BACHELOR OF SCIENCE IN MEDICAL LABORATORY SCIENCE:

LABORATORY MANAGEMENT
COURSE MODULE COURSE UNIT WEEK
1 4 4
Information Management

 Read course and unit

objectives
 Read study guide prior to
class attendance
 Read required learning
resources; refer to unit
terminologies
 Participate in weekly
discussion board (Canvas)
 Answer and submit course
unit tasks

At the end of this unit, the students are expected to:

 Demonstrate proper communication skills and work ethics.
 Discuss the efficient work flow and laboratory operations through organized communication
system.
 Describe the basic contents of policy and procedure manuals
 Distinguish the importance of documents and records
 Identify the features of laboratory information system
  Discuss the importance of laboratory management
 Discuss the advantages and disadvantages of computerization
 Identify the features of laboratory information system
 Explain the information provided by the LIS

Clinical Laboratory Management, 2nd Edition Edited by L. S. Garcia ©2014 ASM Press, Washington,
DC doi:10.1128/9781555817282.ch23) page 451. (10 points will be coming from the reading in the AT)

Information management is a system that incorporates all the processes needed for effectively
managing data—both incoming and outgoing patient information.

Laboratory are loaded with information and effective communication is one of the most important skills
needed in pathology, to delivered the services effectively.

Communication can be defined a number of ways:

 The exchange of thoughts, messages, or information using speech, signals, writing, or behavior
 The art and technique of using words effectively to impart information or ideas
 A system, such as mail, telephone, television, or computer, for sending and receiving messages
 The exchange or transmission of ideas, attitudes, or beliefs between individuals or groups.

Importance of communication in the management theories

1. Chester I. Barnard wrote in 1938 in Functions of the Executive that the first executive function is to
develop and maintain a system of communication .

2. In The Management of Organizations, Hicks stated, “Organizational interaction depends on

communication. Communication is of prime concern to managers because it makes cooperative action
possible.

3. Peters and Waterman, in In Search of Excellence (10), state, “The nature and uses of
communication in excellent companies are remarkably different from those of their non - excellent
peers.

Communication and information flow or transfer throughout the healthcare setting are very
complicated. Information must be exchanged between internal departments, external departments,
external vendors and regulators, and the laboratory’s clients (customers). Any time the flow of
information is improved, the efficiency of the laboratory will be improved
Delivering the Message
Management should have a communication strategy—a plan that is used whenever the laboratory has
information that it wants to disseminate.

The purposes should include the education of all clients on:

 The appropriate utilization of laboratory services (test orders, frequency of test orders, specimen
collection and transport, testing turnaround times, report formats, additional report comments,
reference ranges, consultation options, and test limitations)
 The extent of services offered (test menu, test available for STAT testing, and comprehensive
test parameters)
 Regulations concerning the operation of the laboratory as well as any mandated communication
(hours of operation, performance of tests per shift, STAT reporting, critical value reporting, and
laboratory organization chart)

Elements of a communication plan:

 Define objectives and purpose of the plan.

o Use a concise message.
o Gear communication to education level of recipient

 Identify the structure and format of written communiqués.

o Design a format and use it as a template for all written communications.

 List recipients of laboratory communication.

o Identify all stakeholders who should receive communication (medical staff, laboratory
staff, administration, clients, computer services, patients, etc.).

 Identify the method(s) of communication.

o Written (memo, newsletter, email, specimen collection manual, etc.),
o Verbal (phone call, intercom, etc.)
o Visual (banner, poster, video, etc

Means and Mechanics of Effective Communication

Heller (5) wrote, “For effective communication, you must be aware of the means and the channels . . .
with which to transmit and exchange information.

Methods of communication
Action : Examples
Verbal : Telephone, intercom, face-to-face
Written : Memoranda, email, newsletter, flyer, manual
Visual : Videos, posters, presentation, personal digital assistants
Intradepartmental Communication
Laboratory managers must encourage a routine exchange of thoughts and messages between the
laboratory departments, management and staff, and different shifts. The laboratory’s organizational
structure is based on the disciplines of pathology and laboratory science, which may not always be
conducive to an open flow of information.

