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Abstract
Background: A laboratory requisition form (LRF) is the main communication link between the laboratories and the clinicians. In a cytopathology laboratory, incomplete forms with inadequate information significantly impact the quality of the results and waste precious time of the lab. Aims: The aim of this study was to audit the LRFs for adequacy of demographic and clinical data and to analyze the reasons for the same. Settings and Design: A retrospective study was conducted in the cytopathology laboratory of a tertiary care center. Materials and Methods: All the original LRFs received for Pap smears and FNACs of 1-month duration were retrieved. The forms were scrutinized for the presence of specific parameters which were classified as patient information, clinician information and clinical information. In addition to the completeness of the form, clarity of the data was also noted. Statistical Analysis: The data were entered on excel worksheets and percentage of Pap smear and FNAC forms lacking information of various parameters was calculated. Results: A total of 431 LRFs were received in the month of January 2020. These included 274 Pap smear LRFs and 157 FNAC LRFs. Patient information was mentioned in predominantly all the forms, however, clinician and clinical information, which is indispensible for reporting, was missing in a significant proportion of the Pap smear and fine needle aspiration cytology (FNAC) forms. Conclusions: Receiving inadequately filled LRFs has been an age-old problem in all medical laboratories. Audit of inadequacy of LRFs helped in assessing the prevailing practices in the hospital and gave an insight into the quality of information available to the cytologists for reporting. Many clinicians withhold information out of ignorance about its importance or due to lack of time to fill up the details on the LRF. Also, filling out a LRF is a task usually delegated to the junior doctor in the OPD and the significance of filling the LRF correctly and comprehensively is often not emphasized upon adequately by the senior clinicians. This audit helped us taking preventive action by giving feedback to the clinicians and emphasizing to them the importance of clinical data on the LRF and in improvising the LRF using a more objective and user-friendly format.
Keywords: Audit, cytopathology laboratory, laboratory requisition form
How to cite this article: Introduction 
A laboratory requisition form (LRF) is the main communication link between the laboratories and the users (clinicians). The clarity and comprehensiveness of the LRF are important indicators of quality in any laboratory. The provision of key clinical information of the case on the LRF by the referring doctor, often has a bearing on the final result of the laboratory investigation.
It is mandatory to accurately mention all the patient parameters on the form like name, age, gender, and unique identification number. Details of the referring department are also required for traceability.
In a cytopathology laboratory, proper interpretation of cytological features of any case requires adequate clinical data, review of previous cytology/histopathology slides, review of all previous treatment received and radiological findings. Thus, complete clinical information on the cytopathology LRF ensures a good quality cytology report. Incomplete forms with inadequate information significantly impact the quality of the results and waste precious time of the lab.
Lack of clinical information which critical to proper interpretation of cytomorphological features has not been widely attended to in cytology labs and there is paucity of adequate literature on the topic. This study was conducted with the aim of auditing the LRFs for adequacy of demographic and clinical data and exploring the various possible reasons for the deficiency of the same. The impact of incomplete data was analyzed and various solutions were suggested.
Materials and Methods The study was conducted in the cytopathology lab of the Department of Pathology, Hamdard Institute of Medical Sciences and Research for a period of 1 month. The ethics committee approval was obtained on 1.7.21. It was a retrospective descriptive study. One month was randomly selected (January 2021) and all the original LRFs received for Pap smear More Detailss and FNACs in that month were retrieved from record section of the laboratory. The forms were scrutinized for the presence of specific parameters which were classified as patient information, clinician information, and clinical information. Patient information included name, age, gender, patient unique identification number. Clinician information included referring department and unit, physician's name, signature, and phone number. Parameters assessed under clinical information were symptoms, examination findings, relevant/prior investigations, last menstrual period (LMP) (for Pap LRFs), previous treatment if any and provisional diagnosis were also analyzed. In addition to the completeness of the form, clarity of the data was also noted. The forms were evaluated for the handwriting (understandable/nonunderstandable) and use of abbreviations.
The data were entered on excel worksheets and percentage of Pap smear and FNAC forms lacking information of various parameters was calculated. The study was performed according to the Helsinki Declaration and patient confidentiality was maintained at all times.
Results A total of 431 LRFs were received in the month of January 2020. This included 157 FNAC LRFs and 274 Pap smear LRFs.
Pap smear LRF
A total of 274 Pap smear LRFs were analyzed in a period of 1 month [Table 1]. All the Pap smear LRFs mentioned the name, gender, age, and unique identification number of the patient. While the department was mentioned in all the LRFs, departmental unit was mentioned in 92.3% forms while the referring consultant was mentioned in only 62.4% forms. While most of the forms had signature of the clinician (98.9%), contact number was mentioned in only 0.4% forms.
