36C25718Q0600-001.doc

PERFORMANCE WORK STATEMENT (DRAFT)

A. GENERAL Information

1.0 Scope and Objectives

Under the authority of Public law 104-262 and 38 USC 8153, the Contractor agrees to provide Health Care Resources and Pathology support services, in accordance with the terms and conditions stated herein, to the Department of Veteran Affairs Medical Center, for the Amarillo Veteran Affairs Health Care System (AVAHCS), Amarillo, Texas. The contractor shall provide all resources necessary to accomplish the services described in the Performance Work Statement (PWS) except as may otherwise be specified. All professionals providing services under the terms of this contract will be board certified in Anatomical and Clinical Pathology as described herein and possess the requisite skills and experience to perform the services defined in this work statement. VA by-laws and the VA central office rules state that any pathologists for this department shall be Board Certified in Anatomical and Clinical Pathology. Intent is to procure 1.7 FTE Physician Services coded as 100% patient care as well as call coverage to maintain 24/7 coverage at all times. Due to the nature of this acquisition and to ensure the continuity of services, this will not be an agency locum tenens contract.

2.0 Services

a.

The Contractor shall provide all necessary labor, consultation, assistance, and expertise to provide pathology coverage services to include:

(1) Surgical (including gross only), non-GYN cytology, peripheral smear, and bone marrow cases.

(a)

The Contractor shall perform these services for 130 business days a year and provide services on 50 additional business days during the year (400 hours). This is expected to be used to cover any leave usage by the VA pathologist(s), but can be used at the discretion of the VA. All days will be determined at the discretion of the VA. Cases collected on a Saturday, Sunday or Federal Holiday will count as arriving on the next business day for workload purposes. See price cost schedule.

(b) The Contractor shall perform up to 200 non-GYN cytology cases a year for consultation/review as part of the above coverage and as otherwise needed by the

VA.

(c) The Contractor shall perform up to 240 First Time Malignant reviews a year on cases from the VA Pathologist to include a written confirmation if the diagnosis is confirmed.

(d) The contractor shall provide On-Call Services, as required, M - F (1630-0800), and

Saturday and Sunday (24-hour coverage) as required, with a 20-minute response time, from time of notification from the VA. If the VA Pathologist is on leave or unavailable, On-Call Services will be provided M - F 0800-1630 as well. Payment is made for additional services through the VA laboratory fee-basis budget.

(e) OB-GYN specimens which include, but are not limited to: cervical cones, cervical biopsies, endometrial biopsies, hysterectomies, salpingectomies, and oophorectomies, are rare specimens at the VA and will be sent to the Contractor for signout and correlation with the PAP smears regardless of the day received.

(f) The VA reserves the right to purchase additional 10-day blocks as needed should the work force at the VA change and/or anticipated

(2) All GYN pap smears (approximately 350+ per year). On all cases done by Thin Prep technique and requiring further testing, payment is made for the additional testing through the VA laboratory fee basis budget.

(3) Occasional consults needed “Within 30 minutes after the time that the slides are transported from the VA hospital to be taken to the consultant facility” as soon as possible and/or rare cases inadvertently sent on an incorrect day (approximately 4 cases per month).

(4) Frozen sections when the VA pathologist(s) is/are on leave or are otherwise unavailable to perform. Cell viability –frozen sections will be finalized within 30 minutes from the time that the frozen section reaches the Amarillo VAHCS histology department. Contractor shall be able to meet the finalization time, after notification of arrival of frozen sections at the VA and shall directly call the results back to VA surgeon, if in the operating suite so that the surgeon can then continue the operation in a timely, safe manner.

(5) The pathologist finalizing the case will perform the CPT, ICD10, Topography, Morphology and Tissue Committee codes for all cases finalized for Amarillo VAHCS. Completed CAP synoptic reports will be provided on all malignant cases as requested by the VA, if applicable. Coding shall be completed at off-site contracted facility, by Contracted Pathologist.

(6) Review of up to 10% of casework for the Amarillo VAHCS for the random review quality assurance program.

(7) Contractor shall provide all necessary labor, consultation, assistance, and expertise to provide FTE pathology coverage services at contracted Pathologists facility, off-site from

VA hospital. VA courier will be responsible for delivery of all specimens to contracted pathologist/facility after pick up from Amarillo VA.