Interdepartmental Communication
The flow of communication beyond the laboratory includes that between the laboratory and the
institution’s administration (whether it is the vice president of clinical services or the office manager in a
physician’s office) and its clients (e.g., patients, physicians, and non-physician caregivers). Written
interdepartmental communication tends to be more formal than intradepartmental and needs to be
carefully structured.

External Communication
Entities external to the organization include insurance companies, the federal government, accrediting
agencies, competitors, and others. There are myriad regulations that affect a laboratory’s operation,
such as a license to operate and personnel policies.

Documents and records— what are the differences?

Documents provide written information about policies, processes and procedures.
Characteristics of documents:
 communicate information to all persons who need it, including laboratory staff, users and
laboratory management personnel;
 need to be updated or maintained;
 must be changed when a policy, process or procedure changes;
 establish formats for recording and reporting information by the use of standardized forms—
once the forms are used to record information, they become records.

Some examples of documents include a quality manual, standard operating procedures and job aids.

Records are the collected information produced by the laboratory in the process of performing and
reporting a laboratory test.

Characteristics of records :
o need to be easily retrieved or accessed;
o contain information that is permanent, and does not require updating.
 Some examples of records include completed forms, charts, sample logs, patient
records, quality control information and patient reports.
Documents include all the written policies, processes and procedures of the laboratory. In order to
develop laboratory documents, it is important to understand each of these elements and how they
relate to each other.
What is a policy?
A policy is “a documented statement of overall intentions and direction defined by those in the
organization and endorsed by management”.
1 Policies give broad and general direction to the quality system.

What is a process?
Processes are the steps involved in carrying out quality policies. ISO 9000 [4.3.1]2 defines a process
as a “set of interrelated or interacting activities that transform inputs into outputs”.

What are procedures?

Procedures are the specifi c activities of a process (ISO 9000 [3.4]). Procedures are very familiar to
laboratorians—a procedure is easily described as the performance of a test.

Job aids, or work instructions, are shortened versions of SOPs that can be posted at the bench for easy
reference on performing a procedure. They are meant to supplement, not replace, the SOPs.

Why are documents important?

Documents are the essential guidelines for all of the laboratory operations. Some of the important
documents that every laboratory should have include:
Quality manual—this is the overall guiding document for the quality system and provides the
framework for its design and implementation. A laboratory is required to have a quality manual for ISO
accreditation
SOPs—SOPs contain step-by-step written instructions for each procedure performed in the laboratory.
These instructions are essential to ensure that all procedures are performed consistently by everyone
in the laboratory.
Reference materials—good reference materials are needed in order to find scientific and clinical
information about diseases, laboratory methods, and procedures.

Documents in the laboratory.

 written clearly and concisely—it is better to avoid wordy, unnecessary explanations in the
documents;
 written in a user-friendly style—it might be helpful to use a standard outline so the general
structure will be familiar to staff and easily used by new personnel;
 written so as to be explicit and accurate, reflecting all implemented measures, responsibilities
and program
 maintained to ensure that it is always up to date.

What is a quality manual?

The quality manual is a document that describes the quality management system of an organization
(ISO 15189).
Its purpose is to:
 clearly communicate information
 serve as a framework for meeting quality system requirements
 convey managerial commitment to the quality system.
Writing a quality manual
When writing a quality manual, it is a good idea to use a steering committee. Because the quality
manual needs to be tailored to the specific needs of the laboratory, each facility should carefully
consider how to best involve those who are needed. Involve the policy makers for the laboratory. It is
also essential to involve the bench technologists, to take advantage of their expertise and get their buy-
in.
The quality manual should state policies for each of the twelve essentials of the quality system. Also
describe how all the related quality processes occur, and make note of all versions of procedures
(SOPs) and where they are located. For example, SOPs are a part of the overall quality system.
Although there are usually too many to include directly in the quality manual, the manual should specify
that SOPs be developed and indicate that they be compiled in the SOP manual.

The key points to remember about the quality manual are:

 there is only one official version
 the quality manual is never finished—it is always being improved
 it should be read, understood and accepted by everyone
 it should be written in clear, easily understood language • the quality manual should be dated
and signed by the management.

What is an SOP?
Standard operating procedures (SOPs)
SOPs are also documents, and contain written step-by-step instructions that laboratory staff should
meticulously follow when performing a procedure. A laboratory will have many SOPs, one for each
procedure conducted in the laboratory.

Written SOPs ensure the following.

