Lab safety: biosafety
Biohazard spill management
Biosafety levels
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
5 why's technique
Fishbone diagram
RCA2
Critical values in clinical chemistry
Critical communications in healthcare
Communication in customer service
Embedding small specimens
Speed embedding
Brush technique
- 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
$125,89012.6%
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%
Financial management:
effective budgeting in the laboratory
- Ian McNeal, CPA
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Comparison: FDA versus CLIA / CMS oversight of testing (FDA: Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) [Accessed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 |
Contributed by Mai Thy Tran, M.D.
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Options for lab accreditation
CLIA | CAP | ISO 15189 | COLA | JC | |
Purpose |
|
|
|
|
|
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 list | Yes | No | N/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 |
CAP15189
UKAS accreditation
CAP accreditation
What is CLIA?
What is the Joint Commission?
Who is FDA?
CDC
CMS
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
- 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
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Workflow examples
Root cause analysis (RCA)
Plan, Do, Study, Act (PDSA) cycle
Failure mode and effects analysis (FMEA)
Root cause analysis techniques
Formal quality assurance programs | Informal quality assurance programs |
---|---|
Retrospective case review | Autopsy |
Proficiency testing | Diagnostic consult |
Prospective case review | Patient referral |
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 |
WHO: LQSI series - implementing a laboratory quality management system
Laboratory quality management and standards
CAP: quality management
Contributed by Name, Degrees
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Contributed by Name, Degrees
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Contributed by Name, Degrees
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Contributed by Name, Degrees
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Cytology images
Contributed by Name, Degrees
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Electron microscopy images
Contributed by Name, Degrees
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Molecular / cytogenetics images
Contributed by Name, Degrees
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Validation of reference intervals and reportable rangeBack to topDiagrams / tables
Contributed by Duy K. Doan, M.D. and Lewis A. Hassell, M.D.
Validation of reportable rangesStandard 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
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