REGULATION,ACCREDITATION & LEGISLATION
BLOODBORNE PATHOGENS
1983: PROSPECTIVE PAYMENT SYSTEM
• For Medicare patients who 3stablish
payment based diagnosis related
groups (DRG)
o – patient classification
scheme
• Hospitals are paid a fixed amount per
DRG.
1984: DEFICIT REDUCTION ACT
• “DEFRA”
• Establish out-patient laboratory fee to
schedule control cost.
1988: CLINICAL LABORATORY Improvement
Act (CLIA) of 1988
• All laboratories must be certified by
the federal government with
mandated quality assurance,
personnel, and proficiency testing
standards.
1989: PHYSICIAN SELF-REFERRAL BAN
• Prevents the physician from referring
Medicare patients to self-owned
laboratories.
o Medicare - Insurance under
US Government
▪ 65 or older
▪ Disabilities
▪ End stage renal
disease (ESRD).
Example: dialysis and
transplant
1990: THREE-DAY RULE
CMS
• Payment for any laboratory testing
done within three calendar days
before admission as in-patient will not
be reimbursed.
o Testing is considered to be
part (hospital stay)
1992: OCCUPATIONAL EXPOSURE TO
• Establishes OSHA guidelines to limit
unnecessary exposure to biological
hazards.
OCCUPATIONAL EXPOSURE TO Hazardous
Chemicals
• Establishes OSHA guidelines to limit
unnecessary exposure to hazardous
chemicals.
1996: HEALTH INSURANCE PORTABILITY and
Accountability Act (HIPAA)
• This law protects patients from
inappropriate dispersion of personal
information.
• Access t Protected Health Information
(PHI)
Katumbas ng DATA PRIVACY ACT ang HIPAA
1997: OIG COMPLIANCE GUIDELINES
• OFFICE OF THE INSPECTOR GENERAL
– OIG
• Help the laboratories to develop
programs that promote high ethical
and lawful conduct.
o Billing practices
o Fraud abuse
AUGUST 24, 1998
• Physicians must know how to select
the most appropriate test’s needed
and should avoid the “shotgun”
approach to test ordering practices.
• Shotgun approach – taking test that is
not related to the patient’s condition.
o Response sa CMS
2001: CMS NATIONAL COVERAGE
DETERMINATIONS
• Replaced most local medical review
policies which are used to determine
whether laboratory tests are
medically necessary and
reimbursable.
Tulio, Joshua Patrick Lewis R.
2003: HAZARDOUS MATERIAL Regulations GOVERNMENTAL

• Deals with shipment o f blood and - EEOC – Equal employment opportunity

other potentially biohazardous commission
products. - FDA – Food and Drug Administration
- HHS - Department of Health and Human
2007: HI-TECH ACT
Services
• Contains incentives related to EEOC
adoption of healthcare information
technology and electronic health - Dealing with fair employment practices
record.
FDA (part of HHS)
o (EHR)
• Provides patients the access to their - Regulates and manufactures of biologics
PHI of which the access provided and medical devices and test kits.
within 30 days of the request.
HHS
LABORATORY0RELATED GOVERNMENTAL
- Oversees
AGENCIES

GOVERNMENTAL
GOVERNMENTAL
- CDC-Centers for Disease control and
prevention - NARA – National Archives and Records
- CMS - Centers for Medicare and Admin
Medicaid Services - NRC – Nuclear Regulatory Commission
- EPA – Environmental Protection - NIDA- National Institute on Drug Abuse
Agency

CDC (Centers for Disease control and

prevention) NARA

- For public health safety - Provides databases and access to the

✓ Under HHS – US DEPT OF HEALTH Federal Register
AND HUMAN SERVICES ✓ Where labs and other regulations
are published
CMS (Centers for Medicare and Medicaid
Services) NRC

- Largest healthcare medical programs in - Enforces federal guidelines for the proper
the U.S. use of non-military nuclear facilities.
✓ MEDICARE NIDA
✓ MEDIC AID
▪ Low-income individuals - Performing and maintaining quality
control for drug abuse testing.
EPA (Environmental Protection Agency)

- Enforces standards for disposal of

hazardous lab materials. NIOSH – National F Occupational Safety and
✓ Formalin Health
✓ Xylene NIH – National Institutes of Health
✓ Potential Carcinogen

Tulio, Joshua Patrick Lewis R.

