SHC Lab Service IFB OCMP-26-25349.pdf

Laboratory Services for Springfield Hospital Center

Solicitation #: OCMP-26-25349 IFB Document

IFB for Maryland Department of Health Page 1 of 34

STATE OF MARYLAND

MARYLAND DEPARTMENT OF HEALTH SPRINGFIELD HOSPITAL

CENTER

(MDH-SHC)

INVITATION FOR BIDS (IFB)

LABORATORY SERVICES FOR SPRINGFIELD HOSPITAL CENTER

IFB NUMBER 26-25349

ISSUE DATE: JULY 6, 2026

A Prospective Bidder that has received this document from a source other than eMarylandMarketplace

Advantage (eMMA) https://procurement.maryland.gov should register on eMMA https://emma.maryland.gov/

NOTICE TO BIDDERS

SMALL BUSINESS RESERVE PROCUREMENT

This is a Small Business Reserve Procurement for which the award will be limited to certified small businesses. Only businesses that meet the statutory requirements set forth in State Finance and

Procurement Article, §§14-501—14-505, Annotated Code of Maryland, and that are certified by the

Department of Social and Economic Mobility’s (DoSEM) Office of Small, Minority & Women

Business Affairs (OSBA) Small Business Reserve Program are eligible for award of a contract. Before awarding a contract under a procurement designated as a small business reserve procurement, the

Procurement Officer shall verify that the apparent awardee is certified by the OSBA as a certified small business through eMMA. However, if small businesses do not show interest in this solicitation, the Procurement Officer has the right to remove the SBR designation via an Amendment on eMMAMINORITY BUSINESS ENTERPRISES ARE ENCOURAGED TO RESPOND TO THIS

SOLICITATION.

https://procurement.maryland.gov/ https://emma.maryland.gov/ https://gomdsmallbiz.maryland.gov/Pages/sbr-program.aspx https://gomdsmallbiz.maryland.gov/Pages/sbr-program.aspx

IFB for Maryland Department of Health Page 2 of 34

KEY INFORMATION SUMMARY SHEET (KISS)

1. Invitation for

Bids

Services - Laboratory Services for Springfield Hospital Center

2. Solicitation

Number:

OCMP-26-25349

3. IFB Issue Date: July 6, 2026

4. IFB Issuing

Office:

Maryland Department of Health (MDH- or the “Department”)

5. Procurement

Officer:

Calvin T. Johnson

201 W. Preston Street, Baltimore, Md 21201

Email:

Phone Number:

calvin.johnson@maryland.gov

443-681-8694

6. Bids are to be sent to:

Submit on emma.maryland.gov under Solicitation Number 26-25349

To submit a bid, bidders must first register on emma.maryland.gov. We recommend registering in advance to become acquainted with the site.

7. No Bid Notice

Feedback Form

If you are not submitting a bid for this solicitation, submit Attachment

1 with your reasons why.

8. Pre-Bid

Conference:

Thursday, July 16, 2026

10:00 – 11:00am Local Time

Google Meet joining info

Video call link: https://meet.google.com/zjz-cavj-hik

Or dial: 4330-531-(US) +1 484 PIN: 569 393 511#

See Section 4.3 for additional details.

See Attachment 2 to RSVP by July 15, 2026

9. Scheduled Site

Visit N/A

10. Questions Due

Date and Time:

August 7, 2026; 2:00pm Local Time

IFB for Maryland Department of Health Page 3 of 34

11. Bid Due

(Closing) Date and Time:

August 17, 2026; 2:00pm Local Time

Bidders are reminded that a completed Feedback Form is requested if a no-bid decision is made (see Attachment 1 - No Bid Notice/Vendor

Feedback Form).

12. Public Bid

Opening Date, Time, and

Location

Monday, August 17 2026;

3:00 – 3:30pm Local Time

Google Meet joining info

Video call link: https://meet.google.com/uga-uuvc-vep

Or dial: 5852-893-(US) +1 914 PIN: 842 624 504#

13. MBE [[OR]]

DBE

Subcontracting

Goal:

An overall Minority Business Enterprise (MBE) or Disadvantaged

Business Enterprise (DBE) subcontract participation goal of __0___ percent of the total contract dollar amount, including all renewal option terms, if any, has been established for this procurement. The overall

MBE or DBE subcontract participation goal includes the following subgoals, which have been established for this procurement:

__0___% for African-American MBEs;

___0__% for Asian-American MBEs;

__0___% for Hispanic-American MBEs; and

_0____% for Woman-Owned MBEs.

N/A

14. VSBE

Subcontracting

Goal:

This solicitation includes a VSBE participation Goal of __0___%

N/A

15. Procurement

Method:

A Contract will be awarded in accordance with the Competitive Sealed

Bidding method under COMAR 21.05.02.

16. Multiple or

Alternate Bids:

Multiple or alternate Bids will not be accepted.

17. Contract Type: Indefinite quantity with fixed unit prices

18. Contract

Duration:

One (1) year base period with one (1) six-month option period.

IFB for Maryland Department of Health Page 4 of 34

19. Primary Place of

Performance:

Springfield Hospital Center

6655 Sykesville Rd

Sykesville, MD 21784

20. SBR

Designation:

Yes

21. Federal

Funding:

No

IFB for Maryland Department of Health Page 5 of 34

Table of Contents - IFB

1 Minimum Qualifications

1.1 Bidder Minimum Qualifications

2 Contractor Requirements: Scope of Work

2.1 Summary Statement

2.2 Background and Purpose

2.3 Contractor Responsibilities and Tasks

2.4 Supplemental Category of Work Requirements and Responsibilities

3 Standard Terms and Conditions

3.1 Contract Initiation Requirements

3.2 End of Contract Transition

3.3 Invoicing

3.4 Liquidated Damages

3.5 Work Orders

3.6 Payments by Electronic Funds Transfer

3.7 Prompt Payment Policy

3.8 Federal Funding Acknowledgement

3.9 Conflict of Interest Affidavit and Disclosure

3.10 Non-Disclosure Agreement

3.11 Maryland Healthy Working Families Act Requirements

3.12 The State of Maryland’s Commitment to Purchasing Environmentally Preferred Products and

Services (EPPs)

