
The early diagnosis and treatment of cervical cancer precursors or cervical carcinoma- in-situ (CIS) may delay or
prevent the progression of invasive disease. Treatment at the localized stage may include any of the following
clinical procedures: loop electrosurgical excision (LEEP), conization (cold knife cone biopsy), cryosurgery, laser
surgery, and when necessary hysterectomy. Longitudinal studies have shown that in untreated patients with in situ
cancer, 30-70% will develop invasive carcinoma over a period of 10 -12 years. However, in about 10% of patients,
lesions can progress from in situ to invasive in a period of less than one year (NCI, 2002).




Cervical cancer accounts for 6% of all malignancies in women
Annually, there are an estimated 16,000 cases of invasive cancer of the cervix and 5,000
deaths in the United States.
40-50% of the women who will die from invasive cervical cancer are over age 65.
90% of these cases can, and should be detected early through the use of Pap test.
Source: The National Cancer Institute, 2002
Symptoms
Women with cervical cancer precursor lesions or CIS are often asymptomatic. Symptoms of late stage disease may
include light bleeding or spotting, separate from a woman's menstrual cycle, painful intercourse, or postcoital
bleeding.
PATIENT EDUCATION
Women should be instructed to ...
 Schedule an appointment approximately two weeks (10-18 days) after the first day of her last menstrual
period.
 Not douche 48 hours prior to the test.

Not use tampons, birth control foams, jellies or other vaginal creams or vaginal medications for 48 hours
prior to the test.

Refrain from intercourse 48 hours prior to the test.
Source: American Society of Cytopathology
RISK ASSESSMENT
Women with an increased risk for cervical cancer include:
 Women who initiated sexual intercourse prior to age 16;
 Women with five or more sex partners in a lifetime;
 Women with a history of Human Immunodeficiency Syndrome (HIV); Human Papilloma Virus (HPV) or
other sexually transmitted diseases;
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SERIAL #: PH RFP 12-023


Women exposed to cigarette smoke;
Women with prenatal exposure to diethylstilbestrol (DES)- maternal use of DES to prevent miscarriage,
used from 1940 -1970;
Women who have not had a Pap test within the previous five years; and
Women with a history of cervical cancer or dysplasia.



