Lab Man Week 4

As a lab manager, one needs to have a strong understanding of:

PATIENT and EMPLOYEE SAFETY

Hierarchy of Control

is a traditional method used to prevent workplace hazards.

An Important Infection Control Practice

Hand Hygiene

Chemical Hygiene Plan

Defines the policies and procedures for all chemicals used in the laboratory.

Physical Hazards and other Laboratory Associated Hazards

1.Ergonomics
2.Noise
3.Latex
4.UV light exposure
5.Radiation Safety
6.Radioactive Waste
7.Compressed gasses
8.Centrifuges
9.Dry ice
10.Fire prevention and safety

Who is responsible for regulations relating to general workplace safety and protecting the health of U.S. workers

OSHA

What is PT testing?

CLIA approved Proficiency Testing programs allow laboratories to evaluate their performance on a regular basis; usually 2 to 3 times a year. These programs also allow laboratories to improve the accuracy of the patient results they provide.

If proficiency specimens are not commercially available (most commonly seem in molecular testing)

vLaboratories can exchange blind split samples
vBlinded samples are measured or documented by independent means such as chart review

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF __

1996

PT is performed usually

two - three times a year

You __ share results with other laboratories

cannot

Requirements for PT

Must fulfill all standards
Keep Results for at least 2 years, signed by person who completed the PT, and lab director

A laboratory is defined as

any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.

Laborites that must be CLIA certified includes

cash only models and insurance model laborites

Analytes that do not have a Proficiency Testing program available must be evaluated at least __ a year

twice

What certificate types are available?

◻Certificate of Waiver

◻Provider Performed Microscopy

◻Certificate of Compliance

◻Certificate of Accreditation

Who needs a CLIA certificate?

Any person or facility that performs laboratory tests on human specimens for the purpose of diagnosis and/or treatment is required by federal law to have a CLIA certificate.

Certificate of Waiver

These tests have been approved by the FDA for home use and require very little training to perform.

What are Provider Performed Microscopy tests?

Tests performed by a health care provider such as a doctor, physician's assistant, or nurse practitioner. These tests include: microscopic sediment analysis, wet preps, KOH preps, and other microscopic based procedures.

Is proficiency testing required for Provider Performed Microscopy?

No, proficiency testing is not required for Provider Performed Microscopy. However, the quality of the tests performed must be evaluated at least twice a year.

What types of tests are classified under a Certificate of Compliance?

Moderate or high complexity tests

How often must analytes without a Proficiency Testing program be evaluated under a Certificate of Compliance?

At least twice a year

How frequently are facilities with a Certificate of Compliance inspected?

Every two years

What components must be included in the Quality Assurance program of a facility with a Certificate of Compliance?

Quality control, personnel policies, patient test management, and proficiency testing

What is a Certificate of Accreditation?

These certificates have the same standards as the Certificate of Compliance, but are inspected by a CMS-deemed professional organization, not CMS directly.

Who inspects Certificates of Accreditation?

A CMS-deemed professional organization, not CMS directly.

What are the requirements for testing personnel

For tests classified as waived or moderately complex, testing personnel must have at least a high school diploma or G.E.D. and documentation of training before performing tests.

For tests classified as high complexity, testing personnel must have an associate of science degree or higher and documentation of training before performing tests.

How often must all personel be evaluated

within six months of hire and annually after that.

Laboratories need to comply with requirements that pertain to their laboratory in order to maintain

licensure and accreditation

Compliance agencies

◦Centers for Medicare and Medicaid Services (CMS)
◦Occupational Safety and Health Administration (OSHA)
◦Food and Drug Administration (FDA)
◦College of American Pathologists (CAP)
◦Commission on Laboratory Assessment (COLA)
◦American Association of Blood Banks (AABB)

PURPOSE OF ACCREDITATION

To recognize quality
To inform the public that an institution has met minimum standardsTo improve the quality of patient care

Agencies review ____ of the laboratory operation.

all aspects

Identifies deficiencies as phase I or phase II
Two year cycle;

Year 1 self-evaluation
Year 2 on-site inspection
Cycle repeats again

What is a Phase I Deficiency in a CAP Inspection?

Requires a response

What is a Phase II Deficiency in a CAP Inspection?

Requires a response AND documentation that supports that response

AABB

◻Inspection every two years
◻For transfusion services (blood bank) only
◻Inspector is usually a blood banker from another accredited blood service
◻Deficiencies handled the same as CAP

NAACLS (National Accrediting Agency for CLS)

◻It is aaccreditation of educational programs for MLS

◻University/colleges and hospital programs

◻Accreditation can be awarded up to seven years

Clinical and Laboratory Standards Institute (CLSI)

◻CLSI is a World Health Organization Collaborating Center for Clinical Laboratory Standards and Accreditation.

Quality Control (QC)

uis the process by which one monitors analytical procedures in order to ensure the accuracy and precision of test results and thus the validity of patient results prior to their reporting

Quality control is accomplished by

monitoring QC materials such as serum, urine, and CSF alongside with patient samples

Internal QC involves the following:

Monitoring control results over time for changes in precision (random error) or accuracy (systematic error)

External QC involves the following

The comparison of a lab's assay results from unknown test samples with the mean results of those obtained on the same samples by other labs

QC material is prepared by

pooling either human or animal source body fluids.

Lot Switch

uIt is good practice to assay an old lot number of control alongside a new lot number of control when first using it.

