D.6 Laboratory Computer Procedure Manual.pdf

CONTENTS

I. OVERVIEW OF LABORATORY COMPUTER SERVICES

II. LABORATORY MODULE WORKFLOW

III. HOW TO USE THIS MANUAL

IV. INTRODUCTION TO VA COMPUTER SYSTEM

V. ENVIRONMENTAL AND PERSONNEL SECURITY

Environmental and Security Controls in the Laboratory Laboratory ADP Training Objectives

VI. DATA MANAGEMENT

Data Entry, Verification, and Reports Laboratory Calculations & Report Checks Review of Reportable Calculations Calculations/Delta Check Worksheet Documentation of Review of Computer-generated Reports Data Retrieval and Storage

VII. HARDWARE, SOFTWARE, AND SYSTEM MAINTENANCE

Howdy: Automated Computerized Phlebotomy Log-In Process

VIII. BACK UP PROTOCOLS

Laboratory Computer Contingency Protocol Tech’s Quick Reference Guide VistA READ ONLY Guide

IX. MENU MANAGEMENT

X. CPRS, LAB ORDERS& ADD-ON PROTOCOL

XI. LABORATORY SERVICE ADP CONTINGENCY PLAN

XII. GLOSSARY OF TERMS

D.6 Laboratory Computer Procedure Manual 36C24621R0068

OVERVIEW OF LABORATORY COMPUTER SERVICES Page 1 of 2

Pathology and Laboratory Medicine COMPUTER PROCEDURE MANUAL VA Medical Center, Salem, VA Approved by: _______________ Written: June 17, 1999 Chief, P&LMS

Revision Date: Approved by: Revision Date: Approved by: Revision Date:

Approved by:

04/04/05 Beatrice Wilkinson 06/15/10 Aaron Ibarra 04/04/08 Beatrice Wilkinson 12/11/14 Suzanne Stoneman 01/23/09 Beatrice Wilkinson 01/09/18 Suzanne Stoneman

OVERVIEW OF LABORATORY COMPUTER SERVICES

The Laboratory Information System is part of a larger shared in-house Hospital Information System. As of August 22nd, 2015 VistA servers were migrated to the Defense Enterprise Computing Center (DECC) that is physically located at the Warner Robbins Region 3 Data processing Center. The new operating system is Linux based. Access to the laboratory portion of the system is gained through an access authorization process in order to protect the programs, files and patient data. The Veterans Health Information Systems and Technology Architecture (VISTA) software is not a commercial package. It was written and is periodically upgraded by the Department of Veterans Affairs. The laboratory is using Version 5.2 of VistA LAB, installed in March 1995. This software system is used nationwide by 23 Veterans Integrated Service Networks (VISN), including 163 Veteran Affairs (VA) Medical Centers and more than 800 Outpatient Clinics. Because the system is shared, the laboratory is not responsible for all aspects of data storage and retrieval, hardware, software, system maintenance, security, or personnel.

Specific laboratory responsibilities in these areas are addressed in sub-sections of this manual. As necessary, references are made to services with whom responsibility is shared or delegated by the hospital. Chief, Pathology and Laboratory Medicine Service (P&LMS) has delegated the responsibility of bi-annual review of laboratory computer procedures to the Laboratory Information Manager.

The laboratory uses the computer system for accessioning, processing, reporting, and storing data in Chemistry, Blood Gas, Hematology, Coagulation, Urinalysis, Serology, Microbiology, Mycology, Mycobacteriology, Parasitology, Cytology, Surgical Pathology, Autopsy and Blood Bank. Accessioning, review and data entry of referral tests started on April 01, 1996. The Laboratory Electronic Data Interchange (LEDI) II software that provides a VA to VA interface was implemented with the first referral site in May 2004. LEDI III that provides a VA to Department of Defense (DOD) or commercial lab interface was installed on January 13, 2005. A Virtual Private Network (VPN) and a national solution/agreement for protection of privacy and security followed. Implementation of LEDI III with an automated HL7 interface between Salem and its Referral Laboratory started in October 2007.

Providers of care enter electronic orders for all sections of the lab except Anatomic Pathology. Requests for this section are submitted on standard VA forms which are completed by ward personnel.

OVERVIEW OF LABORATORY COMPUTER SERVICES Page 2 of 2

Implementation of physician electronic order entry began in March 1995, and was expanded to include most areas of the hospital prior to the implementation of the Computerized Patient Record System (CPRS) on October 30, 1998. During down times, manual request forms are completed by ward personnel and submitted to the laboratory for all sections.

The computer generates an interim report (work copy) of all test results for each ward or clinic as the tests are completed and verified, if requested. The interim report prints all the ordering locations subject to urgency cut-off as requested by the Automated Data Processing Applications Coordinator (ADPAC) for that location. Reports ordered with an urgency of STAT or Life Threatening Emergency (LTE) print at all locations. Printing of cumulative patient reports was discontinued on December 18, 2000, and was replaced by the electronic record in CPRS. The cumulative report format that consolidates test results to enhance the clinician review process is available in CPRS but has been eliminated from display in the lab software. Blood product allocations are available on-line to ward personnel upon completion of crossmatch or unit selection. After verification, Clinical and Anatomic Pathology results are available on-line to appropriate users. An electronic signature was added to the verification/release process for Anatomic Pathology starting in June 2004.