The Human Papillomaviruses (HPV)
Research suggests that the most important risk factor for the development of cervical cancer is the presence of the
human Papilloma viruses (HPV). There are over 80 distinct types of HPV identified, approximately 30 of which
infect the human genital tract. HPV types 16 and 18 are most often associated with invasive disease (NCI, 2002).
As HPV is sexually transmitted, barrier methods of contraception have been shown to lower the incidence of
cervical neoplasia (NCI, 2002). Some of the high risk types that are included in commercial HPV tests included
types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, & 68.
Smoking
Smokers have a 50% higher risk of developing cervical cancer (ASC, 2000). Smoking elevates the risk of cervical
cancer by exposing women who smoke and those who inhale second-hand smoke to cancer-causing chemicals that
damage the DNA in cells of the cervix. A woman's risk increases relative to the number of cigarettes smoked per
day and the number of years she has smoked.
Essentially there are two invasive cervical cancer prevention strategies: 1- Primary Prevention: prevent cervical
cancer precursors. Precursors can be prevented by decreasing exposure to HPV by delaying sexual intercourse and
limiting the number of sexual partners. Abstaining from smoking is another way to decrease the risk of cervical
cancer precursor lesions. 2- Secondary Prevention: routine Pap test screening. Pap test screening helps to identify
cervical cancer precursor lesions at the earliest, most treatable stage. The risk of developing invasive cervical cancer
is 3 to 10 times greater in women who have not been screened (NCI, 2002). The risk also increases with longer
duration following the last normal Pap test. Screening every 2 to 3 years, however, has not been found to increase
likelihood the risk of finding invasive cervical cancer above the risk expected with annual screening (NCI, 2002).
 WWHP’s CERVICAL CANCER SCREENING POLICY
PAP TEST SCREENING FREQUENCY
In 1988, a consensus recommendation was developed by the American College of Obstetricians and Gynecologists
(ACOG), the American Nurses Association, the American Cancer Society, the National Cancer Institute, the
American Medical Association, the American Academy of Family Physicians, and the American Medical Women's
Association. The recommendation suggested that all women who are or who have been sexually active, or women
who have reached 18 years of age should have an annual cervical Pap test and pelvic examination. It was further
recommended that after a woman had three or more consecutive satisfactory annual examinations, the Pap test could
be performed less frequently at the discretion of her physician. The U.S. Preventive Services Task Force (1996)
recommended that the time between Pap tests should be 1-3 years, depending on the presence of risk factors for
cervical cancer. The risk of an abnormality occurring within 3-5 years after three consecutive negative annual
smears is minimal in low-risk patients. Pap test screening of high-risk women should be scheduled annually;
however, the physician may feel that screening more frequently is necessary.
DEFINITIONS:
Consecutive - refers to the Pap test results within the specified time period of five years (60-months). For
example, if a woman who has been enrolled in the program for 5-years presents for a Pap test in 2001 and
she has had three "consecutive" normal Pap test results in 1997, 1999, and 2000 she would not be eligible
for Pap test screening until 2003.
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Documented - all Pap tests to calculate screening interval must be done while enrolled in
the WWHP and documented in the WWHP CaST database.
Normal Pap test result - includes a result of Negative for Intraepithelial lesion or Malignancy.
Screening Interval - the time between screening Pap tests.
Seventy-five percent of the women who have had three documented and consecutive normal Pap test results over a
five-year period (60 months) should NOT have a Pap test when they return for cervical cancer screening the fourth
year. The screening interval for these women should increase to a Pap test once every three years. Twenty-five
percent of women screened by the WWHP may continue to have annual Pap tests if they meet the high-risk criteria
defined by the WWHP Medical Advisory Board.
Women with an Abnormal Pap Test Result
Women who have had a history of prior dysplasia may be screened annually or more frequently as determined by
their clinician. Pap testing should not exceed four Pap tests within a 12-month period. Often clinicians will request
repeat Pap tests at a screening interval of 3, 4, 6, or 9 months. Once the abnormal Pap test results resolve and there
are three documented normal Pap test results over a period of three years, the screening interval should be increased
to once every three years. If later a woman has an abnormal Pap test, she would resume more frequent screening, as
determined by her clinician.
Cervical Cancer Risk Criteria
Twenty-five percent of the women screened for cervical cancer may continue with annual screening, at the
discretion of their clinician. Providers wishing to continue annual re-screening, in the presence of three consecutive
normal Pap test results, must document in the comment section of the WWHP screening form the client's cervical
cancer risk or other rationale for continued annual Pap test screening.
To be eligible for annual Pap test screening women must meet the following criteria:
 Abnormalities were found within the last three years; OR
 There is presence of anyone of the following:
o Five or more sexual partners in a lifetime
o History of a sexually transmitted disease
o History of HIV/lmmunosuppression
o Absence of any Pap smears within the previous seven years
o Prenatal exposure to DES (diethylstilbestrol)
SCREENING POST HYSTERECTOMY
Although vaginal smears are often done for follow-up of women who have had a hysterectomy for malignancy, a
retrospective study suggests little or no benefit of routine vaginal screening for women who have had a
hysterectomy for reasons other than cervical neoplasia. Investigators found a low prevalence of vaginal dysplasia
(0.1%) and a high false positive rate of vaginal smears from women who have had a hysterectomy for benign
disease (NCI, 2002).
Approximately 35 percent of women 50 years of age or older have had a hysterectomy. The majority of women
who have had a hysterectomy do not have a cervix and are not at risk for developing cervical cancer. If a woman
gives a history of a hysterectomy for cervical neoplasia, she should be followed with an annual Pap test for three
years following the hysterectomy. If all three consecutive Pap tests are within normal limits, her screening interval
should be increased to Pap tests every three years, rather than annually.
A woman should not have a Pap test, through the WWHP, if she has had a hysterectomy for fibroids or reasons other
than cervical dysplasia.
A small percentage of women have had a supracervical hysterectomy and have an intact cervix. The presence of a
cervix is easily determined on physical examination. These women are at risk of developing cervical cancer.
Therefore, they require continued Pap smears based on the current cervical screening policy.
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WWHP Cervical Cancer Screening
Policy for Women Post Hysterectomy
WWHP Reimbursable Procedures
Pelvic Exam
Pap test
Women who have had a hysterectomy for
cervical neoplasia
Yes
Yes
Women who have had a supracervical
hysterectomy (cervix intact).
Yes
Yes
Women who have had a hysterectomy for
reasons other than cancer or cervical
dysplasia; but are unsure if their cervix is
intact.
Women who have had a hysterectomy for
reasons other than cervical neoplasia, and
do not have a cervix.
Yes
Yes, if they have a cervix or history
of cancer
---------------------------No, if they do not have a cervix
No
No
COMPLETING THE CYTOLOGY LABORATORY REQUISITION FORM
At a minimum, the following information should be accurately completed on the cytology requisition form: the
patient's first and last names, her age and/or date of birth, the source of the specimen and the date it was collected.
The name, address and telephone number of the requesting clinician should also be included to ensure prompt
reporting.
To assist the cytology technicians and cytopathologists with a thorough interpretation of the Pap test specimen, the
cytology requisition form should also include information with regard to the patient's clinical history. Information
such as the date of the patient's last menstrual period (LMP), parity, postmenopausal, estrogen or other hormone
therapy, use of an intrauterine device (IUD), diethylstilbestrol exposure, chemotherapy, radiation therapy, previous
gynecologic surgeries/treatments, history of cancer, previous abnormal cytology results, and any clinical findings
observed at the time of examination, such as an infection or visible lesion.
ADEQUACY/QUALITY OF PAP TEST SPECIMEN
The Pap test, when correctly obtained from a woman with a cervix, should contain endocervical components from
the squamocolumnar junction and material from the ectocervix. Studies have shown that the use of an endocervical
brush can increase the yield of endocervical cells by seven-fold (ACOG Technical Bulletin, August 1993). It is
strongly recommended that an endocervical brush be used to collect the endocervical specimen, in addition to the
use of a plastic cervical spatula. The use of a wooden spatula and/or cotton tipped swab are strongly discouraged as
they both retain cellular materials (ASC, 2000).
The presence of the endocervical component (endocervical cells and/or squamous metaplastic cells and/or cervical
mucus with endocervical cells) in the Pap test indicates that the transformation or squamocolumnar junction zone
has been sampled. The endocervical component should be present in the Pap test collected from most premenopausal patients with a cervix. It is not uncommon for the endocervical component to be absent in Pap tests
from pregnant, post-hysterectomy, and post-menopausal women, as well as those women who have cervical
conization and LEEP procedures. If endocervical cells are absent, and if the patient has a poor screening history, it is
suggested that the Pap test be repeated in 3-6 months. If the patient has routinely been screened with a history of
normal Pap tests, the patient should be instructed to return at the appropriate routine screening interval.
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SERIAL #: PH RFP 12-023
REPORTING OF PAP TEST RESULTS
The Bethesda System
The National Cancer Institute convened the first workshops on the Bethesda System in 1988 and 1991 to clarify the
confusion of multiple cytological reporting systems. The goals were to provide better communication between the
cytopathologists and the referring providers and to facilitate cytologic and histologic correlation in cervical and
vaginal samples. The classification that was developed is called The Bethesda System (TBS) for reporting the
Cervical/Vaginal Cytological Diagnoses. The National Cancer Institute convened a third workshop, Bethesda 2001,
held April 30 -May 2, 2001, to review issues regarding terminology and reporting of cervical cytology. Nine forum
group sessions covered topics including: specimen adequacy, non-neoplastic changes, atypical squamous cells of
undetermined significance (ASCUS), atypical glandular cells of undetermined significance (AGUS), ancillary
testing (HPV DNA testing, etc.), endometrial cells, squamous intraepithelial lesion (SIL), automated computer
review, and recommendations. The groups revised the Bethesda System of reporting to include the following
reporting system, now referred to as the Bethesda System 2001.
The Bethesda System 2001 includes the following features (detailed in Figure 1). A description of specimen type,
an evaluation of specimen adequacy, an interpretation/result of the specimen, the method of review, and all ancillary
testing performed on the specimen and the result(s) of the ancillary testing.
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Figure 1
SPECIMEN TYPE
SPECIMEN ADEQUACY
Satisfactory
for
Evaluation
Unsatisfactory
for
Evaluation
(reason
specified)
GENERAL
CATEGORIZATION
Negative
for
Intraepithelial Lesion or
Malignancy
Epithelial
Cell
Abnormality
(“Squamous”
or
“Glandular” specified)
AUTOMATED REVIEW
ANCILLARY TESTING
BETHESDA SYSTEM 2001
Conventional Pap test, Liquid-based or other technology


