unit 8: equipment & inventory management

Equipment Management

ensure accurate, reliable and timely testing

* maintain **high level of lab performance**
* reduces **variation** in test results
* improves **confidence** in accuracy of results
* lowers repair **costs**
* lengthens **instrument life**
* reduces **interruption** of services
* increases **safety**
* greater **customer satisfaction**

Equipment Management Benefits

* selection & purchasing
* installation
* calibration & evaluation
* maintenance
* troubleshooting
* service & repair
* reiting & disposing

Equipment Management Program Considerations

**Why and how will** the equipment be used?

### Selecting Equipment: *Criteria to Consider*

The instrument should be matched against the service the laboratory provides

What are the **performance characteristics** of the instrument?

### Selecting Equipment: *Criteria to Consider*

Is it sufficiently accurate and reproducible to suit the needs of the testing to be done?

What are the facility **requirements**?

### Selecting Equipment: *Criteria to Consider*

requirements for physical space

* Will the **cost** of the equipment be **within the laboratory’s budget**?
* Will reagents be **readily available**?
* Will reagents be provided **free of charge** for a limited period of time? If so, for how long?
* How **easy** will it be for staff **to operate**?
* Will instructions be available in a **language** that is understood?
* Is there a **retailer** for the equipment in the country, with available services?
* Does the equipment have a **warranty**?
* Are there any **safety issues** to consider?

### Selecting Equipment: *Criteria to Consider*

Others

* Is it better to **purchase or lease** equipment?
* Factor in **repair costs**
* Manufacturer should provide all of the necessary **information to operate and maintain equipment**
* Consider **savings** that could be negotiated if the laboratory needs **more than one piece of equipment**

### Acquiring Equipment

Things to Consider

Lease Plans

### Acquiring Equipment

* **periodic** payments are made
* usually 3-5 years
* purchased or leased for **longer periods at reduced rate**

Rental Plans

### Acquiring Equipment

* **periodic** payments are made
* without purchase option
* the equipment is **returned**
* **another rental** is agreed or it is metered

wiring **diagrams**, computer **software** information, a list of **parts** needed, and an operator’s **manual**

### Acquiring Equipment: *Before purchasing, ask if*

___ are **provided**

install the equipment and train staff

### Acquiring Equipment: *Before purchasing, ask if*

the manufacturer will **___** as part of the purchase price

trial period

### Acquiring Equipment: *Before purchasing, ask if*

the warranty includes a ___ to verify that the instrument performs as expected

manufacturer’s maintenance

### Acquiring Equipment: *Before purchasing, ask if*

the ___ can be included in the contract and, if so, whether maintenance is provided on a regular basis

Replacement

### Acquiring Equipment: *New Equipment Justifications*

equipment **can not be** **repaired or excessive cost of repair** results in unacceptable delays

Increased workload

### Acquiring Equipment: *New Equipment Justifications*

volume increase justifies either **automation or additional personnel**

Cost reduction

### Acquiring Equipment: *New Equipment Justifications*

**reduction of operational expenses** state primarily in terms of personnel and supplies

New and/or improved methodology

### Acquiring Equipment: *New Equipment Justifications*

better patient care

Essential

### Acquiring Equipment: *Priority Need*

needed **immediately** to maintain quality patient care

Necessary

### Acquiring Equipment: *Priority*

as “**essential**” but **greater leeway** with regard to time of acquisition

Desirable

### Acquiring Equipment: *Priority*

means of reducing **cost**

Others

### Acquiring Equipment: *Priority*

means of improving **general working condition**

* verify that all **physical requirements** have been met
* consider **vendor’s responsibilities** for installation
* checklist of the **expected performance specifications** should be developed

