PRE-ANALYTICAL QUALITY ASSURANCE PROGRAMME

1) SAMPLE COLLECTION RECEIVING AND PROCESSING FOR NON GYNAEC CYTOLOGY (FNAC AND FLUID) AND GYNAEC CYTOLOGY:

• Standard requisition forms are available for gynaec and non gynaec cytology in different clinical departments as per protocol. (ANNEXURE-1 A, 1 B:CY/ INTERNAL DOCUMENTS – B/ PRIMARY SAMPLE COLLECTION MANUAL)
• The clinician fills all the patient's detail and clinical details in requisition form and send request to the Cytopathology section, NCHSLS.
• Unique identification number is given as follows:

Outdoor patients are numbered with prefix 'OC'

Indoor patients are numbered with prefix ‘IC'

PAP smears are numbered with prefix 'P'

At the start of the every year, patients are numbered starting from 1 with the appropriate prefix.

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  SAMPLE COLLECTION AND PROCESSING FOR FNAC:

• Patient comes with completely filled requisition form to FNAC procedure room- OPD Lab- 10.
• After explaining the procedure, its need and complications associated with it, consent of the patient or the guardian in case of paediatric cases is taken in his/her language. Consent record book is maintained. Annexure of standard consent format is attached. (ANNEXURE-2: CY/INTERNAL DOCUMENTS-B/ PRIMARY SAMPLE COLLECTION MANUAL)
• A unique lab identification number is issued for each patient.
• Detailed clinical history and examination findings are noted on requisition form and the details are recorded in receiving register. (CY/ RECORDS 13 A, B/RECORD REGISTER – INDOOR/OUTDOOR)
• FNAC procedure is carried out with patient lying in supine or sitting position on simple examination couch by using 10 cc disposable syringes, 22-24 gauge needles for superficial swellings and 18-22 gauge needles for deep seated swellings.
• The procedure is done under aseptic and universal precautions.
• Area is sterilised using spirit and Povidone iodine. After fixing the swelling properly, needle is inserted in the representative area and fine needle aspiration is done by back and forth movement of the needle till the adequate material is drawn into the hub.
• Aspirated material is taken and spread evenly on the slides. Prepared slides are wet fixed for HE and PAP stain and dry fixed for MGG stain in methanol for 10 minutes.
• For thyroid and highly vascular lesions, FNA is carried out without aspiration.
• As per requisition by clinician, for very deep seated lesions (e.g. liver metastasis, ovarian mass or any intra abdominal lesion) USG guided FNA is carried out in radiology department.
• Needle prick injury- In case of accidental needle prick injury during FNA procedure, SOP for occupational exposure & post exposure prophylaxis is followed (ANNEXURE III:CY/INTERNAL DOCUMENTS A/SOP 18) records of which are maintained. (CY/RECORDS 7/ ACCIDENT /INCIDENT RECORD)

• SAMPLE COLLECTION AND PROCESSING FOR FLUID CYTOLOGY:

• Clinician sends duly filled standard requisition forms for fluid cytology which are available in all clinical departments. (ANNEXURE-I A:CY/ INTERNAL DOCUMENTS-B/ PRIMARY SAMPLE COLLECTION MANUAL)
• Sample is collected in properly labelled clean plastic container and is transported within 2 hours of sample collection with completely filled requisition form in Cytopathology section of Pathology department by ward boy.
• After complete verification of patient details on requisition form and the labelled container, sample is received by the lab technician with aseptic precautions. A unique lab identification number is generated and proper clinical details are recorded in receiving register. (CY/RECORDS 13A/RECElVlNG REGISTER- INDOOR)
• In case of any incomplete patient details and incorrect sample labelling, sample is returned for correction after verbal communication and remarks are recorded in receiving register. (CY/RECORDS 13A/RECElVlNG REGISTER- INDOOR)
• The gross examination findings of the fluid samples (Body fluid, CSF, Urine, BAL, and Sputum) are entered in the form by the resident doctor.
• With proper aseptic precautions, laboratory technician processes the sample for centrifugation and Cytospin preparation.