Specimen rejected/not processed (reason specified)
Specimen processed and examined, but unsatisfactory for evaluation of epithelial abnormality
because of (reason specified)
INTERPRETATION/RESULT
ORGANISMS
 Trichomonas vaginalis
 Fungal organisms morphologically consistent with Candida spp.
 Shift in flora suggestive of bacterial vaginosis
 Bacteria morphologically consistent with Acitnomyces spp.
 Cellular changes consistent with Herpes simplex virus
OTHER NON-NEOPLASTIC FINDINGS
 Reactive cellular changes associated with: inflammation; radiation; or intrauterine contraceptive
device (IUD)
 Glandular cells status post hysterectomy
 Atrophy
OTHER
 Endometrial cells in women  40 years of age
SQUAMOUS CELL
Atypical Squamous cells
 Of undetermined significance (ASC-US)
 Cannot exclude HSIL (ASC-H)
Low Grade Squamous intraepithelial lesion (LSIL)
 Encompassing: HPV/mild dysplasia/CIN I
High Grade Squamous intraepithelial lesion (HGSIL)
 Encompassing: moderate and severe dysplasia, CIN 2 and 3, CIS Squamous cell carcinoma
GLANDULAR CELL
Atypical
 Endocervical cells (NOS or specified comments)
 Endometrial cells (NOS or specified comments)
 Glandular cells (NOS or specified comments)
Atypical
 Endocervical cells, favor neoplastic
 Glandular cells, favor neoplastic
Endocervical Adenocarcinoma in situ
Adenocarcinoma
 Endocervical
 Endometrial
 Extrauterine
 Not otherwise specified (NOS)
OTHER
Other Malignant Neoplasms
If examined by an automated device, the device should be specified
If an ancillary test is performed, a brief description of the test methods and a report, results should be
included
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FOLLOW-UP and MANAGEMENT OF PAP TEST FINDINGS
NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY

Notify the patient of the Pap test results, and instruct the patient in the importance of returning for her next
screening Pap test at the determined interval(s), or if she becomes symptomatic with any gynecological
problems.
NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY, WITH:
I. Organisms:
Trichomonas vaginalis
Fungal organisms morphologically consistent with Candida spp.
Shift in flora suggestive of bacterial vaginosis
Bacteria morphologically consistent with Actinomyces spp.
Cellular changes consistent with Herpes simplex virus

Notify -the patient of her Pap test results and have her return for a culture and/or wet mount, if needed, to
identify the causative agent (if not done at time of the initial visit). Counsel the patient and offer a course of
treatment for specific type of vaginitis. Verify this action by documenting it in the patient's medical record.
Schedule the patient for a clinic visit.
o Trichomonas vaginalis may be managed by treatment if the patient is symptomatic. If there are
no symptoms, a confirmatory test should be considered. Resume routine screening.
o Women presenting with fungal organisms morphologically consistent with Candida spp
should be offered therapy, if symptomatic. Resume routine screening.
o Shift in flora suggestive of bacterial vaginosis (BV), offer therapy for BV only if symptomatic.
Resume routine screening.
o Bacteria morphologically consistent with Actinomyces spp. is significant if intrauterine device
is in situ. If a patient with an IUD is asymptomatic for pelvic inflammatory disease, then
antimicrobial treatment or following the patient with no treatment may be appropriate. The IUD
need not be removed in the asymptomatic patient.
o Cellular changes consistent with Herpes simplex virus (HSV) are suggestive of HSV shedding.
HSV culture or treatment is unnecessary unless indicated for other reasons. Resume routine
screening.