3.13 Insurance Requirements

3.14 Corrective Action Plan (CAP)

3.15 Nonvisual Access Compliance

4 Bid Submission Information and Instructions

4.1 eMaryland Marketplace Advantage (eMMA)

4.2 Electronic Means

4.3 Pre-Bid Conference

4.4 Questions

4.5 Bid Due (Closing) Date and Time

4.6 Receipt, Opening and Recording of Bids

4.7 Duration of Bids

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4.8 Revisions to the IFB

4.9 Cancellations

4.10 Incurred Expenses

4.11 Protest/Disputes

4.12 Bidder Responsibilities

4.13 Acceptance of Terms and Conditions

4.14 Compliance with Laws/Arrearages

4.15 Verification of Registration and Tax Payment

4.16 False Statements

4.17 Confidentiality of Bids / Public Information Act Notice

4.18 Use of Bidder’s Form Not Binding on State

4.19 Attachments and Documents Required with the Bid (Table A)

4.20 Bid Delivery Instructions

4.21 Bid Evaluation Criteria and Award Basis

4.22 Tie Bids

4.23 Reciprocal Preference

4.24 Documents Required upon Notice of Recommendation for Contract Award (Table B)

5 IFB Appendices and Exhibits

5.1 Appendices (Table C)

5.2 Exhibits (Table D)

6 Exhibit 2 Contract

IFB for Maryland Department of Health Page 7 of 34

1 Minimum Qualifications

1.1 Bidder Minimum Qualifications

The Bidder must document in its Bid that it satisfies the following Minimum Qualifications:

A. The Bidder must be Clinical Laboratory Improvement Act (CLIA) certified. Required

Documentation: The Bidder shall provide with its Bid a current (CLIA)-88 certification as issued by the Centers for Medicare & Medicaid Services for each laboratory it will use in providing services under this Contract.

B. Bidder will provide for each laboratory required licensures for laboratories it will use in providing services under this Contract. Required Documentation: The Bidder shall provide with its Bid the following:

1. Current Medical Laboratory License issued by the appropriate licensing entity within the state where the laboratory is located.

2. Current copy of license issued by the Maryland Department of Health, Office of

Healthcare Quality for laboratories located in Maryland.

C. Bidder will provide College of American Pathologists (CAP) certification and/or The Joint

Commission certificate for each laboratory it will use in providing services under the

Contract.

D. The Bidder must have at least three (3) years of experience within the past five (5) years providing laboratory services to companies, hospitals or organizations in a health-related field. Required Documentation: The Bidder shall provide with its Bid "Attachment L

Reference Checks" with two or more references filled out.

THE REMAINDER OF THIS PAGE IS INTENTIONALLY LEFT BLANK.

IFB for Maryland Department of Health Page 8 of 34

2 Contractor Requirements: Scope of Work

2.1 Summary Statement

2.1.1 This Invitation for Bids (IFB) is issued to procure the goods or services, as specified in this Section 2, from a contract between the successful bidder(s) and the State of Maryland

(“State”): The successful bidder will provide laboratory services to patients at Springfield

Hospital Center (SHC), a Maryland Department of Health (MDH) Healthcare System

Facility.

2.1.2 It is the State’s intention to obtain goods and services, as specified in this IFB, from a contract between the selected Bidder and the State.

2.1.3 This is a single award IFB See IFB Section 4.21 Bid Evaluation Criteria and Award

Basis for more Contract award information.

2.1.4 A Contract award does not ensure a Contractor will receive all or any State business under the Contract.

2.2 Background and Purpose

Springfield Hospital Center (SHC), located in Sykesville, MD, is a regional psychiatric hospital operated by the State of Maryland, Maryland Department of Health. SHC is accredited by the Joint

Commission and provides a wide range of clinical services for the treatment of persons with mental illness. The State is issuing this solicitation for propose of providing laboratory services for SHC.

2.2.1 Project Goals

A. Provide timely diagnostic and laboratory testing as required.

B. Return tests results within a reasonable time frame, as established elsewhere in this solicitation.

C. Minimize retesting.

2.2.2 State Staff and Roles

The State will provide a Procurement Officer and Contract Monitor.

2.2.3 Other State Responsibilities

A. The State will provide normal office working facilities and equipment reasonably necessary for Contractor performance under the Contract.

B. Any special requirements (e.g., reprographic services, computer time, key data entry) shall be identified by the Contractor and submitted with the Bid documents. The special requirements will be reviewed during the contract award and MDH Data

Agreement review processes.

C. The State is responsible for providing required information, data, documentation, and test data to facilitate the Contractor’s performance of the work and will provide such additional assistance and services as is specifically set forth.

2.3 Contractor Responsibilities and Tasks

2.3.1 Comprehensive Lab Services

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The Contractor shall:

A. The Contractor shall provide or arrange for the provision of a comprehensive array of laboratory services for the patients of SHC including, but not limited to:

1. Individual routine and STAT tests (See Appendix 1 Abbreviations and Definitions);

reporting of test results within prescribed time frames;

2. Monday - Friday (Business Days as defined in Appendix 1 Abbreviations and

Definitions) pick-up of all individual routine laboratory specimens and seven (7) days per week for STAT tests;

3. Laboratory supplies and materials necessary to carry out the requirements of the

Contract;

4. Specimen preparation equipment and laboratory equipment.

B. Laboratory Information and Services Standards

1. Each Bidder shall submit as part of its Bid a list of the scheduled hours of operation of each laboratory site that will be involved in any way in the performance of this

Contract and a brief description of the nature of that involvement (i.e., routine pick-ups might be handled by one site and non-routine pick-ups occurring on evenings or weekends might be handled by a different site).

