2009 Accreditation Process Guide for Laboratories

Item Number:
APGL09

Price: $119.00

2009 Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing

Item Number:
CLSM09

Price: $265.00 

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on how to validate and use Excel® the requirements can be met. This seminar will demonstrate how requirements will be met.

Areas Covered in the seminar:

• FDA and other agency’s requirements for spreadsheet validation - What do inspectors ask and what documents should be available.
• How to design spreadsheets for part 11/GxP/SOS/HIPAA compliance.
• Validation during design, development, installation and on-going use.
• When, what and how much to test?
• How to handle standard Excel functions?
• How to ensure and validate spreadsheet integrity for GxP and part 11?
• How to apply risk based validation to spreadsheet applications.
• Validation of 'ad hoc' spreadsheet applications.
• How to ensure spreadsheet security and integrity.
• How to document planning, specifications, installation, testing and changes.

Objective Decisions: Verify and Validate Laboratory Testing (PS04)

18 June 2009 1:00–2:00 PM Eastern (US) Time

Recent CLSI guidelines describe laboratory experiments that users can perform over a few days’ time to verify and validate manufacturer’s performance claims. These guidelines, when paired with CLSI guidelines for manufacturers, provide a resource for making objective decisions about whether the performance a user observes is consistent with the claimed performance. This session describes CLSI method evaluation guidelines designed for user verifications of performance.

Speaker:
R. Neill Carey, PhD, FACB
Clinical Chemist, Peninsula Regional Medical Center

Register Now! Only $195 per site

Related CLSI Documents:
EP15-A2–User Verification of Performance for Precision and Trueness
EP06-A–Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach
C28-A3–Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory

Salute: Chirurghi, Contro Errori Check List Operazioni Come Piloti

  Labs on the brink of ISO 15189 approval

November 2008
Feature Story

Anne Ford

Some people say that excellence lies in the details. For Benita Haines, excellence lies in dessert.

Haines is the quality management, compliance, and education coordinator for Piedmont Medical Laboratory, Winchester, Va., which was awaiting, at CAP TODAY press time, the CAP’s decision on the lab’s accreditation under CAP 15189. That’s a new College program that accredits labs to the International Organization for Standardization’s 15189 standard for medical laboratories. Overseeing Piedmont’s implementation of ISO 15189, as the standard is known, has been no mean feat. Haines pulled out every trick in the book to get staff buy-in, including skits, game-show-style quizzes with fun prizes, and, perhaps most memorable, a lively introduction to the principle of root-cause analysis using a single burnt cookie. (More on that later.)

Was it worth it? “Definitely,” Haines says. She credits ISO 15189 with improving everything from staff morale to billing processes, workflow, and client satisfaction: “We were looking for an international standard that brought together the entire aspect of our business, including customer service and marketing.” And in ISO 15189, she says, they found it.

So what is this magical mystery standard? Simply put, ISO 15189:2007 is an internationally recognized laboratory accreditation standard that specifies the quality management system and competency requirements unique to medical laboratories. It’s based on ISO/IEC 17025 and ISO 9001. Introduced in 2003, and developed with CAP input, 15189 has gained some standing abroad as a mandatory accreditation, such as in Australia, the Canadian province of Ontario, and many European countries. In the United States, 15189 accreditation remains optional.

The College launched the CAP 15189 accreditation pilot program in January of this year and released the program formally this fall. Among the program’s pilot laboratories is Piedmont, which had completed the accreditation assessment and was expecting the CAP’s accreditation decision at press time. Another, Avera McKennan Hospital and University Health Center in Sioux Falls, SD, had completed its accreditation assessment on Nov. 6 and was awaiting the formal results. And Blanchard Valley Hospital, Findlay, Ohio, has completed the gap and pre-assessments. Other labs are preparing to submit their applications.

