J and A - Lab Testing.pdf

PRIORITY:

REQUISITION NUMBER:

REQUEST, TURN- IN, AND RECEIPT FOR PROPERTY OR SERVICES

TO: A&MM OFFICER Requesting Office TO BE COMPLETED BY

SUPPLY PERSONNEL

Action Requested

Delivery

Date Prepared Date Required

ITEM NO. DESCRIPTION

See SCHEDULE/DELIVERY Files

QUANTITY UNIT ESTIMATED UNIT COST TOTAL COST ACT.

OR STOCK NO. UNIT COST NOTE1

VENDOR INFORMATION: NO.

VENDOR:

CONTACT:

PHONE:

ACCT#:

DUNS:

DUNS+4:

Ref. Voucher Number:

SPECIAL REMARKS: See Special Remarks Attachment

DELIVER TO:

FOB TERMS DELIVERY DATE QUOTE DATE BY (Initials)

JUSTIFICATION OF NEED OR TURN-IN (If recurring need, indicate 30 day estimate. If turn-in, do not use this form if circumstances require use of VA Form 90-1217, Report of Survey)

See Justification of Need Attachment

Originator of Request:

Signature of Initiator

Approving Official:

/ES/

Date

VA FORM 90-2237ADP MAR 1985

STANDARD

506-20-1-029-0002

06-13-2019 12-01-2019

UNIVERSITY OF MICHIGAN

PATHOLOGY ASSOCIATES

1301 CATHERINE ROAD

PO BOX 8671

ANN ARBOR MI 48109-0602

073133571

313-936-1891

VARSHA SHAH

Supervisor,Medical Technologist

DEENISE TRAN

Blood Bank Supervisor

SPECIAL REMARKS

Request contract with University of Michigan MLabs in order to provide reference laboratory services for patients of the VAAAHS.

JUSTIFICATION OF NEED

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1.00 YR $415,000.0000 $415,000.00

The VAAAHS (VAAAHS) requests a base year contract with University of Michigan MLabs for reference laboratory testing . The test menu will be varied and based upon patient test orders placed by clinicians. The obligations are paid by a purchase order. The period of service is from December 1, 2019 through November 30, 2020. The COR is Varsha Shah, extension 55530. The Contracting Officer is May Bridget.

Funding/Req. Number: 1 $ ,000.00 506-20-1-029-0002

GRAND TOTAL $415,000.00

ACCOUNTING AND APPROPRIATION DATA

ACRN APPROPRIATION

REQUISITION

NUMBER AMOUNT

1 506-3600160-029-822300 Pathology and Laborator-2560

MEDICAL CARE CONTRACTS

\T\-010022354

506-20-1-029-0002 (P)

$415,000.00

A.2 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY

DELIVERY

DATE

0001 1.00

FOR OFFICIAL GOVERNMENT USE ONLY

Rev 7 July 2014

INDEPENDENT GOVERNMENT COST ESTIMATE (IGCE)

1. PROJECT TITLE: LAB TESTING AND CONSULTATION

2. PROJECT MANAGER Period of Performance

FROM TO

0 /01/2020 /202

DESCRIPTION OF COST ELEMENTS

1. DIRECT LABOR (List Labor Categories)

ESTIMATED

HOURS

RATED PER

HOUR ($)

ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

$0.00 $ .00 $0.00

$0.00

$0.00

$0.00

$0.00

TOTAL DIRECT LABOR $0.00

2. OVERHEAD RATE (%) TOTAL

LABOR ($)

ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A $0.00

3. MATERIALS/SERVICES (Excluding Information Technology (IT) ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A $0.00

4. INFORMATION TECHNOLOGY SUPPORT ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A

TOTAL IT SUPPORT $0.00

5. TRAVEL ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A $0.00

6. SUBCONTRACTOR (S) CONSULTANT (S) ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

TOTAL SUBCONTRACTOR (S) CONSULTANT(S) $0.00

7. OTHER DIRECT COSTS ESTIMATED

COST (S)

TOTAL ESTIMATED

COST ($)

Year 1 $ 000.00

8. TOTAL ESTIMATED COST

IGCE SUBMITTED BY: WENDY STEWART TITLE: CS

OFFICE/DIVISION/BRANCH: 506 - AAVAMC DATE: 03/31/2020

Each period of performance requires an IGCE – (base award, and all option periods require an

IGCE)

INDEPENDENT GOVERNMENT COST ESTIMATE (IGCE)

1. PROJECT TITLE: LAB TESTING AND CONSULTATION

2. PROJECT MANAGER Period of Performance

FROM TO

/202 /202

DESCRIPTION OF COST ELEMENTS

1. DIRECT LABOR (List Labor Categories)

ESTIMATED

HOURS

RATED PER

HOUR ($)

ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

$0.00 $630,000.00 $0.00

$0.00

$0.00

$0.00

$0.00

TOTAL DIRECT LABOR $0.00

2. OVERHEAD RATE (%) TOTAL

LABOR ($)

ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A $0.00

3. MATERIALS/SERVICES (Excluding Information Technology (IT) ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A $0.00

4. INFORMATION TECHNOLOGY SUPPORT ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A

TOTAL IT SUPPORT $0.00

5. TRAVEL ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A $0.00

6. SUBCONTRACTOR (S) CONSULTANT (S) ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

TOTAL SUBCONTRACTOR (S) CONSULTANT(S) $0.00

7. OTHER DIRECT COSTS ESTIMATED

COST (S)

TOTAL ESTIMATED

COST ($)

Year 2 $630,000.00

8. TOTAL ESTIMATED COST

IGCE SUBMITTED BY: WENDY STEWART TITLE: CS

OFFICE/DIVISION/BRANCH: 506 - AAVAMC DATE: 03/31/2020

INDEPENDENT GOVERNMENT COST ESTIMATE (IGCE)

1. PROJECT TITLE: LAB TESTING AND CONSULTATION

2. PROJECT MANAGER Period of Performance

FROM TO

01/202 3 /202

DESCRIPTION OF COST ELEMENTS

1. DIRECT LABOR (List Labor Categories)

ESTIMATED

HOURS

RATED PER

HOUR ($)

ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

$0.00 $661,500.00 $0.00

$0.00

$0.00

$0.00

$0.00

TOTAL DIRECT LABOR $0.00

2. OVERHEAD RATE (%) TOTAL

LABOR ($)

ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A $0.00

3. MATERIALS/SERVICES (Excluding Information Technology (IT) ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A $0.00

4. INFORMATION TECHNOLOGY SUPPORT ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A

TOTAL IT SUPPORT $0.00

5. TRAVEL ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A $0.00

6. SUBCONTRACTOR (S) CONSULTANT (S) ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

TOTAL SUBCONTRACTOR (S) CONSULTANT(S) $0.00

7. OTHER DIRECT COSTS ESTIMATED

COST (S)

TOTAL ESTIMATED

COST ($)