Procedure:

• Fluid is centrifuged for 10 min at 2000 rpm in a calibrated centrifuge and also processed for Cytospin preparation on calibrated Cytotek instrument.
• Smears are prepared from the sediment, wet fixation is done for HE & PAP stain and dry fixation is done for MGG stain in methanol for 10 min.
• Standard operating procedure (SOP) and Work desk instructions (WDI) of sample processing of fluid and sputum samples are available in processing room. (ANNEXURE- IV:CY/INTERNAL DOCUMENTS C/WDI)
• Equipment calibration record (CY/RECORDS 21/CALlBRATlON RECORDS) and logbook of equipments are maintained. (CY/RECORDS 22 B, C/LOGBOOK OF REMI CENTRIFUGE, CY/RECORDS 22 A/LOG BOOK OF CYTOTEK) and Master records of all equipments are maintained. (CY/RECORDS 20 MASTER RECORD OF EQUIPMENTS)
• Left over fluid are stored in calibrated refrigerator at 2-8 ⁰ C temperature after processing.

• SAMPLE COLLECTION AND PROCESSING FOR GYNAEC CYTOLOGY:

• Conventional PAP smears for cervical cytology are collected at gynaec OPD by clinician after taking informed consent.
• After collection of the sample, smears are immediately prepared by laboratory technician and fixed in methanol for 10 minutes which is changed daily.
• The smears are received at cytopathology section with completely filled requisition form for gynaec cytology and are allotted a unique identification number to each case after verifying the details. All the details are recorded. (CY/RECORDS 13C/RECElVING REGISTER-PAP)
• Smears are stained with PAP stain.

2) STAINING PROCEDURES FOR GYNAEC AND NON GYNAEC CYTOLOGY:

• The smears for non- gynaec cases are wet fixed for H&E and PAP stain and dry fixed for MGG stain.
• Staining procedure is as per SOP guidelines. (ANNEXURE- V:CY/INTERNAL DOCUMENTS A/SOP-6,7,8)
• After staining and proper drying of the slides, smears are mounted with DPX and properly labelled.

• All the reagents for fixation, processing and staining are indented from central store, NCH Surat, the records of which is maintained in inventory records. (CY/RECORDS 14/1NVENTORY RECORDS)
• On receiving new lot of reagents, it is verified for its quality before using the reagent and records are maintained in lot validation register. (CY/RECORDS 9D/STAlN LOT VALIDATION REGISTER)
• All reagents are properly labelled with name, lot no., expiry date etc. Inflammable reagents are stored separately and labelled as “Inflammable reagents”
• Reagent safety data sheets are available in laboratory documents. (CY/INTERNAL DOCUMENTS 28/MATERlAL SAFETY DATA SHEET)
• Environmental conditions for FNA collection room & Cytopathology processing room is properly maintained and recorded by calibrated Thermohygrometer. (CY/RECORDS 19/ RECORD OF LABORATORY ENVIRONMENT)
• All the laboratory technicians are properly trained for receiving, processing, staining, reagent preparation, equipment maintenance, safety precautions, biomedical waste disposal and all other authorized work. Regular training and competency evaluation are also carried out. Records of which are maintained in staff competency record. (CY/RECORDS 18/RECORD OF QUALIFICATION/EXPERIENCE/COMPETENCE AND PERSONAL HEALTH)
• The staining quality for each stain (H&E, PAP and MGG) is checked daily and records are maintained in daily Quality Control register for stain. (CY/RECORDS 9C- LOG BOOK OF STAINS/ INTERNAL QC RECORDS)
• The stock solution for the stains is prepared on monthly basis and working solution is freshly prepared on daily basis. The stock solution for pap stain is preserved in a calibrated refrigerator.
• Working solution is labelled properly with name and date of preparation and filtered daily before using the stain.

ANALYTICAL QUALITY ASSURANCE PROGRAMME

• Each gynaec and non gynaec cases are being reported by authorized signatory in Cytopathology section.
• Cytological findings with conclusion are reported in standard reporting format for gynaec and non gynaec cases (ANNEXURE VI)
• Cases are reported in accordance with following guidelines.
  • PAP- The Bethesda System for Reporting Cervical Cytology (2014)
  • For thyroid lesions —The Bethesda system for reporting in Thyroid Cytopathology (2017)
  • For salivary gland lesions-Milan System for reporting in Salivary gland Cytopathology (2017)
  • Urinary cytology -Paris System for reporting urine cytology (2016)
• Findings are correlated with clinical and radiological details and wherever necessary cases are also discussed with concerned clinician before final reporting.
• Ancillary techniques like special stains, cell block preparation and Immunocytochemistry (ICC) are used as and when required.
• The reports are generated in an electronic format and dispatched in a printed format.
• Any newly/ unsuspected/ incidentally diagnosed cases of malignancy are considered critical and the clinician is immediately informed telephonically. Records of which are maintained in register. (CY/RECORDS 5/CRlTlCAL AND VERBAL COMMUNICATION)

• PROFICIENCY TEST

1) External Quality Assurance Programme.

