Solicitation 75H71021R00005 - Cytology Pathology Histology Lab Testing Services.pdf

COVERPAGE

SOLICITATION NO: 75H71021R00005

ISSUE DATE: February 12, 2021

DUE DATE: March 11, 2021

The Navajo Area Indian Health Service (NAIHS) is requesting proposals from interested Offerors to provide REFERRAL LABORATORY CYTOLOGY, PATHOLOGY, AND HISTOLOGY TESTING SERVICES to NAIHS facilities. It is requested that you review the enclosed Request for Proposal (RFP) instructions and provide this office with a proposal, utilizing the information contained therein.

COMPLETION OF SOLICITATION REQUIREMENTS

Ensure all forms and additional information is completed in its entirety. Verify calculations before signing the proposal. Provide four (4) copies of offer.

A. Standard Form 1449 – Solicitation/Contract/Order or Commercial Items. Provide (1) SF-1449 with original signatures.

B. Section B-2: Fee Schedule C. Section B-15 : Contractor’s Representative D. Section E-1: 52.212-2 Evaluations - Commercial Items E. Section E-2: 52.212-3 Offeror Representations & Certifications - Commercial Items F. Prospective Offerors are required to complete registration in the System for Award

Management (SAM) database in accordance with FAR 4.1102

Your proposal shall be prepared and submitted in accordance with FAR 52.212-1 Instructions to Offeror - Commercial Items. This paragraph shall stipulate the submission of all required documents, certifications, etc., to determine your responsibility of providing the required services.

All proposals must be received in the Division of Acquisition Management and Contracts by the due date listed above.

Chinle Comprehensive Health Care Facility Division of Acquisition Management & Contracts ATTN: Tanya Begay, Supervisory Contract Specialist PO Drawer “PH” Off Hwy 191 & Hospital Drive Chinle, AZ 86503

MARK YOUR ENVELOPE “LABORATORY CYTOLOGY, PATHOLOGY, AND HISTOLOGY

TESTING SERVICE”

The anticipated period of performance will be for one (1) basic year with four (4) option years.

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

Window Rock AZ 86515 PO Box 9020 Navajo Area Office

CODE 16. ADMINISTERED BYCODE

X

X

621511

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED OR29

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

03/11/2021 1700 MT

02/12/2021

928-674-7635TANYA JOHNSON

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBERa. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75H71021R00005

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 64 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

Address of Hospitals/Health Centers Issuing Delivery Task Orders NAIHS Hospitals/Health Centers

15. DELIVER TO

Window Rock AZ 86515 PO Box 9020

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$35.00

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULEX

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

Navajo Area Office

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

The Contractor shall provide Referral Cytology/Histology/Pathology Laboratory Testing Services to the Navajo Area Indian Health Service (NAIHS) facilities in accordance with the Performance Work Statement.

Period of Performance: 04/01/2021 to 12/31/2021

1 Basic Year: April 1, 2021 through December 31, Continued ...

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

X

XX

DATED

DEEANDRA SALABYE

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

To be shown on individual task orders.

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 2/2012) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

2 First Year Option: January 1, 2022 - December 31, (Option Line Item)

11/30/2021

Period of Performance: 01/01/2022 to 12/31/2022

3 Second Year Option: January 1, 2023 - December

31, 2023

(Option Line Item)

11/30/2022

Period of Performance: 01/01/2023 to 12/31/2023

4 Third Year Option: January 1, 2024 - December 31, (Option Line Item)

11/30/2023

Period of Performance: 01/01/2024 to 12/31/2024

5 Fourth Year Option: January 1, 2025 - December

31, 2025

(Option Line Item)

11/30/2024

Period of Performance: 01/01/2025 to 12/31/2025

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

64 2 of

REFERRAL LABORATORY CYTOLOGY, PATHOLOGY, AND HISTOLOGY TESTING

SERVICE – NAVAJO AREA INDIAN HEALTH SERVICE

SOLICITATION NO.: 75H71021R00005

TABLE OF CONTENTS

SECTION A - SF1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B – OVERVIEW

B-1 PURPOSE OF CONTRACT

B-2 FEE SCHEDULE

B-3 DEFINITIONS

B-4 CONTRACTOR FURNISHED PROPERTY

B-5 PERFORMANCE WORK STATEMENT

B-6 QUALIFICATION REQUIREMENTS

B-7 GOVERNMENT FURNISHED PROPERTY

B-8 APPLICABLE DOCUMENTS

B-9 PERIOD OF PERFORMANCE

B-10 CONTRACTING OFFICER RESPONSIBLITIES

B-11 PRIVACY ACT NOTIFICATIONS

B-12 CONTRACTING OFFICERS REPRESENTATIVE

B-13 OFFICIAL AUTHORIZED TO PLACE ORDERS AGAINST THIS CONTRACT

B-14 INVOICE SUBMISSION

B-15 CONTRACTOR REPRESENTATIVE

SECTION C – CONTRACT CLAUSES

C-1 52.212-5 CONTRACT TERMS & CONDITIONS IMPLEMENT STATUTES OR

EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021)

C-2 52.216-18 ORDERING (AUG 2020)

C-3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C-4 52.216-21 REQUIREMENTS (OCT 1995)

C-5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C-6 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C-7 52.232-18 AVAILABIITY OF FUNDS (APR 1994)

C-8 52.232-19 AVAILBILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

C-9 52.237-7 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (JAN 1997)

C-10 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C-11 HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)

C-12 DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITON REGULATIONS

(HHSAR) (48 CFR CHAPTER 3) CLAUSES

C-13 352.237-70 PRO-CHILDREN ACT (DEC 2015)

C-14 352.237-71 CRIME CONTROL ACT OF 1990-REPORTING OF CHILD ABUSE (DEC

2015)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS OR ATTACHMENTS

D-1 CONTRACTOR PERFORMANCE ASSESSMENT REPORT (CPAR) STANDARD

EVALUATION

D-2 U.S. DEPARTMENT OF LABOR SERVICE CONTRACT ACT WAGE DETERMINATION

SECTION E - SOLICITATION PROVISIONS

E-1 52.212-2 EVALUATION- COMMERCIAL ITEMS (OCT 2014)

E-2 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL

ITEMS (JAN 2021)

E-3 52.216-1 TYPE OF CONTRACT (APR 1984)

E-4 52.233-2 SERVICE OF PROTEST (SEP 2006)

E-5 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

SECTION B – OVERVIEW

B-1 PURPOSE OF CONTRACT:

1.1 GENERAL: This performance based work statement describes the requirements to provide

Referral Laboratory Cytology, Pathology, and Histology Testing Services for Navajo Area Indian Health Service (NAIHS) facilities. Federal Acquisition Ciru

1.2 BACKGROUND: The Indian Health Service (IHS) is an agency within the US Department of Health and Human Services (DHHS), and is responsible for providing federal health services to American Indians and Alaska Natives. The provision of health services to members of federally recognized tribes grew out of the special relationship between the federal government and Indian tribes. The IHS is the principal health care provider and health advocate for the Indian people. The IHS goal is to assure that accessible health care services are available to the American Indian and Alaska Natives. The IHS currently provides health services to approximately 1.5 million American Indians and Alaska Natives, who belong to 557 federally, recognized tribes in 34 states.

