I.A.1

"The laboratory or the organization of which it is a part shall be an entity that is legally identifiable and can be held legally responsible."

Q.

What kind of "proof" do you need for a public hospital lab?

A.

A laboratory license will suffice.

"The laboratory should have policies to ensure that personnel are free from commercial, financial and other pressures that may adversely affect the quality of work."

Each facility management should identify the unique pressures that may be faced by their staff and define policies and processes to help reduce or remove those pressures. Examples include employee assistance programs, flexible scheduling, conflict of interest guidelines between staff and clients, workload policies. 

"The facility shall evaluate staff skills to perform assigned tasks following training and periodically thereafter."

No, the employer must assess staff skills for those tasks assigned.

Assessors will not pass judgement on the competence of laboratory staff. During an accreditation assessment, evidence should be produced by the laboratory that demonstrates the employer's confidence in the competence of its employees.

No, the list only provides examples. The method of assessment will vary according to the nature of the work. 

There should be an assessment of skills following the initial training process - usually through a checklist signed off between the trainer and the trainee. As for the periodic re-evaluation of skills, it is up to each facility to define when and how they will do this for each job description. 

Yes, facilities are expected to assess all staff including technologists, laboratory assistants, clerical staff, management, etc. The extent and frequency is at discretion of the facility and will vary according to the complexity of the task and the potential for error.

"The quality management system shall encompass all management activities and processes relating to quality assurance."

The mapping of processes should be a high priority. It is stated throughout the OLA requirements that the laboratory shall have documented policies, processes, and procedures. One way to document a process is to create a flow chart, but a table or description is also acceptable.

II.C.1

"The laboratory shall have a quality manual whose purpose is to describe the laboratory's quality management system. Note: A suggested table of contents (based on ISO 15189) for the quality manual is...."

Please refer to "OLA Guidance for Laboratory Quality Manuals" available at www.qmpls.org.

No, POCT should be included within the policies described in the overall laboratory quality manual.  

There should be one quality manual that describes the overall policies of all departments. The overall policies for things such as document control, personnel, inventory, occurrence management should be fundamentally the same.

II.D.7

"Internal audits should be conducted at intervals defined in the quality management system (suggest once per year) to verify that operations continue to comply with the quality management system, both managerial and technical."

An internal audit of your Quality Management System is a formal self-assessment. It may, however, be done in parts.

II.F.1

"Laboratory management shall define, document and maintain a policy, process(es) and procedures to control documents and records. Documents and records may be maintained and stored on any appropriate medium."

It is not included in the OLA requirements.  

II.F.5

"All documents relevant to the quality management system shall have a unique identification."

There is no OLA requirement for a document header to have a full address, or for logos of all affiliated sites to be on documents. However, the requirements are explicit in the case of patient reports. These must contain the name and address of the laboratory, and the name and address of the laboratory where the examinations were carried out. 

It is insufficient to put identification only on a cover page of the manual. The header must appear on at least the first page of each procedure within the manual. If the procedure consists of multiple pages, sufficient information must be on each page to be able to identify the correct placement of the page should it become separated from the rest of the document.

II.F.6

"Documents shall include the date of issue."

If you are officially implementing a new system on a particular date, you may use that as the effective date for existing documentation. Otherwise, indicate "unknown" and record revision dates.

II.F.9

"Documents shall contain authority for issue."

It is the individual who has the authority to approve of or revise the document's contents.

Who is responsible for signing an SOP?

The laboratory director OR designated responsible person is responsible for review and approval of all documents. 

Is an electronic signature acceptable?

Yes, an electronic signature is acceptable provided the laboratory can prove that only approved personnel have the ability to place the signature on the document.

Where must the signature appear?

On each document.

Where must evidence of annual reviews appear?

Evidence of subsequent annual reviews of a manual in its entirety may be recorded on each individual document contained within a single manual or on a log sheet at the beginning of the manual.

For annual review of procedures, who signs?

The laboratory may define who is the most appropriate individual to review procedures. 

When procedure is revised, who must sign the changes and where? 

It is up to each laboratory to create a process for document change and what changes require approval. 

Do process flow charts have to be approved?

Process flow charts are controlled documents and need all of the information listed in II.F.6-II.F.10. 

II.F.11.1

"A retention period for superseded documents shall be defined."

