Sigh....Both CLIA and state laws in the US were NEVER intended or written to apply to physicians but the CMS cytology section has told JC and CAP that they do.
I got a verbal from my state attorney general's office in a few years ago that indeed this was the case. I then got a legal opinion from a private firm to back this up and JC took it to CMS and CMS refused to relent.
I then got both my senator and US congressmen involved. BOTH. This is now months. I refused to sign off on the deficiency because it was not based in the law and therefore fraudulent.
I contacted the US AG office. I even hired a lobbyist and dropped a grand before I threw in the towel.
The reason: CMS has already fined pathology groups and hospitals nearly 8 figures for their new enforcement of the cytology CLIA law. As such they cannot back down now or else they would have to pay these fines back.
I am considering full legal action with the idea I have suffered irreparable harm to my practice as a result of the both the daily cap and time spent logging the total minutes I spend reviewing each slide. I could easily put that damages amount at 2-3 million with very good justification.
Heck maybe I roll the bones and do it.
CAP IS fighting this, google it and they have lost. This needs to go to a full federal court case.
Here was an example of what I was telling JC/CMS:
Thank for the opportunity to review this matter regarding Standard QSA.08.04.01: Cytology workload limits. As this issue came up with the prior JC inspection here and this was extensively discussed. I had assumed this was settled for us and we altered our processes at that time because we were told JC had sought and received legal counsel agreeing with our assessment of the Clinical Laboratory Improvement Amendment. I was shown internal JC communication logs to this effect and this was not included in our final written findings report as a result.
Currently, I practice in a relatively small rural medical facility that serves as a community's local trauma center. I am solo pathologist now and have staff of 2 histotechnologists. In 2009, my practice gave up review of gynecologic slides due to the cost of hiring a cytotechnologist in this relatively high cost of living location. We continued to offer diagnoses of non-gynecologic cytology as a service to our physicians and their patients because we felt this was an important part of serving our community. Of this type of specimen, our annual volume is roughly 350 cases a year.
In review of the CLIA 88 law, § 263a : part f, number 4 subparagraph (B) The standards established under subparagraph (A) shall include—(i) the maximum number of cytology slides that any individual may screen in a 24-hour period,(ii) requirements that a clinical laboratory maintain a record of (I) the number of cytology slides screened during each 24-hour period by each individual who examines cytology slides for the laboratory, and(II) the number of hours devoted during each 24-hour period to screening cytology slides by such individual.
Also pursuant to this clarification is California law which was an amendment to the Section 1271 of the Business and Professions Code, relating to cytotechnologists passed as part of Senate Bill 1355 and signed into law in 2004 by the Governor of California which states: 1271. (a) A cytotechnologist shall not examine more than 80 gynecologic slides in a 24-hour period when performing a manual review of slides.
(b) The maximum workload limit in subdivision (a) is the maximum number of gynecologic slides that a cytotechnologist shall examine in a 24-hour period without regard to the number of clinical laboratories or other persons for which the work is performed. Cytotechnologists, who examine both gynecologic and nongynecologic slides, shall do so on a pro rata basis so that the maximum workload limit in subdivision (a) is not exceeded, and so that the number of gynecologic slides examined is reduced proportionally if both gynecologic and nongynecologic slides are examined in a 24-hour period.
(c) The maximum workload limit in subdivision (a) is for a cytotechnologist who has no duties other than the evaluation of gynecological slides. Cytotechnologists who have other duties, including, but not limited to, the preparation and staining of cytologic slides, shall decrease on a pro rata basis the number of slides examined.
The state of New York has similar law to California in 10 CRR-NY 58-1.12 as additional legal reference.
In seeking legal review of this, I would add the following important and relevant details:
1.) My practice does not review any gynecologic slides at all.
2.) My practice does not employ a “screener” to review slides prior to rendering of a formal written diagnosis by a board certified pathologist, myself. Therefore , § 263a : part f, number 4 subparagraph (B) does NOT apply.
3.) “Screening” in cytology has a specific general in use definition in the field of pathology meaning initial review by an individual who identifies areas of interest (AOIs) within a cytologic preparation. “Screened” slides are then reviewed by a properly boarded and licensed physician to render the diagnosis. The processing of “screening” is not mandatory for billing of cytology related CPT codes in CMS guidance and is only present in some practices as merely a tool to enhance throughput volumes and efficiency.
4.) California’s law directly specifies the job classification whose workload is to be monitored: cytotechnologists, which I am not, making this clearly non-applicable to my practice.
In no way did the Clinical Laboratory Improvement Amendment intend to restrict properly licensed physicians from providing needed medical care to patients by capping their daily volume in rendering diagnoses.
I would urge your leadership staff and legal counsel to stop and think about the ramifications of restricting the number of patients a physician can care for in any setting.
I have since sought extensive legal opinion from private attorneys, the California state district attorney’s office specifically in regards to 2004 amendment to the Business and Professions Code here in my state as well as a judge within the California judiciary. I am fully confident in my interpretation of both the applicable laws and the standards of the Joint Commission but feel full and final clarification is needed to address this matter.