(a) The technical part of the surgical cases grossed at the VA and the non-GYN cytology cases excluding urine cytology and bone marrow cases will be performed at the VA with the slides delivered by courier service to the Contractor’s facility. At the Contractor’s request, urine Thin Prep preparations will be prepared at the Contractor’s facility, whenever possible. PAP smears will be stained at the Contractors’ facility to guarantee uniform staining of the PAP smears, also at the Contractor’s request.

(b) In regard to surgical pathology cases, simple cases will be grossed at the VA by the VA Pathology Assistants and/or sent to the Contractor’s facility for gross examination in the rare instance the staff at the VA is unable to process them in a timely manner (estimated <5 days/year). Complex cases will be sent to the Contractor’s facility for gross examination and Complex cases will be sent to the Contractor’s facility for grossing in.

(1) Simple cases will include skin biopsies, other biopsies, hernia sacs, appendices, benign gallbladder specimens.

(2) Complex cases include skin ellipses or other specimens that have sutures denoting orientation, organ resections (colectomies, prostatectomies, lung lobectomies, nephrectomies, etc.), radical neck specimens, and amputation specimens.

( c ) OB-GYN specimens which include, but are not limited to: cervical cones, cervical biopsies, endometrial biopsies, hysterectomies, salpingectomies, and oophorectomies, are rare specimens at the VA. These specimens will be sent to the Contractor for signout and correlation with the PAP smears regardless of the day received. PAP smears will be stained at the Contractor’s facility to guarantee uniform staining of the PAP smears. If additional testing is required beyond routine H&E sections, payment may be made for the additional testing through the VA laboratory fee-basis budget with prior approval from the VA Pathologist.

(d) When flow cytometry, cytogenetics, immunofluorescence studies, nontumoral muscle biopsies with muscle enzymes, stone analyses, nontumoral renal biopsy workups, or other esoteric tests are needed, the VA will pay for the fee basis lab to perform the test or will send it to another VA facility for processing.

(e) Any special stains which are available at the VA and are needed on VA cases (whether the gross was done at the Contractor’s facility or at the VA) can be performed at the VA when the Contractor requests that the VA perform the stain. This would include routine stains, Immunostains, and other special stains.

(f) If a special/immunohistochemical/in situ stain is needed by either the Contractor or the VA Pathologist, the VA may elect (on a case by case basis) to pay for such stains through the VA fee basis budget in the interest of decreased turnaround time (TAT) and improved patient care.

(g) When outside consults are needed on VA cases, the VA will send the case to another VA or to a fee basis consultant at the VA’s expense for the first 100 cases/year. The cost of any cases over 100 will be equally shared by the Contractor and the VA with the Contractor’s share being deducted from the monthly payments made by the VA. The Contractor shall notify the VA personnel (preferably verbal communication at the time of finalizing) when one of the VA cases signed out by the Contractor will need to go out for consult.

(h) The finalized pathology reports will be returned to the VA electronically and remotely verified by the Contractor into VistA or any successor computer system.

(i)The workload figures identified above are intended to reflect averages for planning only and should not be construed to represent actual daily workload projects. For example, there could be three (3) bone marrow cases on any given day, but on other days it would be expected that there may be none. The Contractor agrees to provide services for the specified number of days regardless of the amount of workload generated on any given day.

3.0. Accreditation

a. All services performed by the Contractor shall meet or exceed VA standards and at a minimum, The Joint Commission (TJC) standards should be met. The contractor is required to develop and maintain the flowing documents for each Contractor employee working on the contract:

(1) Credentials and qualifications for the job.

(2) A current competence assessment checklist (an assessment of knowledge, skills, abilities, and behaviors required to perform a job correctly and skillfully includes knowledge and skills required to provide care for certain patient populations, as appropriate).

(3) A current performance evaluation and Quality Assurance (QA) records supporting the ability of the Contractor’s employee to successfully perform the worked required in this Solicitation.

(4) Listing of relevant continuing education for the last two (2) years; and

(5) Anatomical Pathology Board Certification and at least one Pathologist with

Hematopathology board certification.

b.

The Contractor will provide current copies of these records at the time of contract award and annually on the anniversary date of contract award to the COTR or, upon request, for each

Contractor employee working on the contract.

