Sunday, May 18, 2008

May 16, 2008

Letter from the CSRC Medical Director

April 24, 2008

Re: SB 1526

To Whom It May Concern:

I am licensed California physician and have 26 years of experience working with patients suffering from sleep disorders/obstructive sleep apnea as a Full Professor of Medicine at the University of California, Davis in the Division of Pulmonary & Critical Care Medicine and have been concerned with the lack of regulation in this field. I am currently the California Society for Respiratory Care Medical Director. I understand that SB 1526 is on the table to address regulation, however I have many concerns. Briefly they are:

1) Regulation by Physicians
In my opinion, it is inappropriate and irresponsible for government to create an unfunded mandate for physicians to oversee a practice that is so clearly tied to respiratory care. While there are 80+ sleep disorders, Obstructive Sleep Apnea is routinely the most common sleep disorder diagnosed and treated. “The therapeutic and diagnostic use of oxygen, the use of positive airway pressure including continuous positive airway pressure (CPAP) and bilevel modalities, and maintenance of nasal and oral airways that do not extend into the trachea” is respiratory care. The American Association for Respiratory Care designated Polysomnography a sub-specialty of respiratory care over 5 years ago. In addition, approximately 4 years ago, the Commission on Accreditation for Allied Health Education Programs established accreditation for polysomnography programs both independently and as “add-on” programs to existing respiratory care programs. A more logical path for any type of regulation should fall under the Respiratory Care Board.

2) Criminal Background Checks
This issue of regulating this field was propelled as a result of a sleep technician (not licensed) who was arrested for sexually molesting several patients. I understand there are other sleep technicians with criminal backgrounds (for heinous crimes) also continuing to practice in the field. SB 1526 proposes to require criminal background checks, however it fails to ensure one clearinghouse, as each employing physician would be responsible only for his/her employees (and potential employees). While most would agree on paper that a person convicted for child molestation would be a bad candidate, there will always be someone who will find it acceptable for whatever reason (took a plea bargain, happened 5 years ago, whatever ‘story’ an applicant would choose to tell). Furthermore, there is no way to draw a line as to what convictions are acceptable and which are not - there will always be extenuating circumstances left for each employing physician to make a determination.

3) Patients Rights & Certification Transparency
SB 1526 provides no mechanism for patients to verify the qualifications or discipline taken against a technician by an employer. A technician who is incompetent, unqualified and/or dangerous (even incidents resulting in patient harm/death), would only be known by his previous employers. Employment checks are not required nor is the person verifying employment rarely going to “slander” a former employee in fear of law suits. In many instances, disparaging information is probably confidential. The public has no access.

4) Care Providers
Currently, to qualify to sit for the RPSGT credentialing examination, a person must have up to 18 months of experience and/or have graduated from an approved education program. With only one education program in the state, this bill fails to address how it will allow people to gain experience. The bill mentions “trainees” in subdivision (e) of section 3575, however there are no requirements set forth (supervision, criminal background checks, education, experience etc...). Currently the American Academy of Sleep Medicine has an 80-hour course that approved employers may provide, and is a good adjunct to an 18-month training course. However, the 80-hour course alone is not sufficient to learn the skills necessary to safely and competently perform “the therapeutic and diagnostic use of oxygen, the use of positive airway pressure including continuous positive airway pressure (CPAP) and bilevel modalities, and maintenance of nasal and oral airways that do not extend into the trachea.” I am concerned that this course will somehow be sufficient to allow a level of independent practice.

5) Supervision by Telephone
Supervision is defined as “a critical watching and directing (as of activities or a course of action).” SB 1526 provides that, supervision “means that the supervising physician and surgeon shall remain available, either in person or through telephonic or electronic means, at the time that the polysomnographic services are provided.” I have concerns that given the definition, using the term supervision is misleading. Further, while SB 1526 does not provide for supervision of trainees, currently, the “trainee” job description of the sleep association provides that a trainee may provide respiratory care under the supervision of a “technician.”

I am glad to see that attention has been given to the need to regulate sleep technicians. However, I believe SB 1526 as written will only perpetuate the disparities and problems that currently exist.

Please contact me at (916) 734-3564 or sylouie@ucdavis.edu if you have any questions or would like to discuss further.

Sincerley,

Samuel Louie, M. D.

Samuel Louie, M. D.
Professor of Medicine
Director, Pulmonary Services Laboratory
DIrector, Department of Respiratory Care
Division of Pulmonary & Critical Care Medicine
Department of Internal Medicine
May 16, 2008

First, Get Caught Up!

Dear RCPs.

Have you ever wondered what the CSRC does? For the past 5-plus years, we have been working with the California Thoracic Society, the American Academy of Sleep Medicine, the AARC & with the Respiratory Care Board to help prevent unlicensed personnel from working in sleep labs, especially those which utilize the application of oxygen and positive pressure to the airway.

In the recent issue of Breathing Matters, published by the Respiratory Board of California (RCB), an article on the front page discussed this matter. The article reviewed the circumstances by which a citation was issued to a sleep technologist who was accused of inappropriate behavior.
This last July action of the RCB in the Salinas area left the sleep community in an uproar. The CSRC, along with the RCB, the AARC, and representatives from the CMA, AASM, Board of Medicine, CAMPS, and other industry representatives, met in Sacramento on December 17 with Michael Miller of Senator Perata’s Office. The meeting took place in Senator Perata’s “Boiler Room”, located under the roof of the Capitol Building. True to the room’s name, it did not take long for the conversation to get hot. Obviously, some in the sleep community got folks fired up over the RCB issuing citations by manipulating the facts. Unfortunately this action may, in the end, destroy Polysomnography as a stand-alone profession.

