The DOT, FDA, OSHA, and your accreditation organization are watching how you conduct your oxygen business, so start with the basics, then address the details.

During a recent accreditation resurvey of a respiratory provider, the surveyor accompanied a service technician on a home visit to a concentrator patient. It was a routine stop to drop off six portable cylinders and perform a concentrator check.

In anticipation of their arrival, the patient had lined up his six empties in his front hallway. The service tech made the exchange, analyzed the output from the concentrator, had the patient sign the delivery ticket for confirmation, and would have departed if the surveyor had not lingered to ask a few questions. “Where are your backup tank and portables?” he asked, and the patient happily led them to a closet where his backup stood, and then on to his garage where his truck was parked. The patient said he spent most of his time at the American Legion Hall so he stored his portables in the truck. Several tanks were thrown into the back of his pickup, and the portable currently in use (with a conserver regulator on it) was wedged into a box in the truck cab that also held motor oil bottles.

The company got written up for the following:
• The patient had freestanding cylinders that the service technician did not address by reeducating the patient and correcting the situation.
• The service technician never checked the concentrator’s alarm by disconnecting it while it was running, one of the manufacturer’s required steps for performing routine maintenance checks.
• The patient’s liter flow on the concentrator at the time we arrived was 2 lph (continuous). The physician’s prescription in the file back at the office was for 3 lph. The service tech was unaware of the patient’s prescribed liter flow, and was unable to identify a noncompliance problem that needed to be addressed. Additionally, the patient was not wearing his oxygen throughout the home visit, which is also noncompliant with the order for continuous oxygen. The company also had not obtained a written order from the physician for the conserving device.
• The patient stored his backup E cylinder in a closet with the door closed, and a closet is an unventilated space. If the patient incompletely turned off or forgot to turn off the flow of oxygen, it could result in an unsafe buildup of oxygen.
• The patient’s storage of his portable cylinders in the pickup truck (unsecured, co-mingled with petroleum products) was a hazardous material disaster waiting to happen.

These written recommendations formally referenced specific care planning standards and federal regulations governed by the Occupational Safety and Health Administration (OSHA), and are just a few of the problems that can be uncovered in the course of an accreditation survey of respiratory providers. Service technicians typically have little oversight by management once they are hired, trained, and out in the field—and sometimes the surveyor is the first person who has gone out with the tech to observe him in action.

Preparing for Accreditation
Understand and embrace the concept that if it isn’t documented, it didn’t happen. Staff members are more accountable, and your liabilities will decrease with a paper trail.

Patient education is the end result of your staff’s knowledge. You will need a detailed staff orientation checklist that addresses introduction to your company and specific expectations for the job, as well as equipment-specific competency documentation where a manager verifies that this employee is knowledgeable about how to set up, maintain, and troubleshoot equipment. Employees who deal with equipment should have personal safety in-services that cover hepatitis B vaccinations, infection control procedures such as consistent use of a hand sanitizer between customer encounters, and access to other personal protective supplies. You will want to verify that your representative’s clinical license and/or driver’s license is current.

Be aware of the requirements within your state’s respiratory practitioner law. Some states require that a licensed clinician follow up a service technician delivery of equipment to perform the “teach” regarding the therapeutic benefits of oxygen and prescription compliance; some states do not.

Safety Regulations
Department of Transportation (DOT), Food and Drug Administration (FDA), and OSHA federal and state regulations impact oxygen providers. Some oxygen patients are still smoking cigarettes or have other household members who smoke. Your home representatives should consistently be on the alert for safety issues such as the presence (or absence) of a smoke detector, a functional fire extinguisher, and storage of oxygen away from sources of heat, electrical sparks, or petroleum products. Oxygen users should have a “no smoking” sign.  

Many states require HME providers to have a dispensing permit from the Board of Pharmacy if the HME is not affiliated with a pharmacy. Compressed oxygen containers must be secured or clustered to protect them from falling and becoming a torpedo. There must not be any freestanding cylinders in the warehouse, delivery vehicle, or customer’s home! Many HME providers need to purchase additional racks to make this a reality and accommodate the various size tanks. Milk crates and cardboard boxes are not acceptable storage or transport containers.

The DOT requires that oxygen containers be secured on the vehicle (no bungees here) and a hazardous manifest (a document outlining the number of containers and hazard class) be completed whenever oxygen is transported in a vehicle, regardless of amount. If more than 1,001 pounds of product is on the vehicle, it must be placarded with yellow (liquid oxygen) or green (compressed gas) diamonds, and the driver of that vehicle must have a commercial driver’s license with a hazardous materials endorsement. Companies with placarded vehicles must register with RSPA (Research and Special Programs Administration, a division of DOT), and if they cross state lines, the company must obtain a registration number from the DOT.

Within the warehouse, the FDA requires that suppliers establish a quarantine area for the rare tank that is out on hydro test, has been in a fire, or has been donated by a patient. Providers must also maintain segregation of full from empty tanks.

Transfilling of either liquid oxygen or compressed gas cylinders (moving product from one container to another) requires registration with the FDA and complex policies and documentation of the transfill and purity confirmations. OSHA and DOT both stipulate fire safety rules such as minimizing combustibles and sources of heat or ignition where oxygen is stored, as well as adequate ventilation to prevent an unintended accumulation of oxygen from venting tanks.

Capture the serial numbers of your rental equipment and ideally link them to individual patients. Compressed and liquid oxygen have unique lot numbers, and you need a system that links the lot number of the tank contents in case of a recall.

Concentrator Maintenance
Concentrators must be maintained per manufacturers’ guidelines. That means having a systematic method to know who has which machine, and when that machine is due for periodic maintenance (PM). You might be able to use your billing software to create these reports, or a spreadsheet, or even index cards organized by month. Get the concentrator manufacturer’s book and look up the steps for routine maintenance.