The NAIHS administers health care to approximately 300,000 tribal members of the Navajo Nation, through various health centers and hospital facilities, and outpatient/outreach programs. The Navajo Nation is the largest Indian tribe in the Unites States and has the largest reservation that encompasses more than 25,000 square miles throughout northern Arizona, western New Mexico and southern Utah.

There is a need to supplement and augment the cytology, pathology, and histology laboratory testing services not available in most NAIHS facilities. There are greater needs felt by the remote and rural areas served by the NAIHS.

B-2 FEE SCHEDULE: The Contractor shall be compensated at a fixed unit price listed for

Referral Laboratory Cytology, Pathology, and Histology Testing Services provided in accordance with the Performance Work Statement (PWS).

2.1 BASIC YEAR: APRIL 01, 2021 THRU DECEMBER 31, 2021

LINE

ITEM

DESCRIPTION UNIT ESTIMATED

QUANTITY

BASE

UNIT

PRICE

MINIMUM

EST. PRICE

1 Abdominal Fluid Cyology ea 20 $ $ 2 B/M Smr; Int; 1st Site ea 2 $ $

3 Decalcification; 1st ea 8 $ $ 4 Er/Pr,Immunohistochem, Paraffin ea 2 $ $ 5 Fine-Needle Aspiration ea 44 $ $ 6 HPV, High+Low- Risk ea 2 $ $ 7 HPV, High-Risk ea 56 $ $ 8 HPV,Hybrid Capture, High Risk ea 232 $ $ 9 Immunohistochem: 1st Antibody ea 4 $ $

10 Imunohistochem: 2nd Antibody ea 2 $ $ 11 Pap Smear, 1 Slide ea 5118 $ $ 12 Pap Smear 1 Sld W Mat Indx ea 24 $ $ 13 Pap IG, HPV-HR ea 248 $ $ 14 Pap IG, HPV-H+LR ea 500 $ $ 15 Pap IG (Image Guided) ea 92 $ $ 16 Pap LB, Rfx HVP All Pth ea 14 $ $ 17 Pap IG, Rfx, HVP All Pth ea 130 $ $ 18 Pap IG, Rfx HPV ASCU ea 1752 $ $ 19 Pap IG, Ct-Ng, Rfx HPV All ea 8 $ $ 20 Pap IG, Ct-Ng, HPV-HR ea 8 $ $ 21 Pap IG,Ct-Ng,Rfx HPV ASCU ea 22 $ $ 22 Pap IG, CT-NG ea 10 $ $ 23 Pap LB, Rfx HPV ASCU ea 6592 $ $ 24 *Pap LB, HPV-HR ea 3730 $ $ 25 *Pap LB, HPV-H+LR ea 48 $ $ 26 Pap LB (Liquid-Based) ea 66 $ $ 27 Physician Read Pap ea 1106 $ $ 28 Pleural Fluid Cytology ea 20 $ $ 29 Pleural Fluid Cytology (Prof) ea 2 $ $ 30 Pleural Fluid Cytology (Tech) ea 2 $ $ 31 Spec-Stain; Grp I-Micro 1st ea 38 $ $ 32 Spec-Stain; Grp I-Micro 2nd ea 10 $ $ 33 Spec-Stain; Grp II-All Oth 1st ea 6 $ $ 34 Spec-Stain; Grp II-All Oth 2nd ea 2 $ $ 35 Spec-Stain; Grp II-All Oth 3rd ea 2 $ $ 36 Spec-Stain; Grp II-All Oth 4th ea 2 $ $ 37 Spec-Stain; Grp II-All Oth 5th ea 2 $ $ 38 Spec-Stain; Grp II-All Oth 6th ea 2 $ $ 39 Sputum Cytology ea 8 $ $ 40 883021 88302 Surgical Pathology ea 126 $ $

41 883022 88302 Surgical Pathology ea 73 $ $ 42 883071 88307 Surgical Pathology ea 125 $ $ 43 883072 88307 Surgical Pathology ea 18 $ $ 44 883073 88307 Surgical Pathology ea 9 $ $ 45 *883091 88309 Surgical Pathology ea 25 $ $

883041 88304 Surgical Path-1st Site ea 530

47 883051 88305 Surg Path-1st Site ea 1390 $ $

883042 88304 Surgical Path-2nd Site ea 44

49 883052 88305 Surg Path-2nd Site ea 370 $ $ 50 883053 88305 Surg Path-3rd Site ea 56 $ $

883043 88304 Surigal Path-3rd Site ea 9

52 883054 88305 Surg Path-4th Site ea 15 $ $ 53 883055 88305 Surg Path-5th Site ea 2 $ $ 54 Urine Cytology ea 122 $ $ 55 Urine Cytology (Prof) ea 2 $ $

56 Urine Cytology (Tech) ea 2 $ $

TOTAL (Est. min amount) $

2.2 FIRST OPTION YEAR: JANUARY 1, 2022 THRU DECEMBER 31, 2022

DESCRIPTION UNIT

ESTIMATED

QUANTITY

BASE

UNIT

PRICE

MINIMUM

EST. PRICE

1 Abdominal Fluid Cyology ea 20 $ $ 2 B/M Smr; Int; 1st Site ea 2 $ $ 3 Decalcification; 1st ea 8 $ $ 4 Er/Pr,Immunohistochem, Paraffin ea 2 $ $ 5 Fine-Needle Aspiration ea 44 $ $ 6 HPV, High+Low- Risk ea 2 $ $ 7 HPV, High-Risk ea 56 $ $ 8 HPV,Hybrid Capture, High Risk ea 232 $ $ 9 Immunohistochem: 1st Antibody ea 4 $ $

10 Imunohistochem: 2nd Antibody ea 2 $ $ 11 Pap Smear, 1 Slide ea 5118 $ $ 12 Pap Smear 1 Sld W Mat Indx ea 24 $ $ 13 Pap IG, HPV-HR ea 248 $ $

