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WWe began managing the respiratory care depart-

ment at Johnson Memorial Hospital, a 165-bed ruralhospital near Indianapolis, in summer of 1999.Unfortunately, we both had to become quickly accli-mated to the department. Within the first week, wediscovered serious problems with previous stateinspections of the arterial blood gas (ABG) labora-tory. Though neither of us had extensive experiencein laboratory accreditation, we realized we wouldhave to quickly overcome the learning curve.

The ABG laboratory had serious problems withregulatory compliance for several years, earning the

institution numerous Type I violations from the

state inspector two surveys in a row. AType I viola-tion is the most urgent, serious inspection result alaboratory can receive. Most of the problems iden-tified in the first problematic survey had gone unad-dressed through the second, and still had not beenaddressed. Our next inspection was scheduled to beperformed within four months; without immediatestrict adherence to details of laboratory regulations,not only would patient care continue to be endan-gered, the loss of ABG laboratory state licensure wasalmost guaranteed. Upon researching the reason forthis long-standing deficiency, we found that thedepartment consists of 12 full-time therapists; and,

like most small hospitals, only one person handledall the details of ABG laboratory certification.

Acommon problem of small institutions happenswhen a sole person is responsible for handling certi-fication details and then leaves employment. Uponresignation, the details go unattended; and certifi-cation is in danger. This was precisely the problemfound at our hospital, except the problem was com-

A B G L a b o r a t o r i e s

by John Olmstead, MBA, RRT, and Brenda Wilkerson, CRT

AARC Tmes October 2000 45

C r i t i c a l D e t a i l s o f

Arterial Blood GasLABORATORY CERTI FI CATI ON

Take-Home Notes An ABG laboratory out of compliance risks loss of

laboratory accreditation and closure, which can

negatively affect a hospitals service and financial

operations.

Small hospital department managers who also run an

ABG laboratory can follow this step-by-step guide for

bringing the lab under compliance with state and

national regulations.

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46 AARC Tmes October 2000


pounded by the fact that theindividual responsible for thedetails of ABG certification/licensure was expected to be flu-

ently knowledgeable about thedetails of certification/licen-sure with no training and nosupport from upper manage-ment. The person was alsoexpected to address all needs ofthe laboratory while at the same

time carrying a full workload ofrespiratory therapy treatments,providing full-time account-ability for respiratory staffing,acting as a resource for solvingall equipment problems, andperforming all departmentmanagerial duties.

In addition, this person wassupposed to have begun a sleep

laboratory and create programsfor outpatient pulmonary reha-bilitation and asthma education,as well as serve on numerousother hospital-wide committees.In a nutshell, the job had becomeuntenable.

Upon this persons resigna-tion, attention to ABG labora-tory licensure seemed fairlyinconsequential in comparisonto the other responsibilities ofthe position. In light of the pre-

vious surveys, the state inspec-tors had been quite forgiving.

State inspections happenevery two years. The inspectorhad to know that the laboratorysviolations were occurring over afour-year period of time, andpossibly longer; but, for what-

ever reason, it had passed inspec-tion. However, with anotherinspection looming, correctionsneeded to happen immediately.

The hospital would most likelyhave its license to perform andanalyze arterial blood gases sus-pended if we could not show doc-umented improvement on theseoutstanding issues. Although theABG laboratory is only one small

part of total hospital operations,an inability to perform ABGswould mean the hospital may notbe able to admit mechanicallyventilated patients, performinpatient and outpatient surg-eries, or admit patients with anyserious form of pulmonary orcardiac disease.

Administration could ar-

range ABG coverage through alicensed contract service whileregulatory issues were rectified,but hospital workflow would beseverely hampered; and, ulti-mately, some patients wouldhave to be transferred to morecapable institutions for care.Loss of the ABG laboratorywould have also negativelyaffected financial stability andreputation of the hospital.

Interestingly, we discovered

after speaking with peers in ourarea that our situation was notunique because smaller institu-tions face a much higher risk ofnoncompliance and have a dis-proportionate amount of regula-tory trouble because of the verynature of staffing in smaller hos-

pitals. Employees of small hospi-tals often have expanded scopeof practice far beyond counter-parts in larger institutions.