2. For each laboratory site required to be listed each Bidder shall provide the name, address, and contact number(s) of the laboratory.

3. The Contractor shall keep all such information current throughout the duration of the

Contract and notify the Contract Monitor of any changes to the contact information for each laboratory site providing services under the Contract.

4. The Contractor shall provide laboratory services in accordance with all applicable licensure, certification, and accreditation standards of:

1. State of Maryland, Maryland Department of Health Clinical Laboratory

Improvements Act of 1988 (CLIA-88) as required by the Centers for

Medicare & Medicaid Services;

2. All applicable existing and pending federal licenses; and

3. Any state or jurisdiction other than Maryland where any laboratory testing covered by this Contract is performed.

C. Requests for Specimen Pick-up and Testing

1. Routine Requests for Specimen Pick-up and Testing

The Contractor shall provide regular pick-up for laboratory specimens for all routine tests at SHC’s specimen collection station. The scheduled pick-up shall be no earlier than noon and no later than 2:30 p.m. on Business Days (Monday through Friday, 7:00 a.m. - 3:30 p.m. excluding State recognized holidays). The specimens shall be transported to the Contractor's laboratory for testing after being picked up from

SHC. Specimens shall be delivered to the testing laboratory site in such manner as to ensure the integrity of the specimen chain-of-custody, the viability of the specimen for the requested testing and compliance with the testing timeframes listed in

Section 2.3.J. A list of State holidays can be found at www.dbm.maryland.gov -keyword: State Holidays.

IFB for Maryland Department of Health Page 10 of 34

2. STAT Requests for Specimen Pick-up and Testing

1. The Contractor shall provide on-call STAT coverage to SHC 24 hours per day including weekdays, weekends, and holidays. The Contractor must pick up and report a test by the time specified for each STAT test result from the time SHC notifies the Contractor.

2. A separate flat rate charge per STAT call/pick-up shall be billed at the STAT test fee price indicated on the Bid Form.

3. As indicated on the Price Form, the number of STAT tests varies widely from a low of one (1) to a high of over 100 annually.

D. Lab Test Panels

Descriptions of the laboratory test panels utilized by SHC are outlined below. SHC utilize these test panels to request a comprehensive array of individual tests for patients.

Admissions Panel

Comprehensive Metabolic Panel (CMP)

CBC w/Differential Platelets & ANC

Hemoglobin A1C

Lipid Panel

Rapid Plasma Reagin (RPR) w/Reflex

Thyroid Stimulating Hormone (TSH w/Free

T4 Reflex)

Annual Panel

Comprehensive Metabolic Panel (CMP)

CBC with Differential & Platelets & ANC

Hemoglobin A1C

Lipid Panel

Thyroid Stimulating Hormone (TSH w/Free

T4 Reflex)

Anemia Profile

CBC w/Differential Platelets

Ferritin

Folate

Iron

Reticulocyte Count

TIBC

Vitamin B12

Basic Metabolic Panel

BUN/Creatinine Ratio

Calcium

Carbon Dioxide (CO2)

Chloride

Creatinine

Glucose

Sodium

Potassium

Urea Nitrogen (BUN)

Bilirubin Panel

Bilirubin Total

Bilirubin, Direct and Indirect

Comprehensive Metabolic Panel

(CMP)

Alanine Aminotransferase (ALT)

Albumin

Albumin/Globulin Ratio

Alkaline Phosphatase (ALP)

Aspartate Aminotransferase (AST)

Bilirubin, Total

BUN/Creatinine Ratio Calcium

Calcium

Carbon Dioxide (CO2)

Chloride

Creatinine

Globulin

Glucose

Potassium

Protein, Total

Sodium

Urea Nitrogen (BUN)

CBC with Differential

WBC MCB

RBC McH

HgB MCHC

HCT RDW

Absolute Neutrophil (ANC)

Drug Screen Panel

Amphetamines

Barbiturates

Benzodiazepines

Cannabinoids

Cocaine Metabolite

Ethyl Alcohol

Methadone

Opiates

Phencyclidine

Electrolyte Panel

Carbon Dioxide (CO2)

Chloride

Potassium

Sodium

Hepatic Function Panel (Liver Function)

Albumin

Albumin/Globulin Ratio

Alkaline Phosphatase (ALP)

Aspartate Aminotransferase (AST)

Alanine Aminotransferase (ALT)

Bilirubin, Total

Globulin

Protein, Total

Lipid Panel

Cholesterol HDL Cholesterol

Cholesterol/HDL Ratio LDL Cholesterol

Triglycerides

Thyroid Panel

T3 Update

T4 Total

T7 Free Thyroxine Index

E. Laboratory Test Results

The Contractor shall perform all tests and report all test results to SHC in accordance with the requirements of the Contract. A chart indicating the required time frames for routine and

STAT tests is provided in Section 2.3.J. The results of all applicable STAT tests shall be reported to SHC within four (4) hours from the time SHC notifies the Contractor that a

STAT test has been ordered.

1. The Contractor shall transmit all routine laboratory results to SHC’s Laboratory

Services via secure internet connection in a format that can be downloaded into an easily readable format so that the user can print them out.

2. The Contractors shall telephone the results of all tests ordered on a STAT basis to a telephone number specified by the SHC and fax or e-mail a copy of the laboratory results to the telephone number(s) or e-mail address specified by SHC.

3. All laboratory procedures will be performed in a timely and quality-assured manner.

4. When SHC begins using an Electronic Health Record (EHR), the Contractor shall construct an interface within ninety (90) days that allows for the direct transmission of all ROUTINE and STAT laboratory results to SHC's EHR within the time requirements listed in the Time Requirements table in Section 2.3.1.F.

5. The listed time requirements contained in Section 2.3.1.F may be revised by SHC with updated requirements provided to the Contractor, as necessary, based on current technology and standards of practice.

