unit 2: planning for management of clinical labs

Clinical Laboratory management planning

process of **assessing an organization's goals** and **creating a realistic, detailed plan of action** for meeting those goals.

road map

The basic steps in the management planning process involve creating a ___ that outlines each task the company must accomplish to meet its overall objectives

__**pre**__**-examination**/pre-analytica

* Patient prep
* Sample collection
* Personnel competency test evaluation
* Sample receipt and accessioning
* Sample transport

**examination**/analytical or post-exam

* Quality control testing

__**post**__**-analytical**

* Record keeping
* reporting

top management

**Planning:**

establishes context, scope, boundaries, and quality policy of QMS

quality objectives

**Planning:**

selected with programs established to achieve objectives

**core** processes

**Planning:**

QMS & their interactions

performance indicators

**Planning:**

established for the core processes

control

**Planning:**

established to ensure customer requirements are met

ISO 9001:2015

requires the organization to **plan, identify, and monitor**

interested parties

ISO 9001:2015:

the ___ that are **relevant** to the organization’s purpose and its strategic direction

external issues

ISO 9001:2015:

to consider ___ that could **impact their business strategy**, such as new technology and potential market forces

attention

**Importance of Planning in the Clinical Lab:**


1. Planning **focuses** ___ on the __objectives of the clinical laboratory__

risks of uncertainties

**Importance of Planning in the Clinical Lab:**


2. Planning **reduces** ___ on managing clinical labs

interdepartmental

**Importance of Planning in the Clinical Lab:**


3. Planning helps in **coordinating** ___ **goals and objectives** in the clinical labs

economical operation

**Importance of Planning in the Clinical Lab:**


4. Planning gains ___

operational costs

**Importance of Planning in the Clinical Lab:**


4. Planning gains economical operation and reduces ___

revenue

**Importance of Planning in the Clinical Lab:**


4. Planning gains economical operation and reduces operational costs and increases ___ in the clinical lab

controlling

**Importance of Planning in the Clinical Lab:**


5. Planning facilitates ___ by allocating resources appropriately, establishing standards of performance, and more effective financial management in the clinical lab

good succession planning programs

**Importance of Planning in the Clinical Lab:**


6. Planning helps executive development and ensures ___ for the clinical lab

path of workflow

**Planning the Workflow of Clinical Labs:**

* Planning in the clinical laboratory considers the **entire set of operations that occur in testing of patient samples**
* __begins__ with the **patient** and __ends__ in **reporting and results** interpretation.

quality

**Planning the Workflow of Clinical Labs:**

* **Planning in the context of Quality Management System** ensures ___ in the many __processes and procedures__ performed in the clinical laboratory
* the laboratory environment
* quality control procedures
* communications
* record keeping
* competent and knowledgeable staff
* good-quality reagents and equipment.

**WHO Quality Management Handbook**: Planning for the development of quality practices in a clinical laboratory in twelve areas

**Planning the Workflow of Clinical Labs:**

**transcends the Path of Workflow** from pre-analytical, analytical, to post-analytical flow processes in a clinical laboratory

Organization

**Focus of Planning in Critical Areas of Clinical Lab Management:**

* **Planning the structure and management** of the laboratory that implements the quality policies ensures **quality performance**

Personnel

**Focus of Planning in Critical Areas of Clinical Lab Management:**

* Diligently planning the most **important laboratory resource**, ensures **competent and motivated teams** in implementing quality management systems

Equipment

**Focus of Planning in Critical Areas of Clinical Lab Management:**

* planning the **acquisition and validation** of ___ by carefully and properly choosing, and ensuring maintained systems through **preventive maintenance programs** helps an __effective path of workflow__

Purchasing and Inventory

**Focus of Planning in Critical Areas of Clinical Lab Management:**

* Planning reagents and supplies management in the laboratory can produce **cost savings** ensures **supplies and reagent availability.**

Process controls

**Focus of Planning in Critical Areas of Clinical Lab Management:**

* Planning the ___ ensures **quality control** for testing, appropriate management of the sample, collection and handling, and method verification and validation.

