RFP-75H70624R00006-MedTech-RB-9.12.24--.pdf

Section A Indian Health Service Request for Proposal for Great Plains Area Indian Health

Service (GPAIHS) – Medical Laboratory Technologists for the Rosebud IHS Hospital, Rosebud, South Dakota

(RFP) 75H70624R00006

You are invited to submit a proposal in accordance with the requirements of the following Solicitation.

Proposals must be received by the Government no later than the local time on the Due Date stated in the table below.

Issue Date: 9/12/2024

Due Date: 10/1/2024

Time: 12:00 p.m., CST

Points of Contact:

Wenda Wright

(605) 226-7724 wenda.wright@ihs.gov mailto:wenda.wright@ihs.gov

75H70624R00006

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 1

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

CAUTION: LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

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K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

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SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 253 (c) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

Aberdeen Area Indian Health Servic Federal Building 115 Fourth Ave, SE Aberdeen SD 57401

WENDA L WRIGHT 605

wenda.wright@ihs.gov

226-7724

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AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev. 9-97)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

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17-25 26-27 28-36 37-39

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12. In compliance with the above, the undersigned agrees, if this offer is accepted within _____0_________ calendar days (60 calendar days unless a different period is inserted

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Section B Solicitation No. RFP-75H70624R00006 Medical Laboratory Technologist Services, Rosebud IHS Hospital, Rosebud, South Dakota

SECTION B – PRODUCTS OR SERVICES AND PRICES/COSTS

B.1. OVERVIEW

The Great Plains Area – Indian Health Service (GPAIHS) is requesting proposals in accordance with this Request for Proposal to provide Medical Laboratory Technologist Services for the Rosebud IHS Hospital, Rosebud, South Dakota. This is a Buy-Indian, Small Businesses set-aside. As such, small business contractors shall provide the commercial services described in Section C, Description/Specifications/Performance Work Statement (PWS). Except as otherwise specified in the contract, the Contractor shall furnish the necessary personnel (up to 12 Medical Technologists), equipment, materials, services, and otherwise do all things necessary for the performance of the work set forth herein.

B.2. CONTRACT TYPE

This is a Firm Fixed-Price, Non-Personal Healthcare Service, Commercial Item, Indefinite Delivery/Indefinite Quantity (ID/IQ), Single Award, Contract to provide Medical Laboratory Technologist Services for the Rosebud IHS Hospital, Rosebud, South Dakota. Period of Performance: October 15, 2024 (Tentatively) through October 14, 2025 with Four Option Years. The guaranteed minimum amount is $200,000. The maximum amount of the contract for all five years is $7.5 million. The period of performance for this contract is up to one year with four one-year ordering periods. The Great Plains Area of the Indian Health Service (GPAIHS) reserves the unilateral right whether to exercise the option periods. Be advised that the quantities of hours within are, “estimates only” and GPAIHS is not obligated to order the “maximum quantities”. The period of performance, hour requirements, and obligated funding will be specified in individual task orders issued under the IDIQ Contract.

B.3. CONTRACT PRICING

Offerors are invited to submit a written proposal per the instructions in Section L, Instructions for Proposal Preparation. The Firm Fixed-Price rate shall include travel, lodging, per diem, fringe benefits (e.g., life insurance), social security, federal, state, and local taxes, plus all other costs pertinent to the performance of this IDIQ Contract.

B.4. SCHEDULE OF PRICES

Schedule of Prices

CLINs Labor Category Estimated Hours

Hourly Rate

Total Price

Base Year – October 15, 2024 - October 14, 2025 (Tentatively) Rosebud Hospital (RBH), Rosebud, SD 0001 Medical Technologists (up to 12) 34560 $ -

Total Estimated Price for Base Ordering Period

CLINs Labor Category Estimated Hours

Hourly Rate

Total Price

Optional Ordering Period One (1) – October 15, 2025 – October 14, 2026 (Tentatively) Rosebud Hospital (RBH), Rosebud, SD

Section B Solicitation No. RFP-75H70624R00006

0002 Medical Technologists (up to 12) 34560 $ - Total Estimated Price for Optional Ordering Period

CLINs Labor Category Estimated Hours

Hourly Rate

Total Price

Optional Ordering Period Two (2) – October 15, 2026 – October 14, 2027 (Tentatively) Rosebud Hospital (RBH), Rosebud, SD 0003 Medical Technologists (up to 12) 34560 $ - Total Estimated Price for Optional Ordering Period $ -

CLINs Labor Category Estim ated

Hours

Hourly Rate

Total Price

Optional Ordering Period Three (3) – October 15, 2027 – October 14, 2028 (Tentatively) Rosebud Hospital (RBH), Rosebud, SD 0004 Medical Technologists (up to 12) 34560 $ -

CLINs Labor Category Estimated Hours

Hourly Rate

Total Price

Optional Ordering Period Four (4) – October 15, 2028 – October 14, 2029 (Tentatively) Rosebud Hospital (RBH), Rosebud, SD 0005 Medical Technologists (up to 12) 34560 $ -

Total Estimated Contract Price for the Base + Four (4) Optional Ordering Periods

B.6. OPTION PERIODS

a. Unless the Government exercises its option pursuant to the applicable option clause referenced in the Contract Clauses section, this contract consists only of the Base Ordering Period specified.

