7 FTE MED TECH Laboratory Scientist SOW DRAFT.docx

B.3 STATEMENT OF WORK

The contractor(s) shall provide services at the VA Palo Alto Healthcare System (VAPAHCS VAMC) Pathology and Laboratory Medicine Service for Clinical Laboratory Scientists (Medical Technologists). This is a new requirement for the VAPAHCS VAMC which is needed to augment staffing shortages for current and anticipated vacancies over the next five years.

The duties and responsibilities of the providers include, but are not limited to the following:

1. Medical Technologist

a. Perform a full range of automated and non-automated laboratory procedures in the areas of chemistry, urinalysis, hematology, serology, bacteriology, and immunohematology according to established protocols.

b. Evaluates the suitability of the specimen for analysis, requesting new specimen if determined to be unusable. Prepares specimens for analysis; ensuring that the physiologic states of the specimen properties are maintained.

c. Selects, performs, evaluates, and monitors the performance of test procedures using manual and /or instrumental techniques in accordance with established protocols. Recognizes and reacts to indicators of malfunction; locates and implements corrections.

d. Conducts quality control procedures on equipment, reagents, and products and maintains proper records for quality control reports.

e. Calibrate, standardizes, adjusts and maintains instruments on which trained. Verifies correct instrument operation using established procedures and quality control checks and monitoring. Identifies the cause of common problems and makes repairs.

f. Evaluates the validity of data in relation to the test system and accepted assay procedures; correlates quantitative data with patient data (i.e., history, medications) to verify results.

g. Performs additional tests to clarify or confirm abnormal patient results. Recognizes abnormal results that require immediate attention by the ordering provider and reports them directly.

h. Responsible for the generation of laboratory results from the work area into the laboratory computer system

i. Edit and verify results recorded into the computer system.

j. Stock and maintain specialized supplies used in the work area.

k. Accession and receive samples into VA laboratory information system package for in-house testing or sends out to reference laboratories.

l. Perform phlebotomy to obtain patient specimens for laboratory testing including blood cultures and compatibility samples on an as-needed basis.

[End of Statement of Work]

B.4 SPECIAL TASK ORDER REQUIREMENTS

1. SERVICES

a. The services specified herein may be changed by written modification to this task order. The VA Contracting Officer will prepare the modification (reference FAR clause 52.212-4(c), Changes) and, prior to becoming effective, shall be properly executed. Only the Contracting Officer is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this task order. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the task order price to cover any increase in costs incurred as a result thereof.

b. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered.

c. Contractor is required to maintain medical liability insurance for the duration of this task order. Medical liability insurance must cover the provider for services in all states where services are rendered by the provider.

d. The services to be performed by the contractor will be performed in accordance with VA policies, procedures, regulations, and the medical staff bylaws of the VA facility (copies and/or links will be provided upon request). In all cases, dignity of the patient shall be given the highest regard and the precepts of the American Hospital Association’s “Bill of Rights for Patients” shall be observed.

2. TERM OF TASK ORDER

This task order is effective for one year, plus any exercised options. The contractor shall perform no services after expiration of the base year or any option year unless and until the Contracting Officer authorities such services in writing.

Availability of Funds During a Continuing Resolution: At the beginning of each new fiscal year (October 1st) the federal government or parts thereof may be operating under a Continuing Resolution (CR) and only be funded for a limited period of time rather than for the entire fiscal year. If, at any time, funds for this contract are provided under a CR, funds will only be available for performance under this contract up to and including the expiration date of the CR, and any extension thereof. The government’s obligation for performance of this contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the government for any payment may arise for performance under this contract beyond the expiration date of the CR, and any extension thereof, until funds are made available to the contracting officer for performance and until the contractor receives notice of availability.

3. BUSINESS HOURS

Laboratory Services hours of operation: 24 hours a day, 7 days a week.

