Being prepared isn’t just for the Boy Scouts. Medicare and Accreditors both could appear at your doorstep any day, and it helps to have a plan. Because the medical equipment industry is under scrutiny, these inspections occur without advance notice, and the possibility of key managers being unavailable is real. Despite the absence of these managers, certain documents need to be quickly located, and it helps to assemble these documents so that any staff know where to find them.
Medicare and Accreditation organizations both want all the licenses and permits required for your business. A good comprehensive resource to check for reviewing your state’s requirements is: http://www.palmettogba.com/palmetto/statelicensure.nsf. This valuable site can keep you from being blindsided regarding bedding & sterilization permits, state dispensing licensure, and other unique requirements for the products and services you provide. Copies of these permits, licenses, etc. must be posted in an area where the public can see them; and you need to check that these items are un-expired.
KEY DOCUMENTS
Understand that each accreditation organization has its own unique requirements that go beyond what is listed in this article. A master sheet that identifies where the following minimum documents can be found will help staff retrieve the binders and files that your surveyor / site visitor wants to see. The documents that should be readily available are:
 Performance Improvement raw data and reports
 If your company is more than a handful of employees, an organization chart with names will be helpful.
 The file with Incident Reports (also known as “Adverse Events”)
 The file with Complaint Reports and copies of letters sent to patients within 14 days of receiving the complaint.
 Your policy & procedure manual
 Personnel files: where the files are located and who has access to them
 Information about your last emergency drill or actual emergency (held within the last 12 months); plus the retrospective evaluation of what worked, what didn’t and needs modification
THE INSPECTION
All accreditation organization representatives will want to get started with the inspection as soon as possible after they arrive.
Although the rhythm of the inspection may vary slightly by accreditation organization, your staff should make it a priority to review the stack of delivery tickets or route logs for customers who are already scheduled for staff contact. Understanding what the surveyor wants to find is key. Most accreditation organizations do NOT want to see a new setup nor a pickup. They do not want to see delivery of a box of diapers or supplies. The surveyor will pick which patient to see your staff interacting with from the route log or delivery tickets. You have the opportunity to stack the deck and should take full advantage of that by reviewing which customers and which services are on schedule as well as which staff are going to provide that service. If your company provides respiratory products, a cylinder exchange, liquid oxygen delivery, or concentrator check is exactly what the surveyor wants to observe, because this patient has an established file and relationship with your company. If you provide rehab, a visit to a patient who needs an in-home repair or adjustment of a recently delivered chair is perfect. In the absence of anything but supply deliveries or pickups, you may need to volunteer a local customer or adjust a customer contact from another day to today. Think about who you are going to volunteer and verify their customer file meets all the requirements! The customer has the right to refuse the surveyor, and a preliminary phone call to the customer asking for permission will (or should) occur prior to the visit. The surveyor will be happy if he or she can be curbside at a customer’s home by 10am. Most surveyors do not ride along with staff in the truck or van. If a manager from your company can drive their own car with the surveyor as passenger to the client’s home, great. The first time your delivery vehicle will be observed is upon arrival at the customer home as the driver retrieves whatever is needed for this home visit.
Some staff reminders are:
 Secure EVERYTHING on vehicle (hand truck, crates with supplies).
 Be aware of ALL the medical equipment patient has, not just the item you are there for that day. Ask about any problems with equipment, look it over for safe installation, proper function.
 Use hand sanitizer before and after home visit – share some with the surveyor!
o Remember that gloves are not a substitute for use of hand sanitizer
If you provide respiratory:
 Oxygen cylinder racks must NOT be secured with a stretch cord- use non-stretch nylon webbing straps with buckle!
 Verify use of oxygen against the MD signed prescription you have on file for that patient- know the liters per minute, hours /day BEFORE you walk in the door.
o If the patient isn’t using it within the parameters of the order—re-educate!!! Let the surveyor hear you re-educating!
 Watch for free-standing cylinders in the patient home. If there are any- correct the situation and re-educate the patient!!
 During concentrator check or swap out of equipment- do NOT take patient off oxygen for even a minute, even if the patient says it is okay. Get the backup or portable- put patient on the back-up before turning off or disconnecting the concentrator for the check.
 Check oxygen output at the far end of extension tubing (verify liter flow is as prescribed at patient end) with a flow pen.
 Make sure they have a NO SMOKING sign! Give them one if it isn’t up on door or entryway, and gently push them to put it up.
 Assess the patients level of comprehension of use of concentrator and back-up tank; and prescription compliance.

Upon return to your facility, the surveyor will review the file of the patient visited for required demographics, orders, and documentation; then move on to review your company’s equipment cleaning and maintenance process, interviewing staff who perform this function and observing how it is done.
As noted in the ‘key documents’ list, at some point in the inspection, management will be interviewed for their knowledge and involvement in the Performance Improvement process, staff training (and personnel files), and compliance with the specific accreditation organization’s standards.