“It appears that the interest is actually much greater than we had projected,” says Cordelia Sever, MD, chair of the CAP 15189 Accreditation Committee and director of clinical pathology at Pathology Associates of Albuquerque. “We hope we will be able to accommodate all labs, within their desired time frame, that take this step in the next year. Since it takes time to hire and train staff to offer a top-quality ISO 15189 program, if demand exceeds current capacity, there may be a few months’ delay. Nevertheless, laboratories can purchase the standard and start educating themselves and basically get in line for accreditation.”

To answer the question on everyone’s lips: No, CAP 15189 does not replace the College’s longstanding Laboratory Accreditation Program. The two programs are complementary. Whereas the LAP focuses on procedural excellence and good laboratory practice, fulfills CLIA requirements, uses discipline-specific checklists, and relies on unannounced inspections, the ISO standard uses announced inspections, is less prescriptive in nature, and emphasizes operational systems improvement, risk mitigation, and quality management. And, of course, ISO 15189 accreditation is optional, whereas if you decide to drop out of the LAP (or the program of another deemed accrediting body), you should probably prepare yourself for probing phone calls from the Centers for Medicare and Medicaid Services.

William J. Castellani, MD, CAP liaison to and member of ISO Technical Committee 212, Work Group 1, which produced the 15189 standard, describes it this way: “It pulls the basic requirements that constitute good laboratory practice and that are promoted by the Laboratory Accreditation Program into a structure that assists in ensuring that all of those requirements are evaluated on an ongoing basis and kept in focus. It is not regulatory in the United States; therefore, there’s no punitive effect of the accreditation process. Because it is nonregulatory, we have the ability to organize the accreditation process in a much more structured manner.” Dr. Castellani is medical director of clinical chemistry at Penn State Milton S. Hershey Medical Center and vice chair of the CAP 15189 Accreditation Committee.

Further, the 15189 requirements “are not brand-new principles that descended from heaven on stone tablets,” he says. “These are basic concepts”—such as document control, preventive action, and management review—“that have been put together in a very organized way. You’ll see things that are familiar but implemented in ways you may not have thought of.” Familiar though its concepts may be, becoming 15189-accredited is no walk in the park, he stresses: “You can’t implement 15189 on your lunch break. It focuses on certain quality aspects that are really hard to implement and take a lot of effort. The laboratory has to commit to those quality aspects so that these efforts contribute significantly to an improvement of their service. If you want full implementation, it requires support throughout the institution, throughout the administration.”

So why would a laboratory want to go to all the trouble of acquiring another accreditation, especially one that’s not even mandatory? Several reasons, not least of which is competition. “Sioux Falls is a very, very competitive environment from a health care perspective,” says Leo Serrano, Avera Mc­Kennan administrative director. “We wanted to differentiate ourselves at a higher level and prove that our quality was unmatched. We know we have excellent productivity and excellent service, but getting full external recognition is important.”

Joe Skrisson, Piedmont CEO and executive director, agrees. “ISO 15189 accreditation is an important level of quality that you can put out there on your shingle,” he says. “I wouldn’t want us to be unprepared if a competitor did that. And obviously we’re competing against LabCorp and Quest.”

But the biggest advantage that ISO 15189 confers, Dr. Sever thinks, is its application as a quality management system, particularly for those laboratories that have already made some Lean- and Six Sigma-related efforts. “That seems to be a pattern, that the laboratories that have already done Lean and Six Sigma are more interested in ISO,” she says. “ISO is very complementary to Lean and Six Sigma. The biggest problem with those programs is sustainability. People embark on them and have initial good success, but then they kind of drift back into the prior state. The ISO quality management system is a very good umbrella to maintain and further develop whatever they have managed to establish.”

Dr. Castellani agrees: “It serves as a very good structure upon which to put other quality systems such as Lean and Six Sigma and anything else that comes down the pike. Right now we talk about Lean and Six Sigma, and in five years we may be talking about other approaches that help promote quality. The ISO quality system provides a foundation for any and all of these systems.”