### Installing Equipment

maintenance and operation programs

### Getting Equipment Ready for Use:

Assign **responsibility** for performing ___

use of parts and supplies

### Getting Equipment Ready for Use:

Develop a **system** for recording ___

**calibration, performance verification, and proper operation** of the equipment

### Getting Equipment Ready for Use:

Implement a **written plan** for ___

scheduled maintenance program

### Getting Equipment Ready for Use:

includes __daily, weekly and monthly__ maintenance tasks

Provide **training** for all operators

### Getting Equipment Ready for Use:

___ to **properly use the equipment** should be authorized as operators

initial calibration

### Equipment Calibration:

Follow the manufacturer’s **directions** carefully when performing ___

Calibrate

### Equipment Calibration:

___ **with each test run**, when first putting it into service

stability and the manufacturer’s recommendation

### Equipment Calibration:

Determine how often the instrument will need to be **recalibrated**, based on its ___

working correctly with respect to **accuracy and precision**

### Performance Evaluation

Prior to testing patient specimens, it is important to **evaluate the performance of new equipment** to ensure it is ___

quality control solutions

### Performance Evaluation

To check precision

parallel testing and compare it with another method

### Performance Evaluation

To check accuracy

ability to **detect disease** and to determine **normal and reportable ranges**

### Performance Evaluation

Test methods using kits or laboratory instruments need to be evaluated for the ___

get the **same results** using the kits or equipment

### Performance Evaluation: *Verification*

laboratories need to **verify** the manufacturer's performance claims, and demonstrate they can ___

**comparing** the results to the expected or certified value

### Performance Evaluation: *Verification*

testing samples with **known** values and ___

stability and uniformity

### Performance Evaluation: *Verification*

If equipment is **temperature controlled**, establishing the ___ of the temperature

Validation

### Performance Evaluation: *Verification*

can be carried out by running samples in __parallel__ using **both old and new equipment** and methods for a period of time to determine that the expected results can be obtained.

* Preventive maintenance
* Provision for inventory
* Troubleshooting
* Repair of equipment

Maintenance Plan

Preventive maintenance

### Maintenance Plan

comes **before a failure**, while the equipment is in **operating condition**

Repair

### Maintenance Plan

* applies to **unscheduled maintenance**
* comes after the instrument has **failed**

Calibration

### Maintenance Plan

* assurance that the instrument **measures certain parameters within specified tolerance**
* considered part of preventive maintenance

oversight

### Initial Steps in Implementing Equipment Maintenance Plan

assigning **responsibility** for providing ___

written **policies and procedures**

### Initial Steps in Implementing Equipment Maintenance Plan

___ including **routine maintenance plans** for each piece of equipment that specify the frequency with which all maintenance tasks should be performed

format

### Initial Steps in Implementing Equipment Maintenance Plan

___ for records, creating logs and forms, and establishing the processes to maintain records

training staff

### Initial Steps in Implementing Equipment Maintenance Plan

on the use and maintenance of the equipment, and ensuring that all staff understand their specific responsibilities

Preventive Maintenance

### Maintenance Plan

* includes measures such as __systematic and routine cleaning, adjustment and replacement of equipment parts at scheduled intervals__
* should be performed at **regular intervals**: daily, weekly, monthly or yearly

* **inaccurate test results** due to equipment failure
* **delays** in reporting results
* low productivity
* **large repair costs** (on the lab owners)

### Maintenance Plan: *Preventive Maintenance*

ensures that the equipment performs at **maximum efficiency** and will **increase the lifespan** of the equipment and help to prevent:

Equipment Inventory

### Maintenance Plan

* should keep an **inventory log** of all equipment in the laboratory
* log should be updated with **information on new equipment** and include **documentation of when old equipment is retired**

Instrument type, make and model number, and serial number

### Maintenance Plan: *Inventory*

so that any problems can be discussed with the manufacturer

new, used or reconditioned

### Maintenance Plan: *Inventory*

Date the equipment was purchased, and whether it was purchased ___

documentation

### Maintenance Plan: *Inventory*

Presence or absence of ___, spare parts and maintenance contract

expiration date

### Maintenance Plan: *Inventory*

Warranty’s ___

year of acquisition

### Maintenance Plan: *Inventory*

Specific inventory number indicating the ___

Troubleshooting

### Maintenance Plan

Needed when there are changes such as:

* **Drift** in quality control or calibrator values
* **Obvious flaws** in equipment function
* Equipment **fails to operate**

* Arrange to have access to backup instruments
* Ask the manufacturer to provide a replacement instrument during repairs
* Send the samples to a nearby laboratory for testing

\--

* **Do not use faulty equipment!** Seek help from the manufacturer or other technical expert. Place a note on the equipment so all staff are aware that it is not in use

### Maintenance Plan: *Troubleshooting*

If problems cannot be identified and corrected in-house, attempt to find a way to continue testing until the equipment can be repaired?