The rules have changed. The products and services to be reviewed by an accreditation surveyor have been expanded. Regardless of whether your business is located in one of the competitive bidding cities, any provider that wants to bill Medicare for Durable Medical Equipment, Prosthetics, and Orthotics (DMEPOS) must now be in compliance with the Quality Standards.
Historically, most accreditation organizations turned a blind eye to any HME service provided except rental medical equipment that had been delivered to the patient’s residence. All this changed last year when accreditation organizations became ‘recognized’ by Medicare as part of the mandatory accreditation process for competitive bidding. Medicare now requires that the next time you see an accreditation representative, the surveyor will review any service that is billed on behalf of the patient, regardless of whether the customer walks in the door to pick it up or it is sent as a mail-order supply. Even if your company never bills Medicare, the accreditation organizations are going to apply the CMS Quality Standards consistently to eligible services, regardless of what insurance company or government agency is billed. In particular, prosthetics like mastectomy products, orthotics (either off-the-shelf or custom fabricated); surgical supplies including wound care, diabetic strips, and urologicals will now be included in the survey process.
Legitimate companies will not have any problems with the ‘I. Business Services Requirements’ that address Administration, Financial Management, Human Resource Management, Consumer Services, Performance Management, Product Safety, and Information Management.
Within the ‘II. General Product Specific Standards’ is a possible hitch you may have overlooked if you provide mail order products to the patient. The CMS requirement is:
Verify that the beneficiary has received training and instructions on the use of items at the time of initial mail order delivery of items; and
• Record in the beneficiary’s record that such instruction was provided.
Historically, providers were allowed to bill CMS with the UPS tracking number as confirmation. This tracking number is not enough to meet the new requirement.
For the first (initial) shipped item, your company must ensure the patient received instruction on the item sent. Most diabetic and ostomy supply items have manufacturer-provided instructions; and printed on the box for wound care items are instructions such as ‘Store in a cool dry location…wash your hands with soap & water before handling…’ but you may want to create a one page form that is tucked into the shipping container that is more clearly identified as ‘instructions’ so the customer realizes they actually were provided with this information. The harder challenge is getting documentation into the patient file that they actually received this instructional information. It is unclear at this time whether your company may telephone the customer and make a note in the record that confirms they received the instructional information; versus must have a signed and dated document physically returned by the customer. This could be a delivery ticket, or perhaps a pre-printed postage-paid postcard that has the order # written in at the time it is tucked into the box. If the majority of your business is mail-order, you could also use this opportunity to combine questions regarding customer satisfaction on the postcard. Note the last question that is also a bizarre requirement within the Quality Standards Performance Management section.

The burden of creating a tickler system to chase down the postcards or delivery tickets not returned; and matching up the returned forms with the patient will also be new to the provider.

Are you prepared for an unannounced Medicare visit?  As you know, a site visit is always scheduled during the re-enrollment period with documentation requested and pictures taken by the inspector.  Anecdotal evidence from all regions of the country indicates that Medicare contractors are performing inspections that are not based on re-enrollment.  If you haven’t already seen Medicare, there is a high degree of probability they WILL be at your front door soon.

The inspection covers about six pages of questions. Sample forms and licenses are requested.

This is what was asked, witnessed or requested:

ASKED:

1) Are you Accredited and for how long?

2) How many locations do you have?

3) Can you tell me the areas of service you cover?

4) What is your title?

5) What is your core business?

6) What is your ethnic population mix?

7) How do you handle the non-english speaking census? (The suggested answer is: either with translators on staff or access to your local university language department, if there was no one in the family or friends that could translate, which normally there is.)

If you provide oxygen:

8a) What qualifications do your personnel have for the oxygen equipment?

8b) Do you have contract or full time respiratory therapists?

A step-by-step process of what to collect, what to do with it once you’ve collected it, and how to present that data.

By Vianna Zimbel, BS, RT

860-657-9530 vzimbel@aol.com

Do you have brain cramp when it comes to Performance Improvement?  Most companies are good at collecting customer satisfaction surveys, but fail at everything else associated with this important and required process.

First- Remember that Performance Improvement is DATA DRIVEN, meaning it isn’t a hunch that your company is doing a pretty good job, or notes from a managers meeting. Performance Improvement is numbers. You can prove it. It isn’t where staff discuss “problems with AR”, it is unexpected denials by code and dollar amount.

Second- Medicare dictates a core list of topics for which your company must collect data:

1. customer satisfaction surveys




1. minimum questions (you can add more questions if you wish) are:




1. timeliness of service


2. response to concerns or complaints


3. the impact of your company’s business practices on the customer’s access to products & services (did they get what they need?)






2. adverse events (also known as incidents)




1. if you had none, state that fact.


2. If you had incidents in the past quarter, state that fact in your report and review for trends (your driver’s traffic accidents? Missed/late deliveries that caused a patient hospitalization for lack of the equipment? A particular product not functioning or malfunctioning?) What company process was changed in response to that incident? Who was responsible for making the change? When did the change occur and when do you expect results from that change?




3. complaints




1. define a ‘complaint’ (usually if the beneficiary demands to talk with a supervisor or manager) and then track TYPE of complaints as well as TIMELINESS of responding to complaints according to Medicare’s Quality Standards that require responding, in writing, within 14 calendar days of the complaint.