Section B Solicitation No. RFP-75H70624R00006

b. Pursuant to FAR Clause 52.217-8, Option to Extend Services and FAR Clause 52.217-9, Option to Extend the Term of the Contract, set for in Contract Clauses of this contract, the Government may, by unilateral contract modification, require the Contract to perform the Optional Ordering Period(s) of this contract.

Section C Solicitation No.: RFP-75H70624R00006

Section C – Description/Specifications/Performance Work Statement

Performance Work Statement Medical Technologist

General The mission of the Rosebud Indian Health Service Unit (RSU) is to provide the best possible health care and laboratory services to the Native American population on the Rosebud Indian Reservation in South Dakota. To meet the mission, the RSU requires Contractor Medical Technology support to assist the laboratory department during times of laboratory staff shortages.

This is a firm-fixed-price performance-based service contract for Medical Technology support services for the RSU beneficiaries served by the laboratory of the RSU. However, there are significant constraints on the contractor's solution to achieving the purpose of this contract.

The RSU staffing levels are determined by acuity and standards of care. Therefore, this contract establishes a minimum level of support coverage that must be maintained during each shift. While there are no restrictions on the maximum number of Contractor Personnel hired for this contract, the medical service physical presence cannot fall below contractually established minimums regardless of patient workload.

The practical consequence of this for the Contractor is that although it is a firm fixed price performance-based contract, the staffing requirement takes on the characteristics of a labor hour contract in that the contract identifies specified skill types/levels for a stipulated number of hours.

Throughout this contract, all references to "Contractor" refers to the awardee. All references to "Contractor Personnel” refer to Contractor staffing provided in support of the contract.

Scope The minimum staffing requirement for this contract is the equivalent for up to 12 full time technologists over the course of the contract. Since the RSU operates 365 days a year, this contract may require multiple individual Contractor Personnel to meet this requirement. The Government may significantly increase or decrease the level of effort of this task order at any time by contract modification in response to staffing requirements. There are 3 Deliverables associated with this contract. 1. Candidate Submission Packets, 2. Quality of Care Activity 3, 3.

Invoices/Pricing

The roles and responsibilities of Contractor provided technologists are those typical of a hospital or clinic that provides health care such as outpatient and inpatient services for patients, to include emergency room services, obstetrical services, behavioral health, surgery, mobile units, and public health activities.

The services to be delivered under this contract by the Contractor to the Government are non-personal services and no employer-employee relationship exists or will exist under the contract between the Government and the Contractor Personnel.

Contractor Personnel under this contract shall not be:

Placed in a position where they are under the supervision or evaluation of a Government employee (except for mandatory peer review and authorized "work direction"): or

Placed in a position of supervision, management, or control over Government Personnel, or Personnel of other Contractors, or become a part of the Government.

Given the nature of the contract requirements and the medical working environment, it may be necessary for specifically designated Government supervisory personnel to provide "work direction" to the Contractor Personnel. This is accomplished while preserving the non-personal services nature of the contract. The operational need to work as a team is accomplished in a manner consistent with preserving the management responsibilities of the Contractor.

Section C Solicitation No.: RFP-75H70624R00006

The Contractor is at all times responsible for the quality of Contractor Personnel work. It is the direct responsibility of the Contractor to perform all tasks normally associated with an employer-employee relationship, e.g., completing time cards, resolving quality of work issues, ensuring high motivation and morale, and resolving Government-identified Contractor performance concerns.

The physical absence of an on-site Contractor direct line supervisor does not relieve the Contractor of these responsibilities. For example, the completion and accuracy of time cards is a direct responsibility of the Contractor, not the Government. Since this is a non-personal services contract, the Government will not assume the supervisory functions except to the extent of providing the work direction addressed above.

To function effectively and efficiently as a team member in this environment, the work demands Contractor Personnel with a high degree of laboratory knowledge, skills, and abilities.

Contractor management plays a key role in sustaining this high performing, highly motivated, and responsive laboratorian support effort that enhances the image of the RSU and gains the confidence of the supported Native American population.

