Office of Clinical Laboratory Affairs Bulletin
Office of Clinical Laboratory Affairs Bulletin
Statement of Ownership. OCLAB is an unofficial publication of the Office of Clinical Laboratory Affairs (OCLA). It is published on an irregular basis (hopefully 4 times per year). The purpose is to furnish timely information on policy, activities and programs relevant to compliance with the Clinical Laboratory Improvement Program (CLIP). Distribution is to all registered laboratories and Quality Management Offices in the medical treatment facilities. The views expressed are not necessarily those of the Department of Defense, or the Departments of Army, Navy or Air Force. Comments on proposed topics or content should be sent to: Office of Clinical Laboratory Affairs, ATTN: AFIP-ZD(Newsletter), 1413 Research Blvd, Building 102, Rockville, MD 20850-6000. Electronic messages should be sent to martig@email.afip.osd.mil.
Updating CLIP Registration
Laboratories must notify our office within 30 days if there are changes in facility name, location, or directorship (section 493.51 of CLIP Manual). Additionally, if your laboratory is College American Pathologists (CAP) accredited, you must notify the CAP Accreditation Department. CAP, unlike the CLIP office, also requires a Curriculum Vitae for all newly designated laboratory directors.
Current Test Complexity List
Want to keep abreast of the latest in test complexity as determined by CDC and the PHS? Want to know what tests have been approved as minimally complex (waived)? The internet link below will take you to the CDC file transfer protocol (ftp) site that has the latest test complexity files. The files here are in several formats, from Word Perfect to database to ASCII. Pick the one that fits your needs and download it, then extract it using a file decompression program such as WinZip.
ftp://ftp.cdc.gov/pub/laboratory_info/CLIA/
JCAHO Fellow Information
As some of you may know, DoD has mandated that all fixed medical facilities in DoD will be JCAHO accredited by mid 1998. How does that affect laboratories? JCAHO hospital and ambulatory (clinic) standards require the laboratory (laboratory is defined in the Glossary of the DoD CLIP manual, AFIP Pamphlet 40-24) be accredited by COLA, CAP or JCAHO, and submit a copy of the recommendations and award letter to the Joint Commission. This includes those sites in which laboratory testing may occur and which are often overlooked by the primary laboratory such as blood gas laboratories, nuclear medicine departments, health and wellness clinics, and health fairs. These sites are required, just like traditional laboratory sites, to be included in a current CLIP certificate and to be accredited as a laboratory by CAP, JCAHO or COLA. Both certification and accreditation must be renewed every 2 years.
What about sites that are only performing waived (minimally complex) testing? Joint Commission does not require laboratory specific on-sight survey of all waived sites, although they must meet the standards for waived testing. These standards may be found in the Patient Assessment chapter of the Comprehensive Accreditation Manual for Hospitals and the Comprehensive Accreditation Manual for Ambulatory Clinics. In addition, the Comprehensive Accreditation Manual for Pathology and Clinical Laboratory Services has a separate (the last) chapter for Waived Testing. Waived testing sites must also possess a current CLIP certificate. Since the testing done at these sites is waived, the overview provided every 3 years during the hospital/clinic triennial survey is sufficient. However, if a laboratory surveyor is in the facility for survey of other sites, waived test sites may also be surveyed. In contrast to JCAHO, CAP treats all testing, including waived testing, as highly complex. Therefore, if your waived testing sites are CAP accredited, they must meet all applicable CAP standards, including proficiency testing, and be accredited every 2 years.
What involvement does the laboratory have during the hospital/clinic survey? There is usually an hour scheduled for one or more surveyors to visit the laboratory. Surveyors will generally address issues related to patient care and other issues to help them establish an overall pattern of compliance for the facility. For more information, look in the laboratory portion of the Guide to Survey Preparation. (Although this is separate from the accreditation manual, almost every facility has one.)
There has been a point of confusion regarding hospital surveys done in the last half of 1994. During that time (approximately 6 months), JCAHO allowed the hospital surveyors to accredit laboratory sites that only did a very few tests. These included nuclear medicine and blood gas laboratories. Many facilities thought these laboratories were accredited for three years, just like the hospital. In reality, as with any laboratory accreditation, they were only accredited for 2 years and should have been reaccredited (by a laboratorian) in 1996. Many of these laboratories are now being cited as 'unaccredited' during the hospital's triennial survey.