4.0. Medical Records Requirement

a.

Medical Records Standards: The Contractor, Contractor employees, and

Subcontractors shall be subject to the Privacy Act of 1974 and HIPAA of 1996. The contractor is not authorized to release any medical record information. The AVAHCS is the sole entity authorized to release this information upon written request submitted via facsimile or mail from the patient. The AVAHCS will provide the Contractor with access to pertinent patient medical information, within the existing privacy rules and regulations, for the purpose of providing coordinated comprehensive medical care. Contractors shall ensure the confidentiality of all patient information and shall be held liable in the event of the breach of confidentiality.

5.0 Contractor-Furnished Equipment

a. Contractor will not be required to provide any Contractor-furnished equipment other than what is necessary to provide requested services.

6.0 Type and Term of Contract Firm Fixed Price

7.0 Special Contract Requirements

1. TERM OF CONTRACT

This contract is effective for one year from date of award, or other mutually agreed on effective dates, plus four (4) one-year option periods that may be exercised by the VA. The contract is subject to the availability of funds. The contractor shall perform no services after September 30 of any year until the Contracting Officer authorizes such services in writing.

2. QUALIFICATIONS

Personnel assigned by the Contractor to perform the services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by the personnel working on this contract shall be full and unrestricted licenses.

Contracted Pathologist/personnel are subject to approval through the credentialing process.

“Credentialing and privileging is to be done in accordance with VA Directive 1663 and in accordance with the provisions of VHA Handbook 1100.19 (October 2, 2007).” Each person assigned to work under this contract shall be licensed by the Anatomical Pathology Board Certification and at least one Pathologist with Hematopathology board certification.

3. WORK HOURS

A. The services covered by this contract shall be furnished by the contractor as defined herein.

B. The following terms have the following meanings:

(1) Work hours: Monday through Friday, 8:00 a.m. - 4:30 p.m.

(2) National Holidays: The 10 holidays observed by the Federal Government are:

New Years’ Day Martin Luther King Birthday Presidents’ Day Independence Day Labor Day Columbus Day

Thanksgiving Christmas Memorial Day

Veterans’ Day And any other day specifically declared by the President of the United States to be a national holiday.

(3) Off-Duty hours: Monday through Friday, 4:30 p.m. - 8:00 a.m. and weekends.

(4) 50 additional days Pathology Service coverage for primary Pathologist absence/administrative activities (as required).

(5) On-Call Coverage Pathology Services Monday-Friday (as required) 4:30 p.m. - 8:00 a.m.;

24-hour coverage in case of VA Pathologist absence; and Saturday and Sunday (24-hour coverage) as required.

4. PERSONNEL POLICY

The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the contractor shall provide the following for their personnel:

· Workers compensation

· Professional liability insurance

· Health examinations

· Income tax withholding, and

· Social security payments.

The parties agree that the contractor, its employees, agents and subcontractors shall not be considered VA employees for any purpose.

5. RECORD KEEPING

The Contractor shall establish and maintain a record keeping system that will record the hours worked by the contractor employee(s). Recorded hours worked shall be sent electronically to the Laboratory Manager/COR, monthly, at time of invoicing. At this time, invoices shall be sent to:

Brenda Brock, Brenda.brock@va.gov

6. CONTRACT PERFORMANCE MONITORING

A. The Administrative Officer, Ms. Brenda Brock Brenda.brock@va.gov , shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

B. QUALITY ASSURANCE SURVIELIENCE PROGRAM (QASP)

Performance Standards Section 2 – Services

Performance Standards Section 2 – Services ( a )

Performance Standards Section 2 – Services (5)

Performance Standards Section 2 – Services (6)

Performance Standards Section 2 – Services (7) (h)

Performance Standards

C. The contractor shall be required to perform at a high level of professional care, defined as:

consistent validation of findings through peer review of rendered services. All contractor practices shall strictly adhere to current TJC standards. The contractor shall maintain an active quality assurance review and quality improvement program, which will report its activity to appropriate AVAHCS committees.

(1) Quality:

(a) Upon request the Contractor shall provide copies of performance evaluations for each pathologist annually.

