Laboratory Information System (LIS) Overview:

Histology Management in LIS:

 Basic Information: Capture essential details such as Case ID, Case Name, Specimen id, Specimen
Name, Status and Current Department.

The following steps are involved to perform histology process:

 Step 1: The Pathologist identified the case and Triage the case to the Histology department for
lab processing through Triage Module.

 Step 2: The histology department receives and acknowledge the case in the system through
Histology Module.

 Step 3: The Histo-technologist examine the specimen and document the Macroscopic features
in Histology module. At this stage specimen is ready for grossing.

 Step 4: The Histo-technologist marked the case to the grossing team from NGLIS system for
further processing.

 Modules: Histology lab process contains 5 steps:

 Grossing:

 The grossing team dissect the specimen to obtain multiple tissues and add
details into Histology module.

 The grossing team print Cassette Labels with Machine (Leica IP C). These details
should be added in the Histology module in grossing section.

 The grossing team filled the Grossing sheet from histology module.

 The core step of grossing is to add cassettes to the processing machine

(HistoCore Pegasus) for reagents and dehydrating. The grossing team should
add details received from processing machine.

 The Grossing team marked the case to the embedding team from NGLIS system
for further processing.

 Embedding

 Embedding team use the barcode reader scan to automatically log information.
This information should reflect in Histology module.

 Embedding team add the status that Tissue is embedded in Paraffin Block.

 The embedding team marked the case to the cutting team from NGLIS system
for further processing.

 Cutting
  Cutting Team working as per triage request so that slides are assign as per
required test slides.

 The Glass Slides that are available have specific label and QR code. The labels
are added through Epredia SlideMate Printer. The Cutting team should add
details into the Histology module cutting section.

 Output: Cutting team add the status that slices are cut from the Paraffin
embedded tissue Block. (Note: Slices are cut with Microtome device)

 The cutting team marked the case to the baking team from NGLIS system for
further processing.

 Baking

 Baking team receives the case and start working. Baking team place slide in
machine to melt and remove the Paraffin wax.

 Output: Baking team add the status that tissue sections are stick to glass slides.

 The baking team marked the case to the staining team from NGLIS system for
further processing.

 Staining

 Staining team receives the case and start working. The following machines are
used in staining process:

 Leica Bond-III

 Ventana

 Output: Output of staining, when observed through a microscope, allows for a

comprehensive understanding of the structure and composition of tissues at the
microscopic level.

 The staining team marked the case to the Histo-Tehnologist from NGLIS system
for further processing.

 The Histo-Tehnologist observed the output of staining through microscope and add
comments on report and publish for pathologist for diagnosis.

 The report template should be available in histology module and Histo-

Tehnologist can update the report.

Q: Is it required to provide access to the histology report at every level in order to enable
feedback/analysis from all departments?

Client Management in LIS:

 Basic Information: Capture essential details such as ID, Name, and Account Type, billing
preferences, Priority, Report preferences, delivery methods and contact information. Correct

 Multiple Offices: Clients may operate in multiple locations or states. Correct

 Hierarchical Structure: Implement a parent-child relationship where the main entity

acts as the "parent" and individual offices as "child" entities. This is not common in the
current service model because clients who have multiple locations fluctuate between
them. It seems to me that we have to consult with Sales if we want to differentiate
the accounts.

 Unique Identification: Assign a unique identifier (Client ID) to each office, capturing
specific details like address and contact information or may be an input from Salesforce.

The accounts are assigned account numbers according to the zip code and a dash and
an ascending number are placed according to the order of creation. Example: the first
account created in the zip code 10030, its account number will be 10030-1, the second
created in that location will be 10030-2 and so on, and the improvement that can be
made is that the system automatically assigns the next code available in the system
without the agent having to search for which one is available.

 Preferences:

 Centralized: Set by the main client and applied to all offices. Agree

 Localized: Specific to each office, accommodating unique requirements. Agree

 State-Specific Regulations: Address varying regulations across states, especially

concerning medical testing and data privacy. Agree

 Reporting: Generate both consolidated reports for the main client and specific reports
for individual offices. You need to explain me more this vision.