3.1. WORK SCHEDULE

a. Contract staff shall supplement fulltime VA Staff. Overtime may be necessary on weekdays (non-holiday) and is applicable for any time over 40 hours in a one week pay period worked at the VA. Overtime shall be pre-approved by the Lab Manager or Lab Supervisor. A regular shift may be any segment of time that is comprised of a continuous 8.5hrs inclusive of lunch, including but not limited to the following:

Medical Technologist work week Day Shift: Sunday through Saturday, 0800 – 1630 Evening Shift: Sunday through Saturday, 1530 – 0000 Swing Shift: Sunday through Saturday, 1200 – 2030 Night Shift: Sunday through Saturday, 2200 - 0630 Overtime on an as-needed basis All authorized key personnel will have a 30-minute unpaid lunch break.

b. SCHEDULING/ABSENCES

i. Contract staff must contact the contractor regarding cancellations, changes in scheduling availability, etc. The contractor will, in turn, contact the VA of employee cancellation.

ii. Contract staff must contact the contractor regarding absences, requests for time off, changes in scheduling availability, etc. The contractor will, in turn, contact the VA. Additionally, if contract staff are unable to make it to a scheduled shift or will be late, they shall notify the VA Lab Manager or designee as soon as possible so that alternate staff arrangements can be made.

The missing of two scheduled shifts (“no call/no show”) by contract staff may be grounds to restrict/cease contractor employee from being scheduled for future shifts or result in removal.

3.2 FEDERAL HOLIDAYS

The 11 holidays observed by the Federal Government are: New Year’s Day (January 1st), Birthday of Martin Luther King Jr. (3rd Monday in January), Washington’s Birthday (3rd Monday in February), Memorial Day (last Monday in May), Juneteenth National Independence Day (June 19th), Independence Day (July 4th), Labor Day (1st Monday in September), Columbus Day (2nd Monday in October), Veterans Day (November 11th), Thanksgiving Day (4th Thursday in November), Christmas Day (December 25th) and any other day specifically declared by the President of the United States to be a national holiday.

When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies.

4. QUALIFICATIONS OF PERSONNEL

a. Personnel assigned by the contractor to perform the services covered by this task order shall have a full and unrestricted license in a State, Territory, or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approved by the VA Facility Director. The Contracting Officer will be notified prior to any changes in personnel. VA reserves the right to approve the assignment of individual personnel furnished by the contractor to perform the functions specified in the task order.

b. Personnel assigned by the contractor to perform the services covered by this task order shall be proficient in written and spoken English (38 USC 7402).

c. Contractor’s assigned personnel must be computer literate as patient documentation is directly inputted in the patient’s electronic medical record. Proficiency in the use of the Veterans Health Information Systems and Technology Architecture (VISTA) system and the Computerized Patient Record System (CPRS) are preferred. It is anticipated that a new electronic medical record system may be implemented during the performance period of the task order. VA will provide training on the medical record system.

d. Contractor’s assigned personnel shall possess the following qualifications:

Medical Technologist

· Degree – Bachelor’s degree

· Education – Graduate from a medical technology program accredited by the National Accrediting Agency for Clinical Laboratory Science (NAACLS).

· Certification – Current certification/registration as determined by the American Society of Clinical Pathology (ASCP) or American Medical Technologist (AMT).

· Experience: Minimum one-year experience (inclusive of clinical training) within the past 5 years.

e. Evidence of completion of required licensure, credentials, required training, current competencies and fingerprints/background investigations must be validated for all contractor personnel referred to perform services under this contract prior to providing direct patient care.

f. Any new requirements for mandatory education and/or competency reassessment, which occur during the task order period must be completed by the individual contractor employee(s) within established timeframes.

g. The contracted individual will be required to show two proofs of identification on their first day of work. Acceptable proof of identification is listed below:

Acceptable PICTURE IDs:

· State-Issued Driver’s License

· State DMV-Issued ID Card

· US Passport

· Military ID/Dependents Card

· Foreign Passport

· Permanent Resident Card/Alien Registration Card w/Photo Acceptable NON-PICTURE IDs:

· Social Security Card

· Certified Birth Certificate

· State Voter Registration Card

· Native American Tribal Document

· Certificate of US Citizenship

· Certificate of Birth Abroad Issued by Dept of State

h. INFECTION CONTROL FINGERNAIL GUIDELINES: Artificial nails carry more bacteria than short natural nails. Therefore, only natural nails are allowed. Artificial fingernails or extenders (including overlay nail products nail products such as gel, acrylic, or shellac) are NOT to be worn by any healthcare worker who provides care to patients under this task order. Nails should be short enough to allow the individual to thoroughly clean underneath them and not cause glove tears.

5. APPROVAL OF CONTRACTOR PERSONNEL

The VA reserves the right to refuse acceptance of any contractor employee or subcontractor employee under this contract when that individual does not qualify under the requirements of VHA Directives 1100.20 and 1100.21(1) and/or the specific VA Hospital/Medical Center Policy on Credentialing and Privileging or fails to perform at the proficiency level expected.

