ColonCancerCheck - LRT - Quality Assurance Specifications

Introduction

LRT Submission Validation - CCC FOBT Results

All data submission files from each lab will be validated through the LRT front end. Validation occurs when the file is uploaded to LRT.

The submission process loads the file into the LRT staging table and validation is performed on the loaded data. Only kits that pass validation are accepted into the LRT clinical result program table which is used to feed downstream CCO systems.

Acknowledgement Report

Each submission will create an Acknowledgement Report. The Report should be viewed to confirm all data was accepted into LRT.

The Acknowledgement Report will show the acknowledgement (validation) status of each kit submitted in the file. A kit consists of 3 records (flaps) which are used to calculate an overall result for the kit.

Three Types of Acknowledgement Status

LRT submission validation generates three types of acknowledgement status: Accept, Reject and Error.

During validation each kit is assigned overall acknowledgement status indicating if the kit was accepted, rejected or errored. The rules for assigning the kit acknowledgement status are:

a. If all 3 records for the kit are accepted, overall kit status is Accept else

b. If one or more record is rejected, overall kit status is Reject else

c. If one or more record is errored, overall status is Error

Accept: Data submitted for the kit passed validation and was accepted into LRT clinical result program table

Reject: Data submitted for the kit contains 1 or more severe errors and has been rejected. Reject messages are output to the Acknowledgement Report file.

Error: Data submitted for the kit contains 1 or more errors. Error messages are tracked and reported back to the Lab via the Lab Data Quality Report. Error messages are also output to the Acknowledgement Report file. In most cases, labs are expected to resubmit a correction.

QA Checks Defined - CCC Fecal Occult Blood Test (FOBT) Result Data

The QA checks are grouped by prefixed letter as follows:

'A' prefix	Accept - Content Validated, Record Accepted. Record passes validation and is accepted.
'R' prefix	Reject - File Errors, File Rejected. File contains severe errors or file format errors. Entire file is rejected.
'R' prefix	Reject - Content Errors, Record Rejected. Record contains severe errors. Entire record is rejected.
'E' prefix	Error - Content Errors, Record NOT Rejected. Record contains validation errors. Entire record is retained, including erroneous fields).

