At first glance this might seem to be an obvious audit: the order is either in the record, or it’s not. But if you think that’s all this is about, you’ve missed the point. And this point is just the tip of the proverbial iceberg.
The Need to Know
The ‘need to know’ for healthcare provider staff at all levels increases daily, perhaps even more than you imagine. (REALLY!) Let’s consider just the short list of what your staff needs to know about: medical record documentation integrity, accuracy, and specificity; the need for physician signatures; countless regulations and regulatory monitoring agencies, such as the RACs, ZPICs, MICs, MACs. And the list goes on, regardless of the provider type or site of service.
What Did the Doctor Order?
Month to month each of us who authors these articles seeks to deliver timely and relevant information to you the reader. The bulk of my article this month focuses on a case involving a single provider type, Skilled Nursing Facilities (SNFs), and a question of what a physician ordered versus what was done for the patient. The issue involved however, does NOT concern only SNFs. The issue is applicable to ALL provider types and has been affirmed and upheld by many state courts for 45 years.
45 Years Ago
A landmark case decided in 1965 was the first to enunciate the concept that “present-day hospitals, as their manner of operation plainly demonstrates, do far more than furnish facilities for treatment…” and have assumed the role, like it or not, of being ultimately responsible for arranging and coordinating total health care. In Darling v. Charleston Community Memorial Hospital, the Illinois Supreme Court decided to hold a hospital responsible when nurses attending a patient failed to either inform the attending physician about a condition that was about to become irreversible; or if the physician failed to act, to advise the hospital authorities so that appropriate action might be taken.
That is, the hospital, not the physician, was ultimately held responsible for the standard of medical care and treatment offered within the facility.
Before 1965, hospitals did not “treat” patients – only physicians did that. The Darling decision, however, showed that hospitals were seen to have evolved, and were no longer simply buildings where private physicians cared for their private patients. Since that decision, various state courts have held that a “hospital” is directly liable for failing to monitor a physician exercising staff privileges such as treating patients in the hospital.
A More Recent Case
In 2007, CMS filed a case against a skilled nursing facility (SNF) as a result of a state site survey that found some irregularities in its patient care. The SNF was fined over $300,000 because its staff did not question a physician’s orders for a drug regimen.
Are you surprised? I’m not. This particular case was about the need for a lab test to be conducted but the case could just as easily have concerned perhaps an admission status order, the specificity of some diagnosis, the interpretation of a lab test, the need (or lack of need) for some type of procedure, a patient’s discharge status… uh oh… here’s another list that goes on and on, also!
So, what does that have to do with the new issue listed above, the one that Connolly posted on July 1? Does it really matter what “Provider Type Affected” is listed there? Does the following discussion regarding a decision related to a SNF really only apply to SNFs?
Facilities Have to Get it Right, Regardless
Is it hard to see the connection? Not for me, and I hope not for you.
So with that in mind please read the following with serious regard and think about the implications for your organization. While you’re at it, think about this: when you start with the idea that facilities must monitor physician orders, it’s not exactly a huge leap to the greatly anticipated (and feared) RAC “Medically Necessary Complex Reviews” which we have already heard are right around the corner!
Failure to Question a Physician Order Costs $300,000
The CMS Departmental Appeals Board (DAB) upheld an Administrative Law Judge’s decision that a skilled nursing facility (SNF) posed immediate jeopardy to its residents when its nursing staff did not question or compel a physician to administer clearly needed drug-monitoring tests for two of its patients, in Decision No. 2317, dated May 17, 2010. The decision let stand civil money penalties (CMPs) totaling more than $305,000.00, and CMS’s imposition of a discretionary denial of payment for new admissions (DPNA) for six days.
Medicare Participation Requirements Cited
In order to participate in Medicare, a long-term facility must comply with the participation requirements set forth in 42 C.F.R. Part 483, subpart B. 42 C.F.R. § 483.1. State agencies under contract with CMS perform onsite surveys to assess compliance with these requirements. 42 C.F.R. §§ 488.300, 488.305. Deficiencies – or failures to meet participation requirements – are reported by the state survey agency on a standard form called a “Statement of Deficiencies” (SOD). (See: State Operations Manual (SOM), Appendix P – Survey Protocol for Long-Term Care Facilities)
CMS may impose enforcement remedies (including CMPs) when it determines, on the basis of survey findings, that a facility is not in “substantial compliance” with one or more participation requirements. 42 C.F.R. § 488.402. “Substantial compliance” means a level of compliance such that “any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.” 42 C.F.R. § 488.301. Under the regulations the term “noncompliance” refers to “any deficiency that causes a facility to not be in substantial compliance.”
A Case in Kentucky
The majority of the CMPs imposed in this case involve deficiencies (or failure to meet participation requirements) reported by a state survey agency on a standardized form, a “Statement of Deficiencies” (SOD), and the facility’s “substantial noncompliance” which CMS determined placed the facility’s residents in “immediate jeopardy” – meaning that the facility placed its residents in “a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment or death to a resident” according to 42 C.F.R § 488.301.
An SOD issued by Kentucky state agency surveyors in November 2007, identified several findings of noncompliance that the surveyors considered to pose immediate jeopardy. One of the findings, evidently enough to justify the surveyors conclusions all by itself, involved a case where one resident, called Resident 1 in the briefs, was prescribed the anticoagulant medication Coumadin. Hemorrhage, necrosis, death or permanent disability can result when Coumadin is not in a therapeutic range. Laboratory tests for Prothrombin Time and International Normalized Ratio (PT/INR) are used to determine whether Coumadin is in a therapeutic range and should be performed at least monthly.
