P01 Anatomic Pathology Referral PWS.docx

Performance Work Statement (PWS) Anatomic Pathology Referral Laboratory Testing Services Specializing in Renal Biopsy Michael E. DeBakey VA Medical Center (“MEDVAMC”) 2002 Holcombe Boulevard Houston, TX 77030

1. GENERAL: This is an acquisition for non-personnel services to provide Anatomic Pathology Laboratory Testing Specializing in Renal Biopsy for Veterans at the Michael E. DeBakey VA Medical Center (“MEDVAMC”). The MEDVAMC shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the MEDVAMC. As a tertiary care medical center with a complex Nephrology Section and a stand-alone VA transplant center the MEDVAMC has the Nephrology and Transplant expertise to take care of Veterans with complex renal treatment requirements, organ failure, has on-site highly successful United Network for Organ Sharing (“UNOS”) – approved kidney and liver transplant programs (catering to Veterans from all over the country), which further enhances the acuity of care provided at the MEDVAMC.

1.1 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, tools, materials, and supervision necessary to perform Anatomic Pathology Laboratory Testing Specializing in Renal Biopsy. The contractor shall perform to the standards in this contract.

1.2 Scope: The contractor shall provide all Anatomic Pathology Laboratory Testing Specializing in Renal Biopsy and be able to perform the following services and stains in house due to the critical nature, possible long-term complications, and the ability to determine what additional studies/stains are required or not for accurate diagnosis, at each step in the process, based on their pathological finding seen during analysis.

TC*

PC*

TC*

PC*

TC*

PC*

TC*

PC*

TC*

PC*

TC*

PC*

TC*

PC*

TC*

PC*

TC*

PC*

Note: TC is the Technical Component of the process and includes the cutting, imbedding and staining of the tissue. PC is the Professional Component of the process and includes the renal pathologist and their interpretation.

1.3 Period of Performance: The period of performance shall be for one (1) 12 Month Base Year and four (4) 12-month option years. The Period of Performance reads as follows:

1.4 Estimated Number of Renal Biopsy Specimens:

1.5 Hours of Operation: Contractor MUST assure adequate staffing to provide same day (Monday through Friday) continuous diagnostic and reporting capabilities for all Anatomic Pathology Laboratory Testing Specializing in Renal Biopsy at all times with Emergency weekend and Holiday cases accepted with prior arrangements. In addition, the laboratory shall provide accessibility to an Anatomic Pathologist who Specializes in Renal Biopsy to discuss clinical implications of the reported test(s).

Services shall be performed during the VA normal business hours, 8:00 a.m. through 4:30 p.m., Monday through Friday, excluding Federal holidays any scheduled work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO). VA follows all Federal holidays that are set by law (USC Title 5 Section 6103).

The Government hereby provides notice and Contractor hereby acknowledges receipt that Government personnel observe the listed days as holidays:

Juneteenth National Independenc Day June 19

*If a holiday falls on a Saturday, the preceding Friday will be treated as a holiday for pay and leave purposes. If a holiday falls on a Sunday, for most Federal employees, the following Monday will be treated as a holiday for pay and leave purposes.

In addition to the days designated as holidays, the Government observes the following days:

1. Any other day designated by Executive Order;

2. Any other day designated by the President’s Proclamation; and

3. Any other day designated by Federal Statute.

1.6 Place of Performance: The work to be performed under this contract shall be performed at the Contractors fully licensed and accredited laboratory in full compliance with the Clinical Laboratory Improvement Amendments (CLIA). Due to the critical nature Renal Biopsy Specimens cannot be sent to a subcontractor as possible long-term complications, and the Renal Pathological requirements essential to determine what additional studies/stains (if any) are critical for accurate diagnosis the contractor must have the technical expertise and extensive experience Specializing in Renal Biopsy. Renal Biopsy Specimen Test Results are extremely time sensitive as the Veteran is treated based upon the results from the Renal Biopsy Test Report. Dependent upon the Veteran’s current medical state this is a potentially life-threatening condition.

1.7 Requirements Contract Information: This solicitation will result in a single award, firm fixed-price requirements contract with estimated quantities.

1. CONTRACT ADMINISTRATION

The Department of Veterans Affairs, National Contracting Office (NCO) 16, Division III, Services Team B warranted Contracting Officers are the only group authorized to award a requirements contract from this solicitation. After the requirements contract award, only a Contracting Officer from NCO 16, Division III, Services Team B can authorize any action at the requirements contract level, including basic contract modifications. The Government reserves the right to reassign contract administration to other Contracting Officers on NCO 16, Division III, Services Team B. Pricing shall be provided in response to this solicitation for a binding price for the services listed in the PWS and section B Price/Cost Schedule.

2. AUTHORITY TO ISSUE ORDERS

NCO 16, Division III, warranted Contracting Officers are the only group authorized to place Task Orders under this requirements contract except as otherwise delegated in writing by NCO 16, Division III, Services Team B warranted Contracting Officer. The NCO 16, Division III, Services Team B Contracting Officer which issues the respective Task Order will be responsible for all administration functions for the given Task Order. During the term of the contract, NCO 16, Division III Services Team B reserves the right to add other customer groups within NCO 16, Division III to be supported by this requirements contract.

