Sample Functional Requirements Worksheet

A - Feature is available and installed. B - Feature is available but not yet installed. D - Feature is currently under development (Indicate anticipated date of availability). N - Feature is not available.
	Functional Description	Feature Availability	Vendor Comments
A.	SYSTEM ARCHITECTURE AND MAINTENANCE
A.1	Provide a system with client/server architecture that operates in a Windows environment.
A.2	Provide a system that employs a centralized relational database.
A.3	Allow the system to operate on both local and wide area networks, linking all practice sites and databases. Able to move information from one database to another.
A.4	Allow full system functionality from any workstation within the network.
A.5	Provide a scalable system that can be expanded easily as our facility grows.
A.6	Provide an operational environment which will ensure the security and integrity of the system and all its data.
A.7	Provide for redundant storage of all system data files.
A.8	Provide for redundant processing capabilities to protect against processor failures.
A.9	Provide a check-point recovery capability to restore data files after a system failure.
A.10	Provide expanded descriptions for error messages.
A.11	Please describe any scheduled maintenance procedures.

B.	SECURITY AND AUDITING

B.1	Provide a multi-level security system to ensure the confidentiality of patient-related information and to control access to system functions and features.
B.2	Restrict access to specific areas of the application based on system function to be performed.
B.3	Restrict access to specific patient records based on specific tests performed.
B.4	Allow password protection at different levels.
B.5	Allow a user of proper security clearance to modify the database parameters once the system is live, without requiring programming knowledge.
B.6	Restrict access to configuration tables, profile indexes, etc. to designated lab personnel via security controls.
B.7	Maintain an automated system log of user sign-on activity.
B.8	Maintain an audit trail for system entries including user code, date, and time of each system transaction.
B.9	Provide multi-level password security down to options within menus.

C.	INTERFACING

C.1	Provide operational software or interfaces for the following equipment and/or applications (Please provide a functional description of each interface available):
C.1.1	Chemistry analyzer
C.1.2	Immunoassay analyzer
C.1.3	Hematology analyzer
C.1.4	Coagulation analyzer
C.1.5	Urine Strip Reader
C.1.6	Microbiology Analyzer
C.1.7	Other laboratory instruments
C.1.8	Practice Management system
C.1.9	Billing system
C.1.10	Electronic Medical Record
C.1.11	Reference Laboratory
C.2	Allow analyzer interfaces to operate so that result verification and reporting can be performed simultaneously at multiple workstations.

D.	ORDER ENTRY

D.1	Allow multiple test ordering for a single patient using a common demographic record.
D.2	Allow laboratory orders to be entered from an off-site location.
D.3	Allow the lab to develop and customize orderable items.
D.4	Allow simple test ordering: Single header linked to a single test result field (e.g. Glucose).
D.5	Allow compound test ordering: Single header linked to multiple test result fields (e.g. CBC, Lipid Panel, Comprehensive Metabolic Panel.)
D.6	Allow the user to order tests by entering test codes and/or by selecting from a test menu.
D.7	Automatically alert users to previously ordered lab work.
D.8	Allow at the time of ordering a request that patient lab results be sent to more than one provider.
D.9	Allow the cancellation of orders for patients who do not show for appointment.
D.10	Provide Medical Necessity validation based on lab-defined valid diagnosis codes for each applicable test.
D.11	Allow the generation of a Medicare-compliant ABN form when test ordering fails medical necessity validation.
D.12	Allow entry of four diagnosis codes for each ordered test.
D.13	Provide automatic testing destination routing as specified in payor's contract.
D.14	Provide automatic label printing as orders are entered.
D.15	Allow lab-defined label configuration.
D.16	Describe the bar code formats your LIS accepts and prints.
D.17	Provide the specific sample requirements or sample tube types at the time of order entry.
D.18	Store diagnosis codes in registration function.
D.19	Support retrieval of patient records by partial (e.g. first few letters of) patient last name.
D.20	Include test, profile, or battery name (mnemonic code) in order data.
D.21	Process orders for profiles that include multiple tests (e.g. cardiac enzyme profile).
D.22	Allow a miscellaneous test code so previously undefined tests can be ordered and charged.
D.23	Ability to correct a field on a window without having to re-enter entire order transaction.
D.24	Allow entry of orders for future dates.
D.25	Allow splitting one ordered test into more than one request (e.g. group tests, pre-op, and coag screen).
D.26	Automatically check for and warn of duplicate single test orders with profile orders.
D.27	Support cancellation of tests--logging accession #, test code, patient name, reason, date, time, and tech ID.
D.28	Provide simple method to order additional test requests on sample already received and processed in lab.
D.29	Allow cancellation of an order without canceling prior results.
D.30	Provide flexible, customizable Sample ID formats.
D.31	Print sample collection labels for timed and routine collections.
D.32	Allow for multiple labels per test to print.
D.33	Print instructions/comments (e.g. do not collect from right arm) on sample labels.
D.34	Print aliquot labels when more than one test is drawn in the same collection tube.
D.35	Provide that uncollected samples continue to appear on subsequent lists until cancelled or collected.
D.36	Provide for easy free text entry of information such as critical result notification, sample rejection, or culture sites.
D.37	Provide for intelligent prompting for accessioning; e.g. When a wound culture is ordered, the system prompts the user for site/location.
D.38	Provide easy access to sample requirements for laboratory users.
D.39	Provide intelligent sample labeling – groups samples in chemistry together and prints on labels, while hematology tests print on separate label and microbiology prints separately. Allows for making the number of labels customizable for each test.
D.40	Provide intuitive user interface – easy to locate windows for accessioning, reporting queries, etc.
D.41	Provide for an easy, systematic, and logical method of adding, editing, or deleting tests in the test code dictionary.
D.42	When looking up a patient in the system, tests performed on that patient and test results are made available without additional steps.