1. Collect complaints and then state the number in your PI report and review for trends.


2. How many complaints were responded within the 14 day guideline?




1. What company process was changed in response to the complaint(s)? What process can be changed to ensure beneficiaries get a written response within 14 days? Who is responsible for the change? When will the change occur and when do you expect results from that change?








4. Billing & Coding Errors




1. Medicare now requires that you trend billing & coding errors. They do not dictate anything beyond that. If you subscribe to RemitData you are already compliant, but otherwise, run a report of ‘unexpected’ denials and decide whether you want to present the information by total dollars denied, or how often that the code pops up compared to total number of claims billed.

Those are the basics for Medicare Compliance.

Accreditation organizations ask for additional data collection, such as:

1. Patient Files




1. Most accreditation organizations also require you to review customer records for ‘completeness and accuracy’. YOU decide what you want to audit in these files. You will need to create an audit checklist, pull files and review.  You probably want to use this opportunity to make sure problematic documents are completed. Be prepared for post-payment audits by internally policing documents that support claims for reimbursement: look for signed delivery tickets, date of delivery/date item billed, verifying you have the document for which you are using the ‘KX’ modifier. Remember that since this must be data driven, you’ve got to use that checklist you created for file audits to eventually create a summary figure: number of files audited divided by number that are compliant = a percentage.




2. You’ve got to look at something that is ‘high risk and/or high volume’ for your business.  It could be maintaining oxygen concentrators according to manufacturers guidelines (total concentrators out on rent vs. total number that have been PM’d within your defined timeframes).  It could be Customer education and documentation that it was provided for the equipment or supply provided.


3. Some accreditation organizations have their own unique set of additional topics they want you to collect data on.

Now comes the step most homecare companies don’t do very well: crunching the data numbers into percentages or pie charts or frequency of occurrences; and having a group meet on a quarterly basis to review those numbers.

Someone needs to identified as the group secretary who will take notes about whether and if the findings are below acceptable levels, a clear action plan with who is responsible for the activity, when it is going to occur, and what the expected changes will be as a result of the activity. Each topic should be spelled out in the report.  Next quarter, review the results with a second go-round of audits.  Did the planned action result in an improvement as anticipated, or does an alternative action need to be proposed because the earlier plan did not result in an improvement?

Are you prepared for an unannounced Medicare visit?  As you know, a site visit is always scheduled during the re-enrollment period with documentation requested and pictures taken by the inspector.  Anecdotal evidence from all regions of the country indicates that Medicare contractors are performing inspections that are not based on re-enrollment.  If you haven’t already seen Medicare, there is a high degree of probability they WILL be at your front door soon.
The inspection covers about six pages of questions. Sample forms and licenses are requested.
This is what was asked, witnessed or requested:

ASKED:
1) Are you Accredited and for how long?
2) How many locations do you have?
3) Can you tell me the areas of service you cover?
4) What is your title?
5) What is your core business?
6) What is your ethnic population mix?
7) How do you handle the non-english speaking census? (The suggested answer is: either with translators on staff or access to your local university language department, if there was no one in the family or friends that could translate, which normally there is.)

If you provide oxygen:
8a) What qualifications do your personnel have for the oxygen equipment?
8b) Do you have contract or full time respiratory therapists?

REQUESTED:

1. Any applicable DME License; Sales Tax Certificate;  Occupational License, Oxygen License(s) Make sure you have moved these from your back room to an area where the general public can see them (front entrance or retail area). The licenses and certificates must be displayed in an area accessible to customers and patients.
2. Complaint/Incident Policy and Complaint/Incident Form
3. Patient Guides for products you provide written in English and any other language that is predominantly in the community you serve.  (Links to percentage response from #6 above) If you don’t have the forms, keep your numbers low.
4. New Equipment and Used Equipment Warranty Statement and a form if available.
5. Rent/Purchase Letter for patients still under that criteria    
6. Rent/Purchase Letter that meets new Criteria (13 months /36 months). Even though officials at Medicare state that there is no letter required to advise the beneficiary that the rented equipment will be purchased after 13th month, the inspector requested this.  Try to have these in both English and Spanish.
7. Copies of General Liability & Professional Liability Insurance coverage. The traditional Insurance Certificate Information is no longer accepted. Inspectors seem to be requesting copies of the " Policy Declaration Pages".
8. Phone Numbers of Insurance Companies, not your Agent.

WITNESSED:  Building Sign, Front Door Hours posting, Handicap Space Access, Bathroom Access for wheelchair, Active File Records Area, Dead File Records Area, Inve

