ITB ADPH Cytology Specs 011526.pdf

Laboratory Contract Specifications

The Alabama Department of Public Health (ADPH) is seeking to establish contract with a laboratory supplier to read and report on Image-Guided Pap Smears, Aptima HPV tests, HPV primary screening, biopsy tissue samples, genotyping, and p16 biomarker analysis. The biopsy tissue samples will be collected from Colposcopy (vulva, vagina, cervix), Endocervical

Curettage (ECC), Endometrial Biopsy (EMB), Loop Electrosurgical Excision Procedure

(LEEP), Cervical Polypectomy, Endocervical Brushings (ECB), and Punch Biopsy.

I. General Requirements:

The laboratory must provide evidence of the following:

1. Have on its Staff a board-certified pathologist with training and current experience in cytopathology, preferably with added qualification in cytopathology

(i.e., a cytopathology residency with passing of the Cytopath Boards).

2. Any Physician reading and reporting upon smears and biopsy tissue samples must possess either a regular license or a special purpose license from the State of

Alabama Board of Medical Examiners in accordance with Chapter 24 of Title 34 of the Code of Alabama 1975.

3. Certification by the CLIA (Clinical Laboratory Improvement Amendments) and provide a summary report of the most recent CLIA inspection upon request.

4. The laboratory’s cytotechnologists are graduates of an accredited school of cytotechnology and are registered through examination by the American

Society of Clinical Pathologists (ASCP).

5. All personnel examining Pap smears or biopsy tissue samples have passed a

CLIA-approved proficiency test.

6. Laboratory Organization chart.

7. The laboratory must use the latest Bethesda Classification System of reporting cytology test results. Any deviation from the Bethesda System language and terminology must be mutually agreed upon in advance. Lab shall state "Follow up per ADPH protocol” on all specimens requiring follow-up.

8. Detailed description of laboratory facilities quality control program, including reports generated. A copy of the reports generated for the last three years must be provided with the bid.

9. Laboratory must indicate and provide documentation of experience in providing liquid-based cervical cytology and HPV testing (e.g., number of years' experience, number of tests performed annually, use of Hologic imaging system, etc.).

10. Laboratory must indicate and provide documentation of experience in providing (CIN) grades 2 and 3, HSIL, (AIS) adenocarcinoma in situ, or cancer (collectively, CIN 2-3+) (e.g., number of years' experience, number of tests performed annually).

11. Assurance of the availability for ADPH agency staff to consult laboratory personnel, preferably a cytopathologist and/or supervising cytotechnologist, during normal business hours regarding Pap smear and Colposcopy biopsy results and management.

12. If the laboratory's ASC/SIL ratio or percentage incidence of other abnormal cases falls outside of the 5th or 95th percentiles, include documented reasons.

13. Provide evidence of successfully providing laboratory services to Public Health entities in rural and hard-to-reach areas for the last three years, preferably within

Alabama.

14. The laboratory must have a computer system which produces all cytology, HPV and (CIN) grades 2 and 3, HSIL, (AIS) adenocarcinoma in situ, or cancer (collectively, CIN 2-3+) reports, monthly statistical data and itemized billing by clinical site; it must provide for the proper accession of specimens as they are received from clinics statewide, and for their orderly handling, preparation, staining, etc. The laboratory must provide materials and supplies for these analytical procedures.

15. Provide a comprehensive list of all tests the laboratory is capable of performing on gyn/oncology specimens.

16. Online training at no expense to the department.

17. Must provide third-party billing and invoicing for each county site.

18. Must be ICD-10 proficient.

19. Must provide a laboratory requisition form unique to each county site to include:

a. the provider(s) that practice at each site;

b. ability to modify as changes to county sites occur;

c. ability to identify specific program areas (Family Planning, Breast and

Cervical Cancer, Disease Control, etc.) for billing purposes and grant data requirements;

d. ability to report data elements described above in monthly summary reports in paper and electronic format.

20. Must provide a phone call to State and County Health Department staff for

(CIN) grades 2 and 3, HSIL, (AIS) adenocarcinoma in situ, or cancer

(collectively, CIN 2-3+) results within 48 hours of result.

21. Must provide the laboratory's annual rates for the past three years for the following:

a. (CIN) grades 2 and 3, HSIL,

b. (AIS) adenocarcinoma in situ,

c. cancer (collectively, CIN 2-3+)

d. Genotyping

e. Aptima HPV testing,

f. HPV Primary testing

g. p16 biomarker

h. computer-assisted ThinPrep imaging system with dual review functions (Image-Guided Pap smears).

