Coleen Curran

le01.jpg (11069 bytes)Among the 2,600 laboratories accredited by the Joint Commission on Accreditation of Healthcare Organizations (Joint Commission) are those in hospitals, clinics, long-term care facilities, homecare organizations, behavioral health organizations, ambulatory sites and physicians offices. But that’s not all. The Oakbrook Terrace, Ill.-based agency also accredits freestanding and public health labs, blood transfusion and donor centers and laboratories in federal facilities such as the Department of Veterans’ Affairs and the Department of Defense.

Some laboratories fear their Joint Commission inspection every two years while others relish it. Wherever you fall in this line-up, more information is always better than less. That’s why we asked Marilyn Simms, associate director of the Standards Interpretation Group to answer our questions about what laboratorians can do to better prepare for Joint Commission inspections and how to avoid those dreaded Type 1 recommendations.

What do you do?
My primary job is to interpret laboratory standards. I answer phone calls and letters. I help with training when we have a new surveyor class. I work a little bit with developing the laboratory standards.

What types of accreditation programs do you offer?
We have nine accreditation programs: hospital, long-term care, ambulatory care, behavioral healthcare, homecare, long-term care pharmacies, laboratories, networks and assisted living.

How many labs do you work with?
We evaluate and accredit more than 2,600 organizations with laboratory services. That includes independent labs and those connected with other healthcare organizations. We also have cooperative agreements with other accrediting agencies.

How do the cooperative agreements work?
Cooperative agreements permit the Joint Commission to rely on the process finding and decisions of other accrediting organizations rather than duplicate what they do. Under these agreements, we will accept the accreditation decision of other accrediting groups for specific components of an organization under-going Joint Commission review. For standards not covered by other accrediting bodies, we may conduct a limited survey. For the laboratory accreditation program, the Joint Commission has cooperative agreements with the College of American Pathologist (CAP), the Commission on Office Laboratory Accreditation (COLA) and the American Society for Histocompatibility and Immunogenetics (ASHI). We’ve recently begun to accept the American Association of Blood Banks accreditation, although right now it’s just a network accreditation.

What do you mean by network accreditation?
The Joint Commission accredits healthcare networks with a slightly different process. We perform a corporate-wide survey and then sample some of their entities. If it has laboratories that are not accredited by the Joint Commission or one of our cooperative agencies, then we would sample those with selected standards. So not every hospital and lab in a network has gone through an entire Joint Commission survey. We survey the network’s structure. We go through the standards for rights, responsibilities and ethics, continuum of care, education and communication, health promotion and disease prevention, leadership, management of human resources, management of information and some sort of performance improvement activity. Then we have selected standards for the components. It’s accrediting them at the corporate level.

10 Most Frequently Cited Standards

1.    QC.1.1 Proficiency testing services used for specialty and subspecialty equal or exceed applicable laws and regulations with respect to variety and frequency of  testing and satisfactory performance criteria. (16.8%)

2.    QC.1.1.1. The laboratory maintains a cumulative record of participation in a proficiency testing program that includes documentation of the review and evaluation of each individual result exceeding the stated limits of satisfactory performance. (11.4%)

3.    QC. 1.3. The laboratory’s quality control system includes daily surveillance of results by appropriate personnel. (8.4%)

4.    WT.1 The organization defines the extent to which waived test results are used in patient care (definitively or only as a screen.) (7.6%)

5.    HR.7 Staff members’ abilities to fulfill expectations of their job descriptions are assessed. (7.2%)

6.    QC.5.10.1 Staff monitoring blood transfusions are trained to recognize or suspect adverse reactions, have a written plan of action to follow in the event of such a reaction, and report any such reaction as soon as possible to the blood transfusion service and to the practitioner responsible for the individual. (7.1%)

7.    QC.5.1.5 The laboratory uses policies and procedures related to administering blood and blood components and using infusion devices and ancillary equipment. (6.3%)

8.    QC.1.1.3 The laboratory performance on proficiency testing is maintained at an acceptable level. (6.1%)

9.    QC.7.1 The laboratory verifies each procedure and test parameter against known standards or controls within the range of clinically significant values each day of  use. (For hematology tests) (6.0%)

10.    WT.1.4 Quality control checks, as defined by the organization, are conducted on  each procedure. (For waived tests.) (5.1%)

Why is Joint Commission accreditation important to laboratories?
Accreditation is recognized as a symbol of quality. It provides a lever for continuous performance improvement and indicates the laboratory’s commitment to providing quality care. Additionally, the Healthcare Finance Administration (HCFA) recognizes Joint Commission accreditation as meeting its CLIA ’88 requirements.

Who are lab surveyors and how many do you have?
Joint Commission laboratory surveyors are experienced medical technologists. Most have advanced degrees and average more than 20 years experience in the field. They receive rigorous on-going training to ensure they stay on the leading edge of laboratory issues. There are about 30 surveyors in the country.

What do surveyors look for during a survey?
Surveyors take a thorough look at the laboratory during the two-day survey. They evaluate the laboratory’s compliance with approximately 250 Joint Commission standards. They do this by observing lab practices, validating policies and procedures, looking at environmental concerns, interviewing staff and reviewing medical records.