Written by: Beatrice W. Wilkinson, MT

Review Date: Reviewed by: Review Date: Reviewed by: Review Date: Reviewed by:

02/15/09 Beatrice Wilkinson 03/27/14 Suzanne Stoneman 04/14/10 Penny Gooch 02/04/15 Dr. Ulirsch 01/10/12 Suzanne Stoneman 12/21/16 Suzanne Stoneman 02/04/13 Suzanne Stoneman 01/31/17 Suzanne Stoneman

LABORATORY MODULE WORKFLOW Page 1 of 1

ADP SECTION PROCEDURE MANUAL

VA Medical Center, Salem, VA Approved by: ______________ Written: April 04, 2005 Chief, P&LMS

LABORATORY MODULE WORKFLOW

CPRS Physician Order Entry

Ward Collect or Send Patient

Accession Test

Multipurpose AccessioningCreation of Collection List for Lab Collect

Inpatient Phlebotomy

Receipt/Itemize Routine Lab Collect

Enter/Verify Data Manual/Auto

Results Reporting

Anatomic Pathology Reports with Electronic Signature

Quality Control/Quality AssuranceManagement Reports

Blood Bank Patient and Transfusion Report

Interim Reports for Verified Clinical Labs

Written by: Beatrice Wilkinson, MT

Review Date: Reviewed by: Review Date: Reviewed by: Review Date: Reviewed by:

04/04/05 Beatrice Wilkinson 02/04/13 Suzanne Stoneman 09/08/06 Beatrice Wilkinson 03/27/14 Suzanne Stoneman 01/23/09 Beatrice Wilkinson 02/04/15 Dr. Ulirsch 04/14/10 Penny Gooch 12/21/16 Suzanne Stoneman 01/10/12 Suzanne Stoneman

HOW TO USE THIS MANUAL Page 1 of 1

Written: April 4, 2005 Chief, P&LMS

Revision Date: Approved by: Revision Date: Approved by: Revision Date: Approved by:

04/14/08 Beatrice Wilkinson 01/23/09 Beatrice Wilkinson

HOW TO USE THIS MANUAL

This manual is designed to serve as a laboratory VistA applications training guide for laboratory personnel. The user will first learn about:

• The VA computer system

• Sign on and sign off procedures

• Special commands, keys and conventions

• Basic communications with the computer

Next, the user will learn about specific laboratory policies concerning:

• Environment and security

• Data management – entry, retrieval and storage

• Maintenance

• Back-up contingency protocols

The user will learn about laboratory menu options, workflow, and basic troubleshooting. An alphabetical listing of option documentation, a glossary of terms and pertinent references are included at the end of this manual.

Written by: Beatrice Wilkinson, MT

Review Date: Reviewed by: Review Date: Reviewed by: Review Date: Reviewed by:

02/05/09 Beatrice Wilkinson 02/04/15 Dr. Ulirsch 04/14/10 Penny Gooch 12/21/16 Suzanne Stoneman 01/10/12 Suzanne Stoneman 02/04/13 Suzanne Stoneman 03/27/14 Suzanne Stoneman

INTRODUCTION TO VA COMPUTER SYSTEM Page 1 of 3

Written: January 23, 2009 Chief, P&LMS

06/16/10 Aaron Ibarra 01/09/18 Suzanne Stoneman

INTRODUCTION TO VA COMPUTER SYSTEM

A computer system is composed of hardware and software.

I. Hardware

A. The main computer servers and processors are located in Warner Robbins, GA (DECC) and are connected to the lab via a main computer network.

B. Computer workstations in the lab are Personal Computers (PCs). Each PC has a CENTRAL PROCESSING UNIT (CPU), MONITOR, KEYBOARD, and MOUSE. A PC has a processor and contains a hard drive, local memory, and disk drives.

II. Software

Lab software is a package within the Veterans Health Information Systems and Technology Architecture (VistA) software that runs our Hospital Information Systems. The software consists of the computer programs that allow you, your network workstation, and the main computer to interact. VistA contains a set of instructions that control what you see on your monitor screen, what instructions you may enter on your keyboard, and what the main computer will do with the instructions you have entered. VistA uses an interactive language, meaning that a dialogue takes

CPU

Mouse

Keyboard

Monitor

INTRODUCTION TO VA COMPUTER SYSTEM Page 2 of 3 place in which you give the computer information and the computer asks for more information or further instructions.

A. VistA Prompts and the Cursor

A computer prompt is followed by the colon “:” or a question mark “?” and a cursor (usually a flashing rectangle). The prompt is an instruction the computer gives you or a question the computer asks on your monitor. The prompt tells you what kind of information the computer is seeking (such as, Select NAME: ), and the cursor indicates that the computer is ready for you to type the information on your keyboard. Press the Enter or Return keys to send your response to the computer.

B. General VistA Conventions and Keys

The following are a list of General Actions you can use throughout VistA’s many applications.

Try to keep them mentally handy as many of them can get you out of trouble:

? Provides general information about what the system expects to receive at a given prompt.

?? Provides more detail concerning what the system expects to receive at a given prompt.

??? Provides the maximum information concerning what the system expects to receive at a given prompt.

// A prompt followed by a “//” indicates a default. When entering orders for an outpatient in OE/RR, the patient location defaults to the last location the patient was checked in to.

It appears as follows:

Patient Location: Portsmouth// The “//” lets you know that Portsmouth is the default answer to the prompt Patient Location. You can change the answer if you want.

Date At any date prompt, you can enter T for today’s date, T-1 for yesterday’s date, T+2 for two days into the future, T+3 for three days into the future, etc. The system will accept up to +/- 999 days. It will also accept a number of numeric date formats. Examples would be 082298, 08/22/98, 8/22/98, 8-22-98, etc.

^ The up-arrow “^” stands for “exit” and allows you to exit an option or prompt.

^(Option) The up-arrow “^” followed by an option name or option synonym exits from the current option to the newly designated option.

^(Prompt) If you are in an option that has many prompts, and you want to skip some

(allowing that they are not required fields), you can use the “^” followed by the title of the prompt (or field) you want to jump to.

INTRODUCTION TO VA COMPUTER SYSTEM Page 3 of 3

^^(Prompt) The “^^” command is commonly referred to as the “Rubber Band Jump”. This is because you can jump to a prompt or option, complete or use it, and be returned back to where you entered “^^”.

@ This is the delete command. Enter it at a default entry to remove a default answer you wish to erase but not necessarily replace.

- The minus or hyphen is used to delete names from a mailing list. For example, if you are sending a message to a group of people but don’t want Smith, John to see it, type –SMITH,JOHN at the and to prompt.

<Space><Enter> On a select question or prompt, if you wish to enter the same answer just previously used for that question, you may respond with a space and the enter key.

