LABMNGT

ORGANIZATION

A collection of people working together under a defined structure for achieving a predetermined outcome

ORGANIZATIONAL DESIGN

Consists of four structural models; each component is specifically functioned to fulfill the mission and vision of the entire organization

FUNCTIONAL COMPONENT

shows the hierarchical organization level

LIST OF HIERARCHICAL ORGANIZATIONAL STRUCTURE

1. Laboratory Director
2. Chief Medical Technologist
3. Section Head
4. Medical Technician
5. Senior Medical Technologist
6. Junior Medical Technologist
7. Medical Technician
8. Laboratory Assistant

Laboratory Director

either a Pathologist/Physician trained in Laboratory Management

Chief Medical Technologist

works under the supervision of a Registered Pathologist works under the supervision of a Registered Pathologist

Section Head

works under the supervision of the Chief Medical Technologist

Medical Technician

a person who holds a bachelor’s degree in Medical Technology and works under the

supervision of a Registered Medical Technologis

some lab technicians are strictly phlebotomists while some perform less complex tests and procedures than medical technologists

Laboratory Assistant

assists the Medical Technologist or Lab Technicians whose activities should be limited to nontechnical procedures

SELF-CONTAINED

arranged along a common platform;

imperative to declare the subdivided area of work (specialty testing, clinical services, anatomic services, and transform services subsections)

MATRIX COMPONENT

merely shows different areas of work and the person assigned as section head; with this, each staff member can have

independent functions irrespective whether they are assigned to the hematology of clinical chemistry sections, or performing routine or special tests

NETWORK COMPONENT

reflects an information technology model; consists of units or realignment of works to reduce duplications and revenue generating services; some laboratories may have an affiliated lab or satellite lab, which are part of networking services

LEVEL OF AUTHORITY

literally means the commanding authority and one who is responsible for giving orders

Chief Pathologist

the director or person in charge of the clinical and anatomic laboratory; a duly Registered Physician who is specially trained in the methods of laboratory medicine and microscopic study of tissue, secretion, and excretion of human body and its function to diagnose and characterize disease of living patients; may also conduct autopsies

Dean / Department Head

has the authority to give orders and enforce policies

LEVELS OF COMMUNICATION

covered under special entity known as information management, which refers to the collection and management of information from sources and the distribution of that information to the audience

Policy Manual

states the laboratory and institutional policy for the guidance of those working in a laboratory

Policy Manual

examples: dress code, rules on food, relationships, etc.

Procedure Manual

consists of standard operating procedures or technical manuals

Administrative Manuals

working guidelines; safety manuals and quality management manuals

Manual procedures and collection instructions

book of instructions covering the ordering of tests, proper method of collection, transport and storage of specimens

The Laboratory User’s Manual

contains information about laboratory services

Laboratory Bulletins

include periodic laboratory bulletins and newsletters

DIVISION OF WORK

the designated function of a department to divide and delegate tasks or workload; it is the mandatory responsibility of a leader to avoid work confusion and complications and overlapping

HOSPITAL-BASED

Attached to a hospital and perform complete tests on patients

\
The head is the Chief Pathologist

WORKFLOW OF HOSPITAL-BASED

Receive specimen Assign laboratory number (Computer Registration) Analysis Tabulation of 2 or more results Verification by competent Pathologist Forward results to Physician/Nurse

SCHOOL-BASED

* Perform minor analysis and submit collected samples to private or -community laboratories for thorough analysis
* Headed by the Dean or Department Head

WORKFLOW OF SCHOOL-BASED

Sample analysis Forward laborious analysis to private or hospital laboratory Receive results the following day Forward results to school clinics Tabulation and Verification of result Forward to school clinic

CLINICAL PATHOLOGY LABORATORY (Hierarchy of Laboratory Staff from highest authority to lowest):

* Pathologist
* Clinical Laboratory Scientist / Medical Technologist
* Cytotechnologist
* Clinical Laboratory Technician
* Phlebotomist

ANATOMIC PATHOLOGY LABORATORY (Hierarchy of Laboratory Staff from highest authority to lowest):

* Pathologist
* Pathology Assistant
* Cytotechnologist
* Histotechnologist
* Histotechnician

Closed” Laboratory

equipped simply with the equipment that requires manual operation; services rendered are usually routine lab exams (urinalysis, fecalysis, and CBC); floor area is about 10 square meters