“With the enormous cost pressures in medicine, anybody who wants to truly survive or gain further improvements has to implement” a quality management system such as ISO 15189’s, Dr. Sever adds. “Especially in larger laboratories, it’s probably impossible to keep pace with the next wave of health care mandates without these techniques.”

The journey toward ISO 15189 implementation at Piedmont started in late 2004, when Skrisson came onboard as CEO and executive director. “We were in dire need of having some type of quality management program to rally the troops around,” he says. “There really wasn’t a quality management system in place at PML that supported consistency and having a written procedure for everything you do.”

After researching several possibilities, Piedmont chose the ISO standard because it addressed the business and marketing aspects of its operations as well as the technical ones, and because of its global recognition. After deliberating between the American Association for Laboratory Accreditation (which accredits mechanical, electrical, chemical, environmental, and many other types of labs) and the CAP as its accrediting body for the standard, Piedmont chose the latter, “mostly because it was a recognizable format in the laboratory world,” Haines says. “We felt that it gave comfort to our staff because they were very familiar with the College, so that made them feel a little more comfortable throughout the entire assessment process.”

And what a process it was. “Just getting the document control under wraps was a major undertaking,” Haines says. One of ISO 15189’s core requirements—document control—entails ensuring that no outdated documents are in circulation and that a record is kept of updates/ changes to those documents. Intimidating pros­pect though it was, Haines knew that getting a sound document-control system in place was a vital early step. “We knew that if we could standardize our procedures, then when we went in to make process improvement changes, we would not be working with a procedure that was unstable,” she says. So department by department, Haines made sure that every form, policy, and procedure existed in an electronic format and removed paper manuals from the workbench. That alone took more than a year.

Another crucial piece of the puzzle, of course, was staff education. That’s where dessert came in handy. “We have a vast array of different types of employees, from couriers to PhDs,” Haines says. She knew she needed to keep her educational efforts interesting, entertaining, and accessible. So when explaining one key component of ISO 15189—the standard’s requirement that laboratories analyze the root causes of any errors that arise—she used something everyone can get excited about: cookies.

“I took a burnt cookie, and asked them why the cookie was burnt,” she says. “We drilled down to a root-cause analysis, which basically went something like: The cookie was burnt because the timer didn’t go off. Well, why didn’t the timer go off? They got to the fact that preventive maintenance was never done on the oven, so the timer was broken and never got fixed.”

Skrisson adds, “After going through that process, they really understood how to drill farther down to make sure they get at the real cause of something, not just the symptom. They had a good time. And at the end of it, everybody had cookies.” (No, not burnt ones.)

A tasty illustration, to be sure, but how does it translate into everyday laboratory quality management? Pretty easily. During the laboratory’s internal audit against the 15189 standard, Haines discovered that her lab’s processing staff had missed a test. Thanks to ISO, she used root-cause analysis to find out why, instead of being satisfied with the superficial “we were just too busy” answer. It turned out that the staff had been busy because two runs had come in at the same time. And why were two runs coming in at the same time? Because a courier had gotten diverted from his usual run to pick up a stat test—delaying his delivery, throwing off the laboratory’s workflow, and swamping the processing staff with so many tests that they missed one. The solution lay in reorganizing the couriers’ workflow, not in pointing a finger at an employee or relying on the tried-and-true “we were just too busy” excuse.

“It’s a lot easier to just blame it on an employee, but nobody comes to work intending to make mistakes,” Skrisson says. When errors arise, “your process probably isn’t set up properly.” And, during process improvements, “the more the bench-level employees buy into that [concept], you get real excited for them, because they start understanding how they can get more quality time in their day if they get involved in making some of these changes. If you get them to the point where they can see the improvement and realize it’s made their day easier, then you’ve got 120 percent buy-in from them.”