The computer will insert the most recent response to that question.

DEVICE When you are prompted for a device, it generally refers to a printer. Simply type in the name of the printer you would like to send the message to. Entering HOME here will print the message to your computer screen. Entering P-Message will convert a report into a mail message.

Written by : Beatrice Wilkinson, MT

02/05/09 Beatrice Wilkinson 02/04/13 Suzanne

Stoneman 12/21/16 Suzanne Stoneman

04/14/10 Penny Gooch 03/27/14 Suzanne Stoneman

01/31/17 Suzanne Stoneman

01/10/12 Suzanne Stoneman 02/04/15 Dr. Ulirsch

ENVIRONMENTAL AND SECURITY CONTROLS IN THE LABORATORY Page 1 of 2

VA Medical Center, Salem, VA Approved by: __________________ Written: April 1991 Chief, P&LMS

08/30/96 Jill James 01/26/09 Beatrice Wilkinson 01/17/18 Suzanne Stoneman 02/20/97 Beatrice Wilkinson 07/24/12 Suzanne Stoneman 10/13/04 Beatrice Wilkinson 03/27/13 Suzanne Stoneman

ENVIRONMENTAL AND SECURITY CONTROLS IN THE LABORATORY

I. ENVIRONMENTAL SECURITY

A. Physical Security: The laboratory is a secure area of the hospital. All doors are secured and locked and/or the areas are maintained by laboratory personnel. Other house staff and visitors may enter only under supervision. All video display terminals and printers are located in secured areas and are not readily viewed or accessible by passers-by. Equipment will be placed such that the wires and cabling are protected from traffic.

B. Electrical and Fire Protection:

1. Electrical power interruptions and surges: The systems contained in the computer room are protected by a Power Distribution System. The systems have a central processing unit (CPU) battery back-up providing ten minute memory retention and are located in the computer room. Remote peripheral areas (i.e. lab) have surge protectors installed on all equipment.

2. Fire: The computer room is equipped with an Integen fire extinguishing system. The computer training room, supply storage area, Automated Data Processing (ADP) staff offices, and remote peripheral areas (i.e. lab) are protected with a water sprinkler system and hand held fire extinguishers. Fire training is required yearly as part of the safety program.

3. Personal Activities/Behavior: No eating, drinking, or smoking is allowed near computer equipment.

4. Equipment and Data preservation: Information Resources Management (IRM) has preservation procedures which are followed in regard to fire and software/hardware failure.

II. PERSONNEL SECURITY

A. Data Security: Access to the laboratory database is controlled through authority levels of menu management utilizing access codes, verify codes, and security keys. All laboratory personnel have access necessary to perform their job functions. Specific security keys, controlling menu options, and access are assigned for specific positions. Different menus

ENVIRONMENTAL AND SECURITY CONTROLS IN THE LABORATORY Page 2 of 2 exist for the following basic positions within the laboratory: Phlebotomist/Technician, Phlebotomy Supervisor, Secretary, Pathology Program Assistant, Medical Technologist (MT), Lead MT, Supervisor MT, Blood Bank Lead Technologist, Chief MT/Lab Manager, Anatomic Pathology Tech, Cytotechnologist/AP Supervisor, Pathologist, Service Chief, Lab Information Manager (LIM), MT Technical Specialist/Back-up LIM and Ancillary Testing Coordinator.

1. Access: It is the responsibility of the Service Chief, in cooperation with the LIM, to assess an employee’s level of access based on what is required for proper job performance. Access is limited to a “need to know” and an “ability to perform” basis.

Refer to Salem OIT Standard Operatory Procedure (SOP) 51 R3200 VistA Access Review Menu. This SOP establishes procedures and responsibilities for recurring review (every 180 days) of VistA accounts to ensure appropriate level of access or continued need.

2. Access Codes: Assigned by the local IT Specialist on an individual basis after clearance by the LIM or Service Chief. A verify code, which is created by the user, is used in the sign-on process. Verify codes must be changed every 90 days as prompted by the system.

B. Training:

1. Responsibility: The LIM is responsible for introducing Pathology and Laboratory Medicine Service (PALMS) personnel to VistA. Training in the detailed use of the system will take place in the individual sections. The LIM also serves as a liaison and reference to other services involved with utilization of the package (Community Based Outpatient Clinics (CBOCs), Quality Management, Nursing, Infection Control, and Pulmonary).

2. Supervisors will ensure that their employees comply with both the letter and spirit of the Health Insurance Portability and Accountability Act of 1966 (HIPAA) and security regulations as well as security control procedures. A security statement has been added to all laboratory position descriptions, and the Veteran Affairs National Rules of Behavior are reviewed and signed annually. Annual mandatory training modules for Privacy and for Computer Security are completed VISN-wide and monitored by the facility Privacy Officer and the facility ISO.

3. Training checklist: A training checklist will be given to each new lab employee. The end of the computer training, the new user and LIM will sign the checklist. The number of hours training will also be recorded. Prior to the employee’s start date they will complete all required training and sign the hospital security agreement, VA National Rules of Behavior.

Written by: Beatrice Wilkinson Review Date: Reviewed by: Review Date: Reviewed by: Review Date: Reviewed by:

02/05/09 Beatrice Wilkinson 03/27/14 Suzanne Stoneman 04/14/10 Penny Gooch 12/21/16 Suzanne Stoneman 01/10/12 Suzanne Stoneman 01/17/18 Suzanne Stoneman

LABORATORY ADP TRAINING OBJECTIVES Page 1 of 2

Written: 01/17/18 Chief, P&LMS

LABORATORY ADP TRAINING OBJECTIVES

(Employee will date and initial each section after reviewing with the Laboratory Information Manager)

___________: 1.) NETWORK ACCESS

(Initials/date)

User name: VHASAMxxxxx Password: requires 8 or more characters, alphanumeric with punctuation, lower case

Do not use “^” or “;”

Use same password for Network login and Vista login Must change password every 90 days (will prompt you of upcoming change) Must sign in every 90 days or lose access to the network

Always lock your computer or log off when you leave your workstation.