Management of personnel insmall and large hospitals alsodiffers. Typically, clinical man-agers of smaller hospitals comefrom staff or supervisory posi-tions found in larger hospitals.Smaller hospital management isoften filled with experiencedclinical personnel who cangreatly help the advancement ofclinical practice in smaller insti-tutions but have limited experi-ence with the broader scope of

hospital operations. The ABGlaboratory is a prime example ofthis; in larger hospitals, ABGanalysis may be performed by adepartment wholly dedicatedto just ABGs. Even if the respi-ratory care department handlesthe drawing and analysis of theABGs, a laboratory will typi-cally handle routine quality con-trol (QC) performance andmaintenance. As a result, therespiratory supervisor advanc-

ing to manager would have lit-tle, if any, knowledge about thesubject.

Also, smaller hospitals havesmaller education budgets; thus,the new manager may have littlesupport for overcoming thelearning curve of regulatorycompliance, and the possibilityof failure becomes more likely.

Our previous two state inspec-tions consistently showed thedeficiencies listed below, all of

which classify as Type I deficien-cies (violations): Missing policies and proce-dures pertaining to the perfor-mance and analysis of arterialblood gases. No ABG competencies hadever been performed beyond the

Our first step was to learn all

necessary steps in gaining

certification and/or licensure.

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general department employeeorientation. No documented followupcould be located when QC tests

analyzed as deficient. No log of ABG machine defi-ciencies was being kept. No medical director review ofABG machine QC was in place. No performance improvementplan was in place; quality assur-ance was not monitored.

All of these inspection defi-ciencies add up to the most detri-mental inspection result a labora-tory can receive: Type I violations.These violations can result in

delays or loss of accreditation andcan ultimately trigger a costly fol-lowup inspection survey. Facedwith the loss of ABG laboratoryaccreditation, we pulled togethera plan that would guarantee regu-latory compliance. The process ofcreating our plan led us to chartthe confusing but necessary stepsof gaining ABG machine certifi-cation and laboratory licensure.

Step one

Our first step was to learn allnecessary steps in gaining certifi-cation and/or licensure. While anumber of organizations areinvolved with certification, theyall have common goals: ensuringthe hospital is correctly drawingand analyzing ABGs and ensur-ing the test information is accu-rate. The following lists all theorganizations needed to obtainlicensure.CLIA (Clinical Laboratory

Improvement Amendments) In1967, Congress passed the Clini-cal Laboratory ImprovementAmendments, which estab-lished quality standards for alllaboratory testing. These stan-dards were updated in 1988. Bylaw, CLIA certification must beobtained before a laboratory

may operate. Steps to obtaininga CLIAcertificate include: Applying for a CLIA certificate Providing proof of participa-

tion in a CLIA-approved exter-nal proficiency testing program Passing an inspection per-formed by a CLIA laboratoryinspector Becoming accredited through aCLIA-approved accreditingagency.

External proficiency

testing

ABG analyzers must havequality control tests run once

every eight hours to assure ana-lyzer accuracy. In addition to thisroutine QC testing, the labora-tory must pay an external organi-zation to review the accuracy ofthe analyzer and the proficiencyof the analyzer operator once aquarter. Typically, the depart-ment will perform a special QCtest once every three monthsusing QC controls sent to thehospital by the external organi-zation.

Once the control tests are per-formed, the results are recordedand sent to the external organi-zation for grading. Problemswith test results can be either theresult of a bad analyzer or poortesting technique on the opera-tors behalf.

These results are kept near theABG analyzer and reviewed dur-ing inspections. Failure to com-ply with participation in anexternal proficiency testing pro-

gram will result in suspension/revocation of state licensure.Our hospital chose the Collegeof American Pathology Profi-ciency Testing Program.