1. Consistency—everyone should perform the tests exactly the same way so that the same result can
be expected from all staff
2. Accuracy—following written procedures helps laboratory staff produce more accurate results than
relying on memory alone because they will not forget steps in the process.
3. Quality—consistent (reliable) and accurate results are primary goals of the laboratory, and could be
considered as the definition of quality in the laboratory.

A good SOP should be:

 detailed, clear and concise, so that staff not normally performing the procedure will be able to do
so by following the SOP—all necessary details (e.g. ambient temperature requirements and
precise timing instructions) should be included;
 easily understood by new personnel or students in training;
 reviewed and approved by the laboratory management—approval is indicated by a signature
and a date (this is important to ensure that the procedures being used for testing in the
laboratory are those that are up to date and appropriate);
 updated on a regular basis.
Preparing SOPs
Firstly, it is important to assess the scientific validity of the procedure. Then, when writing the
procedure, include all steps and details explaining how to properly perform the procedure. The SOP
should refer to any relevant procedures that may be written separately, such as instructions for sample
collection or quality control. Finally, a mechanism should be established for keeping SOPs updated.

SOPs should include the following information:

 title—name of test;
 purpose—include information about the test (why it is important, how it is used, and whether it
is intended for screening, to diagnose, or to follow treatment and if it is to be used for public
health surveillance);
 instructions—detailed information for the entire testing process, including pre-examination,
examination and post-examination phases;
 name of the person preparing the SOP;
 signatures of approving officials and dates of approval—it is necessary to follow the laboratory’s
quality policy and regulatory requirements.

Pre-examination instructions should address sample collection and transport to the laboratory, and
conditions needed for proper sample handling

Examination instructions should address the actual step-by-step laboratory procedures to follow and
the quality control procedures needed to ensure accuracy and reliability.

Post-examination instructions should provide information on reporting the results, including the unit of
measurement to be used, the normal (reference) range, ranges that are life-threatening (sometimes
called “panic values”) and instructions for how to deal with an urgent report.

Manufacturer’s instructions
The instructions that manufacturers provide in their product inserts tell how to perform the test, but do
not include other important information that is specific to laboratory policy.
The manufacturer’s instructions may describe recommended quality control procedures for the test, but
the recommendations may not be as comprehensive as protocols that a laboratory has put into place.

What is a job aid?

A job aid is a shortened version of an SOP. It is designed for use directly at the testing site. It should be
placed in a visible location, and serves as a reminder of the steps that need to be completed. The job
aid and the SOP must include the same instructions.

Importance of records
Records are laboratory information, either written by hand or computer-printed. They are permanent,
and are not revised or modified. They should be complete, legible and carefully maintained, as they are
used for many purposes, such as:
 Continuous monitoring—without access to all the data collected as a part of a quality system
process, continuous monitoring cannot be accomplished.
  Tracking of samples—well-kept records allow for tracking of samples throughout the entire
testing process; this is essential for troubleshooting, looking for sources of error in testing and
investigating identifi ed errors.
 Evaluating problems—well-kept equipment records will allow for thorough evaluation of any
problems that arise.
 Management—good records serve as a very important management tool.

Examples of laboratory records

 sample logbook, registers;
 laboratory workbooks or worksheets;
 instrument printouts—maintenance records;
 quality control data;
 external quality assessent or profi ciency testing records;
 patient test reports;
 personnel records;
 results of internal and external audits;
 continuous improvement projects;
 incident reports;
 user surveys and customer feedback;
 critical communications (e.g. letters from regulatory agencies, government or administrative
offices within the health care system).

The following is a list of test report contents required by ISO 15189:

 identification of test;
 identification of laboratory;
 unique identification and location of patient, where possible, and destination of the report;
 name and address of requestor;
 date and time of collection, and time of receipt in laboratory;
 date and time of release of report;
 primary sample type;
 results reported in SI units or units traceable to SI units, where applicable;

 applicable comments relating to quality or adequacy of sample, methodology limitations or other
issues that affect interpretation;
 identification and signature of the person authorizing release of the report;
 if relevant, notation of original and corrected results.

Storing documents and records

Storage must be given careful consideration, as the main goal of documentation is finding the
information when it is needed.

