MU-JHU CORELAB QUALITY IMPROVEMENT PROGRAM …



|Author: Ali Elbireer |Document Number: |Imp20-01 |

| |Effective (or Post) Date: |19 Feb 2007 |

|Document Origin |Company: |MU-JHU Lab |

| |SMILE Approved by: |Jo Shim |

|Review by |Heidi Hanes |Review date |21Apr20 |

|SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific |

|processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other |

|applications. If you have any questions contact SMILE |

MU-JHU CORELAB QUALITY MANAGEMENT QUALITY IMPROVEMENT PROGRAM

2006 REPORT

1. Amended Reports 2

2. Turn-Around-Time (TAT) 3

3. Specimen Management 5

4. ERROR MANAGEMENT SYSTEM 7

(a) INTERNAL QUALITY ASSURANCE REPORTS – Process Improvement Reports (PIR) 7

(b) EXTERNAL QUALITY ASSURANCE REPORTS – Customers Services Concerns (CSC) 9

6- Customer Service 11

7- Other Quality Improvements Efforts Accomplished in 2006 11

(a) Laboratory Safety: 11

(b) Other Training: 11

• Annual Mandatory Education (AME): 11

• Continuing Education (CE): 11

• Good Clinical Laboratory Practice (GCLP): 11

1. Amended Reports

1st Quarter: Amended reports were low for the first quarter of the year at a total of sixty two (62). Majority of the errors were demographic. These errors were communicated to the clinics in an effort to improve record keeping and error reduction.

No technical error was reported during this period.

2nd Quarter: Amended reports drastically increased during the second quarter of the year to a total of two hundred and thirty seven (237). The cause of such huge increase was the improper installation and setup of the new Chemistry instrument, for example BUN (Blood Urea Nitrogen) analyte results were erroneously reported as Urea on installation of a new Chemistry Instrument (Cobas Integra 400 Plus). This error was corrected by programming the correct conversion factor in the instrument such that it displays BUN directly. Clinicians were immediately notified; erroneous results corrected, and amended reports sent.

3rd Quarter: Amended reports dropped to thirty eight (38), much lower than the second quarter.

4th Quarter: Amended reports remained at a low level of forty six (46).

This was because of the intervention of the processing team who constantly communicate any unusual events detected on the requisition forms that could compromise specimen integrity.

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2. Turn-Around-Time (TAT)

Turn-around-time was monitored based on the period from when the specimen is received in the Laboratory up to the time when its results are entered into the LIS database. Thus, we realize the need to monitor the period from when the clinician orders the test until the specimen is received in the lab - and the period from results entry in the computer system until the clinician receives results. Our current processes are not capable of automatically monitoring the whole TAT process. Nevertheless, we periodically monitor the whole process manually and we carefully monitor the Customer Service Concern Reports for any TAT concerns.

TAT was monitored throughout the year using a TAT tracking log (see below)

We only monitored the overall average TAT on a monthly basis until July 2006. In August we started discipline/bench specific TAT. Overall, the TAT trend is relatively stable (+/- 10 hours), hence, the need to analyze it overtime to observe trends. The log clearly indicates that throughout the year the Core Lab was able to hit its set targeted TAT (i.e., 15 Hr Average for all tests) .

With the exception of the period between March & May when the lab experienced a huge backlog of PCR-RNA tests pending due to increased testing demands from the clinics which was aggravated by a lack of proper follow-up/planning from the laboratory side. Nevertheless, we learned from this experience and since then we cross-trained additional 4 techs in the PCR area.

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3. Specimen Management

A tracking log was set up to document specimen problems at the lab processing /reception level to help prevent erroneous results being produced & released to studies/projects.

The following specimens’ unacceptable/rejection criteria were monitored:

Patient’s age, Patient’s sex, Visit code, Specimen ID, Haemolysis, Icteric/Lipemic, clotted specimens and Volume of the sample received.

Throughout the 2006 year, the highest number of received samples with queries/comments was during the months of August at sixty three (63) and October at forty two (42).

In both months, the problem reported was icteric (jaundice)/lipemia. After investigating the root causes, we found that it was due to a high number of newborn babies and infants handled as a result of the Normal Reference Range Study currently in process. Whenever trends are identified we immediately notify the Client’s/ Study’s team to ensure they utilize good phlebotomy practices which includes both proper specimens labeling, and blood collection.