“Open” Laboratory

the discrete services are placed in one large room, where all the sections are confined; has a floor size of about 20 square meters; also classified as a secondary category laboratory’ can render all lab services and all equipment are manually operated and semi-automated, except that it cannot serve as a drug center

Core Laboratory

involves consolidation of various sections of the laboratory; has merging and novation of one or more sections

Regional Laboratory

specific low volume or expensive laboratory services are consolidated into one laboratory; services rendered require strict compliance with the regulation of the hospital

Regional Laboratory

also called hospital-based laboratory or clinical pathology laboratory

Reference Laboratory

a traditional full-service lab that handles all kinds of testing, especially esoteric tests

Example of reference laboratory in Philippines

* Reference Laboratory Services of Research Institute of Tropical Medicine (RITM)
* East Avenue Medical Center Reference Laboratory (for confirmatory drug testing)
* National Reference Laboratory for Measles and Dengue Virus, etc.

Point of Care Laboratory

testing is usually bought to the patient’s bedside; this service is offered by the hospital laboratory equipped with portable or handy equipment that can be used by the patient

STAT Laboratory

also known as “response laboratory”; often located in or near an emergency department or surgical suite; these services are available in some countries and in tertiary-based laboratories

Limited Service Laboratory

provides a limited number of routine and/or specialty services on a stat or non-stat basis; example if hospitals have a research lab rendering specific lab examinations

Essential to all aspects of health care are laboratory results that are

* accurate,
* reliable, and
* timely

Quality Management System Definition

* Coordinated activities to direct and control an organization with regard to quality (ISO,CLSI).
* All aspects of the laboratory operation need to be addressed to assure quality; this constitutes a quality management system.

Complexity of a Laboratory System

* preexamination
* examination
* postexamination

Path of Workflow

The patient → test collection → sample collection → Laboratory Analysis examination phase → report recreation → report transport

The entire process of managing a sample must be considered:

* the beginning: sample collection
* the end: reporting and saving of results
* all processes in between.

Laboratory tests are influenced by

* laboratory environment
* knowledgeable staff
* competent staff
* reagents and equipment
* quality control
* communications
* process management
* occurrence management
* record keeping

Twelve Quality System Essentials

set of coordinated activities that function as building blocks for quality management

Organization

Personnel

* human resources
* job qualifications
* job descriptions
* orientation
* training
* competency assessment
* professional development
* continuing education

Equipment

* acquisition
* installation
* validation
* maintenance
* calibration
* troubleshooting
* service and repair
* records

Purchasing and Inventory

* vendor qualifications
* supplies and reagents
* critical services
* contract review
* inventory management

Process Control

* quality control
* sample management
* method validation
* method verification

Information Management

* confidentiality
* requisitions
* logs and records
* reports
* computerized laboratory information systems (LIS)

Documents Records

Occurrence Management

* complaints
* mistakes and problems
* documentation
* root cause analysis
* immediate actions
* corrective actions
* preventive actions

Laboratory Assessment

* External
* Proficiency testing (EQA)
* Inspections
* internal accreditations

Process Improvement

* opportunities for improvement (OFIs)
* stakeholder feedback
* problem resolution
* risk assessment
* preventive actions
* corrective actions

Customer Service

* customer group identification
* customer needs
* customer feedback

Facilities and Safety

* safe working environment
* transport management
* security
* containment
* waste management
* laboratory safety
* ergonomics

Implementing Quality Management

does not guarantee a ERROR-FREE Laboratory But it detects errors that may occur and prevents them from recurring

Laboratory Quality Management System

Coordinated activities to direct and control an organization with regard to quality.

ISO 9000:2000

ISO

International organization for Standardization

ISO

* Guidance for quality in manufacturing and service industries


* Broad applicability; used by many kinds of organizations
* uses consensus process in developing standards

CLSI

Clinical and laboratory standards institute

CLSI

* Standards, guidelines and best practices for quality in medical laboratory testing
* Detailed; applies specially to medical laboratories

System Requirements

Model for QA in design, development production, installation, and servicing

Model for QA in design, development production, installation, and servicing

General requirements for the competence of testing and calibration laboratories

ISO 15189:2007

Quality management in the clinical laboratory

* The foundation of international medical laboratory quality management
* Medical laboratories–Particular requirements for quality and competence

HS1-A2 A Quality Management System Model for Health Care

* describes quality system model, 12 essentials
* aligns to ISO 15189 and parallels ISO 9000
* applies to all health care systems

