Introduction to Laboratory Management by frouira




Laboratory Management
        Laboratory Information Systems (LIS)

       A lab information system ("LIS") is a class of
software that receives, processes, and stores
information generated by medical laboratory processes.
These     systems     often   must    interface  with
instruments and other information systems such
as Hospital Information System (HIS).
There are many laboratory disciplines requiring the
support of computerized informatics. These include:
•Blood bank donor center
•Blood bank transfusion
•Surgical Pathology
•Cytology (Cytopathology)
•Flow cytometry
  Basic operation

 Order entry and check in
       An order is placed in the system usually by a
physician or laboratory scientist. The order or lab request
contains a list of tests to be performed on one or more
patient specimens (e.g., blood or urine). In many cases,
each order is tracked with a unique identifier. This
identifier (which is usually a number) is often referred to
as Lab ID. In this hypothetical case, a CBC is ordered which
is a panel of sub-tests including white blood cell count, red
cell blood count and other blood-related tests.
Specimen receiving
     After the specimen is collected, it is sent/brought
 to the lab for processing typically in a batch. This
 event should be recorded in the LIS. On reception of
 the specimen in the testing lab, either manual or
 automated lab work can begin. Many tests, such as
 CBCs or Chemistry profiles, are performed by
 automated analyzers.
 Send test orders to analyzers
      Most LIS systems can be configured to download the
  specimen data to an analyzer either after the order is
  placed or when a specimen is received in a testing lab.
  When the specimen's barcode is read by the instrument,
  the unique ID from the specimen label is matched with the
  order previously downloaded to the instrument. This
  system is often called "Batch Download".
Results entry
     When results of lab tests are available, they are
 entered into the system manually or automatically
 downloaded from an instrument. Once these results
 are double-checked by the Medical Laboratory
 Scientist or auto verified, they are released. Released
 results are often automatically printed or written on
 lab reports which are delivered to the attending
 physician or clinic. Results must be verified and
 released to attending physicians as soon as possible.
Lab reporting
      Lab Reports are the final output of all LIS systems
 and, in many cases, the primary LIS interaction with
 healthcare professionals outside the lab. The reports
 can either be printed or faxed in paper-based labs;
 they can be delivered via email or file in paperless
 labs. The degree to which an LIS supports
 customizable lab reports and flexibility in modes of
 delivery of results is one major factor in determining
 its success in the marketplace.
 Patient Demographics
      Patient demographics form the core of the data for any
  medical institution. They allow for the identification of a
  patient and his categorization into categories for the
  purpose of statistical analysis.
 Date of birth, gender
 Birth year, gender, country, postal code, ethnicity, blood type
 Contact information (Name, Phone, Address)
 Emergency contact information, family doctor, insurance provider
               Method Evaluation
 Application of research for the laboratory

       Research the primary purpose for basic research (as
  opposed to applied research is discovering, interpreting, and
  the development of methods and systems for the
  advancement of human knowledge on a wide variety
  of scientific.
       it relies on the application of the scientific method, a
  harnessing of curiosity. It makes practical applications
  possible. Scientific research is funded by public authorities,
  by charitable organizations and by private groups, including
  many companies.
 Introduction to statistical analysis

            Measures of Central Tendency

MODE - is the most frequently occurring value.
Median - the midpoint of a distribution
Mean - the sum of the numbers divided by the
 number of numbers.
                Measures of Dispersion
o Measurements of central tendency (mean, mode and
  median) locate the distribution within the range of
  possible values, measurements of dispersion
  describe the spread of values.
  o the most commonly used method to evaluate the
        differences in means between two groups
 Interpretation of experimental studies
      Precision indicates how well a method or
 instrument gives the same answer when a single
 sample is tested repeatedly. Precision measures the
 random error of a method, which is the scatter in the
 Within-Run Precision - Within run precision provides
 an optimistic estimate of the expected daily
 performance of a method or instrument since there has
 been minimal opportunity for operating conditions to
 change during the analytical run. Both pooled patient
 sera and quality control samples can be used for
 precision studies.
Between run replication- is the best
 indicator of a method's overall precision
 because it measures the amount of random
 error inherent in the method from day to day
 and takes into account variable factors such as
 changes in operators, reagents and ambient
 operating conditions.
   Compliance and Regulatory Issue
 Regulatory/accrediting agencies, standards and regulations

o College of American Pathologists (CAP) Laboratory
  Accreditation Program
  Standards of Accreditation:

  The CAP's accreditation program is an internationally
  recognized program that is based on the exchange of
  professional information and inspection. Multi-disciplinary
  teams of professionals serve as inspectors, allowing CAP to
  intensely evaluate many different medical and health
o Clinical Laboratory Improvement Amendments

      Clinical Laboratory Improvement Amendments
  regulates the safety and effectiveness of clinical
  laboratory diagnostic testing.
  A laboratory is any facility that does laboratory
  testing on specimens derived from humans to give
  information for the diagnosis, prevention, treatment
  of disease, or impairment of, or assessment of
o ( CLSI ): Clinical And Laboratory Standards Institute

      The Clinical and Laboratory Standards Institute
  (CLSI) is a global, nonprofit, standards-developing
  organization that promotes the development and use
  of voluntary consensus standards and guidelines
  within the healthcare community. For healthcare
  professionals, CLSI documents offer practical
  operating guidelines that lead to consistent practices,
  precision, and efficient use of resources.
o The National Accrediting Agency for Clinical
  Laboratory Sciences (NAACLS)