Provided by LtCol Loraine Anderson, Last year's AF Fellow at JCAHO
HM-8501 NEC Phase Out
Due to legislative changes brought about by the Clinical Laboratory Improvement Amendments (CLIA), Navy Medicine stopped training basic laboratory technicians (HM-8501s) and began phasing out associated billet requirements in 1995. Billet file changes have been recently completed by converting the remaining HM-8501 billets to either HM-8506 or HM-0000. Therefore, to accurately account for all available HM assets, members still holding the HM-8501 NEC will have one of the following actions taken:
1) If no SRB entitlement remains or if the member is attending or under orders to another "C" school, the member's HM-8501 NEC will be archived.
2) If selective reenlistment bonus (SRB) entitlements still exist, members will be DNEC'd as HM-0000 at their current activity.
Members with SRB entitlements have until 1 April 1998 to request and be approved to attend HM-8506 school, or they may request to have their NEC archived sooner. This action is not punitive in nature, rather qualification requirements within the laboratory field have been raised to a new level and we must attain, then maintain these revised DOD standards. Questions regarding changes should be directed to the HM/DT Enlisted Community Manager at (703) 695-3868/3865; DSN 225; email: p221o@bupers.navy.mil.
This information is from LCDR Dodge, the Enlisted Community Manager and was published in Volume 4/97 of LINK, the professional bulletin of Navy enlisted personnel.
Testing Personnel Requirements
To perform high complexity testing, an individual must meet the qualification found in paragraph 11-41 of the DOD Clinical Laboratory Improvement Program manual (AFIP Pamphlet 40-24, dtd 8 July 96). Anyone hired to perform high complexity testing must have an AA or AS degree or higher in a laboratory science or equivalent credits to an associate's degree. Individuals with a high school diploma or equivalent and documented training appropriate for the testing performed are qualified to do high complexity testing if they were performing this testing on or before April 24, 1995. These individuals must have appropriate supervision consisting of on-site supervision by a general supervisor when they perform high complexity testing. If they were hired to perform the testing before Jan 13, 1993, they can do the testing without supervision as long as all testing is reviewed by a general supervisor within 24 hours.
Electronic QC and CLIA Regulations
Do you have POCT sites that are using instruments that have electronic controls? Wondering what the regulations say on the use of these controls? QC requirements are being re-evaluated by HCFA as part of the process of preparing the final CLIA regulations. All determinations as to the use of internal electronic controls in meeting CLIA requirements will be reviewed at that time. In the meantime, internal electronic controls are acceptable provided the following conditions are met.
1. The lab must verify manufacturer's claim and run external (usually
liquid) controls periodically to validate that no change has occurred with
the test system.
2. The manufacturer's QC protocol calls for the use of electronic QC.
3. The required number and levels of QC are run (usually 2 levels per day).
4. A documented record of the QC results is kept (pass/fail or numerical).
5. The testing personnel and supervisors appropriately monitor the data.
6. Remedial actions are taken and documented in out-of-control situations.
The use of these procedures should satisfy any of the accrediting agencies
that inspect your labs. Remember to document everything you do.
Watch these pages for updates when HCFA publishes the final rules in
the Federal Register.
URLs of Note
Virtual Phlebotomy
http://parsons.ab.umd.edu/~vguy/phleb.htm
The Ultimate Phlebotomy Home Page
http://zensoft.com/pages/phlebotomy.html
The Needle Phobia Page
http://www.webcom.com/cfsc/needles.html
CAP Checklist Updates
Lab General Checklist #01.5240 Phase I
"Is the frequency/ duration of on-site visits, and involvement of the consulting pathologist in the laboratory's activities considered adequate?" Commentary in the Consulting Pathologist section indicates that once-per-month visits to the outlying laboratories by the consulting pathologist is the standard. Coordination with CAP has allowed the following policy for CLIP registered laboratories accredited by CAP:
1. The consulting pathologist must visit the outlying laboratory at least once per month and document evidence of involvement in that laboratory's activities. Trip reports should be filed for review during the laboratory's QA committee meetings.
2. The consulting pathologist can delegate the responsibilities for visiting outlying laboratories to other qualified individuals. Qualified refers to individuals that meet the CLIP definitions of Laboratory Director. Trip reports must be written by the designated individual and reviewed by the consulting pathologist, then filed for review during the laboratory's QA committee meetings.