MAJOR TASKS:

Medical Technologists/Technician services shall include quality diagnostic laboratory medicine responsibilities. The following list is not an all-inclusive list but shall encompass the majority of tasks as would be expected in standard of care for a high complexity laboratory in any CLIA inspected laboratory:

1. Provide examination for all patients presenting to the Laboratory Department after being examined by a Health Care Provider.

2. Independently operates high complexity laboratory equipment to meet the needs of the department.

3. Receives patients, conducts proper patient identification x 2, and explains methods of procedures, special collection instructions and/or criteria to obtain the best possible laboratory results.

4. Performs phlebotomy procedures on all age classifications for venipuncture or capillary collection of samples.

5. Performs maintenance on all laboratory equipment per manufactures required timeframes as is consistent with all standard laboratory protocols across the industry.

6. Maintains a quality control system for the laboratory setting on a daily basis to meet all CLIA, HIPAA and JCAHO standards. This includes using Levey Jennings criteria for acceptance or rejection of quality control results, utilizing best practices methods for problem solution to ensure systems are fully operable before any patient testing is performed.

7. Performs a variety of routine to highly complex tests to meet the needs of the Medical Staff, as well as, the needs of the specialty clinic physicians. Areas of Laboratory medicine include:

hematology, chemistry, blood banking, urinalysis, serology, reference testing, and general microbiology.

8. Assists the Laboratory staff in maintaining records of all functions of this department and keeps documentation on file as required by HIPAA and CMS/JCAHO. This includes any repairs of equipment, surveys, etc. Contractor shall abide by the HIPAA and CMS/JCAHO standards.

9. Notifies staff (providers) of any repairs or downtime of equipment. [Professional communication skills]

10. Maintains accurate records of patient workload examinations on a daily basis.

11. Contractor must be able to assist in a cardiac arrest situations. This will include knowing

CPR and recognizing anaphylaxis and respond to other emergency situations with other staff members. BLS is required by the Indian Health Service for consideration of a contract candidate.

12. The Contractor shall provide coverage in the Laboratory Department as needed during staff vacancies, vacation, sick leave, etc.

Section C Solicitation No.: RFP-75H70624R00006

WORK HOURS:

Contractor Personnel schedule will be 80 hours in a two-week period plus or minus 12 hours based on laboratory needs. Shift rotation is required and will be based on staffing needs. The Contractor Personnel's schedule will be assigned, maintained and monitored by the Laboratory Supervisor or delegate. The Contractor Personnel are subject to floating through all laboratory departments and shifts as assigned.

***The Government may require the removal and replacement of Personnel as a result of security actions or other reasons, e.g., removal of unqualified or habitually careless Personnel or the removal of Personnel that cannot perform the assigned tasks or display unacceptable conduct and behavior.

Definitions

Professional Effort – That effort expended by the Contractor to ensure all contactor employees perform all work specified in this contract. This effort includes providing required qualified personnel, properly supervised, and following professionally accepted medical methodologies and practices. The effort is further characterized by the Contractor and Contractor Personnel operating at all times with the Government's best interest in mind, using efficient and effective methods. Failure to provide this required effort by either the Contractor or Contractor Personnel may result in a contract deduction for loss of value. For Contractor Personnel performance that does not qualify as "professional effort" this may mean a contract price deduction that reflects decreased value of services received.

Contracting Officer (CO) – Individual at the RSU 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.

Contractor – The firm awarded this contract.

Contracting Officer's Technical Representative (COTR) – A federal employee designated by the contracting officer who assists the contracting officer in the administration of this contract. The COTR is primarily responsible for the day - to - day management of the contract.

Customer Complaints: A criticism submitted against the Contractor or Contractor Personnel to the RSU by a patient or facility staff. This is one of the methods used to monitor the Contractor's performance.

Full time. 80 hours every two weeks.

Non - personal services contract: A contract under which the personnel rendering the services are not subject, either by the contract's terms or by the manner of its administration to the supervision and control usually prevailing in relationships between the Government and its employees as defined in FAR 37.

Orientation: An activity designed to provide basic familiarization of the facility and transition the technologist/technician into the RSU and the laboratory where the services will be provided.

Past Performance Information: Relevant Information regarding a Contractor's actions under previously awarded contracts. It includes the Contractor's record of conforming to requirements; 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.

Personal Protective Equipment (PPE): The equipment used to protect medical personnel from exposure to biological. chemical, and radioactive hazards, Section C Solicitation No.: RFP-75H70624R00006

Providers: Physicians, Advanced or Independent Licensed Practitioners, Surgeons, Midwives, etc (See Medical By-laws)

Quality Assurance Surveillance Plan (QASP): A written document prepared and used by the government for Quality Assurance Monitoring of the Contractor 'performance.

Quality Control (QC): Those actions taken by the Contractor to control quality of services provided. The Contractor’s equivalent of the Government's Quality Assurance Surveillance Plan.