7. KEY PERSONNEL AND TEMPORARY EMERGENCY SUBSTITUTIONS

The Contractor shall assign to this contract the following key personnel:

A. During the first ninety (90) days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the Contracting Officer, in writing, within 15 calendar days after the occurrence of any of these events and provide the information required by paragraph (c) below. After the initial 90-day period of the contract, the Contractor shall submit the information required by paragraph (c) to the Contracting Officer at least 15 days prior to making any permanent substitutions.

B. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the Contracting Officer. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The Contracting Officer will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

C. For temporary substitutions where the key person will not be reporting to work for three (3) consecutive work days or more, the Contractor will provide a qualified replacement for the key person. This substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

8. CONFIDENTIALITY

A. The Contractor is subject to the provisions of the Privacy Act of 1974 and the Health Insurance Portability and Accountability Act (HIPAA) as well as all applicable VA laws and regulations.

Contractor shall be limited in their access to only those VISTA menus required to perform the service. Contract employees will provide the Contracting Officer on an annual basis documentation of privacy training. (see also 10. Privacy Awareness Training) B. The Contractor shall keep confident the contents of all medical documents entrusted to its care.

Employees of the Contractor shall not disclose to any unauthorized person, firm or corporation knowledge entrusted during performance of the contract which relates to the following, but not limited to:

i. Names of patients.

ii. Names of physicians, nurses or any other employee of the medical center.

iii. The type or content of any dictated reports.

C. All contractor personnel shall observe the requirements imposed on sensitive data and information by law, Federal regulations, VA statutes and policy, Veterans Health Administration (VHA) policy and guidelines and the associated requirements to ensure appropriate screening of all personnel (e.g., Privacy Act of 1974, Public Law 93-579, the requirements of the FPM 731, Subchapter 2 under E.O. 10450, etc.). In accordance with FPM Chapters 731 and 7s 5 CFR Ch. 1 (1-1-95 edition) and Executive Order 10450, the security risk level assigned is considered Low Risk (LR) equating to noncritical sensitive defined as "These positions have limited potential for adverse impact involving limited scope of duties without independent or semi-independent action or decision making". CONTRACTOR PERSONNEL HAVING ACCESS TO VA COMPUTER

SYSTEMS SHALL BE REQUIRED TO UNDERGO A BACKGROUND INVESTIGATION

COMMENSURATE WITH THE LEVEL OF SECURITY RISK. THE COSTS ASSOCIATED WITH THE

BACKGROUND INVESTIGATION SHALL BE BORNE BY THE CONTRACTOR.

D. Investigative Process for Low Risk and Nonsensitive Positions. Unless exempted under the provisions of VA Directive 0710, appointees and contract personnel appointed to Low Risk/Nonsensitive positions must be the subjects of a National Agency Check with Written Inquiries (NACI) investigation conducted by OPM. See 5 CFR §736.201(c), Investigative Requirements. HRM at VA field facilities and VA Central Office will coordinate the initiation of the NACI investigations within 14 calendar days of an individual’s appointment, and make final suitability determinations for individuals in these positions. However, the initiation and adjudication of contract personnel will be handled by the Security and Investigations Center. For non-citizen contract personnel, a National Agency Check with Law Enforcement and Credit (NACLC) will be initiated by the Security and Investigations Center within 14 calendar days of the individual’s placement in the position. NACLC investigations require the same forms and processes as for the NACI investigations, however with the addition of a credit check.

(1) The individual must complete an original SF 85, Questionnaire for Nonsensitive Positions, one SF 87, OF 306, and an employment application consisting of a resume or OF 612. The HRM Officer or designee will provide these forms for completion to the newly appointed individual to a Low Risk/Nonsensitive position. Title 38 appointees or employees may submit, as applicable, VA Form 2850, VA Form 2850a, VA Form 2850b, or VA Form 2850c in lieu of the resume or OF 612.

(2) The individual must complete all forms and return them within 5 calendar days. Individuals hired under contract for these positions must submit their forms to the VA Law Enforcement Training Center/SIC, 2200 Fort Roots Drive, Bldg 104, North Little Rock, AR 72114.

E. In order to maintain Patient Medical Records the Contractor shall have access to the Department of Veterans Affairs System(s) of Records entitled, “Patient Medical Records - VA

(24VA136)”.

