NHS Information Authority

Data Standards Programme

Changes to KC61 will provide more information about laboratories and improve the reporting of cancers diagnosed as a result of screening. Part C2 is not mandatory until 1 April 2004.

PATHOLOGY LABORATORY INVESTIGATION

Attributes of this Class are:

	O	MARKER LYMPH NODE RESULT
	O	PATHOLOGY INVESTIGATION PRIORITY
	O	PATHOLOGY RESULT DUE DATE
	O	PATHOLOGY RESULT DUE TIME
		PRIMARY SCREENING

BIOPSY REFERRAL OUTCOME

A code used to reference an outcome of a REFERRAL FOR BIOPSY. For cervical histology, biopsies are taken after a colposcopy has been performed.

For cervical histology for KC61 purposes, the classification is:

a.	Cervical Cancer (including micro-invasive)
a.	Cervical Cancer - stage 1B or worse
b.	Adenocarcinoma in situ
b.	Cervical Cancer - stage 1A
c.	CIN3
c.	Adenocarcinoma in situ/CGIN
d.	CIN2
d.	CIN3
e.	CIN1
e.	CIN2
f.	HPV only
f.	CIN1
g.	No CIN/No HPV
g.	HPV only
h.	Inadequate biopsy
h.	No CIN/No HPV
i.	Colposcopy - Nothing Abnormal Detected (NAD)/no biopsy taken
i.	Seen in Colposcopy - NAD no biopsy taken
j.	Results not known by laboratory
j.	Outcome known - none of the above
k.	Non cervical cancers detected
k.	Seen in Colposcopy - result not known
l.	No outcome available
m.	Inadequate biopsy
n.	Non cervical cancers detected

For cervical histology for KC65 purposes, the classification is:

a.	Cancer (including micro-invasive)
b.	Adenocarcinoma in situ
c.	CIN3
d.	CIN2
e.	CIN1
f.	HPV/cervicitus only
g.	No CIN/No HPV (normal)
h.	Inadequate/unsatisfactory biopsy
i.	Result not known by clinic

For breast cancer screening for KC62 purposes,the classification is:

a.	Benign or negative
b.	Inconclusive
c.	Positive; i.e. cancer detected
	i.	non-invasice or possibly micro-invasive
		a.	low (DCIS only detected)
		b.	intermediate (DCIS only detected)
		c.	high (DCIS only detected)
		d.	grade not known (DCIS only detected)
	ii.	definitely micro-invasive
		a.	low (DCIS only detected)
		b.	intermediate (DCIS only detected)
		c.	high (DCIS only detected)
		d.	grade not known (DCIS only detected)
	iii.	invasive size not known
		a.	Grade I
		b.	Grade II
		c.	Grade III
		d.	grade not known
	iv.	invasive size known
		a.	Grade I
		b.	Grade II
		c.	Grade III
		d.	grade not known
		v.	invasive status not known
d.	Biopsy not done or result not yet know

References:
KC65 - Colposcopy Clinics, Referrals, Treatments and Outcomes
KC61: Pathology Laboratories - Cervical Cytology and Outcome of Gynaecological Referrals
KC62: Adult Screening Programmes - Breast Screening

This attribute is also known by these names:

Context	Alias
plural	BIOPSY REFERRAL OUTCOMES

PRIMARY SCREENING

PRIMARY SCREENING

A classification of whether the PATHOLOGY LABORATORY INVESTIGATION is for primary screening or other reason ('other' may include rapid review, checking, quality assurance and abnormal or clinical reporting).

Primary screening is the first examination of a sample sent for screening.

Classification

a.	Primary screening
b.	Other reason

References:
DSCN 03/2003 Cervical Screening Statistics - Revision of Central Statistical Returns: KC61

This attribute is also known by these names:

Context	Alias
plural	PRIMARY SCREENINGS

KC61 1

Central Return Form Guidance

KC61: Pathology Laboratories - Cervical Cytology and Outcome of Gynaecological Referrals

Contextual Overview

1. The Department, NHS Cervical Screening Programme (NHSCSP), Regional Offices and trusts require information from PATHOLOGY LABORATORIES on cervical cytology and outcome of referrals.

1. The Department, NHS Cervical Screening Programme (NHSCSP), Strategic Health Authorities and trusts require information from PATHOLOGY LABORATORIES on cervical cytology and outcome of referrals.

2. The information helps to monitor the process of achieving the Government's target to reduce the incidence of invasive cervical cancer and to ensure that the screening programme is managed effectively. The information is used to ensure that the laboratory is achieving acceptable standards in examining smears in line with guidance provided by the NHS Cervical Screening Programme.