Year 3 $661,500.00

8. TOTAL ESTIMATED COST

IGCE SUBMITTED BY: WENDY STEWART TITLE: CS

OFFICE/DIVISION/BRANCH: 506 - AAVAMC DATE: 03/31/2020

INDEPENDENT GOVERNMENT COST ESTIMATE (IGCE)

1. PROJECT TITLE: LAB TESTING AND CONSULTATION

2. PROJECT MANAGER Period of Performance

FROM TO

01/202 /202

DESCRIPTION OF COST ELEMENTS

1. DIRECT LABOR (List Labor Categories)

ESTIMATED

HOURS

RATED PER

HOUR ($)

ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

$0.00 $694,575.00 $0.00

$0.00

$0.00

$0.00

$0.00

TOTAL DIRECT LABOR $0.00

2. OVERHEAD RATE (%) TOTAL

LABOR ($)

ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A $0.00

3. MATERIALS/SERVICES (Excluding Information Technology (IT) ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A $0.00

4. INFORMATION TECHNOLOGY SUPPORT ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A

TOTAL IT SUPPORT $0.00

5. TRAVEL ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A $0.00

6. SUBCONTRACTOR (S) CONSULTANT (S) ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

TOTAL SUBCONTRACTOR (S) CONSULTANT(S) $0.00

7. OTHER DIRECT COSTS ESTIMATED

COST (S)

TOTAL ESTIMATED

COST ($)

Year 4 $694,575.00

8. TOTAL ESTIMATED COST

IGCE SUBMITTED BY: WENDY STEWART TITLE: CS

OFFICE/DIVISION/BRANCH: 506 - AAVAMC DATE: 03/31/2020

INDEPENDENT GOVERNMENT COST ESTIMATE (IGCE)

1. PROJECT TITLE: LAB TESTING AND CONSULTATION

2. PROJECT MANAGER Period of Performance

FROM TO

/202 /202

DESCRIPTION OF COST ELEMENTS

1. DIRECT LABOR (List Labor Categories)

ESTIMATED

HOURS

RATED PER

HOUR ($)

ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

$0.00 $729,303.00 $0.00

$0.00

$0.00

$0.00

$0.00

TOTAL DIRECT LABOR $0.00

2. OVERHEAD RATE (%) TOTAL

LABOR ($)

ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A $0.00

3. MATERIALS/SERVICES (Excluding Information Technology (IT) ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A $0.00

4. INFORMATION TECHNOLOGY SUPPORT ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A

TOTAL IT SUPPORT $0.00

5. TRAVEL ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

N/A $0.00

6. SUBCONTRACTOR (S) CONSULTANT (S) ESTIMATED

COST ($)

TOTAL ESTIMATED

COST ($)

TOTAL SUBCONTRACTOR (S) CONSULTANT(S) $0.00

7. OTHER DIRECT COSTS ESTIMATED

COST (S)

TOTAL ESTIMATED

COST ($)

Year 5 $729,303.00

8. TOTAL ESTIMATED COST $3, 378.00

IGCE SUBMITTED BY: WENDY STEWART TITLE: CS

OFFICE/DIVISION/BRANCH: 506 - AAVAMC DATE: 03/31/2020

STATEMENT OF WORK

REFERENCE LABORATORY SERVICES, ANATOMIC PATHOLOGY

CONSULTATION, BLOOD IRRADIATION, AND TRANSPORT

C.0 SCOPE:

C.0.1 VA ANN ARBOR HEALTHCARE SYSTEM (VAAAHS): The Contractor shall provide reference laboratory testing for the patients of the VA Ann Arbor Healthcare System (VAAAHS), Pathology and Laboratory Medicine Service (PALMS) (113), located at 2215 Fuller Road in Ann Arbor, MI 48105. The VAAAHS requests a base year contract for reference laboratory testing with four (4) additional contract option years. The test menu provided to the VAAAHS will be varied and based on the patient test orders placed by the clinicians. Approximate 5% yearly increase in patient volume.

C.0.2 TOLEDO COMMUNITY BASED OUT-PATIENT CLINIC (TCBOC): The Contractor shall provide reference laboratory testing for the patients of the Toledo Community Based Out-Patient Clinic (TCBOC), located at 1200 South Detroit Avenue in Toledo, Ohio, 43614. The TCBOC requests a base year contract for reference laboratory testing with four (4) additional contract option years. The test menu provided to the TCBOC will be varied and based on the patient test orders placed by the clinicians.

Approximate 5% increase in patient volume.

C.1 DEFINTION OF NEED:

C1.1 VA ANN ARBOR HEALTHCARE SYSTEM: The VAAAHS requests a base year contract that includes four (4) additional contract 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. Patient specimen slide consulted interpretation for second opinion by the pathologist at the reference laboratory shall be included in this request. The contractor shall provide blood irradiation services exclusive of courier service. The turn-around-time (TAT) for blood irradiation should not exceed one hour from the time the call is placed by the VAAAHS laboratory employee to the courier service, courier blood pick-up, reference laboratory blood product irradiation, and delivery to the VAAAHS, room E331. The contractor shall provide anatomic pathology consultation with interpretation within 24 hours of the request. Test results on specimens sent to the reference laboratory for Immunoperoxidase testing shall be reported to the VAAAHS within 24 hours. Patient specimen transport shall be included in the contract.

In the event a result is of critical value, the contractor will attempt to contact the ordering provider. If they do not have a pager or if they are unable to contact the provider, the reference laboratory may contact the VAAA PALMS Blood Bank department at 734-

845-5159 to report the critical value. The referring laboratory staff will then attempt to contact the ordering provider to report the critical value.

C.1.2 TOLEDO COMMUNITY BASED OUT-PATIENT CLINIC (TCBOC): The Contractor shall provide reference laboratory testing for the patients of the Toledo Community Based Out-Patient Clinic, 1200 South Detroit Avenue, Toledo, Ohio, 43614.

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 TCBOC or VAAAHS. The TCBOC sends the patient specimens for reference laboratory testing to the VAAAHS to prepare the TCBOC patient specimens for transport to the reference laboratory. Test results on specimens sent to the reference laboratory for Immunoperoxidase testing shall be reported to the VAAAHS within 24 hours. Patient specimen transport shall be included in the contract.

C.2 DUTIES OF CONTRACTOR:

C.2.1 VA ANN ARBOR HEALTHCARE SYSTEM: The Contractor shall provide courier service pick-up at the VAAAHS, 2215 Fuller Rd., Ann Arbor, MI 48105, room E333 (Central Receiving), to collect packaged laboratory specimens that are ready for transport. The reference laboratory shall provide courier service pick-up twice a day at a mutually agreeable time. The courier will transport the samples to the respective reference laboratory facility for patient testing. Patient specimens and patient specimen slides requiring STAT processing will be sent to the testing facility via laboratory courier service provided by the reference laboratory. The STAT testing menu shall include tests listed on the attached document “STAT Test Menu.” Test results shall be reported within one hour upon receipt at the reference laboratory. The results shall be reported to the VAAAHS PALMS employees during normal business hours, as indicated in C.2.1.1.

