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Biosafety for lab and pathology
Clinical images

Contributed by Arun R. Napit, M.B.B.S.
Biohazard specimen bag

Biohazard specimen bag

Safety data sheet

Safety data sheet

Biohazard disposal bin

Biohazard disposal bin

Biosafety cabinet

Biosafety cabinet


Eyewash

Eyewash

Shower

Shower

Door with biohazard sign

Door with biohazard sign

Personal protective equipment (PPE) suit

PPE suit



Images hosted on other servers:
Biohazard sign

Biohazard sign

Hazard symbols

Hazard symbols

Personal protective equipment (PPE)

CDC guidelines for PPE

Videos

Lab safety: biosafety

Biohazard spill management

Biosafety levels


Building resilience in the workplace
Diagrams / tables

Contributed by Lewis A. Hassell, M.D. (adapted from Deloitte: Bridge Across Uncertainty, Cranfield: Organizational Resilience)
Relationship between stress outcomes and resources to mitigate

Stress outcomes versus resources

Components and attitudes in highly resilient organizations

Highly resilient organizations

Videos

Resilience in the workplace

How to give an effective performance review

How to use SWOT analysis

Value and range of risk assessment


Employee selection to drive organizational culture

How trust drives everything in an organization

Resilience, well being and performance in the workplace by Derek Mowbray



Causal analysis
Videos

5 why's technique

Fishbone diagram

RCA2



Critical reporting systems and laboratory communications
Diagrams / tables

Contributed by Phuoc T. Christie-Nguyen, M.D.
Anatomical pathology critical values sample log

Anatomical pathology critical values sample log

Critical values report documentation template

Critical values report documentation template

Anatomical critical value system diagram

Anatomical critical value system diagram

Chemistry and microbiology critical value system diagram

Chemistry and microbiology critical value system diagram

Microscopic (histologic) images

Contributed by Phuoc T. Christie-Nguyen, M.D. (source: University of Michigan virtual slide box)
Skin with <i>Cryptococcus neoformans</i> infection

Skin with Cryptococcus neoformans infection

Videos

Critical values in clinical chemistry

Critical communications in healthcare

Communication in customer service


Frozen section overview
Videos

Embedding small specimens

Speed embedding

Brush technique


Laboratory budgeting
Diagrams / tables
  • Costs can be classified in different ways as shown in the following tables (McPherson: Henry's Clinical Diagnosis and Management by Laboratory Methods, 23rd Edition, 2016):

    Direct Indirect (overhead) Variable Fixed Salary Nonsalary Operating Capital
    Reagents ~ ~ ~ ~
    Proficiency testing ~ ~ ~ ~
    Analyzer service ~ ~ ~ ~
    Analyzer ~ ~ ~ ~
    Testing staff ~ ~ ~ ~
    Management staff ~ ~ ~ ~
    Rent ~ ~ ~ ~


    Sample laboratory budget
    Description Current actual Current budget Variance % Variance
    Inpatient charges
    Outpatient charges
    Total revenues
    $246,958
    $1,574,862
    $1,821,820
    $219,370
    $1,476,560
    $1,695,930
    $27,588
    $98,302
    $125,890
    12.6%
    6.7%
    7.4%
    Salary - professional
    Salary - technical regular
    Salary - technical overtime
    Total salary
    $36,484
    $50,548
    $9,438
    $96,470
    $35,213
    $53,030
    $2,610
    $90,853
    $(1,271)
    $2,483
    $(6,828)
    $(5,617)
    -3.6%
    4.7%
    -261.6%
    -6.2%
    General lab supplies
    Reagents
    Lease, rentals
    Total supplies
    $24,546
    $130,356
    $2,070
    $156,972
    $19,476
    $75,464
    $2,070
    $97,010
    $(5,070)
    $(54,892)
    $0
    $(59,962)
    -26.0%
    -72.7%
    0.0%
    -61.8%
    Total expenses $253,422 $187,863 $(65,579) -34.9%
    Reference: Lab Med 2003;34;515
Videos

Financial management:
effective budgeting in the laboratory
- Ian McNeal, CPA


Laboratory developed tests
Diagrams / tables

Images hosted on other servers:
Historical timeline of clinical laboratory regulation

Historical timeline
of clinical
laboratory regulation



Comparison: FDA versus CLIA / CMS oversight of testing (FDA: Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) [Accessed 4 March 2024])
U.S. FDA oversight CLIA '88 / CMS oversight
Focus on devices themselves and how they perform Focus on laboratory processes to use devices, not device quality
Review of analytic validity performed before test may be used on patients Review of analytic validity performed during a 2 year inspection cycle; test may be in use for 2 years before assessment of data and test use
Analytic validity large in scope with thousands to tens of thousands of data points Analytic validity may be performed on the smallest number of patients required for statistical significance
Requires assessment of clinical validity / utility of testing Does not require clinical validity / utility
Review requires assessment of patient safety Review does not require assessment of patient safety
Required demonstration of effectiveness in determining presence / absence of condition being assessed No required demonstration of effectiveness in determining presence / absence of condition being assessed
Requires adverse event reporting to identify inaccurate, unsafe and ineffective devices Does not require adverse event reporting
Requires removal of unsafe devices from market Does not remove devices from the market