As mentioned earlier, CLIAregulations require the labora-tory to be accredited through aCLIA-approved accrediting

agency, meaning youll be payinganother agency for anotherinspection similar to that of theCLIA inspector. Our hospital

chose the Joint Commission onAccreditation of Hospitals forour ABG laboratory, as our largerLaboratory department wasalready using the Joint Commis-sion as its accrediting agency.This information is also availableon the CLIAweb site: wwwwww..hhccffaa..ggoovv//mmeeddiiccaaiidd//cclliiaa//cclliiaahhoommee..hhttmm..Obtain state licensure

Next, an application is madeto the State Department of

Health; and the medical lab sur-veyor will schedule anotherinspection of the laboratory toassure all requirements are beingmet. If all certifications are inplace (in our case, CLIA andJoint Commission, as well asCAP Proficiency Testing), then astate license will be granted for aone-year period. Surveys are con-ducted once a year.

Step two

Once we learned specificallyhow to obtain licensure, wereviewed the inadequacies of ourcurrent operation to discoverspecifically how the Type 1 viola-tions were occurring so we couldformulate a plan to pull the labo-ratory into compliance. We thor-oughly reviewed the inspectorscomments and the regulationswith which we were noncom-pliant; however, most of thechanges put into place were the

result of common-sense deduc-tion about how one would assurethat: Staff can competently obtain anABG. Staff can competently operatethe ABG analyzer. Staff can ensure the analyzer is

(cont inued on page 49)

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I. General Administrative & Personnel

1 Has a CLIA certificate been obtained? If not, has an application been submitted?1 Have all personnel (director, clinical consultant, technical consultant

[general/technical supervisor, if high complexity] and testing personnel) beenlisted on the CLIA application form?

1 Are all personnel qualified by CLIA regulations for the duties they perform in thelaboratory?

1 Is documentation available for education, experience, and special training for allpositions covered by the regulations as listed above?

1 Is there a written job description detailing the responsibilities of all personnel inthe laboratory?

1 Are there sufficient appropriate personnel to perform the testing workload?1 Is a system in place and a written procedure available for initial and continued

evaluation of the competence of laboratory personnel?1 Are the director and medical director available as required for consultation?

II. Facility and Safety1 Is there an Exposure Control Plan for Bloodborne Pathogens for the

laboratory?1 Is it readily available to employees, and have they been familiarized with its

contents?1 Are universal precautions used in the laboratory?1 Is appropriate personal protective equipment readily available?1 Have the staff been trained in their application and use?1 Is there a Chemical Hygiene Plan for hazardous materials, if needed?1 Is it readily available to employees and have they been familiarized with its

contents?1 Are Material Safety Data Sheets available for all hazardous materials used in the

laboratory?1 Are all hazardous materials stored appropriately (e.g., flammables cabinets,

acids and alkali stored separately, etc.) and labeled properly?1 Are all disposable sharps discarded in an appropriate sharps container?1 Are red-bag containers and sharps containers readily available?1 Is eating, drinking, smoking, application of cosmetics and handling of contact

lenses strictly forbidden in laboratory areas?1 Are refrigerators used for food separate and apart from those used for

specimens (i.e., no storage of food in laboratory refrigerators or laboratoryareas)?

1 Are all electrical equipment or appliances up to generally accepted standards of

electrical safety?1 Are fire extinguishers available and in proper working order?1 Do staff personnel know how to use them?1 Are laboratory personnel familiar with alternate routes of escape?

III. Patient Test Management1 Are all tests requested in writing?1 If a test is ordered orally, is it followed with a written request within 30 days?

Does the writ ten requisition contain:1 The patients name and/or other unique identifier?1 The name or other identifier of the person requesting the test?1 The test to be performed?1 The date (and time, if appropriate) of specimen collection?1 Any additional information to assure accurate and timely testing and reporting

of results?

Does the l aboratory have and follow writt en procedures for:1

Preparation of the patient?1 Collection of the specimen?1 Labeling of the specimen?1 Preservation and/or transportation of the specimen?1 Processing of the specimen?

Do laboratory records show:1 Patients name or other unique identifier through all phases of testing?1 Date and time specimen was received in the laboratory?1 Condition of unacceptable specimen and disposition thereof?1 Date that all testing was performed?1 Identity of all personnel performing testing?

Are the results of laboratory testing:1 Released only to authorized persons?1 Reported in timely fashion?

Does the laboratory report contain:1 The name and address of the laboratory?1 The test performed?1 The result?1 The unit of measurement?1 The pertinent normal range for the test?