Master List of QA Checks

Code#	Entity	Data Element	Condition	Message	Reject
Accept - Content Validated, Record Accepted
A000	LRT Clinical Result Program		Overall kit is accepted	Accept: Record submission successful	No
Reject - File Errors, File Rejected
R000	LRT Clinical Result Program		Overall kit is rejected	Reject: Correction and resubmission may be required	Yes
R008	LRT Clinical Result Program		Data file is empty	No records in the data file	Yes
R009	LRT Clinical Result Program		Missing or invalid file column headings. Name and number of columns in the file does not match the FOBT Results Program Data template	Invalid file format. Missing or invalid file column headings. Name and number of columns in the file must match the FOBT Results Program Data template	Yes
R010	LRT Clinical Result Program		Data file does not have .csv extension	Invalid file format. .csv file extension expected	Yes
R011	LRT Clinical Result Program		Virus found in data file	Virus found in data file. Cannot process	Yes
R014	LRT Clinical Result Program		Data file has less than 3 records (header record not included in count)	Invalid file. Minimum of 3 records of data required	Yes
R015	LRT Clinical Result Program		Data file exceeds pre-defined record limit (set at 10,000 for LRT Enhancement implementation July 2010)	Invalid file. Maximum number of records <max # of records> in file exceeded	Yes
Reject - Content Errors, Record Rejected
R001	LRT Clinical Result Program	Lab License Number, FOBT Accession Number, New FOBT Accession Number	Action Code is "A" and Lab License Number + FOBT Accession Number (or Lab License Number + New FOBT Accession Number for re-accession) already exists	Duplicate: Lab License Number + FOBT Accession Number already submitted in LRT	Yes
R002	LRT Clinical Result Program	Lab License Number, FOBT Accession Number, Action Code	Action Code is "R" and Lab License Number + FOBT Accession Number does not exist	Lab License Number + FOBT Accession Number does not exist in LRT - revision cannot be applied	Yes
R003	LRT Clinical Result Program	Action Code	<> " A" or <> "R"	Invalid Action Code, value must be A or R. Value must be consistent across all 3 flaps	Yes
R004	LRT Clinical Result Program	Create Date	Original LRT submission date (Create Date) for Lab License Number + FOBT Accession Number is over six months from submission date	Revision rejected, original submission over six months old	Yes
R005	LRT Clinical Result Program	Lab License Number	Null or not same as LRT account login	Missing or invalid mandatory field Lab License Number, Must be populated with up to 5 digits	Yes
R006	LRT Clinical Result Program	FOBT Accession Number	Null	Missing mandatory field FOBT Accession Number	Yes
R007	LRT Clinical Result Program	New FOBT Accession Number, Action Code	Action Code is "A" and New FOBT Accession Number is not Null	Invalid Action Code, New FOBT Accession Number (re-accession) must be submitted as a revision	Yes
R013	LRT Clinical Result Program	FOBT Accession Number	<> alphanumeric or data field too long	Invalid FOBT Accession Number. Must be up to 15 alphanumeric	Yes
R016	LRT Clinical Result Program Archive	Lab License Number, FOBT Accession Number, New FOBT Accession Number	Lab License Number + New FOBT Accession Number exists in archive. New FOBT Accession Number exists in Previous FOBT Accession Number field.	Lab License Number + FOBT Accession Number has been re-accessioned. Cannot revise or re-use an FOBT Accession Number that has been re-accessioned	Yes
Error - Content Errors, Record NOT Rejected
E000			Overall kit is errored	Error: Information on submission contains invalid data. Correction and Revision is required	No
E001	LRT Clinical Result Program	Kit Receipt Date	Null or date not in YYYYMMDD format	Missing or invalid mandatory field Kit Receipt Date. Must be YYYYMMDD format	No
E002	LRT Clinical Result Program	Kit Receipt Method	Null or <> "M" or <> "D"	Missing mandatory field Kit Receipt Method. Valid values are “M” and “D”	No
E003	LRT Clinical Result Program	FOBT Card Flap Number	Null	Missing mandatory field FOBT Card Flap Number	No
E004	LRT Clinical Result Program	FOBT Kit Result Date	Null or date not in YYYYMMDD format	Missing or invalid mandatory field FOBT Kit Result Date. Must be format YYYYMMDD	No
E006	LRT Clinical Result Program	Participant Unique Identifier Type	<> "OHN" or <> "OTH" or <> Null	Invalid Participant Unique Identifier Type. If available accepted valid values are “OHN”, “OTH” or blank	No
E007	LRT Clinical Result Program	Participant Unique Identifier Type, Participant Unique Identifier	Participant Unique Identifier Type is "OHN" and (Participant Unique Identifier does not pass MOH MOD-10 Cyclical Redundancy Check or Participant Unique Identifier contains leading zeros)	If “Participant Unique Identifier Type” is “OHN” then Participant Unique Identifier must be 10-digit Ontario Health Number	No
E008	LRT Clinical Result Program	Participant Unique Identifier Type, Participant Unique Identifier	Participant Unique Identifier Type is "OHN" and Participant Unique Identifier is null	If “Participant Unique Identifier Type” is “OTH” then Participant Unique Identifier cannot be blank	No