To lock computer, press CONTROL ALT DELETE keys and click on LOCK THIS COMPUTER or click the

WINDOWS key + L.

To log off computer, click on LOG OFF

PIV card pin log-in. Remember to renew your PIV card a month before it expires with your LIM.

__________: 2.) VISTA ACCESS

(Initials/date)

Access code: assigned by IT; this code will never change Verify code: use Network password as your Verify Code Tool box (^TBOX) for user characteristics and Password change Electronic Signature: use same as PIV pin Review VistA Training Guide Review Computer User Manual Vista Email: read/send/save/delete Vista special functions and commands:

( ^ # * keys) HALT: will halt your vista session

__________: 3.) OUTLOOK MAIL

(Initials/date)

Outlook sign in Read/delete/send messages Empty deleted items folder Encrypt emails containing sensitive or confidential information

__________: 4.) INTERNET EXPLORER

VA SALEM home page, news, links VA TMS continuing education

__________: 5.) MY COMPUTER

Public P:\drive (public drive, lab folder, everyone in lab can see this file) Public N:\drive (personal folder, no one else can see but you)

LABORATORY ADP TRAINING OBJECTIVES Page 2 of 2

__________: 6.) COMPUTER ASSISTANCE

Contact Laboratory Information Manager/ADPAC at ext 1424 Call the National Service Desk at ext. 2057, option 2, option 3

__________: 7.) CPRS

Log into CPRS and check access Review lab results and lab orders

__________: 9.) VistA RO

“READ ONLY” patient database for downtime—Search VistA RO, click VA Health Care Network, click Salem, VA; Log-on is same as VistA.

__________: 10.) VATAS

“VA TIME AND ATTENDANCE SYSTEM” – where you enter your leave request and review your timesheet

Attachment: “Laboratory Day to Day Computer Operator Guide”

I understand and have completed the basic Lab ADP training objectives:

Employee (Printed name) Employee Signature Date

Contact hours

ADP Coordinator

Written by: Suzanne Stoneman, MT

Laboratory Day-to-Day Computer Operator Guide

Vista Quick Tips:

Access Code and Verify Code:

Should have received this during computer training

Special Keys:

^ - will allow you to quickly jump to any menu if typed prior to a command

@ - is used to “pend” items or delete comments

# - is inserted in a result field to indicate there is a comment for that result

* - is used to cancel a test or show something has been canceled

? – can be entered anywhere in VISTA to show you allowable entries

Space bar enter – this will allow the last patient or info you placed in a given field to automatically be typed as data input without having to type it all out again

Enter – will bring you back to previous screen and once you get to main menu screen will exit you out of VISTA

^halt – will exit you from VISTA without entering through all the menus

Commonly Seen Terms:

Pending – an order exists but has not been collected or processed yet Active – order has been collected but not complete Collected – order has been collected but not complete Completed – order has been collected and completed Merged – two lab orders have been combined On Collection List – order has been set up for morning or afternoon routine lab draw but not collected yet Not in Lab – order was supposed to be collected that day but lab did not receive blood on patient Accession #- Is the number that starts back at 1 each day for each in house laboratory section. Listed with lab bench first, then date and then specimen number for that day ie) CH 0925 15 – indicates this is a specimen in the chemistry department from the date of September 25th and it was the 15th chemistry that came in that day.

UID #: A unique identification number given to each specimen ie)1192650002 the first three digits indicate the testing location (chemistry, heme, coag etc) the second set of three digits indicates the day of the calendar year and the last four digits indicates the specimen number in that location on that day.

Order #: number generated by the computer when a doctor electronically signs off an order in CPRS. This is the number we use to accept specimen into the laboratory

Accession – term used for accepting orders

Main Menu:

This will be a little different depending on what kind of access you have to certain menus. For training purposes we will just show you how to navigate around in the computer and what options you are looking for.

Technologist additional Menu options

Cytology/Histology additional Menu option

Supervisor additional Menu option

Phlebotomy Menu:

Add tests to a given accession

• When there is reflex testing needed per laboratory protocol

Examples: adding FT4 to TSH, DIFF (manual diff) to CBC, Direct LDL to TRIG >400, CKMB to TROP >0.08

Add tests to a given accession

• Use this option to add URINE CULTURES to URINE (Reflex) when urine reflexes to culture.

Delete entire order or individual tests

• This option can be used when discontinuing a test in VistA.

Itemized routine lab collection

• This option is used to receive specimens in VistA from AM & PM collections drawn from wards as LAB COLLECT (LC)

List of lab orders not collected

• This option is used to see if any inpatients lab order was missed from morning lab collect

Order/test status

• This option is used to look up pending orders (orders that still need to be processed)

• Review older orders – status (complete, active or pending)

• Can use this menu to find accession number for blood already received if a doctor calls for add on tests.

• Can also use this menu to view at what time a test was resulted

• Can use this menu to look up the doctor who ordered the test.

• In order to look up patient orders in, manually type ^ORD

• Search can be done as below

I. Patient Full Name II. Patient SSN

III. Patient First letter of last name and last four SSN

Print collection list/labels

• This option is used by the third shift to print up the labels that will be collected by the lab on our inpatient wards

Print future collection labels

• This option is used before downtime so the third shift can print up the labels that will be collected by the lab on our inpatient wards

Receipt of routine lab collection from wards

• This option is used Monday –Friday after blood has been collected from the impatient wards.

• This option is also used to cancel orders due to patient refusal

• Also can be used to “pend” collections that will be drawn later due to difficult sticks or patient not available.

Test description information

• Will provide reference ranges

• Critical values for test

• Specimen collection types

• Tube type

• Minimum volume required

Accessioning Menu:

Accessioning tests ordered by ward order entry

• This option is used to accept blood into the lab

Delete test from an accession

• This option is used when there is a duplicate order

• The test is accessioned in error

• There is QNS for test to be performed

• Patient could not provide specimen

• There are canned comments that are entered and will expand for each of these.