Medicare’s Quality Standards require a Performance Improvement program. Although mandatory accreditation is a rolling process linked with competitive bidding areas, compliance with Quality Standards is both nationally and immediately applicable to all medical equipment providers.  Surprise visits in the past reviewed for compliance with the 21 Supplier Standards. The next time you have a Medicare site visit, the inspector will be reviewing against the recently released Quality Standards.
A component that has consistently been problematic for HME providers seeking accreditation is Performance Improvement. Now, Performance Improvement is not just for those  seeking accreditation- Medicare requires it too. Performance Improvement is a systematic analysis of key operations in your company.   This activity has many names, but whether you call it Quality Assurance (QA), Performance Improvement (PI), Improving Organizational Performance (IOP), or Total Quality Management (TQM)……the concept of gathering data about your company to determine how it is performing is a universal requirement by the Medicare Quality Standards.  For the purpose of this article, I’ll call it Performance Improvement, but you can call it whatever you want, so long as you do it. 
Performance Improvement has been a challenge for many HMEs because most are entrepreneurial and nimble, adjusting process and policies very quickly when a referral source complains or a revenue generating activity fails.   Since few in our industry come from a manufacturing background, the concept of Quality Assurance is generally foreign to HME providers.  None-the-less, you will find that if you tackle the standards and develop a program that is relevant to your company, it is a worthwhile endeavor.
So how do you make Performance Improvement a real program?  First, management must have ‘buy in’ and actively communicate this to the employees.  If the corporate attitude is to just go through the motions for the purpose of a survey, it does not take staff long to pick up on this message and dismiss the topic.  Second, although it will require an individual to act as primary coordinator for the program, it is wrong for the entire company to think that just one person is responsible for the entire Performance Improvement Process.  Everyone should be chartered and enabled (key word here) to identify activities that are counter-productive to an efficient company whose goals are to provide safe, effective medical equipment and to get paid for those services.  That means that employees who ‘own’ the process should be on the committee to provide insight to reality and design a way to measure the topic at hand.  Take your most vocal employee, perhaps the one who complains a lot, and put them on the committee with the rule that any problem brought to the table must be accompanied by a proposed resolution.
A mistake made by many organizations is to think that PI is only collecting information about customer satisfaction.  The Medicare Quality Standards stipulates that at a minimum, each supplier shall measure:

1. Timeliness of response to beneficiary questions, problems, and concerns (Read capturing and trending complaints with attention to documenting complaints within 5 calendar days and providing notification to the beneficiary of the results of you investigation and response within 14 days).

2. Impact of the supplier’s business practices on the adequacy of beneficiary access to equipment, items, services, and information; (I suggest putting a question on your satisfaction survey: “Please rate the impact of Medicare rules have on your ability to obtain products from <your company name>; or keeping a log of items that are requested that you cannot provide).
3. Frequency of billing and coding errors (e.g. number of Medicare claims denied, errors you find in records after you have been notified of a claims denial); and
4. Adverse events to beneficiaries due to inadequate or malfunctioning equipment, items, or services (e.g., injuries, accidents, hospitalizations).
5. Beneficiary satisfaction with and complaints about product(s) and service(s);

The questions you ask for customer satisfaction, and how you ask them, is up to you (and your accreditation organization).  Do you send a postcard, or call the customer?  What questions do you ask? Who do you ask (all customers or just certain equipment recipients, only new setups, referral sources….)?  It is all up to you.  Keep it relevant to what you, the company, want to know about the experience your customers had with your company; and keep it simple.   
Once you’ve identified what you specifically are going to collect data on (typically referred to as ‘the plan’) you need to implement it and actually collect the data.  Minutes from regular manager meetings can potentially be a source of ideas for Performance Improvement, but the meetings themselves rarely meet the requirements of a Performance Improvement meeting unless specific data is presented and discussed.
A key stipulation is that Performance Improvement must be data driven.  For most topics, you must have a numerator and a denominator (18 out of 20 customer satisfaction surveys = 90%).  Your company must determine it’s ‘comfort level’ for acceptable results, (typically referred to as a ‘threshold’).  Some measures will have a 90% threshold; some, such as if you choose accurate CMN completion for submitted claims, should be 100%.  Data should be reviewed by the committee, and if the findings are below acceptable levels, a clear action plan with who is responsible for the activity, when it is going to occur, and what the expected changes will be as a result of the activity should be spelled out in the report.  Next quarter, review the results with a second go-round of audits.  Did the planned action result in an improvement as anticipated, or does an alternative action need to be proposed because the earlier plan did not result in an improvement?
In the end, if you make this process ‘real’, you will find that it quickly evolves into a dynamic program at your company.  As the Nike ad says: ‘Just do it.”  Put a date on the calendar, hold the meetings, collect and compare data over time.  You’ll find that Performance Improvement is the squeaking wheel that gets the grease.  Focus on a problematic issue, let everyone know your company is working on clearly identified target goals, and an amazing evolution towards achievement will occur.  

We know Medicare requires accreditation for bidding HME suppliers to continue providing products to Medicare beneficiaries within the ten competitive bidding cities. The grace period for attaining accreditation is tight: the DMEPOS provider must be accredited by August 31, 2007, literally two months after the bids must be completed and submitted.
WHAT ARE THE OPTIONS?
The organizations named by Medicare as ‘recognized’ for accrediting HME providers are:

1. HealthCare Quality Association on Accreditation (HQAA) (www.hqaa.org)
2. Board of Orthotist / Prosthetist Certification (BOC) (www.bocusa.org)
3. The National Association of Boards of Pharmacy (NABP) (www.nabp.net)
4. The Compliance Team, Inc. (www.exemplaryprovider.com)
5. The Joint Commission (JCAHO) (www.jointcommission.org)
6. Accreditation Commission for Health Care (ACHC) (www.achc.org)
7. Community Health Accreditation Program (CHAP) (www.chapinc.org)

Three other organizations were also named but are only authorized to accredit orthotic providers or rehab facilities: National Board of Accreditation for Orthotic Suppliers, American Board for Certification in Orthotic & Prosthetics and CARF (rehab facilities). These organizations are not authorized to accredit suppliers of durable medical equipment.