F. Time Requirements for Completing and Reporting Tests

Time Requirements

MAXIMUM TIME FOR

REPORTING TEST

RESULTS FROM TIME

NOTIFICATION WAS

MADE BY SHC TO

CONTRACTOR

PROCEDURE NAME ROUTINE STAT

Admission Panel 24 hours N/A

Annual Panel 24 hours N/A

Basic Metabolic Panel 24 hours 4 hours

Comprehensive Metabolic Panel 24 hours 4 hours

Drug Screen Panel 24 hours N/A

Hepatic Function Panel (Liver Profile) 24 hours 4 hours

Iron Panel 24 hours N/A

Lipid Panel 24 hours N/A

PT and PTT 24 hours 4 hours

ACTH 5 days N/A

Aluminum 24-48 hours N/A

Alpha-Fetoprotein (AFP) Tumor Marker 48 hours N/A

Amitriptyline and Nortriptyline 48 hours N/A

Ammonia, Plasma 72 hours N/A

Amylase, Serum 24 hours 4 hours

Anti-Nuclear Antibody (ANA) w/RFX, Serum

24 hours

(preliminary) 48 hours (final)

N/A

Calcium, 24-hour Urine 24 hours N/A

Carbarn azepine, Serum 24 hours 4 hours

CBC w/Differential & Platelet & ANC 24 hours 4 hours

Carcinoembryonic Antigen (CEA), Serum 24 hours N/A

Creatine Kinase (CK), Total, Serum 24 hours 4 hours

CRP (C reactive protein) 24 hours N/A

Creatine Kinase (CK) Total, with isoenzymes 72 hours N/A

Clozapine Level 5 days N/A

Creatinine, Random Urine 24 hours N/A

Cortisol 24 hours N/A

D-DimerQN 24 hours N/A

Digoxin 24 hours 4 hours

Erythrocyte Sedimentation Rate (ESR), Westergren 24 hours 4 hours

Ferritin 24 hours N/A

Folate, Serum (Folic Acid) 48 hours N/A

Follicle Stimulating Hormone (FSH), Serum 72 hours N/A

Glucose, Fasting, Serum 24 hours 4 hours hCG, (Human Chorionic Gonadotropin), Total, Qualitative, Serum 24 hours 4 hours hCG, (Human Chorionic Gonadotropin), Total, Qualitative, Urine 24 hours 4 hours

Haptoglobin 24 hours N/A

IFB for Maryland Department of Health Page 3 of 34

Hemoglobin AIC, Blood 24 hours N/A

Hemoglobin/Hematocrit (Hgb/HCT) 24 hours 4 hours

HBV DNA QN PCR w/Rflx 14 days N/A

HCV DNA QN PCR w/Rflx 5 days N/A

Hepatitis C, RNA Quant/Qualitative 7 days N/A

Hepatitis C, Genotyping 7 days N/A

HIV, Genotyping 7 days N/A

Human Papillomavirus (HPV) 7 days N/A

INR 24 hours 4 hours

Influenza 24 hours 4 hours

Lead 5 days N/A

Levetiracetam (Keppra) 24 hours N/A

Liver Fibrosis Test (Fibro sure) 7 days N/A

Luteinizing Hormone (LH), Serum 24 hours N/A

Lipase, Serum 24 hours 4 hours

Lithium, Serum 24 hours 4 hours

MRSA 24 hours N/A

Magnesium, Serum 24 hours 4 hours

Microalbumin, Random, Urine 24 hours N/A

Myoglobin 24 hours N/A

Nortriptyline 24 hours N/A

O&P Giardia Ag I Soec 4 days N/A

Osmolality, Serum 24 hours N/A

Osmolality, Urine 24 hours N/A

Oxcarbazepine (Trileotol) 72 hours N/A

PTH Parathyroid Hormone 24 hours N/A

PAP Smear Thin-Prep w/Reflex HPV 7 days N/A

Phenobarbital 24 hours 4 hours

Phenytoin (Dilantin), Serum 24 hours 4 hours

Phosphate (as Phosphorus), Serum 24 hours 4 hours

Prolactin, Serum 24 hours N/A

Protein, Electrophoresis, Serum 48 hours N/A

Prothrombin Time (PT), (INR), Blood 24 hours 4 hours

Prostate Specific Antigen (PSA Total) 24 hours N/A

Activated Partial Thromboplastin Time (aPTT), Plasma 24 hours 4 hours

QuantiFERON TB Gold 24 hours N/A

Reticulocyte Count, Blood 24 hours 4 hours

Rheumatoid Factor, Serum 24 hours N/A

T3 Total, Serum 24 hours N/A

T4, Free, Serum (Non-Dialysis) 24 hours N/A

T4 (Thyroxine), Total, Scrum 24 hours N/A

Testosterone, Total, Serum 24 hours N/A

Thyroid Peroxidase Antibody 48 hours N/A

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Thyroid Stimulating Hormone (TSH), with Free T4 Reflex, Serum 24 hours N/A

Troponin 24 hours N/A

Uric Acid 24 hours 4 hours

Urinalysis with Microscopv 24 hours 4 hours

24-Hour Urines 48 hours N/A

Urine Cultures (C & S) 72 hours N/A

Valproic Acid, Scrum 24 hours 4 hours

Vancomycin 24 hours 4 hours

Vitamin B-12 and Folate, Serum 72 hours N/A

Vitamin D 25 – Hydroxy 72 hours N/A

G. Critical/Panic Values

1. No later than two weeks before the Go-Live Date, SHC will provide the Contractor with the Department's approved listing of tests/values which may differ from the

Contractor's listing of critical/panic values submitted as part of its Bid. SHC’s

Contract Monitor shall approve the listing of Contractor's values, modifying as appropriate any values of the Contractor for tests based on the Department's approved listing of tests/values. The Contractor must use the modified values for any tests provided under this Contract.