1 Does the laboratory have and follow written procedures for reportingimminently life-threatening results?

1 Does laboratory policy prohibit reporting results that exceed the reportablerange for the instrument or system?

1 Are test reports maintained in a manner that permits ready identificationand timely accessibility?

1 Does the laboratory notify the appropriate person of any errors?1 Is a corrected report issued?

Are the following records maintained for two years:1 Test requisitions?1 Test reports, including instrument printouts and worksheets, and reports

from reference laboratories?1 Corrected reports?1 Documentation of all quality control activities?1 Documentation of all quality assurance activities?

IV. Proficiency Testing1 Is the laboratory registered with an approved PT provider?1 Are PT results reviewed by the director?1 Are deficiencies investigated and remediation instituted if indicated based

on this review?

V. Instrument Maintenance1 Is an instrument log maintained for each instrument used in the laboratory?

Is the following recorded in the instrument log:1 Daily and periodic maintenance: procedure and log?1 Scheduled and unscheduled manufacturers preventive maintenance?1 Instrument problems and attempts to rectify recorded in maintenance log?

VI. Procedure Manual1 Does the laboratory have a Procedure Manual?1 Does it contain all procedures performed in the laboratory?1 Is it accessible and understandable to testing personnel?1 Do procedures accurately reflect actual laboratory practice?1 Is the Procedure Manual reviewed and signed by the director?1

Are all new procedures or changes in procedure signed by the director?

Does each procedure contain1 Procedure for obtaining specimens for the test?1 Any special instructions to the patient that may be required?1 Procedure for handling, preservation and storage?1 Criteria for rejection of unacceptable specimens?1 Directions for preparation of reagents, standards, controls, etc., for the test?1 Directions for performing the test?1 Normal or expected ranges for the test, panic values, etc.?1 Procedure to follow if quality control is out of range?1 Sample handling in the event of instrument or system malfunction?

1 Is each procedure reviewed and signed annually by the director?1 Are discontinued procedures maintained for two years?

VII. Quality Control1 Is a quality control program maintained for the ABG laboratory?1 Does it state acceptable limits and procedures to follow if limits are exceeded?1 Are controls run in the same manner as patients?1 Are quality control results reviewed by the director?1 Are prepared controls labeled as to content, preparation date, storage

requirements, and expiration date?1 Are all expired materials discarded on or before the expiration date?

VIII. Quality Assurance1 Does the laboratory have a written quality assurance program?1 Are the effectiveness of policies and procedures periodically evaluated?1 Does the evaluation identify problems and suggest solutions?1 Are the solutions monitored to ensure their effectiveness?1 Are the results of the evaluations discussed with the laboratory staff?1 Are breakdowns in communications between physicians and laboratory

personnel recorded?1 Are corrective actions taken to remedy these breakdowns?1 Does the laboratory have a procedure for documenting, investigating, and

correcting complaints about the laboratory?

Checklist forCLIA Compliance


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accurate, so medical decisionsbased on results are sound. Staff can identify instanceswhen the analyzer is not produc-

ing accurate results and can takespecific actions to remedy thesituation.

It is important to consultthe lab director whenever youare working on certification/licensure issues. ABGs are con-sidered moderately complextests, which make up a smallminority of the vast numbersof tests that full-scale labora-tories perform. Lab directors

are subjected to numerousinspections on an annual basisand thus are experts in gainingregulatory compliance. Usethem as licensure consultants;their advice is invaluable.

Below is a compilation ofthe deficiencies that causedour ABG laboratory to receiveType 1 violations during theirlast joint commission surveys,along with our action plansenacted to bring the labora-

tory into compliance. Most ofthese deficiencies were sited inthe last two inspections aswell.

Missing Policies and

Procedures: Joint Commission

Standard HR.1.

Problem: During the course ofestablishing the ABG labora-tory, all necessary policies andprocedures were written. How-ever, if they cannot be found in

the Policies & ProceduresManual when the inspectorlooks for them, the laboratorywill definitely receive a defi-ciency. Amissing policy meansthe staff cannot reference theparticular policy if a questionarises; ABGs cannot be prop-erly performed if the staff does

not know how to performthem.Solution: Replace or rewrite allpolicies and procedures in the

ABG manual.