After normal business and on weekends STAT test results shall be reported via telephone to the clinical laboratory technologist on duty or via paging system or telephone to the requesting physician as indicated on the requisition form that was submitted with the STAT specimen. Once patient testing is completed, the patient test result report shall be accessible through one of the following patient test result report delivery options:

1. Contractor shall provide a full-featured fully customizable web-enabled access point for VAAAHS PALMS employees to review and print all patient test results performed by the reference laboratory. The contractor shall provide the secured website address, which shall be accessible via Internet Explorer as the primary web browser. The secured website shall be made accessible to VAAAHS PALMS employees via username and password provided by the contractor. The contractor secured website shall provide a menu option to allow for patient test results to be printed on demand and the option to print automatically to the designated printer at the VAAAHS PALMS administrative office, room C312. The contractor shall provide the Information Technology (IT) support representatives to facilitate the installation.

2. The contractor shall provide a secure file transfer (sFTP) application that delivers a sFTP server (push) or that allows for secure pick up (pull) of sensitive patient data directly to the VAAAHS PALMS sFTP server. The contractor shall provide the option for individual VAAAHS PALMS employees to securely log on to the contractor sFTP application and pick up files using a web browser. The user shall be required to change their password every six months for security reasons. In both cases, the sFTP server shall notify a client-enabled group email account of reports ready to be picked up. In the case of the individual user pick up from the server, files shall be purged from the server four days after email notification. All patient data files shall be available in pdf format. The contractor IT team shall provide the technical support and assist the VAAAHS IT team to establish the transfer of files between sFTP servers if that option is chosen; this involves setting up secure directories on the client sFTP side along with a user name and password for the contractor-initiated connection if the files are to be pushed to the client sFTP server. The contractor shall provide the option to pull the files from the contractor sFTP server. The contractor will set up the directories on the contractor server and allocate a user name and password for the client sFTP server to use to connect to the contractor sFTP server.

The reference laboratory shall be in close proximity to the VAAAHS and provide laboratory courier service on STAT demand and on an as-needed basis. The courier service is expected to answer all calls placed by VAAAHS employees within 15 seconds.

The STAT request, pick-up of specimen(s), and delivery time to the reference laboratory shall not exceed 30 minutes. The reference laboratory shall provide reference laboratory testing with reflex testing at an additional charge, customer support telephone service and courier transportation services 24 hours a day, 7 days a week, and 365 days a year. The contractor shall provide the specialized tubes required for select patient testing, special packing material, specimen transport request forms, reference laboratory testing and reporting, quarterly turn-around-times reports on patient test results, and a report delivery method as stated above in sections 1 and 2. The contractor shall provide an electronic and a paper test menu and a pricing schedule. Combined patient test/assay volume is greater than 3,800 tests per year. The results will be made available to the VAAAHS PALMS administrative office depending on the chosen option as stated in section 1 and 2.

C.2.2 TOLEDO COMMUNITY BASED OUTPATIENT CLINIC: The TCBOC will send specimens to the VAAAH’s Central Receiving Department, room E333, for packaging preparation for transport. The Contractor shall provide courier service pick-up at the VAAAHS, 2215 Fuller Rd., Ann Arbor, MI 48105, room E333 (Central Receiving), to collect packaged laboratory specimens that are ready for transport. The courier service is expected to answer all calls placed by VAAAHS employees within 15 seconds. TCBOC STAT patient specimens will be send to the VAAAHS for patient specimen preparation for transport to the reference laboratory. STAT request, pick-up of specimen(s), and delivery time to the reference laboratory from the VAAAHS to the reference laboratory shall not exceed 30 minutes. The courier will transport the sample to the reference laboratory facility for patient testing and reflex testing at an additional charge.

Once patient testing is completed, the patient test result report shall be accessible through one of the following patient test result report delivery options:

1. Contractor shall provide a full-featured fully customizable web-enabled access point for VAAAHS PALMS employees to review and print all patient test results performed by the reference laboratory. The contractor shall provide the secured website address, which shall be accessible via Internet Explorer as the primary web browser. The secured website shall be made accessible to VAAAHS PALMS employees via username and password provided by the contractor. The contractor secured website shall provide a menu option to allow for patient test results to be printed on demand and the option to print automatically to the designated printer at the VAAAHS PALMS administrative office, room C312. The contractor shall provide the Information Technology (IT) support representatives to facilitate the installation.

2. The contractor shall provide a secure file transfer (sFTP) application that delivers a sFTP server (push) or that allows for secure pick up (pull) of sensitive patient data directly to the VAAAHS PALMS sFTP server. The contractor shall provide the option for individual VAAAHS PALMS employees to securely log on to the contractor sFTP application and pick up files using a web browser. The user shall be required to change their password every six months for security reasons. In both cases, the sFTP server shall notify a client-enabled group email account of reports ready to be picked up. In the case of the individual user pick up from the server, files shall be purged from the server four days after email notification. All patient data files shall be available in pdf format. The contractor IT team shall provide the technical support and assist the VAAAHS IT team to establish the transfer of files between sFTP servers if that option is chosen; this involves setting up secure directories on the client sFTP side along with a user name and password for the contractor-initiated connection if the files are to be pushed to the client sFTP server. The contractor shall provide the option to pull the files from the contractor sFTP server. The contractor will set up the directories on the contractor server and allocate a user name and password for the client sFTP server to use to connect to the contractor sFTP server.

The reference laboratory shall be in close proximity to the VAAAHS and provide laboratory courier service on STAT demand and on an as-needed basis. The courier service is expected to answer all calls placed by VAAAHS employees within 15 seconds.

The STAT request, pick-up of specimen(s), and delivery time to the reference laboratory shall not exceed 30 minutes. The reference laboratory shall provide reference laboratory testing inclusive of reflex testing at an additional charge, customer support telephone service and courier transportation services 24 hours a day, 7 days a week, and 365 days a year. The contractor shall provide the specialized tubes required for select patient testing, special packing material, specimen transport request forms, reference laboratory testing and reporting, quarterly turn-around-times reports on patient test results, and a report delivery method as stated above in sections 1 and 2. The contractor shall provide an electronic and a paper test menu and a pricing schedule. Combined patient test/assay volume is greater than 250 tests per year. The results will be made available to the VAAAHS PALMS administrative office depending on the chosen option as stated in section 1 and 2.

C.3 CONFORMANCE STANDARDS

C.3.1 VAAAHS AND THE TCBOC: The contractor shall maintain full compliance with applicable Federal and State regulations. All services provided under this contract shall be performed in conformance with the Nation Fire Protection Agency (NFPA), Occupational Safety and Health Administration (OSHA) and other applicable national, state and local regulatory agencies. Vendor shall 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 will be provided to the VAAAHS.