Information Management

**Focus of Planning in Critical Areas of Clinical Lab Management:**

* Planning the **production of the main output** of the clinical laboratory (*information in the form of test reports*) **ensures accuracy, confidentiality, and accessibility** of the information which are managed through either __paper systems or computers__

Documents and Records

**Focus of Planning in Critical Areas of Clinical Lab Management:**

* planning the **creation and storage of documents** needed in the laboratory that informs how to do things ensures that documents are accurate, up to date, and accessible.

Occurrence Management

**Focus of Planning in Critical Areas of Clinical Lab Management:**

* Planning for detecting and managing detect these **problems**, handling them properly, learning from mistakes and acting so that __they do not happen again__

Occurrence

**Focus of Planning in Critical Areas of Clinical Lab Management:** *Occurrence Management*

* is an error or an event that **should not have happened**

Assessment

**Focus of Planning in Critical Areas of Clinical Lab Management:**

* a **tool** for examining laboratory performance and comparing it to standards, benchmarks or the performance of other laboratories.

internal

**Focus of Planning in Critical Areas of Clinical Lab Management:** *Assessment*

* performed **within** the laboratory using its own staff

external

**Focus of Planning in Critical Areas of Clinical Lab Management:** *Assessment*

* conducted by a group or agency **outside** the laboratory

Process Improvement

**Focus of Planning in Critical Areas of Clinical Lab Management:**

* Planning for **continuous improvement** of the clinical laboratory processes is a **primary goal** and must be __done in a systematic manner__ to ensure **alignment, effectiveness, and efficiency**

Customer Services

**Focus of Planning in Critical Areas of Clinical Lab Management:**

* Planning and benchmarking ___ ensures that that the laboratory understand and assess who their customers are and use **feedback for making improvements** to align with external changes

Security

**Focus of Planning in Critical Areas of Clinical Lab Management:** *Facilities and Safety*

* process of **preventing unwanted risks and hazards** from entering the laboratory space

Containment

**Focus of Planning in Critical Areas of Clinical Lab Management:** *Facilities and Safety*

* seeks to **minimize risks and prevent hazards** from leaving the laboratory space and causing harm to the community

Safety

**Focus of Planning in Critical Areas of Clinical Lab Management:** *Facilities and Safety*

* policies and procedures to **prevent harm** to workers, visitors and the community

Ergonomics

**Focus of Planning in Critical Areas of Clinical Lab Management:** *Facilities and Safety*

* addresses **facility and equipment adaptation** to allow **safe and healthy working conditions** at the laboratory

**determination** of objectives

**Qualities of a Good Planner:**

* Proficiency in the ___

imagination

**Qualities of a Good Planner:**

* Good judgment, ___, foresight and experience

accept changes

**Qualities of a Good Planner:**

* Ability to ___

opportunities and hazards

**Qualities of a Good Planner:**

* Ability to evaluate laboratory ___

**achievement** of the objectives

**Values Derived from Planning for Clinical Laboratory Management:**


1. The ___ of the clinical laboratories in the most **efficient and economical** manner.

accurate control

**Values Derived from Planning for Clinical Laboratory Management:**


2. The use of **efficient methods and the development of standards** necessary for ___ within the clinical lab

goal-directed actions

**Values Derived from Planning for Clinical Laboratory Management:**


3. **Integration of activities** of the different units in the clinical laboratory toward ___

reduction

**Values Derived from Planning for Clinical Laboratory Management:**


4. The ___ of emergency, unexpected problems, and management of risks in the clinical laboratory

**Indicators of Poor Planning**

1. Delivery **dates** **not met**
2. **Idle** machines
3. Materials **wasted**
4. Some machines doing jobs that **should be done
by **__**smaller**__ **machines**
5. Some laboratory **personnel** **overworked**, others are **underworked**
6. Skilled workers doing **unskilled work**
7. Laboratory Personne**l fumbling on jobs** for which they have not been trained
8. Quarreling, bickering, buck-passing and **confusion**

**Benefits of Good Planning**

1. Jobs turn out **on time**
2. **Good relationship** with other
departments
3. People using their **highest skills**
4. Workers know how their jobs **fit**
into the total pattern
5. **Machines doing their proper jobs**
6. Equipment in good shape
7. Materials available
8. Waste kept to a minimum

