SOW Specialized Fungal Reference Lab Testing.pdf

STATEMENT OF WORK

SPECIALIZED FUNGAL REFERENCE LAB TESTING

C.0 SCOPE:

C.0.1 VA ANN ARBOR HEALTHCARE SYSTEM: The Contractor shall provide reference laboratory testing for specialized fungal testing for the patients of the VA

Ann Arbor Healthcare System and Toledo CBOC. The VAAAHS requests a base year contract for reference laboratory testing that includes 4 additional contract option years. The test menu requirements will vary and are based on patient test orders placed by the physicians.

VA Ann Arbor Healthcare System (VAAAHS) is located at:

VAAAHS

Pathology and Laboratory Medicine Service (PALMS) (113)

2215 Fuller Road

Ann Arbor, Michigan 48105

Toledo Community Based Out-Patient Clinic is located at:

TCBOC

1200 South Detroit Avenue, Toledo, Ohio, 43614.

C.1 DEFINITION OF NEED:

C.1.1 VA ANN ARBOR HEALTHCARE SYSTEM: VAAAHS requests a base year contract for the VAAAHS, that includes 4 additional option years. The test menu provided to the VAAAHS will be varied and based on the patient test orders placed by the clinicians. These laboratory tests are not performed in-house for various reasons such as low testing volume or specialized equipment requirements that are not available at the VAAAHS.

C.1.2 TOLEDO CBOC: VAAAHS requests a base year contract for the Toledo

CBOC, that includes 4 additional option years. The test menu provided will be varied and based on the patient test orders placed by the clinicians. These laboratory tests are not performed in-house for various reasons such as low testing volume or specialized equipment requirements that are not available at the VAAAHS.

C.1.3. Test Menu is as follows:

Antigen Detection

Test Code Test Name CPT Code Alt CPT

Code

Histoplasma Antigen Quantitative EIA

Blastomyces Antigen Quantitative EIA

Coccidioides Antigen Quantitative EIA

Other Antigen Detection Tests

Aspergillus Galactomannan EIA

(1→3) β-D-Glucan Colorimetric Assay

Cryptococcus Antigen EIA

Antibody Detection Tests

Histoplasma IgG IgM Antibody EIA

Coccidioides IgG IgM Antibody EIA

Other Antibody Detection Tests

Histoplasma Antibody ID

Coccidioides Antibody ID

Blastomyces Antibody ID

Aspergillus Antibody

C.2 DUTIES OF CONTRACTOR:

C.2.1 VA ANN ARBOR HEALTHCARE SYSTEM and COMMUNITY BASED

OUTPATIENT CLINIC (CBOC):

C.2.2. The Contractor shall provide the address of the receiving facility to which

VAAAHS laboratory specimens shall be sent to and receive the laboratory specimens packaged by VAAAHS, 2215 Fuller Rd., Ann Arbor, MI 48105, Room E333 (Central

Receiving). The Toledo CBOC will send specimens to the VAAAHS Central

Receiving area for packaging preparation for transport. These packaged laboratory specimens that are ready for transport are shipped VIA UPS. UPS will transport the sample to the respective vendor receiving facility for patient testing.

C.2.3. The Contractor shall provide the specialized specimen collection tubes and shipping kits required for select patient testing, specimen transport request forms and written instructions on how to complete them by VAAAHS personnel.

C.2.4. The Contractor should provide courier and flight services for the transportation of specimens

a. Flights to be made from an airport that provides the best efficiency in getting the specimen to the contractor while maintaining the integrity of the specimens.

b. Courier service for pickup of patient specimens shall be provided 7 days a week and pickup times required are as below:

i. Monday – Friday at 2:00 pm EDT and at 6:00 pm EDT

ii. Saturday, Sunday and Federal Holidays at 3:30 pm EDT.

C.2.5. The Contractor shall provide dry ice

C.2.6. The Contractor should provide Chain of Custody forms (if required)

C.2.7. The Contractor should provide Specimen Transport Request Forms (can be printed from their website).

C.2.8. The Contractor shall provide Customer Telephone Service 24/7/365 days a year.

C.2.9 The contractor shall provide monthly reports to VAMC, to include at a minimum, through an appropriate electronic format (no PI/PHI can be included).

a. Tests ordered (including test code and name)

b. Number of unsatisfactory specimens

c. Calendar year-to-date CPR Code and cost.

d. Number of tests performed in current month

C.2.10. The Contractor shall provide positive notification of receipt of each specimen and an estimated result delivery time for each specimen upon receipt.