In addition, VA reserves the right to restrict the services or require dismissal of any contractor employee or subcontractor employee under this task order if personal or professional conduct jeopardizes patient care. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, physical or verbal abuse, or other conduct resulting in formal complaints by the patient(s). Standards of conduct shall mirror those prescribed by current federal personnel regulations. The Contracting Officer and the Contracting Officer’s Representative (COR) shall deal with issues raised concerning task order personnel’s conduct. The final decision maker on questions of acceptability is the Contracting Officer.

6. HHS/OIG

To ensure that the individuals providing services under the task order have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (https://exclusions.oig.hhs.gov/) for each person providing services under this task order. The listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs. During the performance of this task order the contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. Any healthcare provider or entity that employ or enter into task orders with excluded individuals or entities may have a Civil Monetary Penalty (CMP) imposed against them. By signing this offer, the Contractor certifies that all persons or entities listed in the contractor’s proposal have been compared against the OIG list and are NOT listed as of the date the offer was signed.

7. JOINT COMMISSION STANDARDS

Although Joint Commission accreditation is not required, the contractor shall perform the required work in compliance with Joint Commission Standards. A copy of these standards may be obtained from the Joint Commission on Accreditation of Healthcare Organizations, One Renaissance Blvd., Oakbrook Terrace, IL 60181

The Contractor will be responsible to ensure the contractor employees or subcontractors providing work on this task order are fully trained and completely competent to perform the required work. Contractor will gather all credentialing documents requested by the VA as well as any other documentation that the carrying out of this task order may require. However, the contractor is neither able to nor is the contractor required to make clinical competence determinations on behalf of the VA.

8. RECORD KEEPING SYSTEM - CONTRACTOR

Contractor must establish a record keeping system of contractor hours worked. Records shall be reviewed and/or shared with VA upon request.

9. MEDICAL RECORDS

Clinical or other medical records of VA veteran patients treated by Contractor under this task order are VA records.

10. HIPAA COMPLIANCE

Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (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 and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). Contractor is conducting health care services on the VA’s behalf – therefore, no BAA is required.

11. CONTRACT PERFORMANCE MONITORING

a. Contractor’s employee(s) shall report to Lana Hur, Lab Manager or designee, upon arrival at the VA Palo Alto VAPAHCS – Building 100, Laboratory (Fourth Floor).

b. Monitoring of contractor’s performance shall be demonstrated through clinical and administrative record reviews. COR will be responsible for verifying task order compliance. COR will designate appropriate VA personnel to monitor services through one or a combination of the following mechanisms:

1. Departments being served will monitor Contractor performance to ensure that services called for in the task order have been received by VA in a timely manner. The COR will be responsible for verifying task order compliance. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer.

2. Documentation of services performed will be reviewed prior to certifying payment. The COR will perform periodic spot checks and document with the using service to ensure records are properly monitored. VA will pay only for services actually provided, and in strict accordance with the Price Schedule. Task order monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided.

3. The using service, through the COR, will provide a written statement annually to the Contracting Officer to include a summary of Contractor actions and a statement that all requirements of the task order have been fulfilled as agreed. This summary evaluation will be submitted 20 days prior to expiration of task order (and/or prior to election of option year renewals, if applicable).

c. Contractor's employee(s) may not certify bills for payment.

12. QUALITY ASSURANCE MONITORING

a. Contractor shall maintain a Quality Control Program related to the laboratory clinical support services covered under this task order. The results of all Quality Improvement activities performed by the Contractor involving VA patients will be shared with facility staff. This will include, but not be limited to, quality improvement plans, minutes of staff meetings where quality improvement has been discussed and which include practitioner-specific findings, conclusions, recommendations, written plans for actions taken in response to such conclusions and recommendations, and evaluation of those actions taken. Monitors should reflect at a minimum, issues related to quality care and appropriateness of referral.

b. Copies of provider certification are also required to be submitted annually to the COR. In addition, updated Joint Commission survey results for the contractor, if Joint Commission certified, shall be forwarded to the COR upon receipt.

c. The contractor will meet or communicate with the facility staff for process review and improvement of task order performance on an as needed basis.

d. Quality factors that VA may consider when monitoring quality of care may include, but are not limited to: patient medical records, availability of contract staff, security/privacy, and patient satisfaction.