Laboratory inspection and accreditation
Diagrams / tables

Contributed by Mai Thy Tran, M.D.
How checklist items are developed at CAP

How checklist items are developed at CAP



Images hosted on other servers:

CAP accreditation process and timeline

CAP virtual and onsite inspection




Options for lab accreditation
CLIA CAP ISO 15189 COLA JC
Purpose
  • Assure accuracy, reliability of test results according to federal standards that are overseen by 3 federal agencies (FDA, CDC, CMS)
  • Work at state level (state department of health)
  • Confirm the laboratory is in compliance with CLIA standards
  • Intense proficiency testing monitoring
  • Focused on CAP checklists
  • Optional in U.S.
  • Laboratory needs to sustain integrated quality management system (QMS) across all parts of organization
  • International expert consensus
  • Effectiveness of corrective action
  • Create systems that will prevent problems and reduce errors
  • Help your clinical laboratory meet CLIA and COLA requirements
  • Laboratories within JC health care organizations to be accredited by COLA to meet JC requirements
  • Is ISO 9001:2015
  • Confirm the laboratory is in compliance with CLIA regulation
  • Leading Laboratory designation, help laboratories achieve high quality outcomes, assure professional development, engage in trusted leadership and earn laboratory visibility
Inspector CLIA inspectors (usually state department of health personnel) Peer inspections by CAP inspectors and self inspections by staff Certified inspectors COLA surveyor (most often medical technologists) JC surveyors
Accreditation cycle 2 years 2 years 3 years 2 years 2 years
Frequency of inspection Every 2 years Peer inspections every 2 years and annual self inspection Annual internal audit Every 2 years Every 2 years
Cost One time registration fee of $100; certification fee based on the annual testing volume and number of laboratory specialties performed ($180 - $9,500 / year) Nonrefundable one time application fee of $1,200 (domestic) or $1,500 (international); CAP's annual accreditation fee is determined based on the laboratory's size and complexity The fee schedule will include an annual base fee and fees for assessments; cost will vary depending on the size and scope of the lab Enrollment fee and certification fee Onsite survey fee; annual fee based on the number of specialties the lab provides and the number of locations



Example for lab accreditation check list
Lab accreditation - general check listYes NoN/A
Specimen collection, handling and reporting
Proficiency testing
Quality management
Result reporting and referral of testing
Quality of water and glassware washing
Reagents (storage, handling, labeling)
Instrument and equipment maintenance / function check
Personnel
Laboratory computer services
Physical facility
Laboratory safety
Videos

CAP15189

UKAS accreditation

CAP accreditation


What is CLIA?

What is the Joint Commission?

Who is FDA?


CDC

CMS


Lean workflow / Six Sigma
Diagrams / tables

Contributed by Stephen J. Hardy, M.B.A.
Value added flow chart

Value added flow chart

Laboratory order flow chart

Laboratory order flow chart



Images hosted on other servers:
Critical information from value stream mapping

Critical information from value stream mapping

Future state value stream map

Future state value stream map

Videos

What is Lean?

What is Six Sigma?

5 whys

Lean / Six Sigma - waste, DMAIIC, etc.


Managers, steps and duties

Descriptive statistics

Five S

Value stream mapping basics


What is Kanban?

What is DMAIIC



Organization of the laboratory
Diagrams / tables

Contributed by Richard E. Horowitz, M.D.
Missing Image

Hierarchical chart


Patient safety
Diagrams / tables
  • Spaghetti diagrams or workflow charts can be created in order to maximize the utility and efficiency of work space (see Lean workflow)
  • Root cause analysis (RCA): problem → ask why (and then why again and again and again) → root cause → corrective action

Images hosted on other servers:

Workflow examples

Histology specimen workflow

Fishbone diagram of RCA

Videos

Root cause analysis (RCA)

Plan, Do, Study, Act (PDSA) cycle

Failure mode and effects analysis (FMEA)

Root cause analysis techniques


Peer (case) review in anatomic pathology
Diagrams / tables

Table 1:
Formal quality assurance programs Informal quality assurance programs
Retrospective case review Autopsy
Proficiency testing Diagnostic consult
Prospective case review Patient referral


Table 2: Current formal quality assurance program for AP
Characteristic Proficiency testing Internal case review (retrospective) Internal case review (prospective) External peer case review by subspecialist (retrospective)
Adds to the pathologist workload
Peer reviewed ? ?
Standardized
False negative & positive cases
QA total process
Benchmarking
Ability to influence the diagnosis in real / near real time
Key positive feature(s) Established minimum quality tool Most common QA practice Real time External subspecialist review, does not use pathologist time
Negative consideration Does not QA the full case detail from gross to report Demanding on pathologist and technologist time Most demanding on pathologist and technologist time Program needs to be double blinded for confidentiality
Best demonstrated practice CAP and ASCP proficiency programs ADASP guidelines on QC & QA in AP quality assurance UPMC QualityStar™ external QA case review by subspecialist