Record retention
Retention times for records should be determined in each laboratory, based on a number of factors:
 the length of time the laboratory will need to have access to its records;
 government requirements or standards that dictate record retention times;
 whether the laboratory is engaged in ongoing research requiring many years of data;
 the time interval between the laboratory’s assessments or audits.
Information Management system
Laboratory directors need to ensure that the laboratory has an effective information management
system in place in order to achieve accessibility, accuracy, timeliness, security, confidentiality and
privacy of patient information.

Important elements
 unique identifiers for patients and samples
 standardized test request forms (requisitions)
 logs and worksheets
 checking processes to assure accuracy of data recording and transmission
 protection against loss of data
 protection of patient confidentiality and privacy
 effective reporting systems
 effective and timely communication

Common problems occur when managing laboratory information.

 incomplete data for test interpretation, or insufficient or illegible identification— systems should
be designed to minimize this occurrence; for example, when using electronic systems, it is
possible to design fields so that if information is missing, data entry cannot be completed;
 forms that are inadequately designed to meet laboratory and client needs;
 standardized forms prepared by others that may not be suitable for all laboratories;
 inability to retrieve data due to poor archiving processes or insufficient backup of computerized
information;
 poor data organization, which may hinder later data analysis efforts to meet research or other
needs;
 incompatibility between computerized information systems and equipment or other electronic
systems, resulting in problems with data transmission.

LABORATORY INFORMATION SYSTEMS

A laboratory information system (LIS) is a computer network of hardware and software for receiving,
processing, and storing laboratory data and information. It can interface with laboratory instruments to
transfer data into patient records, evaluate quality control data, and store preventive maintenance
records. In addition, an LIS can interface with an HIS, pathology information system, and other
information systems.

Components of an LIS
1. The LIS software user interface determines how the user will interact with the system. It will have
specific screens for entering data, sending reports, reporting results, etc. The software will have
features such as security, access control, file maintenance, etc

2. Request entry: Requests for laboratory tests to be performed can be entered through clients located
in the nursing units or remote primary care practitioner's office. In the case of outpatients, requests can
be entered when the patient arrives at the laboratory.
3. Data (results) entry
a. Electronic data interface (EDI) connections between an LIS and a clinical instrument allow
automatic transfer of patient test results to the LIS.
b. Manual data entry: Laboratory scientist enters patient results at a client
c. Release patient results: The results are added to the LIS, but they are not released to clients
outside the laboratory until the results and quality control are reviewed and verified.
Alternatively, autoverification can be used. In this case, the computer uses a set of instructions
to determine if the results should be released. Because the results are not held up for manual
review, autoverification is quicker. To help with verification, reference ranges and panic values
can be programmed into the LIS.
d. Point of care testing: Portable laboratory instruments, like handheld analyzers, can connect to
an LIS via a wireless connection.
4. Data storage
a. Redundant arrays of independent disks (RAID): LISs are regulated by the Food and Drug
Administration, and they are required to have mirrored hard drives. Data are stored on two
separate hard drives of the LIS server.
b. System backup: Each day the data are to be copied to a tape, or other portable storage
device, and removed from the laboratory.

5. System security: Ongoing procedures to ensure the security of patient data and user profiles
(usemames and passwords) to prevent unauthorized access must be in place. Users should have
access only to the patient information and LIS functions needed to perform their job (minimum
necessary use). Antiviral software (e.g., McAfee and Norton) should be installed to protect the system
from harmful malware, especially for networks with a Windows operating system.

6. Barcoding can facilitate processing of clinical specimens.

7. Interface: The LIS can be connected to clinical instruments and other information systems through an
EDI. An interface is typically bidirectional, meaning information is sent to and from the instruments and
the information systems. With a unidirectional interface, analyte results from an instrument are sent to
the LIS, but the LIS cannot send requests to the instrument. So that instruments and computers used in
healthcare can communicate with each other, the Health Level 7 (HL7) communication standard was
adopted. HL7 is an international committee formed in 1987 to formulate data standards, a set of rules
that allow healthcare information to be shared and processed in a uniform and consistent way.

8. Manual procedures: If the computer system goes down, a contingency plan for manual procedures
and forms needs to be in place.

9. System maintenance: LISs need to be shut down (taken offline) periodically for software upgrades
and other maintenance. Occasionally, the system will become nonresponsive (crash).