GP26-A3 Application of Quality Management System Model for Laboratory Services

* describes laboratory application of quality system model
* relates the path of workflow to the quality system essentials
* assists laboratory in improving processes
* relates to HS1-A2 and ISO 15189

Quality management

applicable for the medical laboratory as it is for manufacturing and industry

Clinical Laboratory

“a facility for the biological, microbiological, hematological, biophysical, cytological, pathological or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings.” (CLIA ’88)

Laboratory Settings

* Hospitals “Traditional” laboratory
* Rapid Response Lab
* Stat Labs
* Point of Care Testing

More lab settings

* Clinics
* Reference labs
* Specialty labs
* General Reference labs
* Public Health Laboratories
* Federal (CDC)
* State Laboratory (WISLH)
* Industry
* Insurance Companies

Laboratory Sections

* Anatomic Pathology
* Histology
* Prepares and views tissue samples
* Cytology
* Clinical Pathology
* Chemistry
* Hemostasis
* Hematology
* Immunology
* Blood Banking
* Microbiology
* Urinalysis

General Staffing

* Medical Laboratory Scientist MLS
* Medical Technologist MT
* Clinical Laboratory Scientist CLS

Baccalaureate degree

* Medical Laboratory Technician MLT


* Clinical Laboratory Technician CLT

* Associate degree

* Clinical Laboratory Assistant CLA
* Histotechnologist
* Cytotechnologist
* Phlebotomist

Top 10 Reasons to Become a Clinical Laboratory Scientist

The Clinical Laboratory

The clinical laboratory is a facility where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis, and treatment of diseases. (AO 2007-0027)

Disciplines of Clinical Laboratory Tests

* Clinical Chemistry
* Hematology
* Immunohematology/Blood Bank
* Microbiology
* Immunology/Serology
* Clinical Microscopy
* Histopathology
* Cytology
* Toxicology
* Endocrinology
* Molecular Biology
* Cytogenetics

Regulation of Clinical Laboratories

Any person, firm or corporation, operating and maintaining a clinical laboratory shall register and secure a license annually at the Office of the Secretary of Health.

BASED ON OWNERSHIP:

* Government
* Private

BASED ON FUNCTION:

* Clinical Pathology
* Anatomic Pathology

BASED ON INSTITUTIONAL CHARACTER:

* Institutional-based
* Free Standing

BASED ON SERVICE CAPABILITY:

* Primary


* Secondary
* Tertiary
* Limited

Classification of Clinical Laboratories according to ownership

1. GOVERNMENT LABORATORY
2. PRIVATE LABORATORY

GOVERNMENT LABORATORY

Operated and maintained (partially or wholly) by the national government, a local government unit (provincial, city, or municipal), any other politic unit or any department, division, board, or agency

PRIVATE LABORATORY

Owned, established, and operated by any individual, corporate, association, or organization

Classification of Clinical Laboratories according to function

1. Clinical Pathology laboratory
2. Anatomic Pathology Laboratory

Clinical Pathology laboratory

Anatomic Pathology Laboratory

Classification of Clinical Laboratories according to service capability

PRIMARY

* Routine hematology (CBC)
* Qualitative platelet determination
* Routine urinalysis and fecalysis
* Blood typing (for hospital based labs)

SECONDARY

* Tests provided by a primary category laboratory
* Routine clinical chemistry (glucose, BUN, uric acid, creatinine, total cholesterol)
* Quantitative platelet determination
* Crossmatching, Gram staining, KOH (for hospital-based)

SECONDARY

* Tests provided by primary and secondary category labs
* Special chemistry • Special hematology (coagulation tests)
* Immunology
* Microbiology – Culture and Sensitivity \*Aerobic AND anaerobic (hospitalbased) \* Aerobic OR anaerobic (nonhospital based)

LIMITED

* For institutionbased laboratory only
* Provides the laboratory tests required for particular service in institutions (dialysis centers, social hygiene clinics)

The license (LTO)

The ___ shall be issued only to clinical laboratories that comply with the standards and technical requirements formulated by the BHFS.

Exempted from the licensing requirement but are required to register with the BHFS:

* Research laboratories
* Teaching laboratories
* Special clinical laboratories operating independent of a clinical laboratory
* National Tuberculosis Reference Laboratory of the National Tuberculosis Control Program (NTRL) and its regional TB reference laboratories performing TB culture (according to AO No. 2007-0027-A)