C.2.11. The Contractor shall provide reference laboratory testing and reporting with current reference ranges.

C.2.12. Once patient testing is completed, the laboratory results shall be faxed to the

VAAAHS Streem-Fax, 734-745-3207, or a printed copy of laboratory results will be mailed to the Central Receiving Office, within twenty four (24) hours following the test completion, except when specimens are picked up the day before a weekend or holiday (in which case the results shall be provided the following business day).

C.2.13. The Contractor shall notify the facility immediately of any critical values or results within two (2) hours. A list of critical values requiring notification will be provided by the VA to the Contractor for this purpose.

C.2.14. The Vendor shall provide electronic and paper test menu and pricing schedule.

C.2.15. 80% of the testing services provided by the contractor should be performed in-house for a better (TAT) turn-around-time.

C.2.16. The Contractor should provide and maintain a user-friendly public website which allows easy reference for researching test information (test number/CPT

Coding, patient preparation, test utility and result interpretive guidelines.

C.3. REPORTS:

C.3.1. Patient Report shall consist of minimum, Two (2) full Patient Identifiers.

Physician’s Name

Facility Name

CLIA number (if requested)

Account number

Name of testing laboratory

Type of specimen

Date/Time specimen was collected

Date/Time specimen was received

Date/Time test was reported

Test Ordered

Test Result

Flagged abnormal ranges

Reference ranges

Any additional comments related to the test provided by submitting laboratory

Any other information the laboratory has that may indicate a questionable validity of test results

Unsatisfactory specimens shall be reported, regarding their unsuitability of testing.

C.4. SPECIMEN RETENTION:

The Contractor shall store all blood and body fluid specimens after all the testing has been completed, in the event of repeat or add on testing for one week at conditions that maintain sample viability and suitability for testing. Upon request, samples shall be returned to the collecting VA facility via courier in conditions that will maintain the sample viability and suitability for testing. All anatomical pathology specimens shall be returned within two (2) weeks of test completion.

C.5 CONFORMANCE STANDARDS:

C.5.1 VAAAHS AND THE TOLEDO CBOC: Vendor must maintain full compliance with applicable Federal and State regulations. All services provided under this contract must be performed in conformance with the Nation Fire Protection

Agency (NFPA), Occupational Safety and Health Administration and other applicable

National, State and Local regulatory agencies. Vendor must maintain a CLIA certificate of accreditation, and The Joint Commission, and/or the College of

American Pathology (CAP) accreditation. A copy of the CLIA certificate must be provided to VAAAHS.

C.6 HOURS OF WORK:

C.6.1 VAAAHS AND THE TOLEDO CBOC: Contractor shall receive specimens via UPS, Monday through Friday. Patient testing shall be done a minimum of

Monday through Friday but may include weekends if the reference site chooses to perform weekend testing. STAT testing must be an available option. Once testing is completed the reports must be faxed to VAAAHS Streem-Fax 734-745-3207

C.6.2 The eleven holidays observed by the Federal Government are New Years Day, Martin Luther King Day, President’s Day, Memorial Day, Juneteenth Day, Independence Day, Labor Day, Columbus Day, Thanksgiving Day, and Christmas

Day. Also, any other day declared by the President of the United States to be a national holiday.

C.7 MEDICAL LIABILITY INSURANCE LIMITS:

C.7.1 VAAAHS AND THE TOLEDO CBOC: In accordance with VAAR 852.237-

7, Indemnification and Medical Liability Insurance, the contractor shall maintain liability insurance or self-insurance of not less than $1,000,000.00 per specialty per occurrence.

C.8 QUALIFICATIONS

i. Licensing and Accreditation

1. Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The Contractor/Subcontractor shall have all the licenses, permits, accreditation and certificates required by law. The reference laboratory shall be licensed/accredited by the College of American Pathologists (CAP) or The Joint

Commission (TJC), or any other licensing and/or Accreditation in order to perform the required testing listed in this SOW. In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical

Laboratory Improvement Act of 1988.

2. The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of all sanctions current or pending throughout the United

States of America prior to contract award. In addition, the Contractor shall be responsible for providing written guarantee or evidence that all Subcontractors have appropriate licensure and accreditation to perform tests that the primary Contractor cannot perform prior to contract award and as requested by the Contracting Officer

(CO). All proposed Subcontractor changes during the contract performance period must have prior approval by the CO. Changes to the requirements shall be addressed by bilateral modification.