10. Disaster recovery: Every laboratory needs a plan to restore the system after system disruption by a
storm, fire, or other hardware damaging situation.
Information Provided by an LIS
 1. Patient demographics
2. Work lists
3. Data retrieval (inquiry)
a. Generate patient results: Flag critical values, print reports if requested, etc.
b. Perform delta checks: Results of an analyte assay are compared to the most recent
previously performed results on the same patient
c. Patient results can be retrieved electronically at a client or via the Internet with a Web
browser.
4. Reflex testing: If an initial test result is positive or outside normal parameters, the LIS can
automatically order a second appropriate test.

5. Current procedural terminology (CPT) codes: The CPT codes describe medical, surgical, and
diagnostic services and are designed to communicate information about medical services and
procedures among physicians and other healthcare professionals. CPT codes are used for
billing purposes and can be programmed into the LIS.

6. Quality control: An LIS can analyze quality control specimens and prepare charts and reports
(e.g., Westgard rules, Levey-Jennings charts).

7. Quality assurance can provide reports on turnaround time, documentation of critical result
reporting, and corrected reports.

8. Management reports: Cost per billable test calculations, test volume, turnaround time,
employee hours, workload data, etc.

9. Encoding systems: Systemized Nomenclature of Medicine—Clinical Terms (SNOMED—CT)

is a comprehensive database of standardized terminology for healthcare. Once implemented, it
will allow automatic data analysis over a wide range of clinical information systems. Logical
observation identifiers names and codes (LOINC) is another database of universal standards for
healthcare.
.
Selecting an LIS
1. The process begins with a laboratory needs assessment, where data are collected on the information
needs of the laboratory.
2. Needs are analyzed to determine feasibility of a system and what is needed to get the job done.
3. Laboratory managers and administrators form a committee and prepare a request for proposal
(RFP). The RFP contains information about the laboratory facility, lists specific requirements needed in
an LIS, and poses questions about LISs. This information may include interface capabilities tohospital
information systems and laboratory instruments, remote user access, system requirements, custom
features, hardware and software maintenance contracts, etc. The RFP is distributed to vendors.
4. Vendors will respond to the RFP describing how their systems will meet the needs of the laboratory
and the estimated cost of the systems.
5. The RFP responses will be reviewed by the committee. To prevent information overload and
confusion, only a few of the vendors, those that submitted an RFP response that match the needs
assessment, should be selected to give demonstrations.
6. Vendor demonstrations and visits to other laboratories using the systems help narrow the choices.
Vendor demonstrations should be scheduled within a short time frame so that information is fresh in
everyone's mind.
7. Selection is based on the system that can best meet the laboratory's needs at the lowest cost (i.e.,
the cost does not outweigh the benefit).

Installation
1. The installation process is important and very time-consuming. It is critical to identify any errors early
in the process before the system is activated (goes live).
2. Vendor representatives will install the server, clients, network connections, and software.
3. Testing: A thorough test of individual components (unit test) and a test of the system (integration
test) are performed.
4. Training laboratory personnel and other healthcare providers on the LIS is an expensive process. It
is important to discuss this with the vendor before accepting a proposal. Management needs to know
how many people the vendor will train. It will become the responsibility of the laboratory personnel
receiving training to train others. Training will also be needed for healthcare providers outside the
laboratory.
5. Communication: Before the LIS goes live, it is important to communicate to all members of the
healthcare team about the planning and timeline of the process.