The big three accreditation organizations with name recognition are the Joint Commission, CHAP, and ACHC.  It is important to be aware of the full range of options because a pharmacy based HME provider will find the NABP accreditation to be less expensive and complicated than the more well known choices. Another frequently overlooked option available to HME suppliers is the Board of Orthotist / Prosthetist Certification. This organization can accredit a durable medical provider supplier even when it does not provide orthotics or prosthetics. Again, the BOC version of accreditation standards is simpler and far less expensive than the big three. These two options should be seriously considered for the HME provider looking to get accredited only for Medicare purposes. To become a participating provider with payors like Blue Cross/ Blue Shield or other managed care insurers the HME provider must contact the contract rep at the insurer to find out which accreditation organizations meet their criteria—their list is currently much shorter than Medicare’s.

WHAT ABOUT IF YOU ARE NOT IN A COMPETITIVE BIDDING CITY?
First- lucky you. However, don’t think you can stop thinking about accreditation for a few years. Our industry has distributed the Supplier Standards for at least a decade, currently a list of 21 requirements for the HME provider that bills for products provided to Medicare beneficiaries. In August of 2006 CMS released the Quality Standards.  The link to download these standards is: http://www.cms.hhs.gov/CompetitiveAcqforDMEPOS/04_new_quality_standards.asp
CMS states on their website: Suppliers must comply with the quality standards in order to furnish any Durable Medical Equipment (DME), prosthetic device, prosthetic, or orthotic item or service for which Part B makes payment, and also in order to receive or retain a provider or supplier billing number used to submit claims for reimbursement for any such item or service for which payment can be made by Medicare.  No matter where your company is located in the United States, the next time you see a Medicare representative, that person will be looking for activities that support these  extensive standards. Although we are now down to 14 pages from the original draft of several hundred, compliance with these standards should be a priority at your company. 
WHAT’S IN THE CMS QUALITY STANDARDS?
If you are not accredited, these Quality Standards will push you to develop a policy manual that addresses administration, financial management, human resources, how you provide equipment and services, handle complaints, collect information on the performance of your company (performance management), and more.
If your company is already accredited, you already meet or exceed most of the CMS Quality Standards. However, be sure to

1. modify your Customer Satisfaction survey to include a question for the beneficiary asking them about how your company’s business practices impact their access to products and services. This may seem like an odd question, but the thought behind this is linked with Competitive Bidding and the criticism that by having less suppliers and lower reimbursement the beneficiary will loose or have limited access to products they need. They want us to ask the question, but how to pose it to our customers is a challenge. But, before you reprint 1,000 postcards, take a moment to convene your staff and ensure that any specific questions required by CMS and your accreditation organization are on the card.
2. Include ‘billing and coding errors’ in your Performance Improvement data collection and aggregation process. Specifically, CMS wants “frequency of billing and coding errors (e.g. number of Medicare claims denied, errors the supplier finds in its own records after it has been notified of a claims denial)”. CMS wants us to collect data on this topic, present  and trend it in our Performance Improvement reports.
3. Take a look at your policies on Complaint reporting. CMS imposes strict time frames for responding to a beneficiary complaints you probably don’t have. Within five (5) calendar days of receiving a beneficiary’s complaint, you must notify the beneficiary, using either oral, telephone, e-mail, fax, or letter format, that you have received the complaint and that you are investigating. Within 14 calendar days, you must provide written notification to the beneficiary of the results of your investigation and response. You also must maintain documentation of all complaints that you receive, copies of the investigations, and responses to beneficiaries. This is going to take complaint reporting at most HMEs to a new level, with careful time-stamp documentation of date complaint received, and date customer is provided with a follow-up report.
4. Providers of high-end rehab seating and mobility systems must have proof that there is at least one qualified RTS on location; and the rehab techs must have documented proof of 10 hours of in-service / continuing education specific to rehab technology.

