Quality Management Plan

TJUHBB POL 01.001

Principle

The QM program is incorporated into the laboratory workflow to integrate all aspects of the laboratory's scope of care, including proficiency testing, quality control, inpatient, and outpatient services, specimen transportation, specimen receiving and processing, instrument and reagent handling, results reporting, personnel assessment and safety. The program ensures optimum patient specimen identification and result integrity throughout the pre-analytical, analytical, and post-analytical processes. This program is also used to detect and evaluate significant errors, incidents, and other problems that could affect patient management, which allows for an on-going system evaluation to identify and correct problems that may interfere with patient care services.

Terms of Accredidation

The biorepository maintains compliance with the CAP terms of accreditation. The biorepository must notify CAP regarding the following:

• A. If the biorepositroy is investigated by a government or other oversight agency, or if there is adverse media attention related to biorepository performance; notification must occur within 2 working days after the biorepository is aware of an investigation or adverse media attention. The notification must include complaints or warning letters issued by the oversight agency.
• B. If there is any change in the biorepository test menu. Notification must occur prior to starting new patient testing.
• C. If there is a change in location, ownership, or directorship of the biorepository. Notification must occur no later than 30 days prior to the change(s); or no later than 2 working days after an unexpected change.

Quality Assurance

• Monthly QA reports are submitted to the QA department. Several parameters are assessed.
• QA meetings are held monthly and all issues are discussed in that forum. Minutes are on file.
• Performance improvements are reported to the QA committee on a rotating basis.

Specimen Quality Assessment

Quality of banked specimen will assessed for a minimum of 10% of participants' samples. These results will be reviewed with the Director on a bi-annual basis, unless greater than 10% of samples do not pass quality checks as outlined below.

• Formalin-fixed tissue
  • Tissue preserved in formalin will be embedded in formalin with slides stained for hemotoxilin and eosin. 10% of slides will be reviewed by a pathologist for the following:
    • Histologic Diagnosis
    • Hemorrhage
    • Psuedopalisading Necrosis
    • Percentage tumor cells present in sample
    • Percentage necrosis
    • Agreement of histologic and clinical diagnoses
• This data will be stored in OpenSpecimen.
• Fresh Frozen Tissue
  • 10% of tissue biospecimen will be assessed for RNA quality via extraction and tapestation analysis
  • RNA integrity number equivalent (RIN) > 7.5 is considered passing
  • Any samples with RIN < 7.5 will be reported to the Director
  • Analysis report will be uploaded into database and made available to researchers
• RNAlater Samples
  • Tissue stored in RNAlater will be assessed for quality at the time of utilization. This is because it is expected that the quality of RNAlater samples is superior to fresh frozen tissue due its suspension in a stabilizing solution.
    • RNA quality assessments (i.e. RIN, A260/280, nucleic acid concentrations) will be reported to the biorepository by the investigator.
  • Frozen Whole Blood
    • Frozen whole blood samples are stored for normal genetic controls.
    • Upon send out for DNA analysis, DNA quality assessments (i.e. A260/280, nucleic acid concentration) should be reported back to the biorepository by the investigator.
  • Frozen Buffy Coat
    • Prior to freezing, quality of buffy coat is analyzed by using a Cell Countess.
      • The number of cells are counted and logged into OpenSpecimen to assess the quality of the sample.
    • Plasma is assumed to be of good quality, as long as buffy coat appears to have a total count of greater than 10 million cells.

Specimen Inventory Assessment

Quality research utilizing tissue from the biorepository will depend on consistency and integrity of the samples. In addition to ensuring the quality of individual tissue samples, it is vital that an inventory of frozen samples is maintained and checked for inconsistencies.

• Freezer location evaluation - every month, 1 specimen box will be removed for evaluation.
  • Ensure that the barcode is correct
  • Check the orientation of samples within the box
    • the 1st sample lines up with the 1st box position
  • Using the Biotillion boxmapper, RFID tags for the cryovials are read and displayed.

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Maintaining sample integrity

Frozen samples must not be exposed to room temperature for more than five minutes. Replace the box as soon as the RFID tags are read and proceed using the tag numbers.

• Examine the locations indicated along with the locations specified in both the inventory management software (OpenSpecimen) as well as the back-up inventory document.

Sample Rejection

In order to ensure the overall quality of the biorepository, it is necessary to outline conditions that warrant rejection of a sample. All rejected samples must be completely deidentified and disposed of via infectious waste protocols as outlined in the Laboratory Safety Policy.

Histological Slides

• Formalin-fixed samples are handed off to the Histology Laboratory for paraffin-embedding and histology slides.
  • Histological diagnosis is performed by a neuropathology attending and compared to the clinical diagnosis. In cases where the two do not match, the difference is noted in OpenSpecimen.
  • Formalin-fixed pieces are also assessed for necrosis and hemorrhage. The presence of extent of necrosis and hemorrhage is also noted in OpenSpecimen.

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Delegation of histology slide quality check

The neuropathology attending may delegate this duty to a pathology resident. In this case, the neuropathology attending must verify the work of the resident and sign off that the slides and diagnoses were reviewed by an attending. This sign-off must be kept on file in the biorepository.

Blood

• Proper tracking of blood samples from the OR is critical to maintain quality banking standards.
  • A sample may be rejected if it is unlabeled or the custody of the sample is undocumented.
  • A sample may be rejected if it remains at room temperature for greater than two hours before the start of processing.
  • A sample may be rejected if the integrity of the blood tube is compromised. This can include leakage or a broken/loose cap.
  • A sample may be rejected if it has clotted before freezing or further processing for plasma and white blood cells.

Fresh Tissue

• Fresh tissue from the operating room must be quickly processes in order to maximize RNA integrity. Accurate times must be kept by either the circulating nurse or the biorepository collector for warm ischemia (from when blood supply to tumor is cut), cold ischemia (time on ice), and flash freezing.
  • Any specimen for which there is no record of warm ischemia must be rejected.
  • Any specimen for which the warm ischemia time exceeds 30 minutes must be rejected.
  • Any specimen for which the cold ischemia time exceeds 30 minutes must be rejected.
  • Any frozen specimen which exceeds 10 mm in diameter may be rejected due to inadequate flash freezing.

PERSONNEL ASSESSMENT

• Personnel competency
  • All personnel are qualified to perform any and all of the tests offered by the clinical immunology laboratory. Personnel files are available for review.
• Personnel monitoring and evaluation
  • The Supervisor performs annual employee performance appraisals. They are approved by the Section Director. They are under the personnel policy and guidelines of Thomas Jefferson University's department of Human Resources. Reviews are kept electronically by employee.

SAFETY

• Chemicals used in the clinical immunology are primarily components of kits. The manufacturer provides SDS sheets. Carcinogenic potential, reproductive toxicity and acute toxicity are all listed on the SDS pages.
  • Employees are required to review the SDS listing and know how to access them online via the desktop icon.
  • Employees are required to review assigned topics in Health Stream computer system annually and to pass the respective tests with at least 80%.
  • Please see attached chemical list for those chemicals not provided in kits.
    • SDS pages are included in MSDS binder for these chemicals.
• There are very few hazardous chemicals in the section, please refer to Chemical Inventory for a complete list.

Revisions

POL ID	Date Revised	Author	Summary of Changes
POL 01.001	08/05/2016	Patel, Miraj	Policy finalized.

Version	Category	Approval	Date
01.001	Administration	Stephen Peiper, MD	08/05/2016