PEFORMANCE WORK STATEMENT (PWS).pdf

REFERRAL LABORATORY CYTOLOGY, PATHOLOGY, AND HISTOLOGY TESTING

SERVICE – NAVAJO AREA INDIAN HEALTH SERVICE

B-1 PURPOSE OF CONTRACT:

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

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

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.

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 that are not available in most NAIHS facilities. There are greater needs felt by the remote and rural areas served by the NAIHS.

The government anticipates award of a Requirements Type contract with one (1) one-year base period and four (4) one-year option periods.

B-5 PEFORMANCE WORK STATEMENT

5.1 Purpose: 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. 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 Contractor Qualifications: Offeror shall have at least 3 years of experience providing laboratory pathology/cytology/histology testing services. 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 ensure testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under CLIA’88 regulations, the College of American Pathology (CAP) accreditation standards, other accrediting organizations and state standards.

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

5.2.4 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 or email M – F during standard business hours.

5.3: The Contractor shall provide routine and specialized Laboratory Testing Services to NAIHS facilities M-F during standard business hours:

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. The Contractor shall accept all pathology samples, with the exception of frozen sections for immediate evaluation. Due to the rural location of the NAIHS sites, the Contractor is unable to provide this service level.

The Contractor shall provide laboratory test request forms preprinted with each NAIHS account information. The contractor shall provide any necessary test request forms for specialized testing (i.e. cytogenetics, tissue, etc)

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 7 days a week (if necessary) to hospital sites and M-F to clinic facilities, including federal 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 ensure 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 to ensure safety and integrity of specimens. The Contractor shall comply, except during catastrophic weather events that may present delays where specimens will need to be held and stabilized until transport of specimens is safe. Proper notification of delays will be made by contractor to affected NAIHS sites.

• The Contractor shall provide written guidelines on packaging and storage of 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.

• The Contractor shall have an acceptable tracking mechanism in place to monitor specimen pickups from each NAIHS site.

5.3.3 Specimen Testing:

• 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 needs of each NAIHS facility. Any update to the Directory shall be communicated and distributed in a timely manner in electronic or written format.

• 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 that affects 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 that affects 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 that affects 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 cases 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 that affects 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’s 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.

• Contractor shall adhere to current privacy regulations, patient confidentiality requirements, and HIPPA regulations in performance of the contract.

• Quality control Program - Contractor shall develop and/or maintain an effective quality control program to ensure the services are performed in accordance with the PWS.

The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s quality control program is how contractor assures that work products comply with requirements of the contract.

The contractor’s quality control program is to be delivered within 30 days after contract award and is subject to acceptance and possible revisions by government.

• Contractor shall have an acceptable and verifiable information technology contingency plan in place to protect all laboratory operations against unexpected and unauthorized cybersecurity attacks. Contractor will notify customers within 24 hours of any security breach affecting customers or l operations.

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 with 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 for providing, 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 http://cms.hhs.gov/CLIA/ http://security.ish.ogv/isa.cfm http://www.cms.hhs.gov.hippa/

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: One (1) one-year base period 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.

PERIOD OPTION PERIODS

BASE PERIOD: 12 MONTHS DURATION

FIRST YEAR PERIOD: 12 MONTHS DURATION

SECOND YEAR PERIOD: 12 MONTHS DURATION

THIRD YEAR PERIOD: 12 MONTHS DURATION

FOURTH YEAR PERIOD: 12 MONTHS DURATION

B-10 REQUESTING ITEM LIST: 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).

*Note: Quantities are estimates only. Not limited to item description.

ITEM

NUMBER ITEM DESCRIPTION UNIT

ESTIMATED

ANNUAL

QUANTITY

1 Abdominal Fluid Cytology 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 http://www.cap.org.apps/cap.portal http://www.jointcommission.org/ http://www.cms.hhs.gov/CLIA

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

46 883041 88304 Surgical Path‐1st Site ea 530

47 883051 88305 Surg Path‐1st Site ea 1390

48 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

51 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