As a pilot laboratory, Piedmont was required to undertake a step of the ISO 15189 accreditation process that is normally optional—the gap assessment, which was complet­ed in April. “The gap assessment is an on-site, three-day assessment where they’re looking at the entire standard,” Haines explains. “I would recommend it. We felt like we were pretty good after our internal audit, but they [the CAP inspectors] were still able to find, I believe, 13 nonconformances, and four were major.” During the next step, the pre-assessment (which, again, was mandatory in the pilot labs’ case but is optional), the inspectors returned for just one day to reassess those nonconformances. The final assessment took place in September.

Standardized workflows, reduced waste, improved incident tracking, heightened staff morale, and greater awareness of best practices are just some of the benefits Haines says have come about as a result of implementing ISO 15189 as a quality management system. She’s pleased with the many process improvement projects the new system has sparked as well, such as the reworking of the ­­couriers’ routine as well as a major change to billing procedures that improved cash collections by 15 percent. To top it all off, since 2005 Piedmont has lost three medical technologists to attrition, yet increased its accession numbers by 30 percent—all because of “small process improve­ment projects that have changed workflow dramatically enough that we didn’t need to hire someone else to accommodate the work,” she says.

One potential hurdle to a laboratory adopting ISO 15189, of course, is achieving administrative go-ahead. Avera McKennan lucked out in that regard, Serrano says. “We’re sponsored by the Presentation and Benedictine Sisters, and the sisters are adamant that quality is a very big part of our mission,” he says. “So when we presented this idea of ISO accreditation to our senior management, they didn’t even ask for an ROI. [When we said,] ‘This is going to clearly demonstrate that we are the highest quality,’ they said, ‘How much does it cost?’ We gave them our estimate, and they said, ‘Do it.’”

It helped that Avera McKennan had already established a Lean presence in its laboratory four years ago, making it no stranger to the idea of rigorous quality improvement. “We’ve Leaned ourselves, gone back and re-Leaned ourselves, and gone back again,” Serrano says. To lab quality management manager Cheryl Wildermuth, who has overseen the laboratory’s ISO application process, 15189 is the natural “next step after you’ve gone through Lean, Six Sigma, whatever, because it helps you organize all those things you already do and put them into a system and a process that’s easy to maintain.”

Just as at Piedmont, one of the biggest challenges during the lab’s internal audit was the document-control requirement. “I went through and made a list of every existing procedure we had,” says Wildermuth, “which was over 1,400.” While there are software packages to help with such document wrangling, ISO does not mandate any particular method, so she stuck with good ol’ Excel.

“The big thing people don’t realize,” Serrano says, “is that ISO ­doesn’t tell you how to do things. It tells you what you have to have and lets you develop the best way of doing it for your facility, recognizing that no two labs are identical.”

Like Piedmont, Avera McKennan underwent the gap, pre-, and accreditation assessments. While “I never envisioned a walk in the park,” Wildermuth says, the gap assessment “was by far the most in-depth inspection I have ever been through, but at the same time the most professional and the most rewarding.”

“I concur totally,” Serrano says. “We are a CAP-accredited laboratory, we are AABB-accredited, we are a Joint Commission accreditation facility, we are a licensed blood bank, and we are a FACT-accredited laboratory as a result of our stem cell transplant program. This was by far the most thorough, the most in-depth, and the most professional inspection assessment that I have ever experienced, and I have been doing this for 44 years.”

Rigorous as the journey toward 15189 accreditation has been, Serrano believes it’s an investment that can only pay off. “ISO 15189 will, in my opinion, ultimately become the world standard that you will be measured to,” he says. “Piedmont Medical and Avera McKennan are either risk-takers or pioneers or fools, I’m not sure which. I like to think that we are pioneers.”

The question that Dr. Sever hears most often about ISO 15189 accreditation is: “What’s the financial impact of this?” The answer: “It depends.”

“There’s the cost of the accreditation, which depends on how many site visits the laboratories need and how far along they are,” she says. “But that’s not the only cost. Laboratories that have not implemented good document control may need to invest significantly in electronic systems. The other big thing is supplier management; oftentimes it requires electronic systems, especially in larger laboratories. So it entirely depends on where the laboratory is in the journey. People who are far along—they may have a pretty easy time getting there. People who have not put a lot of energy into getting there may need more resources.”