Service and Repair

### Maintenance Plan

* May be provided by manufacturers from where the equipment is purchased
* Set up a **procedure for scheduling service** that must be periodically performed by the manufacturer
* Some warranties require that repairs be **handled only by the manufacturer**

biomedical service technicians in-house

### Maintenance Plan: *Service & Repair*

* Large facilities sometimes have ___ who perform equipment maintenance and repair

Routine service

### Maintenance Plan: *Service & Repair*

* as not to interrupt the flow of work

Retiring and Disposing

### Maintenance Plan

Occur when instrument is:

* Not functioning and not repairable
* Outmoded and should be replaced with new equipment

accumulate, takeup valuable space and created hazard

### Maintenance Plan: *Retiring & Disposing*

**Fully retired equipment** should be disposed of in an appropriate manner so that it will not ___

Salvage usable parts

### Maintenance Plan: *Retiring & Disposing*

particularly if the equipment is **being replaced with another similar one**

Smaller, commonly used equipment

### Equipment Maintenance Documentation

may be managed with an equipment maintenance document or manual that deals with all such equipment in the laboratory

* **Step-by-step instructions** for routine maintenance
* Directions for **calibrating** the instrument
* Guide for **troubleshooting**
* Any required manufacturer’s **service and repair**
* List of any **specific items** needed for use and maintenance, such as spare parts.

### Equipment Maintenance Documentation

Must include:

Purchasing & Supplies Inventory Management

### Equipment Maintenance Documentation

“**uninterrupted availability of reagents, supplies and services** is needed for __efficient and cost-effective laboratory operations__”

* Supplies and reagents are **always available** when needed
* **High-quality reagents** are obtained at an appropriate cost
* Reagents and supplies are **not lost** due to improper storage, or **kept and used beyond expiration**

### Purchasing & Supplies Inventory Management

Benefits

* Vendor/manufacturer qualifications
* **Purchase agreements**
* __Receiving, inspecting, testing, storing, and handling__ of materials
* Must allow for **tracking materials** to individual patients
* Assessing and maintaining inventory
* Controlling **expiration periods**
* Dispatching supplies to **satellite laboratorie**s

### Purchasing & Supplies Inventory Management

Key Components

inspected and appropriately tested

### Purchasing & Supplies Inventory Management

All purchased material should be ___ to ensure that specifications are met, and policies should be established for storing and handling materials as they are delivered to the laboratory

identify specific test materials used

### Purchasing & Supplies Inventory Management

The laboratory should be able to ___ for performing tests on any given day, so that if there is a problem with a patient's result, the laboratory will know what reagents were used

Product Research

* **Comparative** evaluation
* By **consultation** with other users
* By **reference** to publications offering **comparative studies** of equipment and supplies.

Product Specifications

* Help assure **adequate quality of materials**
* Inventory control helps **quality of purchase** after reagents and supplies.

* Define **criteria** for supplies or materials to be purchased
* Look for the **best price**, taking into account the qualifications and credibility of the supplier
* Consider the advantages and disadvantages of purchasing **“brand name” compared to “generic” products**

### Selecting Vendors

The laboratory should:

* Whether the vendor **delivered the specified goods**
* Whether the central procurement body assured that **user specifications were met**

### Selecting Vendors

Factors when evaluating vendors after purchase

Purchase requisition or order

### Selecting Vendors: *Documents Involved*

States the **desired goods or services** with an estimate of the cost

Packing slip

### Selecting Vendors: *Documents Involved*

Accompanies the shipped goods

Invoice

### Selecting Vendors: *Documents Involved*

Where payment is made

local or national government requirements

* FDA approval

### Selecting Vendors: *Considerations in Setting Up Purchases*

Understand any ___ that need to be accommodated in the contracts.

