Attachment G - Traceability Matrix FINAL.xlsx

1. Title Page

2. Table of Contents

No response required in this tab

2. Table of Contents Details all tabs within the workbook No response required in this tab

3. Instructions Provides instructions for tabs the Offeror must fill out in their response No response required in this tab

4. Desirable Business Functionalities Details all desirable business functionalities for the solicitation Response required in tab

5. Desirable Technical Functionalities Details all desirable technical functionalities for the solicitation Response required in this tab

6. Service Requirements Details all service requirements for the solicitation, including deliverables, and submission timing/frequency of these deliverables No response required in this tab

7. Mandatory Performance Req. Details all performance requirements for the solicitation Response required in this tab

8. Performance Definitions Details performance metrics and definitions the contracted Vendor must maintain through their Solution No response required in this tab

9. Key Staff Mandatory and Non-mandatory, key staff roles, responsibilities, and experience desired to support successful implementation of the Solution No response required in this tab

3. Instructions

A. Yes: Offeror Solution can meet this desirable business functionality.

B. No: Offeror Solution cannot meet this desirable business functionality.

A. Out of the Box: The desirable functionality will be met through available functionality.

B. Configuration: Adjusting the settings and options within the software to meet the desirable functionality without altering the core code of the software.

C. New Development/Customization: The desirable functionality will be met through customization, which requires custom code development.

D. Third-Party Product: The desirable functionality will be met by commercially available third-party software and is not included in this Proposal. NOTE: The name of the proposed third-party software vendor and proposed components must be indicated under "Explanation or Comments".

E. None: The desirable functionality will not be met by the Solution.

A. Yes: Offeror Solution can meet this desirable technical functionality.

B. No: Offeror Solution cannot meet this desirable technical functionality.

A. Out of the Box: The desirable functionality will be met through available desirable technical functionality.

B. Configuration: Adjusting the settings and options within the software to meet the desirable technical functionality without altering the core code of the software.

C. New Development/Customization: The desirable technical functionality will be met through customization, which requires custom code development.

D. Third-Party Product: The desirable technical functionality will be met by commercially available third-party software and is not included in this Proposal. NOTE: The name of the proposed third-party software vendor and proposed components must be indicated under "Explanation or Comments".

E. None: The desirable technical functionality will not be met by the Solution.

Note: DoIT will not negotiation any SLRs if exceptions are not proposed in the Offer.

Instructions: Offeror shall provide any exceptions to the SLR in column H.

4. Desirable Business Fn.

a. patient demographics

b. name

c. date of birth (DOB)

d. contact information

e. other relevant demographics as determined by DoIT Optional -

a. sex at birth

b. ethnicity

c. race B2 Coordinate Specimen Intake Process and Sample Management Sample Management The solution should allow easy and efficient sample tracking, registration, and identification, including, but not limited to:

a. single specimen ID which does not change from accessioning to reporting

a. patient/source name

b. sex

c. date of birth

d. address

e. submitter

f. external ID

g. date/time collected

h. test to be performed

i. specimen source B9 Coordinate Specimen Intake Process and Sample Management Sample Management The solution should accept and manage environmental sample information including, but not limited to the following:

a. Supply facility number

b. Name

c. Location

d. Field and Preservation Data

e. Collection date/time

f. Collector's name and address

g. Name and address of additional contacts

h. Sample type and matrix

a. test protocols

b. test catalogs

c. test codes B17 Perform Specimen Analysis Test and Assay Management The solution should allow for customizable:

a. test profiles

b. test panels

c. test workflows

a. grouping of samples

b. tests

c. results into batches for streamlined processing, review, and reporting B20 Perform Specimen Analysis Test and Assay Management The solution should provide comprehensive test management capabilities, including, but not limited to:

a. test definition

b. test scheduling

c. test result entry B21 Perform Specimen Analysis Test and Assay Management The solution should support sample preparation and aliquot management, including, but not limited to:

a. tracking of sample aliquots

b. dilutions

c. derivatizations

d. managing sample preparation protocols, calculations, and results B22 Perform Specimen Analysis Test and Assay Management The solution should support environmental monitoring capabilities, including, but not limited to:

a. monitoring environmental samples, such as air, water, and surface samples

b. managing related data, results, and reports

a. each type

b. frequency

c. run placement

d. acceptance criteria

a. analyst name

b. date

c. time

d. method code

e. sample number

f. final volume, dilutions, reagents, and QC samples

a. sample collection date-time

b. receive date-time

c. test method

d. temperature

a. tracking of reagents

b. consumables

c. other laboratory supplies

d. managing reagent expiration dates

e. stock levels

f. reordering

g. manual adjustments of inventory amounts B50 Manage Inventory and Logistics Inventory Management The solution should support inventory tracking through features including, but not limited to:

a. inventory levels

b. reordering

c. stock management

a. chemicals

b. reagent test kits

c. gloves

d. lab coats

a. SDS sheets

b. package inserts for exposure and safety information B62 Manage Inventory and Logistics Inventory Management The solution should track the inventory of laboratory supply products with fields including, but not limited to:

a. receive date

b. product name

c. lot number

d. expiration date

e. quantity

f. location of storage

g. procurement vendor name B63 Manage Inventory and Logistics Sample Tracking The solution should provide robust sample tracking features, including, but not limited to:

a. sample receipt

b. storage

c. transfer

d. disposal B64 Manage Inventory and Logistics Sample Tracking The solution should support chain of custody documentation to ensure sample integrity and traceability, including, but not limited to:

a. electronic signatures

b. audit trails

a. Invoice Number

b. Billing Date

c. Provider ID

d. Provider Name

e. Provider Address

f. Number of Specimens

g. Bill Amount

h. Validation Stamp Area

i. Current Date

j. CPT Codes

k. ICD10 codes

l. Cost/Price B71 Report and Delivery Data Report and Delivery Data The solution should provide robust reporting and analytic capabilities including, but not limited to:

a. generating standard reports

b. generating ad hoc reports

c. tracking key performance indicators (KPIs)

d. providing insight into laboratory operations

e. providing insight into laboratory performance

a. Follow data accessibility permissions

b. Be configurable as read only or read‐write access based on permissions

c. Be flexible and ad hoc configurable

e. Incorporate search engine capabilities for free text fields

f. Utilize logical expressions (>, <, =, contains, and, or)

g. Be exportable in .XLSX and .CSV table formats

h. Capable of selecting samples to for report generation

a. comma-delimited flat files B81 Report and Delivery Data Report and Delivery Data The solution should allow ad hoc queries based on fields including, but not limited to:

a. submitter ID numbers

b. funding code

c. lab section

d. test type

e. result

f. sample type

g. sample source B82 Report and Delivery Data Report and Delivery Data The solution should be able to generate ad hoc reports including, but not limited to:

a. total tests

b. positivity rates

c. positive test patterns by type of test

d. turn-around-time statistics

a. number of incomplete samples

b. number of complete samples

c. completed but unprocessed samples

d. average processing time

e. aid in planning resources

1) notifying the staff of pending testing requests that have not been reported

2) alerting staff of samples beyond turn around time

3) alerting staff to samples with pending demographic data needed to meet acceptability requirements

4) providing end of day logs that shows samples pending results

a. transmission of food sample collection data to the LIMS electronically

b. full integration with the food safety application

c. ability to electronically send test results and raw test data to the food safety application and update the field record

a. analyzers

b. all equipment listed in Attachment K - Laboratory Tests & Equipment

a. manufacturer

b. model number

c. serial number

d. year of purchase

e. state property ID number

f. any required instrument service dates

a. Name

b. Mailing address

c. National Provider Identification (NPI) or Submitter's code number

d. Contact name

e. Telephone numbers

a. user actions

b. data changes

c. system events for compliance with regulatory requirements

a. sample routing

b. approval workflows

c. user-defined workflows

a. out-of-spec results

b. overdue tasks or pending approvals to ensure timely actions and compliance with laboratory processes

a. quality control sample management

b. control charting

c. alert notifications for out-of-spec results B133 Manage Lab Services Delivery and Administration Quality Control The solution should have quality control features including, but not limited to:

a. setting up and managing quality control samples

b. generating quality control charts

c. tracking and managing quality control data for ongoing performance monitoring and assessment

a. name

b. date of birth (DOB)

c. gender

d. contact information

e. other relevant demographics as determined by DoIT

f. mother's name Optional -

a. ethnicity

b. race B138 NBS - Conduct Dried Blood Spot Testing Test Ordering The solution should allow authorized health care providers to place orders for newborn screening tests based on established screening protocols including, but not limited to:

a. blood tests

b. metabolic tests

c. performing molecular (DNA-based) screening

a. amino and urea cycle disorders

b. biotinidase deficiency

c. congenital adrenal hyperplasia

d. congenital hypothyroidism

e. cystic fibrosis

f. fatty acid oxidation disorders

g. galactosemia

h. lysosomal storage disorders

i. organic acid disorders

j. phenylketonuria

k. severe combined immune deficiency

l. sickle cell disease

a. sample collection date

b. sample type

c. sample collection location

5. Desirable Technical Fn.

A. Drill down and look up functionality to minimize time required for access to more detailed information B. Multi-tasking and multiple window capability, including split screens C. Search capabilities to allow retrieval by name, DOB, specimen number or other parameters as defined by DoIT D. Ability to tab and mouse through data fields and screens.