E009	LRT Clinical Result Program	Participant Unique Identifier	Data field is too long or <> alphanumeric	Invalid Participant Unique Identifier. If available must be up to 16 in length. Must be alphanumeric	No
E010	LRT Clinical Result Program	Participant First Name	Data field is too long	Invalid Participant First Name. If available must be up to 20 in length.	No
E011	LRT Clinical Result Program	Participant Middle Name	Data field is too long	Invalid Participant Middle Name. If available must be up to 20.	No
E012	LRT Clinical Result Program	Participant Last Name	Data field is too long	Invalid Participant Last Name. If available must be up to 30 in length.	No
E013	LRT Clinical Result Program	Participant Last Name, FOBT Card Flap Result	Participant Last Name populated with 1 character or Null and FOBT Card Flap Result fields <> Null	If kit processed Participant Last Name must be populated with more than 1 character.	No
E014	LRT Clinical Result Program	Participant Address Line 1	Data field is too long	Invalid Participant Address Line 1. If available must be up to 32 in length.	No
E015	LRT Clinical Result Program	Participant Address Line 2	Data field is too long	Invalid Participant Address Line 2. If available must be up to 32 in length.	No
E016	LRT Clinical Result Program	Participant City	Data field is too long	Invalid Participant City. If available must be up to 30 in length.	No
E017	LRT Clinical Result Program	Participant Province	Less than or more than 2 characters in length and does not match any entry in Appendix 1 (Prov/State Codes)	Invalid Participant Province/US State. If available must be 2 characters in length. Accepted valid values are the official 2-letter abbreviation for Canadian province or US state	No
E018	LRT Clinical Result Program	Participant Postal Code	Data format <> ANANAN or 99999 or 99999-9999	Invalid Participant Postal Code/Zip Code. If available must be ANANAN or 99999 or 99999-9999 format.	No
E019	LRT Clinical Result Program	Participant Province, Participant Postal Code	Participant Province is Canadian province (Appendix 1) and Participant Postal Code format <> ANANAN	If Participant Province is Canadian then Participant Postal Code must be ANANAN format if available	No
E021	LRT Clinical Result Program	Participant Date of Birth	Date not in YYYYMMDD format	Invalid Participant Date of Birth. If available must be format YYYYMMDD	No
E021	LRT Clinical Result Program	Participant Date of Birth, Kit Receipt Date	Participant Date of Birth plus 130 years is greater than Kit Receipt Date	Invalid Participant Date of Birth. Cannot be future dated or calculate to an age greater than 130	No
E023	LRT Clinical Result Program	Participant Gender	<> "M" or <> "F" or <> Null	Invalid Participant Gender. If available valid values are “M”, “F” or blank	No
E024	LRT Clinical Result Program	Participant Phone Number - Area Code	Data field not 3 digits	Invalid Participant Phone Number - Area Code. If available must be 3 digits	No
E025	LRT Clinical Result Program	Participant Phone Number - Local Number	Data field not 7 digits	Invalid Participant Phone Number - Local Number. If available must be 7 digit local phone number (no hyphen)	No
E026	LRT Clinical Result Program	Participant Phone Number - Extension	Data field too long and not digits	Invalid Participant Phone Number – Extension. If available must be up to 5 in length. Must be digits only.	No
E027	LRT Clinical Result Program	Test Requisition Date	Date not in YYYYMMDD format	Invalid Test Requisition Date. If available must be format YYYYMMDD .	No
E028	LRT Clinical Result Program	Test Requester Type	<> "PH" or <> "RX" or <> "TH" or <> "NP" or <> Null	Invalid Test Requester Type. Valid values are “PH”, “RX”, “TH”, “NP” and blank	No
E029	LRT Clinical Result Program	Test Requester Type, Test Requester Unique Identifier	Test Requester Type is "PH" and Test Requester Unique Identifier is null or not digits or < 5 digits or > 6 digits	If Test Requester Type is “PH” then Test Requester Unique Identifier must contain 5 or 6 digit CPSO number if available or ‘00000’ if not known	No
E030	LRT Clinical Result Program	Test Requester Type, Test Requester Unique Identifier	Test Requester Type is "RX" and Test Requester Unique Identifier is null or not 10 alphanumeric	If Test Requester Type is “RX” then Test Requester Unique Identifier must contain10 alphanumeric pharmacy unique identifier if available or ‘00000’ if not known	No
E031	LRT Clinical Result Program	Test Requester Type, Test Requester Unique Identifier	Test Requester Type is "TH" and Test Requester Unique Identifier is null or not 10 digits	If Test Requester Type is "TH" then Test Requester Unique Identifier must contain 10 digit participant Ontario Health Number if available or '00000' if not known	No
E032	LRT Clinical Result Program	Test Requester Type, Test Requester Unique Identifier	Test Requester Type is "NP" and Test Requester Unique Identifier is null or too long	If Test Requester Type is “NP” then Test Requester Unique Identifier must contain up to 8 alphanumeric Nurse Practitioner Number if available or ‘00000’ if not known	No
E033	LRT Clinical Result Program	Test Requester First Name	Data field too long	Invalid Test Requester First Name. If available must be up to 20 in length	No