14 Pap IG, HPV-H+LR ea 500 $ $ 15 Pap IG (Image Guided) ea 92 $ $ 16 Pap LB, Rfx HVP All Pth ea 14 $ $ 17 Pap IG, Rfx, HVP All Pth ea 130 $ $ 18 Pap IG, Rfx HPV ASCU ea 1752 $ $ 19 Pap IG, Ct-Ng, Rfx HPV All ea 8 $ $ 20 Pap IG, Ct-Ng, HPV-HR ea 8 $ $ 21 Pap IG,Ct-Ng,Rfx HPV ASCU ea 22 $ $ 22 Pap IG, CT-NG ea 10 $ $ 23 Pap LB, Rfx HPV ASCU ea 6592 $ $ 24 *Pap LB, HPV-HR ea 3730 $ $ 25 *Pap LB, HPV-H+LR ea 48 $ $ 26 Pap LB (Liquid-Based) ea 66 $ $ 27 Physician Read Pap ea 1106 $ $ 28 Pleural Fluid Cytology ea 20 $ $ 29 Pleural Fluid Cytology (Prof) ea 2 $ $ 30 Pleural Fluid Cytology (Tech) ea 2 $ $ 31 Spec-Stain; Grp I-Micro 1st ea 38 $ $ 32 Spec-Stain; Grp I-Micro 2nd ea 10 $ $ 33 Spec-Stain; Grp II-All Oth 1st ea 6 $ $ 34 Spec-Stain; Grp II-All Oth 2nd ea 2 $ $ 35 Spec-Stain; Grp II-All Oth 3rd ea 2 $ $ 36 Spec-Stain; Grp II-All Oth 4th ea 2 $ $ 37 Spec-Stain; Grp II-All Oth 5th ea 2 $ $ 38 Spec-Stain; Grp II-All Oth 6th ea 2 $ $ 39 Sputum Cytology ea 8 $ $ 40 883021 88302 Surgical Pathology ea 126 $ $ 41 883022 88302 Surgical Pathology ea 73 $ $ 42 883071 88307 Surgical Pathology ea 125 $ $ 43 883072 88307 Surgical Pathology ea 18 $ $ 44 883073 88307 Surgical Pathology ea 9 $ $ 45 *883091 88309 Surgical Pathology ea 25 $ $

883041 88304 Surgical Path-1st Site ea 530

47 883051 88305 Surg Path-1st Site ea 1390 $ $

883042 88304 Surgical Path-2nd Site ea 44

49 883052 88305 Surg Path-2nd Site ea 370 $ $ 50 883053 88305 Surg Path-3rd Site ea 56 $ $

883043 88304 Surigal Path-3rd Site ea 9

52 883054 88305 Surg Path-4th Site ea 15 $ $ 53 883055 88305 Surg Path-5th Site ea 2 $ $ 54 Urine Cytology ea 122 $ $ 55 Urine Cytology (Prof) ea 2 $ $

2.3 SECOND OPTION YEAR: JANUARY 01, 2023 THRU DECEMBER 31, 2023

DESCRIPTION UNIT

ESTIMATED

QUANTITY

BASE

UNIT

PRICE

MINIMUM

EST. PRICE

1 Abdominal Fluid Cyology ea 20 $ $ 2 B/M Smr; Int; 1st Site ea 2 $ $ 3 Decalcification; 1st ea 8 $ $ 4 Er/Pr,Immunohistochem, Paraffin ea 2 $ $ 5 Fine-Needle Aspiration ea 44 $ $ 6 HPV, High+Low- Risk ea 2 $ $ 7 HPV, High-Risk ea 56 $ $ 8 HPV,Hybrid Capture, High Risk ea 232 $ $ 9 Immunohistochem: 1st Antibody ea 4 $ $

10 Imunohistochem: 2nd Antibody ea 2 $ $ 11 Pap Smear, 1 Slide ea 5118 $ $ 12 Pap Smear 1 Sld W Mat Indx ea 24 $ $ 13 Pap IG, HPV-HR ea 248 $ $ 14 Pap IG, HPV-H+LR ea 500 $ $ 15 Pap IG (Image Guided) ea 92 $ $ 16 Pap LB, Rfx HVP All Pth ea 14 $ $ 17 Pap IG, Rfx, HVP All Pth ea 130 $ $ 18 Pap IG, Rfx HPV ASCU ea 1752 $ $ 19 Pap IG, Ct-Ng, Rfx HPV All ea 8 $ $ 20 Pap IG, Ct-Ng, HPV-HR ea 8 $ $ 21 Pap IG,Ct-Ng,Rfx HPV ASCU ea 22 $ $ 22 Pap IG, CT-NG ea 10 $ $ 23 Pap LB, Rfx HPV ASCU ea 6592 $ $ 24 *Pap LB, HPV-HR ea 3730 $ $

25 *Pap LB, HPV-H+LR ea 48 $ $ 26 Pap LB (Liquid-Based) ea 66 $ $ 27 Physician Read Pap ea 1106 $ $ 28 Pleural Fluid Cytology ea 20 $ $ 29 Pleural Fluid Cytology (Prof) ea 2 $ $ 30 Pleural Fluid Cytology (Tech) ea 2 $ $ 31 Spec-Stain; Grp I-Micro 1st ea 38 $ $ 32 Spec-Stain; Grp I-Micro 2nd ea 10 $ $ 33 Spec-Stain; Grp II-All Oth 1st ea 6 $ $ 34 Spec-Stain; Grp II-All Oth 2nd ea 2 $ $ 35 Spec-Stain; Grp II-All Oth 3rd ea 2 $ $ 36 Spec-Stain; Grp II-All Oth 4th ea 2 $ $ 37 Spec-Stain; Grp II-All Oth 5th ea 2 $ $ 38 Spec-Stain; Grp II-All Oth 6th ea 2 $ $ 39 Sputum Cytology ea 8 $ $ 40 883021 88302 Surgical Pathology ea 126 $ $ 41 883022 88302 Surgical Pathology ea 73 $ $ 42 883071 88307 Surgical Pathology ea 125 $ $ 43 883072 88307 Surgical Pathology ea 18 $ $ 44 883073 88307 Surgical Pathology ea 9 $ $ 45 *883091 88309 Surgical Pathology ea 25 $ $

883041 88304 Surgical Path-1st Site ea 530

47 883051 88305 Surg Path-1st Site ea 1390 $ $

883042 88304 Surgical Path-2nd Site ea 44

49 883052 88305 Surg Path-2nd Site ea 370 $ $ 50 883053 88305 Surg Path-3rd Site ea 56 $ $