Fast lab test order (WARD COLLECT)

• This option is used when re-ordering in-patient stat tests canceled by lab, to be recollected.

Fast lab test order (ROUTINE)

• This option is used when re-ordering in-patient tests canceled by lab, to be collected by lab on the next routine collection.

Fast lab test order (SEND PATIENT)

• This option is used when re-ordering out-patient tests canceled by lab, to be collected at a future date.

Inquiry to LAB TEST file

• This option is used to look up test information and the panel members

Lab add test(s) to an existing order

• Can be used to add Urine Culture to a URINE (Reflex)

Lab orders by collection type

• Prints the lab orders by location, patient, collected, uncollected and partially collected

Lookup accession

• This will provide all information about an accession including:

♦ Order #, Date & Time received, collection time, provider, UID, patient location, patient info, specimen type, all test ordered and time each test was reported, and specimen priority.

Order/test status

• This option is used to look up pending orders (orders that still need to be processed)

• Review older orders – status (complete, active or pending)

• Can use this menu to find accession number for blood already received if a doctor calls for add on tests.

• Can also use this menu to view at what time a test was resulted

• Can use this menu to look up the doctor who ordered the test.

Print future collection labels Reprint accession label(s)

• This option is used to reprint from a single accession location

• When you need more labels for labeling pour offs

Reprint order accession label(s)

• This option is to reprint an entire order for a patient

Review by order number

• Will show who accepted the orders and what time they came in

• Will show the status of a given order

• Patient information

• Accession numbers for each test ordered

• Test ordered for each accession

Process data in Lab Menu:

EA Enter/verify data (auto instrument)

• This option is used to verify results that automatically transmit from the instrument into VISTA via DI

• There are different Load/Work Lists and Profiles that need to be entered depending on the instrument/bench you are working on. ie) Select Load/Work List Name: “EASYLINK” and Profile:

“EASYLINK” are typed in for the Dimension Vista 1500 and Centaur analyzers.

• Results are verified by accession number with the exception of Immunology test on the Centaur. VISTA will prompt you to put in the accession number you want to verify

• Results are then reviewed by the tech and are verified and released by entering in their initials

EM Enter/verify/modify data (manual)

• This option is used to verify results manually (results do NOT automatically transmit from instrument). Each result needs to be typed in by the tech for all tests ordered on that accession and verified by entering in their initials

• VISTA will prompt for the accession number you need to enter results for (Note: the accession area followed by the accession number needs to be entered. i.e.: “CH 15” or “UR 54” or “HE 31”.

• VISTA will then prompt for the Work Load Area ie) “SPEC” needs to be typed in for the work load area to manually enter an OSMO result.

Build a load/work list

• This option is used to build and print a work list which includes all the specimens that need to be completed for that specific test.

• VISTA will prompt for Load/Work List name, here is where you would type in, for example: SPECIAL CHEMISTRY

• It will go thru multiple questions one of which asks if you would like to unload the work list first. Type YES. Then you can continue thru and print your work list

Unload Load/Work List

• This option will remove entries from the specified tray(s) and make the accession(s) available again for adding to a work list or load list.

• This is used for Osmo, Acetone, Bup/Oxy screens, Preg, Body Fluids, Urine Eos, Crystals, etc…when you want to build a new list

• Unloading the work list can also be done during the process of building a new work list (see Build a Load/Work List)

Result Menu:

• Main Menu option 5

Interim Report

• This option is used to look up patient report/results by name for specific start and end date.

Lab Shipping Menu :

Main Menu LSM

• See processing guidelines for detailed shipping instructions.

DATA ENTRY, VERIFICATION AND REPORTS Page 1 of 3

Written: May 1991 Chief, P&LMS

06/18/99 Beatrice Wilkinson 02/04/09 Beatrice Wilkinson 01/17/18 Suzanne Stoneman 08/15/03 Beatrice Wilkinson 08/11/10 Aaron Ibarra 09/08/06 Beatrice Wilkinson 07/25/12 Suzanne Stoneman

DATA ENTRY, VERIFICATION AND REPORTS

I. Specimen Request/Specimen Verification Prior to accessioning patient requests (orders) into the computer, lab personnel will check the printed order and the labeled specimen for discrepancies. Problems will be resolved before accessioning.

II. Verification of Results and Patient Reports

A. Clinical Lab

1. Manual and automated result entries are verified before final acceptance and reporting.

Verification is performed by the technologist performing the test or by a second technologist. The technologist performing the test is responsible for the correctness of the data. Ordinarily, the testing technologist will correct errors. In the absence of the testing technologist, the corrective action will be given to an appropriate supervisor or designee.

2. Instrument printouts are compared to worklists and/or transmitted data prior to verification. Result entries are checked against defined error limits, e.g. Quality Control (QC) and delta checks, comments on specimen quality are noted, and any data errors are corrected in the computer before verification and reporting.

3. After results are verified, the reports are available immediately for review by authorized personnel in the Computerized Patient Record System (CPRS). CPRS, the electronic chart, is the permanent patient record.

a. Verified results with an urgency of STAT or Life Threatening Emergency (LTE) are automatically printed on the appropriate ward printer. An option to print all reports is available to each location by request of ward personnel.

b. All critical reports must be telephoned to and read back by the ordering physician or other provider on the patient’s treatment team and documented under comments in the computer for the specified test. Documentation must include the called to and read back by statement, physician’s name, date and time of notification, and the technologist’s initials.

B. Anatomic Pathology (AP) AP techs enter appropriate data for their sections and the pathologist utilizes Voicebrook dictation system to dictate directly into VistA. The printed final reports are reviewed for

DATA ENTRY, VERIFICATION AND REPORTS Page 2 of 3 accuracy and completeness by the pathologist. Anatomic Pathology reports (Cytopathology, Surgical Pathology, and Autopsy) are electronically signed in the computer system by the pathologists or the cytotechnologist in the case of negative PAP smears. All signed reports are available for electronic display in CPRS. Final reports are printed and retained in the lab for reference during computer downtimes.