For guidelines on treatment please refer to the Centers for Disease Control and Prevention, 2002 STD
Treatment Guidelines, available online at: http://www.cdc.gov/nchstp/dstd or hardcopies are available by
phone at: 1-888- 232-3228 (press 2,5,1,1 to go to STD information), or by Mail: DSTDP, Training &
Health Communications Branch, 1600 Clifton Rd., NE Mailstop E-02, Atlanta, GA 30333
NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY, WITH:
II. Other Non-Neoplastic Findings:
 Notify the patient of the Pap test report and the need to follow the recommendations of the health care
provider. Verify this action by documenting it in the patient's medical record. Schedule the patient for a
clinic visit.
Reactive cellular changes
 This finding includes reactive cellular changes associated with inflammation, radiation and the use of an
intrauterine contraceptive device (IUD)
o Inflammation could be due to gonorrhea, chlamydia, or other pathogens. Consider contacting
patient and offer testing for gonorrhea, chlamydia, and/or a wet mount for other pathogens, as
indicated.
Page 54 of 73
SERIAL #: PH RFP 12-023
o
o
Women with reactive cellular changes and a history of radiation therapy should be re-screened in
one year.
Women with reactive cellular changes and have an intrauterine device (IUD) in place should be
re-screened in one year.
Glandular cells post-hysterectomy
 This finding is considered benign. Resume routine screening.
Atrophy
 Atrophic changes or atrophy with inflammation (Atrophic Vaginitis) is a potential indication for
treatment with estrogen. Treatment options include estrogen vaginal cream (daily) or oral regimens.
o Treatment with estrogen is contraindicated if there is a history of breast cancer (estrogen
dependent or unknown receptors), endometrial cancer/undiagnosed vaginal bleeding, or a history
of deep vein thrombosis.
NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY, WITH:
III. Other:
Endometrial Cells in women  40 years of age
 This may indicate a need to evaluate the endometrium (such as an endometrial biopsy). This may be an
indication for this procedure especially if the patient has abnormal bleeding/post menopausal bleeding
circumstances that would usually call for an evaluation of the endometrium. If the Pap was unrelated to
menses, then an endometrial evaluation might be considered.
EPITHELIAL CELL ABNORMALITY
Squamous Cells
Atypical Squamous Cells:
Pap test results interpreted as atypical squamous cells of undetermined significance (ASC-US) have a 5-17% chance
of having cervical intraepithelial neoplasia (CIN) 2, 3 confirmed by biopsy, while CIN 2, 3 is identified in 24 - 94%
of women with ASC-H (atypical squamous cells, cannot exclude high grade intraepithelial lesions) (JAMA, 2002).
Atypical Squamous Cell of Undetermined Significance (ASC-US)
 Notify the patient and counsel her regarding the seriousness of the Pap test report and the need to follow the
recommendations of the health care provider. Verify this action by documenting it in the patient's medical
record. Schedule the patient for a clinic visit.
 The preferred approach to managing women with ASC-US diagnosed by conventional Pap test includes
co-collected DNA* testing for oncogenic HPV types (high-risk HPV panel only); OR patients with ASCUS may be followed with repeat Pap testing. If repeat cytology is the method of follow-up, women should
have a repeat Pap test within 4-6 months. If the repeat Pap test is negative the patient can resume routine
screening. If the HPV DNA is positive for high-risk types of HPV, or if one of the repeat Pap test is
positive (ASC-US or more severe) the patient should be referred for colposcopy. Another acceptable
approach is immediate colposcopy for the patient with ASC-US.
 Post-menopausal women with ASC-US, with evidence of atrophy, can be managed by undergoing a 3-6
week course of intravaginal estrogen cream followed by a repeat Pap test one week after the completion of
estrogen therapy. If the repeat Pap test is "negative for intraepithelial lesion or malignancy" (NIL) the
patient should be referred for a repeat Pap test in 4-6 months. If NIL, the patient can be referred for routine
Pap test screening. Women may also be referred for immediate HPV DNA testing, repeat cytology or
colposcopy (as noted in the managing women with ASC-US bullet).
 Women who are immunosuppressed should be referred for immediate colposcopy. This includes women
who are HIV positive regardless of CD4 count or therapy.
Page 55 of 73
SERIAL #: PH RFP 12-023