C.4 HOURS OF WORK:

C.4.1 VAAAHS: The contractor shall provide a specimen transportation courier Monday through Friday, twice a day, at a mutually agreeable time to collect routine specimens for laboratory analysis. STAT tests will be sent via laboratory courier service provided by the reference laboratory for transportation of patient specimens from the VAAAHS to the reference laboratory facility. The courier service is expected to answer all calls placed by VAAAHS employees within 15 seconds. The STAT request, pick-up of specimen(s), and delivery time to the reference laboratory shall not exceed 30 minutes. Routine reference laboratory testing is provided by the contractor 5 days a week and STAT test will be completed 24 hours per day, 7 days per week, and 365 days per year.

C.4.2 The ten holidays observed by the Federal Government are New Year’s Day, Martin Luther King Day, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas Day. Also, any other day declared by the President of the United States to be a national holiday.

C.5 MEDICAL LIABILITY INSURANCE LIMITS:

C.5.1 VAAAHS AND THE TCBOC: 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.6 PAYMENT:

C.6.1 VAAAHS AND THE TCBOC: 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 certified invoice and money will be distributed from the appropriate VAAAHS or TCBOC control points to pay the obligations. The obligations l shall be paid via separate purchase orders for each of the facilities.

C.6.2 The Supervisory Medical Technologist (Laboratory Manager) or Designee will perform invoice certification for the Pathology and Laboratory Medicine Service for the VAAAHS and the TCBOC. 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 the VA Contracting Officer for resolution.

Invoices for contract services for the VAAAHS and TCBOC should be mailed to:

Resource Office (20V) VA Ann Arbor Healthcare System 2215 Fuller Road Ann Arbor, MI 48105

C.7 TERM OF CONTRACT FOR VAAAHS AND THE TOLEDO CBOC:

C.7.1 The contracts will be effective for one (1) year from the date of the contract award with (4) four additional contract option years. The contract is subject to the availability of appropriated funds.

C.8 MISSION AND VISION STATEMENT:

C.8.1 Mission: Honor America’s veterans by providing exceptional health care that improves their health and well-being.

C.8.2 Vision: To be a patient centered integrated health care organization for veterans, providing excellence in health care, research, and education; an organization where people choose to work; and an active community partner and back-up for national emergencies.

C.9 ACCREDIATION COMPLIANCE STANDARDS:

C.9.1 GENERAL: The contractor shall continuously meet all applicable accreditation standards. The patient population treated at the VA Ann Arbor Healthcare System, located in Ann Arbor, Michigan also includes patients from the Toledo Community Based Outpatient Clinic, Toledo, Ohio, which serves the Northwestern Ohio area, Flint Community Based Outpatient Clinic, Flint, MI and Jackson Community Based Outpatient Clinic, Jackson, MI.

C.9.2 PATIENT RIGHTS: Protection of all patients’ rights is of highest priority.

Patient privacy and confidentiality shall be maintained at all times.

C.9.3 SAFETY: The VAAAHS shall inform the contractor of all applicable Safety Alerts received by the VAAAHS. For every applicable alert, the contractor shall take the necessary steps to redesign processes to prevent occurrence and provide written feedback to the Contracting Officer Representative (COR) describing prevention actions taken within one (1) business day or sooner if the VAAAHS COR or medical center requests action.

C.9.4 PERFORMANCE IMPROVEMENT: The contractor shall comply with the VAAAHS 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 TAT’s on a quarterly basis. Vendor shall provide quarterly TAT report for all patient testing requests sent for analysis. The Quality Management Coordinator will provide a quarterly report to VAAAHS management team for review.

Contractor PI activities may be directed by the VAAAHS, VISN, or VHA, as well as accreditation or licensing bodies. The contractor shall abstract, compile and report PI data as requested by the VAAAHS. VA Data collection methodology, report format, and reporting deadlines will be defined by the VAAAHS. Examples of required PI activities include the VHA Performance Measures/Clinical Practice Guidelines program, and the Joint Commission ORYZ 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 control to prevent risk to the veteran. VA monitoring for continuous compliance with Joint Commission standards shall be directed by VAAAHS staff and communicated to the contractor through the COR. VA aggregate and/or practitioner-specific data collected by the VAAAHS will be provided to the contractor in accordance with established reporting schedules. VA measures related to contract compliance will be identified by the

COR.

C.9.5 INFORMATION MANAGEMENT: The VAAAHS Information Management plan shall be followed by the contractor. Documentation and record keeping shall be in accordance with VAAAHS policies and procedures.

C.9.6 CONFLICT OF INTEREST: Conflict of Interest acknowledgement document(s) shall be signed by all procurement officials and copies filed in the OPF in accordance with VHA Handbook 1660.3. Contracting Officials, CORs, 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.9.7 LEADERSHIP/COMPETENCY OF PERSONNEL:

The contractor shall effectively manage daily operations, information and support systems, and maintain competency for staff providing services.

C.10 TEST MENU REQUIREMENTS FOR THE VAAAHS AND THE TCBOC:

All patient specimen reflex testing shall be provided by the reference laboratory and may be billed separately in certain circumstances.

The reference laboratory shall provide all histocompatible, Immunoperoxidase, and genetic tissue testing in addition to the test menu as stated below:

Test Description by CPT Code, Laboratory Section, and Estimated Specimen Quantities

AVIAN PANEL 86331 SENDOUT 5

IMMUNOFLUORESCENCE DIRECT TISSUE BIOPSY 88346 TC AP 1

IMMUNOHISTOCHEMISTRY EA 88342 TC AP 4

BLOOD PRODUCT IRRADIATION,EA UNIT 86945 BLOOD BANK 66

COCAINE SCREEN URINE 80101 CHEMISTRY as needed COCAINE, GCMS, QUANT 82520 CHEMISTRY as needed

CREATININE URINE 82570 CHEMISTRY 1

CYCLOSPORINE 80158 CHEMISTRY 69

DRUG SCREEN PRELIM URINE PANEL 80101 x7 CHEMISTRY 5 DRUG SCREEN SERUM 80101 x3, 80100, 84600

CHEMISTRY 11

EVEROLIMUS 80299 CHEMISTRY 1

FENTANYL URINE 80299 CHEMISTRY 2

FLUOXETINE (PROZAC) 80299 CHEMISTRY 1

HCG BETA 84702 CHEMISTRY as needed

HEMOGLOBIN, PLASMA 83051 CHEMISTRY 2

HEPATITIS B CORE IGG IGM 86704 CHEMISTRY 1

HEPATITIS B SURF AB 86706 CHEMISTRY 18

HEPATITIS B SURF AG 87340 CHEMISTRY 15

HEPATITIS C AB 86803 CHEMISTRY 31

IGG AND ALBUMIN CSF 82784 CHEMISTRY 1

IRON LIVER TISSUE 83540 CHEMISTRY 3

LIDOCAINE LEVEL 80176 CHEMISTRY 1

LITHIUM, PLASMA 80178 CHEMISTRY as needed

OPIATE GCMS QNT 83925 CHEMISTRY 3

OPIATE GCMS QUAL 80102 CHEMISTRY as needed OPIATE SCREEN, URINE 80101 CHEMISTRY as needed