3. For those regional laboratories that have insufficient capability to make monthly visits to remote outlying laboratories, quarterly visits are allowed, provided the arrangements are written into the laboratory's QA plan regarding oversight of outlying laboratories and the oversight plan is submitted to and approved by the CLIP Office. The plan must indicate, at a minimum, the qualified individuals that will be making the visits, the frequency of visits, rational for less than monthly visits, and indicators that would trigger more frequent visits (ie. Unsuccessful proficiency testing, CAP Phase II deficiencies, repeated problems with QC records). The quarterly visits must be augmented with monthly telephonic consultations, the content of which should be documented and maintained in memorandum format.
POCT Checklist #30:0380 PHASE: II NEW
"In the absence of a designated on-site supervisor, are the results of tests performed by personnel reviewed by the POCT director, laboratory supervisor, nursing supervisor, or the person in charge of the POCT section on the next routine working shift?" Remember, the CAP does not classify tests based on the complexity level. All laboratory tests are treated in the same manner. This question, therefore, is in line with the supervisory review required for all other tests. A number of facilities that have their POCT sites accredited by CAP have run afoul of this question. One of the individuals indicated in the question must review all results, preferably before resulting the test, otherwise on the next routine working shift. This period will vary depending on the shift schedule of the POCT site. The review must be documented.
JCAHO Recognition of COLA
COLA has received full recognition of its Laboratory Accreditation program from the JCAHO for all its accreditation programs. Effective immediately, the Joint Commission recognizes and relies on COLA accreditation for laboratories affiliated with other health care institutions accredited by the Joint Commission. This means that laboratory directors may choose COLA accreditation to fulfill Joint Commission accreditation requirements for their institutions.
JCAHO Lab Inspection Findings
The following are the most common JCAHO standards which have been generating findings during recent surveys of both hospital and outpatient laboratories:
LD.2.4 The laboratory director provides for orientation, in-service training, and continuing education for all personnel in the department.
LD.2.7 The laboratory director recommends reference laboratory services to the clinical staff for acceptance through its designated mechanism.
OC.1 Each specialty and subspecialty has a documented quality control plan.
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.
QC.1.2.1 The laboratory uses a system to evaluate and correlate the relationship between results for the same test performed with different methodologies or instruments or at different sites.
QC.1.3 The laboratory's quality control system includes daily surveillance of results by appropriate personnel.
QC.1.5 The laboratory ensures that quality control results meet its criteria for acceptability before it reports patient test results.
QC.6 Using appropriate controls, the laboratory verifies each procedure in clinical chemistry at least once each day of use.
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.
IM.7.2 All requests for laboratory tests are made in writing or through electronic means.
IM.7.10 The laboratory has current descriptions of and instructions for all analytical methods and procedures.
HR.4 New staff orientation provides initial job training and information, and assesses capability to perform job responsibilities.
WT.1.4 Quality control checks, as defined by the organization, are conducted on each procedure.
WT.1.4.1 At a minimum, manufacturer's instructions are followed.
WT.1.5 Appropriate quality control and test records are maintained.
Personnel Changes at CLIP
Effective 15 November 1997, CMSgt Denis Barnard will no longer be the Air Force point of contact at the CLIP office. He is moving to Offutt AFB in Nebraska to be the Enlisted Manager of the clinical laboratory and to provide consultation to Tom Osborne at the University of Nebraska in his quest for another national championship. SMSgt Williams will be arriving in December to be the USAF point of contact. Continue to call (301) 319-0072 for information/problems and your call will be forwarded to Col Warnken.
SAFMLS Reminder
The 22nd Annual Meeting of SAFMLS will be in San Antonio, TX, from 7-11
April 1998 at the San Antonio Convention Center. Watch your mail for the
registration packet. There are loads of informative workshops and presentations
planned. Make your choices and get your registration form in early for the
best seats. You can also get information on the schedule of workshops/presentations/posters
from the SAFMLS website: http://www.safmls.org
SAFMLS membership forms and other information can also be found on the website.
OCLA Phone Numbers / Address
Army COL Martig 301-319-0133 SFC Miller 301-319-0073 millerv@email.afip.osd.mil |
Navy CDR Mann 301-319-0132 HMC Callahan 301=319-0074 callahan@email.afip.osd.mil |
Air Force Col Warnken 301-319-0134 CMSgt Barnard 301-319-0072 |
AFIP-ZD/OCLA, 1413 Research Blvd, Bldg 102, Rockville MD 20850-6000
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