Historically, most accreditation organizations turned a blind eye to any HME service provided except rental medical equipment that had been delivered to the patient’s residence. All this changed last year when accreditation organizations became ‘recognized’ by Medicare as part of the mandatory accreditation process for competitive bidding. Medicare now requires that the next time you see an accreditation representative, the surveyor will review any service that is billed on behalf of the patient, regardless of whether the customer walks in the door to pick it up or it is sent as a mail-order supply. Even if your company never bills Medicare, the accreditation organizations are going to apply the CMS Quality Standards consistently to eligible services, regardless of what insurance company or government agency is billed. In particular, prosthetics like mastectomy products, orthotics (either off-the-shelf or custom fabricated); surgical supplies including wound care, diabetic strips, and urologicals will now be included in the survey process.
Legitimate companies will not have any problems with the ‘I. Business Services Requirements’ that address Administration, Financial Management, Human Resource Management, Consumer Services, Performance Management, Product Safety, and Information Management.
Within the ‘II. General Product Specific Standards’ is a possible hitch you may have overlooked if you provide mail order products to the patient. The CMS  requirement is:
Verify that the beneficiary has received training and instructions on the use of items at the time of initial mail order delivery of items; and
• Record in the beneficiary’s record that such instruction was provided.
Historically, providers were allowed to bill CMS with the UPS tracking number as confirmation. This tracking number is not enough to meet the new requirement. Many state Medicaid programs want more documentation than a UPS tracking number too.
For the first (initial) shipped item, your company must ensure the patient received instruction on the item sent. Most diabetic and ostomy supply items have manufacturer-provided instructions; and printed on the box for wound care items are instructions such as ‘Store in a cool dry location…wash your hands with soap & water before handling…’ but you may want to create a one page form that is tucked into the shipping container that is more clearly identified as ‘instructions’ so the customer realizes they actually were provided with this information and confirm receipt of it. The harder challenge is getting documentation into the patient file that they actually received this instructional information. You must have a signed and dated document physically returned by the customer. This will probably be a delivery ticket that has been modified to include a phrase about receipt of instruction in the boiler-plate language signed by the customer. This rule applies even if you have the item drop-shipped direct to the customer from a wholesaler.
When you have an accreditation survey anytime in 2007 forward, the surveyor will not only be reviewing for compliance with their standards, but also the CMS Quality Standards.

A few standards will have been added or modified as a result of the CMS Quality Standards, but the emphasis continues to be on the National Patient Safety Goals.  Pay attention to these and be prepared to demonstrate to your surveyor how you meet them!

1. The newest goal is for oxygen providers.  The goal is to reduce the risk of fires in the homes of oxygen patients. Forms staff use for home assessments (both clinicians and drivers) should be modified to document the presence or absence and working order of smoke detectors, fire extinguishers and fire safety plans; as well as review of all medical equipment for fire risks. This set of checks should occur each time a representative from your company is in the patient’s residence.
1. Another component of this goal is to provide education to the patient and family regarding causes of fire and fire prevention activities, and to assess the patient’s level of comprehension and compliance and reports any concerns to the patient’s physician.

The following are not new, but continue to be important enough to discuss again:

1.  Staff who take orders must have access to a list of ‘do not use’ abbreviations that include the minimum abbreviations as specified on JCAHO’s website. While it is true many HME providers never use these abbreviations anyway, you still need to ensure Customer Service and clinicians on staff are aware of the list. These abbreviations are linked with serious accidents in healthcare, and the goal is to wipe them out of usage across the continuum of care, regardless of whether you think it is relevant to your services or not.
2. Read-back of a verbal order after writing it down (pertinent to Customer Service and clinicians).
3. Compliance with the CDC hand washing guidelines =  Use the waterless hand sanitizer with consistency.  Teach staff that they must use this product BEFORE and AFTER a customer encounter--- and that use of gloves does not replace use of hand sanitizer. After the gloves come off, use the alcohol gel!
4. Implement a fall reduction program and evaluate the effectiveness of the program. (Measurable reduction in risk for patient falls).  The key word here is measurable. Add a checkbox to all the documents your staff use when going to a customer’s residence (probably the delivery ticket or work order) that states ‘___ tripping hazards minimized’.  Be sure to in-service and remind staff who go into customer’s homes to be on the lookout for tripping hazards and to do what they can to educate and minimize the chances of a customer tripping and falling.  By consistently checking this box to indicate this activity occurred, you can then make a statement in your PI report that ‘100% of the time, when staff are in customer’s homes, tripping hazards are assessed and when identified brought to the attention of the customer’. Be alert for patients that share that they have fallen recently.
5. Specifically ask customers about safety and how improvements can be made.  Surveyors seem to prefer this to be a question on the satisfaction surveys.  While we are on that subject, the new CMS Quality Standards include the requirement that you inquire about patient access to products and services.  I believe this is targeted at determining whether competitive bidding has a negative impact on patients ability to get what they need. A suggestion is  to add the following question to your customer satisfaction surveys:

How would you rate Medicare's rules regarding home medical equipment and the impact these rules have on your access to the products and services you believe you require?

Graph your Performance Improvement data and incorporate these into reports that discuss whether the findings are acceptable or not. If the data indicates something must be done, you need a concise action plan of who is responsible, and what will change when.
Remember, Performance Improvement is NOT JUST CUSTOMER SATISFACTION! You should be reviewing Infection Control logs, customer chart audits for accuracy, Incidents, Complaints, and tripping hazard minimization at a minimum.
Lastly, an annual study of critical failure points in your business (as related to patient care) should be performed. Actions should be implemented that decrease the risk of this failure from happening and are measurable. For instance, if 25% of your concentrator customers refuse a back-up tank, implement actions to decrease this to as close to zero as possible. 
You no longer need to publish, post, and distribute notices to announce your upcoming survey because you don’t know when they are coming. As a result of this, you now need to notify your customers that they may contact JCAHO if they have unresolved concerns after bringing them to your attention. You need to provide your customers with information on how to contact JCAHO. (If your concerns are not addressed to your satisfaction, you may contact the Joint Commission’s Office of Quality Monitoring.  To report any concerns or register a complaint call 1-800-994-6610 or email complaint@jcaho.org). Similarly, you need to notify your employees that they may contact JCAHO, and they may do so without retaliatory or disciplinary action.