883043 88304 Surigal Path-3rd Site ea 9

52 883054 88305 Surg Path-4th Site ea 15 $ $ 53 883055 88305 Surg Path-5th Site ea 2 $ $ 54 Urine Cytology ea 122 $ $ 55 Urine Cytology (Prof) ea 2 $ $

2.4 THIRD OPTION YEAR: JANUARY 01, 2024 THRU DECEMBER 31, 2024

DESCRIPTION UNIT ESTIMATED

QUANTITY

BASE

UNIT

PRICE

MINIMUM

EST. PRICE

1 Abdominal Fluid Cyology ea 20 $ $ 2 B/M Smr; Int; 1st Site ea 2 $ $ 3 Decalcification; 1st ea 8 $ $ 4 Er/Pr,Immunohistochem, Paraffin ea 2 $ $ 5 Fine-Needle Aspiration ea 44 $ $ 6 HPV, High+Low- Risk ea 2 $ $ 7 HPV, High-Risk ea 56 $ $ 8 HPV,Hybrid Capture, High Risk ea 232 $ $ 9 Immunohistochem: 1st Antibody ea 4 $ $

10 Imunohistochem: 2nd Antibody ea 2 $ $ 11 Pap Smear, 1 Slide ea 5118 $ $ 12 Pap Smear 1 Sld W Mat Indx ea 24 $ $ 13 Pap IG, HPV-HR ea 248 $ $ 14 Pap IG, HPV-H+LR ea 500 $ $ 15 Pap IG (Image Guided) ea 92 $ $ 16 Pap LB, Rfx HVP All Pth ea 14 $ $ 17 Pap IG, Rfx, HVP All Pth ea 130 $ $ 18 Pap IG, Rfx HPV ASCU ea 1752 $ $ 19 Pap IG, Ct-Ng, Rfx HPV All ea 8 $ $ 20 Pap IG, Ct-Ng, HPV-HR ea 8 $ $ 21 Pap IG,Ct-Ng,Rfx HPV ASCU ea 22 $ $ 22 Pap IG, CT-NG ea 10 $ $ 23 Pap LB, Rfx HPV ASCU ea 6592 $ $ 24 *Pap LB, HPV-HR ea 3730 $ $ 25 *Pap LB, HPV-H+LR ea 48 $ $ 26 Pap LB (Liquid-Based) ea 66 $ $ 27 Physician Read Pap ea 1106 $ $ 28 Pleural Fluid Cytology ea 20 $ $ 29 Pleural Fluid Cytology (Prof) ea 2 $ $ 30 Pleural Fluid Cytology (Tech) ea 2 $ $ 31 Spec-Stain; Grp I-Micro 1st ea 38 $ $ 32 Spec-Stain; Grp I-Micro 2nd ea 10 $ $ 33 Spec-Stain; Grp II-All Oth 1st ea 6 $ $ 34 Spec-Stain; Grp II-All Oth 2nd ea 2 $ $ 35 Spec-Stain; Grp II-All Oth 3rd ea 2 $ $

36 Spec-Stain; Grp II-All Oth 4th ea 2 $ $ 37 Spec-Stain; Grp II-All Oth 5th ea 2 $ $ 38 Spec-Stain; Grp II-All Oth 6th ea 2 $ $ 39 Sputum Cytology ea 8 $ $ 40 883021 88302 Surgical Pathology ea 126 $ $ 41 883022 88302 Surgical Pathology ea 73 $ $ 42 883071 88307 Surgical Pathology ea 125 $ $ 43 883072 88307 Surgical Pathology ea 18 $ $ 44 883073 88307 Surgical Pathology ea 9 $ $ 45 *883091 88309 Surgical Pathology ea 25 $ $

883041 88304 Surgical Path-1st Site ea 530

47 883051 88305 Surg Path-1st Site ea 1390 $ $

883042 88304 Surgical Path-2nd Site ea 44

49 883052 88305 Surg Path-2nd Site ea 370 $ $ 50 883053 88305 Surg Path-3rd Site ea 56 $ $

883043 88304 Surigal Path-3rd Site ea 9

52 883054 88305 Surg Path-4th Site ea 15 $ $ 53 883055 88305 Surg Path-5th Site ea 2 $ $ 54 Urine Cytology ea 122 $ $ 55 Urine Cytology (Prof) ea 2 $ $

2.5 FOURTH OPTION YEAR: JANUARY 01, 2025 THRU DECEMBER 31, 2025

DESCRIPTION UNIT ESTIMATED

QUANTITY

BASE

UNIT

PRICE

MINIMUM

EST. PRICE

1 Abdominal Fluid Cyology ea 20 $ $ 2 B/M Smr; Int; 1st Site ea 2 $ $ 3 Decalcification; 1st ea 8 $ $ 4 Er/Pr,Immunohistochem, Paraffin ea 2 $ $ 5 Fine-Needle Aspiration ea 44 $ $ 6 HPV, High+Low- Risk ea 2 $ $ 7 HPV, High-Risk ea 56 $ $ 8 HPV,Hybrid Capture, High Risk ea 232 $ $

9 Immunohistochem: 1st Antibody ea 4 $ $ 10 Imunohistochem: 2nd Antibody ea 2 $ $ 11 Pap Smear, 1 Slide ea 5118 $ $ 12 Pap Smear 1 Sld W Mat Indx ea 24 $ $ 13 Pap IG, HPV-HR ea 248 $ $ 14 Pap IG, HPV-H+LR ea 500 $ $ 15 Pap IG (Image Guided) ea 92 $ $ 16 Pap LB, Rfx HVP All Pth ea 14 $ $ 17 Pap IG, Rfx, HVP All Pth ea 130 $ $ 18 Pap IG, Rfx HPV ASCU ea 1752 $ $ 19 Pap IG, Ct-Ng, Rfx HPV All ea 8 $ $ 20 Pap IG, Ct-Ng, HPV-HR ea 8 $ $ 21 Pap IG,Ct-Ng,Rfx HPV ASCU ea 22 $ $ 22 Pap IG, CT-NG ea 10 $ $ 23 Pap LB, Rfx HPV ASCU ea 6592 $ $ 24 *Pap LB, HPV-HR ea 3730 $ $ 25 *Pap LB, HPV-H+LR ea 48 $ $ 26 Pap LB (Liquid-Based) ea 66 $ $ 27 Physician Read Pap ea 1106 $ $ 28 Pleural Fluid Cytology ea 20 $ $ 29 Pleural Fluid Cytology (Prof) ea 2 $ $ 30 Pleural Fluid Cytology (Tech) ea 2 $ $ 31 Spec-Stain; Grp I-Micro 1st ea 38 $ $ 32 Spec-Stain; Grp I-Micro 2nd ea 10 $ $ 33 Spec-Stain; Grp II-All Oth 1st ea 6 $ $ 34 Spec-Stain; Grp II-All Oth 2nd ea 2 $ $ 35 Spec-Stain; Grp II-All Oth 3rd ea 2 $ $ 36 Spec-Stain; Grp II-All Oth 4th ea 2 $ $ 37 Spec-Stain; Grp II-All Oth 5th ea 2 $ $ 38 Spec-Stain; Grp II-All Oth 6th ea 2 $ $ 39 Sputum Cytology ea 8 $ $ 40 883021 88302 Surgical Pathology ea 126 $ $ 41 883022 88302 Surgical Pathology ea 73 $ $ 42 883071 88307 Surgical Pathology ea 125 $ $ 43 883072 88307 Surgical Pathology ea 18 $ $ 44 883073 88307 Surgical Pathology ea 9 $ $ 45 *883091 88309 Surgical Pathology ea 25 $ $