Advantages of computerized systems

 Error reduction—. It will also provide information that is legible.
o Quality control management—it becomes easy to keep good quality control records,
perform analysis on quality control data and generate statistics automatically.
 Provision of options for data searching—a variety of parameters can be used for data retrieval;
 Access to patient information—most computer systems allow access to all recent laboratory
data for a patient. This is very useful in the process of checking the most recent results against
previous data to look for changes, which is a good practice and helps to detect errors
 Generate reports—it is easy to generate detailed, legible reports quickly.
  Ability to track reports—a computer system makes it much easier to track reports, to know
when work was finished, who performed the work, when the data was reviewed and when the
report was sent.
 Ability to track and analyze trends—the computer and its databases provide very strong search
capabilities and, with careful design, it will be possible to retrieve and use large amounts of data
effectively to track and analyze trends of various kinds.
 Improved capability for maintaining patient confidentiality—it is often easier to maintain
confidentiality of laboratory data when using a computer than when dealing with a handwritten
report form, if computer user codes are established to control access to the data.
 Financial management—some systems will allow for financial management; for example,
patient billing.
 Integration with sites outside the laboratory—a LIMS can be set up so that data comes into the
laboratory system directly from a patient or client registration point. Data can be transmitted to
many sites or interfaces as needed. Results can be provided directly to computers accessible to
the health care provider or public health official. Computers can handle data entry into a national
laboratory database and almost any other data application that is needed.
 Manufacturer-provided training—purchased LIMS often include on-site training for staff. To
make the full use of the system, it is essential that either on-site training of all staff, or training at
the manufacturer’s headquarters, is provided.
Disadvantages
 Training—personnel training is required and, because of the complexity of LIMS, this training
can be time-consuming and expensive.
 Time to adapt to a new system—when starting up a computer system, it may seem inconvenient
and unwieldy to laboratory staff. Personnel accustomed to manual systems may be challenged
by such tasks as correcting errors, and uncertain of how to proceed when encountering
situations where a field must be filled in.
 Cost—purchase and maintenance are the most expensive parts of a computerized system, and
the costs can be prohibitive in some settings.
 Physical restrictions—adequate space and dedicated electrical requirements are necessary, as
well as placement of the computer away from heat, humidity and dust.
 Need for backup system—all computer information must be carefully backed up. Loss of data
due to a damaged disk or system crash cannot be tolerated, and backup systems will be critical.

Communication Exchange of thoughts, messages, or information (through speech, signals,

writing, or behavior); art and technique of using words effectively to impart information or ideas;
system, such as mail, telephone, or television, for sending and receiving messages; exchange or
transmission of ideas, attitudes, or beliefs between individuals or groups.

External communication Occurs with entities outside of the organization (e.g., insurance
companies, regulatory agencies, accreditation organizations).
Intradepartmental communication Occurs within the laboratory between management, sections
or divisions, and work shifts. Tends to be informal.

Information management is a system that incorporates all the processes needed for effectively
managing data—both incoming and outgoing patient information

Job aid is a shortened version of an SOP. It is designed for use directly at the testing site. It should be
placed in a visible location, and serves as a reminder of the steps that need to be completed.

Laboratory information system (LIS) is a computer network of hardware and software for
receiving, processing, and storing laboratory data and information

Manufacturer’s instructions. The instructions that manufacturers provide in their product inserts tell
how to perform the test, but do not include other important information that is specific to laboratory
policy.

Turnaround time (TAT). The interval between the beginning of one event and the end of another
event in the total testing process.

The Laboratory Information System: Making the Most of It in the Clinical Microbiology Laboratory
Joseph M. Campos. Clinical Laboratory Management, 2nd Edition Edited by L. S. Garcia ©2014
ASM Press, Washington, DC doi:10.1128/9781555817282.ch24… page 458

 Create / make a requisition and reporting form with a complete information needed by a
physician
 Submit an example of an SOP with ISO standard format.
 What are the impacts of LIS in relation to covid pandemic . (minimum of 150 words)
 Read in advance the topic for next session “Management of Change” and be ready for the
pre -test.

Clinical Laboratory Management, 2nd Edition Edited by L. S. Garcia ©2014

ASM Press, Washington, DC doi:10.1128/9781555817282.ch24

WHO Library Cataloguing-in-Publication Data Laboratory quality

management system: handbook.

Microbiology Laboratory Manual Online. Department of Microbiology, Mount

Sinai Hospital Joseph and Wolf Lebovic Health Complex, Toronto, Ontario, Canada (http://www.
mountsinai.on.ca/education/staff-professionals/microbiology).
APHL. Guidebook for implementation of laboratory information systems in resource poor settings.
Association for Public Health Laboratories, 2006 (http://www.aphl.org/aphlprograms/
global/initiatives/Pages/lis.aspx). Bentley D. Analysis of a laboratory information management
system (LIMS). University of Missouri, St Louis, MO, 1999 (http://www.umsl.edu/~sauterv/
analysis/LIMS_example. html#BM1_).

Ciulla, Anna P. Success in Clinical Laboratory Science, (4th ed.). New Jersey: Pearson Education,
Inc., 2010