As JCAHO continues with unannounced surveys, it helps to have a plan. More than one person at your company should know where the Performance Improvement reports are store, in addition to the complaint and incident reports, infection control logs, in-service records, personnel files, and policy manual.
Surveyors generally arrive by 8:30am. You can log on to your ‘Jayco’ extranet to see the name and photo of your surveyor, just in case you want to validate this person is the real thing and not a poser.  Think about where the surveyor can setup shop for the day- ideally away from overhearing customer service staff on the phone.
JCAHO continues with the Tracer Method of performing surveys. The surveyor will pick the customer to visit from the stack of work orders.  They want to be as non-disruptive to the daily routine as possible by simply tagging along some activity your staff were going to do anyway.  The surveyor does not want to see a new setup. The ideal home visit is to a customer that has several pieces of equipment or services from your company, lives close to your business, and has been on service for several months (such as a repair of a bed, a concentrator check, cylinder exchange or a liquid oxygen delivery).

Do you ever get complaints?
Does your company ship items to beneficiaries?

If you answer ‘yes’ to either of these questions, you should be aware of new rules within the CMS Quality Standards that affect your company. In August 2006, CMS released the Quality Standards.

COMPLAINTS
Under the heading Consumer Services  #3 (on the third page) it states
“Within five (5) calendar days of receiving a beneficiary’s complaint, the supplier shall notify the beneficiary, using either oral, telephone, email, fax, or letter format, that it has received the complaint and that it is investigating. Within 14 calendar days, the supplier shall provide written notification to the beneficiary of the results of its investigation and response. The supplier shall maintain documentation of all complaints that it receives, copies of the investigations, and responses to beneficiaries.”
When a patient calls and is so upset he/she adamantly wants to talk with a manager, you probably have a documentable complaint on your hands. Telling the patient you will look into the matter happens at the time of that conversation, so complying with the 5 day rule is usually not a problem. The change with which organizations must be vigilant lies with responding IN WRITING and within the 14 day window.
You have always been required to have a complaint log. However, the new version should include a column for date of complaint and date beneficiary notified of resolution. You can download a form from the Palmetto website. Go to www.palmetto.com and follow links to DMERCs, >> national supplier clearinghouse >> supplier enrollment >> standards & compliance >> additional information >> model forms: equipment warranty and beneficiary complaints. After reading NSC’s information about the supplier standard, you can click on the icon of a paperclip at the top of the page to download the documents which include forms and policies.
A second component of the Quality Standards complaint process you should implement is under the heading Performance Management, second bullet point.  It requires,
“at a minimum, that each supplier shall measure…. the timeliness of response to beneficiary questions, problems, and concerns.
That translates to a statement in each Performance Improvement Report summarizing how many complaints your company received and whether the response by your company was within the required timeframe.
INITIAL MAIL ORDER
On page 5 of the CMS Quality Standards, under the heading Training / Instruction to Beneficiary and Caregiver, bullet point 4, it requires:
“Verify that the beneficiary has received training and instructions on the use of items at the time of initial mail order delivery items; and record in the beneficiary’s record that such instruction was provided.”
Many companies provide diabetic or other mail order supplies and historically have been able to prove delivery of these supplies by the UPS Tracking number. Unfortunately, you now need to develop and include some kind of postcard or other document that confirms you sent instructions on the storage or safe use of the supply or device. The headache becomes a migraine when you consider drop shipping directly from the manufacturer. 

The link to the webpage where you can download the CMS Quality standards is: http://www.cms.hhs.gov/CompetitiveAcqforDMEPOS/04_new_quality_standards.asp
Within the October 2006 R3 publication, there is more information on CMS Quality Standards & Accreditation.

Mandatory accreditation by insurance companies and CMS has created a surge of interest in accreditation organizations such as the Community Health Accreditation Program.
Do you know what to prepare?  When the site visitor arrives, they will begin with an inspection of your facility, go to visit customers with your staff, review patient and personnel records as well as other documentation.
Here is some insight to the process that should help you achieve a successful CHAP Accreditation:
Patient Records   CHAP requires documentation of
1) customer education for each item they receive; plus a ‘leave behind’ info sheet on that product.  This could be the manufacturer’s booklet if the item is new, but prepare some equipment information sheets for re-rentals like beds, wheelchairs, nebulizers and oxygen systems.
2) documentation of assessment of the patient’s home.
You can keep add simple checkboxes to one of your current forms like a delivery ticket to accomplish this documentation.  You rarely need a separate new form.

Be sure one of the handouts to customers includes the Patient Rights & Responsibilities, and CHAP phone number.  Consider printing this on the back of one of your current ‘leave behind’ papers.
3) If you are a respiratory provider, you need a prescription for the oxygen. A complete oxygen prescription is LITERS PER MINUTE, HOURS PER DAY, and ‘method of administration’ (usually via nasal cannula).  You also need a specific MD order (in writing, for the conserver).  An option is to write the liters / minute, hrs per day, and nasal cannula (and conserver, if you’re dispensing this too) in Section C of the CMN so when the MD signs the CMN, you also get a Rx.  For patients already on service, consider a prescription confirmation form (faxed to MD after you complete it) for signature.   Remember, RANGES are good (that is, 2-4 liters per minute, 8-24 hours per day).  You’ll cut yourself a lot more leeway re: monitoring for patient compliance. Don’t forget to log the lot number of oxygen dispensed
The CHAP survey progresses from the patient home visit back to the patient file, personnel files, and equipment files. 