Hospitals run levels of controls per ____

shift change, per instrument or batch run

Accuracy

a measure of how closely a test result agrees with the "true" value for that sample

Precision

A measure of how closely repeated measurement of a sample (replicates) agree with each other

Imprecision

Measurements do not closely replicate, and the SD will be larger

Reliability

A measure of both the accuracy and precision of a method

Central Tendency

Represents a large group of data points that are equal to or very nearly the same as one data point (cluster of data points) and are represented by a peak on a frequency diagram

Normal or Gaussian Distribution

Implies that there are approximately the same number and distribution of data points to either side of the peak (bell-shaped curve). Mean, median, and mode are approximately equal values

Mode

the most frequent number or value found in a data set.

Range

the difference between the high and low values of data in a data set.

Variance

A mathematical representation of the dispersion or degree of tightness of data points around the mean or peak in a data set. It is the square of the SD

Variance Formula (population)

Standard Deviation

the mathematical representation of the dispersion or degree of tightness of data points around the mean or peak in a data set. It is easily calculated by taking the square root of the variance

Confidence Interval (CI)

refers to the limits (high and low) between which a specified proportion of the data points in a data set will fall.
68% CI = mean +/- 1 SD
95% CI = mean +/- 2 SD
99% CI = mean +/- 3SD

Coefficient of Variation

the SD divided by the mean and multiplied by 100 to obtain a percentage.
% CV = SD/mean (100)

Levey-Jennings Charts

An approach to monitoring method performance for precision and long term accuracy

Trend

A small but steady and continuous change of the control values on one direction.

Often indicate reagent or calibrator deterioration or gradual instrumental failure

Shift

A change of the mean for the control material.

New mean is continuous but different from the original mean

Can be caused by resetting an instrument, a small but consistent flaw in the instrument, or a change of lot number of control

95% rule

Rule of thumb; the control value should fall within +/- 2 SD (95%) of the mean

Imprecision

large amount of scatter about the mean. Usually caused by errors in technique

Inaccuracy

may see as a trend or a shift, usually caused by change in the testing process

Random error

= no pattern. Usually poor technique, malfunctioning equipment

Westgard rules

"Multirule Quality Control"
Uses a combination of decision criteria or control rules
Allows determination of whether an analytical run is "in-control" or "out-of-control"

4 different areas that the LIS communicates between

–Laboratory LIS TEAM (all depts)

–Pharmacy

–Doctors Notes

–Nurse Notes

LABORATORY LIS requirements

Needs to be user friendly

Customizable

Secure of patient records

Cost-Effective

Bi-directional

Test Menu

Sample Requirements

Two different access codes or passwords per user for access to system

–User ID

–Unique password

–HIPAA mandated

Assign a ___ accession number to each patient sample received and/or each test ordered

unique

Provide a clear result screen page for each lab result that includes __/__ranges and flagging of critical values

normal/therapeutic

Provide a unique file for each assay that provides information about the assay

–Sample type, volume required, ranges, reference lab sent

(1/3) additional minimum requirements for LIS

Two different access codes or passwords per user for access to system

–User ID

– Unique password

–HIPAA mandated

Assign a unique accession number to each patient sample received and/or each test ordered

–M12345

Provide a clear result screen page for each lab result that includes normal/therapeutic ranges and flagging of critical values

Provide a unique file for each assay that provides information about the assay

–Sample type, volume required, ranges, reference lab sent

(2/3) additional minimum requirements for LIS

Record for each test such as time collected, rec’d, and initials or unique identifier of who received it, and who released results

Allow techs to create worksheets for testing

Create lists of pending logs and overdue tests

Print bar-code labels

Interface with major instruments so that demographics and tests ordered may be downloaded

(3/3) additional requirements for LIS

Allow for reports to be pulled

–Tests per month

–Workload units

–TAT (turn-around-times)

Allow for additional tests to be added to an existing order

Allow access to past laboratory tests

Allow for comments to be entered in the test results field

–Verified K level; Called to Dr. Robert Benson at 0100

Back up files daily

System components of LIS

Computer: hardware software date entry tools
Servers
Interface software

Electronic medical record contains

all patient information

Electronic LIs systems help with disease __

surveillance

LIS systems improve ___ ___

lab efficiency

new LIS system take how long to complete?

months to years

STEPS in LIS Acquisition

Define system Requirements

Request Bids

Request Demonstrations

Assign Staffing Roles

Implementation

Standard Operating Procedures

Data Security

Data Retention

Define System Requirements

Construct a workflow diagram and consider the data management requirements

Create a team of lead technologists who can provide insight on each lab section for reports

The __ is ultimately responsible for safe-guarding the health of its employees.

EMPLOYER

How long should a safety/incident report be maintained

30 years

R.A.C.E

Rescue, Alert/Alarm, Confine, Extinguish/Evacuate

P.A.S.S

Pull, Aim, Squeeze, and Sweep when using a fire extinguisher.

Safety Data Sheets (SDS),

previously called Material Safety Data Sheets must be provided to the laboratory for all chemicals received. Employers must provide the SDS to their employees.

Know the colors of the safety diamons

What are the types of fir extinguishers? class ABCD

Class A (water base) - for paper and wood

Class B (foam or dry chemical) – flammable liquid or gases

Class C (foam or dry chemical) – for electrical

Class D (graphite or dry chemical) – metal fires

Safety training and review records must be maintained during employee’s tenure and for ___ after the employee has left employment

3 years

Biosafety

addresses the safe handling and containment of infectious microorganisms, genetic material, and hazardous biological materials in order to protect employees and the general public.

Biosecurity

addresses the protection of infectious microorganisms, genetic material, and hazardous biological materials from intentional misuse, for example bioterrorism.

Infectious Disease Classifications

Cat. A: Infectious substance affecting humans. UN2814

Cat. A: Infectious substance affecting animals. UN2900

Cat. B: Infectious substance-biological substance. UN3373

Risk Assessment Cycle

1.Identify hazards
2.Evaluate associated risks
3.Determine controls to mitigate risks
4.Implement controls
5.Assess effectiveness of risk assessment