Example of Reporting in LIS for Client Management:

Consolidated Reports for the Main Client (e.g., a healthcare chain):
 Total number of tests ordered across all branches.
 Overall percentage of tests that have been completed.
 Average turnaround time for results across all branches.
 A summary of abnormal results across all branches.
 Specific Reports for Individual Offices (e.g., a specific clinic in the chain):
 Number of tests ordered by that specific clinic.
 Details of pending tests for that clinic.
 Turnaround time for results for that specific clinic.
 A breakdown of results, for instance: 50 normal results, 10 with elevated
levels, 5 critical, etc.
Example Scenario:
  Let's say "Healthcare Group A" is a chain of clinics that sends samples to a
central lab for testing. This group has ten clinics across the state.
 Using a Consolidated Report, the management of "Healthcare Group A" can
quickly see that across all ten clinics, they've sent 1,000 test samples this
month, with a 5% rate of abnormal results.
 However, the manager of Clinic 5 from "Healthcare Group A" wants to see
data only for his clinic. Using the Specific Report, he can see that his clinic sent
80 test samples, and 10% of those had abnormal results. This may prompt him
to investigate further, as his clinic has a higher abnormal rate than the group
average.

Physician Management in LIS:

 Physician Profiles: Each physician has a unique profile containing personal details, qualifications,
contact information, and associations with clients or offices. Physicians are identified by the NPI
and the Licenses, which is their unique ID as doctors and here we only use their NPIs. Tiger has
an important deficiency that affects a lot and that is that it does not automatically identify if
the Doctor has been created before under another account and duplicate your creation.

 Roles & Responsibilities: Define roles such as "Referring Physician" or "Attending Physician" and
assign specific permissions based on these roles. Correct, there are more roles that we need to
add.

 Access to Cases:

 Role-Based Access Control (RBAC): Ensure physicians access cases based on their roles
and associations. Correct

 Case Ownership: The physician who orders a test has primary access to the case details
and results. Correct

 Shared Cases: Allow for cases to be shared with other physicians, especially in scenarios
requiring consultation or collaboration. Correct

 Notification System: Inform physicians about relevant case updates, such as test
completion or critical results. Correct

Order Entry & Result Reporting:

 Physician Details: Capture information about both the primary (referring) and any additional
(attending) physicians involved in a case. Correct, and also the office management related to
the case.
  Result Delivery: Customize result delivery based on the preferences of the involved physicians,
ensuring timely and efficient communication.

In the system we have 3 delivery methods in the cases when the reports are sent manually that
we do not know how to handle, after a report is sent by Fax or by Email it is not known which user
sent it, nor to whom it was sent. And it is something that must be corrected. An adjustment must
be made in which the system automatically sends the reports to those designated once the report
is signed or ready in any of its versions. We must avoid manually sending the reports that are
coded by notes in the system.

We must review the Umbrella functionality. - The multiple offices is umbrella

Client Portal:

 Access: Provide a secure portal for both referring and attending physicians to access case details
and results. We must make it conditional, according to who the client prefers to send the
reports.

 Functionalities: Allow physicians to view, download, annotate, and communicate about shared
reports within the portal. Correct

Data Sharing & Communication:

 Report Sharing: Facilitate manual sharing of reports between physicians when collaboration is
required. This is explained in my Power Point.

 Secure Messaging: Implement a secure messaging system to ensure data privacy while allowing
for efficient communication. Correct

 Collaboration Tools: Integrate tools that enable physicians to discuss results, add annotations,
or consult directly within the system. Correct

Permissions, Confidentiality, & Audit Trails:

 Authorized Access: Ensure that only authorized individuals can access patient reports, based on
their roles and associations. Correct

 Data Protection: Comply with data protection regulations, such as HIPAA, and implement
encryption for added security. Correct

 Audit Trails: Maintain detailed logs of all activities related to case access, ensuring transparency
and accountability. Correct
Here's a conceptual representation of what an RBAC table might look like:

RBAC Table:

Role ID Role Name Resource/Functionality Permission (CRUD)

001 Attending Physician Order Test C, R
001 Attending Physician View Test Result R
001 Attending Physician Share Test Result R, U
002 Referring Physician View Test Result R
002 Referring Physician Annotate Test Result U
003 Lab Technician Process Test C, R, U
003 Lab Technician Update Test Status U
004 Admin Manage Users C, R, U, D
004 Admin Manage Roles C, R, U, D
005 Billing Clerk Access Billing Info R, U
005 Billing Clerk Generate Invoice C

Notes:

Role ID: A unique identifier for each role.

Role Name: The name of the role, which represents a specific set of responsibilities within the
organization.

Resource/Functionality: The specific system resource or functionality that the role has access to.

Permission (CRUD): The type of access the role has to the resource/functionality. CRUD stands for
Create, Read, Update, and Delete.

Let’s discuss all of this Roles, I need to understand them better.