3. Information on the return is also used in Public Expenditure Survey (PES) negotiations, resource allocation to the NHS and Departmental accountability.

4. Information based on the KC61 return is published annually by the Department in the Statistical Bulletin `Cervical Screening Programme'.

Completing Return KC61: Pathology Laboratories - Cervical Cytology and Outcome of Referrals

5. KC61 returns are required by all PATHOLOGY LABORATORIES carrying out cervical cytology within NHS HEALTH CARE PROVIDERS. This applies to independently managed NHS laboratories, including cytopathology laboratories and also private laboratories if they are commissioned to report on smears for the NHS.

   Each return requires the ORGANISATION CODE and ORGANISATION NAME of the NHS Trust and must be signed by a CONSULTANT in one of the Pathology SPECIALTY. It also requires the PATHOLOGY LABORATORY NAME and PATHOLOGY LABORATORY CODE. Note that PATHOLOGY LABORATORY CODES are maintained and issued by the Organisation Codes Service on behalf of the NHS Cervical Screening Programme.

5. KC61 returns are required by all PATHOLOGY LABORATORIES carrying out cervical cytology within NHS HEALTH CARE PROVIDERS. This applies to independently managed NHS laboratories, including cytopathology laboratories and also private laboratories if they are commissioned to report on smears for the NHS.

   Each return requires the ORGANISATION CODE and ORGANISATION NAME of the NHS Trust and must be signed by a CONSULTANT in one of the Pathology SPECIALTIES. It also requires the PATHOLOGY LABORATORY NAME and PATHOLOGY LABORATORY CODE. Note that PATHOLOGY LABORATORY CODES are maintained and issued by the Organisation Codes Service on behalf of the NHS Cervical Screening Programme.

6. A PATHOLOGY LABORATORY's KC61 return should include only those REQUESTS FOR PATHOLOGY INVESTIGATION received by that laboratory. A REQUEST FOR PATHOLOGY INVESTIGATION forwarded to another laboratory for primary screening should only be included in the second laboratory's return.

6. A PATHOLOGY LABORATORY's KC61 return should include all the original REQUESTS FOR PATHOLOGY INVESTIGATION received by that laboratory. A REQUEST FOR PATHOLOGY INVESTIGATION forwarded to another laboratory should only be included in the first laboratory's return (except Part A3).

7. Smears re-screened as part of internal or external quality control or for any other reason should not be included in the KC61 return.

7. Smears re-screened within the same Laboratory as part of internal or external quality control or for any other reason should not be included in the KC61 return. The number of requests sent to or received from another Laboratory for primary screening or other reason should be recorded in Part A3.

8. Where more than one slide is associated with one REQUEST FOR PATHOLOGY INVESTIGATION, only the most significant CYTOLOGY RESULT TYPES may be counted for the KC61.

9. The return KC61 is completed annually and submitted within two months of the end of the period.

10. Parts A and B of the return relate to all smears reported by the laboratory where the smear was received and registered between 1 April of one year and 31 March of the following year. If this date is not recorded, the CERVICAL SMEAR EXAMINED DATE can be used as a proxy. Part C of the return relates to smears where the date of the smear which led to a referral fell in the first three months of the financial year (April, May and June.)

10. Parts A and B of the return relate to all smears reported by the laboratory where the smear was received and registered between 1 April of one year and 31 March of the following year. If this date is not recorded, the CERVICAL SMEAR EXAMINED DATE can be used as a proxy. Part C1 of the return relates to smears where the date of the smear which led to a referral fell in the first three months of the financial year (April, May and June). Part C2 is a duplicate of Part C1, but will collect data relating to gynaecological referrals from smears registered during the whole of the financial year prior to the current year.

KC61 3

Central Return Form Guidance

KC61: Pathology Laboratories - Cervical Cytology and Outcome of Gynaecological Referrals

Part A2: Laboratory Processing from Receipt of Smear to Authorisation of Report

1. Part A2 collects information about the backlog of smears in laboratories.

1. Part A2 collects information about the backlog of smears in laboratories. The laboratory which receives the original request should issue the report and include the information within this return.