III. “Corrected” or “Modified” Reports

A. The computer automatically flags modified reports.

For CH subscripted tests ( example: Chemistry, A1C, Hematology, Urinalysis, Coagulation, Serology, and Molecular Diagnostics), the system will automatically populate “(name of test) reported incorrectly as (value)” in the comments section of the report. For MICRO subscripted tests (Microbiology, Blood Culture, Urine Culture, Parasitology, Mycology, and AFB), any change will cause the report to again show on the list for supervisory review. When a correction is made in these areas, it is also documented in the Bacteriology remarks section of the report.

Corrections are permanently documented on the patient reports.

B. The physician is verbally notified of the correction.

The call, recipient, technologist, date and time of the call are noted as comments.

C. Correction of Erroneous Results When the technologist initiates a corrected report, a “Corrective Action Report” form must be completed and given to the appropriate supervisor.

D. Anatomic Pathology Modified Report When an AP report is modified, the report clearly prints “Modified Report” and gives the name of the modifier and date. Only pathologists are allowed to modify and electronically sign reports in Surgical Pathology. The Cytotechnologist is allowed to modify Cytology reports under the direction of the verifying Pathologist.

IV. Internal Reports

A. Incomplete Status Reports Sections performing CH subscripted tests pull incomplete status reports at designated intervals.

This report allows the section to verify timely test performance and catch errors that may have been made during the ordering/accessioning process. The Anatomic Pathology version of the Incomplete Status Report is the List of Unverified Reports.

B. Print Corrected Lab Results Biweekly, the LIM will generate a report of the preceding two week’s corrected reports. The report searches CH subscripted tests for the comment “reported incorrectly as” and prints a report for a specified date range. Evidence of corrected results will be permanently reflected in the patient record. The corrected lab report is routed through the supervisors. Printouts are filed electronically with the ADP Coordinator for two years.

C. Search for Critical Value Flagged Tests A report of critical CH subscripted test results as part of the QA program.

D. Significant Culture Report Utilized by the Infectious Disease nurse.

DATA ENTRY, VERIFICATION AND REPORTS Page 3 of 3

V. Audit Trails Several options exist for identifying individuals who enter or modify patient data.

A. Security bulletins An electronic bulletin is issued from IRM when an individual accesses an employee record.

These messages are checked against employee responsibilities and authorized access. If an employee enters an employee record, even his/her own, and the entry is unauthorized or inappropriate, then appropriate action will be taken. The message is forwarded to the individual and the LIM, who then forwards the message to the appropriate supervisor. The Service Chief is notified of a second occurrence. Employee access is disabled after the third occurrence until remedial rules of behavior training is completed.

B. Print of Corrected Lab Results Captures the initials of the person verifying the change and reports the test value changed.

C. Audit of Deleted/edited Comments Shows comments deleted/edited from a specified patient report. Note: comment may only be deleted by personnel with the LRSUPER key.

D. Accession List by Date Captures the initials of the tech performing the test in accession areas where CH subscripted tests are performed.

E. Supervisor Summary Reports Various options print information pertaining to testing, workload, and technologist verification.

VI. Report Checks As changes (reference ranges, test additions) are made, patient reports will be checked for proper format and reference range accuracy. Changes will be documented in the site notes field for the specific test in the Laboratory Test file in VistA. Section Supervisors sample reports monthly across all interfaces as compared to analyzer hard copy or worksheet as part of the Quality Assurance (QA) program. We do not have multiple instruments performing the same tests with different reference ranges. Reference ranges are printed on each test report, so there are no manual overlays or reference tables.

Written by: Yvette Spangler

02/05/09 Beatrice Wilkinson 02/04/13 Suzanne Stoneman 12/21/16 Suzanne Stoneman 04/14/10 Penny Gooch 03/27/14 Suzanne Stoneman 01/10/12 Suzanne Stoneman 02/04/15 Dr. Ulirsch

REVIEW OF REPORTABLE CALCULATIONS Page 1 of 2

Written: August 2010 Chief, P&LMS

01/09/18 Suzanne Stoneman

REVIEW OF REPORTABLE CALCULATIONS

Every two years or when a system change that may affect calculations is made, the calculations that are based on user-modifiable formulas performed by the Laboratory Information Systems (LIS), middleware and analyzers will be checked against manual methods to verify that that the calculation routines are performing correctly. This will ensure the accuracy of reportable patient results and detect error that may have been inadvertently entered into the calculation program.

I. Calculations performed by VistA (Laboratory Information System) The calculation routines for the following assays are stored in VistA under the DELTA CHECKS file

(62.1): Creat Cl., Creat 24 hr, PO4 24hr, Protein 24hr, Gluc 24hr, Mg 24hr, Calcium 24hr, Uric Acid 24hr, Na 24hr, K 24hr, Cl 24hr, TRP, FENA, FEUN, and estimated GFR.

1. In VistA, order the tests containing the calculations to be verified.

2. Manually enter the assay values using “Enter/verify data (auto instrument)”.

3. Compare the calculated results generated against the expected results using the “Yearly

Calculations.xlsx” worksheet.

II. Calculations performed by Middleware A. CentraLink The calculation routines for the following assays are stored in CentraLink as result management rules: A/G ratio, Anion Gap, LDL/HDL ratio, Calculated LDL, TIBC, and Random Urine Microalbumin.

1. In VistA, order the tests/parent tests and/or panels that contain the calculated tests to be verified.

2. Manually enter the assay values into CentraLink.

3. The CentraLink will calculate the values based on the manual results.

4. Compare the calculated results generated against the expected results using the “Yearly

Calculations.xlsx” worksheet.

III. Calculations performed by Analyzers

A. INR

Refer to the Central Laboratory Manual for the procedure on INR calculation verification.