22. A detailed plan for providing onsite orientation on specimen collection, specimen packaging, transport, and other issues related to providing liquid-based cervical cytology, HPV testing, and colposcopy biopsies, and ongoing training and information for clinic staff participating in the project.

23. Indicate the process ADPH clinics will need to follow in preparing ThinPrep, HPV specimens, and colposcopy specimens for shipment, utilizing standard packing and shipping procedures for receipt by the laboratory (e.g., collection devices, mailers, courier services, etc).

24. The laboratory's policies and procedures for the processing and storage of specimens.

25. Provide daily courier service to select county health departments except on state holidays to collect specimens, as well as provide the needed supplies necessary for collection, packaging, transportation, and pick up of specimens.

Services at the health departments are provided Monday through Friday from

8:00 a.m. until 5:00 p.m. A detailed description of the bidder's current courier service must be provided with the bid.

26. A description of turnaround time for results, which should not exceed seven

(7) business days from receipt of specimen. Include the methods for reporting the results of the ThinPrep Pap smears, HPV test, and colposcopy biopsies to providers. Test results needing immediate attention, such as HSIL (CIN) grades 2 and 3, HSIL (AIS) adenocarcinoma in situ, and cancer (collectively, CIN 2-3+), are to be faxed, phoned, or electronically sent based on mutually agreed upon procedures, to the appropriate clinic site at the time of reporting.

27. With the implementation of CureMD, ADPH's Electronic Health Record

(EHR), proof must be provided that shows satisfactory ordering and receiving of results via bidirectional interface. Provide evidence of success in performing this with at least three other entities, preferably Public Health entities, in the last three years.

28. The types of reports, including test results and statistical reports that will be provided to clinics in the project. Samples of reports to include individual client test results, statistical reports, and any additional reports, such as summaries of clients with abnormal test results, should be included with the proposal. The frequency of statistical reports and the laboratory's ability to produce special reports should also be addressed. Include details on the mechanism that reports can be transferred to county and state level sites (such as fax, internet-based access, a specific computer software package, etc.)

29. The laboratory's policies and procedures for mailing slides for review (include details for external review of normal slides or slides for legal review, etc.)

30. Agreements to an on-site visit to the laboratory by representatives of the agency, including coverage of expenses; includes a maximum of two people every two years.

31. Current liability insurance coverage $1,000,000 per occurrence.

32. Include a listing of all days considered to be holidays by the laboratory.

II. Service Specifications:

1. Any physician reading and reporting upon smears, (CIN) grades 2 and 3, HSIL, (AIS) adenocarcinoma in situ, or cancer (collectively, CIN2-3+) must possess either a regular license or a special purpose license from the State of

Alabama Board of Medical Examiners in accordance with Chapter 24 of Title

34 of the Code of Ala., 1975.

2. Laboratory must show evidence of the processing, interpretation, and reporting of a minimum of 60,000 or more ThinPrep Pap smear and (CIN) grades 2 and

3, HSIL, (AIS) adenocarcinoma in situ, or cancer (collectively, CIN2-3+) cases during each of the past three years.

3. Laboratory must use the FDA approved ThinPrep liquid-based Pap smear manufactured by Hologic Corporation. A unit price for the ThinPrep Pap test must be included in the proposal with the use of the Hologic ThinPrep imaging system.

4. The laboratory must use the FDA-approved HPV reflex – Aptima HPV test for high-risk typing manufactured by Hologic. The Laboratory must be able to perform HPV testing on the same sample submitted for the initial liquid-based

Pap test. The laboratory should indicate whether it provides an HPV-only testing option (via an HPV-only vial). If HPV testing is not done onsite, provide a description of how the tests are processed. A unit price per HPV test must be included in the proposal.

5. The laboratory must use the latest Bethesda Classification system of reporting

Cytology test results. The lab must provide a sample of the narrative descriptive nomenclature routinely utilized on ThinPrep lab reports.

6. The laboratory must complete all tasks involving the processing, interpretation, clinic report preparation, and return of Pap smear reports to their respective originating clinics within seven (7) working days of the receipt of raw specimens in the laboratory.

7. Additional turnaround time for HPV testing should be described in this proposal if beyond 7 days from receipt of specimen.

8. Laboratory agrees that any disputes will be handled under Alabama law.

9. Laboratory abides by all state and federal laws, rules, and regulations related to the confidentiality of a patient's information.