Pregnant women should be followed per the guidelines for non-pregnant women with ASC-US (as noted
in the managing women with ASC-US bullet).
Atypical Squamous Cells Cannot Exclude High Grade Squamous Intraepithelial Lesion
(ASC-H)
 Notify the patient and counsel her regarding the seriousness of the Pap test report and the need to follow the
recommendations of the health care provider. Verify this action by documenting it in the patient's medical
record. Schedule the patient for a clinic visit.
 Women should always be referred directly for colposcopic evaluation, with subsequent follow-up
determined by the findings at evaluation.
*This approach is only cost effective if DNA specimen is obtained at the time of original Pap smear, “reflex
testing,” usually with a liquid-based specimen.
SQUAMOUS INTRAEPITHELIAL LESIONS
Squamous intraepithelial lesion encompasses a spectrum of noninvasive cervical epithelial abnormalities traditionally
classified as a flat condyloma, dysplasia/carcinoma in-situ, and CIN. In the Bethesda System 2001, the spectrum is divided
into low-grade and high-grade lesions.
 Low-grade lesions (LSIL) encompass the cellular changes associated with HPV cytopathic effect (koilocytotic
atypia) and mild dysplasia/CIN 1.
 High-grade lesions (HSIL) encompass moderate dysplasia, severe dysplasia, and carcinoma in-situ/CIN 2, 3).
Gynecological cytology cases showing diagnostic HSIL in which there is a non-diagnostic cytological evidence of
invasion should be diagnoses as HSIL and accompanied by the comments "with features suspicious for invasion."
Source: Bethesda 2001 Post-Workshop Recommendations
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Low Grade Squamous Intraepithelial Lesion (LSIL)
Approximately 15-30% of women with LSIL on cervical cytology will have CIN 2, 3 identified on a subsequent
cervical biopsy (JAMA, 2002). The National Cancer Institutes ASCUS/LSIL Triage Study (AL TS) noted that 83%
of the women referred for LSIL evaluation tested positive for high-risk HPV types (JAMA, 2002).






Notify the patient and counsel her regarding the seriousness of the Pap test report and the need to follow the
recommendations of the health care provider. Verify this action by documenting it in the patient's medical
record. Schedule the patient for a clinic visit.
The next step in patient management for LSIL is colposcopy.
If high-grade dysplasia (CIN) is confirmed on the colposcopy the patient needs treatment.
If no dysplasia is found on colposcopy the the patient will need follow-up Paps at 6 and 12 months. If all
are NIL then she can resume yearly screening. If ASC-US or greater, then refer again for colposcopy.
Postmenopausal women with LSIL with evidence of atrophy should be offered a course of intravaginal
estrogen cream treatment for 3-6 weeks; 1 week post- treatment the Pap test should be repeated. If the
repeat Pap test is positive (ASC-US or more severe) refer for colposcopy. If the repeat Pap test is negative,
repeat the Pap test in 6 months. Alternatively, immediate colposcopy can be offered. OR HPV DNA
testing can be offered - - those positive for high-risk HPV types are referred for colposcopy, and those with
a negative test being rescreened with a Pap in 12 months.
Pregnancy Recommendations. In most cases, pregnant women with LSIL should be referred for
colposcopy
High Grade Squamous Intraepithelial Lesion (HSIL)







Notify the patient and counsel her regarding the seriousness of the Pap test report and the need to follow the
recommendations of the health care provider. Verify this action by documenting it in the patient's medical
record. Schedule the patient for a clinic visit.
HSIL SHOULD ALWAYS BE REFERRED FOR COLPOSCOPY. Schedule the patient for immediate
colposcopy.
The colposcopy is considered satisfactory if the entire squamo-columnar junction is visualized. Patient
management is directed by the result of this examination and the results of histological evaluation obtained
by a directed biopsy of the abnormal area defined on colposcopy exam.
If CIN 2-3 is identified, definitive treatment is indicated. Treatment may include conization, laser ablation,
LEEP and in some cases cryosurgery or hysterectomy.
If the colposcopy is satisfactory, and only CIN 1 or no CIN is found. A review of the Pap, colposcopy
and histology should be done (with one pathologist reviewing all materials). Treatment should be managed
according to a revised diagnosis. If HSIL is upheld on review of the Pap and not confirmed with the
colposcopy and biopsy then a LEEP or cone biopsy is recommended.
If the colposcopy is considered unsatisfactory and no lesion visualized. The materials should be
reviewed as the above bullet and managed accordingly.
If the colposcopy is unsatisfactory and CIN is found on histology then the patient should undergo
treatment with a LEEP or cone biopsy.
Note: The cytobrush should be used to sample the endocervix in the follow-up of women with HSIL.
Squamous Cell Carcinoma


Notify the patient and counsel her regarding the seriousness of the Pap test report and the need to follow the
recommendations of the health care provider. Verify this action by documenting it in the patient's medical
record. Schedule the patient for a clinic visit.
Promptly refer the patient for evaluation and treatment.
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GLANDULAR CELLS
The atypical glandular cell (AGC) category is associated with a substantially greater risk for cervical neoplasia than
atypical squamous cells or LSIL categories. Studies have found that 9-54% of women with AGC have biopsied
confirmed CIN, 0-8% have biopsy confirmed adenocarcinoma in-situ (AIS), and less than 1- 9% have invasive
carcinoma (JAMA, 2002).
Atypical (Not Otherwise Specified [NOS] or Specified Comments):
Endocervical Cells,
Endometrial Cells
Atypical Glandular Cells
Atypical, Favor Neoplastic:
Endocervical Cells or Glandular Cells
Endocervical Adenocarcinoma In Situ
Adenocarcinoma:
Endocervical
Endometrial
Extra uterine
Not Otherwise Specified
Other:
Malignant Neoplasm







