Standard Operating Procedures for Diagnostic Testing

Published 02/25/2021

Palmetto GBA is republishing the following article due to requests we received from providers. All information in this article remains the same.

Many health care organizations have established standard operating procedures (SOPs) addressing common clinical scenarios. These SOPs are rooted in evidenced-based, decision-making and are supported by published, peer-reviewed literature. In order for Palmetto GBA to cover the service(s) described by a given SOP the service(s) in question must be within a defined benefit category as established by Title XVIII of the Social Security Act (for example, diagnostic testing).

The implementation of SOPs for services such as diagnostic testing requires the diagnostic skills of physicians. SOPs are typically developed and approved by relevant medical specialists. For example, SOPs for the performance of urine cultures following urinalyses are generally developed and approved by medical specialists in such fields as Infectious Diseases, Clinical Pathology and Urology.

Palmetto GBA will consider appropriately documented SOPs for diagnostic testing as supportive of reasonable and necessary diagnostic testing services, provided that:

  1. A copy of any applicable SOP is included in documents submitted in response to additional documentation requests (ADRs);

  2. The SOP is indeed evidence-based;

  3. The SOP has been clearly communicated to the treating/ordering physician; and

  4. There is documentation to support that the services provided adhered to the relevant SOP

Please note that instructions commonly referred to as standing orders differ from SOPs. The implementation of SOPs for diagnostic testing requires the diagnostic skills of a physician, while "standing orders" are conditional instructions given by physicians and do not require diagnostic skills for their implementation.

The following examples illustrate the important difference between standing orders and SOPs:

'Standing orders' for capillary blood glucose testing and insulin coverage do not require diagnostic skills. The individual performing the test simply follows the instructions outlined in the physician's conditional statements with regard to testing schedule and insulin coverage. The beneficiary then receives a predetermined dose of insulin according to the result of the capillary blood glucose test. The results are then communicated to the physician.

SOPs for diagnostic testing require that physicians first evaluate the beneficiary and select the appropriate SOPs based on their differential diagnosis. Treatment decisions, based on the results of the diagnostic tests, are incorporated into SOPs and are considered by physicians, as the test results become available. A beneficiary presenting to the emergency department with shortness of breath and chest pain requires a physician-level evaluation prior to implementing any existing SOP for congestive heart failure vs. cardiac ischemia (with or without myocardial infarction) vs. pulmonary embolism with pulmonary infarction.

The implementation of SOPs for diagnostic testing requires active physician participation.

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