Verifiable Emergency: An unexpected unplanned episode requiring valid documentation to confirm the occurrence.

Specifically Designated Government Personnel. At the provider's initial orientation, the identity of this individual will be provided. This government person may be a shift supervisor or department supervisor or another designated individual by the COR II.

Work direction. A communication to Contractor Personnel that director approves approaches, documents, determines shifts, presentations or refinements to work: fills in details or otherwise completes the general description of work or documentation items: shifts emphasis among work areas or tasks: or furnishes similar instructions to Contractor Personnel.

Applicable Documents

The Joint Commission (TJC) Centers for Medicare and Medicaid Services (CMS) Standards Accreditation Association for Ambulatory Health Care(AAAHC) Section 231 of Public Law 101-6&7, the Crime Control Act of 1990 Section 4087 of Public Law 101-630, the Indian Child Protection and Family Violence Act.

Health Insurance Po1iability and Accountability Act (HIP AA) of 1996.

Privacy Act (1974) HHS Residual Standard of Conduct RSU ·written policies; procedures; standards of care; and hospital and nursing protocols

Government Furnished In the provision of medical services, the Contract Contractor Personnel will be authorized to use all areas of the medical treatment facility available to civil services and commissioned personnel in similar positions. The same restrictions apply to the Contractor Personnel as any other Indian Health Service personnel to use these areas for official business activities only.

The Contractor Personnel will be authorized to use all administrative and ancillary support available to RSU personnel. This will include but not be limited to copy machines, fax machines, medical library, Internet, and telephone services. The same restrictions to use these items for official RSU business apply.

The RSU shall provide all required blank Government forms applicable for documentation in the Indian Health Service patient record system. Applicable forms shall include Patient Care Component (PCC) forms. An appropriate orientation to the necessity of such forms will be provided by RSU personnel.

The RSU shall assume the responsibility of patient care coordination. The service unit shall provide a multidisciplinary approach in order for patient to receive the best care possible. The RSU shall encourage patients to be independent, well informed and active participants in their own healthcare.

Therefore, coordinating care must balance between fostering this independence and ensuring that patients receive optimal and appropriate healthcare.

Section C Solicitation No.: RFP-75H70624R00006

Specific Requirements

Deliverable Item #1: Candidate Submission Packets - The Contractor shall provide qualified Medical Technologists/Technicians to work at the RSU for acceptance by Laboratory Manager/ Designee or the COR II.

Before Contractor Personnel commence work prior to the arrival of Contractor Personnel at the RSU, the contactor shall ensure the Contractor Personnel meet or exceed the following requirements:

EXPERIENCE. The Contractor Personnel shall have a minimum of twelve (12) months experience in a hospital laboratory setting within the last thirty-six (36) months.

ENGLISH LANGUAGE REQUIREMENT. The Contractor Personnel shall read, understand, speak, and write English well enough to effectively communicate with Native American Patients and other health care workers.

COMPUTER KNOWLEDGE. The Contractor Personnel shall possess knowledge of computer operations and have proficiency in the use of word processing, email, electronic patient records. Laboratory information systems, and other similar software as required.

CRIMINAL BACKGROUND CHECK REQUIREMENT. The Contractor shall provide all required background check documents at least 60 calendar days before Contractor Personnel are to report to RSU. Contractor will not be paid for employee contract services prior to completion of background checks.

CERTIFICATIONS. The Contractor Personnel shall have ASCP (or equivalent to) certification.

CULTURAL SENSITIVITY. The Contractor Personnel shall possess sufficient initiative, interpersonal relationship skills and social sensitivity such that Contractor Personnel can relate constructively to patients from the Native American community.

INITIAL AND CONTINUING DOCUMENTATION: [Employee Health] Contractor shall provide documentation of the following: MMR (immunization or titer levels for Rubella and Rubeola), history of chicken pox disease or positive titer (varicella vaccination must be accomplished if lack of immunity), Tetanus Diphtheria (Td), TB Mantoux skin test (PPD) if positive, minimum requirement will be follow-up with the Contractor's physician and a chest x-ray. Contractor shall ensure a physician provides documentation of "no active respiratory disease." Annual immunization for Influenza or Medical Exemption Waiver approved by Infection Control Officer at Rosebud Service Unit. All Contractor Personnel who will have occupational exposure to blood or body fluids, or other potentially infectious materials, shall receive Hepatitis B vaccine series, sign a voluntary declination, or have documented proof of immunity to Hepatitis B infection. The Contractor shall ensure all Contractor Personnel are current on all immunizations and medical tests as required for employment; updated records of immunizations and medical tests will be kept by contractor.

COMPLIANCE. The Contractor Personnel shall report to the Employee Health Nurse or the

COR II all information necessary to assure the Contractor Personnel's health records are correct and current, and comply with the CMS, TJC, OSHA, CDC, IHS and HHS health-requirements.

