Process Control

In the provision of diagnostic services, it is essential we maintain control over the results provided so reliability can be assured. Access to the laboratory including testing areas and patient information storage areas, is restricted to those staff who are qualified and authorised to be within the test area. The factors which require control are ;

Precision of results

• Test methods used
• Quality control procedures applied
• Quality of interpretative advice provided

Rapid processing and reporting of results

• Provision of efficient courier services
• Maintenance of equipment
• Maintenance of a safe and suitable working environment.

Maintenance of records of testing and test reports

• Maintenance of computer hardware and software
• Maintenance of appropriate document control
  
  

Test methods and the monitoring of our test results

Test methods that are published and accepted by the pathology industry are selected by our practice. We ensure that there is compliance to our documented test methods. We encourage the constant review of our methods, and audit each section of the laboratory .

In addition, the laboratory participates in several external QC programs. The checking and monitoring of these results ensures reliability and the maintenance of a high standard. We also use internal QC which monitors our reagents and equipment. The results of the internal / external QC procedures are monitored by the Lab Manager and discussed in monthly QC meetings.

Quality control procedures

Dermpath Lab participates in several external QC programs, which are either managed or recognised by NATA. In these programs, we conduct tests and issue results which are parallel to those conducted in the laboratory.

Interlaboratory and reference material comparisons are performed where appropriate.

Computing software

We invest resources into ensuring that we have appropriate computing software by purchasing well established packages or by contracting to have specific programming performed. In the latter case, we require the resulting software to perform to agreed performance criteria before it is accepted into our system.

SPECIMEN MANAGEMENT

Specimen control at reception point

We control specimen receipt by couriers from the courier records. The control of specimens in the laboratory, is documented in the Specimen Reception Manual.

Our specimen reception staff check the paperwork provided by the client and ensure that the necessary quotient of specimens and clerical details are complete. This may require phone follow up.

Specimen identification and traceability

Specimen identification and traceability is maintained throughout the entire testing process. Each individual package of samples is unwrapped and the specimen reception staff check that all the specimens received correspond to the details laid out on the request form.

The specimens are then given a unique number. This number is also applied to the request form, and carries through to the results report, invoice and receipt.

Our records enable us to trace specimens from the time they are collected until the time they are discarded. Our records (connected by the unique lab number) also provide information to enable us to perform audit trails from specimen collection to result dispatch.

Missing and unacceptable specimens

Missing specimens are defined in our laboratory as any specimen that is needed to fulfil a doctor's request that hasn't been received by the laboratory. The protocol for following up these specimens is as follows ;

1. The incident is recorded.
2. The surgery or collecting centre is notified.
3. The doctor is notified and a 'To follow" sheet is sent .
4. Photocopies or back copies of the request form are placed in the "Specimen requests to follow file", which is organised alphabetically.
5. When a specimen is received that doesn't have accompanying paperwork, the contents of this file are checked. If the request form is found in this file, specimen and paperwork are matched up, and the data entry staff is notified.

If the specimen is classified as being unsuitable or unacceptable by the Specimen Reception supervisor, the same procedure is adopted as above, so that a suitable specimen is received. If this is not possible, and the doctor wants us to continue regardless, a note is put on the report to that effect.

RECORD MANAGEMENT

Organisation and storage of request forms

Request forms are kept for a total period of 18 months.

Result report features

Our result reports aim to give a clear, unambiguous statement of test results.

• Details of sample identification Result,
• Plus the inclusion of reference ranges and comments if appropriate.

Our result sheets include:

• The name and qualifications of the person in whom the accreditation is held.
• Identification of our laboratory by street address, phone number.
• Date of issue of the report.
• Unique identification number of the document, which is the Lab number assigned to the specimen on receipt.
• Test results, with normal ranges and abnormal flags where appropriate.
• The signature of the approved signatory.

Each page of the document bears a page number, and the total number of pages in the report. At the bottom of the final page, the doctor is provided with a summary of the tests requested, and any tests pending in the case of an ***INTERIM REPORT ***.

Results issued by other laboratories

In reports which include results from other laboratories, the identity of the referring laboratory is noted.

Reports from other laboratories are stored for a period of 6 months, after the results have been transcribed onto our reports.

Storage of result documents

All result storage is facilitated by our computer system.This system allows for phone result dispatch, reprinting of results on request and laboratory access to previous reports.

Issuing of interim reports
Dermpath Laboratories issues Interim Reports when Final Reports are to take a long time (as in the case of "send away" results), and information is available which the doctor may find useful in the meantime.

Such reports are labelled as "INTERIM" in the bottom left hand corner, and specify "TESTS PENDING".

TRAINING

Training policy
To be competitive and to provide exemplary customer service, Dermpath Laboratories needs a workforce that is sufficiently skilled to use the available instrumentation and to have sufficient knowledge to "value add" to the job undertaken.

The company recognises, together with its employees, that it is essential for a training program to be in place to satisfy these needs. This program must identify the existing skills of the employee, while determining any training gaps. This latter point applies particularly to new employees.

In addition to training, extra supervision is given to more junior, inexperienced staff at the discretion of the Department Head.

Training may be on the job, instructional training or internal or external training courses.

Training programs

Dermpath lab requires training to be an important part of our policy to ensure that all staff are aware of how to carry out their duties in an efficient manner, following all the procedures which are necessary to produce laboratory reports which are of a standard consistent with our clients' high expectations.

The company has established the criteria for education, training and experience for every position within the company. These requirements have been established in consultation with the Laboratory heads. Consideration has been given to occupational health and safety requirements, good laboratory practice and any training requirements advised by instrument suppliers.

Laboratory heads insure that staff are adequately trained to perform the duties required of them and that they are familiar with work instructions and procedures pertaining to their area of employment. Training modules are available for each section of the laboratory.