883041 88304 Surgical Path-1st Site ea 530

47 883051 88305 Surg Path-1st Site ea 1390 $ $

883042 88304 Surgical Path-2nd Site ea 44

49 883052 88305 Surg Path-2nd Site ea 370 $ $ 50 883053 88305 Surg Path-3rd Site ea 56 $ $

883043 88304 Surigal Path-3rd Site ea 9

52 883054 88305 Surg Path-4th Site ea 15 $ $ 53 883055 88305 Surg Path-5th Site ea 2 $ $ 54 Urine Cytology ea 122 $ $ 55 Urine Cytology (Prof) ea 2 $ $

2.6 Referral Laboratory tests to be ordered under the requirement type contract on an “As Need” basis by all NAIHS Medical Facilities’ as listed herein.

2.7 The Contractor agrees to perform cytology/histology/pathology laboratory testing at the next unit prices listed therein.

B-3 DEFINITIONS:

3.1 Acceptance: An authorized representative of the Government has inspected and agreed that the work meets all requirements of this contract, to include documentation requirements.

3.2 Approval: The Government has reviewed submittals, deliverables, or administrative documents (e.g., insurance certificates, installation schedules, planned utility interruptions, etc.) and has determined the documents conform to contract or contract requirements.

Government Approval shall not relieve the Contractor from responsibility for complying with contract requirements.

3.4 Chartable Patient Report: Shall include: name and address of testing laboratory; Patient name and identification number, or unique patient identifier; name of physician of record, or legally authorized person ordering test, as appropriate; date and time of specimen collection, when appropriate; date of release of report (if not on the report, this information should be readily accessible); Anatomic source and/or type of specimen, when applicable; test result(s) (and units of measurement, when applicable; reference intervals, as applicable;

basis for correction/amendment (if applicable); and conditions of specimen that may limit adequacy of testing. Report parameters must comply with current CMS requirements.

3.5 Contracting Officer (CO): Individual at the IHS authorized and warranted to issue contracts and to make subsequent modification(s). The CO has the authority to make determinations on all matters of dispute regarding this contract.

3.6 Contractor: The individual/company awarded this contract.

3.7 Customer Input: Positive or negative feedback against the Contractor submitted to the Contracting Officer.

3.8 COR (Contracting Officer Representative) Designee: A federal employee who assists the ordering/issuing activity and the contracting officer in the administration of task orders issued under this contract. The PO is primarily responsible for the day-to-day program management of the ordering activity’s task or delivery orders.

3.9 Correlations: The process of evaluating new procedures and testing specimens against different methodologies or same analytical equipment. The test results are plotted against each other to determine accuracy and precision.

3.10 Critical / Panic Results: Results that fall outside of “normal” patient reference ranges that are deemed life threatening in nature.

3.11 Federal Acquisition Regulation (FAR): The FAR is the primary regulation for use by all

Federal Executive agencies in their acquisition of supplies and services with appropriated funds.

3.12 LDM (Laboratory Data Manager): Computer system that manages all aspects of ordering tests, reporting results, and retrieving results.

3.13 Optimal Conditions: The shipping and storing conditions of biological specimens to preserve the integrity of the analyte.

3.14 Ordering Activity: An authorized user of IHS that may issue a task or delivery order to obtain required services under this contract.

3.15 Ordering Activity Contracting Officer (CO): An employee of IHS authorized and warranted to issue task orders and to make subsequent task order modification(s) under this contract. The Ordering Activity CO has the authority to make initial determinations on all matters of dispute regarding task orders.

3.16 Past Performance Information: Relevant information regarding a contractor’s actions under previously awarded contracts. It includes the contractor’s record of conforming to specifications and to standards of good workmanship; the contractor’s record of containing and forecasting costs on any previously performed cost reimbursable contracts; the contractor’s adherence to contract schedules, including the administrative aspects of performance; the contractor’s history for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the contractor’s business- like concern for the interest of the customer.

3.17 Primary / Centralized Test Site: The test site to where all specimens are initially transported prior to sorting and analyzing.

3.18 Quality Assurance Surveillance Plan (QASP): An organized written document prepared and used by the Government for Quality Assurance surveillance of the contractor’s performance.

3.19 RPMS (Resource Patient Management System): Host computer system utilized by the

IHS.

3.20 Special Pickup: A pickup and transport of specimens outside of established facility pickup times.

3.21 Service Unit: The local administrative unit of IHS.

3.22 Task Order: An order issued in accordance with the terms of the contract and ordering activity’s specific requirements. An ordering activities written order to obtain services, at a minimum shall include the following where applicable: description of services, skill categories, hours, price, period of performance, contract number, and the ordering activities task or delivery order number.

3.23 Unacceptable Specimen: Specimen that is inadequate for testing, whether due to inadequate temperature storage, age, collection method, contamination, insufficient quantity (QNS), improper preservation, etc.

B-4 CONTRACTOR FURNISHED PROPERTY:

4.1 Information: All unique Contractor information related to this lab testing service that is necessary for Government operations shall be made available to the Contracting Officer or COR designee. The designated point of contact (as identified by Contractor) shall supply any requested information.

4.2 Specimen Collection Supplies: The Contractor shall supply each NAIHS facility with specimen collection supplies as described in 5.0, “Performance Based Requirements”, of this document.

4.3 Specimen Transport Supplies: The Contractor shall supply each NAIHS facility with specimen transport supplies as described in B-5, “Performance Based Requirements”, of this document.

4.4 Communication (LDM): The Contractor shall supply each NAIHS facility with a Laboratory

Data Management (LDM) system as described in B-5, “Performance Based Requirements”, of this document.

4.5 Laboratory Request Forms: The Contractor shall supply each NAIHS facility with

Laboratory Request Forms as described in B-5, “Performance Based Requirements”, of this document.