Deliverable Item #2: Quality of Care Activity 3

After Contractor Personnel commence work.

ORIENTATION. The Contractor shall ensure that all contract Personnel participate in the RSU facility orientation (not already provided by Contractor) and in-service/clinic/ward/laboratory specific orientation prior to furnishing services under this contract. Initial clinic/ward/laboratory orientation

Section C Solicitation No.: RFP-75H70624R00006 must occur within five duty days of contract performance start date. Facility Orientation must occur within ten (10) calendar days of employment start date.

Ongoing throughout the period of performance: Contractor shall develop a Staff Satisfaction Survey as outlined below, and shall submitted it to the COR II and Laboratory Manager/Supervisor, and Quality Assurance Coordinator on a quarterly basis on the calendar year cycle (Jan, Apr, July, Oct)

SUPPORT LEVEL the Contractor shall ensure the contractually required support level is maintained at all times. This contract is for specified skill types/levels - not for specific individuals. The Contractor shall ensure that all Contractor Personnel are present for all hours of the workday. If for any reason the specified staffing levels are not maintained, due to vacation, leave, appointments, etc. and replacement Personnel will not be provided, the Contractor shall obtain the written approval of the Laboratory Supervisor/ designee or the COR II prior to the Contractor Personnel's absence.

Otherwise, the Contractor shall provide a fully qualified and SCL cleared replacement, so there is no gap in service.

AVAILABILITY. The Contractor Personnel shall be available for work in the work area per work direction schedule.

The Contractor shall ensure Contractor Personnel provide professional effort and conform to Government policies regarding daily lunch breaks and other breaks. The Contractor shall ensure Contractor Personnel communicate to the Laboratory Supervisor for reporting to work as it relates to inclement weather (late due to travel conditions etc).

Contractor Personnel shall obtain approval of the Contractor prior to any absence from work.

The Contractor shall then coordinate with the COR II to determine if backfill is necessary. The Contractor shall request approval from the COR II at least 30 calendar days in advance of any planned absence. The exception is verifiable emergencies.

If a Contractor Personnel is absent due to illness for three or more consecutive clays, the

Contractor shall provide to the Laboratory Supervisor/ designee or the COR II written documentation from a qualified health care provider that Contractor Personnel is free from communicable disease and state the cause of the Contractor Personnel's illness. Statement that Contractor Personnel is fit for service may be requested if deemed necessary.

If services are not provided by Contractor Personnel the RSU reserves the right to procure such services from another source and deduct these costs and all administrative costs from payments due the Contractor.

QUALITY OF CARE

The Contractor shall comply with the following quality of care protocol:

It shall be understood that eligible patients under treatment will be rendered services that provide the best medical care within the Contractor's professional training and experience.

All services rendered shall be in accordance with current standard medical practices to assure quality of care. A Work Schedule will be provided to the contractor by the Laboratory supervisor prior to the dates a technologist is needed.

The Contractor shall be familiar and adhere to the policy and procedures of the Bylaws of Medical Staff of the Indian Health Center, Rosebud Service Unit in South Dakota. The credentials of the Contractor shall comply with the Medical Staff By-laws of the service unit for all services provided in Public Health Service clinics. The Contractor shall agree to abide by the HIPAA and CMS standards.

The quality of work performed by the Contractor will be subject to review by chart audits and site visits by the Contract Officer Technical Representative, Vendor Project Officer or designee. Quality Review audits will be conducted by the Laboratory Manager/ Supervisor for competency initially, at 6 months and annually as per CLIA guidelines. Quality Review audits will be conducted by the Laboratory Manager/Supervisor monthly for compliance with critical value reporting, corrected reports, and workload statistics to evaluate the effectiveness of the services provided and if any indicators are not within established QA

Section C Solicitation No.: RFP-75H70624R00006 benchmark parameters a copy will be shared to the COR II and the Vendor for evaluation and utilized toward deductions of the contract price as described under PROFESSIONAL EFFORT. Deductions will be 5% of hourly rate for consistent failure to meet benchmarks more than 1 quarter during the period of performance. Evidence will be provided by the Laboratory Manager/ Supervisor of quality assurance efforts to re-train, and or improve the performance of the staff for good faith efforts to ensure compliance with expectations of Quality Improvement Initiatives.

The quality of work performed by the Contractor will also be subject to review by the Medical Staff of this facility and the Laboratory Director responsible for final reports of the laboratory tests.

The Contractor shall ensure all Contractor Personnel on site comply with the following:

EFFICIENCY. Balancing the need for complete patient care with the requirement to process as many patients and patient samples or other laboratory duties as possible during a shift.