2. The results of all tests deemed critical/panic values by the Contractor, as well as all

STAT orders, shall be telephoned to a telephone number specified by SHC, with a copy of the laboratory results being faxed or emailed to the telephone number(s), email addresses, or sent via other electronic methods specified by SHC.

critical/panic values shall be reported 24 hours a day as soon as known, but not later than one (1) hour after a critical/panic value for a test result is known by the

Contractor.

H. Retesting (Without Cost)

If the original test result appears to be inconsistent with the clinical evaluation of the patient, SHC may request a retest to verify the accuracy of the original test result. The Contractor shall perform such retests at no cost to the State. In the event that SHC determines that the number of retests by the Contractor is excessive compared to the standard margin of error in maintaining quality controls, according to CLIA-88, the Contract Monitor will immediately notify the Contractor. The Contract Monitor will provide the Contractor all necessary documentation requested in order to justify and explain the need for retesting. If such problems cannot be resolved to SHC’s satisfaction, this situation will be referred to the

Procurement Officer. If the Procurement Officer deems it appropriate, the Contract can be terminated for default in accordance with Exhibit 2 Sample Contract, Section 17.

I. Laboratory Supplies/Materials

1. The Contractor shall provide all supplies/materials necessary to carry out the

Contract requirements, that at a minimum will include all supplies/materials proposed in its Bid. The Contractor shall also implement its plan as also proposed in its Bid to prevent depletion of any of its required supplies/materials throughout the

Contract. All supplies/materials shall meet current Occupational Safety and Health

Administration (OSHA) requirements. These supplies/materials include, but are not

IFB for Maryland Department of Health Page 5 of 34 limited to, centrifuge, urine containers, blood collection tubes with hemo-gard tops

(plastic tubes when available), serum separator tubes, lead-free "vacutainer" tubes, toxicology "vacutainer" tubes, pap smear supplies, culture tubes and media, stool containers, needles, glucose beverage, and miscellaneous supplies (i.e., baggies and pre-printed request slips).

2. The Contractor shall coordinate at least monthly with the Contract Monitor to assure that an adequate inventory of supplies/materials is maintained at all times. The

Contractor shall maintain the inventory of supplies/materials to the satisfaction of the Contract Monitor to permit completion of all required tests.

J. Laboratory Test Request Forms

1. The Contractor shall provide electronic and hard copy forms (for use in emergency situations if the electronic form is not available) for use by SHC when ordering tests.

The laboratory test request forms, both electronic and hard copy, shall include the following pertinent patient and specimen information, at a minimum:

Patient’s Full Name (Last, First);

Patient's Medical Record Number;

Date of Birth;

Ordering Physician's Name & NPI Number;

Specimen Information: Date collected/ Time collected Phlebotomist Name or Initials

Test(s) to be ordered;

ICD-10 code (in the event that the code changes, Contractor must notify Contract

Monitor as soon as possible but in no event later than one (1) Business Day after the

Contractor receives notice of the changed code); and

SHC’s address and telephone number: 6655 Sykesville Rd, ATTN: Lab Services

Sykesville, MD 21748

SHC Phone Number: 410-970-7115

2. As required, the Contractor shall permit direct ordering of all routine and STAT laboratory requests directly from SHC’s installed EHR.

K. Specimen Collection Reference Manuals

1. Within five (5) days after Contract Commencement, the Contractor shall submit copies of its specimen collection reference manual submitted with its Bid as follows:

For SHC’s Laboratory Services: 1 manual;

One manual for each unit/ALP Treatment Rooms- 12 manuals;

For the Nursing Supervisor's Office: 1 manual;

For the Contract Monitor: 1 manual; and

2. Manuals shall be kept current. The Contractor shall provide ongoing updates to the manuals as warranted by changes in the procedures for specimen collection and/or the availability of tests.

3. Not more than three (3) months after the Go-Live Date and at 3-month intervals thereafter for the duration of the Contract, the Contractor shall either provide all needed updates or a written affirmation to the Contract Monitor that its manual is current.

L. Specimen Preparation Centrifuge and Other Possible Equipment

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1. No less than five (5) days before the Go-Live Date, the Contractor shall provide to

SHC a centrifuge with a capacity to process 50 specimens per day to be kept on-site and used by SHC staff.

2. If deemed appropriate by the Contractor Account Representative and the Contract

Monitor, the Contractor shall also provide additional equipment to SHC to prepare specimens for better and/or faster testing. Any non-centrifuge Contractor-provided equipment may be provided either prior to the Contract Go-Live Date or any time thereafter.

3. The Contractor shall maintain the centrifuge and any other provided specimen preparation equipment in working order, provide routine preventive maintenance, and ensure that copies of all preventive maintenance reports are provided to the

Contract Monitor.

4. For the centrifuge and any other equipment to be installed as of the beginning of the

Contract, the Contractor shall inspect and test the equipment prior to placement at

SHC before the start of the Contract.

5. Approximately six (6) months after the Go-Live Date and at approximately six (6) month intervals thereafter for the duration of the Contract, the Contractor shall inspect, and test all provided equipment and provide a copy of the results of the inspection and testing to the Contract Monitor within five (5) days of the inspection/testing.

6. The Contractor shall replace any nonfunctioning or malfunctioning equipment within one (1) Business Day of becoming aware of the nonfunctioning or malfunctioning equipment, either through inspection/testing or notification by SHC.

7. All Contractor-provided equipment will be returned at the conclusion of the

Contract. However, if the Contractor is selected to perform a follow-up contract, at the option of the Department, some or all of the existing equipment may be retained for use under the new contract.

M. Computerized Laboratory Test Requests & Results

1. The Contractor shall provide for use by SHC the equipment and software required to transmit and receive test requests and results in order to carry out the requirements of the Contract (i.e., printer, modem line, fax, or secure internet site access) as outlined in its Bid, and ensure that all necessary equipment is installed, in service, and instruction provided to the SHC no less than five (5) days prior to the Go-Live

Date. The Contractor shall implement, as described in its Bid, its plan for how test requests are transmitted and received as well as its Bid-described backup plan should the computer equipment fail to transmit or receive test requests and results either at the SHC or the Contractor's site.