F. “Contractor personnel who obtain access to hardware or media which may manipulate or store drug or alcohol abuse data, sickle cell anemia treatment records, records of tests or treatment for or infection with Human Immunodeficiency Virus (HIV) or medical quality assurance records protected by 38 U.S.C. 4132 or 3305, as defined by the Department of Veterans Affairs, shall not have access to the records unless absolutely necessary to perform their contractual duties.

Security of Sensitive Data (see M-11, Chapter 16, “AIS Automated Information Systems Security”, paragraph 16.09 and Appendix 16B) describe these data in greater detail. Any individual who has access to these data will disclose them to no one, including other employees of the Contractor not involved in the performance of the particular contractual duty for which access was obtained. Violation of these statutory provisions, as stated in Department regulations, by the Contractor or the Contractor’s employees, may involve imposition of criminal penalties.” The VA facilities shall provide access to the cited VA Manual provisions.

G. In addition to abiding by the above confidentiality statement, other statements regarding patient confidentiality and computer security may need to be signed by each contractor employee performing on this contract.

9. PRIVACY AWARENESS TRAINING

A. Privacy Training: Contractor and their sub-contractors assigned work under the contract are required to receive annual training on patient privacy as established by HIPAA statutes. Training must meet VHA’s and the Department of Health and Human Services Standards for Privacy of Individually-identifiable health information. Contractor shall provide documented proof to the contracting officer that all employees assigned work and/or having access to Protected Health Information have received annual training. Proof of training is to be forwarded to the Contracting Officer. Information on fulfilling the training requirement as stated in this paragraph can be found at https://www.ees-learning.net. For contractors and sub-contractors who do not have access to VHA computer systems, this requirement is met by receiving VHA National Privacy Training, other VHA approved privacy training or contractor furnished training that meets the requirements of the HHS standards.

B. Rules of Behavior for Automated Information Systems: Contractor personnel having access to VA Information Systems are required to read and sign a Rules of Behavior statement which outlines rules of behavior related to VA Automated Information Systems. The COR will provide, through the facility ISO, the Rules of Behavior for the respective facility.

C. VA Cyber Security Awareness Training: Each contractor assigned work under the contract is required to receive and document completion of VA training on Cyber Security. The requirements for fulfilling this provision can be found at https://www.ees-learning.net.

Contractor shall provide documented proof to the Contracting Officer that all contractor employees servicing a VA contract have received annual training.

D. A Business Associate Agreement (BAA) shall be required for any contract that requires either a

SAC or a NACI or higher and that is not otherwise exempt from the requirement for a BAA.

10. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA)

In accordance with 45 CFR 164.502(e), the Privacy Rule includes exceptions to the Business Associate standard. This contract and its requirements meet the following exception and do not require a Business Associate agreement in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a Business Associate agreement is not required for this contract.

11. REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT SYSTEM

(CPARS)

A. As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed $100,000, and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, Virginia. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for contractor responsibility determination information.

B. Each contractor whose contract award is estimated to exceed $100,000 is required to register with CPARS database at the following web address: www.cpars.csd.disa.mil. Help in registering can be obtained by contacting Customer Support Desk @ DSN: 684-1690 or COMM: 207-438- 1690. Registration should occur no later than thirty days after contract award, and must be kept current should there be any change to the contractor’s registered representative.

(a) For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the contractor’s designated representative for comment. The contractor representative will have thirty days to submit any comments and re-assign the report to the VA contracting officer.

(b) Failure to have a current registration in the CPARS database, or to re-assign the report to the VA contracting officer within those thirty days, will result in the Government’s evaluation.

12. POST AWARD ORIENTATION

The Contracting Officer will schedule a post award orientation conference for contract orientation purposes as required by IL 003A3-12-04.

13. SECURE FAX

Please review VA Handbook 6500 that requires the following statement on all fax cover sheets be included: This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribution, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.”

14. CREDENTIALING AND PRIVILEGING

Contract must state that “Credentialing and privileging is to be done in accordance with VA Directive 1663 and in accordance with the provisions of VHA Handbook 1100.19 (October 2, 2007).”

15. SECURITY INFORMATION

The C&A requirements do not apply and that a Security Accreditation Package is not required.

1 | Page