OVERTIME. Regular work schedule will be on a 40 hr per week basis but due to the expectation that during shift change there is the potential for overtime to ensure smooth transition on basis of workflow and patient volume of testing. These hours will be approved by the Laboratory Supervisor/designee or the COR II or Specifically Designated Government Personnel

RECORDS. Prepare all medical record documentation to meet or exceed the established standards of the RSU, the RSU Laboratory policies and procedures, and TJC/CMS guidelines to include, but not be limited to: timeliness, legibility, accuracy·, content, and signature. All medical record information generated in the performance of this contract will remain the property and subject to the exclusive control of the Indian Health Service. Use only RSU approved abbreviations to document care in the health care record. Ensure complete patient identifying information is on all documentation that is to become part of the health care record.

INFECTION CONTROL. Comply with all APIC and RSU infection control and safety procedures, practices, and standards.

ACCREDITATION. Meet all applicable TJC and CMS Accreditation Standards for Healthcare Organizations during the performance of this contract.

PATIENTS RIGHTS. Respect and maintain the basic rights of Patients, to include but not be limited to personal dignity.

STANDARDS OF CONDUCT. Adhere to the Standards of Conduct for Federal Employees during the time of the contract services. A copy of the standards will be provided to the Contractor upon receipt of the contract.

HIPAA. Complete HIPAA Act of 1996 Privacy Rule training.

COMMUNICATIONS. Maintain open and professional communication with members of the medical community and coworkers/colleagues.

OTHER SUPPORT. Provide immediate evaluation and management of emergency problems as they occur.

REFERRALS AND CONSULTS. Follow regulations and policies, when arranging patient's referrals or consultation. Follow RSU Release of information Policy when dealing, with patient laboratory results.

ATTENDANCE AT PROFESSIONAL MEETINGS. Attend and participate in meetings, professional staff conferences, and other appropriate professional activities as required by the COR II.

Section C Solicitation No.: RFP-75H70624R00006

PUBLIC LAW. Comply with the requirements of Section 231 of Public Law 101-6&7, the

Crime Control of 1990 and Section 4087 of Public Law 101-630, the Indian Child Protection and Family Violence Act. Report any information or all circumstances of which Contractor Personnel are aware that may pose a violation to the COR II.

PROCEDURES. Only perform procedures consistent with the RSU and RSU Laboratory operating capacity and equipment. Evaluates requested procedures to determine the suitability of specimen for analysis, requesting a new specimen if determined to be unsuitable. Prepares specimen for analysis, insuring that the physiological state is maintained. Prepares reagents and primary reference materials. Selects, performs, evaluates and monitor the performance of non- routine and specialized test procedures using manual and/or instrumental techniques in accordance with established protocols. Recognizes and reacts to indicators of malfunction; locates and implements corrections; obtains analytical data for reporting: and correlates data to verify results. Reports results to appropriate individuals. Calibrates, standardizes, adjusts and maintains instruments. Verifies correct instrument operation using established procedures and quality control checks. Identifies the cause of common problems and make simple repairs. Conducts Quality Control procedures on equipment, reagents and maintains proper records for Quality Control reports.

KNOWLEDGE. Professional knowledge of Medical Technology principles, concepts and methodology sufficient to perform a broad range of emergency tests and routine tests, including complex and non-routine analysis, run quality controls. Skill and Knowledge sufficient to use and maintain complicated instruments, knowledge of technical physiologic, and mechanical indicator of malfunction sufficient to locate and correct errors. Should have knowledge of regulatory agency requirements sufficient to insure work is consistent with standards of the agency. The Medical Technologist selects an analytical approach appropriate for each assay and carries out the successive steps. Handles problems and documents corrective actions in accordance with the established policies, procedures and instructions. Guidelines include hospital policies, instruments manuals, handbooks, logs, and procedural manuals, which contain description and instructions for analytical methods and procedures, including control and calibration procedures. Uses judgment in interpreting and adapting instructions to recognize and react to indicators of malfunction and evaluating validating testing. This position is to personally perform the full range of procedures offered by the laboratory. These include, but are not limited to Hematology, Chemistry, Blood Banking (Type. Rh, Screen. Cross Matching), Urinalysis, Coagulation, Blood Gases, Microbiology, Phlebotomy, Adult and Pediatric Venipuncture, and Skin puncture.

PATIENT DATA. Collect, interpret and record; and communicate pertinent patient data relevant to the patient's care before, during and after laboratory procedure.

PATIENT LABORATORY ORDERS. Accurately review and confirm patient orders. And ordered diagnostic tests/reports and reports any abnormalities or inconsistencies to the laboratory supervisor or designee.

HOSPITAL PROTOCOLS. Adhere to established service unit and hospital protocols in preparing patients when completing phlebotomy tasks, collecting samples, and labeling specimens, including compliance with National Patient Safety Goals. For example specimen rejection policy for unlabeled specimens.