2. The Contractor shall make any necessary equipment changes (within the scope of the Contract) throughout the Contract duration and provide any associated training for the use of the installed equipment to SHC staff.

3. The Contractor's computerized laboratory equipment shall permit approved SHC staff to obtain and/or perform the following at will:

1. Laboratory Services Staff:

Enter daily requests for patient laboratory testing;

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Enter/delete/change SHC physician names;

Print a daily (or as needed by date) accession log of all tests requested, sorted alphabetically by patient last name;

Review and print individual patient profiles: monthly and/or annually;

Review individual test results; and

Review cumulative test results.

2. Clinical Staff (read-only access, as needed, for the purpose of):

Reviewing individual patient profiles;

Reviewing individual test results; and

Reviewing cumulative test results.

N. Quality Assurance Program

1. As a condition of SHC’s accreditation by The Joint Commission, it is necessary for the Contractor for the duration of the Contract to have a quality assurance (QA) program that meets the requirements of CLIA-88. The Contractor shall implement its QA program, as described in its Bid.

2. The Contractor's QA Program shall address how quality assurance is continuously monitored and maintained in relation to national standards and standards established in accordance with the Contractor's licensure and certification.

O. Training

1. The Contractor shall implement its proposed training as described in its Bid. The

Contractor shall provide ongoing training in the collection and preparation of specimens to identified staff at SHC in accordance with the Contractor's QA

Program. The Contractor shall also notify the Contract Monitor of any significant changes in laboratory procedures, supplies, and equipment and provide ongoing training and in-service.

2. The Contractor shall also provide a one-hour training or longer as needed, session on basic operational procedures for a maximum of five (5) laboratory staff on-site at

SHC within two (2) Business Days of a request for such training during the first ninety (90) days of the Contract. After the first ninety (90) days have been completed, the Contractor shall conduct training at least once in each Contract year, typically within two (2) weeks before or after each anniversary date of the Go Live

Date at a time directed by the Contract Monitor with due consideration of the preferences of the Contractor, and on other occasions (i.e., system changes, and issues identified during the quality assurance process) as deemed necessary by the

Contract Monitor.

P. Technical Assistance/Support and Inspections/Surveys

1. The Contractor shall be available to SHC staff during Normal Hospital Business

Hours for consultation pertaining to technical support and laboratory testing results, as needed.

2. Additionally, the Contractor shall be available, if needed, during inspections of SHC

(i.e., the Joint Commission survey to provide needed assistance concerning the performance of testing and reporting of laboratory values).

3. The Contractor shall make available the list of contacts provided as part of its Bid available for technical support and laboratory testing. The Contractor shall ensure

IFB for Maryland Department of Health Page 8 of 34 that its list of contacts remains current during the Contract, including contact information (name, title, phone, fax, and email) for administrative, operational, clinical, technical, and other specialists needed to provide the necessary labor, materials, vehicles, equipment and supervision for laboratory services at SHC.

Q. Meetings

1. The Contractor shall designate an account representative (Contractor's Account

Representative) who shall meet with SHC quarterly at SHC or virtually to discuss the services performed and provided under this Contract. Meetings will be scheduled at a date and time mutually agreeable to both parties. In the event that either party cannot attend a scheduled meeting, another date/time during that month will be scheduled at the time of the cancellation. The scheduling of meetings will be handled by the Facility Contractor Administrator.

2. Meeting minutes of the quarterly meetings referenced above will be recorded by the

Contract Monitor, and copies distributed to the Contractor. The Contractor will have seven (7) calendar days to respond to the minutes.

R. Performance Review

1. These IFB specifications and the Contract will form the basis of the performance review as a means of quality control and quality assurance to determine the degree of Contractor compliance and level of performance satisfaction. Examples of unacceptable performance include but are not limited to:

Recurring errors in test results;

Inaccurate or incomplete reporting;

Uncorrected equipment failure;

Inconsistency in pick-up times for routine test specimens;

Untimely reporting of routine test results;

Inaccessibility for STAT orders;

Untimely pick-up or completion of STAT orders; and

Failure to report critical/panic values.

2. Incidents of unacceptable performance will be documented by the Contract Monitor with a copy to the Procurement Officer and the Contractor's Account Representative.

Upon receipt of documentation of an incident of unacceptable performance, the

Contractor shall submit a plan of correction identifying the timeframe for completion to the Contract Monitor within five (5) days for review and approval.

The Contract Monitor will approve or reject the plan within one (1) Business Day.

The Contractor shall make any changes requested by the Contract Monitor to the plan of correction within two (2) Business Days and resubmit.

3. If an incident of unacceptable performance is life-threatening or has the potential to cause severe personal harm, the Contractor shall initiate corrective action, as directed by the Contract Monitor, on a priority basis to ensure that the threat to life or severe personal harm is alleviated within the shortest time practical, but no longer than 2 hours.

4. When the Contractor is notified by the Contract Monitor of an incident or unacceptable performance of this nature, the Contractor shall inform the Contract

Monitor of what it will do to prevent a recurrence of the incident or unacceptable performance and the time frame to implement this action.

IFB for Maryland Department of Health Page 9 of 34

5. If the Contract Monitor does not believe the proposed corrective action is adequate to prevent another such occasion or will take too long to implement, the Contract

Monitor will inform the Contractor that the proposed action is rejected. Within two

(2) calendar days of the Contract Monitor's rejection of the Contractor's proposed corrective action plan, the Contractor shall submit a revised plan to the Contract

Monitor to alleviate the situation.