SOLICITATION NO.: 75H71021R00005

B-5 PEFORMANCE WORK STATEMENT

5.1 Purpose: The purpose of the contract is for the provision of referral laboratory (cytology & histo-pathology) testing services for the Navajo Area Indian Health Service (NAIHS) facilities.

5.2 Scope: The Contractor shall provide cytology / histology / pathology lab testing services to the following NAIHS locations: Chinle Comprehensive Health Care Facility, Tsaile Health Center, Pinon Health Center, Tohatchi Health Center, Crownpoint Health Care Facility, Kayenta Health Center, Inscription House Health Center, Gallup Indian Medical Center, Dzilth-Na-O-Dith-Hle (DZ) Health Center, Four Corners Regional Health Center, and the Northern Navajo Medical Center. The relative number of specimens submitted by each NAIHS location is variable and dependent upon the size of each facility. As a whole, 5,200 PAP smears, 14,000 PAP liquid-based preparations, 500 HPV tests, 200 cytology tests, and 3,000 gross pathology specimens should be submitted annually among the NAIHS locations. As a general standard, these testing services do not encompass clinical lab specimens.

5.2.1 Duties and Responsibilities: These duties encompass cytology / histology / pathology lab testing to include specimen collection, specimen pickup/transport, testing, and reporting.

5.2.2 Place of Performance: With regard to specimen collection, pickup/transport and ordering/reporting, the service shall be performed at the various NAIHS facilities. With regard to specimen testing, the service shall be performed at the Contractor’s testing locations.

5.2.3 Point of Contact: The Contractor shall provide a point of contact that shall be responsible for the performance of the services. This individual shall have full authority to act for the Contractor on all matters relating to the daily operation of the contract. The Contractor shall designate this individual in writing to the Contracting Officer (CO) before the contract start date. An alternate may be designated, but the Contractor shall identify those times when the alternate shall be the primary point of contact.

5.2.4 Availability: The point of contact shall be available via telephone M – F during standard business hours.

5.3: The Contractor shall provide routine and specialized Laboratory Testing Services to NAIHS:

5.3.1 Specimen Collection: The Contractor shall supply within 72 hours of request, all histopathology specimen containers, 10% formalin vials, fine needle aspirate kits, bone marrow kits and collection materials, including pre-packaged pap smear kits with cytobrushes, fixative packing materials, thin-prep vials and any other materials necessary for the collection and transporting of specimens. Contractor shall be capable of receiving orders via email, fax and website.

The Contractor shall supply a list of the types of specimens that are not routinely accepted for pathologist gross examination and microscopic examination.

5.3.2 Specimen Transport:

Contractor shall provide all formalin filled specimen containers, Parafilm, biohazard transport bags, and any other supplies necessary for specimen transport. Materials shall be available to meet each NAIHS facility pickup schedule.

Contractor shall provide transport (courier) services Monday – Friday, including holidays. Each NAIHS facility shall mutually agree upon specimen transport times.

Holiday transport “may” be deferred after a personal phone call had been made to each NAIHS facility pickup location, and the deferral is agreed upon.

Contractor shall ensure the timely transport of specimens, and ensures specimen integrity. Specimens shall not be in transport more than 12 hours from the NAIHS facility pickup location to the Contractor primary testing site. Specimens shall be maintained at optimal conditions for testing during the entire transport time.

The Contractor shall provide written guidelines on packing specimens. Electronic or written standard operating procedures shall be immediately available to the NAIHS facility and documented training of technical laboratory staff shall be performed on specimen packaging as requested by a NAIHS facility.

5.3.3 Specimen Testing:

Each of the Contractor’s testing facilities shall be certified and shall maintain certification as a medical laboratory in accordance with CMS/CLIA ’88 guidelines.

Contractor’s CLIA certificate(s) shall be retrievable and provided to each NAIHS facility.

Contractor shall supply a Directory of Testing Services and Interpretive Guide. The Directory shall be an alphabetical listing of procedures with corresponding test codes.

The Directory shall include profile/panel breakdowns, methodologies, reference ranges and panic/critical values. The Directory shall be distributed in sufficient quantities to meet the need of each NAIHS facility. Any update to the Directory shall be communicated and distributed in a timely manner.

Specimen testing shall be performed at the Contractor’s facility. 95% of testing shall be performed at the Contractor’s primary/centralized testing site. No more than 5% of specimens are to be referenced to another location, either of a Contractor’s testing site, or “other” testing site.

Specimen testing shall be performed in a timely manner. Cytology testing shall be completed and reported within 5 days of receipt of the specimen. Histopathology testing shall be completed and reported within 14 days of receipt of the specimen.

Contractor shall notify the requesting NAIHS facility when an unacceptable specimen is received. Notification shall be made within 24 hours of discovery of the unacceptable nature of the specimen. No specimen is to be discarded until communication with the requesting NAIHS facility has been established, and the requesting facility approves of the disposal.

Contractor shall provide a “special pickup” and/or repeat testing resulting from Contractor negligence. Repeat testing shall be performed within 24 hours of notification and at the Contractor’s expense.

Contractor shall repeat testing upon request. When NAIHS providers feel that reported results do not correlate with the clinical status of the patient, the Contractor shall repeat the specimen testing within 24 hours of request. If repeat testing does not resolve the conflict, the Contractor shall submit the specimen to an “outside” facility, (mutually agreed upon), at the Contractor’s expense.

The Contractor shall have the capability of providing specialty specific telephone consultation on medical, technical and procedural problems within 30 minutes after being called by the NAIHS physician. The Contractor shall provide to all NAIHS facilities at least two (2) weeks in advance of the schedule of all person/persons on call.

The Contractor shall verify all abnormal cytological smears through a certified Clinical Pathologist and shall telephone all gynecologic cases with significantly abnormal (high-grade SIL) or malignant cytological findings to the ordering physician within 24 hours and document on the final report. Any significant discrepancy found during retrospective review and that will affect patient care, shall be issued in a corrective report.

Specimen(s) removed during surgery is to be described, evaluated and interpreted by qualified personnel under CLIA-88 and other applicable Federal and State requirements. All cases presenting a questionable diagnosis must be referred to another board certified anatomical pathologist for opinion. Any significant discrepancy found during retrospective review and that will affect patient care, shall be issued in a corrective report.

The pathologist must correlate all cervical biopsy (colposcopy) specimens with the corresponding (or most recent) cervical cytology specimen. Any significant discrepancy found during retrospective review and that will affect patient care, shall be issued in a corrective report.

Gross specimens shall be retained for 30 days after interpretation. Slides and tissue blocks shall be stored for the number of years recommended by CAP.