Total number of smears registered

2. This is the total number of PATHOLOGY LABORATORY INVESTIGATIONS received and registered in:

Quarter 1 - As at 30 June yyyy (Line 0001)

Quarter 2 - As at 30 September yyyy (Line 0002)

Quarter 3 - As at 31 December yyyy (Line 0003)

Quarter 4 - As at 31 March yyyy (Line 0004)

Number of results reported (to woman or HA) within

3. The number of results reported are subdivided into the following time periods:

0-2 weeks (column 3)

3-4 weeks (column 4)

5-6 weeks (column 5)

7-8 weeks (column 6)

9-10 weeks (column 7)

More than 10 weeks (column 8)

0-2 weeks 0-14 days (column 3)

3-4 weeks 15-28 days (column 4)

5-6 weeks 29-42 days (column 5)

7-8 weeks 43-56 days (column 6)

9-10 weeks 57-70 days (column 7)

More than 10 weeks over 70 days (column 8)

4. The interval to be reported is from the date of receipt of the smear at the laboratory, the SAMPLE RECEIPT DATE, and the date of authorisation of the final report, the PATHOLOGY RESULT REPORTED DATE (for the SAMPLE COLLECTED).

Total (line 0005)

5. This is the total for all time periods counted in lines 0001 to 0004.

Part A3: Number of Smears Primary Screened for/by Another Laboratory

Part A3: Requests Screened for/by Another Laboratory

6. Part A3 records information about the numbers of imported and exported smears dealt with by laboratories.

Number of Smears Sent to Another Laboratory (Line 0001)

6. Part A3 records information about which laboratories import and export smears.

Requests Sent To Another Laboratory For Screening (Line 0001)

7. This requires the number of REQUESTS FOR PATHOLOGY INVESTIGATION where the REQUEST FOR DIAGNOSTIC TEST for the primary screening is to be sent to and carried out by another PATHOLOGY LABORATORY.

Number of Smears Received from Another Laboratory (Line 0002)

7. This requires the number of REQUESTS FOR PATHOLOGY INVESTIGATION where the REQUEST FOR DIAGNOSTIC TEST for the screening is to be sent to and carried out by another PATHOLOGY LABORATORY, sub-divided by details of Laboratory sent to and whether for primary screening or 'other'. 'Other' may include rapid review, checking, abnormal or clinical reporting etc.

Requests Received From Another Laboratory For Screening (Line 0002)

8. This requires the number of REQUEST FOR PATHOLOGY INVESTIGATIONS where the REQUEST FOR DIAGNOSTIC TEST for the primary screening of the received smear has been sent from another PATHOLOGY LABORATORY.

8. This requires the number of REQUESTS FOR PATHOLOGY INVESTIGATIONS where the REQUEST FOR DIAGNOSTIC TEST for the screening of the received smear has been sent from another PATHOLOGY LABORATORY, sub-divided by details of Laboratory received from and whether for primary screening or 'other'. 'Other' may include rapid review, checking, abnormal or clinical reporting etc.

Part A3: Where More Than One Smear is Taken

9. Part A3 also requires the number of instances where a single report is derived from more than one sample.

Number of Instances Where a Single Report is Derived from More Than One Sample (Line 0003)

10. This requires the number of REQUESTS FOR PATHOLOGY INVESTIGATIONS where there is more than one SAMPLE COLLECTED.

10. This requires the number of REQUESTS FOR PATHOLOGY INVESTIGATIONS where there is more than one SAMPLE COLLECTED. Full details should be available on request.

KC61 5

Central Return Form Guidance

KC61: Pathology Laboratories - Cervical Cytology and Outcome of Gynaecological Referrals

KC61: Pathology Laboratories - Cervical Cytology and Outcome of Gynaecological Referrals

Part C: Outcome by 31 March yyyy for Women Recommended for Gynaecological Referral where the Smear was Registered during April- June yyyy.

Part C1: Outcome by 31 March yyyy for Women Recommended for Gynaecological Referral where the Smear was Registered during April- June yyyy.

1. Part C requires the analysis of the number of women subsequently referred for gynaecological investigation following a smear. This is where the CYTOLOGY SCREENING ACTION TYPE of a SCREENING TEST has a classification of Refer for medical assessment or under medical treatment (Suspend) (S). The date of the smear must be between 1 April and 30 June. The CYTOLOGY RESULT TYPES for each woman is used to allocate her to one of appropriate subdivisions of Most significant result in columns 3 7.

1. Part C1 requires the analysis of the number of women subsequently referred for gynaecological investigation following a smear. This is where the CYTOLOGY SCREENING ACTION TYPE of a SCREENING TEST has a classification of Refer for medical assessment or under medical treatment (Suspend) (S). The date of the smear must be between 1 April and 30 June of the current data year. The CYTOLOGY RESULT TYPES for each woman is used to allocate her to one of appropriate subdivisions of Most significant result in columns 3 to 9.