• Cytopathology laboratory participates in external quality assurance programme conducted by Tata Memorial Hospital, Mumbai. (EQAS DIAGNOSTIC CYTOPATHOLOGY)
• Annually 2 cycles of EQAS Cytology are received which includes gynecological and non gynaec cytology cases (Fluid and FNA cytology cases). Feedback reports received from EQAS Diagnostic Cytopathology) are stored. (CY/2/RESULTS OF EQA AND INTER LABORATORY COMPARISON)
• In case of any non concordance in results, the root cause analysis is done and further improvement in reporting is done accordingly.

2) Internal Quality Control

• It is carried out within the department every month, one case of each fluid, FNA cytology and gynaec cytology are randomly selected and reported by 2 different authorized signatory from other sections of Pathology department.
• Findings of both pathologists are recorded in register and reviewed. (CY/9A/ INTEROBSERVER COMPARISON OF FNA, FLUID, GYNAECOLOGY CYTOLOGY)
• In case of any discordance in diagnosis, slides are reviewed, root cause analysis is carried out and recorded.

3) Histopathology Correlation:

• Diagnosed cases in cytopathology are correlated with histopathological diagnosis whenever possible. Record of which is maintained. (CY/ 9B/ CYTO HISTO CORRELATION)
• All discordant cases are reviewed carefully and root cause analysis is done.

POST-ANALYTICAL QUALITY ASSURANCE PROGRAMME

• DISPATCH OF REPORTS:

• Reports of outdoor FNAC cases are dispatched to patient or their relatives in OPD 10.
• Fluid cytology reports and indoor FNAC reports are dispatched at cytopathological section to the concerned clinician/ patient's relatives after taking sign of receiving person.

• Gynaec cytology reports are sent to the gynaec department which are dispatched to the patient directly in gynaec OPD
• The electronic and printed copies of all cytopathology reports are saved for 5 years. (CY/24/EXAMlNATlON REPORT)
• Electronic reports are password protected by authorised signatory from unauthorised editing and tampering of reports. (ANNEXURE Vll, SOP-19)

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  TURN AROUND TIME:

• TAT and out of TAT cases are recorded starting from the receiving sample/ slides at cytopathology section till the dispatch of reports. (CY/RECORDS 4a/TURN AROUND TIME INDOOR AND OUTDOOR), (CY/RECORDS 4b/TURN AROUND TIME, ASCUS/SIL RATIO-GYNAECOLOGY)
• TAT for all cases (Fluid, FNA cytology cases) - within 3 working days.
• Out of TAT cases are calculated month wise for outdoor, indoor case and gynaec cytology.
• Acceptable limit for Out of TAT cases is <5% and if this limit is crossed then the root cause analysis is done and records are maintained.
• ASCUS/SIL RATIO: Annually ASCUS/SIL ratio is derived from all the reported cases of gynaec cytology and records are maintained.
• Acceptable limit for ASCUS/SIL ratio is <3:1 and if this limit is crossed then the root cause analysis is done and records are maintained.

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  FEEDBACK FORMS:

• Feedback forms are available at cytopathology section for staff/ patients and clinician and corrective actions if any are taken accordingly at the earliest and reviewed annually. (CY/RECORD IO/FEEDBACK AND ACTION TAKEN)

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  DATA ANALYSIS:

• All the data and receiving record% including FNA, Fluid cytology, gynaec cytology, intra operative cytology, USG guided and special stains are monitored monthly and annually.

• STORAGE OF LEFT OVER FLUID SAMPLES:

• The left over samples are stored at 2-8 ˚C in a calibrated refrigerator arid records of which are maintained. (CY/REFRIGERATOR TEMPERATURE SHEET)

• STORAGE OF CYTOLOGY SMEARS:

• The cytology smears are stored for 5 years in a storage cabinet.

• STORAGE OF CYTOLOGY REPORTS AND REQUISITION FORMS:

• The cytology reports are stored in form of duplicate printed comes as well as electronic copy in a password protected computer for a period of 5 years and requisition forms are stored for one month.

Cytopathology (IQC PLAN)

Cytopathology (IQC PROCEDURE)

Cytopathology (EQAS PLAN)