Where can I find a list of the most frequently cited standards?
Each year, the Joint Commission publishes a list of the top ten most frequently cited standards in Joint Commission Perspectives, so healthcare organizations can evaluate their own compliance in these areas. (See the box on the next page. The percentage following each indicates the percentage of laboratories receiving a recommendation for improvement for that standard.)

Are there any other areas that people have trouble with?
Sometimes there is confusion about the way CLIA ‘88 defines certain specialty testing. This can affect CLIA certificates and proficiency testing. For example, there is a specialty of immunology which includes many serology kits. There is also the specialty of virology. If a laboratory is using a kit to test for a viral antibody, the test would fall under immunology. But if the kit tests for a viral antigen, it is classified as virology.
     Lab managers review the list of regulated analytes (analytes required to be included in a proficiency testing program) for immunology and see that a particular test is not on the list. They therefore assume they are not required to enroll for proficiency testing for that analyte. In actuality, if the test is for the viral antigen, the laboratory’s proficiency testing program needs to cover viral antigen testing, and their CLIA registration should indicate they are performing virology. If we survey and find that they are not enrolled for viral antigen testing in such as case, we will write a Type 1 recommendation.
      There is not a regulated list of the antigens, as there is not a requirement to test each one. The requirement is to include viral antigen testing (as many antigens as possible in your enrollment) in your proficiency testing menu. This is an issue that people have overlooked or not understood, and there, causes quite a few Type 1 recommendations.

What are the consequences of a Type 1 recommendation?
Laboratories receiving Type 1 recommendations must come into compliance with those recommendations within a specific time frame. For example, we would want to see that they have enrolled in proficiency testing for the test or tests cited. If they had received any results back, we’d like to see those results.
     The Joint Commission verifies compliance with recommendations for improvement through either a written progress report from the organization or an on-site focus survey. Progress reports are the most common type. If there are a number of Type 1 recommendations in an organization, then we may do a focus survey. We try to send in the same surveyor for the focus survey as the one who made the original finding.

What can laboratory staff do to better prepare for a survey?
They should start by incorporating Joint Commission standards into their daily operations. Accredited organizations are expected to be in compliance with the standards at all times. Following the standards consistently promotes quality care and reduces risk. Conducting periodic mock surveys can help the organization identify areas in need of improvement, as well as validate what the laboratory is doing well.
     We also offer a variety of publications and educational programs to assist organizations in complying with the standards and improving their organizational performance. Customized education programs are also available. Laboratories can get more information about these on our web site, or by calling our customer service center at 630-792-5800.

Tell me about the scoring system?
The scoring ranges from one to five. One is substantial compliance on a particular standard and a five is non-compliance. We have Type 1 and supplemental recommendations. A score of three, four or five on a standard causes a Type 1 recommendation. So when we say, the percentage that scored 3,4, or 5, that means the percentage of labs that received a Type 1 recommendation, the kind of recommendation we require a response for.

What would be an example?
Take standard WT.1.4, for example. If there are lapses in a laboratory’s documentation of quality control checks, even though these checks have been defined by the organization, the laboratory would receive a recommendation for improvement in this area.

Can you explain “deemed status?”
Deemed status is an option available to laboratories seeking Joint Commission accreditation. In order for a laboratory or other healthcare organization to participate in and receive payment from Medicare or Medicaid programs, it must be certified as complying with the conditions of participation set forth by the federal government. This certification is based on a survey conducted by a state agency on behalf of HCFA. However, if a national accrediting organization such as the Joint Commission provides HCFA with “reasonable assurance” that the healthcare organizations it accredits meet the federal conditions of participation, HCFA may grant the accrediting organization, in this case the Joint Commission, “deeming” authority. HCFA then “deems” each accredited healthcare organization as meeting Medicare and Medicaid certification requirements. The healthcare organization would have “deemed” status and would not be subject to the Medicare survey and certification process. Since 1995, the Joint Commission has offered laboratories the option of seeking deemed status for CLIA ’88 through accreditation.
    Deemed status through accreditation is an option, not a requirement. Organizations seeking Medicare approval may choose to be surveyed either by an accrediting body, such as the Joint Commission, or by state surveyors on behalf of HCFA.

How often are the standards for the lab updated?
We print a new manual every two years, but if a new federal requirement comes up, we have a process to implement it sooner. We would publish it in our Perspectives publication and put it on our Web site. We have had to do that a few times. We also look at any trends or any area where we might be able to address something better than we have. It’s not all just regulations that we update, although in the lab, regulations do play a big part. For example, in the manual we published last fall, we added standards for in vitro fertilization. We based it on new federal guidelines that are out and also on information from the Society for Assisted Reproductive Technology. There seemed to be a need for accreditation in that area, so we decided to add those.

Do surveyors look at point-of-care testing? How does it affect what you do?
We would look at point of care testing whether the lab or somebody else oversaw it. I suppose the only way it affects what we do is, if the lab is oveseeing it, it’s probably a little better coordinated and may make the survey of it a little easier. We look at exactly the same standards we use in the laboratory. For waived tests, we have a special waived testing standard that actually incorporates a lot of what’s in our other standards. But for the rest of the point of care, they’re surveyed under the same standards — the quality control requirements, proficiency testing, equipment maintenance, requesting and reporting mechanisms.