TITLE: Quality Control: Hematology

PURPOSE:

Quality control is run in Hematology to show that instrument and reagent systems are functioning properly and that patient results are correct. All QC material in the department is tested in the same manner as patient samples are run. All reagents used in Hematology are used within the specified expiration dates as dictated by the manufacturer. Part of the Quality Control program, includes the review of data generated and reported out on various computer management logs. These include: the review of daily activity logs and daily exception reports; pending reports multiple times per shift to account for orders and result verification in a timely manner, to assure quality patient management. The Sr. Tech or designee reviews these materials at the end of each shift or the following day.

All specimens for Hematology and Coagulation are labeled with a demographic label from the unit or a LIS label. All specimens have the date, time of collection and the initials of the person drawing the specimens. Certain tests have time limitations and those are adhered to as such:

CBC 24 hours at room temperature

ESR 24 hours at room temperature

Retic 2 hours at room temperature for manual retics, 24 hours for the automated

DxH/LH780.

PT 24 hours at room temperature or refrigerated

PTT 4 hours room temperature

FIB 4 hours room temperature

D-Dimer 4 hours room temperature

Hematology specimens are stored post analysis at room temperature for the current day and the previous day. Coag specimens are stored at room temperature for the current day, then refrigerated for 7 days.

PERSONNEL

Medical Technologists

Technicians

SPECIMEN

None

REAGENT PREPARATION & EQUIPMENT

All reagents, calibrators, cellular controls, and solutions in Hematology and Coagulation are properly labeled, as applicable and appropriate, with: the content and quantity, concentration or titer; storage requirements; date prepared or reconstituted/opened by the laboratory and the expiration date on the individual vial/container or the box housing the individual smaller bottles. There is no requirement to routinely label individual containers with the “date opened”; however, a new expiration date must be recorded if opening the container changes the expiration date, storage requirement, etc. All reagents are stored according to manufactures instructions and used within their expiration dates. Reagents with no stated manufactures expiration are used until visible or performance changes occur, then discarded.

QUALITY CONTROL

Appropriate material designated as Quality Control sample for each test, levels are designated as low, normal, and high

STEPWISE PROCEDURE

XN-450/XP-300

Run Sysmex Control Material 2 times per 24 hours.

Following the Shut down and Start up, run at least 3 levels quality control on the corresponding analyzers.

NOTE: Each lot number of control material, which includes automated cell parameters, is

entered into the control files on the analyzers. The manufacturer assay values are

entered. We run the new lots of quality control along with the current lots of quality

control material 4-7 days. Means and S.D.’s of the automated cell parameters for

the new QC lots are compared to the manufacturer assay values and accepted if

within range. Assay values are tracked for the remainder of the lot and/or month

and QC data is sent in to BCQM for evaluation against peer group

for both analyzers.

3. QC data is acceptable if:

a.	All controls are within +/- 2SD of mean.

b.	Two controls are within +/- 2SD and the other is between 2-3 SD of the

mean.

4. QC data is not acceptable if:

a.	One control is greater than 3 SD of the mean.

b.	Two or three controls are greater than +/- 2SD of the mean.

c.	One control is between 2-3 SD of the mean on two successive runs.

5. Document QC outliers on Quality Control sheets in the Daily Preventive(XP-300) and Insight (Xn-450). Results of QC must be within limit prior to reporting patient results. Instrument problems causing QC outliers are documented on troubleshoot logs.

6. Notify senior technologist or designee if any parameters are out of limits and not

resolved. Call the hot line if a problem seems to be apparent and no one else is

available to assist you. Problems with both Yorkville analyzers, send specimens to RCMC Lab.

7. As a means of Quality assurance and system checks, we perform QC counts after

changing the XN-450/XP-300 reagemts. Background counts must be within

acceptable limits. Printouts of the background counts are saved in the appropriate binder.

B. Manual Platelet, or Manual WBC

1.	Use a patient’s blood sample that has been run through the analyzer, whose platelet count is approximately 200 to 300 and/or WBC is approximately 8.0 to 10.0.

