Quality management

1. Laboratory policy on the protection of personal data

Diagnosis Laboratory Center ensures the protection of confidential information and personal data from customers. Diagnosis Laboratory Center ensures that the access to the facilities and records of the laboratory to authorized persons only in order to avoid loss, unauthorized access and misuse of information. All laboratory staff committed to maintaining the confidentiality of the information by signing the relevant confidentiality statement (Quality Manual version 1, §4.1.2).

2. Laboratory policy on providing advisory services

Diagnosis Laboratory Center provides professional advice on the selection of appropriate tests and the use of its services, the frequency of repetition of the examinations and the appropriate type of sample (e.g. blood, urine, etc.). Diagnosis Laboratory Center advices for clinical evidence, restrictions on procedure of the examinations (if necessary) in order to meet the needs of its customers.

Furthermore, the laboratory provides customers the medical opinions and judgments on the interpretation of test results, as well as tips on taking and transporting the samples, their acceptance criteria and the action taken in cases of inadequate samples.

Diagnosis Laboratory Center seeks the good cooperation and maintains continuous communication with customers and treating doctors, during the execution of the tests and after the delivery of results, providing advice and guidance on medical subjects and specialized information, opinions and interpretations based on results.

These tips are provided by the lab director Stefanos Yioukkas. The customer information is done either through personal or telephone, or through the website. (Quality Manual version 1, §4.7.1).

3. Complaints procedures

Customers may submit complaints concerning the laboratory operation in person by contacting the secretary during working hours or in writing using the survey of customer satisfaction provided by the secretary of the laboratory or via email.

Every complaint is recorded in a suitable form of recording complaints.

All complaints must be complete, clear and detailed.

If the investigated complaint is justified, the Laboratory applies corrective actions.

In any case, whether the complaint is justified or not, the laboratory informs the client of the results of the investigation and the corrective actions taken either verbally or by email (depending on how the complaint was delivered).

When the complaint raises doubts about the quality of test results or the compliance of the laboratory with the policies and procedures or the requirements of accreditation, then an inspection of the involved activities to determine if any non-conformities is followed. The inspection results are recorded.

Where the inspection identifies non-compliances, the D4.9 procedure applies (Identification and control of nonconformities).

Complaints are laboratory indication of customer satisfaction. Complaints are used to improve the management system, the examinations and customer service. (Quality Process D4.8, version 1).

4. Customer opinion

Diagnosis Laboratory Center seeks the opinion of customers for the provided services and measures their satisfaction with the use of customer satisfaction survey questionnaire. The questionnaire which can be filled all clients is located in the reception of the laboratory.

The information gathered by customer satisfaction questionnaires, assessed by the laboratory and discussed in the review by management and used to improve the management system and operation of the laboratory. (Quality Manual version 1, §4.8.2).

5. Cooperation with customers

Diagnosis Laboratory Center gladly accepts cooperation with customers or their representatives in clarifying their claims.

Customers or their authorized representatives are entitled to have access to laboratory and watch the performance of tests on their samples. In this case the laboratory takes precaution to protect the confidentiality and privacy of information of other customers. (Quality Manual version 1, §4.8.2).

6. Consent

The attendance of the patient to the laboratory is an automatic patient consent for the laboratory to obtain the original sample and perform the requested examinations.

In cases where the patient is not able to give consent for taking a sample, the lab asks to be given a written consent from the husband/wife or first grade relative of the patient.

For samples submitted or sent by a third party (e.g. from hospital), consent is not required, as the responsibility of sampling and sample identification of the patient belongs to the bearer or sender. (D5.4 Procedure, version 1).

7. Laboratory turnaround time

Result reports are delivered by the reception of the laboratory. Patients or authorized persons are requested to demonstrate an identification document (ID card or driver’s license).

Results for routine tests of samples taken before noon any working day (Monday to Friday) are ready within the same day and can be delivered to customers on the same day by hand, fax or email. For specialized tests that need more days for the results, then the client either locally informed or notified by phone.

The results for samples taken in the afternoon working day (Monday to Friday) can be ready either on the same day or the next day.

The results for samples taken on Saturday can be delivered to customers by hand, fax or email the same day until 13:00 or  next Monday. (D5.8 Procedure, version 1).