      (NAACLS)  is committed to being the premier
  agency for accreditation and approval of educational
  programs in the clinical laboratory sciences and
  related healthcare disciplines through the
  involvement of expert volunteers and its dedication
  to public service.
o ( JCAHO ) stands for the Joint Commission on
  Accreditation of Healthcare

      Organizations, known commonly as the Joint
  Commission. It is an independent agency that certifies
  the performance standards of health care programs.
  The organization provides guidelines on laboratory
o The Health Insurance Portability and Accountability Act

       (HIPAA ) has had far-reaching implications across the
  health care industry, addressing patients' rights and
  holding hospitals and facilities more accountable in terms
  of protected health information. The law protects a
  patient's medical records and which parties may view
  them, giving the patient the final say in giving consent to
  facilities and doctors. Laboratories must follow similar
  protocols        for       protecting        patient       .

Training Workers

     Under HIPAA, all laboratory workers must be
 trained on procedures that facilitate patient
 confidentiality. All training received by laboratory
 staff must be documented with attendance taken at
 each session in order to maintain compliance with
 federal regulations. This is to ensure that every staff
 member working in a given facility understands the
 regulations set forth in HIPAA and is able to
 implement these standards in a compliant manner
 that protects the laboratory and the patient.
Disclosure of Information

      A facility must give full disclosure of protected
  health information, if required by law to do so,
  within 30 days of the patient's request or move the
  treatment process along. A laboratory may also
  release this information when payment or other
  health care operations are required or if consent has
  been granted by the patient. In almost all cases
  (insurance billing being an exception) patient consent
  is required before confidential medical records or
  test results may be disclosed to a third party.
Notification of Patient Rights

      Laboratory staff must adequately inform a
  patient of his HIPAA rights. This includes the filling
  out and signing of certain forms that disclose this
  confidentiality information to the patient with copies
  kept on file by the lab and a copy given to the
  patient. In signing the acknowledgment form, the
  patient is also giving the lab permission to view his
  medical records and to share any test results within
  the lab in order to facilitate his treatment.
o OSHA (Occupational Safety and Health Administration)

      (OSHA) is the government organization
  responsible for the safety of employees in the
  workplace. Created by the Occupational Safety and
  Health Act in the 1970's, OSHA works to prevent
  work-related injuries, illnesses and deaths while also
  enforcing safety related standards and practices by
o ( COLA ) - Commission on Office Laboratory

 COLA is the premier clinical laboratory education,
 consultation, and accreditation organization. They
 are an independent accreditor whose practical,
 educational standards have a positive and immediate
 impact. They offer clinical laboratory education to all
 types of labs - from large hospitals to POLs to home
 healthcare services - and provide education,
 coaching, and consulting to the entire staff - from
 nurses to medical assistants to testing personnel to
o Centers for Medicare & Medicaid Services (CMS)

  The Centers for Medicare & Medicaid Services (CMS)
  is an agency within the US Department of Health &
  Human Services responsible for administration of
  several key federal health care programs. In addition
  to Medicare (the federal health insurance program
  for seniors) and Medicaid (the federal needs-based
o Laboratory      Accreditation     Program       (LAP)

  The CAP’s Laboratory Accreditation Program (LAP)
  is the most respected and recognized accreditation
  program in the world. Throughout the decades,
  there has been tremendous growth in the number
  of LAP-accredited labs which verifies the pathology
  community’s trust in the CAP to promote continuous
  quality improvement. There is no other program in
  the world that exhibits the same quality and integrity
  as the CAP’s LAP program.
o Environmental Protection Agency ( EPA )

      was established on December 2, 1970 to
  consolidate in one agency a variety of federal
  research,      monitoring,     standard-setting   and
  enforcement activities to ensure environmental
  protection. Since its inception, EPA has been working
  for a cleaner, healthier environment for the American
Principles of Laboratory Management
• The average human being has an inherent dislike of work and will avoid it
  if he can.
• Because of their dislike for work, most people must be controlled and
  threatened before they will work hard enough.
• The average human prefers to be directed, dislikes responsibility, is
  unambiguous, and desires security above everything.
• These assumptions lie behind most organisational principals today, and
  give rise both to “tough” management with punishments and tight
  controls, and “soft” management, which aims at harmony at work.
• Both these are “wrong” because man needs more than financial rewards
  at work; he also needs some deeper higher order motivation – the
  opportunity to fulfil himself.
• Theory X managers do not give their staff this opportunity so that the
  employees behave in the expected fashion.
• The expenditure of physical and mental effort in work is as
  natural as play or rest.
• Control and punishment are not the only ways to make
  people work, man will direct himself if he is committed to the
  aims of the organisation.
• If a job is satisfying, then the results will be commitment to
  the organisation.
• The average man learns, under proper conditions, not only to
  accept but also to seek responsibility.
• Imagination, creativity, and ingenuity can be used to solve
  work problems by a large number of employees.
• Under the conditions of modern industrial life, the intellectual
  potentialities of the average man are only partially utilised.
 Identifies more than one responsibility for managers
 to choose to motivate

Only presents two extremes of managerial behaviour
        Blake and Mouton’s Managerial Grid

• The managerial grid model (1964) is a behavioral
  leadership model developed by Robert R.
  Blake and Jane Mouton. This model originally
  identified five different leadership styles based on
  the concern for people and the concern for
  production. The optimal leadership style in this
  model is based on Theory Y
Maslow's hierarchy of needs

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