10. Laboratory complies with current federal requirements and is licensed under the laws of the state of Alabama.

III. Quality Assurance:

The laboratory must have in place a well-defined, documented, continuous internal as well as external quality control program as stipulated by CLIA regulation.

IV. Supplies/Forms:

The laboratory will be responsible for all Pap smear and tissue specimens reaching its facility. This will include furnishing the laboratory for clinic sites statewide, as well as all necessary supplies for collecting and transporting specimens from the clinic sites to the laboratory. The laboratory must furnish a sample collection kit, mailing supplies, and a laboratory requisition form with this proposal.

1. The lab will accept phone, fax, or web requests for supplies. Lab supplies should be received in clinics within 7 working days from the request. Include a description of an automatic reordering process if available.

2. The unit price submitted by the laboratory for ThinPrep Pap smear test, HPV, (CIN) grades 2 and 3, HSIL, (AIS) adenocarcinoma in situ, and cancer

(collectively, CIN 2-3+) test must include all costs for specimen collection devices, transport supplies, and shipping and handling to and from the laboratory.

V. Data

The laboratory has the capability of providing electronic data reports in a format that can be copied and pasted into an Excel spreadsheet, as specified by the department, such as:

1. The overall rates of ASC-US, LSIL, HSIL, AGC, ASC-H, CIN, unsatisfactory results and NILM but EC/TZ absent/insufficient.

2. The percentage of laboratory ASC-US cases that are HPV high risk positive.

3. A quarterly clinic site list by patient name, patient ID number, program from which specimen was obtained (Family Planning, Breast and Cervical Cancer

Program, Maternity, etc.), date specimen received, date results reported, provider name or number on all patients with abnormal findings.

4. A monthly report that addresses which patients at an individual site require follow-up due to abnormal findings.

5. A semi-annual and annual report that reflects the total Pap smears by age, race and diagnosis by clinic site, county, and state totals.

6. A quarterly report that addresses unduplicated patient by diagnosis, clinic site and provider.

7. An annual report that gives the total number Pap tests by clinic site, by provider and the total number of unsatisfactory Pap tests.

8. The Overall rates/ percentage (CIN)grades 2 and 3, (AIS) adenocarcinoma in situ, or cancer (collectively, CIN 2-3+ results to include negative as well as abnormal.

9. Ability to accommodate adhoc reports upon request with the data elements captured from the requisition form.

VI. Payment:

Submit reimbursement vouchers or invoices for ThinPrep Pap tests, HPV test, and biopsy tissue samples (biopsy of cervix, biopsy of vulva, biopsy of vagina, endometrial biopsy

(EMB), Endocervical curettage (ECC), Endocervical Brushings (ECB), and loop electrode biopsy) performed at each Health Department location, in a format specified by the department. At a minimum, invoicing should be performed once each month, and include:

1. Location of the specific clinic

2. Type of test(s) processed by patient name (initial + surname), and health department patient identification number

3. Date specimen collected

4. Program Area

5. Total amount due

VII. References:

The bidder must provide names and phone numbers of a minimum of three users as references that are utilizing lab testing services with requirements similar to the

Department which must be functionally satisfactory.

Proposal checklist: Did laboratory include the following:

1. Pathologists’ Credentials

2. Proof of CLIA certification.

3. Cytotechnologists’ credentials.

4. Laboratory Organizational Chart.

5. Detailed description of QA process.

6. Sample of the Bethesda narrative descriptive nomenclature routinely utilized on

ThinPrep lab reports.

7. Experience in use of ThinPrep Pap tests and HPV tests - number of years’ experience with testing, number of tests performed annually, use of Hologic Imaging System, etc.

8. Provide a comprehensive list of all tests the laboratory is capable of preforming on gyn/oncology specimens.

9. Description of clinical or technical support available to ADPH staff during normal working hours (toll free numbers, case specific reviews, etc.)

10. If the laboratory’s annual ASC/SIL ration or percentage incline of other abnormal cases falls outside of the 5th or 95th percentiles, include Documentation of reasons if applicable.

11. Description of the laboratory policy and procedure for processing specimens and orienting ADPH staff regarding but not limited to the distribution of specimen kits to clinic sites; packaging, shipping and transporting of specimens; process for acceptance of supply order forms from clinic sites: accession of specimens upon receipt at laboratory; the processing and storage of specimens; turnaround time and reporting of lab results, including those needing immediate attention such as

HSIL, (CIN) grades 2 and 3, HSIL, (AIS) adenocarcinoma, or cancer

(collectively, CIN 2-3+). Describe pertinent details regarding the transfer of reports to county and state-level sites (such as fax, internet-based access, specific software, etc.)