Principles of laboratory quality improvement
Diagrams / tables

Contributed by Yaolin Zhou, M.D.
A3 template

A3 template

EPIDEM and PDSA

EPIDEM and PDSA


Quality assurance for cytopathology
Diagrams / tables

Contributed by Husam Jum'ah, M.D. and Santhi Ganesan, M.D.
Fishbone diagram

Fishbone diagram

QA in gynecologic and non gynecologic cytology

QA in gyn and nongyn cytology

Prospective QA in gynecologic cytology

Prospective QA in gyn cytology

Retrospective QA in gynecologic cytology

Retrospective QA in gyn cytology

Correlational QA in gynecologic cytology

Correlational QA in gyn cytology

Correlational QA in non gynecologic cytology

Correlational QA in nongyn cytology


Quality management systems
Diagrams / tables

Contributed by Hai Duong Nguyen, M.D., M.Sc.
An integrated quality management system

Integrated quality management system

The clause structure of ISO 9001:2015

Clause structure of ISO 9001:2015

The path of workflow

Path of workflow

Simple generic model for quality management system

Simple generic model for quality management system

PDCA related to the 10 clauses of the ISO 9001:2015

PDCA related to 10 clauses of ISO 9001:2015

Structure of ISO 9001:2015 in the PDCA cycle

Representation of structure of ISO 9001:2015 in PDCA cycle

Videos

WHO: LQSI series - implementing a laboratory quality management system

Laboratory quality management and standards

CAP: quality management


Revenue cycle management
Diagrams / tables

Contributed by Brian H. Le, M.D., M.B.A.
Key steps for pathology / laboratory RCM

Key steps in pathology / laboratory RCM



Topic name
Diagrams / tables

Contributed by Name, Degrees

Short caption



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Notes:
  • Can include images on our server or other servers
  • Add a
    between the table and section header
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  • See detailed image instructions in Microscopic (histologic) images
  • Click here to view the different types of images
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    • or
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    • tags are obsolete, use style="text-align:center" instead
    • End the table using


    • Table title in bold (no italics)
      Heading Heading Heading
      Text text text text text Text text text text text Text text text text text
      Text Text Text
Radiology images

Contributed by Name, Degrees

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Notes:
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  • See detailed image instructions in Microscopic (histologic) images
  • Click here to view the different types of images
Clinical images

Contributed by Name, Degrees

Short caption



Images hosted on other servers:

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Notes:
  • Includes intraoperative images or images of the patient
  • Can include images on our server or other servers
  • Does not include radiology images, which belong in the Radiology images section
  • Does not include gross images, which belong in the Gross images section
  • See detailed image instructions in Microscopic (histologic) images
  • Click here to view the different types of images
Gross images

Contributed by Name, Degrees

Short caption



Images hosted on other servers:

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Notes:
  • Images of excised specimen
  • Can include images on our server or other servers
  • See detailed image instructions in Microscopic (histologic) images
  • Click here to view the different types of images
Microscopic (histologic) images

Contributed by Name, Degrees

Short caption

Shared caption

Short caption

Shared caption


Notes:
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Cytology images

Contributed by Name, Degrees

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Notes:
  • Can include images on our server or other servers
  • Format Diff-Quik with hyphen
  • Always capitalize Pap
  • See detailed image instructions in Microscopic (histologic) images
  • Click here to view the different types of images
  • For CNS tumor topics only, cytology and frozen section images should be grouped together in frozen section rather than separated (use heading "Intraoperative frozen / smear cytology images" for these)
Flow cytometry images
  • Composite images are allowed for this section only
Electron microscopy images

Contributed by Name, Degrees

Short caption



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Notes:
Molecular / cytogenetics images

Contributed by Name, Degrees

Short caption



Images hosted on other servers:

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Notes:
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  • See detailed image instructions in Microscopic (histologic) images
  • Click here to view the different types of images
Videos

Short caption

Shared caption



Notes:

Validation of reference intervals and reportable range
Diagrams / tables

Contributed by Duy K. Doan, M.D. and Lewis A. Hassell, M.D.
Normal distribution, serum sodium

Normal distribution, serum sodium

Reportable range

Reportable range



Validation of reportable ranges
Standard values Observed values Means
Replicate 1 Replicate 2 Replicate 3
0 2 0 4 3
200 220 210 200 210
400 400 400 400 400
600 620 630 610 620
800 760 760 790 770
1,000 920 900 880 900

  • In this example:
    • Expected reportable ranges: 0 - 1,000 mg/dL
    • Number of concentration levels: 5
    • Number of replicates: 3
Videos

Reference intervals, the basics

Back to top
Recent Laboratory Administration & Management of Pathology Practices Pathology books

Cipriani: 2022

Dauterman: 2022

Dauterman: 2022

Dauterman: 2019

Domen: 2020

Garcia: 2013

Gouws: 2020

Harmening: 2020

Hassell: 2015

Lester: 2022

McPherson: 2021

Ohanele: 2023

Valenstein: 2005

Wagar: 2019

WHO: 2012

Zhai: 2016



Find related Pathology books: general surgical pathology, lab medicine, management, frozen section
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