Test Instruction

Stool Collection

• Collect the stool specimen (bowel-movement only) in a wide mouth container, bedpan, or a clean newspaper or plastic wrap placed over the toilet seat opening. This prevents the fecal specimen from falling into the toilet bowl (Collection container does not have to be sterile, but must be clean). DO NOT TAKE STOOL FROM TOILET BOWL. Stool sample cannot be tested if mixed with water or urine. Do not submit diapers for testing – place fecal materials to a suitable container.
• Collect enough stool into the screw-capped container provided, equivalent to at least the size of a golf ball, or if liquid, approximately 5 tablespoons. It is important to sample areas of the specimen, which are bloody, slimy, or watery.
• Close the lid tightly.
• Label the container with the patient’s name and the date of collection.
• Place the container in a plastic bag.
• Wash your hands thoroughly.
• Deliver to the laboratory as soon as possible. If specimen cannot be delivered immediately, refrigerate until delivery.

Clean Catch, Mid-Stream Urine collection (Females)

• Remove appropriate garments for urination.
• Wash hands thoroughly.
• With one hand, separate the urinary opening and hold open until the process is complete.
• Using a saturated soapy sponge, wash from front to back three times using a different soap and pad each time.
• Wash with warm sterile water to remove soap residue.
• The patient should avoid a few milliliters into the toilet and then collect urine in a sterile container (Do not stop the flow of urine through this process).
• Secure the lid on the container.
• Deliver to the laboratory as soon as possible.

Clean Catch, Mid-Stream Urine collection (Males)

• Remove appropriate garments for urination.
• Wash hands thoroughly with soap and water.
• Cleanse the penis, retract the foreskin (if not circumcised) and wash three times with different soap pad each time.
• Wash with warm sterile water to remove soap residue.
• Keeping the foreskin retracted, allow a few milliliters of urine to pass and then collect urine in a sterile container (Do not stop the flow of urine through this process).
• Secure the lid on the container.
• Deliver to the laboratory as soon as possible.

Semen Analysis

The patient should not have had sexual contact at least for three days. The sperm is gathered in special sterile container carefully and is transported to the laboratory within 30 minutes.

Rules of conduct

RULES OF CONDUCT

(Quality Manual version 1, Appendix B)

1.  The basic principle governing the operation of the clinical laboratory Diagnosis Laboratory Center is the good health of the patients. Although there is a commercial connection service between laboratory and patient, the lab gives priority to the benefit of patients.
2.  The laboratory treats all patients fairly and equally, without discrimination.
3.  The laboratory collects sufficient information to identify the patient, which allows the performance of tests and other procedures of the laboratory, but never collects unnecessary personal information.
4.  Each patient is informed for the purpose of the information collected.
5.  The laboratory may also collect information on invoicing for financial controls and management of resources and security of staff and other patients in case of transmitted diseases.
6.  The collection of original sample for conducting the tests carried out in each case with the consent of the patient. Before sampling is patient information for sampling. If specific sampling procedures, where there is a possibility of complications, the lab provides more detailed explanations and, where necessary, ask the informed consent of the patient.
7.  When sampling laboratory staff takes into account and respects social, cultural or religious differences of patients.
8.  In exceptional or emergency situations, the initial sample collection may be carried out without the consent of the patient, but always keeping in mind that it is beneficial for the patient. In these cases the laboratory aims to get the informed consent of his / her spouse or relative of the patient First Grade.
9.  The laboratory takes care to ensure the required discretion and privacy (privacy) both during sampling and the receipt of the samples, and during the process of collecting the necessary information.
10.  Where tests require providing expert advice, the laboratory shall ensure that the results indicate serious complications can not be communicated directly to patients without the necessary Scientist advice.
11.  The workshop reject samples are delivered in a condition unsuitable for the requested examination, after informing the patient and / or the responsible physician applicant.
12.  All laboratory tests carried out in accordance with the appropriate procedures and with the expected for the laboratory and medical profession skill level.
13.  The workshop categorically rejects any falsification of laboratory results, and any financial transaction performed, doctors or commercial companies.
14.  The results of the clinical tests corresponding to a specific patient are confidential. The results are communicated to the patient and / or the competent attending physician and may be communicated to third parties only with the consent of the patient or as specified by law.
15.  The results of the tests without the patient identifying information may be used for epidemiological, demographic and other statistical studies.
16.  The laboratory is responsible for the proper reporting and proper interpretation of laboratory results.
17.  The workshop ensures the maintenance of data and medical information so as to avoid loss, unauthorized access and misuse. The shelf life of the lab files is determined by the type of file, the usefulness and importance of contents for the health of patients.
18.  Access to medical records of a patient is allowed:

•  The person requesting the examination,
•  The staff of the laboratory for the performance of his duties,
•  To anyone with authorization from the applicant.