Notify the patient and counsel her regarding the seriousness of the Pap test report and the need to follow the
recommendations of the health care provider. Verify this action by documenting it in the patient's medical
record. Schedule the patient for a clinic visit.
All women with atypical glandular or atypical endocervical cells should have colposcopy and
endocervical curettage (ECC). Management with repeat Pap testing is NOT acceptable.
Women with atypical glandular cells who are over 35, or women younger than 35 with AGC who have
abnormal vaginal bleeding, should have an endometrial biopsy (EMB).
Women with an atypical glandular cell Pap test, with a negative colposcopy, biopsy, and ECC should be
followed with repeat Pap testing every 4-6 months until the woman has had four normal Pap tests.
Women with atypical endometrial cells should have an endometrial biopsy (EMB).
Women with atypical glandular cells that favor neoplasia or adenocarcinoma in-situ should have
colposcopy and endocervical curettage (ECC). If disease is not identified through the initial work-up, a
cold knife cone biopsy is recommended. (Please note: The WWHP cannot reimburse for cone- biopsy).
Women diagnosed with invasive cancer on biopsy or ECC requires definitive therapy and should be
referred to a gynecologic oncologist.
FOLLOW-UP and MANAGEMENT OF PELVIC EXAMINATION FINDINGS
 WWHP's Policy with regard to the Removal of Cervical Polyps
Cervical polyps are most often benign lesions and are primarily removed to alleviate symptoms such a post-coital
and/or mid-cycle bleeding. Under the reimbursement guidelines of the National Breast and Cervical Cancer Early
Detection Program the removal of a cervical polyp (polypectomy) as an independent procedure is not an allowable
procedure. However, if a gross cervical lesion, suspicious for cancer, is observed during the client's pelvic
examination, this lesion should be biopsied immediately to rule out cancer. In such cases, if the pathology report
describes the biopsied lesion as a benign growth, such as a cervical polyp, the program may reimburse providers for
the biopsy procedure - as the procedure was performed specifically to rule out malignancy.
Page 58 of 73
SERIAL #: PH RFP 12-023
HOW TO CHOOSE A QUALITY CYTOLOGY LAB
By Sharon Siweck, CT
When seeking to provide cervical screening services it is imperative to have the necessary skills to select a quality
laboratory that will provide a consistent and high level of proficiency. This becomes more crucial when the target
group being offered Pap test screening falls into a " high risk" category identified by either the lack of recent and
consistent cervical screening, or other contributing factors such as a previous abnormal pap test, sexually transmitted
disease, multiple partners, early onset of sexual activity, or prenatal exposure to DES.
Critical to the selection process of a reputable laboratory are several components:
1.
Does the lab have American Society of Cytopathology accreditation? This is considered to be the hallmark
certification of a very high quality laboratory. Minimally, the lab must have a CLIA number, and
frequently will have College of American Pathologists recognition.
2.
The Arizona Department of Health Services, Office of Laboratory Licensure and Certification can provide
information on recent surveys of the laboratory. The last two surveys performed are available under the
"Freedom of Information Act" and may be requested in writing to ADHS, OLLC, 3443 N. Central, Suite
810, Phoenix, AZ 85012. There is a per page charge.
The Centers for Medicaid and Medicare Services (CMS) additionally conducts "Specialized Reviews of
Cytology Laboratories." The intensive and comprehensive nature of these surveys far exceeds all others.
Survey findings may be available either through your State of Federal Regional Offices or through the
Freedom of Information Act from (CMS).
3.
Request from the laboratory a description of the diagnostic classification system they use, it should be the
Bethesda System. Ask for a copy of the requisition form and an example of a report.
4.
The laboratory should supply a copy of the laboratory's specimen submission and handling procedures.
The procedures should detail how specimens will be submitted to the lab and the type of supplies they will
provide to providers utilizing their laboratory.
5.
Ask if the laboratory has adequate cytotechnologist staffing to accommodate your estimated volume and
the estimated turn around time for report receipt. Also determine if the laboratory distributes work out to
satellite laboratories or subcontracts with an outside laboratory. This must be identified on the report form.
6.
Request a copy of the laboratory's annual statistics that identify:
*total case/slide volume of Pap tests
*number of cases reported by diagnosis
*number of cases with discrepant cyto/histo correlation
(if the lab is being utilized for biopsy correlation testing)
7.
Identify who the laboratory contact person will be in the event of problems or questions.
LABORATORY INDICATORS

Atypical Glandular Cells in a typical cytology laboratory should be less than 1%.