NIST – National Institute of Standards and
Techonology
NIOSH (Part of HHS)
- Provides research, information, education,
and training in the field of occupational
safety and health.
- They can make recommendations but do
not have the authority to enforce them.
NIH
- World leader in medical research
NIST (Commerce department)
- Contributed to the development of many
health care products.
OIG – Office of Inspector General
OSHA – Occupational Safety and Health
Administration
DHS – Department of Homeland Security
OIG (Part of HHS)
- Responsible for auditing, inspecting, and
identifying fraud and abuse in CMS
programs.
OSHA (Part of US Department of Labor)
- Develops and enforces workplace
standards to protect employees’ safety
and health.
DHS
- It identifies, regulates, and may inspect
high-risk chemical facilities and radiation
sources that may be risks for terrorism.
NON-GOVERNMENTAL
AABB – American Association of Blood Banks
ASCP – American Society for Clinical Pathology
CAP – College of American Pathologists
AABB
- A peer professional group that offers a
blood bank accreditation.
ASCP
- Largest organization for laboratory
professionals and offers certification for
various specialties.
CAP
- Offers the largest proficiency program in
the US.
CLSI – Clinical and Laboratory Standards
Institute
COLA – Commission on Office Laboratory
Accreditation
TJC – The Joint Commission
CLSI
- Develops standardized criteria regarding
laboratory practices.
COLA
- Non-profit organization that provides
assistance to physician office laboratories
TJC
- A non-profit organization that accredits
nearly 17,000 health care organizations
and programs-based quality standards.
PHILIPPINES
NATIONAL PREFERENCE LABORATORIES
- A laboratory in a government hospital that
hhad been designated by the DOH to
provide special functions and services for
specific diseases.
Tulio, Joshua Patrick Lewis R.
 ✓ Confirmatory testing
✓ Training
✓ Research
✓ EQAS – External Quality Assurance
Specimen
✓ Validation of Fits and Reagents

LUNG CENTER OF THE PHILIPPINES (reference

laboratory)

- Clinical Chemistry

NATIONAL KIDNEY TRANSPLANT INSTITUTE

- Hematology
- Immunohematology
- Immunopathology
- Anatomical Pathology

EAST AVENUE MEDICAL CENTER

- Drug testing
- Water Microbiology

SAN LAZARO HOSPTAL

- STD/AIDS Central Cooperative Laboratory

- Serology

RESEARCH INSTITUE FOR TROPICAL

MEDICINE

- Microbiology (bacteria)
- Parasitology (parasites)
- Mycology (fungi)
- Virology (Virus)

Tulio, Joshua Patrick Lewis R.

