Physicians Office Resource Volume 12 Issue 6 - Page 35

• Glucose monitoring ; Hemoglobin A1C

• Hematology

• Infectious diseases ( such as Influenza and Rapid Strep )

• Pregnancy and fertility

• Tumor / cancer markers

• Urinalysis testing

• Other Chemistries ( Magnesium , Lactate , Micro-albumin , Creatinine )

• D-dimer for thromboembolism

Challenges inherent in managing point of care testing : In the core lab , errors occur most frequently in the pre- and post-analytic phases , however , POCT errors occur primarily in the analytic phase of testing . This is related to a lack of understanding or training of non-laboratory staff who are involved in POCT . In addition , there are possible test limitations and misuse in a particular environment . This often raises concern over the reliability of test results .

More than ever , the laboratory must be proactive in monitoring all aspects of POCT , if quality care is to be maintained . These actions include :

• All Point of Care ( POC ) testing personnel must be properly trained , and have their competency periodically assessed , even if all their testing is waived

• All instruments involved should be used in accordance with manufacturer ’ s requirements with quality control , calibration , and maintenance records monitored ;

• Test results must be verified as to accuracy and ( if previously patient tested ) consistent with a patient ’ s history

• Reagent storage and handling must be monitored

• Utilization of split sampling and proficiency testing is recommended for monitoring quality .

Managing POCT : the Laboratory Liaison Mindful that POC testing may be performed by non-laboratory staff , laboratories often have a staff tech responsible for monitoring this testing , acting as both a liaison , as well as a technical resource for the POC testing staff .

This is an important responsibility , as feedback from the field to the laboratory is needed to identify potential communication problems , complaints , and the needs of both patients and staff .

The bottom line is that there should be no difference in the quality of patient care provided by the laboratory , whether performed within the confines of the laboratory itself , or anywhere else . Ultimate responsibility lies with the laboratory administration and staff .

An alternative model : POCT Management Teams Interdisciplinary POC management teams that include the laboratory , physicians , and nurses are considered as the most effective way to ensure the best oversight . This model increases the probability of inter-departmental cooperation and buyin by non-lab staff of all the procedures required to assure quality POCT . They would be responsible for :

• Determining the test menu

• Selecting methodologies

• Establishing policies and procedures

• Confirming proper training and competency assessment

• Overseeing regulatory compliance

• Documenting corrective action where necessary

• Providing advisory assistance to the

“ The Bottom line , there should be no difference in the quality of patient care , whether performed within the confines of the lab , or anywhere else . Ultimate responsibility lies with the lab administration and staff .”

Ralph Taylor , CEO , Sysmex America , Inc .

users of POC technologies

However , regulatory standards hold the Laboratory Director ultimately responsible for managing and supervising POCT

Compliance strategies in the digital age : The Use of Data Management Systems Technology has now enabled us to monitor all aspects of POCT remotely , from test requests to test results ; from QC to maintenance records to documentation of competency to operate instruments . When possible , use digitalized monitoring to ensure quality work . Here is a sampling of the capabilities of remote monitoring :

Training & Competency Assessments

• Documentation of the initial training , as required by CLIA and Accreditation organizations , prior to POC testing , followed by documented competency assessments at specific intervals .

Quality and Compliance

• QC limits and frequency intervals can be configured on the test instrument or managed remotely through a data management system ...

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• Glucose monitoring; Hemoglobin A1C • Hematology • Infectious diseases (such as Influenza and Rapid Strep) • Pregnancy and fertility • Tumor/cancer markers • Urinalysis testing • Other Chemistries (Magnesium, Lactate, Micro-albumin, Creatinine) • D-dimer for thromboembolism Challenges inherent in managing point of care testing: In the core lab, errors occur most frequently in the pre- and post-analytic phases, however, POCT errors occur primarily in the analytic phase of testing. This is related to a lack of understanding or training of non-laboratory staff who are involved in POCT. In addition, there are possible test limitations and misuse in a particular environment. This often raises concern over the reliability of test results. More than ever, the laboratory must be proactive in monitoring all aspects of POCT, if quality care is to be maintained. These actions include: • All Point of Care (POC) testing personnel must be properly trained, and have their competency periodically assessed, even if all their testing is waived • All instruments involved should be used in accordance with manufacturer’s requirements with quality control, calibration, and maintenance records monitored; • Test results must be verified as to accuracy and (if previously patient tested) consistent with a patient’s history • Reagent storage and handling must be monitored • Utilization of split sampling and proficiency testing is recommended for monitoring quality. Managing POCT: the Laboratory Liaison Mindful that POC testing may be performed by non-laboratory staff, laboratories often have a staff tech responsible for monitoring this testing, acting as both a liaison, as well as a technical resource for the POC testing staff. “ The Bottom line, there should be no difference in the quality of patient care, whether performed within the confines of the lab, or anywhere else. Ultimate responsibility lies with the lab administration and staff.” Ralph Taylor, CEO, Sysmex America, Inc. This is an important responsibility, as feedback from the field to the laboratory is needed to identify potential communication problems, complaints, and the needs of both patients and staff. The bottom line is that there should be no difference in the quality of patient care provided by the laboratory, whether performed within the confines of the laboratory itself, or anywhere else. Ultimate responsibility lies with the laboratory administration and staff. users of POC technologies   However, regulatory standards hold the Laboratory Director ultimately responsible for managing and supervising POCT Compliance strategies in the digital age: The Use of Data Management Systems Technology has now enabled us to monitor all aspects of POCT remotely, from test requests to test results; from QC to maintenance records to documentation An alternative model: of competency to operate instruments. POCT Management Teams When possible, use digitalized monitoring Interdisciplinary POC management teams to ensure quality work. Here is a sampling that include the laboratory, physicians, of the capabilities of remote monitoring: and nurses are considered as the most eff V7F�fRv�F�V�7W&RF�R&W7B�fW'6�v�B�G&���rb6��WFV�7�76W76�V�G0�( "F�7V�V�FF����bF�R��F���F��2��FV���7&V6W2F�R&�&&�ƗG��`���FW"�FW'F�V�F�6��W&F����B'W�ЧG&���r�2&WV�&VB'�4Ĕ�@���'������"7Ffb�b��F�R&�6VGW&W0�67&VF�FF����&v旦F���2�&�� �&WV�&VBF�77W&RVƗG��5B�F�W��F��2FW7F��r�f����vVB'��v�V�B&R&W7��6�&�Rf�#��F�7V�V�FVB6��WFV�7��( "FWFW&֖��rF�RFW7B�V�P�76W76�V�G2B7V6�f�2��FW'f�2�( "6V�V7F��r�WF��F���v�W0�VƗG��B6��Ɩ�6P�( "W7F&Ɨ6���r�Ɩ6�W2�B&�6VGW&W0�( "2Ɩ֗G2�Bg&WVV�7���FW'f�26�( "6��f�&֖�r&�W"G&���r�@�&R6��f�wW&VB��F�RFW7B��7G'V�V�@�6��WFV�7�76W76�V�@��"��vVB&V��FVǒF�&�Vv�FF�( "�fW'6VV��r&VwV�F�'�6��Ɩ�6P���vV�V�B7�7FV����( "F�7V�V�F��r6�'&V7F�fR7F���v�W&R�V6W76'��&VBF�R&W7B�bF��2�B�F�W"'F�6�W2@�wwr���6�6��4�ff�6T�Ww2�6�Ю( "&�f�F��rGf�6�'�76�7F�6RF�F�P�3