2. Note that severe dyskaryosis in column 7 combines CYTOLOGY RESULT TYPEclassifications of Severe dyskaryosis (cat. 4), Severe dyskaryosis/invasive carcinom a (Cat. 5) and Glandular neoplasia (Cat. 6).

2. Note that CYTOLOGY RESULT TYPE classifications of Severe dyskaryosis (cat. 4), Severe dyskaryosis/invasive carcinom a (Cat. 5) and Glandular neoplasia (Cat. 6) are recorded separately in columns 7,8 and 9 respectively.

3. CYTOLOGY RESULT TYPES with a classification of Negative (cat. 2) are not counted.

4. The number of Most significant results in the CYTOLOGY RESULT TYPEcolumns (columns 3 - 7) are further analysed by the BIOPSY REFERRAL OUTCOME (lines 0001-0011). For cervical histology, biopsies are taken at colposcopy.

4. The number of Most significant results in the CYTOLOGY RESULT TYPE columns (columns 3 - 9) are further analysed by the BIOPSY REFERRAL OUTCOME (lines 0001-0014). For cervical histology, biopsies are taken at colposcopy.

5. Part C also includes the formula to calculate the Positive Predictive Value (PPV) of smears reported as moderate dyskaryosis or worse to enable the laboratory to assess whether or not they are reaching an achievable standard.

5. Note that Cervical cancer is sub-divided into 'stage 1B or worse' (line 0001) and 'stage 1A' (line 0002) and that there are four options to describe results which are not applicable or not known: Seen in Colposcopy - NAD no biopsy taken' (line 0009), 'Outcone known - none of the above' (line 0010), 'Seen in Colposcopy - result not known' (line 0011) and 'No outcome available' (line 0012).

6. Part C1 also includes the formula to calculate the Positive Predictive Value (PPV) of smears reported as moderate dyskaryosis or worse to enable the laboratory to assess whether or not they are reaching an achievable standard.

7. Part C1 includes the formula to calculate Lost to follow-up of smears reported as 'Seen in colposcopy - result not known' (line 0011) and 'No outcome available' (line 0012), as a percentage of the Total.

8. Provision has been made to record details of non-cervical cancers at the bottom of Part C1.

KC61 6

Central Return Form Guidance

KC61: Pathology Laboratories - Cervical Cytology and Outcome of Gynaecological Referrals

Part C2: Retrospective Collection

Outcome by 31 March yyyy for Women Recommended for Gynaecological Referral where the Smear was Registered during April yyyy - June yyyy.

1. Part C2 is a duplicate of Part C1 but will collect data relating to gynaecological referrals from smears registered during the whole of the financial year prior to the current year. This is where the CYTOLOGY SCREENING ACTION TYPE of a SCREENING TEST has a classification of Refer for medical assessment or under medical treatment (Suspend) (S). The date of the smear must be between 1 April and 31 March of the previous data year. The CYTOLOGY RESULT TYPES for each woman is used to allocate her to one of appropriate subdivisions of Most significant result in columns 3 to 9.

2. Note that CYTOLOGY RESULT TYPE classifications of Severe dyskaryosis (cat. 4), Severe dyskaryosis/invasive carcinom a (Cat. 5) and Glandular neoplasia (Cat. 6) are recorded separately in columns 7,8 and 9 respectively.

3. CYTOLOGY RESULT TYPES with a classification of Negative (cat. 2) are not counted.

4. The number of Most significant results in the CYTOLOGY RESULT TYPEcolumns (columns 3 - 9) are further analysed by the BIOPSY REFERRAL OUTCOME (lines 0001-0014). For cervical histology, biopsies are taken at colposcopy.

5. Note that Cervical cancer is sub-divided into 'stage 1B or worse' (line 0001) and 'stage 1A' (line 0002) and that there are four options to describe results which are not applicable or not known: Seen in Colposcopy - NAD no biopsy taken' (line 0009), 'Outcone known - none of the above' (line 0010), 'Seen in Colposcopy - result not known' (line 0011) and 'No outcome available' (line 0012).

6. Part C2 also includes the formula to calculate the Positive Predictive Value (PPV) of smears reported as moderate dyskaryosis or worse to enable the laboratory to assess whether or not they are reaching an achievable standard.

7. Part C2 includes the formula to calculate Lost to follow-up of smears reported as 'Seen in colposcopy - result not known' (line 0011) and 'No outcome available' (line 0012), as a percentage of the Total.

8. Provision has been made to record details of non-cervical cancers at the bottom of Part C2.