REVIEW OF REPORTABLE CALCULATIONS Page 2 of 2

Written by: Aaron Ibarra 8/11/10 Review Date: Reviewed by: Review Date: Reviewed by: Review

Date:

Reviewed by:

01/10/12 Suzanne Stoneman 02/04/15 Dr. Karageorge 02/04/13 Suzanne Stoneman 12/21/16 Suzanne Stoneman 03/27/14 Suzanne Stoneman 01/31/17 Suzanne Stoneman

CALCULATIONS/DELTA CHECK WORKSHEET Page 1 of 2

Written: May 2003 Chief, P&LMS

12/29/2010 Aaron Ibarra

CALCULATIONS/DELTA CHECK WORKSHEET

(See Excel worksheet for year 2017 forward)

A. VISTA-CALCULATED RESULTS

TEST EQUATION MANUAL VALUE COMPUTER

VALUE

Creat CL (UCr x vol) / (1440 x SCr)

Creat values in mg/dL ; Vol in mL 150 x 1200 = 125 1440 x 1

Creat / 24 hr (Analyte x vol) / 100 Analyte in mg/dL ; Vol in mL

150 x 1200 = 1800

PO4 / 24 hr 100 x 1200 = 1200

Prot / 24 hr 200 x 1200 = 2400

Gluc / 24 hr 100 x 1200 = 1200

Mg / 24 hr 3.7 x 1200 = 44.4

Ca / 24 hr 10 x 1200 = 120

UA / 24 hr 3.5 x 1200 = 42

Na / 24 hr Or K / 24 hr

(Ion x vol) / 1000 Ion in mmol Vol in mL

150 x 1200 = 180

TRP (1 – [(UP x SC) / (SP x UC)]) x 100 UP = urine phos in mg/dL UC = urine creat in mg/dL SC = serum creat in mg/dL SP = serum phos in mg/dL

1 – ( 100 x 1 )= 0.833 4 x 150

0.833 x 100 = 83.3

FENA (Ur Na / Ser Na) x (SC / UC) x 100 (150 / 125) x (1 / 150) x 100 = 0.8 FEUN (Urea N2 / BUN) x (SC / UC) x 100 (100 / 15) x (1 / 150) x 100 = 4.4

GFR,

estimated

Estimated GFR (ml/min/1.73m2) =175 x (SCr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African American)

GFR Calculator at:

http://nkdep.nih.gov/professionals/ gfr_calculators/idms_con.htm (note: SCr = 1, age is dynamic, check http://nkdep.nih.gov/professionals/gfr_calculators/idms_con.htm http://nkdep.nih.gov/professionals/gfr_calculators/idms_con.htm

CALCULATIONS/DELTA CHECK WORKSHEET Page 2 of 2

VistA calculation against website)

B. EASYLINK-CALCULATED RESULTS

TEST RULE ACTION MANUAL VALUE COMPUTER VALUE

Anion Gap AGAP :=round(((val(NA))-(val(CL)+val(TCO2))) in "mmol/L",0)

(140) – (100 + 30) = 10

LDL/HDL Ratio LDL_HDL := ((CHOL-((TRIG/5)+HDLC))/HDLC) 100 – ((120/5) + 60) = 0.267

Calculated LDL LDLCALC := (CHOL-((TRIG/5)+HDLC)) 100 – ((120/5) + 60) = 16 Microalbumin/ Creatinine Ratio

MA_RANDOM := (MALB/ECRE)*1000 1.5 * 1000 = 7.5

TIBC TIBC_CALC := TRF*1.49 200 * 1.49 = 298

02/05/09 Beatrice Wilkinson 03/27/14 Suzanne Stoneman 01/24/18 Suzanne Stoneman 04/14/10 Penny Gooch 02/04/15 Dr. Ulirsch

02/04/13 Suzanne Stoneman 12/20/17 Suzanne Stoneman

DOCUMENTATION OF REVIEW OF PATIENT REPORTS Page 1 of 1

Written: May 2006 Chief, P&LMS

01/29/09 Beatrice Wilkinson 08/02/2012 Suzanne Stoneman 06/15/10 Aaron Ibarra 03/18/2014 Suzanne Stoneman

DOCUMENTATION OF REVIEW OF PATIENT REPORTS

CAP: GEN.41067**Revised:

Does an individual meeting CAP laboratory director qualifications review and approve the content and format of paper and electronic patient reports at least every two years?

Note: The laboratory director (or a designee who meets CAP qualifications for laboratory director) must review and, at least every two years, approve the content and format of laboratory patient reports (whether paper or computer screen images) to ensure that they effectively communicate patient test results, and that they meet the needs of the medical staff. Further details on review of electronic reports are given in GEN.485000.

REPORT 2018 2019 2020 2021

SURGICAL PATH

CYTOPATHOLOGY

AUTOPSY

PATIENT INTERIM

02/05/09 Beatrice Wilkinson 02/04/2015 Dr. Ulirsch 04/14/10 Penny Gooch 12/21/16 Suzanne Stoneman 01/10/12 Suzanne Stoneman 12/20/17 Suzanne Stoneman 03/18/2014 Suzanne Stoneman 01/24/18 Suzanne Stoneman

DATA RETRIEVAL AND STORAGE Page 1 of 1

Written: August 2003 Chief, P&LMS

02/03/09 Beatrice Wilkinson

DATA RETRIEVAL AND STORAGE

I. Data Retrieval Archiving data from the Lab Data file #63 was discontinued in 1997. Patient reports after December 1988 are available on the live system. The most recent archive date is available to authorized users in the Laboratory Site file #69.9 using FileMan. The VistA Site Manager will determine the timing and method of data retrieval for archived reports.

II. Data Storage

A. Information Management Service (IMS) located in building 74, is responsible for maintaining the database and ensuring adequate storage capacity and response time. IMS is also responsible for all VistA data storage media and for monitoring and testing the automatic alarms and warnings associated with the mainframe system. Testing schedules and records will be found in IMS.

B. In the event of hardware or software failure, IMS has a failsoft system in place to prevent the loss of data. In the laboratory, worklists and instrument printouts from at least two months are held for reference in the sections.

