Q Urological

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Arnold Gilgen

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Aug 3, 2024, 1:22:14 PM8/3/24
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This overview represents the updated European Association of Urology (EAU) Guidelines for Urological Infections. The aim is to provide practical recommendations on the prevention and treatment of urinary tract infections (UTIs) and male accessory gland infections. These guidelines also aim to address the important public health aspects of infection control and antimicrobial stewardship. Separate EAU guidelines are available addressing paediatric urological infections [1] and infections in patients with neurological urinary tract dysfunction [2].

It must be emphasised that clinical guidelines present the best evidence available to the experts, but following guideline recommendations will not necessarily result in the best outcome. Guidelines can never replace clinical expertise when making treatment decisions for individual patients, but rather help to focus decisions - also taking personal values and references/individual circumstances of patients into account. Guidelines are not mandates and do not purport to be a legal standard of care.

The EAU Guidelines Panel on Urological Infections consists of an international multi-disciplinary group of urologists, with particular expertise in this area, an infectious disease specialist and a clinical microbiologist. All experts involved in the production of this document have submitted potential conflict of interest statements, which can be viewed on the EAU website Uroweb: -infections/panel.

A quick reference document, the Pocket Guidelines, is available in print. This is an abridged version, which may require consultation together with the full text version. All documents are accessible through the EAU website Uroweb: -infections/.

For over 60 years, Urological Associates has provided the Quad City region with highly quality, comprehensive, and compassionate urological care.
We have 9 board certified Urologists, five Advanced Practice Providers, along with more than 80 employees. We offer daily appointments in our Davenport and Moline offices. Our team is here to provide you with personalized urological care close to home.

We specialize in diseases of the urinary system, which includes the kidneys, bladder, ureters and urethra, and the male reproductive system. We are able to help patients of all ages solve their urological problems with a variety of treatment options, including the newest therapies and expert surgical intervention.

We understand the unique urological needs of women. We have a team of providers dedicated to developing your individualized treatment plan to achieve an effective cure, optimal rehabilitation and improved quality of life.

Children need urologists too! We have expertise in the treatment of multiple conditions for children of all ages. We work closely with our patients and their families to ensure a comprehensive diagnostic and treatment process.

The da Vinci Surgical System is a surgical robot that is a minimally invasive alternative to both open surgery and laparoscopy. Doctors Kresowik, Lightfoot, Bream and Berneking have been trained in robotics, and are experienced in the use of the da Vinci Surgical System. Urologists have been at the forefront in embracing robotic surgery and making it a standard tool in surgical intervention. We are proud that our experienced team has been part of this revolution.

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As the U.S. Food and Drug Administration (FDA) continues to evaluate the risk of patient infections and contamination issues associated with reprocessed urological endoscopes, the FDA is aware that the current reprocessing instructions for certain urological endoscopes manufactured by Karl Storz are inadequate and are being changed updated by Karl Storz. The affected urological endoscopes include cystoscopes, ureteroscopes, cystourethroscopes and ureterorenoscopes, used for viewing and accessing the urinary tract.

On April 1, 2022, Karl Storz initiated a voluntary recall and issued an urgent field safety notice to instruct users to discontinue all high-level disinfection methods for all affected urological endoscopes and discontinue liquid chemical sterilization for most of the affected urological endoscopes. The affected urological endoscopes should be sterilized after each use by an appropriate sterilization method recommended in the instructions for use.

The FDA wants to ensure that health care providers and users are aware of the change in reprocessing methods for certain urological endoscopes by Karl Storz. The FDA will continue to monitor reports of patient infections or contamination issues with urological endoscopes, and work with manufacturers on adequate reprocessing methods and instructions.

Urological endoscopes are used by health care providers to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract (for example: urethra, bladder, ureters, and kidneys) depending on the intended use and design of the device.

Since 2017, the FDA has evaluated medical device reports that describe patient infections post-procedure or other possible contamination issues associated with reprocessed urological endoscopes. There are multiple possible root causes for these issues, including inadequate reprocessing or maintenance issues (for example, device failed leak testing), reprocessing instructions in the labeling (including cleaning of accessory components), and device design (including specific device components). Based on the available data, we continue to believe the risk of infection is low. However, health care providers and users should be aware that patient infections associated with reprocessed urological endoscopes can and do occur.

The FDA will continue to work with Karl Storz to evaluate the root cause of reprocessing failures, and to ensure that an adequate supply of urological endoscopes are available for users and patient care.

The FDA continues to work with other device manufacturers to evaluate potential causes and contributing factors for patient infections associated with reprocessed urological endoscopes and develop mitigation measures to minimize the risk of infection.

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If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.

Urinary catheters and external urinary collection devices are covered to drain or collect urine for a beneficiary who has permanent urinary incontinence or permanent urinary retention. Permanent urinary retention is defined as retention that is not expected to be medically or surgically corrected in that beneficiary within 3 months.

If the catheter or the external urinary collection device meets the coverage criteria then the related supplies that are necessary for their effective use are also covered. Urological supplies that are used for purposes not related to the covered use of catheters or external urinary collection devices (i.e., drainage and/or collection of urine from the bladder) will be denied as non-covered.

The beneficiary must have a permanent impairment of urination. This does not require a determination that there is no possibility that the beneficiary's condition may improve sometime in the future. If the medical record, including the judgment of the treating practitioner, indicates the condition is of long and indefinite duration (ordinarily at least 3 months), the test of permanence is considered met. Catheters and related supplies will be denied as non-covered in situations in which it is expected that the condition will be temporary.

The use of a urological supply for the treatment of chronic urinary tract infection or other bladder condition in the absence of permanent urinary incontinence or retention is non-covered. Since the beneficiary's urinary system is functioning, the criteria for coverage under the prosthetic benefit provision are not met.

If additional inFlow devices or urological supplies are sent home with the beneficiary, claims for these devices may be billed to the DME MAC only if the beneficiary's condition meets the definition of permanence as defined in the Prosthetic Device benefit. In this situation, use the place of service corresponding to the beneficiary's residence; Place of Service Office (POS) 11 must not be used. If the beneficiary's condition is expected to be temporary, urological supplies may not be billed. In this situation, they are considered as supplies provided incident to a treating practitioner's service and payment is included in the allowance for the treating practitioner services, which are processed by the A/B MAC.

In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.

When the prescribing practitioner is also the supplier, and is permitted to furnish specific items of DMEPOS, a separate order is not required; however, the medical record must still contain all of the required order elements.

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