But inexpensive it isn’t. Says Dr. Castellani: “The initial program was devised with the idea that it be the very best the CAP can provide, which means that it is not an inexpensive program, both for the College to fund in its development and for laboratories to participate in. This is not accreditation on the cheap.”

To labs that would like to become ISO 15189-accredited but find it too pricey a prospect, Dr. Castellani suggests reviewing the standard and adopting its quality management system without going for actual accreditation. “If you don’t have to be accredited to it, that doesn’t mean it doesn’t have utility,” he says. “No matter whether the laboratory chooses to pursue accreditation for the standard or not, it has value as a tool. If laboratories look at the standard and evaluate what they can take away, even outside of an accreditation arena, I think they would find things that would be meaningful additions to how they handle quality. It has value above and beyond, in the same way that Lean and Six Sigma have their value above and beyond full implementation.”

Then, too, the potential return on investment is considerable. “That’s another question that comes: ‘Do we really get much out of it?’” Dr. Sever says. “Again, where are you in the journey? The cost savings can be pretty substantial. It’s hard to quantify, but there is data that show that ISO-certified enterprises in general have better financial performance and are much less likely to disappear.”

The pilot laboratories themselves somewhat downplay the financial concerns associated with 15189 accreditation. “If you’re going to be purchasing more software, maybe even hiring consultants, things like that, it could get quite spendy,” Wildermuth says. “But I think we’ve done it very frugally.” Serrano estimates that the project added about two FTEs worth of work over an eight-month period. Again, however, as a Lean laboratory, Avera McKennan had already made many quality-improvement efforts before beginning the 15189 accreditation process. “If you’re a department that does not have that level of maturity within the quality journey, the expenses could be fairly significant,” he says.

Meanwhile, Piedmont is in the advantageous position of not being “in a hospital environment where you’re fighting for funds from different departments,” Skrisson says. “Since we’re a standalone laboratory, we put our own budget together. It’s up to myself, with board approval, to determine if the return on investment is going to be good. I convinced them that this was exactly what this laboratory needed.”

As interest in ISO 15189 spreads, some say the standard could even be adopted, at least in part, by the Centers for Medicare and Medicaid Services and other bodies. “It appears that CMS is interested in incorporating some of the elements in ISO,” Dr. Sever says. “There is much discussion about quality in medicine and increasing safety and doing what is really effective. The ISO quality management system is very conducive to that idea because it does mandate strong customer feedback loops.” In addition, “we believe there’s a good possibility that in the future, there will be programs that fulfill both CLIA requirements and ISO requirements.”

That would be especially gratifying given that “when we started the CAP 15189 program, in the beginning we had committee members who seriously doubted that this was a value-added thing,” she says. “Which was good, because they asked the hard questions. And pretty much everybody has come around and witnessed the positive impact of adopting the ISO 15189 standard. We believe that it really does what it claims to do.”

Anne Ford is a writer in Chicago. Questions about ISO accreditation can be directed to cap15189@... or to the CAP customer contact center at 800-323-4040.

  Accreditation vs. Certification

The terms "accreditation" and "certification" are sometimes used interchangeably, however, they are not synonymous.  Certification is used for verifying that personnel have adequate credentials to practice certain disciplines, as well as for verifying that products meet certain requirements.

NVLAP is a system for accrediting laboratories found competent to perform specific tests or calibrations or types of tests or calibrations.  NVLAP is not a certifier of test data, a certifier of products, or an operator of a certification program.

Accreditation is used to verify that laboratories have an appropriate quality management system and can properly perform certain test methods (e.g., ANSI, ASTM, and ISO test methods) and calibration parameters according to their scopes of accreditation.