E.	RESULT REVIEW AND REPORTING

E.1	Allow reporting of numerical results to lab-defined number of significant digits per test.
E.2	Allow reporting of alpha results: Single word (e.g., positive or negative) and free text (e.g., short phrases or longer paragraph).
E.3	Allow attachment of a comment to any test header or test field (e.g., allow free text and pre-defined comments).
E.4	Ability to select between reportable and non-reportable comments.
E.5	Allow the user to accept, reject, or re-run a test.
E.6	Allow automatic calculations based on test results from other fields.
E.7	Allow the user to override current test results for a patient.
E.8	Allow the user to retain over-ridden results.
E.9	Provide identification of the verifying technologist when reporting results.
E.10	Provide automatic print reporting capabilities to laser printers.
E.11	Provide scheduler for automatic result delivery.
E.12	Provide automatic fax reporting capabilities.
E.13	Provide ability to send patient reports via the Internet.
E.14	Provide ability to e-mail reports.
E.15	Automatically maintain a record of reports delivered by each reporting modality (FAX, Printer, and E-Mail, etc.). Provide easy access to these results at any time.
E.16	Allow patient test to be incomplete for at least 8 weeks in the system.
E.17	Print daily detailed master log of all work performed in lab for audit purposes.
E.18	Provide capabilities for graphic display of test results.
E.19	Support entry of comments for non-numeric results and interpretative reporting in result entry windows.
E.20	Maintain table of lab-defined panic, delta, and reference result ranges based on age and sex.
E.21	Display previous test's value, time, and date if delta check limit is exceeded during result entry.
E.22	Print list of received but untested samples due to insufficient quantity. Allow for a comment to be placed on the sample accordingly.
E.23	Print list of all patient tests that require it (e.g. exceed delta check, panic values, and reference intervals).
E.24	Allow for cumulative result reporting. Please explain.
E.25	Describe the procedure for correcting test results that have been resulted. After correcting, are the corrections able to be altered?
E.26	Includes features that allow batch reporting for phlebotomy, travel fees, microbiology no growths, and others.
E.27	Provide easy to set-up and use reflex rules (e.g. if TSH >5.5, then do a FT4).
E.28	Provide the date/time reported on reports transmitted by FAX, laser printer, and e-mail.
E.29	Provide a permanent log of all test results that have been edited.
E.30	Provide for release of results after they have been reviewed and approved by technical personnel (there is no merging function).
E.31	Workstations work independently of each other. Multiple functions can occur simultaneously without one party having to exit the system.
E.32	Provide flexible reporting formats.
E.33	Provide the ability to access all patients of a particular client by name, date, or date range.
E.34	Allow look-up of patient and patient results by client number.
E.35	Allow for unlimited “canned comments.”
E.36	Allow comments to be attached to specific tests & specific clients such as “Current Dosage_______” attached to Protime tests.
E.37	Ability for verification of profile components with results released individually.

F.	RULES-BASED LOGIC

F.1	Ability for rules-based logic where laboratory personnel can define criteria in “if-then” statements.
F.2	Ability for Rules program to evaluate all rule entries for tests, not just the first one, so that complex or “cascading” rules may easily be designed, where several rules can be invoked based on one scenario.
F.3	Provide rules-based report routing.
F.4	Provide the ability to create rules to assist in decision support.
F.5	Must have ability to flag results based on criteria other than standard reference ranges to include testing location, drawing location, ordering provider, patient age, and priority of order.
F.6	Charge rule capability.

G.	FLAGS AND DATA COMPARISON

G.1	Allow lab-defined age and sex-related reference ranges for all test results.
G.2	Provide the ability to flag results based on criteria other than standard reference ranges.
G.3	Highlight abnormal results on patient reports without relying solely on color text.
G.4	Allow flagging of test results based on failed lab-defined delta check.
G.5	Flag routine orders when timed pick-up, stats, etc. are ordered, to prevent multiple sticks.
G.6	Provide a means for documenting critical results and critical result documentation; generate reports regarding critical results communicated.

H.	SAMPLE STATUS AND TRACKING

H.1	Provide the ability to track patient samples throughout the testing process.
H.2	Provide the identification of the individual who ordered the test, collected the sample, and released the test results, including the date and time of these occurrences so that this information is accessible throughout the process.
H.3	Support user-defined priorities.
H.4	Support a way to identify the phlebotomist, (doctor, nurse, etc.) in system for samples not drawn by laboratory personnel.
H.5	Include data for tracing order (dates, times, tech ID, results) from order entry to final reporting in master log.
H.6	Provide index to master log by accession number.