Atypical Squamous Cells in a typical cytology laboratory should not exceed 5% of total specimens with
ASC:SIL ratios not higher than 2:1 to 3:1 in general screening populations.
Source: Bethesda 2001 Post-Workshop Recommendations
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CERVICAL ALGORITHM
Algorithm 1.
Management of Women with a Histological Diagnosis of Cervical Intraepithelial Neoplasia Grade
1 (CIN1) Preceded by ASC-US, ASC-H, or LSIL Cytology
Algorithm 2.
Management of Women with a Histological Diagnosis of Cervical Intraepithelial Neoplasia Grade
1 (CIN1) Preceded by HSIL or AGC-NOS Cytology
Algorithm 3.
Management of Adolescent Women (20 years and younger) with a Histological Diagnosis of
Cervical Intraepithelial Neoplasia Grade 1 (CIN1)
Algorithm 4.
Management of Women with a Histological Diagnosis of Cervical Intraepithelial Neoplasia- (CIN
2,3)
Algorithm 5.
Management of Adolescent and Young Women with a histological Diagnosis of Cervical
Intraepithelial Neoplasia- Grade2,3 (CIN 2,3)
Algorithm 6.
Management of Women with Adenocarcinoma in-situ (AIS0 Diagnosed from a Diagnostic
Excisional Procedure
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CERVICAL REFERENCES
American Society of Colposcopy and Cervical Pathology (ASCCP). 2006. Available online: http://www.asccp.org.
American Society of Cytopathology (ASC), 2000, ASC Guidelines. Available Online: www.cytopathology.org
Solomon D., Davey D., Kurman R., Moriarty A., Oconnor D. (2002). Consensus Statement, The 2001 Bethesda
System. JAMA, April 24, 2002- Vol 287, No 16
u.s. Preventative Health Task Force (USPHTF), 1996. Chapter 9. Screening for Cervical Cancer. Available Online:
http://odphp.osophs.dhhs.gov/pubs/guidecps/text/CHO9. txt
National Cancer Institute (NCI), 2002. Cervical Cancer (PDQ) Prevention, Screening and Treatment. Available
Online: www.cancer.gov
National Cancer Institute (NCI), 2001. Bethesda System 2001. Post-workshop Recommendations. Available Online:
www.bethesda2001 cancer .gov
Wright T., Cox JT, Massad S., Twiggs L., Wilkinson E., for the 2001 ASCCP- Sponsored Consensus Conference
(2002). 2001 Consensus Guidelines for the Management of Women with Cervical Cytological Abnormalities.
JAMA, April 24, 2002- Vol 287, No 16
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SERIAL #: PH RFP 12-023
EXHIBIT 4
2011 NBCCEDP Allowable Procedures,
Relevant CPT® Codes, and Medicare
Reimbursement Rates
CPT
Code
Professional
Component
(-26)
Technical
Total
Component Amount
(-TC)
Office Visit
New Patient; history, exam, straightforward decisionmaking; 10 minutes
New Patient; expanded history, exam, straightforward
decision-making; 20 minutes
New Patient; detailed history, exam, straightforward
decision-making; 30 minutes
New Patient: comprehensive history, exam, moderate
complexity decision-making; 45 minutes
New Patient: comprehensive history, exam, high
complexity decision-making; 60 minutes
Established Patient; evaluation and management, may
not require presence of physician; 5 minutes
Established Patient; history, exam, straightforward
decision-making; 10 minutes
Established Patient; expanded history, exam,
straightforward decision-making; 15 minutes
99201
99202
99203
99204
99205
99211
99212
99213
Breast Screening & Diagnostic
Screening Mammogram, Bilateral (2 view film study of
each breast)
Mammography, Diagnostic Follow-up, Unilateral
$
34.71
$
34.71
77057
77055
Mammography, Diagnostic Follow-up, Bilateral
77056
Stereotactic localization guidance for breast biopsy or
needle placement
Mammographic guidance for needle placement, breast
$
43.13
$
79.45
$
27.64
77031
77032
Radiological examination, surgical specimen
76098
Ultrasound, breast(s), unilateral or bilateral, B-scan and/or
real time with image documentation
Ultrasonic guidance for needle placement, imaging
supervision and interpretation
Puncture aspiration of cyst of breast
76645
76942
$
8.08
$
26.94
$
33.36
$
45.40
$
50.74
$
66.11
$
80.13
$
27.70
$
11.00
$
68.11
$
161.63
19000
Puncture aspiration of cyst of breast, each additional cyst,
used with 19000
Breast biopsy, percutaneous, needle core, not using
imaging guidance
Breast biopsy, open, incisional
19001
19100
19101
Page 70 of 73
$
40.59
$
70.17
$
101.69
$
156.49
$
194.90
$
19.45
$
40.93
$
68.19
NonFacility
$
80.11
$
85.45
$
109.24
$
159.59
$
55.34
$
19.08
$
95.05
$
194.98
$
107.10
$
26.17
$
139.72
$
318.56
SERIAL #: PH RFP 12-023
Breast biopsy, percutaneous, needle core, using imaging
guidance; for placement of localization clip use CPT
19295
Breast biopsy, percutaneous, automated vacuum assisted
or rotating biopsy device, using imaging guidance
Excision of cyst, fibroadenoma or other benign or
malignant tumor, aberrant breast tissue, duct lesion,
nipple or areolar lesion; open; one or more lesions
Excision of breast lesion identified by preoperative
placement of radiological marker; open; single lesion
Preoperative placement of needle localization wire, breast
$
209.71
$
538.38
19102
19103
$
461.02
$
511.82
$
157.09
$
66.71
$
88.82
$
140.15
$
134.66
19120
19125
19290
Preoperative placement of needle localization wire,
breast; each additional lesion
Image guided placement, metallic localization clip,
