Using Hospital Accreditation Organizations To Keep A Lab In Compliance

By Author: Larry Chandler
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Hospitals and labs have to keep up with many details in order to stay compliant with the Clinical Laboratory Improvement Amendments (CLIA). Waived testing, microscopy procedures, registration certificates and text complexity are just some of the items necessary to make sure the letter of the law is followed at all times. All of these items are important but like most regulations some rules carry more weight than others.


Regulations of High Importance

There are certain requirements that tower over other requirements. They present possible problems for laboratories in handling the proper CLIA regulated forms. One of the primary obstacles is the necessity to protect documents. Hospital accreditation organizations allow labs to protect documents in different ways.

Records – The CLIA does not lay out the specific rules for protecting documents but they do indicate the final goals that must be reached. Laboratories are required to keep all records confidential and also to install security measures that will protect against destruction, loss or use by unauthorized personnel. ...
... Each lab approaches this issue in different ways. One organization may simply put files away in a locking file cabinet. Another lab may choose to employ technological systems that have a digital vault, double passwords, automated audit files, and encryption.
Syntax – According to hospital accreditation organizations all documents related to CLIA compliance must have a formal written policy in place that describes how records can be used as well as how records can be removed from storage. The policy needs to also outline under what conditions any information may be released. By keeping written policies concerning the records keeping, the lab is better able to protect those records.
Consent Signatures – CLIA states that a patient may not receive particular documents without the patient's signature. This allows simple issues to be resolved in the case that multiple years have lapsed since the initial event. It is important to keep in mind that the consent form is only effective if employees are able to reliably find them. Hospital accreditation organizations suggest that labs use document storage software in order to easily retrieve items.
Retaining records – Concerning the maintaining of records the CLIA states all records have to be kept for a minimum of 6 years after the last entry in the file. If the State laws require a longer period of time then records must be kept according to the state law. It is not wise to use a filing cabinet for this type of retention. Most labs would be well served by finding an off site organization that can provide adequate storage at a reasonable price and guarantee a certain amount of security.

Other Matters for CLIA

Although maintaining compliance with documents is the main thrust of CLIA, labs have to be concerned with other issues too. Change control management, customer complaints management, training are also vital components of staying compliant with CLIA. With so many different tasks and duties to perform and track it is vital that a lab handles each task according to the regulations. This is one reason why so many medical groups have sought out the assistance of hospital accreditation organizations. These organizations can help the labs make sure their current system is adequate and also provide recommendations for any shortfalls.

Larry Chandler is a freelance writer for COLA, one of the leading hospital accreditation organizations or lab accreditation in the country. To find out more about their CLIA compliance recommendations and online CME credit procedures visit their website at www.COLA.org.