12. Description of laboratory reporting of data (including the mechanism for providing reports such as lab software, internet-based access, faxing, etc.) Include samples of reports such as ASCUS, HSIL, HPV, (CIN) grades 2 and 3, HSIL, (AIS) adenocarcinoma, and cancer (collectively, CIN 2-3+) tests by result, etc.

13. Description of policy/procedure regarding mailing slides for review.

14. Description of agreement to onsite visit by ADPH personnel.

15. Proof of insurance coverage.

16. Include listing of all days considered to be holidays by laboratory.

17. A sample collection kit, mailing supplies, and laboratory requisition form.

18. Sample billing statement.

19. Unit price for ThinPrep Pap test using Hologic Imaging System.

20. Unit price for HPV Testing using Aptima HPV test, HPV primary screen, p16 biomarker, and genotyping. If testing is not done onsite, provide description of processing of tests.

21. Unit price for high risk (CIN) grades 2 and 3, HSIL, (AIS) adenocarcinoma, and cancer (collectively, CIN 2-3+). If testing is not done onsite, provide description of processing of tests.

22. Contact information for references.

The supplier must provide ongoing/on-demand training for departmental employees and contracted agencies throughout the contract's duration. Training must be conducted both online and in person.

Costs should include shipping. The supplier is responsible for shipping specimen containers and laboratory requisitions. The department will provide both quantity and shipping information to the successful bidder. There are approximately 71 county health departments statewide.

In order to confirm that all required specifications for biopsy tissue samples (biopsy of cervix, biopsy of vulva, biopsy of vagina, endometrial biopsy (EMB), endocervical curettage (ECC), Endocervical Brushings (ECB), and loop electrode biopsy), and specimen containers are met, the bid proposal must include manuals or materials confirming the specifications for the bid products.

1.) Image Guided Pap Smears

Pap Smear, Cytopathological analysis of liquid-based specimen (THINPREP) for the detection of Cancer, and other abnormalities without the use of an Imaging System

Pap Smear, Cytopathological analysis of liquid-based specimen for the detection of

Cancer, and other abnormalities with the use of an Imaging System

2.) HPV primary screening- Screening for Cervical Cancer and abnormalities by use of HPV testing alone. No Pap cytology testing is performed; only molecular HPV testing is used.

ESTIMATED VOLUME OF PAP SMEARS PROCESSED WITH AND/OR

WITHOUT AUTOMATED IMAGING SYSTEM AND HPV PRIMARY

SCREENING – 25,000 per year

3.) Biopsy tissue samples a.) Cervical Biopsy- Biopsy from Ectocervix b.) Endocervical Curettage (ECC)- Biopsy from Endocervix using a curettage instrument or brush c.) Endometrial Biopsy (EMB)- Biopsy from Endometrium d.) Cervical Polypectomy- Biopsy (removal) or entire Cervical Polyp e.) Vulvar Biopsy – Biopsy from labia minora or majora f.) Vaginal Biopsy- Biopsy from the vaginal canal g.) Endocervical Brushings (ECB) – From the lining of the endocervical canal

ESTIMATED VOLUME OF ALL BIOPSY TISSUE SAMPLES – 2,500 per year

4.) P16 bio marker- Immunohistochemical Stain Performed on surgical biopsies to indicate areas of HSIL (High-grade Squamous Intraepithelial Lesion) – Helps to differentiate

HSIL from LSIL lesions. Estimated Volume – 300 - 500 per year

5.) Genotyping- Molecular testing to determine highest risk HPV subtypes (GENOTYPES) –

(Used to test for 16/18 and sometimes 45subtypes which are most likely to develop into cancer requiring further follow up)

6.) Aptima HPV tests- HPV testing using the Hologic Aptima platform, tests for all high-risk subtypes without further classification that genotyping would offer.

Estimated volume of Genotyping and Aptima HPV tests – 20,000 25,000 per year

7.) Loop Electrosurgical Excision Procedure (LEEP)- Removal of tissue for the diagnosis and treatment of high-grade cervical dysplasia. Biopsy tissue findings should include the extent of the dysplasia, the status of the ectocervical-endocervical margin, and the status of the deep margin. Estimated volume - 300 per year

NOTE: VOLUME OF CYTOLOGY AND PATHOLOGY SPECIMENS ARE BASED ON

NATIONAL GUIDELINES AND YEARLY VOLUMES WILL VARY.