Additional Points:

 Client needs to have details on the Specimen Pickups they have requested.
 Pickup requests are reconciled against the specimens received at the lab at the time of creation.
 Client should reflect the inventory.
 Clients have their holding facility information as well.
 Clients need to have their own notes.
 Clients have special requests against Reporting we need to look into in detail.
1. Specimen Tracking: The Histology module tracks tissue specimens from the point of
receipt to processing, embedding, sectioning, staining, mounting on slides, and final
diagnosis. It assigns unique identifiers to specimens and monitors their status
throughout the histopathology workflow.
2. Tissue Processing: The module manages the processing of tissue specimens, including
fixation, dehydration, clearing, infiltration with embedding medium, embedding in
paraffin wax, and orientation for sectioning.
3. Slide Labeling and Tracking: It generates labels for slides and tracks the association
between slides and corresponding tissue specimens. This ensures accurate identification
and traceability of slides during microscopic examination and diagnosis.
4. Slide Preparation: The Histology module facilitates slide preparation by automating the
sectioning of tissue blocks, mounting tissue sections on slides, and applying appropriate
staining techniques (e.g., hematoxylin and eosin staining) for visualization under a
microscope.
5. Workflow Management: It streamlines the histopathology workflow by scheduling
tasks, assigning worklists to histotechnologists, and monitoring the progress of
specimen processing and slide preparation.
6. Quality Control: The module supports quality control measures by monitoring the
performance of histopathology equipment, tracking reagents and stains, and ensuring
adherence to standard operating procedures (SOPs) for specimen handling and
processing.
7. Reporting and Integration: It generates pathology reports with detailed diagnostic
findings and integrates with the laboratory's LIS or electronic health record (EHR) system
to deliver results to healthcare providers and clinicians.
8. Data Analysis and Management: The Histology module stores and manages data
related to tissue specimens, histopathology tests, patient demographics, and diagnostic
interpretations. It allows for data analysis, trending, and reporting to support research
and quality improvement initiatives.

Certainly! Below are the steps involved in the histology process, taking into account user
and system interactions within a Laboratory Information System (LIS):

1. Specimen Reception:
 User Interaction: Laboratory staff receives tissue specimens from clinicians or
other healthcare providers.
  System Interaction: LIS generates unique identifiers (barcode labels) for each
specimen and records relevant information such as patient details, specimen
type, and collection date/time.
2. Specimen Logging:
 User Interaction: Laboratory staff logs specimen information into the LIS,
including accession number, patient demographics, and specimen source.
 System Interaction: LIS validates and stores the specimen data in its database,
associating the specimen with the patient's electronic record.
3. Specimen Processing:
 User Interaction: Histotechnologists retrieve specimens from the LIS worklist and
perform tissue processing steps (e.g., fixation, dehydration, embedding)
according to standard protocols.
 System Interaction: LIS updates the status of specimens in real-time, tracking
their progress through each processing step and recording timestamps for audit
trail purposes.
4. Embedding and Sectioning:
 User Interaction: Histotechnologists embed processed tissue specimens in
paraffin wax blocks and prepare thin sections using a microtome.
 System Interaction: LIS generates labels for embedding cassettes and slides,
ensuring proper identification and traceability of tissue specimens and
corresponding slides.
5. Staining and Coverslipping:
 User Interaction: Histotechnologists apply tissue stains (e.g., hematoxylin and
eosin) to slides and coverslip them for microscopic examination.
 System Interaction: LIS records staining protocols used, monitors staining quality,
and updates slide statuses as they move through the staining and coverslipping
process.
6. Slide Scanning and Digital Imaging (Optional):
 User Interaction: In some cases, histotechnologists or pathologists may digitize
slides using slide scanning equipment for digital pathology.
 System Interaction: LIS interfaces with slide scanning devices to capture high-
resolution images of tissue specimens, storing digital images in the LIS database
for review and analysis.
7. Microscopic Examination and Diagnosis:
 User Interaction: Pathologists review stained slides under a microscope to
examine tissue morphology and make diagnostic interpretations.
 System Interaction: LIS facilitates slide tracking and case assignment, allowing
pathologists to access relevant patient data, previous test results, and digital
images within the LIS interface.
8. Reporting and Result Entry:
 User Interaction: Pathologists enter diagnostic findings, interpretations, and
comments into the LIS system.
 System Interaction: LIS generates pathology reports, incorporating pathologist's
comments and diagnostic codes, and delivers reports electronically to healthcare
providers or integrates them with the EHR system.
9. Quality Control and Review:
 User Interaction: Laboratory supervisors and quality control personnel review
histology processes, including staining quality, slide preparation, and diagnostic
accuracy.
 System Interaction: LIS generates quality control reports, tracks deviations from
standard procedures, and facilitates corrective actions to maintain quality
standards in histopathology testing.

Throughout the histology process, effective user-system interaction within the LIS
ensures accurate specimen tracking, standardized workflows, timely reporting, and
quality assurance in histopathology laboratories.