2.	Record manual count and automated results on the sheet in the binder

designated for manual counts

3.	Results should be within +/- 10% of the analyzer value for WBC/PLT.

Contact the supervisor or senior tech if a problem exists.

An alternative method of QC is to make and compare a WBC/PLT estimate from a well made and stained peripheral smear and document as “estimate” on your sheet along with the manual count.

C. ESR’s

QC is run each 24 hours that patient samples are run. Levels 1 and 2 are run.

Enter results into the LIS.

Outliers must be documented and resolved prior to patient reporting.

Notify the Sr. Tech if a problem still exists.

D. Stain QC

A check of our Wright-Giemsa stain is made and recorded with a on the Hematology Department Daily Maintenance Log with each day of patient testing.

Unacceptable quality of stain necessitates changing of reagent pack.

F. Body Fluids

QC will be performed if body fluids are set up and counted. We run Streck

Cell Chex® Level 1-UC and Level 2 assayed controls for WBC and RBC. QC

logs are used to show calculations from the hemacytometer counts. QC results are

entered into the LIS.

As a means of quality control of cellular material counted manually on the hemocytemeter, no cell count is to be verified in the computer until the cytospin smear has been examined for the presence of RBC’s, WBC’s and Nonhematopoetic cells. A correlation between the count and the stained smear is verified and documented on the worksheet for each fluid.

NOTES:

The senior technologist, or designee, at least monthly, reviews QC. (From monthly print-

out sheets of the hematology analyzers). *Review also includes QC outlier sheets in

2.	Tolerance limits for quality control material are defined by Sysmex.

3.	Means, CV% , and SD are calculated and reported through Beckman Coulter

Diagnostic’s“Inter-Laboratory Quality Assurance” Program, on a monthly basis.

QC “outlier” sheets are checked at least monthly by the Senior Technologist.

If data from precision statistics changes significantly from previous data, there will be a review of data entry: Input sent to IQAP program, review of assay values/lab means

entered into the analyzers for past and current Quality Control material, and a review of instrument function checks to see if a calibration is indicated by any of the above.

A consult with the Hotline to assist with troubleshooting will be made. Documentation and corrective action will be noted on IQAP forms.

Patient comparisons between analyzers are used to evaluate systems on an ongoing basis.

QC entered through the LIS is edited/reviewed by the Sr. Tech.

REPORTING RESULTS

For manual QC tests not accumulated and stored by an instrument, enter results into LIS in the Result Worklist, or record on forms provided. QI for patient results are monitored daily by means of delta checks built in LIS, Exception Reports and review of Supervisor Reports by the Sr. Tech or designee.

QUALITY MANAGEMENT FOR DETECTION OF ERRORS

As a means of quality of patient care with regards to result reporting, Hematology incorporates the use of the LIS management reports to verify all delta checks, critical values, documentation of our RBTO policy and instrument analysis functions.

These reports include: Pending Reports to identify results not yet verified but received into the Lab, (which are checked at the benches throughout the day).

The Supervisor’s Report, which is the complete log of patient results during each 24 hour period and reviewed by the Sr. Tech or designee.

The Exception Report, which includes any tests or results set up in Soft to flag for review; critical results and the documentation of the RBTO, numeric results changed to alpha or freetext, linearity flags, delta checks etc.

The Sr. Tech, or designee reviews each of these reports. The Sr. Tech or designee also reviews the daily instrument printouts biweekly.

REFERENCES

CAP All Common checklist, 8-22-2018; COM. 30300

CAP Hematology checklist, 8-22-2018; page 49, standard HEM.35768

NCCLS and CAP recommended guidelines, Sysmex QC product insert, Sysmex Quick Guide.

CAP Today March 2001 – Q & A, Albert Rabinovitch, M.D., Ph.D, Checklist Commissioner for CAP.

Hematology Performance Verification Manual; PN4277076AB; pages 7:13-16; 2011