3. DELIVERY ORDER PLACEMENT PROCEDURES

This solicitation will result in a single award, firm fixed-price requirements contract with estimated Quantities. Pursuant to Federal Acquisition Regulation Subpart 16.5. individual Task Orders will be requested from the Contracting Officer via email. Orders may be placed by designated individuals in the NCO 16, Division IIIoffice via email. The contractor shall respond to all Task Order quote requests within three business days. Any Task Orders issued under this requirements contract shall be at the same rate as listed in the PWS and section B Price/Cost Schedule.

2. MEDVAMC FURNISHED ITEMS AND SERVICES:

2.1 The Contracting Officer’s Representative (“COR”) assists the Contracting Officer (“CO”) by monitoring compliance with all contract terms and conditions. The COR delegation will be issued to the contractor after award. The memorandum clearly states the role, responsibilities, and limitation of authority imposed on the COR. Only the Contracting Officer shall have the authority to negotiate changes or to modify the contract. The COR is not authorized in any way to authorize, obligate or commit any changes from the contract on behalf of the Government.

2.2 Services: Authorized personnel within the Histology department at the MEDVAMC will place the specimen into the contractor provided biopsy kit, complete the included documentation and requisition form, include pertinent clinical information and prepare the pre-paid packet for contractor pickup.

3. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

3.1 General: Contractor shall furnish all supplies, equipment and services required to perform work under this contract.

The Anatomic Pathologist Specializing in Renal Biopsy for interpretive reports must have an unrestricted license to practice medicine in one of the states or territories of the United States or District of Columbia.

The Anatomic Pathologist Specializing in Renal Biopsy analysis must have national reputations in their areas of specialization, as evidenced by ongoing publication in academic journals and/or presentations at national pathology meetings. Special attention will be paid to expertise specializing in Renal Biopsy. Sponsorship of renal pathology fellowship programs is also desirable.

Testing and Analysis must be performed by an Anatomic Pathologist Specializing in Renal Biopsy.

3.2 Contractor Qualifications:

Only fully licensed and accredited laboratories in full compliance with CLIA regulations shall actively engage in providing the specific Anatomic Pathology Referral Laboratory Testing Services Specializing in Renal Biopsy outlined in this contract. The contractor shall have all licenses, permits, accreditations, and certificates required by law to perform the required testing in place and effective at the time of offer submission. 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 (CLIA), a certificate of registration is not sufficient.

The contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions, current or pending, throughout the USA, with offering. Copies shall be provided with offeror submission.

The contractor shall maintain current accreditation and notify the CO immediately of any lapse or change in status of state license, Regulatory agency accreditation, CLIA certification, or clinical pathology certification. Should any license/certificate be due for renewal during the performance period of the contract, the contractor shall provide a copy of the renewed licenses/certificates to the CO prior to their expiration.

4. SPECIFIC TASKS:

4.1 Contractor shall provide all Anatomic Pathology Laboratory Testing Specializing in Renal Biopsy for the Department of Veterans Affairs at the MEDVAMC.

4.2 Contractor shall provide all necessary supplies not limited to the following (12 specimen kits at time of fully funded and executed Task Order award):

a. All forms necessary for specimen requisition

b. Kits containing all items needed to store and ship renal biopsy specimens including, but not limited to shall be provided at time of award:

i. Test Requisition Form

ii. Fixatives

iii. Containers

iv. Pre-paid FedEx Pak

v. Appropriate outer packaging

c. Special instructions for sample collection, storage, and shipment

d. Replacement of any needed supplies will be provided within 1 business day of request placed by the COR of the MEDVAMC Pathology and Laboratory Medicine Service.

4.3 Contractor shall provide services in a manner that:

a. Assures consistency of Anatomic Pathology Laboratory Testing Specializing in Renal Biopsy, quality control, and patient safety;

b. Assures adequate staffing to provide continuous availability of Anatomic Pathology Laboratory Testing Specializing in Renal Biopsy:

i. Same day Renal Biopsy Service Monday through Friday;

ii. Emergency weekend and Holiday cases accepted with prior arrangements.

c. Provides effective administration of the Testing Services Specializing in Renal Biopsy;

d. Development of effective policies and procedures for implementation of quality services;

e. All results, including EM, are available on the same day that the biopsy is received at the fully licensed and accredited laboratory in full compliance with CLIA.

4.4 Contractor shall perform to the standards in this contract for all Anatomic Pathology Referral Laboratory Testing Services Specializing in Renal Biopsy.

a. All testing performed must be FDA approved.

b. All testing must be performed according to the manufacturer’s instructions or, changes to manufacturers’ instructions have been appropriately validated and documented as required by accrediting agencies.

c. All Biopsy Services performed under this agreement shall be performed at the Contractors fully licensed and accredited laboratory in full compliance with CLIA.

d. Test result and/or report corrections shall be made with corrected reports faxed to the ordering location within 2 business days of correction request.

e. Contractor will ensure transport of sample shipment in such a manner as to ensure the integrity of the specimens (refer to section 4.2.b).

f. All results, including EM, are available on the same day that the biopsy is received at the fully licensed and accredited laboratory in full compliance with CLIA.