OSMOLALITY BLOOD 83930 CHEMISTRY 9

OSMOLALITY URINE 83935 CHEMISTRY 3

OXYCODONE SCREEN UR 80101 CHEMISTRY 1

PHENCYCLIDINE SCREEN UR 80101 CHEMISTRY 4

PORPHYRINS - QUAL 84119 CHEMISTRY as needed

POTASSIUM FLUID 84132 CHEMISTRY 5

PYRUVATE 84210 CHEMISTRY as needed

SALICYLATE DETERM 80196 CHEMISTRY 13

SODIUM FLUID 84302 CHEMISTRY 5

SULFHEMOGLOBIN 83060 CHEMISTRY 2

TB GOLD QUANTIFERON 86480 CHEMISTRY 362

THIOCYANATE 84430 CHEMISTRY 7

TOXICOLOGY GCMS QUAL UR 80102 CHEMISTRY 153

VALPROIC ACID 80164 CHEMISTRY 1

VOLATILES QUANT 84600 CHEMISTRY 1

TEST DESCRIPTION AND SERVICES CPT LABORATORY QUANTITY

ACETAMINOPHEN 82003 CHEMISTRY 17

ACHR MODULATING AB 83519 CHEMISTRY 3

AMMONIA 82140 CHEMISTRY as needed

AMPHETAMINE GCMS QUAL 80102 CHEMISTRY 3

AMPHETAMINE GCMS QUANT 82145 CHEMISTRY

BENZODIAZEPINE GCMS QUAL 80102 CHEMISTRY 1

BENZODIAZEPINE SCREEN UR 80101 CHEMISTRY 1

BENZODIAZEPINE, GCMS,QNT 80154 CHEMISTRY as needed

BNP(NATRIURETIC PEPTIDE) 83880 CHEMISTRY 124

BUPRENORPHINE SCREEN 80101 CHEMISTRY 1

BUPRENORPHINE URINE SCRN 80101 CHEMISTRY 130

CANNABINOID GCMS QNT 82543 CHEMISTRY 10

CANNABINOID SCREEN UR 80101 CHEMISTRY 1

CARDIAC RISK PROFILE 80061 CHEMISTRY as needed

CEA TEST 82378 CHEMISTRY 5

CHLAMYDIA AB PANEL (SCLAM) 86631,86632 CHEMISTRY 2

ANTI 11A INHIBITOR ARGATROBAN 85130 COAG as needed

ANTI XA LMWH 85130 COAG 26

ANTI XA UFH 85130 COAG 1

D-DIMER ADVANCED 85379 COAG as needed

DIRECT ANTIGLOB MONO, EA 86880 COAG 2

DIRECT ANTIGLOB, POLY, EA 86880 COAG 2

FIBRONOGEN ACTIVITY 85384 COAG as needed

HEXAGONAL PHOSPHOLIP NEUT 85732 COAG 17

PLATELET FUNCTION P2Y12 85576 COAG 2

THROMBOPLASTIN INHIBITION 85705 COAG as needed

FISH MOLECUL CYTOGENICS DNA PR 88271 CYTOGENETICS 5

FISH ONCOLOGY PROBES INTERPHASE HYBRID 100-

300 CELL

88275 CYTOGENETICS 11

TISSUE CULTURE BM OR BLD MALIG 88237 CYTOGENETICS 3

CHROMOSOME ANALYSIS MALIG - BLOOD 88262 CYTOGENETICS 1

CHROMOSOME ANALYSIS MALIG - BONE MARROW 88262 CYTOGENETICS 2

FLOW ADDITIONAL MARKER EA 88185 FLOW 1,915

FLOW PNH RBC 88184 FLOW 1

FLOW PNH WBC 88184 FLOW 3

FLOW RITUXIMAB 86355, 86357,

86360

FLOW 1

FLOW ADDITIONAL MARKER EA 88185 FLOW 1,915

FLOW PNH RBC 88184 FLOW 1

FLOW PNH WBC 88184 FLOW 3

FLOW RITUXIMAB 86355, 86357,

86360

FLOW 1

FLOW SPECIMEN EVALUATION 88108 FLOW 3

IMMUNOPHENOTYPIC ACUTE 88184 FLOW 16

IMMUNOPHENOTYPIC ACUTE 88184 FLOW 1

IMMUNOPHENOTYPIC COMBO 88184 FLOW 21

IMMUNOPHENOTYPIC NONACUTE 88184 FLOW 50

IMMUNOPHENOTYPIC PLASMA CELL 88184 FLOW 24

IMMUNOPHENOTYPIC T-CELL 88184 FLOW 16

T CELLS CD4 AND CD8 COUNT 86360 FLOW 7

T CELLS CD4 AND CD8 COUNT 86360 FLOW 1

CHROMOGRANIN A 86316 HISTO as needed

DONOR SPECIFIC ANTIBODY 86807 X2

HISTOCOMPABILITY

DSA - CARBAMAZEPINE HYPERSENSITIVITY CHEMISTRY as needed

DSA - CELIAC DISEASE (HLA-DQ2 OR DQB) 86816 X2

HISTOCOMPABILITY

as needed

DSA - NARCOLEPSY (HLA-DQB1*0602)