best price

### Selecting Vendors: *Considerations in Setting Up Purchases*

Negotiate for the ___ without undermining quality.

contracts

### Selecting Vendors: *Considerations in Setting Up Purchases*

Carefully review all ___ to make sure the laboratory’s requirements are being met

* should clearly address **payment mechanisms and provisions** to assure reliable availability and delivery of reagents and supplies

penalties

### Selecting Vendors: *Considerations in Setting Up Purchases*

Ask if there are ___ for ending a contract.

how payments will be made

### Selecting Vendors: *Considerations in Setting Up Purchases*

Determine ___, and how the vendor will assure reliable availability and delivery of supplies and reagents.

1. Assign **responsibility**

### Implementing Inventory Management Program

without this, nothing may get done

* The person must be **well trained** and must know his/her responsibilities

2. Analyze **needs** of the laboratory

### Implementing Inventory Management Program

Includes the turnaround time, volume of the test needed to accommodate

3. Establish the **minimum stock** needed for an appropriate time period.

### Implementing Inventory Management Program

It is a very **tedious** part to get a person involved in inventory management

4. Develop needed **forms and logs**.

### Implementing Inventory Management Program

Atleast have a system where forms and logs can be inputted in the computer or system

5. Establish a system for **receiving, inspecting and storing** supplies.

### Implementing Inventory Management Program

Must be properly oriented to the person who is receiving the equipment

6. Maintain an **inventory system** in all storage areas and for all reagents and supplies used in the laboratory

### Implementing Inventory Management Program

* designed so that laboratory can closely **monitor** the conditions of all their reagents and equipments
* Know what **quantities** are available and be alerted when there is a **need to** **reorder** especially if there are already reagents that are depleting
* When is and what are the **levels of inventory** that you should have to be able to place another order

Quantification

* Very important process that can help **calculate how much is required** of any particular item for a given period of time
* Performed when making **annual plans** for the laboratory and this planning will take into account the **usual usage** of supplies and reagents

* ensure **essential supplies** will be available when needed
* **prevent** **overstocking**, which can lead to wastage of expensive materials

### Quantification

Accurate quantification will:

* estimating **annual budget** requirements
* allowing for better planning
* **making decisions and monitoring performance** of the inventory management system

### Quantification

Provides information for:

* Standardized forms
* Card systems
* Logbooks

### Forms & Logs

Good tools for managing the stock

* **Date** reagent or set of supplies are **received**
* **Lot numbers** for all supplies, reagents and kits
* **Pass or fail** acceptance criteria
* **Date** the lot number or box of supplies was **put into service**
* *if not usable, the* ***date*** *and method of* ***disposition***

### Forms & Logs

The information should be recorded:

* **Name and signature** of the person receiving the materials
* Date of receipt
* Expiration date
* **Quantity** of the material received
* **Minimum stock** that should be on hand
* **Current stock** balance
* **Shelf number** or name
* Destination

### Forms & Logs

Additional Information

Receipts of Supplies

All supplies and reagents should be inspected as they arrive in the laboratory to be sure that they are in good condition and to verify that what is received is what was ordered

* **Sign** their name verifying receipt of goods
* **Date** each item received
* Note **expiration date**
* **Store new shipment** __behind existing shipment__
* Create or **update logbook** record

### Receipts of Supplies

Additional task for receiving personnel

clean, organized and locked

### Storage of Supplies

Keep the storeroom ___ to protect the inventory.

well ventilated and protected from direct sunlight

### Storage of Supplies

Make sure storage areas are ___

temperature requirements or safety requirements

### Storage of Supplies

Ensure **storage conditions** are in accordance with the manufacturer’s instructions, paying particular attention to any ___

good shelving

### Storage of Supplies

Use ___ strong enough to **support** items, and **organize** items carefully on the shelves to prevent movement shifts or falls