From this meeting, many misconceptions were expressed on about the RCB action. The Sleep Community Physicians were requesting an exemption from any and all types of licensure & enforcement of the Respiratory Care Act. Their logic was in part based on the logic that they have been doing Sleep Medicine all these years and the law was never enforced. A point of clarification: the Respiratory Care Act enacted in 1986 did not have the ability to enforce all of its provisions until 2006.
If licensure is required, the feeling from the AASM & what they got the Docs to buy into; is that the RCPs should be required to take the test to work in Sleep Medicine. This “Poison Pill” move is primarily designed to fill the AASM’s Coffers by requiring RCPs to take their certification exam in order to get a license. The AASM has already tricked two state Respiratory Associations into backing a separate bill for Polysomnography & at the last minute added language to force these state’s RCPs into secondary licensures. This move is vehemently opposed by both the CSRC & the AARC; & is something that the CSRC will be vigilant in preventing.

The following are select questions and comments that were vetted by several Sleep Physicians and were responded to by the CSRC. In many cases, the following Q&A that was responded to by yours truly, shows the intensity of the feeling on this issue by Physicians within the Sleep Community & the extent of the disinformation that was fed them by the AASM.






Q&A

1) The idea that RPC's are exempt from (Polysom) licensure is outrageous.

The true discussion is about unlicensed technicians, not about a licensed practitioner that could be a PA, RN, or RCP.

2) There is nothing in their training which qualifies them to do PSG's.

Which Part, can it be defined? Not being a PSG, I would appreciate knowing what critical part that could not be rapidly trained & mentored by a good, passionate, & knowledgeable Physician or RPSG. The patients would greatly benefit by CTS providing the Leadership in defining the position skill set. I'm very impressed by the elegant & timely guidelines that CTS has put out in the past.

3) The administration of O2 during sleep studies occurs in a small minority of studies.

The severity of this group of patients does warrant another set of trained licensed eyes, As these patients frequently require higher pressures >10cmH2O &/or are in need of bi-level therapy with ST-Timed Respiratory support or ventilation pattern adjustment via the ADAPSV or the AVAP's algorithms.

4) Furthermore, most of the RT's that have worked for me have had to be trained by me or my existing technology staff to do the CPAP and Bilevel adjustment and fitting.... although I admit that they are fast learners.

Healthcare requires a team approach & there is no substitute to learning from the hands of a skilled practitioner. When one has a good education & knowledge base it allows for a faster pickup of new skills.

5) I have never found that legislation insures quality...we all know that there are physicians with "credentials" that we would not let care for or perform surgery on us or our family. But, when a physician signs his name to a report, he is taking responsibility. If a study is unreadable or incorrectly performed, it is the MD's (or DO's) responsibility. If a study is performed perfectly, an unqualified MD can still make the wrong diagnosis or recommendations. Therefore, I continue to believe that the best insurance for quality is a requirement that a board certified MD/DO is the medical director and the reading MD/DO is board certified or eligible. It is not fool proof, but at least the buck stops with the medical director.


The profession of the Respiratory Care Practitioner wouldn’t exist if it weren't for the guidance, time, & support of our Medical Directors & the Physicians we work with. Fortunately, Physicians are the ultimate arbiter of quality & that is why organizations like CTS exist. That said, it is also apparent that an MD is not going to truly be held responsible for criminal conduct, negligence, or incompetence by an employee while under a physician's direction. Furthermore, if an MD did fire a tech for one of these reasons, absolutely nothing would hinder that tech from just finding another job within the field.

6) So, if a license is going to be required, I say it should be based on the RPSGT exam, and RT's have to pass that exam. Otherwise, the legislation is nothing more than the "Respiratory Therapist Full Employment Act."

Like RNs, RCPs are in severe shortage, a recently completed RCP Workforce study done by Dr. Ernest Cowles of the Institute for Social Research at CSUS, projects that within several years time the shortage will continue & will result in over 8000 unfilled RCP positions in California. Currently most sleep labs economically could not presently afford to staff with RCPs. This plight is caused by a great imbalance in medical economics, a condition that would resolve itself once the playing field is leveled.
Once Home Testing takes effect, in all likelihood legitimate labs will suffer further. It is only by ascertaining the minimal competency provided by licensure, that quality labs will flourish & patients will be appropriately served. In dealing with this reality of a labor shortage, SB1125 grandfathers all existing personnel into the profession & sets several pathways for those coming into the field in the years to come one of which is the ability to attain certification of a minimal credential while working. The two week certification A-Step Course currently has not been utilized by over 80% of the personnel currently working within the field.
As of Friday 3/14, the CTS Executive Committee on advice of its Sleep Committee voted “NO” on support of SB1125 Polysomnography Act carried by Senator Denham. However a conclusion of the meeting there was a consensus that some form of licensure is desirable at this point. At this point SB1125 is locked up in committee & has very little chance of being heard. However Senator Perata is vetting an alternate bill on the issue SB 1526, currently it only has placeholder language.
The CSRC & AARC will continue to watch & work on this alternate bill sponsored by Senator Perata to license the Polysomnography field under the Board of Medicine. One thing is certain; we need to be cautious and vigilant that as the Perata bill progresses, to insure that RCPs are not excluded and that those that work in Polysomnography get the recognition they deserve. On Monday 4/7/08, the first hearings on SB 1526 will start, CSRC will be watching the proceedings very carefully, as the various competing sectors of Sleep Medicine fashion their licensure bill.