e. Reporting Adverse Events: The contractor shall have an established program to monitor 100% of adverse events (including patient injury or death, or unusual situations in which the patient may be involved) associated with care of VA patients. The contractor shall collect and report the program information on a quarterly basis. The contractor shall notify the VA of adverse events (as defined above) involving VA patients during provided services. The VA may review specific findings, conclusions, recommendations, written plans for corrective action taken in response to conclusions and recommendations and evaluation for those corrective actions.

f. These measures, standards, and monitoring procedures are illustrated in the following Performance Requirements Summary Matrix:

Medical Technologist

QUALITY LEVEL

MONITORING METHOD

to follow SOPs, data entry error) 1/quarter or by laboratory manager's discretion

Occurrence Reports

mandatory or assigned competency per requirements

100% Competency Record System

scheduled with no unexcused absences.

Customer Satisfaction Communicates effectively, professionally and courteously

98% Customer Feedback, Joint Patient Safety Report (JPSR) or Reports of Contact

95% Copies submitted to Lab Manager for review and signature

13. PROHIBITION OF TASK ORDER PERFORMANCE OUTSIDE THE U.S.

The entire performance of the task order shall be within the borders of the United States of America, the District of Columbia and/or Puerto Rico. The Contractor shall not access any VA data/information (for example, by remote computer access) from locations that are outside the above-stated borders.

Furthermore, the Contractor shall not send, transfer, mail or otherwise transmit any VA data/information to locations outside the above-stated borders.

14. CONTRACTOR CERTIFICATION: CITIZENSHIP RELATED REQUIREMENTS

The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S. Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals.

While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S. Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offeror's response to the RFQ using the subject attachment in Section D of the solicitation document.

15. PAYMENT

a. Contractor’s employees must be present at the VA facility and must be actually performing the required services for the period specified within the task order or the task order cost will be decreased accordingly during each billing cycle. Contract providers shall be responsible for reporting time worked accurately. The Contractor shall be paid for actual hours performed. In the event that the Contract provider works a portion of an hour, the government will adjust payments by 15-minute increments.

b. Timesheets: Contractor is required to provide its employee with a timesheet to record hours worked. All contractor employees performing under this task order will have individual timesheets. The timesheets will be used to document the number of hours worked. The COR will reconcile the contractor invoices with VA records to ensure this monitoring requirement is being adequately observed. Invoices will reflect actual hours worked. The contractor will be reimbursed for only those number of hours identified on the timesheets. The VA pays in 15-minute increments; partial hours shall be rounded to the nearest 15-minute increment up or down using normal rounding rules.

Timesheets must be signed by the Service Managers, or designee, as applicable only. Timesheets signed by other than those listed above will not be accepted with invoices for payment. A list of managerial staff will be provided to the contractor after task order award and discussed with contractor staff during orientation.

c. Sign-in/Sign-out Sheet: The VA will provide the contractor employee with a standardized Sign-in/Sign-out Sheet, identifying arrival and departure times from the VA facility. The COR will compare the Sign-in/Sign-out Sheet to the invoices that are submitted to validate the hours that are worked by each contract employee. An internal time-keeping form is maintained and reviewed for total number of hours worked per month. The COR monitors contractor performance and maintains record keeping of services provided by the contractor. COS provides general oversight of clinical contracts.

d. The VA agrees to reimburse the contractor for services performed, minus any deductions, paid monthly, in arrears, upon receipt of a properly prepared invoice submitted by the contractor. Payments made by the VA under this contract shall constitute the total cost of services provided by the contractor. The contractor hereby agrees; that in no event, shall contractor bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against the beneficiary, the beneficiary’s family, private insurer, Medicare or any other entity acting on the beneficiary’s behalf, for services provided pursuant to this task order. Billings rendered by the contractor to the VA for services furnished a VA beneficiary under the terms of this task order shall be billings in full. This provision shall survive the termination or ending of the task order.

e. Reduction in Services: This is a fixed unit price task order for a specified number of hours. If, at the end of the period of performance, the government has not utilized the total number of hours required under this task order because of a change in its anticipated need, the parties will enter into a modification reducing the scope of the task order with a corresponding adjustment in the total task order price.

f. The payment for any leave, to include sick leave, annual leave, administrative leave, and holidays, are the responsibility of the contractor.

[End of Special Task Order Requirements]