NVLAP accreditation covers both the management system of a laboratory and the technical capabilities of a laboratory.  The assessment of laboratories is performed to check compliance with the requirements of ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories.  NVLAP, as a member of the International Laboratory Accreditation Cooperation (ILAC) and a signatory to the ILAC Mutual Recognition Arrangement, performs the assessment and offers accreditation services in conformance with the requirements of ISO/IEC 17011, Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies.

Upon satisfactory assessment and successful completion of proficiency testing (where applicable), the laboratory is issued a Certificate of Accreditation along with a Scope of Accreditation listing the test methods or calibration parameters that the laboratory is accredited to perform.   The NVLAP accreditation period is one year.  To renew its accreditation, a laboratory must demonstrate that it continues to satisfy all NVLAP requirements for accreditation.

Please visit the following links for additional resources and information about these conformity assessment terms:

• John W. Locke, "Words Matter: Registration, certification or accreditation?," Quality Digest, available at <http://www.qualitydigest.com/feb03/departments/lastword.shtml>. 
• 
  
• Peter Unger, "Accreditation or Registration?," available at <http://ts.nist.gov/Standards/Accreditation/upload/Accreditation-vs-Registration.pdf>.

For more information about NVLAP accreditation, visit the NVLAP website at http://www.nist.gov/nvlap .

Posted February 5, 2007

IAF-ILAC-ISO Joint Communiqué

The American Association for Laboratory Accreditation (A2LA) is a nonprofit, non-governmental, public service, membership society. The mission of A2LA is to provide comprehensive services in laboratory accreditation and laboratory-related training. Services are available to any type of organization, be it private or government. Laboratory accreditation is based on internationally accepted criteria for competence (ISO/IEC 17025:2005). A2LA also offers programs for accreditation of inspection bodies, proficiency testing providers, reference material producers and product certification bodies.
more......

Goals: The fundamental goals of A2LA are to:

• Achieve customer satisfaction through meeting the needs of both laboratories and their users for competent testing and calibration;
• Improve the quality of laboratories and the data they produce; and
• Increase acceptance of accredited laboratory data to facilitate trade.

Recognition: A2LA is a signatory to several bilateral and multilateral recognition agreements. These agreements facilitate the acceptance of test and calibration data between A2LA-accredited laboratories and 46 economies around the globe. In addition, A2LA has recognition from over 30 federal, state and local government agencies, companies and associations. These partners recognize the competence, quality of service and cost effectiveness of A2LA.

Laboratory Accreditation Programs: Laboratories are accredited in the following fields: Acoustics & Vibration, Biological, Calibration, Chemical, Construction Materials, Electrical, Environmental, Geotechnical, Information Technology, Mechanical, Nondestructive, and Thermal. In addition to these broad fields, specifically-tailored programs are available for animal drugs, automotive electromagnetic compatibility (EMC), environmental lead (Pb), fertilizers, food testing, and putting green materials testing. Users of laboratory services are advised to seek the specific scope of accreditation from any accredited laboratory or to visit our searchable directory of accredited laboratories on the A2LA website. The scope identifies the specific testing or calibration capabilities for which the laboratory is accredited.

Training: Periodic public training courses are offered on topics such as laboratory accreditation and the international standard ISO/IEC 17025, laboratory quality management, internal auditing, assessor training, and measurement uncertainty.

New/Revised Documents

 Health and safety in health and social care services

Linee guida, percorsi, processi, procedure, protocolli

Il caos regna sovrano: è tempo di mettere ordine!

Linee guida (LG) e percorsi assistenziali (PA) sono strumenti di governo clinico, necessari per definire gli standard assistenziali e verificare l’appropriatezza dell’assistenza erogata. Nelle organizzazioni sanitarie, termini dal significato diverso vengono spesso utilizzati come sinonimi, ostacolando la condivisione di un linguaggio comune ed esponendo i professionisti a potenziali rischi medico-legali.

January 2009

International Forum on Quality & Safety in Health Care
17-20 March 2009
Berlin, Germany
internationalforum.bmj.com

Registration Opens January 2009!