Readers Respond

Dec. 1, 2010

ISO 15189 in use ’round the world

“ISO 15189:2007 5.8.15 The laboratory shall have written policies and procedures regarding the alteration of reports. When altered, the record must show the time, date, and name of the person responsible for the change. Original entries shall remain legible when alterations are made.”
With increasing interest in ISO 15189 and its use in the international community, it may be of interest to readers to know the position of relevant standards other than those specific to the U.S.

-Ray A. Minnick, MT(HHS), MBA
A2LA Accreditation Officer
Frederick, MD

Editor's note:
Thanks to Ray Minnick of A2LA for reminding us of this standard. It never hurts to have reinforcement of relevant international standards in our increasingly shrinking laboratory world!

Thanks for your editorial in the September 2010 MLO [“HIPAA hits a snag,” p. 4]. I have been aware that the government has pushed two initiatives regarding health information that are in opposition. They are HIPAA and the EMR. HIPAA is well intentioned. However, as the push to streamline medicine by use of EMR involves sharing of personal medical information by more and more people and more and more systems, this data becomes progressively less secure. Given human nature and the current state of the technology, I do not think secure records can be achieved. Not only that, but under the Homeland Security Act, the government has expanded capability to secretly intrude on electronic data.

-Richard Halbert, MD
Department of Pathology

North Colorado Medical Center
Greeley, CO

All creatures great and small
In reference to your article entitled “HIPAA hits a snag” in the September 2010 MLO, I would like to have you expound on the statement, “I just hope I do not learn one day — via one or the other method — that I am actually a dog.” You probably offended a lot of dog lovers out there … I [sic] being one of them. Most times, I feel dogs have more qualities we should strive for as humans, especially in regards to personalities. Obviously, you are a “cat person,” which explains a lot …

-Name Withheld by Request

Editor's note:
We always appreciate any letters our editorials inspire. To clarify for readers offended by the last sentence of “HIPAA hits a snag” column, my comment was not about dogs. It was in response to the odd reactions of two females mentioned in that writing who believed, even for a nanosecond, that because “DNA does not lie,” (1) a child was not genetically linked to one, and (2) the other was not a woman, ergo how to explain this to her children. While my school teachers may have argued that I was “lazy like a dog,” it is quite obvious that no matter who is doing what testing, I am not, in fact, a dog — but certainly would not complain about it if I were.

Chart correction
Thanks to an astute reader who pointed out an error in MLO’s October article “Unexpected laboratory diagnosis: Acquired dysfibrinogenemia in a bleeding patient with liver disease.” On page 30, the chart should list the reference interval range for ALP as 38 U/L to 126 U/L. A corrected chart is available at and in the digital edition of MLO.

Dr. Novis’ article
Having been caught in the power struggle between the administrator (“cut costs; make money”) and the pathologist (“do more tests; make money”) more than once, from my experience as a lab manager, I say that this is not a place one wants to be very often or for very long. In many hospital labs, the pathologist had a major financial interest, especially in the anatomic section, where the secretary, the histo and cyto techs, and the processing equipment belonged to him. Here are some tips based on my “lessons painfully learned.” First, be sure what authorities and responsibilities (actual and perceived) you have in any area where you may have problems, including AP and CP labs, the LIS, and even the OR cryostat. If it “looks like” the lab should be addressing a given situation, get ahead of the power/problem curve. Second, work out your relationships with administrators and the pathologists (plural), as personalities may overshadow what otherwise would be clearly designated lines of communication and/or authority. Some pathologists start out wanting to be hands-on; some never do. Some may relinquish power to the manager as she demonstrates abilities. Remember that it is (usually) to the administrator’s advantage to deal with the manager: less of that messy doctor-mere-mortal dynamic. And remember you are an employee of the hospital. This situation offers both problems and protections that the pathologist as a stand-alone contractor may not have. If you do not have the management and/or interpersonal (read survival) skills you need, acquire them, through a mentor from your favorite peer organization (e.g., CLMA) or business courses — online or at the local college. Remember, this set of relationships is ever-changing. If things are going too smoothly, you probably missed something. Dancing on a razor blade may be exciting, but it generally does not end well, and it is tough on the shoes.

-Chuck Millstein, MBA, MT(ASCP), CLDir(NCA), Retired