The LMP was written in only 21 out of 274 forms (7.7%). Most of the forms did not include clinical symptoms (98.5%) and only seven forms (2.2%) mentioned the detailed clinical (per vaginum and per speculum) examination findings. In 58.4% forms, even the clinical diagnosis was not mentioned. The remaining forms (41.6%), the various diagnosis mentioned included amenorrhea, abnormal uterine bleeding, bleeding per vaginum, cervicitis, dyspareunia, fibroid, infertility, pelvic inflammatory disease, prolapse, pruritis, pyometra, spotting, white discharge, and preoperative work up. Other relevant investigations were mentioned in only six forms (2.2%).
Most of the forms were clear with understandable handwriting (96%). However, unacceptable abbreviations and other short forms were used in 98.9% of the forms. There was no need to call the clinician in any of the cases for any query or history [Table 2].
FNAC LRF
[Table 3] summarizes the details mentioned on the FNAC LRFs. Out of 157 FNAC LRFs evaluated, patient details like name, age, gender and unique identification number were mentioned in all (100%) of the forms. Patients were referred to cytopathology laboratory for FNAC from Surgery, Medicine, Paediatrics, Orthopedics, Otorhinolaryngology, and Dermatology departments. While departments were mentioned in all the forms, details of the departmental unit and referring consultant were missing in many LRFs (68.1% and 54.8%, respectively). While the clinician's signature was present in 86% of the forms, contact number was mentioned in only 24.2% of the LRFs.
When the LRFs were assessed for clarity, 25.8% forms revealed poor, illegible and nonunderstandable handwriting. Abbreviations were used in 29.9% of the forms [Table 4]. The clinicians had to contacted for queries in 10.8% of the cases, majority in surgery department.
Discussion Laboratory investigation results influence 70% of the medical diagnosis and therefore it is an important determinant of the success and cost of patient treatment.[1] Therefore, the goal of any laboratory should be to minimize all types of errors. Laboratory errors may occur during any phase of the laboratory working cycle but most of the errors have been reported during the preanalytical phase.[2] Issues in the requisition forms constitute a significant proportion of lab errors in the preanalytical phase, the main problem being incomplete details on the form.[3]
Receiving inadequately filled LRFs has been an age-old problem in medical laboratories and it has a significant impact on test interpretation.[4] LRFs which are manually filled are prone to having insufficient, incorrect and illegible data.[5] This is more likely to happen when unstructured forms are in use. Such inadequately filled forms may affect the interpretation of results, complicate billing processes and make communication of critical lab results to the physician difficult.[6]
Filling out a LRF is a task usually delegated to the junior most doctor or postgraduate student in the clinical departments and the significance of filling the LRF correctly and comprehensively is often not emphasized upon adequately by the senior clinicians leading to haphazardly and incompletely filled up LRFs. This has an adverse bearing on the quality indicators of the laboratory and also negatively affects the quality of health care services provided by the institution as a whole.
In cytopathology laboratory, importance of liaison between the clinician and pathologist cannot be overemphasized. This is facilitated by presence of pertinent clinical data on the LRFs. An audit of inadequacy of LRFs was conducted to assess the prevailing practices and identify the reasons for the same with the aim of bringing out modifications for ultimate quality improvement.
Pap smear LRF
Pap smear findings have to be interpreted in context of the clinical details on the LRF. This has been emphasized by the Bethesda system of reporting cervical cytology.[7] Complete clinical information on the LRF (like clinical symptoms, local examination findings, provisional diagnosis, menstrual history, history of contraceptive use/hormonal intake/surgical intervention and previous Pap smear reports) ensures a good quality report. Status of HPV testing as well as HPV vaccination should also be conveyed in the LRF, for better correlation. The National Accreditation Board for Testing and calibration laboratories (NABL) guidelines mention that gynecological cytology request form should contain details of menstrual phase, hormone status/therapy, contraceptive use and previous history in addition to other clinical details.[8] However, criteria for rejection of samples of Pap smears, based on adequacy of the filled LRF has not been mentioned by NABL.[8] So whether the samples should be rejected if forms are inadequately filed is unclear according to NABL.
The literature discussing the adequacy of clinical data on Pap request forms is scarce.[1],[9],[10] One study reported that there was no clinical information in 12% of the Pap smear LRFs and in another study, this percentage was 41%. In the current study, while patient details were appropriately filled on all forms, details of the treating gynecologist, most significantly doctor's name was missing in a significant proportion of the LRFs. Doctor's phone number was mentioned in only one form. Lack of contact details affects the timely communication of critical results to the clinicians. In addition, it contributes to wastage of precious time of the lab.