Be sure you can prove that the specific job steps were performed (not just a delivery ticket with “concentrator PM” written on it). If the concentrator has a 9-volt battery for the alarm, be sure to change it and the bacteria filter annually—and know the date for the next replacement. The machine’s permanent record should distinguish between a “check” 4 versus a “replacement” (R). If you use a calibratable analyzer, be sure to document the analyzer calibration prior to use. Nebulizer compressors also should be checked between rentals for meeting the manufacturer’s specifications. It is not sufficient to turn on the machine and verify that it hums. Use a liter flow checker and make sure the compressor’s output meets or exceeds the manufacturer’s specifications.

Equipment coming back from a rental should be clearly identified as contaminated until cleaned and disinfected with a product that is tuberculocidal (effective in killing TB). After cleaning, move the item to the workbench to do periodic maintenance, change filters, and complete a performance check (all documented, of course).

All accreditation organizations require a plan of service and documentation of customer education about the use, maintenance, and trouble-shooting of their oxygen systems. The plan of service should capture who this unique patient is and how your company is modifying the routine to accommodate the individual and your goal of safe and appropriate equipment use. Your form should capture any functional issues (hard of hearing, blindness, and arthritis) that would make changing regulators a difficulty.

Prescriptions
Home respiratory staff members often find it tough to distinguish between documentation they must obtain from physicians to bill for providing the oxygen, and the documentation required by the state Board of Pharmacy to dispense the oxygen. Oxygen and many other HME devices, such as concentrators, nebulizer compressors, conserving devices, and CPAP masks, require a physician’s order to dispense.

Unlike a wheelchair or hospital bed that can be released to the patient/customer without a prescription if they are willing to pay cash, oxygen must have a written doctor’s order regardless of how you are going to be paid. Since third-party payors require some form of documentation to bill for the product, our industry obtains a “detailed written order” so you can get paid, but the fact is, if a customer came in the door and wanted a bed or a wheelchair and was willing to pay cash, you would be allowed to let the customer take the item. This is not the case with oxygen and other “legend devices.” A legend device is an item that the FDA has required the manufacturer to apply the statement “federal law prohibits dispensing without a physician’s order” somewhere on the product.

Each state Board of Pharmacy outlines the requirements for releasing various classes of medications and legend devices to a patient. Historically, drugs and devices must be dispensed via a licensed pharmacy. As the home respiratory industry evolved in the 1970s, states belatedly realized that oxygen was being dispensed from businesses that were not associated with a pharmacist or a pharmacy. Thus, most Boards of Pharmacy wrote legislation that required a non-pharmacy-affiliated business that dispenses oxygen to obtain a special drug wholesaler permit or registration. With this registration, compliance with the rules pertaining to prescriptions applies to the HME provider.

Oxygen is a drug in the class of medications that are not “frequently abused.” Thus, unlike narcotics or barbiturates that must have a written order in hand for the pharmacist to dispense (no telephone orders, no renewal), oxygen may be called in by the physician’s office, accepted by a nonclinical staff person such as a customer service representative, and the order filled prior to obtaining the written physician prescription.

Details of the Prescription
Eventually, you need to obtain the written verification of the verbal order from the physician. For Medicare beneficiaries receiving oxygen, the certificate of medical necessity (CMN) did double duty up until 1997 when the CMN was redesigned and the “hours per day” was eliminated from the form. Since that time, although you may be getting paid for the oxygen, you do not meet Board of Pharmacy prescription requirements if the CMN is the only document on file detailing the doctor’s order.

A prescription must identify the name of the drug (for instance, amoxicillin or oxygen), the strength of the drug (450 mg tablets or 2 to 3 lph), the frequency to take the drug (four times per day or, in the case of oxygen, 12 to 24 hours per day), and the method of administration (take by mouth or via nasal cannula). It is  important to understand what constitutes a valid prescription.

You do not need a separate prescription for portable oxygen. However, it is necessary to have one for billing purposes, so get a prescription.

You must attempt, at the time of the order, to have the referral source fax a valid prescription. All state Boards of Pharmacy accept a fax for this class of drug. Some referral sources will not be able to fax this order and thus you accept the order as a “verbal order” that will have to be backed up in writing.

It helps if you design a form that can be completed by customer service at the time of the telephone order (a “written confirmation of telephone order”). This form has a place for customer service to write in details from the telephone call—such as liters per minute, hours per day, method of administration—as well as other details that may assist the physician in completing the CMN (date and results of oximetry or blood gas tests).

Asking the physician to fax a prescription frequently results in a “bad” prescription. Any faxed prescription that does not “appear correct” should be brought to a supervisor’s attention. Understand that a “good” Board of Pharmacy prescription may not be a valid billing prescription. Once you have the correct faxed prescription or a correct verbal order, customer service must be very specific in transcribing the prescription onto the delivery ticket. Remember, this is the information that will be referenced by the driver to educate the patient at the time of delivery. If you start with a wrong or incomplete prescription, it only gets worse.

Accreditation rep is calling
Even if the Board of Pharmacy never comes to audit your files for a complete prescription, your accreditation representative certainly will. Your company also should have a mechanism for entering this complete prescription into a data base so that each time a technician goes to the patient’s home to perform a concentrator check or cylinder delivery, the technician can verify patient compliance with the prescription on file. As our industry moves toward mandatory accreditation, it will be the site visitor or surveyor that will verify your compliance with having an oxygen prescription that meets all the requirements of the state Board of Pharmacy.

Vianna Zimbel, RCP, specializes in accreditation and regulatory consulting for the HME industry. For more than 15 years, her consulting business has successfully guided hundreds of companies through standards interpretation. Zimbel can be reached via e-mail: vzimbel@aol.com.