Respiratory Equipment in customer homes:
No free standing cylinders ever, anywhere. (I can’t emphasize this enough).  Systematically trigger concentrator checks.  CHAP will verify that all machines are current for maintenance according to manufacturer’s guidelines.   If you have one of the older oxygen analyzers, the analyzer must be calibrated each day prior to being used.  Document that it was calibrated on a calibration log.  Eventually, get the non-calibratable versions so you don’t have to keep the log.
Try to get in the habit of looking at ALL the equipment in the patient’s home, not just swapping out the cylinders.
The Service Tech should be routinely to be provided with information on the patient  about the COMPLETE oxygen  (not just the liter flow--- also the hours per minute prescribed) so that he can verify this when in the customer’s home.  You also want to avoid having the Service Tech ask the patient what their Rx is, and then write it on your forms because frequently what the patient’s version doesn’t jive with the prescription you have on file from the MD.  When non-compliance is discovered, PLEASE write a note indicating this fact and then re-educate the patient about how they should actually be using their oxygen. Can caregivers verbalize how to clean the nebulizer or humidifier and how frequently to do this?  How often do they change the cannula?  Do they know to use no more than 50 feet of extension tubing on a concentrator?  Do they know the after hour number for the company?

Other DME in customer home
 If they have a hospital bed and wheelchair, everything has to meet safety standards.  If the patient or caregiver has re-arranged equipment since it was delivered, does the Service Tech re-educate or modify the installation so that the equipment is as safe to use as possible.  The bed must have it’s plug properly installed in the ‘cheat plug adaptor’ if used.  Wheel locks should be at each end on diagonal (opposite) wheels.  Family should know where spare crank for bed is located.  Have they called the service after hours?  What was their experience? 

Vehicle Inspection
The hand sanitizer must be routinely used (alcohol gel).  Make sure there is a bottle in use and a spare bottle on board at any time.   A Hazardous Manifest needs to be completed when oxygen is transported per Dept of Trans. Regulations.  If you do use straps to hold cylinders, use non-stretch (webbing) strap to secure compressed oxygen tanks on the vehicle. EVERYTHING must be secured against movement while in transit.  No exceptions.

Warehouse
CHAP wants a log of disinfecting the workbench surface every week.  Have a MSDS for disinfectant and any other chemicals used by employees.  You can obtain most MSDSs for any chemical used by your company from the www.hazard.com website.
 ‘Idiot proof’ the equipment in the warehouse.  Clear identification and separation of clean/patient ready equipment, separate from dirty/contaminated equipment, separate from broken/repair equipment areas.  Put up signs, (you don’t have to tape the floor areas, but can if you feel this further distinguishes one are from the other). Make it so that anyone can know the status of any and all equipment.
Label all bottles (if staff decide to decant a chemical into a generic spray bottle).
Clean off gunk first and then apply disinfectant– know how long the chemical takes to be fully effective against TB (typically is 5 or 10 minutes).

Performance Improvement
At a minimum, CHAP requires the data collection, and if possible, trending (and graphing) of:

1. Incidents
2. Complaints
3. Customer Satisfaction
4. Review of infection control logs – this means any time you have employees sick because of illness, it should be logged. 
1. Any time you hear about a customer illness, it should be logged.  
2. Periodically review these two logs for trends. 
5. Patient chart review for completeness & accuracy.
6. Staff Turnover data

ALSO- You need to ‘benchmark (compare your performance against similar companies).  Go to www.medgroup.com/wbm  (winning business models) and input (for free) data about your company and get reports with graphs about how you compare. 

A budget needs to exist.
CHAP standards require a drill of the emergency preparedness plan.  You do need to have one annually. 

Personnel Files
Staff inservices include a review MSDS, Blood-borne pathogens. 
This is a list of the ‘hot issues’ which should be checked within personnel files:

1. Current copy of driver's licenses (if driving to perform services)
2. Current state licensure for Respiratory Therapist
3. Orientation checklist completed even for staff who have been with you forever.
4. Competency & Proficiency review for all direct and support patient care staff (annual).  
5. Performance Evaluation that corresponds to the job description.   This is done annually.
6. Separation of medical records (anything that notes medical findings: workmen’s comp, sick time, etc.) from clerical paperwork to comply with American Disabilities Act.  (There needs to be 2 files for each employee, kept under separate lock).
7. Clinical and Service Staff receive training on Blood-borne pathogens, Universal Precautions, HepB vaccination option
8. Fire safety in-service to all staff
9. Fire Drill
10. Annual "Right to Know" training for ALL personnel (MSDS).
11. Staff In-service: Review of Corporate Compliance (billing) and Patient Privacy (HIPAA) Policies