3. Contractor Personnel assigned by the Contractor to perform the services covered by this contract shall be eligible to provide the services of this contract and licensed in a State, Territory, or Commonwealth of the United States or the District of

Columbia. All licenses held by Contractor personnel working on this contract shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this contract shall be licensed by the governing or cognizant licensing board.

4. Contractor policies and procedures shall comply with the Health Insurance

Portability and Accountability Act (HIPPA)

5. The Contractor shall notify the Contracting Officer in writing of all malpractice investigation or licensure or certification suspension that concerns the Contractor or

Contractor personnel, or any discovery of any disciplinary action taken against laboratory(ies) performing under the contract within 24 hours of notification of an investigation or suspension

ii. Contractor Personnel:

1. The Contractor shall maintain current accreditation and notify the Contracting

Officer of all lapses in state license, Clinical Laboratory Improvement

Amendments (CLIA) certification, or clinical pathology certification. The

Contractor shall provide access via website or email upon request a copy of the renewed licenses/certificates before expiration.

Microbiology – Mycology (120)

Microbiology – Parasitology (130)

Diagnostic Immunology – General Immunology (220)

2. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or American Board of Bioanalysis, certified Bio-analyst.

3. The Contractor shall have at least three years of experience providing laboratory services and shall have at least one-year experience in transporting biomedical materials.

4. The Contractor shall provide all technical advisory/recalls/alerts, prior to or simultaneously with field alerts, should be forwarded to the designated individuals determined at contract award.

5. The Government reserves the right to refuse the use of a subcontractor who fails to comply with evidence of accreditation(s) or licensures(s).

C.9 PAYMENT:

C.9.1 VAAAHS AND THE TOLEDO CBOC: Payment for services satisfactorily performed will be made monthly in arrears upon receipt of a proper invoice at the designated office. Payment will be made by a certified invoice, and money will be distributed from the appropriate VAAAHS or

Toledo CBOC control points to pay the obligations. Funded order with obligation/purchase order for each station shall be provided and shall be referenced on the invoice. The obligations must be paid via Purchase

Orders (PO) for the facility.

C.9.2 The Medical Technologist (Contracting Officer’s Representative COR) will make certification for Pathology and Laboratory Medicine Service for the VAAAHS.

All invoices will be processed in accordance with the Prompt Payment Act. Any discrepancy between the terms of the contract and the amount of the invoice will be promptly referred to by the VA Contracting Officer for resolution. Invoices for contract services for the VAAAHS should be submitted via Tungsten System.

Department of Veterans Affairs

Financial Services Center

Invoices To Be Submitted Electronically https://www.tungsten-network.com/customer-campaigns/veteransaffairs

Phone: 877-353-9791

Fax: 512 460 5429

C.10 TERM OF CONTRACT FOR VAAAHS AND THE TOLEDO CBOC:

The contract will be effective for one year from the date of the contract award, with four (4) additional contract option years. The contract is subject to the availability of appropriated funds.

C.11 MISSION, VISION AND VALUES STATEMENT-VAAAHS AND THE

TOLEDO CBOC:

C.11.1 Mission: The mission of the VA Ann Arbor Healthcare System, including

Community Based Out-patient Clinics, is to provide high quality primary and tertiary https://www.tungsten-network.com/customer-campaigns/veteransaffairs care to eligible veterans through highly qualified staff, mutually beneficial educational affiliations and strong research programs.

C.11.2 Vision: To function as a member of a fully integrated health services network that coordinates all processes for the benefit of the patient.

C.11.3 Values: Patient Satisfaction, Accountability, Compassion, Excellence, Teamwork, and Collaboration, Effective Communication, Adaptability, Mutual

Respect, Diversity, Integrity, and Innovation.

C.12 THE JOINT COMMISSION COMPLIANCE STANDARDS:

C.12.1 GENERAL: All applicable VA and VHA policies, procedures and directives shall be followed by the contractor. The contractor shall continuously meet or exceed all Joint Commission Hospital standards. The patient population treated at the VA

Ann Arbor Health Care System, located in Ann Arbor, Michigan, consists of veterans with varying physical, psychiatric, and psychological needs. Care delivered will reflect the VA Medical Centers Mission, Vision, and Values.

C.12.2 PATIENT RIGHTS: Protection of all patients’ rights is of highest priority.