6. Continuing failure to satisfactorily respond in the time frames required in accordance with this section, more than one (1) incident of unacceptable performance that is life-threatening or with the potential to cause severe personal harm, or more than a total of three (3) situations involving unacceptable performance during a twelve (12) month period may be viewed as grounds for termination of the Contract in accordance with Exhibit 2 Sample Contract, Section

17.

S. Pricing

1. Pricing for the Contract shall be in accordance with the attached Bid Form

(Attachment B). All tests listed on the Bid Form for which Bid prices are to be provided, shall be identified as Tier One Tests (See Appendix 1 Abbreviations and

Definitions of all Tier Tests). Tier One Test prices shall be firm fixed prices - not subject to change or adjustment - for the term of the Contract and any option period(s).

2. In addition to the Tier One Test prices listed on the Bid Form for the individual test procedures, the Bidders shall provide as part of their Bid their complete current

Laboratory Test Schedule, when their Bid is submitted. (See Sections 4.19).

3. Within five (5) Business Days of being notified that it is being selected for Contract award, the selected Bidder must inform the Contract Monitor in writing of up to ten

(10) non-Tier One Tests contained in its Laboratory Test Schedule that it wants categorized as Tier Three Tests, and its rationale for each requested categorization.

The Contract Monitor will either approve the up to ten (10) requested Tier Three

Tests, request more justification for one or more of the requested tests, or reject one or more of the requested Tier Three Tests as not fitting the definition of being rare and volatile in price or some other factor(s). If a test is rejected by the Contract

Monitor as not being appropriate to be categorized as a Tier Three Test, the

Contractor may substitute another test for the Tier Three Test designation until either the maximum of ten (10) tests is reached or it is agreed that fewer than ten

(10) tests satisfy the Tier Three Test definition.

4. All tests contained on the Laboratory Test Schedule that are not on the Bid Form

(not Tier One Tests) or identified by the Contractor and approved by the Contract

Monitor as a Tier Three Test, will become Tier Two Tests.

5. When the Contractor submits its request for the designation of Tier Three Tests within five (5) Business Days of being notified of recommendation for award - it should also provide the Contract Monitor with reasonable justification that the Tier

Two Prices contained in its submitted Laboratory Test Schedule are its routine prices for these tests. Such justification might be in the form of a widely circulated official price list, a screen shot of pricing on a public web site of the Contractor, or copies of invoices to customers showing these prices. The Contract Monitor can

IFB for Maryland Department of Health Page 10 of 34 request additional justification for the purported price of any test determined to be a

Tier Two Test.

6. The prices paid by SHC for any Tier Two Test will be 65% of the Contractor's

Laboratory Test Schedule routine price, as accepted by the Contract Monitor. This

65% of the Contract Monitor-accepted Laboratory Test Schedule price will then become a firm-fixed price that shall apply for the duration of the Contract and any option period(s).

7. The prices entered on the Bid Form are the only charges that may be billed to SHC.

All other costs, such as those listed below, must be factored into the price of the individual test procedures. The listing below is not intended to be an all-inclusive listing of the items needed to perform the required services, but rather examples of the sorts of costs that are to be factored into the price of the individual test procedures and the total Bid:

The means to receive test requests and transmit test results, including interfacing with any EHR system;

Performing retests;

All supplies such as urine bottles, serum vials, lead free vacutainer tubes, toxicology vacutainer tubes;

Specimen/Test Request forms;

Specimen collection reference manuals;

Centrifuges;

An acceptable continuous quality improvement program;

Required training;

Technical assistance/support and attending inspections/surveys; and

Attendance at required meetings.

8. Within 30 days of a new test being available from the Contractor or if a test is deleted or replaced, a revised Laboratory Test Schedule is to be submitted to the

Contract Monitor. The update shall note any test deleted or replaced and include only the name and price of any new test. The Contractor shall not change prices for any test listed on the initial or previously updated version of the Laboratory Test

Schedule. Upon submissions of a revised Laboratory Test Schedule with one or more new tests and associated routine price(s), the 65% price level will be calculated and will then become a firm fixed price for this/these new test(s) for the reminder of the Contract term and any option period(s).

T. Reporting

1. Monthly, within 15 days after the end of the preceding month, the Contractor shall provide SHC with a report summarizing the number of tests performed during the previous month. The individualized report shall include the following information:

The number and type of each routine test performed, The number and type of STAT tests performed, and

The number of retests required due to critical high and/or low laboratory results.

2. Annually, within 15 days before or after the anniversary of the Go-Live Date, the

Contractor shall provide to SHC a comprehensive individualized report summarizing the number of tests performed during the Contract year. The comprehensive annual report shall include the following information:

The number and type of each routine test perfom1ed performed; and

The number and type of STAT tests performed.

IFB for Maryland Department of Health Page 11 of 34

3. The Contractor shall provide the Contract Monitor, within 21 days from the end of the quarter, quarterly reports of patient profiles. These reports shall outline the specific test(s) performed and the individual results of those tests for each patient.

U. Documentation

All written correspondence to SHC shall be on Contractor letterhead and signed by the

Contractor's Account Representative, previously identified designee, or an identified officer of the Contractor.

V. Corrective Action Plan (CAP)

1. MDH may issue a request for a Corrective Action Plan (CAP) to address Contractor performance issues. If any Contractor requirements as described in the IFB or

Contract are not satisfactorily performed, in the determination of the Contract

Monitor, the Contractor shall submit a Corrective Action Plan (CAP) upon request, describing all actions it will take to ensure that the impacted requirements will be satisfied thereafter. This CAP must be submitted to the Contract Monitor for approval within five (5) days of the Contract Monitor's written request identifying such deficiencies.

2. The Contractor shall include the following in the CAP:

Background information;

Problem definition statement;

Findings and root cause description;

Corrective actions; and

Corrective action implementation dates

3. If the Contract Monitor is not satisfied that the Contractor’s proposed Corrective

Action Plan will prevent a recurrence of the deficiency(ies), the Contract Monitor will notify the Contractor and require a revised CAP. The revised CAP must be submitted to the Contract Monitor within three (3) days of the Contract Monitor’s rejection of the previous CAP.