HISTOCOMPABILITY

as needed

DSA - UVEITIS (HLA-B27) 86812

HISTOCOMPABILITY

as needed

SOLID ORGAN TRANSPLANT - C1q BINDING HLA

ANTIBODY

86807 x2

HISTOCOMPABILITY

as needed

SOLID ORGAN TRANSPLANT - ENDOTHELIAL PRECURSOR

CELL - DONOR

86825

HISTOCOMPABILITY

as needed

SOLID ORGAN TRANSPLANT - ENDOTHELIAL PRECURSOR

CELL - RECIPIENT

86825

HISTOCOMPABILITY

as needed

SOLID ORGAN TRANSPLANT - LIVER DONOR REPEAT

CROSSMATCH

86825

HISTOCOMPABILITY

as needed

SOLID ORGAN TRANSPLANT - LIVING DONOR FINAL PRE-

TXP FLOW XM4

86825

HISTOCOMPABILITY

as needed

SOLID ORGAN TRANSPLANT - LIVING DONOR FINAL-TXP 86807 x2

HISTOCOMPABILITY

as needed

SOLID ORGAN TRANSPLANT - MICA ANTIBODY 86807

HISTOCOMPABILITY

as needed

SOLID ORGAN TRANSPLANT - MICA TYPING 86812

HISTOCOMPABILITY

as needed

SOLID ORGAN TRANSPLANT - MONTHLY PRA

HISTOCOMPABILITY

as needed

SOLID ORGAN TRANSPLANT - NEW KIDNEY DONOR 86813, 86817,

86825 as needed

SOLID ORGAN TRANSPLANT - NEW PATIENT 86813, 86817,

86807 x2 as needed

TISSUE TYPE CLASS I AGS ABC 86813

HISTOCOMPABILITY

TISSUE TYPE CLASS II AGS DR/DQ 86817

HISTOCOMPABILITY

C3 COMPLEMENT COMPONENT 86160 IMMUNO 1

C4 COMPLEMENT COMPONENT 86160 IMMUNO 1

GLOMERULAR BASEMENT MEMBRANE * 86255 IMMUNO

NEUTRO CYTOPLAS AB SCREEN * 86255 IMMUNO 1

NEUTRO CYTOPLAS AB TITER * 86256 IMMUNO 1

OLIGOCLONAL BANDS * 83916 IMMUNO 2

QUANTITATIVE TISSUE CULTURE MICRO 2

AFB SMEAR 87206 MICRO as needed ANTIBIOTIC SENSI SP REQ 87184 MICRO as needed

ANTIBIOTIC SENSI, MIC 87186 MICRO 1

BORRELIA AB SCR LYME DISEASE 86618 MICRO as needed

CULTURE AFB 87116 MICRO 1

CULTURE AFB BLOOD MICRO as needed CULTURE AFB other than blood MICRO as needed CULTURE DERMATOPHYTE SCREEN 87101 MICRO as needed

CULTURE FUNGUS BLOOD 87103 MICRO 2

DFA-Direct Fluorescent Antibody - 3 well slides MICRO as needed DNA/RNA CMV QUANT 87497 MICRO as needed

DNA/RNA HBV QUANT 87517 MICRO 1

DNA/RNA HCV QUANT 87522 MICRO 9

DNA/RNA HSV 87529 MICRO 7

DNA/RNA HSV CSF 87529 MICRO 2

DNA/RNA PNEUMOCYSTIS 87798 MICRO 5

HE4 86305 MICRO 1

HSV ANTIGEN 87300 MICRO 6

ORGANISM ID 87081 MICRO 1

PARAINFLUENZA ANTIBODY 86790 x3 MICRO 1 VIRAL CULTURE (HSV&VZV) 87254 MICRO as needed VIRAL CULTURE W CMV 87252 MICRO as needed