The clinical diagnosis was mentioned in only 41.6% of the forms. This was probably because most of the Pap smears were sent for routine screening. However, it is still important to mention the clinical symptoms, if any and per vaginum and per speculum examination on the form, even if negative findings exist. Date of the LMP which is the first question asked in any gynae OPD was mentioned in only 7.7% of the forms. Such clinical details are important for correlating the pathologists' findings on the Pap smear. Inadequate clinical data on the LRF unnecessarily increases the turnaround time (TAT) of Pap test reports, especially in cases where the morphology does not correlate with the scarce data provided.
FNAC LRF
All parts of the FNAC LRF should be completed by the clinician to provide sufficient information for accurate laboratory diagnosis. This also saves time and lab resources. In a laboratory-based audit in Kenya it was found that only 55% of cytology LRFs had sufficient clinical information.[11] In one study from Nigeria it was found that data which were commonly omitted in Pathology LRFs was patient age, gender, location, and clinician's name.[12] In this study, however, the patient parameters were adequately mentioned in all forms. The most common clinician parameter missing was the contact number of the consultant in charge. While the site of FNAC and the provisional diagnosis was mentioned in most forms, important findings like clinical history, examination, and investigations were missing in majority of the forms. These details are especially important for reporting FNACs from organs like thyroid and breast where the clinical, imaging and biochemical parameters (thyroid function tests) have to be correlated with findings on the smear.
Clarity of the LRF
The use of abbreviations is rampant among clinicians in busy out-patient departments. But use of even commonly used abbreviations may lead to laboratory error since staff responsible for data recording in registers may not be familiar with the same. One can familiarize the lab staff with standard medical abbreviations to smoothen the functioning of the lab. However, use of other intradepartmental clinical abbreviations should be discouraged.
Clarity of the form and good handwriting eases out the data entry process and prevents wastage of time. Majority of the forms audited had satisfactory handwriting and were easy to comprehend.
Recommendations for quality improvement
Importance of mentioning demographic details of the patient and the unique hospital identification number is a known fact. Such details should always be clearly and carefully mentioned on the LRF to prevent unnecessary and avoidable errors like sample mismatch. Mentioning contact number of the referring clinician in charge should be made an indispensable practice since it allows the pathologist to easily contact her/him in case of any query as well as to inform critical results like positivity for malignancy. Regular and effective communication between the physician and pathologist enhances the quality of reporting.
Many clinicians withhold information out of ignorance about its importance or due to lack of time to fill up the details on the LRF.[13] Clinicians should be made aware of the pathologist's expectations regarding the clinical data. It is the responsibility of the pathologist to convey to clinicians the essentiality of relevant clinical details for accurate pathological interpretation of the samples.[14] In one study, educational intervention with special emphasis on provision of relevant clinical details on LRF lead to a significant improvement in the quality indicators in Biochemistry laboratory.[15] Giving regular feedback to the clinicians may also improvise the quality of LRFs received.
Having a structured LRF would make it easier for the clinician to fill in the relevant details in a short period of time in a busy clinic. A user-friendly, objective requisition form with a check box configuration would be an effective approach to improve the compliance. After this audit, the cytopathology department formulated a structured requisition form for Pap smear. A comparative study to evaluate its effectiveness in comparison to the older LRF will be a useful measure of quality improvement.
A lab may incorporate different approaches to reduce the “lack of clinical information” available to the pathologist depending upon the individual lab's logistics and resources. Computerization with online entry of patient details and linkage of the system with the laboratory information system may be useful. Dogether et al.[16] recommended the implementation of electronic-based LRF in their study. They compared the use of electronic forms and paper-based forms and found that electronic forms are more accurate, clear, complete, and understandable.
Conducting this audit on the adequacy of data in LRFs gave our laboratory an insight into the quality of information available to the pathologists for reporting. This helped us in improvising on our requisition form and also taking preventive action by giving feedback to the clinicians and emphasizing to them, the importance of clinical data on the LRF. This ultimately was useful in improving the quality of reporting and the overall quality of the lab.
The LRF should provide complete, accurate, clear, and understandable data to the lab staff to facilitate good quality reporting. This will also ensure patient safety by avoiding errors in reporting. Adequately filled-up LRFs are a necessity if accreditation is required. In addition, they are a valuable resource for postgraduate training and research. Therefore, the importance of adequately completing the request forms must be emphasized to all health care workers.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
References 
Correspondence Address:
Dr. Shivali Sehgal
B-4/125, Safdarjung Enclave, New Delhi - 110 029
India
Source of Support: None, Conflict of Interest: None
CheckDOI: 10.4103/joc.joc_160_21
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