5.4 Data Management System:

Contractor shall provide, install, and maintain a Laboratory Data Manager (LDM) at each NAIHS facility. The LDM is to include a color monitor (15” min) stand-alone PC capable of generating requisitions, receiving patient reports, (partial and complete), dual tray laser printer capable of printing minimum 40 pgs/minute with a minimum 1000 DPI resolution. LDM shall be password protected.

The Contractor’s equipment shall have the capability of using the Generic Interface System (GIS) for transferring data from a commercial Reference Laboratory to (and from) the Resource and Patient Management System (RPMS) using standard HL7 messaging.

For NAIHS laboratories that are using or planning to use the EHR Bi-directional Interface, a Virtual Private Network (VPN) connection is installed, thereby ensuring patient confidentiality.

For NAIHS laboratories that are using or planning to use the EHR Bi-directional RPMS Interface or Uni-directional RPMS Interface, the Contractor shall assign a project manager/specialist and dedicate system resources to the set up and testing of the Contractor laboratory interface at each facility.

The LDM system must be installed, and operational/activated within 30 days after award of the contract.

Prior to activation, the Contractor shall train the lab staff at each NAIHS facility on the

LDM.

The Contractor shall be responsible to provide toner cartridges, paper, and any other necessary supplies relative to the maintenance and operation of the LDM supplies relative to the maintenance and operation of the LDM.

The Contractor shall notify the NAIHS facility laboratory if a batch of specimens is received by the Contractor laboratory without electronic orders.

The Contractor shall perform updates to the test database in a timely manner, either through email or regular paper mail.

5.5 Required Reports:

Contractor shall provide a final and "chartable" patient report. The Contractor shall have the capability of providing three (3) manually or electronically signed copies of CPT coded surgical specimen reports returned to the appropriate NAIHS facility within 3 work days for cytology specimens and within 7 work days for histopathology specimens, except for significant and unexpected findings, such as a diagnosed malignancy, which the Contractor shall immediately telephone the requesting physician or on call physician within 24 hours and document on the final report within 2 working days.

The Contractor shall provide, within the same day, urgently required cytology reports on specimens collected in case with a life-threatening clinical presentation. Special or urgent handling shall be noted on the request form.

The surgical pathology report shall include a detailed gross description and microscopic description of each specimen and diagnosis. In cases, when a malignancy is diagnosed, all necessary information to stage the disease, such as tumor grade and its extent within the pathological specimen, must be included in the diagnosis and easily identifiable, such as bold type, etc. Any significant discrepancy found during retrospective review and that will affect patient care, shall be issued in a corrective report.

Contractor shall provide a monthly “workload” report, unique to each NAIHS facility.

The “workload” report shall include the test procedures performed with accompanying procedure code in Month To Date (MTD) & Year To Date (YTD) tallies.

Contractor shall provide a monthly “provider usage” report, unique to each NAIHS facility. The “provider usage” report shall include the provider name, test procedures performed with accompanying procedure code, and tallied by MTD & YTD cumulative costs.

The Contractor shall utilize the most current Bethesda Terminology and Classification of gynecologic (endocervical/vaginal) cytology for all laboratory reports. Each report shall address adequacy of the specimen for diagnostic evaluation and a general categorization of the diagnosis.

The Contractor shall provide a monthly list of patients who received cytology services, date of specimen and degree of dysplasia to all NAIHS facilities. These reports shall be mailed by the 10th day of every month (for all specimens submitted the previous month) to all NAIHS facilities. The required reports shall be printed in original laser ink for readability.

5.6 General Requirements:

Contractor shall provide a 3 part request form for tests / procedures not otherwise able to be ordered electronically through the LDM. Forms shall be delivered within 7 days of request.

10% of normal pap smears/thin preps shall be re-screened in accordance with CLIA-

88. The re-screening must include some cases from high-risk patients, as well as random negative cases. On-site documents for review shall be available upon request and at the discretion of the NAIHS CO or COR designee. On-site review costs will be at the NAIHS expense.

Contractor shall provide a phone directory of key laboratory personnel of all Contractor testing sites, (primary/centralized, secondary, and “outside” reference lab locations).

Any updates to the phone directory shall be communicated in a timely manner. At least 2 copies of the directory shall be provided to each NAIHS facility.

Contractor shall provide "clinical consult” to NAIHS providers / lab personnel. As needed and upon request the Contractor’s Lab Director or Pathologist shall provide “clinical consultation” via telephone to NAIHS providers / lab personnel.

Contractor shall allow on-site reviews of the Contractor’s facility. On-site reviews are to be allowed prior to the award and post award of the contract. On-site reviews are to be allowed as frequently as deemed necessary by the NAIHS CO or COR designee.

On-site documents for review shall be available upon request and at the discretion of the NAIHS CO or COR designee. On-site review costs will be at the NAIHS expense.

The Contractor shall provide, upon verbal or written request, a copy of the original report(s) and the original slide(s) to the originating facility. These requests shall be provided within 5 working days.

Gross specimens, including products of conception, shall be returned to the originating facility when requested. Requested specimens shall be returned within 7 working days to the NAIHS facility.

The Contractor shall maintain a permanent surgical pathology register with patient name, NAIHS patient identifier, sex, age/date of birth, facility location code and results.

On-site documents for review shall be available upon request and at the discretion of the NAIHS CO or COR designee. On-site review costs will be at the NAIHS expense.

REFERRAL LABORATORY CYTOLOGY, PATHOLOGY, AND HISTOLOGY TESTING SERVICE – NAVAJO AREA INDIAN

HEALTH SERVICE

5.7 Performance Based Matrix

PERFORMANCE

OBJECTIVES

INDICATOR

PERFORMANCE

STANDARD

SURVEILLANCE

PLAN

CONTRACTOR

INCENTIVE

The Contractor shall provide Cytology / Histology / Pathology Laboratory Testing Services to Navajo Area Indian Health Service Facilities.

1. Performance

2. Reports

3. Turnaround time on

Deliverables.

1. 100% of tests performed accurately per CLIA’88 Standards

2. 100% of reports to be completed accurately.

3. 100% of Cytology tests to be provided in 5 days & Histopathology tests to be provided in 14 days.

Surveillance systems will include:

1. Random Sampling of Patient Test Management Audits by NAIHS facility lab.

2. Valid customer complaints received based on incident report received by from NAIHS medical or laboratory staff.

1. Payment for service. No payment for incomplete work.

2. Successful Evaluation using the

Contractor Performance Assessment Report (CPAR)

3. Exercise the Option to extend the term of the Contract by One Year.

B-6 QUALIFICATION REQUIREMENTS: The Contactor shall meet the following requirements throughout the term of the contract.