No Order from the Physician
On July 31, 2007, Resident 1 had a PT/INR test, and a nurse’s note indicates test results were then faxed to Resident 1’s physician that same day. A nurse’s note dated the next day, states the physician’s return call included no new orders related to the test results. Apparently, no further communication with the physician occurred or was documented relative to these tests.
On August 29, a “consultant pharmacist” conducted a drug regiment review for the facility and reported that there were “no irregularities” in Resident 1’s drug regimen. On September 28, however, another consultant pharmacist conducted a similar review and stated the facility should “follow up” on the PT/INR tests for Resident 1. The latter consultant stated this testing was needed because the last test was dated July 31, and the tests should be done monthly at a minimum.
Nevertheless, for whatever reasons, the facility did not bring this to the attention of the physician, nor did it request or suggest any further tests according to the medical record. In fact, Resident 1 did not receive another PT/INR test until October 10, when he was hospitalized for subdural hematoma and tested high for INR at that time.
Facility’s Arguments Rejected
In its defense, the facility attempted to argue that it was not responsible for the fact that Resident 1 did not have PT/INR monthly testing after the July 31 date, asserting that in their state (Kentucky), nurses have no authority to order lab tests and certainly no duty to compel physicians to order tests. The facility felt it fulfilled its responsibilities under section 483.25(1) by identifying and monitoring Resident 1 for observable side effects and by ensuring monthly visits from the attending physician.
The ALJ rejected this argument, stating:
“The regulation squarely places the burden upon Petitioner to ensure there is adequate monitoring and Petitioner does not have the option of hiding behind . . . the physician’s . . . failure to act. I take no issue with Petitioner’s assertion that nursing staff may not order laboratory tests or substitute its judgment for that of the physician. However, Petitioner does have the burden under the regulation to ensure that monitoring is done. When monitoring is not done, Petitioner has the burden to show that it took action to ensure the monitoring was done or that the clinical evidence reflects a reasonable explanation for why it was not.”
The DAB agreed with the ALJ and went on to state:
“We agree with the ALJ that the regulation imposes a substantial responsibility on the facility to adequately monitor a resident’s drug regimen. The lead-in language to section 483.25 makes clear that it is the facility’s responsibility to ensure that each quality of care requirement in section 483.25 is met, stating: “Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.” (Emphasis added.) There is nothing in the language of section 483.25(l) suggesting that a facility is responsible only for monitoring it can provide directly or that exempts a facility from alerting a physician when an integral part of that monitoring — an order for laboratory testing — appears to be missing.”
Facilities Are Responsible Regardless of a Lack of Orders
In its decision the DAB quotes several comments and decisions to make several points, but two are quite striking:
(1) that the facility is clearly responsible for the quality of drug therapy provided in the facility, including ensuring that physicians make reasonable medical judgments before prescribing drugs to the facility’s residents;
(2) that a nurse has the responsibility and obligation to question a patient care order that is deemed inappropriate by a nurse according to his/her education and experience, and where a nurse questions the appropriateness, accuracy or completeness of an order, the nurse should not implement said order until it is verified for accuracy with the physician or provider.
The facts of the case according to the DAB decision indicate the facility’s nursing staff was clearly required to question the physician’s failure to order further PT/INR testing after July 31. Also, the attending physician historically issued tests for PT/INR testing, five times – one order each time the physician received results of the PT/INR test, corresponding to the time Resident 1 was readmitted to the facility on May 8 thru July 23, the date of the last test ordered.
The Medical Record is the Final Word
Testimony by the nurses involved and statements made by the physician to the surveyors gives the impression of miscommunication: the physician believed that Resident 1 already had an order for repeat PT/INR tests, while the nurses interpreted his comments in differing ways. Nevertheless, all these statements seemed to conflict with or were at least not substantiated by the medical record. Specifically, there was nothing in the record showing that Resident 1’s physician either made or clearly communicated to the facility an affirmative judgment that Resident 1 did not need a repeat PT/INR test.
Facilities are Responsible to Monitor Physician Orders
The facility also took the position that it was not required to question Resident 1’s physician about the absence of an order for a repeat PT/INR, citing the Board’s quoting with approval the ALJ’s statement that “nurses are not required to challenge those judgments that physicians make which are ‘uniquely within the skill and training of a physician.’” (See DAB Decision No. 1696, July 1, 1999) The DAB disagreed however, because the monitoring of Coumadin therapy, as opposed to prescribing the drug, is not “uniquely within the skill and training of a physician.” The Board emphasized that the regulation imposes substantial responsibility for that monitoring on the facility.
As I said at the opening of this article, the ‘need to know’ for staff at all levels has never been greater than now! Staff must know what’s going on, be actively involved in advocating for their patients, and be vigilant about the care being prescribed. Questions must be asked, documented, and acted upon.
The RAC approved issues lists are a continual reminder that Medicare providers are being watched now more than ever. And cases like the one above are evidence that even more “eyes” are watching all Medicare providers.
Ignorance can be quite costly for a provider these days.
About the Author
Patricia Dear, RN, has more than 30 years of experience in the healthcare industry, working within corporate healthcare entities, for-profit and non-profit hospital systems, legal defense and plaintiff counsel. She is a recognized national speaker on reimbursement and compliance. She is the president and CEO of eduTrax®.
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