Competencies: Joint

Commission Standard HR.3

Problem: Annual competencytesting had never been per-formed in the hospital. As JointCommission and CLIA stan-dards state, earning a respiratorydegree and owning a license isnot enough to prove a staff per-sons skill level. Inspectorsrequire hospitals to prove thera-

pist competency annually, anddocumentation proving compe-tency performance should beavailable upon inspection.Solution: The respiratory super-visor quickly drew up compe-tency documentation and moni-tored all staff as they performedABG analysis and QC controls.The therapists also were inser-viced in remedial steps to per-form when QCs fell out of desig-nated ranges, as well as what to

do if the ABG analyzer needed tobe serviced.

Remedial Action for Deficient

QCs: Joint Commission

Standard QC 1.1.3, QC 1.4.

Problem: Quality controls areperformed roughly every eighthours daily. The therapists hadrarely missed QC performancein our hospital; yet when QCsfell outside designated ranges(which indicate the ABG ana-

lyzer could be producing incor-rect analyses), no action wastaken. In one month, half of allLevel II QCs obtained unac-ceptable values; yet no followupoccurred, and the ABG analyzercontinued to be used. This is acardinal sign of absent training;the staff were performing their

duties as they were instructedand simply did not know of anyfollowup procedures that weresupposed to happen when QCs

fell out of acceptable ranges andneeded corrective action.Solution: First, the respiratorysupervisor performed and doc-umented inservicing on all nec-essary steps pertaining to ABGanalyzer-deficient QC remedialactions. Second, an easy-to-read list of actions was printed,laminated, and posted in plainsight near the ABG analyzer forreference when the QCs fell outof range. Third, a deficiency log

was initiated, on which thera-pists would record instanceswhen the ABG analyzer fell outof service or when QCs fell outof range.

No Review of Lab Activities by

the Lab Director: Joint

Commission Standard QC

1.1.1.

Problem: Unless the hospitalslaboratory department direc-tor is also serving as ABG lab

director, the respiratory caredepartment medical directorusually serves as ABG lab direc-tor. By CLIAregulation, the labdirector is responsible for allpolicies in place that controlthe activities of a department.As part of directorial duties, itis required to have all qualitycontrol and performanceimprovement (PI) informationforwarded to the director forreview. The director can then

give input for improving ser-vice. Dated signatures of QCand PI departmental informa-tion show proof of routinerecord review by the director.Solution: We initiated a logbookof all QC and PI informationtracked by the ABG laboratory,and now material is presented


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to the medical director on amonthly basis. The medicaldirector signs and dates thereports after reviewing monthly

statistics.

No Performance Improvement

Plan in Place: Joint

Commission Standard PI.1,

PI.3, PI.5

Problem: All regulatory agen-cies require health care enti-ties have a plan in place to con-tinually improve the level ofservice provided to patients.To date, no performanceimprovement plan had been

formulated for the ABG labo-ratory.Solution: A PI plan was quickly

formulated and implemented.The measurements of the planare now reported to the med-ical director on a monthly basis

and the hospital quality coun-cil receives a report on a quar-terly basis. Common PI indi-cators measured in the ABGlaboratory include: Number of missed QCs Number of re-draws due topoor samples Universal precaution compli-ance Proper reporting/documenta-tion of ABG results Durations of time between

STAT orders and ABG resultdelivery.

Success is sweet

Our most recent state inspec-tion was in April 2000, and wepassed without incident. We

look forward to our Joint Com-mission inspection in Spring2001 with confidence. Full com-pliance with regulatory stan-dards means that we can feelmore comfortable about inspec-tions, as well as more confidentthat we are delivering the bestpossible care to our patients.

John Olmstead is director of surgical

and ambulatory services at Johnson

Memorial Hospital in Franklin, IN.

Brenda Wilkerson is supervisor of the

hospitals respiratory care department.

EDITORS NOTE

For a more detailed version of this fea-

ture article, including a list of CLIA-

approved proficiency testing pro-

grams and other resources for lab

directors, log on to the AARC web site

at www.aarc.org.

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