PSYCHOSOCIAL HEALTH STATUS. Communicate/document the psychosocial health status of the patient to include patients' perception of care, expectations of care, coping mechanisms, knowledge level, ability to understand, philosophical and religious beliefs and cultural practices.

EQUIPMENT AND SUPPLIES. Ensure the appropriate equipment and supplies are available and based upon patient phlebotomy needs. Monitor and control the environment to include temperature and humidity, sensory environment, and cleanliness. The technologist must be

Section C Solicitation No.: RFP-75H70624R00006 able to operate equipment similar to: Siemens EXLWLM and EXL200. Coulter DXH 900, Sysmex CS-2500, Cepheid, and Ortho ID-MTS Gel System (VISION). Enter appropriate work orders to BIOMED or FACILITIES for proper resolution of downed instruments or other equipment etc.

DOCUMENT. Accurately document according to RSU policies and the RSU Laboratory policies and procedures within EHR, RPMS, and within other systems as required by RSU.

OPERATE EQUIPMENT. Operate various types of laboratory equipment as needed.

MAINTAIN EQUIPMENT. Ensure equipment is properly- cleaned and monitored. Ensure preventive maintenance is performed as necessary and as needed.

Other Requirements.

DRESS AND APPEARANCE. The Contractor Personnel shall present a professional. Conservative and neat appearance. Contractor Personnel shall ensure hygiene, grooming, and dress must meet hospital and service unit standards, in compliance with TJC/CMS, and RSU infection control and safety policies. The Contractor Personnel shall report for duty in a professional manner, in appropriate attire befitting a health care setting, and display a positive and cooperative attitude. A RSU issued name tag will be provided designating "Contractor".

SECTION FLEXIBILITY. The Contractor Personnel will be required to work in all laboratory sections.

The Contractor shall be flexible in rotating temporarily, or permanently moving into, other shifts upon notification by the COTR. The Contractor Personnel identified for rotation or temporary move into a new shift will be required to undergo orientation to the new shift. The technologist should be able to perform independently and with limited orientation and meet CLIA-88 requirements. The Contractor Personnel may be required to take call or be on backup as well as provide coverage in RSU satellite clinic laboratories. Hours may vary: day shifts, evening shifts, night shifts, and weekends and holidays. Including being on-call or back-up during overall staffing shortages. The Contractor Personnel are expected to complete their shift to the end of their scheduled shift. Approval to leave early may be requested and may approved by the Laboratory Supervisor or designee.

ANNUAL TRAINING REQUIREMENTS: The Contractor shall ensure all Contractor Personnel complete annual training as required by RSU.

SECURITY CLEARANCE. The Contractor shall ensure all Contractor Personnel security clearance paperwork is processed in a timely manner for every 120 days contract or longer-term clearance and as required to maintain currency.

PERFORMANCE EVALUATION MEETING. The Contractor shall meet with the COR II at least annually and as requested by the CO. The Contractor may request a meeting with the CO when necessary. Contractor shall sign meeting minutes. Should the Contractor not concur with the minutes, such non-concurrence shall be provided in writing to the CO within ten (10) calendar days of receipt of the minutes.

MEDICAL QUALITY ASSURANCE/PERFORMANCE IMPROVEMENT/RISKMANAGEMENT

(QA/PI/RM). The Contractor shall ensure Contractor Personnel participate in QA/PI/RM activities to the extent required by QA/PI/RM plan or regulation.

None of the functions to be performed are inherently governmental.

The Government will evaluate the Contractor's professional and administrative performance under this contract using quality assurance standards specified in CMS Conditions of Participation.

EMERGENCY HEALTH CARE. The Government will provide emergency health care for the Contractor Personnel for injuries incurred on duty at reimbursable cost to the government.

Section C Solicitation No.: RFP-75H70624R00006

DAMAGE. Any damage determined to have been caused by the Contractor's negligence or wrongful acts shall be repaired by the Contractor at no expense to the Government.

Deliverable Item#3

PRICING/INVOICING. Contractor shall determine contract price using billing rates on their FSS/GSA schedule. Since this is a firm-fixed-price contract, invoicing will not be based upon hours billed as in a labor hour contract. Contractor shall invoice at least by the-end-of the period of performance or bi-monthly-if contract-period exceeds one 1 month in which case partial payment is authorized based upon percent of contract completed and accepted by the Government.