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|4. ERROR MANAGEMENT SYSTEM |

|Core Laboratory follows a standard guidelines for documenting, reporting and following-up on complaints, errors and problems within the Core |

|Laboratory via the Process Improvement Report (PIR) and from outside the Core Laboratory via the Customer Services Concern (CSC) Form. The PIR form |

|is typically completed by & for the lab staff, and utilized as an internal QA tool. The CSC form is for our external customers to point-out issues |

|and opportunities for improvement to lab mgmt/staff. These two forms help us better understand and analyze problems (i.e., Pre-Analytical-Post), |

|resolve technical discrepancies, encourage employees to improve performance, improve communication, and ultimately teamwork. |

|(a) INTERNAL QUALITY ASSURANCE REPORTS – Process Improvement Reports (PIR) |

| |

|In 2006 we analyzed a total of 175,129 tests, and identified a total of 80 Opportunities for improvement (0.05% of total tests). |

| |

|SUMMARY OF INTERNAL QUALITY ASSURANCE REPORTS (PIR) For 2006 |

| |

| | | | | | | | | | | | | | | | |Category |Item |Jan |Feb |Mar |Apr |May |Jun |Jul |Aug |Sep |Oct |Nov |Dec |Total |Cat. Total | |Pre-Analytical |Yellow copies missing Accn #'s |  |  |3 |  |  |  |  |  |  |  |  |  |3 |3 | | |Other |  |  |  |  |  |  |  |  |  |  |  |  |0 | | |Analytical |Wrong Tests Performed |  |  |  |  |1 |  |  |  |1 |  |  |  |2 |28 | | |Tests Not Performed |  |  |  |  |  |1 |1 |3 |  |  |  |2 |7 | | | |"Complete Report" Missing |  |  |  |1 |  |2 |  |1 |  |  |1 |  |5 | | | |Results Error Suspected |  |  |  |  |  |  |  |  |  |  |  |  |0 | | | |Results Error Suspected |  |1 |  |2 |1 |2 |4 |1 |  |  |  |3 |14 | | | |Other |  |  |  |  |  |  |  |  |  |  |  |  |0 | | |Post-Analytical |Results Transcription Errors |  |  |  |  |  |  |4 |  |  |  |  |  |4 |19 | | |Critical Results not Called |  |  |  |  |  |  |  |  |1 |  |1 |  |2 | | | |TAT |  |  |3 |  |1 |2 |  |  |  |  |2 |  |8 | | | |Other |  |  |1 |  |1 |1 |  |  |1 |  |1 |  |5 | | |Total Per Month |0 |1 |7 |3 |4 |8 |9 |5 |3 |0 |5 |5 |50 | | |

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6- Customer Service

We were unable to accomplish this project in 2006. However, we are planning to conduct a Customer/Client Survey questioner, before the end of the 2nd quarter in 2007, to ensure we are meeting the clinical/diagnostic services expectations of the Principle Investigators, Physicians, Nurses, other Healthcare team members, and the Patients. We will compare the findings to the 2005 Clients/Customer Survey.

7- Other Quality Improvements Efforts Accomplished in 2006

(a) Laboratory Safety:

As a means to keep every Lab employee safe and minimize job related hazards, Safety Training was done throughout the year as follows:

• New employees/recruits as part of the orientation program

• Safety training was also done as part of competency evaluation for existing staff

• The agenda for monthly departmental meetings are designed in such a way that there is always a safety talk by a different presenter.

For the first quarter of the year the pressure for most Eyewash stations was low and not very appropriate for use. We rectified the issue by purchasing booster pumps for each Eyewash station. Currently the Eyewashes water pressure is adequate and all are in good working condition.

(b) Other Training:

• Annual Mandatory Education (AME): This was adopted in the general staff meeting held in the Core Lab on the 14th February, 2006.

Every Lab employee apart from the cleaners underwent this training exercise and obtained a pass mark of 80% and above.

• Continuing Education (CE): Several in-house training activities have been carried out for staff during the year more especially for the management team. This was done by either IDI training team and experts from outside.

• Good Clinical Laboratory Practice (GCLP): This was conducted by PPD at Kampala Sheraton Hotel in the month of October 2006. Over 90% of the Core Lab employees attended the three days training exercise and obtained a certificate of attendance.

Report Reviewed By: ______________________

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Two New Chemistry Instruments put in place

PCR Testing Backlog

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