02/05/09 Beatrice Wilkinson 12/20/17 Suzanne Stoneman 04/14/10 Penny Gooch 04/16/18 Suzanne Stoneman 01/10/12 Suzanne Stoneman 02/04/13 Suzanne Stoneman 12/21/16 Suzanne Stoneman

HARDWARE, SOFTWARE, AND SYSTEM MAINTENANCE Page 1 of 2

Written: February 2009 Chief, P&LMS

01/13/2011 Aaron Ibarra 07/25/12 Suzanne Stoneman

HARDWARE, SOFTWARE, AND SYSTEM MAINTENANCE

Information Management Service (IMS) is responsible for all maintenance and repair of network computer workstations and printers.

A. The Lab Information Manager (LIM) or back-up will report equipment problems to the IMS help desk by phone, through the National Service Desk: Ext. 2057 or by the “YourIT” Ticketing System: https://yourit.va.gov/va

B. Hardware modifications are recorded in the Server room on the Downtime Log and vendor-specific hardware maintenance for Hewlett-Packard (HP) is recorded on a HP Web Document. (IRM)

A. IMS is largely responsible for software maintenance after alpha and beta testing is completed by the Information Resource Management Facility Officers and documentation is filed in IMS.

B. The LIM or designee is responsible for evaluating and testing new or revised laboratory software released by the Medical Information Resources Management Office of the Department of Veterans Affairs. New software is tested in the TEST account before going into the LIVE system. Any problems or discrepancies are noted and reported to IMS and/or the developers. Verified patches are tested, and copies of the patch routines are filed in IMS. Any local modifications are documented by the LIM and by IMS. The LIM maintains the integrity of lab files and obtains approval from the Chief, Pathology and Laboratory Medicine Service for all changes, additions, and deletions in programs, test library, and major computer functions.

III. System Maintenance

A. IMS is responsible for scheduling maintenance with digital equipment. System hardware maintenance and 24-hour emergency service are on contract, and these records are available in IMS. Procedures are available in IMS regarding partial/complete downtime and

HARDWARE, SOFTWARE, AND SYSTEM MAINTENANCE Page 2 of 2 recovery. An error log and a written record of unscheduled downtime, which includes reasons for failure and corrective action, are also available in IMS.

B. The LIM also maintains a record of scheduled and unscheduled downtime. A laboratory computer contingency protocol exists to assure prompt processing and useful patient reporting. (See back-up protocols)

C. The system performs an integrity check of restored databases during system downtime recovery.

04/14/10(draft) Penny Gooch 02/04/15 Suzanne Stoneman 01/10/12 Suzanne Stoneman 12/21/16 Suzanne Stoneman 02/04/13 Suzanne Stoneman 12/20/17 Suzanne Stoneman 03/27/14 Suzanne Stoneman

HARDWARE, SOFTWARE, AND SYSTEM MAINTENANCE Page 1 of 2

01/13/2011 Aaron Ibarra 07/25/12 Suzanne Stoneman

HARDWARE, SOFTWARE, AND SYSTEM MAINTENANCE

Information Management Service (IMS) is responsible for all maintenance and repair of network computer workstations and printers.

A. The Lab Information Manager (LIM) or back-up will report equipment problems to the IMS help desk by phone, through the National Service Desk: 1-855-673-4357, option 4, option 2 or by the National Service Desk Ticketing System.

B. The LIM will print a configuration sheet for each networked printer and file as a troubleshooting tool. It includes the printer name, IP address and printer serial number.

Date and printer location will be added for quick reference.

C. Hardware modifications are recorded in the Server room on the Downtime Log and vendor-specific hardware maintenance for Hewlett-Packard (HP) is recorded on a HP Web Document. (IRM)

A. IMS is largely responsible for software maintenance after alpha and beta testing is completed by the IRMFOs and documentation is filed in IMS.

B. The LIM or designee is responsible for evaluating and testing new or revised laboratory software released by the Medical Information Resources Management Office of the Department of Veterans Affairs. New software is tested in the TEST account before going into the LIVE system. Any problems or discrepancies are noted and reported to IMS and/or the developers. Verified patches are tested, and copies of the patch routines are filed in IMS. Any local modifications are documented by the LIM and by IMS. The LIM maintains the integrity of lab files and obtains approval from the Chief, Laboratory Services for all changes, additions, and deletions in programs, test library, and major computer functions.

III. System Maintenance

A. IMS is responsible for scheduling maintenance with digital equipment. System hardware maintenance and 24-hour emergency service are on contract, and these records are available in IMS. Procedures are available in IMS regarding partial/complete downtime and

HARDWARE, SOFTWARE, AND SYSTEM MAINTENANCE Page 2 of 2 recovery. An error log and a written record of unscheduled downtime, which includes reasons for failure and corrective action, are also available in IMS.

B. The LIM also maintains a record of scheduled and unscheduled downtime. A Laboratory computer contingency protocol exists to assure prompt processing and useful patient reporting. (See back-up protocols)

C. The system performs an integrity check of restored databases during system downtime recovery.

04/14/10(draft) Penny Gooch

HOWDY: AUTOMATED COMPUTERIZED PHLEBOTOMY LOG-IN PROCESS Page 1 of 3

06/15/10 Aaron Ibarra 06/11/14 Suzanne Stoneman 04/16/18 Suzanne Stoneman 05/04/12 Suzanne Stoneman 12/11/14 Suzanne Stoneman 07/24/12 Suzanne Stoneman 08/19/15 Suzanne Stoneman

HOWDY: Computerized Laboratory Check-in Application.

PURPOSE:

The HOWDY patient phlebotomy log-in option (named for its welcome) is an automated computerized phlebotomy login process. This option was developed to automate laboratory check-in, accessioning of orders, and printing of specimens in the outpatient phlebotomy area – decreasing patient wait times.

PRINCIPLE:

By keying in the social security number, the HOWDY software queries the database for pending laboratory orders based on a date range of +3 to -30 days and status of SEND PATIENT. The orders are then processed and labels are printed. This process streamlines the accessioning procedure bypassing multiple manual steps.

RESPONSIBILITY:

Daily use: Phlebotomy personnel and Medical Technologists Database Maintenance: LIM and Technical Support MT

PROCEDURE:

HOWDY LOG-ON

COMPUTER…