QUALITY MANAGEMENT, QUALITY
ASSURANCE AND QUALITY CONTROL IN
CLINICAL LABORATORY
QUALITY
- Refers to the degree to which a set of
inherent characteristics of a product,
service or process fulfills requirements
and sets established standards.
1. Accuracy - Closeness of the measured
values to the true or accepted
reference values
2. Precision – repeatability of
measurements indicating consisting
consistency of results.
3. Reliability – the ability of the
laboratory to consistently produce
accurate and precise results overtime.
4. Traceability – the capability to link a
measurement result (validity of data).
5. Compliance – adherence to establish
standards, protocols, regulations
relevant to your laboratory activities.
6. Calibration and Maintenance –
calibrate and maintain your
equipment to get accurate and
reliable results (for equipment).
7. Documentation – proper
recording/documentation
QMS OR QUALITY MANAGEMENT SYSTEM
- Refers to the overall process used to
ensure that laboratory results meet the
requirements for health care services to
patients.
- Used b ISO and CLSI
12 QUALITIES SYSTEM ESSENTIALS
1. Organization – Leadership and
management
2. Customer Focus – (customer
surveys/feedback)
3. Facilities and Safety – (laboratory
design, floor plan, measurement)
4. Personnel – (MT, SMT, HOL
(pathologist), lab tech)
5. Purchasing and inventory (Reagents
and Calibrators)
6. Equipments – (maintenance,
calibration, service, and repair)
7. Process Management (QA and QC)
8. Documents and Records
9. Information Management – (patient
and sample identifier
10. Nonconforming event management
a. LIMS – Laboratory
Information Management
System
b. Laboratory errors must be
corrected (- = +)
11. Assessment (PT/EQA) – Check
reliability
12. Continuous Improvement – PDCA, Six
Sigma, Lean
QUALITY ASSURANCE (part of QMS)
- It is a procedure that focuses on providing
assurance thar quality requested will be
achieved and attained the best possible
product or service to patients.
✓ Confidence
✓ Quality requirements fulfilled
- Proficiency Testing
-quality assurance measure designed to
ensure that laboratories produce accurate
and reliable results. EQA
1. Laboratory will register for the
proficiency testing (PT)
2. Samples of unknown analyte is
distributed (DOH)
3. Testing and reporting of the results
Path of Workflow
- Laboratory must support an optimal path
off workflow by allowing processes that
yield efficient sample handling while
minimizing error.
1. Pre-analytical – Fasting
Samples, handling, transport
a. FBS (6-8 hrs)
b. TAG (12-14 hrs)
c. Choles (NF, 10-12 hrs)
2. Analytical – testing, actual
measurement. Calibration,
Tulio, Joshua Patrick Lewis R.
 maintenance, and quality Control
control.
- Substances having similar composition as
3. Post Analytical – records,
sample used to monitor the status of
reports, validation, data.
analysis.
3 signature from pathologist,
- Matrix is same with the sample.
RMT and QCO. For validation
- Test if the analyzer after calibration is
of results.
giving satisfactory result or not.
- They have value in range (Low, Normal,
High))
QUALITY CONTROL
- Can be obtained from the reagent or
- A process to periodically examine a instrument supplier or third-party control.
measurement procedure to verify that it is ✓ IQC: Daily
performing according to pre-established ✓ EQC: Once a month
specifications. - Calibration – every 5-6 months
- Measures the analytical phase (process - Quality control – daily
flow)
- Post-analytical phase
Reagents
Matrix
- Essential in laboratory analyses, helping to
- Background component of sample other
identify, quantify, or modify the properties
than the test to perform.
of substances.
- Calibrator and Control – should have the
- Reagent differs depending on the test
same matrix with sample.
being performed.
Calibrators (single/multiple parameters)
Analyte
- Solution of known concentration
- Substance or component being analyzed
- Must have the same matrix as sample.
or measured.
- Can be run in single or multiple
- Substance of interest
parameters.
✓ Hema
- Must be purchased separately.
✓ CC
- Expensive
✓ CM
✓ Liquid
✓ Lyophilized (powdered form) GOAL OF QUALITY CONTROL
- Calibrators are used for new batch of
Providing laboratory with confidence by:
reagents.
1. Detecting errors
Standards
2. Evaluating errors
1S = 1SP 3. Correcting errors

1 standard = 1 ___ parameter Due to:

- Solution of known concentration 1. System failure

- Matrix may or may not be same as 2. Environmental conditions
sample. 3. Operator (RMT) Performance
- Provided with kit. - BEFORE REPORTING THE PATIENT RESULTS
- Cost effective.

Tulio, Joshua Patrick Lewis R.

LEVEL-JENNINGS CHART (LJ) - QC ensures that whatever we have done is
as per the requirement, and that is why it
- Most common presentation for evaluating
falls under validation activity.
QC results.
- Allows a quick visual assessment of
method performance, including trend
detection.
- The mean value represents the target (or
expected) value for the result, and the SD
lines represent the expected imprecision
for the method.

- Note that results near the mean (average

value) occur more frequently than results
farther away from the mean.
- Note that a few results are greater than 2
SD, and two results slightly exceed 3 SD,
which is expected on the basis of a
Gaussian distribution of imprecision. For a
large number of repeated measurements,
the number resus expected within the SD
intervals is as follows: ±SD = 68.3% of
observations – ±SD = 95.4% of
observations – ±3 SD = 99.7% of
observation

QA vs. QC

Quality Assurance

- QA aims to prevent the defect.

- It’s a Preventive technique.
- In order to meet the customer
requirements, QA defines standards and
methodologies.
- It is a performed before Quality Control
- QA ensures that everything is executed in
the right way, and that is why it falls under
verification activity.

Quality Control

- QC aims to identify and fix defects.

- It’s a Corrective technique.
- QC confirms that the standards are
followed while working on the product.
- It is performed only after QA activity is
done.

Tulio, Joshua Patrick Lewis R.

Tulio, Joshua Patrick Lewis R.