4.5 Contractor shall Report ALL Anatomic Pathology Laboratory Testing Specializing in Renal Biopsy Results as follows:

a. Renal Biopsy Test results shall be faxed to a secure line. Fax number will be provided following award. Reports for results previously communicated by telephone shall include the name of the individual notified of the result as well as date and time of notification.

b. Results for Renal Biopsy Specimens shall be received within 1 working day of receiving the specimen (Monday through Friday). Prior arrangements should be made for Emergency weekend and Holiday cases for the specimens sent from the Histology and/or Send Out Section of the MEDVAMC P&LMS.

c. Each test report shall include at a minimum:

· Patient’s name

· Identification number (social security number)

· Submitting Physician’s name

· Test Accession Number assigned by VA

· VA Laboratory name

· Patients’ location clinic/ward (if supplied)

· Date/Time specimen received in reference lab

· Test ordered

· Date/Time of specimen collection

· Date test completed

· Case report

· Contractor laboratory specimen number

· Name, address and CLIA number of Contractor laboratory

· Type of specimen

· Any additional comments related to case

d. Unsatisfactory specimen shall be reported with regard to its unsuitability for testing

e. The contractor shall provide all repeat testing, upon the request of the ordering facility, at no additional charge to the government.

f. Test results that are impacted because of shipping or contractor caused delays/damages shall be retested at the expense of the Contractor.

g. Test result and/or report corrections shall be made with corrected reports sent to the ordering location within 2 business days of correction request.

h. Critical Values (for example renal transplant rejection) will be verbally communicated by telephone to the submitting Pathologist &/or Nephrologist of the MEDVAMC

i. Notification by telephone to the submitting Pathologist &/or Nephrologist of the MEDVAMC of delays in testing, unsatisfactory samples, labeling or requisition errors shall be made within 24 hours of receipt of the samples from the Anatomic Pathology section of the MEDVAMC P&LMS laboratory.

j. Access to a web portal for real-time specimen status tracking. Portal shall also support reprinting of test results on an as needed basis. This shall not be the primary method of reporting test results.

4.6 Contractor shall submit invoices monthly in arrears covering the services performed under this contract to the VA’s Electronic Invoice Presentment and Payment System (IPPS) – The FSC uses a third-party contractor, Tungsten, Vendor Electronic Invoice Submission Methods. Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below:

· VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

· A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org).

· The Contractor shall provide an itemized invoice to the required VA invoicing address or submission online through the appropriate website within 30 days of the end of each month services were provided. The invoices shall contain the following information at a minimum:

i.

ii. Contract Number

iii. Purchase Order Number

iv. CPT Code

v. Test Description

vi. Quantity

vii. Price

4.7 Contractor shall, upon completion of testing, retain all specimens as required by Regulatory agencies. Tissue will be available for retrieval by the VA upon request.

5. QUALITY ASSURANCE:

5.1 The government will evaluate the Contractor’s performance under this contract and the Contractor performance will be monitored to determine if it meets the contract standards. A variety of methods may be used. Nonperformance or substandard task performance will be documented if and when it occurs. The Technical Representative will follow the methods of surveillance specified in the Performance Measures.

5.2 Performance Measures: The following performance measures will be regularly tracked and monitored throughout the effective period of this contract by the Technical Representative and reported to the Contracting Officer on a quarterly basis by the Contracting Officer Representative. Acceptable performance on these measures, along with other factors, will be primary indices of contractor performance and a key consideration in contract renewal decisions.

Performance will be monitored using the following criteria:

6. SAFETY AND SECURITY REQUIREMENTS:

6.1 Health Insurance Portability and Accountability Act (HIPAA) Compliance and Requirements: Contractor will adhere to the applicable provisions of Public Law 104-191, HIPAA of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security, use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). As defined in the Health Insurance Portability and Accountability Act (HIPAA) Public Law 104-191, your company may be required to execute a Business Associate Agreement. If contractor’s facility is an entity that is not covered under the provisions of Public Law 104-191 HIPAA, then contractor will be required to execute a Business Associates Agreement.

Contractor certifies that his facility ( ) is ( ) is not an entity that is covered under applicable provisions of Public Law 104-191 HIPAA.

7. INDEMNIFICATION AND MEDICAL LIABILITY:

7.1 In accordance with FAR clause 52.237-7, the Contractor must have all necessary insurance coverage to operate a Pathology Laboratory. Contractor healthcare professionals and physicians providing services under this contract must be covered by medical liability insurance. Contractor must furnish the VA Contracting Officer, prior to award of contract, with a certificate of insurance from his insurance company indicating that the coverage outlined in this document has been obtained. The certificate of insurance shall demonstrate the contract physicians and facility have medical malpractice insurance, general liability, and any other pertinent special insurance certificates. (See FAR clause 52.237-7 Indemnification and Medical Liability Insurance in section C of this document.) The insurance coverage may not be changed or canceled without a thirty (30) day written notice to the VA Contracting Officer.