percutaneous, during
Fine needle aspiration without imaging guidance
19291
19295
10021
Fine needle aspiration with imaging guidance
10022
Breast Screening & Diagnostic
Cytopathology, evaluation of fine needle aspirate;
immediate cytohistologic study to determine adequacy of
specimen(s)
Cytopathology, evaluation of fine needle aspirate;
interpretation and report
Surgical pathology, gross and microscopic examination
CPT
Code
88172
88173
88305
Surgical pathology, gross and microscopic examination;
requiring microscopic evaluation of surgical margins
Screening Mammogram, Digital, Bilateral
88307
G0202*
Diagnostic Mammogram, Digital, Bilateral
G0204*
Diagnostic Mammogram, Digital, Unilateral
G0206*
Anesthesia for procedures on the integumentary system,
anterior trunk, not otherwise specified. Medicare Base
Units = 3 (Each additional base unit = $20.84)
Professional
Component
(-26)
Technical
Component
(-TC)
NonFacility
$
29.71
$
67.84
$
36.15
$
78.98
$
34.71
$
42.80
$
34.71
$
20.35
$
68.11
$
68.44
$
144.26
$
103.51
$
122.55
$
96.16
$
50.06
$
135.95
$
104.59
$
223.24
$
138.22
$
165.35
$
130.87
00400
$
62.52
88164
$
14.87
88141
$
28.56
88142
$
28.51
Cervical Screening & Diagnostic
Cytopathology (conventional Pap test), slides cervical or
vaginal reported in Bethesda System, manual screening
under physician supervision
Cytopathology (conventional Pap test), cervical or
vaginal, any reporting system, requiring interpretation by
physician
Cytopathology (liquid-based Pap test) cervical or vaginal,
collected in preservative fluid, automated thin layer
preparation; manual screening under physician
supervision
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SERIAL #: PH RFP 12-023
Cytopathology, cervical or vaginal, collected in
preservative fluid, automated thin layer preparation;
manual screening and rescreening under physician
supervision
Cytopathology, cervical or vaginal, collected in
preservative fluid, automated thin layer preparation;
screening by automated system, under physician
supervision
Cytopathology, cervical or vaginal, collected in
preservative fluid, automated thin layer preparation;
screening by automated system and manual rescreening,
under physician supervision
Hybrid Capture II from Digene - HPV Test (High Risk
Typing, only)
Colposcopy of the cervix
88143
$
28.51
88174
$
30.06
$
37.28
$
49.39
$
107.51
$
152.41
$
141.64
$
133.93
$
288.06
$
324.21
$
128.80
$
100.74
88175
87621
57452
Colposcopy of the cervix, with biopsy and endocervical
curettage
Colposcopy of the cervix, with biopsy
57454
57455
Colposcopy of the cervix, with endocervical curettage
57456
Endoscopy with loop electrode biopsy(s) of the cervix
57460
Endoscopy with loop electrode conization of the cervix
57461
Biopsy, single or multiple, or local excision of lesion, with
or without fulguration (separate procedure)
Endocervical curettage (not done as part of a dilation and
curettage)
Conization of cervix, with or without fulguration, with or
without dilation and curettage, with or without repair; cold
knife or laser
57500
57505
$
303.35
$
261.80
57520
Loop electrode excision procedure LEEP
57522
Cervical Screening & Diagnostic
CPT
Code
Endometrial sampling (biopsy) with or without
endocervical sampling (biopsy), without cervical dilation,
any method (separate procedure)
58100
Endometrial sampling (biopsy) performed in conjunction
with colposcopy (List separately in addition to code for
primary procedure)
58110
Surgical pathology, gross and microscopic examination
88305
Pathology consultation during surgery, first tissue block,
with frozen section(s), single specimen
Pathology consultation during surgery, first tissue block,
with frozen section(s), each additional specimen
88331
88332
Professional
Component
(-26)
Technical
Component
(-TC)
NonFacility
$
108.81
$
36.15
$
59.11
$
29.04
$
68.44
$
31.37
$
11.00
Page 72 of 73
$
47.92
$
104.59
$
90.48
$
40.04
SERIAL #: PH RFP 12-023
ASC Rates with Relevant CPT Codes
CPT
Code
19000
Facility Price
(for Provider)
$
43.64
19100
$
67.91
$
211.69
$
102.16
$
190.69
$
391.55
$
435.34
Drainage of breast lesion
Bx breast percut w/o image
19101
Biopsy of breast, open
19102
Bx breast percut w/image
19103
Bx breast percut w/device
19120
Removal of breast lesion
19125
Excision, breast lesion
Transportation Services (AHCCCS Rates)
HCPS
Code
Non-emerg. transportation, per mile, volunteer
Non-emerg. transportation, per mile, case worker
A0080
A0160
Taxicab, base rate, per client
Taxicab, rate/ per mile, urban
Taxicab, rural base rate, per client
Taxicab, rate/ per mile, rural
Ambulatory Van, urban base rate per client
Ambulatory Van, urban rate/ per mile
Ambulatory Van, rural base rate per client
Ambulatory Van, rural rate/ per mile
Wheelchair Van, urban base rate per client
Wheelchair Van, urban rate/ per mile
Wheelchair Van, rural base rate per client
Wheelchair Van, rural rate/ per mile
A0100
S0215
A0100
S0215
A0120
S0215
A0120
S0215
A0130
S0209
A0130
S0209
Facility Fee
$
72.99
$
169.57
$
946.62
$
300.96
$
580.77
$
946.62
$
946.62
Amount
0.48
0.48
1.15
1.42
1.15
1.69
7.36
1.42
8.05
1.69
12.36
1.70
10.31
1.84
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