MBO Process

1. Define Organization **Goals**
2. Define **Employees Objectives**
3. Continuous **Monitoring** Performance & Progress
4. Performance **Evaluation**
5. Providing **Feedback**
6. Perfomance **Appraisal**

* Discussion
* Interaction
* Truly committed managers and involved employees in the decision-making process

MBO encourages ___

mission

**Hierarchy of Plans:**

organization’s **purpose and philosophy**

Objectives

**Hierarchy of Plans:**

**ultimate goal** towards which the activities of the organization are directed

Strategies

**Hierarchy of Plans:**

general **program of action** and deployment of resources

Policies

**Hierarchy of Plans:**

general **statement** or understanding which guide or **channel thinking in decision making**

Procedures

**Hierarchy of Plans:**

states a **series of related steps or tasks** to be performed in a sequential way

Rules

**Hierarchy of Plans:**

prescribes a **course of action** and explicitly states what is to be done

Programs

**Hierarchy of Plans:**

**comprehensive plan** that includes future use of different resources

Budgets

**Hierarchy of Plans:**

statement of **expected results** expressed **in numerical terms**

**Strategic** Planning

**Types of Plans:**

* the **identification** of the **mission** and of those **objectives**
* **most efficient** pursuit
* **long-term goals** for the next 5 years
* **top managers** with final authority and responsibility

**Tactical** Plans

**Types of Plans:**

* **action** and deals with the **method**(s)
* **Short-range** – strategy implementation (6 months – 2 years)
* **operational or technical** skill
* **middle managers** (__supervisory__ staff)

**Operational** Plans

**Types of Plans:**

* **detailed plan** used to provide
* team, section or department
* __**Very**__ **short-term** ( for the next 1 week to 1 year)
* Responsibility of **First-line managers**

common pathways

**Planning Lab Design:**


1. Ensure that patients and patient samples do not have ___

2. circulation paths

**Planning Lab Design:**


2. The design should have different ___ between the __public and biological materials__

Reception area

**Planning Lab Design:**


3. should be located as **close as possible to the entry door**

4. authorized personnel

**Planning Lab Design:**


4. Only ___ should have r**estricted access to rooms** where analyses of samples are done, and hazardous chemicals or other materials are stored

Access restriction

**Planning Lab Design:**


5. can be accomplished using signs on door locks and identification badges for staff

Sample **Collection** Areas

**Planning Circulation Pathways in the Clinical Lab:**

Reception area and sample collection room located at the patient’s **entrance**

Sample **Processing** areas

**Planning Circulation Pathways in the Clinical Lab:**

**separated** **from other sections** of the laboratory but nearby the testing areas

**Circulation** Pathways

**Planning Circulation Pathways in the Clinical Lab:**

* clean and dirty laboratory materials should never cross
* contaminated materials should be isolated

**Post-examination** Pathways

**Planning Circulation Pathways in the Clinical Lab:**

* communication system
* efficient & reliable
* transferring of messages

highly automated and manual processes

**Planning Spatial Consideration sin Designing the Lab:**

Laboratory sections (*e.g. Clinical Chemistry, Hematology, Coagulation*) which have ___

turn-around-time (TAT)

**Planning Spatial Consideration sin Designing the Lab:**

Laboratories with **greater** ___ and/or less volume, as well as those requiring special safety features (*e.g. Clinical Microbiology and radio-assay laboratories*) may be **removed from the central area.**

two rooms

**Planning Spatial Consideration sin Designing the Lab:**

**Location of room** with specific requirement such as:

* Molecular biology that needs ___
* Fluorescence Microscopy
* Ultraviolet illumination systems for DNA gel photography

blood bank and the critical care laboratory procedures

**Planning Spatial Consideration sin Designing the Lab:**

should be **readily accessible** to the emergency room, operating room, and ICU.

in-patient population

**Planning Spatial Consideration sin Designing the Lab:**

If the laboratory is serving an ___, **accessibility to corridors and elevators** providing access to the main patient care unit is **essential**

intra-laboratory traffic flow

**Planning Spatial Consideration sin Designing the Lab:**

must be **separated from the outside**. Provisions should be made for ambulatory patients and blood bank donors coming into the laboratory