VZV ANTIGEN 87290 MICRO 4

ALK (2P23) REARRANGE FISH 88368-TC,

88368-26

MOLDX 12

B CELL CL (IGH GENE REARR) 81261 MOLDX 1

BCL6(3Q27) REARRANGE FISH 88368-TC,

88368-26

MOLDX

BCR/ABL1 KINASE DOMAIN MUTATION 81403-TC,

81403-26

MOLDX 4

BCR/ABL1 QNT MAJOR BRKPT 81206-TC,

81206-26

MOLDX 74

BRAF V600E/V600K MUTATIONS 81210-TC,

81210-26

MOLDX 3

CEBPA MUTATION 81403-TC,

81403-26

MOLDX 4

EGFR MUTATION FRAGMENT ANALYSIS 81235-TC,

81235-26

MOLDX 11

EWSR1 (22Q12) REARRANG FISH 88368-TC,

88368-26

MOLDX as needed

EWSR1/ATF1 TRANSLOC PCR 81401-TC,

81401-26

MOLDX as needed

EWSR1/FLI1 EWSR1/ERG TRANS 81402-TC,

81402-26

MOLDX as needed

EWSR1/WT1 TRANSLOCATION PCR 81401-TC,

81401-26

MOLDX as needed

FACTOR V LEIDEN MUTATION 81241-TC,

81241-26

MOLDX as needed

FLT3 MUTATION 81245-TC,

81245-26

MOLDX 6

HER2 FISH 81268-TC,

81268-26

MOLDX 8

HEREDIT HEMOCHROMATOSIS MUTATION 81256-TC,

81256-26

MOLDX as needed

IDH1 & IDHS MUTATIONS 81403-TC,

81403-26

MOLDX 3

IGH/BCL2 TRANSLOCATION PCR 88368-TC,

88368-26

MOLDX 1

JAK2 EXON 12 MUTATION 81403-TC,

81403-26

MOLDX 5

JAK2 V617 MUTATION 81270-TC,

81270-26

MOLDX 4

KIT D816V MUTATION 81270-TC,

81270-26

MOLDX 4

KIT MUTATION FOR GIST 81404-TC,

81404-26

MOLDX as needed

KIT MUTATION FOR MELANOMA 81404-TC,

81404-26

MOLDX as needed

KRAS MUTATION 81275-TC,

81275-26

MOLDX 2

MALT1(18Q21) REARRANGE FISH 88368-TC,

88368-26

MOLDX as needed

MICROSATELLITE INSTABILITY 81301-TC,

81301-26

MOLDX 1

MPL MUTATION 81402-TC,

81402-26

MOLDX as needed

MTHFR C677T MUTATION 81291-TC,

81291-26

MOLDX as needed

MYC (8Q24) REARRANGE FISH 88368-TC,

88368-TC

MOLDX as needed

NPM1 MUTATION 83891 MOLDX 5

PAX/FOXO1 TRANSLOCATION PCR 81402-TC,

81402-26 MOLDX as needed

PCA3 81479-TC,

81479-26

MOLDX as needed

PDGFRA MUTATION FOR GIST 81404-TC,

81404-26

MOLDX as needed

PML/RARA TRANSLOCATION QUAL 81315-TC,

81315-26

MOLDX 5

PROTHROMBIN 20210 MUTATION 81240-TC,

81240-26

MOLDX as needed

SYT/SSX TRANSLOCATION PCR 81402-TC,

81402-26

MOLDX as needed

T CELL CLONALITY PCR 81342-TC,

81342-26

MOLDX 2

UGT1A1 PROMOTER GENOTYPING 81350-TC,

81350-26

MOLDX as needed

UROVYSION FISH 88120-TC,

88120-26

MOLDX 4

ALPHA-1 ANTITRYPSIN FECES 82103 SENDOUT 1

BATH SALTS PANEL, U 83789 SENDOUT 10

CARBOHYDRATE DEFICIENT TR 82373 SENDOUT 6

CHOLESTANOL 82542 SENDOUT 2

COMP BRACANALYSIS 81211 SENDOUT 1

CRMP-5-IGG WEST BLOT 84182 SENDOUT 3

CUTANEOUS IFA IGG SERUM 86255 SENDOUT 1

CYTOTOX AB SCRN CL I 86807 SENDOUT 2

DIURETIC SCREEN, U 82486 SENDOUT 1

DIURETICS PANEL, S 82492 SENDOUT 2

DNA/RNA CMV QNT VIRACOR 87497 SENDOUT as needed

DNA/RNA HHV8 QUANT 87799 SENDOUT 1

DNA/RNA MYCOBACTERIA TB SO 87556 SENDOUT 3

IDENTIFICATION 83904 SENDOUT 27

INVEGA/PALIPERIDONE 83789 SENDOUT 1

LSD Confirmation LC/ 80299 SENDOUT 1

MEPHEDRONE, URINE 84999 SENDOUT 1

METFORMIN SERUM 82491 SENDOUT 3

MYOSITIS PROFILE PANEL 86235 x7 SENDOUT 1

OXYGEN DISSOCIATION 82820 SENDOUT 1

PARANEOPLASTIC AB EVAL 83519 x5, 83520, 86256 x9

SENDOUT 13

PM-SCL AB, ID 86235 SENDOUT 1

POSACONAZOLE SERUM 80299 SENDOUT 1

RESP VIRUSES COMP PCR PANEL 87502, 87798

x3

SENDOUT 1

SEROTONIN RELEASE BLD CNTR WI 86022 x2 SENDOUT 15

SYNTHETIC CANNABINOID 80101 SENDOUT 10

VORICONAZOLE 80299 SENDOUT 12

ANATOMIC PATHOLOGY CONSULTATION FEE FOR SLIDE

INTERPRETATION

SERVICE as needed

621-200 Anatomic Pathology - Services for anatomic pathology include, but are not limited to, surgical pathology, molecular pathology, cytopathology, histology, histochemistry, hematopathology, diagnostic electron microscopy and autopsy pathology. CPT Codes include, but are not limited to, 88000-88099,88300-88399 and 88342-88399.

621-201 Clinical Chemistry - Services for clinical chemistry include, but are not limited to, sugar (glucose), electrolytes (sodium, potassium, chloride and carbon dioxide), enzymes (CK, LD, AST, ALT), cholesterol, urea nitrogen, uric acid and blood gas testing. CPT Codes include, but are not limited to, 80048-80076 and 82000-84999.

621-202 Cytogentics - Services for cytogenetics include, but are not limited to, mniotic fluid and chorionic villus sampling for prenatal chromosome analysis; peripheral blood from patients with congenital anomalies, infertility, or other indications; and bone marrow aspirates for the diagnosis of leukemias. CPT Codes include, but are not limited to, 88230- 88299.

621-203 Cytology - Services for cytology include, but are not limited to, Papanicolaou smear test (pap screen), nongynelogical body specimens (urine, sputa, body fluids, thoracentesis, paracentesis, cerebrospinal fluid, and fine needle aspirations. CPT Codes include, but are not limited to, 88104-88199.

621-204 Clinical Drugs of Abuse and Toxicology - Services for clinical drugs of abuse and toxicology include, but are not limited to, therapeutic drug monitoring, medical drug of abuse testing, comprehensive drug and poison analyses, and specialized stat testing for select toxicants; excludes employment and forensic testing. CPT Codes include, but are not limited to, 80100-80103, 80150-80299 and 82000-84999.

621-205 Endocrinology - Services for endocrinology include, but are not limited to, pediatric and adult functional testing, adrenal cortical, water metabolism, pituitary secretion, gonad responsiveness, thyroid, pancreas, growth status, bone metabolism, endocrine uniformity, and vitamin status.

CPT Codes include, but are not limited to, 82000-84999.

621-206 Hematology - Services for hematology include, but are not limited to, complete blood count, red blood count, white blood count, differential count, platelet count, coagulation (clotting) studies and hemoglobin. CPT Codes include, but are not limited to, 85002-85999.

621-207 Hemostasis - Services for hemostasis include, but are not limited to, comprehensive testing for thrombotic and bleeding disorders;

plasminogen, antithrombin, and fibrinogen; protein C, protein S, and APC resistance; factor assays; inhibitor studies; von Willebrand studies; Factor VIII carrier studies; and platelet aggregation studies. CPT Codes include, but are not limited to, 85002-85999.

621-208 Immunology - Services for immunology include, but are not limited to, adult and pediatric immunodeficiency testing, neutrophil function testing, complement analysis, immunoglobulin and antibody testing/monoclonal gammopathies, cellular immunodeficiencies, molecular diagnosis of infections, pregnancy testing and rubella testing. CPT Codes include, but are not limited to, 86000-86849.

621-209 Microbiology - Services for microbiology include, but are not limited to, bacteriology (aerobic and anaerobic), antimicrobial susceptibility testing, molecular infectious disease testing, mycobacteriology, mycology, parasitology, and clinical virology. CPT Codes include, but are not limited to, 87001-87999.

621-210 Organ or Disease Oriented Panels - Services for organ or disease-oriented panels include, but are not limited to, basic metabolic panel, electrolyte panel, comprehensive metabolic panel, lipid panel, renal function panel, arthritis panel, acute hepatitis panel, hepatic function panel and general health panel. CPT Codes include, but are not limited to, 80048-80076.

621-211 Serology - Services for serology include, but are not limited to, serologic diagnosis (including bacterial, viral, mycoplasma, and parasitic infections), autoimmune testing, congenital diagnostics testing and various bacterial disease markers testing. CPT Codes include but are not limited to 86403-86593.

621-212 Urinalysis - Services for urinalysis include, but are not limited to, urine dipstick chemistry and urine microscopy. CPT Codes include, but are not limited to, 81000-81099.

STAT Test Menu

•Acetaminophen •Alanine Amino Transferase (ALT) •Albumin, Serum •Alkaline Phosphatase •Amikacin •Ammonia •Amylase, Serum •Anti-Xa, Arixtra •Anti-Xa, LMWH •Anti-Xa, UFH •Argatroban Level •Aspartate Amino Transferase (AST) •Basic Metabolic Panel •Bilirubin, Fractionated

•Bilirubin, Total •Blood Survey, Complete Blood Count

• Blood Survey, Differential Count, Automated •Body Fluid Analysis •Body Fluid Analysis, Crystal Exam •Body Fluid Analysis, CSF •Brain Natriuretic Peptide(BNP) •Calcium, Ionized •Calcium, Serum •Carbamazepine •Carbon Dioxide, Total •Carcinoembryonic Antigen •Chloride, Serum •Cholesterol, Serum •Comprehensive Metabolic Panel •Creatine Kinase, Total •Creatine Kinase, Total and MB Isoenzyme •Creatinine, Serum •D-Dimer, Advanced •Dabigatran Level •Digoxin •Disseminated Intravascular Coagulation (DIC) Panel •Drug Screen, by Immunoassay, Urine •Electrolyte Panel •Estradiol •Ethanol, Serum •Fetal Fibronectin (fFN) • Fibrinogen •G-Glutamyl Transpeptidase •Gentamicin •Glucose, CSF •Glucose, Serum •Hematocrit • Hemoglobin, Fetal •Hepatic Function Panel •Human Chorionic Gonadotropin, Beta Subunit

• Infectious Mononucleosis Test

• Iron, Serum •Lactic Acid Dehydrogenase, Serum •Lactic Acid, Plasma •Lidocaine •Lipase, Serum •Lithium •Magnesium, Serum •Malaria Smear

• Microfilaria Smear

• Mixing Study, Inhibitor Screen •Myoglobin, Serum

•Myoglobin, Urine •Osmolality, Serum or Body Fluid •Osmolality, Urine •pH, Body Fluid •pH, Urine •Phenobarbital •Phenytoin •Phosphorus •Platelet Count • Potassium, Serum •Pregnancy Screen, Serum •Protein, CSF • Protein, Total •PT (Prothrombin Time)