Technical Evaluation Criteria- IDIQ Medical Technologist/ Technician

Required Services

Performance Standards Acceptable Levels

Method of Surveillance Incentive

Problem and Approach

• Understanding of problems/ issues arising with laboratory medicine in rural Indian Health Service Facility

• Complexity and Logistical requirements of project

• Possession of necessary organization, experience, and technical skills to accomplish Statement of Work

100% • Performance Evaluation quarterly and annual during entire contract period of performance

Performance evaluation reflected on this element

Medical Technologist/ Clinical Lab Scientist Candidates

Candidates meet identified criteria for suitability

100% • Candidate submission packets by contractor

• Acceptance/approval by GPA Governing Body for Security Background Clearance

Performance evaluation reflected on this element at onset of award

Past Performance and Experience

Accepted contracted services with other Indian Health Services in Great Plains Area to show effective and efficient completion of clinical requirements as outlined in Statement of Work

50% Initial Annual Contract Performance Review of Past Performance and Final Performance Period

Performance evaluation reflected on this element

Quality of Care Activity

Consistent and Accurate laboratory testing, vendor records directly into RPMS & EHR medical records.

Clerical duties to include quality control documentation, equipment maintenance, phlebotomy, complete workload reports, electronic medical record documentation of visits and patient preparation instruction education.

100% Monthly/Quarterly review of:

• EHR Deficiency Reports

• Timeliness of EHR completion

Used for Internal Monitoring of Contract

Quality of Care Activity

Will Implement and monitor a full time quality Assurance and Quality Control program to meet regulation requirements of CMS, Joint Commission, or other accreditation bodies and submit to RSU Improvement Teams as outlined on page 6

- 9 of Statement Of Work. Quality Assurance program specific to laboratory requirements (environmental monitoring, preventative maintenance, quality control processes, etc) will be conducted by

100% Monthly review of the laboratory QA/QC program after concurrence by IHS Performance Improvement Team– conducted by the Laboratory Manager/ Supervisor

Will be provided to the Vendor upon request at any time.

Shall be provided to the Vendor if at any time benchmarks are

Performance evaluation reflected on this element

– May be used for rate reductions

Section C Solicitation No.: RFP-75H70624R00006

Laboratory Director on all technologists in the laboratory department.

not met as per documentation towards reductions in price determinations

Quality of Care Activity 3-

Deliverable #2

Review of complaints submitted by patients Vendor will create a satisfaction survey of their contract staff to assess:

a. How orientation/ training went

b. Feedback of quality of policy and procedure manual internal to lab for assisting them to complete the required job duties

c. Assessment of workload statistics

100% • Patient Satisfaction Surveys

Conducted by RSU QA Dept

• Staff Satisfaction

Surveys Conducted by the Vendor and submitted quarterly to COR II and Lab Manager/Supervisor

Performance evaluation reflected on this element

Pricing / Invoicing – Deliverable #3

Upon Completion of services – an invoice accounting will be provided to the government upon the agreed upon cycle for the duration of the contract

100% • Accuracy of Invoicing

• Review of Deliverables for evaluation of Rate/ Reductions

Performance evaluation

Section E Solicitation No.: RFP-75H70624R00006

SECTION E – INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

The COR, as a duly authorized representative of the Contracting Officer, is responsible for monitoring the Contractor’s performance, evaluating the quality of services provided by the Contractor, and performing final inspection and acceptance of all deliverables and services called for by the contract. The COR shall ensure that services provided by the contractor maintain the required levels of performance throughout the life of the contract.

E.2. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) -

The contractor will be evaluated in accordance with the following:

1. PURPOSE

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

• What will be monitored?

• How monitoring will take place.

• Who will conduct the monitoring?

• How monitoring efforts and results will be documented.

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

The QASP is incorporated by reference into the contract. The QASP is a “living document” and the Government, in its sole discretion, may review and revise it on a regular basis. Changes to the QASP will be affected by a unilateral contract modification. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (CO) – The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned CO: Valerie Heart Broker

Organization or Agency: Great Plains Area Indian Health Service, Aberdeen, South Dakota

b. Contracting Officer’s Representative (COR) – The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned COR: Janelle Byrne Organization or Agency: Rosebud Indian Health Service, Rosebud, South Dakota

3. CONTRACTOR REPRESENTATIVES

The following employee(s) of the contractor serve as the contractor’s program manager(s) for this contract.

Primary:

Alternate:

4. PERFORMANCE STANDARDS

The contractor is responsible for performance of ALL terms and conditions of the contract. CORs will provide contract progress reports quarterly to the CO reflecting performance on this plan and all other aspects of the resultant contract. The performance standards outlined in this QASP shall be used to determine the level of contractor performance in the elements defined. Performance standards define desired services. The Government performs surveillance to determine the level of Contractor performance to these standards.

The Performance Requirements are listed below in Section 5. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the standard and assign a rating. At the end of the performance period, these ratings will be used, in part, to establish the past performance of the contractor on the contract.

5. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

a. DIRECT OBSERVATION. Direct observation of the contractor’s performance by the Federal supervisor.

b. PERIODIC…