I.	PATIENT RECORDS

I.1	Maintain patient databases and provide ability to easily generate historical patient reports.
I.2	Allow patient database search based on:
I.2.1	Patient name
I.2.2	Patient account number
I.2.3	Patient SSN
I.3	Allow the user to search previous patient results for specific tests and easily view historical results of that test.
I.4	Allow the user to graph patient results by test to identify possible trends.
I.5	Allow historical results for multiple tests to be graphed on one normalized graph.
I.6	Allow the user to easily access archived patient records.
I.7	Allow the user to review a specific patient's results without paging through the entire list of patient results.
I.8	Allow for patient searches by a variety of means: Name, Social Security Number, Client, Accession #, or Requisition #.

J.	REFERENCE LABORATORIES

J.1	Allow testing laboratory destination routing based on patient's payor contract.
J.2	Allow testing laboratory destination routing based on laboratory testing menu.
J.3	Provide ability to override specified destination for laboratory testing.
J.4	Differentiate sample type and volume based upon in-house and reference lab requirements.
J.5	Provide bi-directional interfaces to clinical reference laboratories.
J.6	Provide ability to print lab-defined reference laboratory requisition.
J.7	Allow manual entry of reference laboratory test results (e.g., non-interfaced reference laboratories).

K.	QUALITY CONTROL

K.1	Allow implementation of Westgard QC rules and flags.
K.2	Allow flagging of out-of-range QC values.
K.3	Allow entry, storage, and retrieval of corrective action comments.
K.4	Provide ability to view and print QC graphs (Levey-Jennings.)
K.5	Provide ability to plot multiple levels of control on one graph.
K.6	Calculate the following QC statistics:
K.6.1	Cumulative mean.
K.6.2	Observed mean over a specified date range.
K.6.3	Standard deviation.
K.6.4	Coefficient of variation.
K.7	Provide ability to document QC review.
K.8	Provide ability to enter comments by QC level.
K.9	Provide ability to enter comments by QC result.
K.10	Support patient-based quality control procedures.
K.11	Maintain calibration records for on-line instruments.
K.12	Allow for instrument status (recent service, troubleshooting, etc.) to be stored on-line.

L.	OUTREACH

L.1	Provide a web-based outreach solution.
L.2	Describe how your system provides secure access via the web.
L.3	Provide a multi-level security system to ensure the confidentiality of all patient-related information and to control access to outreach functions and features.
L.4	Allow for electronic notification of the physician's review of results.
L.5	Provide the ability to link physician group practice names with individual doctors in the practice.

M.	COMMUNICATION

M.1	E-mail capability for laboratory personnel.

N.	MICROBIOLOGY

N.1	Provide an electronic worksheet that allows for paperless microbiology.
N.2	Allow for ordering of microbiology procedures on the same requisition as general lab procedures.
N.3	Allow for printing of labels specific to media setup protocols for each microbiology procedure.
N.4	Provide bi-directional interface to automated microbiology analyzer.
N.5	Provide ability to alter billing "on the fly" for microbiology procedures performed.
N.6	Provide ability to create preliminary microbiology reports, independent of general lab procedures on the same order.
N.7	Provide ability to create preliminary microbiology reports, independent of general lab procedures on the same order.
N.8	Provide for preliminary reporting of culture results.
N.9	Provide epidemiology reports in a variety of formats.

O.	MANAGEMENT AND ADMINISTRATION

O.1	Provide ability to create completion reports by date.
O.2	Provide ability to create billing summary reports by date.
O.3	Provide ability to create reports of failed medical necessity checks.
O.4	Provide ability to create cancelled test reports that include test name and reason for cancellation.
O.5	Provide for a customizable overdue report that would indicate tests such as urine cultures that become overdue at 4 days while blood cultures become overdue at 7 days and CBC overdue at 4 hours.
O.6	Provide ability to create turnaround time reports by date.
O.7	Provide a summary report for test usage over a user-definable period of time.
O.8	Provide physician utilization report (e.g. number of tests requested by a physician).
O.9	Provide ability to print a list of draws that need to be performed.

P.	DATA MINING

P.1	Provide user-friendly report generator with graphical user interface.
P.2	Provide ability to create reports of previous day test results.
P.3	Provide ability to create abnormal test value report.
P.4	Provide ability to create critical test value report.
P.5	Provide ability to electronically document supervisory review of all critical values.
P.6	Provide ability to generate patient lists (with certain demographic data) who meet specific result criteria for public health reporting.
P.7	Provide ability to mine any field (textual or numerical) in the data base.
P.8	Provide ability to write queries using logic in great detail.
P.9	Provide ability to schedule automatic, unattended runs of data reports.
P.10	Provide ability to store supply records.
P.11	Provide on-line help windows to assist novice users in all applications.

Search Our Site

Customer Sign In

Quick Links

News@orchard

Sample Functional Requirements Worksheet