6.1 Experience: The Contractor shall ensure that all laboratory technical personnel are trained and licensed in accordance to CLIA’88 Standards.

6.2 Accreditation: The Contractor’s personnel performing services under this contract shall be accredited by an accrediting agency such as the Joint Commission, College of American Pathologist, or Centers for Medicare and Medicaid Services.

6.3 The Contractor shall provide to the COR, a copy of the most current accreditation certificate.

B-7 GOVERNMENT FURNISHED PROPERTY:

7.1 Information: All unique government information related to this lab testing service that is necessary for Contractor performance will be made available to the Contractor. The Contracting Officer or COR designee will be the point of contact for identification of any information supplied by the government.

7.2 Communication (Modem) Line: Each NAIHS facility will be responsible to provide, install, and maintain a dedicated communication (modem) line.

7.3 Communication (LDM) Space: Each NAIHS facility will provide space for the Laboratory

Data Management (LDM).

7.4 Specimen Processing / Supplies Space: Each NAIHS facility will provide space for the processing of specimens and storage of collection/processing/transport supplies.

7.5 Specimen Storage: Each NAIHS facility will provide refrigerator and freezer storage space for specimens awaiting pickup and transport.

B-8 APPLICABLE DOCUMENTS:

8.1 Centers for Medicare and Medicaid Services (CMS) http://cms.hhs.gov/CLIA/

8.2 Computer Security Act of 1980. (ISA) Interconnect Security Agreement http://security.ish.ogv/isa.cfm

8.3 Health Insurance Portability and Accountability Act (HIPAA) of 1996.

http://www.cms.hhs.gov.hippa

8.4 Indian Health Services Computer Security Directives.

http://www.ihs.gov/PublicInfo/Publications/IHSManual/TOC.cfm

8.5 College of American Pathologists (CAP) http://www.cap.org.apps/cap.portal

8.6 The Joint Commission (TJC) http://www.jointcommission.org/

8.7 CLIA’88 http://www.cms.hhs.gov/CLIA

B-9 PERIOD OF PERFORMANCE: The effective date of this contract is from APRIL 01, 2021 through DECEMBER 31, 2021 one (1) basic contract year and four (4) one year option periods.

If the Government exercises its option pursuant to 52.217-9 Option to Extend the term of the Contract, the period of performance will be extended in accordance with the following schedule.

YEAR OPTION PERIODS

FIRST YEAR OPTION: January 01, 2022 through December 31, 2022 SECOND YEAR OPTION: January 01, 2023 through December 31, 2023 THIRD YEAR OPTION: January 01, 2024 through December 31, 2024 FOURTH YEAR OPTION: January 01, 2025 through December 31, 2025

B-10 CONTRACTING OFFICER RESPONSIBILITY: Authority to negotiate changes in terms, conditions, or amounts cited in this contract is reserved for the Contracting Officer.

B-11 PRIVACY ACT NOTIFICATION: This contract requires the Contractor, on behalf of the Indian Health Service (IHS), to provide health care to American Indians and Alaskan Natives and report selected medical record as required. The Snyder Act (25 U.S.C. 2001) authorizes the collection of this information.

Disclosure of this information may be made by IHS to: other providers of health care for treatment of health maintenance of American Indian or Alaskan Native people; the Office of Worker’s Compensation Programs, Department of Labor; the Department of Justice or their representation of the United State; and for Congressional inquiry assessment; medical audit; or utilization review;

analytical and evaluation studies; to Federal or State agencies as required by law; research purposes supports by IHS; and identification of handicapped children under 10 U.S.C. 1401 et, seq.

B-12 CONTRACTING OFFICERS REPRESENTATIVE (COR):

SOLICITATION NO.: 75H71021R00005

Colleen Ben, MT, CCHCF, Laboratory Administrative Director, is designated COR for this contract, and the COR shall be responsible for the following:

1. Monitoring the Contractor’s technical progress, including surveillance and assessment of performance and recommending to the Contracting Officer changes in requirement;

2. Performing technical evaluation as required;

3. Performing technical inspections and acceptance required by this contract; and

4. Assisting the Contractor in the resolution of problems encountered in performance.

B-13 OFFICIAL AUTHORIZED TO PLACE ORDERS AGAINST THIS CONTRACT

13.1 The authorized ordering officials, as listed below, shall represent the Government for the purpose of issuing and signing Individual Task Orders under this agreement.

Division of Acquisition Management & Contracts NAIHS-Window Rock, AZ 86515 Telephone No.: (928) 871-5863

DeeAndra Salabye, CS Margaret Shirley, CS Natasha Bitsoi, CS

Unlimited Unlimited $500,000

USPHS-Chinle Comprehensive Healthcare Facility Chinle, Arizona 86503 Telephone No.: (928) 674-7635

Tanya Begay, SCS DeeAndra Salabye, CS Margaret Shirley, CS Natasha Bitsoi, CS

$10,000,000 Unlimited Unlimited $500,000

USPHS-Crownpoint Healthcare Crownpoint, NM 87313 Telephone No.: (505) 786-2527

Thomasina Willie, BS DeeAndra Salabye, CS Margaret Shirley, CS Natasha Bitsoi, CS

$500,000 Unlimited Unlimited $500,000

USPHS-Gallup Indian Medical Center Gallup, New Mexico 87301 Telephone No.: (505) 722-1549

Jericho Lew, SCS DeeAndra Salabye, CS Margaret Shirley, CS Natasha Bitsoi, CS

$20,000,000 Unlimited Unlimited $500,000

USPHS-Northern Navajo Medical Center Shiprock, New Mexico 87420 Telephone No.: (505) 368-6089

Linda DeLaney, SCS DeeAndra Salabye, CS Margaret Shirley, CS Natasha Bitsoi, CS

$10,000,000 Unlimited Unlimited $500,000

USPHS-Kayenta Indian Health Center Kayenta, AZ 86033 Telephone No.: (928) 697-4023

Roxanne Franklin, CS DeeAndra Salabye, CS Margaret Shirley, CS Natasha Bitsoi, CS

$10,000,000 Unlimited Unlimited $500,000

13.2 The authority to obligate the Government shall be in accordance with the acquisition delegation of his/her authority.

SOLICITATION NO.: 75H71021R00005

B-14 INVOICE SUBMISSION: The Contractor shall submit original invoice(s) in accordance with FAR 52.212-4(G) to: the address cited on each task order.

B-15 CONTRACTOR’S REPRESENTATIVE:

Designated Contractor’s Representative, whom we may contact for prompt Contract Administration:

NAME:___…