Patient privacy and confidentiality shall be maintained all times. Computer access will be granted on a need-to-know basis, and security of computerized information will be maintained all times. No patients shall be subject to any research activity without his or her fully informed consent, subject to study approval by the Investigational

Research Board (IRB). The contractor shall abide by the VAMC Code of Ethics, which addresses marketing, admission/transfer/referral/discharge processes, and billing issues.

C.12.3 PATIENT SAFETY: The VAMC shall inform the contractor of all applicable

Sentinel Event or other Patient Safety Alerts received by the VAMC. For every applicable alert, the contractor shall take the necessary steps to redesign processes to prevent occurrence and provide written feedback to the COTR describing prevention actions taken. All events related to patient injury, medication errors, and other breeches of patient safety will be documented utilizing the contractor’s format and reported to the COTR utilizing the VAMC Incident Report. The VAMC shall provide the contractor with VAMC Sentinel Event definitions in the start-up phase. The contractor shall verbally notify the VAMC COTR immediately when a Sentinel Event has occurred, which is to be followed by written notification within one (1) business day or sooner if requested by the medical center. The VAMC shall determine when a

Root Cause Analysis (RCA) is required of the contractor. The contractor shall conduct all Root Cause Analysis according to VAMC policy and within established time frames (45 days). Completed RCAs shall be provided to the VAMC COTR.

C.12.4 PERFORMANCE IMPROVEMENT: The contractor shall comply with the

VAMC Performance Improvement (PI) program as applicable to the Pathology and

Laboratory Medicine Service. Pathology and Laboratory Medicine Service will monitor the vendor’s Test Assay Turn Around Times (TATs) on a quarterly basis.

Vendor shall provide a quarterly TAT report for all patient testing requests sent for analysis. Quality Assurance Technologist will provide a quarterly report to VAAHS management team for review. Contractor PI activities may be directed by the VAMC, VISN or VHA, as well as accreditation or licensing bodies. The contractor shall abstract, compile and report PI data as requested by the VAMC. VA Data collection methodology, report format, and reporting deadlines will be defined by the VAMC.

Examples of required PI activities include the VHA Performance Measures/Clinical

Practice Guidelines program, and the Joint Commission ORYX or Core Measurement program. It is noted that PI activities are dynamic and subject to change, as driven by current priorities and resources. In all cases, the contractor shall continually assess for and act upon clinical and administrative improvement opportunities. High priority shall be given by the contractor to the prevention of risk for the patient. The contractor shall implement process-related internal controls to prevent risk to the veteran. VA monitoring for continuous compliance with Joint Commission standards shall be directed by VAMC staff and communicated to the contractor through the COR. VA aggregate and/or practitioner-specific data collected by the VAMC will be provided to the contractor in accordance with established reporting schedules. VA measures related to contract compliance will be identified by the COTR.

C.12.5 LEADERSHIP: The contractor shall effectively manage daily operations, information and support systems, and conserve physical and financial assets while meeting the mission of the VAMC.

C.12.6 ENVIRONMENT OF CARE: All significant problems identified shall be reported verbally to the COTR within 24 hours. A written corrective plan of action shall be submitted to the COTR within 5 working days. VA timeframes and priorities for completion of action plan items will be mutually agreed upon by the contractor and the VAMC Safety Officer.

C.12.7 INFORMATION MANAGEMENT: The VAMC Information Management plan shall be followed by the contractor. Documentation and record keeping shall be in accordance with VAMC policies and procedures. VAAR-852.273-75 SECURITY

REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY

RESOURCES (Interim – Oct 2008) must be included in the contract per ISO.

C.12.8 CONFLICT OF INTEREST: Conflict of Interest acknowledgement document(s) must be signed by all procurement officials and copies filed in the OPF in accordance with VHA Handbook 1660.3. Contracting Officials, COTRs, selection officials, and others involved in the contracting processes are free from any actual or perceived conflicts of interest. The Contracting Officer will monitor compliance and will review the selection board for conflicts.

C.13. COR DESIGNATION:

C.12.1 The Contracting Officer Representative (COR) is Neelam Palande, MS

(Microbiology), MT (ASCP), Medical Technologist, Pathology and Laboratory

Medicine Service (113), VAAAHS, 2215 Fuller Road, Ann Arbor, MI, 48105. Email address is: Neelam.Palande@va.gov Telephone number is 734-845-5986. This individual is a VA employee and free from any financial or organizational conflict of interest.

mailto:Neelam.Palande@va.gov