E034	LRT Clinical Result Program	Test Requester Middle Name	Data field too long	Invalid Test Requester Middle Name. If populated must be up to 20 in length	No
E035	LRT Clinical Result Program	Test Requester Last Name	Data field too long	Invalid Test Requester Last Name. If populated must be up to 30 in length	No
E036	LRT Clinical Result Program	Test Requester Address Line 1	Data field too long	Invalid Test Requester Address Line 1. If populated must be up to 32 in length	No
E037	LRT Clinical Result Program	Test Requester Address Line 2	Data field too long	Invalid Test Requester Address Line 2. If populated must be up to 32 in length	No
E038	LRT Clinical Result Program	Test Requester City	Data field too long	Invalid Test Requester City. If populated must be up to 30 in length	No
E039	LRT Clinical Result Program	Test Requester Province, Test Requester Type	<> "ON" and Test Requester Province is "PH or "NP"	Invalid Test Requester Province. If Test Requester Type is PH or NP then if populated Province must be “ON ”	No
E040	LRT Clinical Result Program	Test Requester Postal Code	Data field not ANANAN format	Invalid Test Requester Postal Code. Must be ANANAN format if available	No
E043	LRT Clinical Result Program	Kit Receipt Date, FOBT Kit Result Date	Kit Receipt Date not in YYYYMMDD format or > FOBT Kit Result Date	Invalid Kit Receipt Date. Must not be later than FOBT Kit Result Date	No
E045	LRT Clinical Result Program	FOBT Card Flap Number, Lab License Number, FOBT Accession Number	FOBT Card Flap Number <> 1 or <> 2 or <> 3 or 1, 2 or 3 repeats across Lab License Number + FOBT Accession Number	Must contain 3 flaps per FOBT kit. FOBT Card Flap Number must not repeat across kit (Lab License Number + FOBT Accession Number)	No
E046	LRT Clinical Result Program	FOBT Card Flap Sample Collection Date	Date not in YYYYMMDD format	FOBT Card Flap Number <<FOBT Card Flap Number>>: invalid FOBT Card Flap Sample Collection Date. If available must be format YYYYMMDD	No
E047	LRT Clinical Result Program	FOBT Card Rejection Reason	Does not match any entry in Appendix 2 (Card Rejection Code)	Invalid FOBT Card Rejection Reason. If card is rejected, FOBT Card Rejection Reason must be specified. Valid values are “CR01”, “CR02”, “CR03”, “CR04”, “CR05”, “CR06” and “CR07”.	No
E049	LRT Clinical Result Program	FOBT Kit Result Date, Kit Receipt Date	FOBT Kit Result Date < Kit Receipt Date	Invalid FOBT Kit Result Date. Must not be earlier than Kit Receipt Date	No
E050	LRT Clinical Result Program	FOBT Rejection Reason, FOBT Card Flap Result	FOBT Card Rejection Reason and FOBT Card Flap Result reported for same Lab License Number + FOBT Accession Number	If FOBT Card is processed all FOBT Card Flaps must indicate a result	No
E051	LRT Clinical Result Program	FOBT Card Flap Result	Does not match any entry in Appendix 3 (Flap Result Code)	Invalid FOBT Card Flap Result. If FOBT Card Flap is resulted, result must be specified. Valid values are “FR01”, “FR02”, “FR03”, “FR04”, “FR05”, “FR06”, “FR07”, “FR08” and “FR09”	No
E053	LRT Clinical Result Program	New FOBT Accession Number	Data field too long	Invalid New FOBT Accession Number. If available must be up to 15 alphanumeric	No
E055	LRT Clinical Result Program	FOBT Card Rejection Reason, FOBT Card Flap Result	FOBT Card Rejection Reason <> null and FOBT Card Flap Result <> null in same record (flap)	Record cannot have a rejection reason and result. One must be blank	No
E057	LRT Clinical Result Program	FOBT Kit Result Date	FOBT Kit Result Date > Create Date	FOBT Kit Result Date must not be future dated	No
E058	LRT Clinical Result Program	FOBT Card Flap Result	"FR09" reported for all 3 flaps	Invalid FOBT Card Flap Result combination. When FR09 is reported for all 3 flaps,, use CR05 to report as a rejection	No
E059	LRT Clinical Result Program	Test Requester Unique Identifier	Null	Missing mandatory field Test Requester Unique Identifier	No
E060	LRT Clinical Result Program	Test Requester Type, FOBT Card Rejection Reason	Test Requester Type is null and FOBT Rejection Reason <> "CR01" or "CR02" or "CR03"	Invalid Test Requester Type. Can only be blank if FOBT Card Rejection Reason is CR01, CR02 or CR03	No
E061	LRT Clinical Result Program	FOBT Kit Result Date	< LRT ColonCancerCheck Program Start Date (set in LRT configuration file as Jan 7, 2008)	FOBT kit result date is earlier than LIRT program start date	No
E062	LRT Clinical Result Program	Participant Province, Participant Postal Code	Participant Province is US State (Appendix 1) and Participant Postal Code has invalid format (is not format 99999 or 99999-9999)	If Participant Province is populated with US State then Participant Postal Code must be in valid zip code format (99999 or 99999-9999) if available	No
E063	LRT Clinical Result Program	FOBT Kit Result Date	FOBT Kit Result Date for kit is different on one or more flaps. A kit is identified by having the same Lab License Number + FOBT Accession Number	Invalid FOBT Kit Result Date. Must be the same date for all 3 flaps	No
E064	LRT Clinical Result Program	FOBT Card Rejection Reason, FOBT Card Flap Result	FOBT Card Rejection Reason is null and FOBT Card Flap Result is null for same record (flap)	Record cannot have a blank rejection reason and blank result	No