What is the retention time for documents? (not records)? 

Keep a document for as long as it is in effect. In the case of obsolete documents, requirement II.F.11.1 allows each facility the latitude to define its own retention time. However, transfusion medicine procedures must be kept indefinitely.

II.G.2

"The laboratory director or designate shall be responsible for selecting and monitoring referral laboratories and consultants in consultation with the users of the laboratory services, where appropriate."

Could you provide some practical ways for "selecting and monitoring" referral laboratories? How can we assess the quality of the analyses they perform? 

We do not expect each facility to assess the quality of referral laboratory tests directly. We expect that you require your referral labs to submit evidence that proves their competence. This could be a copy of their licensure, or accreditation certificate from OLA or CAP. Alternatively, you can ask for proficiency testing results, QC records, personnel qualification. To monitor, periodically review arrangements and ensure that competence is still valid.

II.G.4

"The laboratory shall ensure that the referral laboratory or referral consultant can demonstrate competence to perform the requested examinations."

We use a large private laboratory as a referral center, that sends samples on to other labs. Are we required to have a copy of every laboratory license where specimens are sent? Would a blanket statement from the referral centre suffice? 

Yes, a blanket statement that outlines how the referral center determines the competence of the laboratories it refers testing to would suffice. 

What needs to be on file for Public Health labs since they are not under the same licensure system? 

All of Ontario’s Public Health laboratories are participating in the accreditation program, and will provide you with appropriate information regarding competence on request.

How do we comply?

Remember that not all of conditions listed will apply to the equipment in your facility. To comply, check with the manufacturers of your various pieces of equipment and see if there is anything that will interfere with the operation of that piece of equipment, and how sensitive it is.

Does this include commercially purchased biochemical media?

Commercially prepared biochemical test media should be subjected to quality control on receipt in the laboratory with appropriate positive and negative control organisms.

Please clarify the terms "math string" and "locking of cells" mentioned in the "What to Look For" for requirement IV.10.

You need evidence that any math (used in off-the-shelf software or software built into equipment) and any formula strings (these are computer programming instructions) do indeed work as expected. You might be able to manually check some calculations but for some things the manufacturer might have to be consulted. By "controlling the locking of cells" we mean to say that any values within computer language (often referred to as contained in cells) cannot be altered accidentally or by unauthorized individuals. This achieved by "locking" the cells containing the data.

Please clarify.

What maintenance does OLA expect on glassware?

Please clarify.

Exactly what should be done to ensure the water is of "suitable quality"?

Bone marrow and CSF were put into a category of medical procedures. Can we consider paracentesis and thoracentesis collection medical procedures?

"Specimens shall be collected in accordance with universal/standard precautions."

When issuing blood or components, is an actual signature required, or are initials adequate?

Is this asking for validation of Blood Bank reagents?

Is this required for qualitative tests with internal quality control? (e.g. occult blood )?

What about very low volume situations?

"The process and/or procedure(s) for critical intervals shall include the immediate notification of clinical personnel responsible for patient care. An appropriate contingency plan shall be documented to follow in the event the physician is unavailable."

Who is considered "clinical personnel" and what, if any, their qualifications should be?

Each facility must define who is authorized to receive critical results on behalf of the care team (ward, floor, clinic, etc).

"Patient data on computer reports and displays shall be compared with original input to ensure the integrity of data transfer at random intervals."

Please clarify.

There must be a process in place whereby somebody randomly and periodically checks final reports to original input such as worksheets, instrument tapes, audiotapes etc... Each laboratory has the latitude to decide the frequency of these checks since it will vary by the nature of the test and the potential for error.

"The facility shall have a designated safety officer to assist laboratory management with safety issues."

Does a lab need a dedicated safety officer to assist lab management with safety issues?

We assume it is most efficient for one person to coordinate all safety issues, on behalf of laboratory management. That is not to say, however, that this person may ask other individuals to monitor certain things or attend meetings and report to her or him.

"The safety program shall be regularly audited and reviewed by laboratory management staff."

What is the difference between an 'audit' and a safety inspection?

The audit is a review of the safety program, for management to ensure it is covering off all safety issues. X.A.4 refers to a physical inspection, by whomever is assigned. 

Is signage required for all entrances? 

Do staff have to wear gloves at all times?

"Footwear shall have closed toes and nonslip soles."