2.4 Supplemental Category of Work Requirements and Responsibilities

2.4.1 Security Requirements

The following requirements are applicable to the Contract:

2.4.1.1 Employee Identification

A. Contractor Personnel shall display his or her company ID badge in a visible location at all times while on State premises. Upon request of authorized State personnel, each Contractor Personnel shall provide additional photo identification.

B. Contractor Personnel shall cooperate with State site requirements, including but not limited to, being prepared to be escorted at all times, and providing information for State badge issuance.

C. Contractor shall remove any Contractor Personnel from working on the Contract where the State determines, in its sole discretion, that Contractor Personnel has not adhered to the Security requirements specified herein.

D. The State reserves the right to request that the Contractor submit proof of employment authorization of non-United States Citizens, prior to commencement of work under the Contract.

IFB for Maryland Department of Health Page 12 of 34

2.4.1.2 Security Clearance / Criminal Background Check

The State reserves the right to refuse any individual Contractor Personnel to work on State premises, based upon certain specified criminal convictions, as specified by the State.

A criminal background check is not required for Contractor Personnel.

A security clearance is not required for Contractor Personnel.

A. .

2.4.1.3 On-Site Security Requirement(s)

a) For the conditions noted below, Contractor Personnel may be barred from entrance or leaving any site until such time that the State’s conditions and queries are satisfied.

1) Contractor Personnel may be subject to random security checks when entering and leaving State secured areas and may be barred from entrance or exit until such time that the State’s conditions and queries are satisfied. The State reserves the right to require Contractor Personnel to be accompanied while in secured premises.

2) Some State sites, especially those premises of the Department of Public Safety and

Correctional Services, require each person entering the premises to document and inventory items (such as tools and equipment) brought onto the site, and to submit to a physical search of his or her person. Therefore, Contractor Personnel shall always have an inventory of tools being brought onto a site and be prepared to present the inventory, as well as the tools or equipment, to the State staff or an officer for review and inspection. Before leaving the site, the Contractor Personnel may again be required to present the inventory list and the tools or equipment for inspection. Upon both entering and exiting the site, State staff or a correctional or police officer may search Contractor Personnel. Depending upon facility rules, specific tools or personal items may be prohibited from being brought into the facility.

b) Any Contractor Personnel who enters the premises of a facility under the jurisdiction of the

Department may be searched, fingerprinted (for the purpose of a criminal history background check), photographed and required to wear an identification card issued by the Department

c) Further, Contractor Personnel shall not violate Md. Code Ann., Criminal Law Art. Section 9-410 through 9-417 and such other security policies of the agency that control the facility to which the

Contractor Personnel seeks access. The failure of any of the Contractor Personnel to comply with any provision of the Contract is sufficient grounds for the State to immediately terminate the Contract for default.

2.4.2 Department of Human Services (DHS) Hiring Agreement

This solicitation does not require a DHS Hiring Agreement.

2.4.3 Substitution of Personnel

THIS SECTION IS INAPPLICABLE TO THIS IFB.

2.4.4 Location of the Performance of Services Disclosure

IFB for Maryland Department of Health Page 13 of 34

This solicitation does not require a Location of the Performance of Services Disclosure.

2.4.5 HIPAA - Business Associate Agreement

In the event the State determines that the functions to be performed in accordance with this solicitation constitute Business Associate functions as defined in the Health Insurance

Portability and Accountability Act of 1996 (HIPAA), the recommended awardee shall execute a Business Associate Agreement as required by HIPAA regulations at 45 C.F.R.

§164.500 et seq. and set forth in Attachment S. This Agreement must be provided within five (5) Business Days of notification of proposed Contract award. However, to expedite processing, it is suggested that this document be completed and submitted with the

Bid/Proposals. Should the Business Associate Agreement not be submitted upon expiration of the five (5) Business Day period as required by this solicitation, the Procurement

Officer, upon review of the Office of the Attorney General and approval of the Secretary, may withdraw the recommendation for award and make the award to the responsible

Bidder with the next highest overall-ranked Bid/Proposal.

2.4.6 Data Ownership and Access Data Use Agreement (if applicable)

The use, access, and distribution of all data shall comply with the requirements of the

Data Use Agrrement (Attachment Y).

As set forth in the Contract, data, databases and derived data products created, collected, manipulated, or

IFB for Maryland Department of Health Page 14 of 34

3 Standard Terms and Conditions

3.1 Contract Initiation Requirements

Once all approvals have been obtained and the Contract is fully executed, the Procurement Officer may schedule a kickoff meeting to be held prior to commencement of Contract performance.

3.2 End of Contract Transition

The Contractor shall cooperate in the orderly transition of services from it to a subsequent contractor at the end of the contract term or upon receipt of a Notice of Termination from the State. Transition shall be provided in a prompt and timely manner and shall proceed in accordance with the schedule provided to the Contractor by the State in the Notice of Transition. Additional instructions regarding transition services may be provided in the event of a Notice of Termination issued by the State.

3.3 Invoicing

Submission of an invoice constitutes the Contractor’s verification that the information in the invoice is accurate as of the time of submission.

An invoice not satisfying the requirements of a Proper Invoice (as defined in COMAR 21.06.09) will not be processed for payment. To be considered a Proper Invoice, invoices must include the following information, without error:

A. Contractor name and address;

B. Remittance address;

C. Federal taxpayer identification (FEIN) number, social security number, as appropriate;

D. Invoice period (i.e. time period during which services covered by invoice were performed);

E. Invoice date;

F. Invoice number;

G. State assigned Contract number;

H. State assigned (Blanket) Purchase Order number(s);

I. Goods or services provided;

J. Amount due; and

K. Any additional documentation required by regulation or the Contract.

Invoices that contain both fixed…