• PTT (Activated Partial Thromboplastin Time)

• Quinidine •Salicylate •Sickle Cell Preparation •Sodium, Serum •Specific Gravity, Fluid •Streptococcus Group A Screen by Immunoassay

• Theophylline •Tobramycin •Triglycerides, Serum •Troponin I •Urea Nitrogen, Serum

(BUN)

•Uric Acid, Serum •Urinalysis •Urinalysis, Macroscopic only •Valproic Acid •Vancomycin •Volatiles Group by GLC (includes ethanol, methanol, isopropanol, acetone, and ethylene glycol)

C.11 COR DESIGNATION:

C.11.1 The Contracting Officer Representative (COR) is Varsha Shah M.S. MT(ASCP) , Senior Staff Specialist, Pathology and Laboratory Medicine Service (113)VAAAHS, 2215 Fuller Road, Ann Arbor, MI a, 48105. Email address is: Sabine.McCorry@va.gov, telephone number is 734-845-5530. This individual is a VA employee and free from any financial or organizational conflict of interest.

C.12 BUSINESS ASSOCIATE AGREEMENT SHALL BE INCLUDED.

VHAPM Part 810 Market Research SOP Page 1 of 4 Revision: 03, Effective Date: 02/04/19

Requirement Title: Lab Testing and Consultation

In accordance with FAR 7.102, contracting officers and acquisition planners are required to perform acquisition planning and conduct market research. The following information is a summary of the acquisition planning: In submitting this request for procurement, the customer considered available sources within the agency, any government furnished information/property, and security considerations IAW VA Directive/Handbook 6500. The contract type for this procurement is (Firm-Fixed- Price and the milestone schedule will be accomplished and documented in the Electronic Contract Management System (eCMS). The information below summarizes the market research results for this requirement.

1. Objective: Per FAR 10.001(a)(2) and VAAR 810.001-70, this report is in support of (check as many as apply):

A new requirement - Ann Arbor VAMC and Toledo CBOC

An acquisition with an estimated value in excess of the simplified acquisition threshold (see FAR subpart 2.1 for current threshold)

An acquisition with an estimated value less than the simplified acquisition threshold where adequate information is not available to develop the requirements package and the circumstances justify the cost of performing the market research;

An acquisition that could lead to a bundled contract (15 U.S.C.

644(e)(2)(A)) (see FAR subpart 2.1 for bundled contract definition);

Other:

2. Background:

a. Title: Lab Testing and Consultation

b. Product or Service Code: Q301 – Medical - Laboratory Testing

c. NAICS Code: 621511 – Medical Laboratory

d. Size Standard for NAICS: $30 Million

e. Estimated contract value: Total for Ann Arbor and Toledo $3,619,289.00;

Ann Arbor $3,315,378.00 and Toledo $303,911.00. Contract ceiling amount: $4,500,000.00.

VHAPM Part 810 Market Research SOP Page 2 of 4

3. Market Research Sources: In accordance with FAR Part 10, VAAR 810 and VAAM M810, market research has been conducted for this acquisition. The following techniques were used (check as many as apply):

Used VA’s VIP database to identify verified capable SDVOSBs and VOSBs.

A VetBiz search was conducted utilizing NAICS Code 621511 and Michigan with 1 VOSB found – Patriot Supply, Inc. located at zip code 48038. Zip Code 48105 was utilized due to the 24-hour result turn-around-time needed and STAT test results needed within one (1) hour of receipt in the laboratory. A VetBiz search was conducted utilizing NAICS Code 621511 and Michigan – 1 VOSB was Found – Patriot’s Supply, Inc.

However, Patriot’s Supply, Inc. does not offer STAT Testing.

Applying personal knowledge in procuring supplies/services of this type.

Contacting knowledgeable individuals in Government and industry regarding market capabilities to meet requirements.

Reviewing the results of recent market research undertaken to meet similar or identical requirements.

Publishing formal requests for information in appropriate technical or scientific journals or business publications.

Querying the Government-wide database of contracts and other procurement instruments intended for use by multiple agencies available at www.contractdirectory.gov and other Government and commercial databases that provide information relevant to agency acquisitions.

Participating in interactive, on-line communication among industry, acquisition personnel, and customers.

Obtaining source lists of similar items from other contracting activities or agencies, trade associations or other sources.

VHAPM Part 810 Market Research SOP Page 3 of 4

Reviewing catalogs and other generally available product literature published by manufacturers, distributors, and dealers or available on-line

Conducting interchange meetings or holding pre-solicitation conferences to involve potential offerors early in the acquisition process.

Conducting market survey:

Other: Reviewed COR’s Market Research:

The University of Michigan's, MLab 300 North Ingalls Street Suite 6a07nib Ann Arbor, MI 48109

LabCorp of America 5250 Auto Club Drive, suite 310A Dearborn, MI 48126

4. Market Research Findings: A VetBiz search was conducted utilizing NAICS Code 621511 and Michigan with 1 VOSB found – Patriot Supply, Inc. located at zip code 48105 – No SDVOSB/VOSB’s found. Zip Code 48105 was utilized due to the 24-hour result turn-around-time needed and STAT test results needed within one (1) hour of receipt in the laboratory. A VetBiz search was conducted utilizing NAICS Code 621511 and Michigan – 1 VOSB was Found – Patriot’s Supply, Inc.

However, Patriot’s Supply, Inc. does not offer STAT Testing. Based on market research, the CO does not have a reasonable expectation that award can be made at a fair and reasonable price offering best value. The VA Rule of Two has not been met for this requirement. The University of Michigan is registered in beta.SAM and their registration expires 05/23/2020. Same or similar past awards: VA251-15-AP-6789-The University of Michigan-$2,800,000.00- 12/01/2014-11/30/2019; VA251-12-C-0048-The University of Michigan- $495,000.00-01/01/2012-12/31/2014. An Intent to Sole Source was posted to FBO on 08/29/2019 and expired on 09/05/2019 with no response. A DSBS search was conducted with seven small businesses found in the 481-zip code area. Of the seven, one is located 5 miles from MLabs; Technical Alternatives located at 4220 Varsity Dr in Ann Arbor, MI and another, Unique Maid Service, is in Ypsilanti, MI and is 8 miles from MLabs. This CS has determined that this is a cleaning service with the ability to clean medical laboratories. This CS has determined that the other 6 would not be able to meet the statement of work for the 30 minutes turnaround time from their business location.

5. Customary Commercial Practices/Standards: N/A

VHAPM Part 810 Market Research SOP Page 4 of 4

6. Market Price: $3,315,378.00

7. Acquisition History: Same or similar past awards: VA251-15-AP-6789-The University of Michigan-$2,800,000.00-12/01/2014-11/30/2019; VA251-12-C- 0048-The University of Michigan-$495,000.00-01/01/2012-12/31/2014.

8. Other…