Category: Administration

Administrative documents, not necessarily technical or medical

Comments in Medinfo Hematos IIG

drzeyd

This post is the policy for using comments in Medinfo software.  A subsequent post will show the process of entering comments.

Principle:

There are several different types of comments in HIIG:

  • Donor Global
  • Patient Global
  • Analytical Comments
  • Result Comments
  • Contraindication Comments

Global Comments appear on the first main screen of either the donor or patient record.  The presence of comments is indicated by a bar at the bottom of the screen (in yellow or blue saying Presence of Comments.  Double-clicking opens the list of entered comments.

Examination/Results Comments appear only when you open the result to which it is attached.  You must know in advance to which result they are linked to find them.

Contraindication Comments appear when entering a donor deferral code

At HMC, we will enter examination/results comments again as global comments (donor or patient) so it is easy for staff to retrieve them and see them with all other comments.  You can do this by cut and paste.

Physicians may enter any of these comment types.  Comments may be entered before or after a test is authorized/verified.  If entered after authorization, the test must be modified to accept the comment and require a special password (not the user sign-into HIIG).  Only results/examination comments are visible in the patient’s medical record.  Global, analysis, and contraindication comments are visible only in HIIG!  Donor comments are only visible in HIIG.

The presence of comments documents physician review of abnormal results as required by the various accreditation standards.

Policy:

  1. Only designated staff may enter comments.
  2. Comments entered after authorization/verification of results will modify the donor/patient record and require a special, high-level password distinctly different from the normal user password.
  3. Enter comments in the following situations:
    1. Telephone call documentation (e.g. critical values).
    2. Interpretations of donor or patient test results, transfusion reactions, etc.
    3. Instructions for the selection of specific and/or modified blood components
    4. Donor eligibility issues (e.g. donor marker testing abnormalities and disposition)
    5. Donor reactions
    6. Donor counseling documentation (e.g. donor counseled at 0930 on 24/3/14 about his abnormal result).
    7. Any special instructions to staff
    8. Any other situation where the transfusion physician/supervisor or designate determines it is desirable to enter a comment
  4. Copy all results/examination-comments and also enter then as global comments against the patient or donor record as applicable.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  2. Workflows 1001-1005, Medinfo Hematos IIG, 2013-2014.

Traceability of Processes in Transfusion Medicine using Medinfo Hematos IIG

drzeyd

Principle:

As part of good manufacturing process, we must trace everything in Transfusion Medicine, from registration through release of components.  The adoption of the Medinfo Hematos IIG computer system allows us to document anyone and everyone who “touches” the blood components and all processes.

Policy:

  1. Each staff member must use his/her personal log-in to sign into Medinfo Hematos IIG HIIG).  Each transaction is recorded with the User ID.
  2. Through the Medinfo Hematos IIG  computer system, we can trace:
    1. Each staff member who handled every step of every process.
    2. Which equipment was used in processing
    3. Which materials were used, including serial number of blood bags and selected reagents
    4. For each component, the donor is identified, including review of all test results, physical examinations, and questionnaire
    5. For each patient, all components received (from which each donor can be traced) and all testing results including transfusion reactions and any applicable protocols
    6. For each reagent lot numbers, expiration dates
    7. For each blood component, test results, serial numbers of blood, transfer, and pathogen-inactivation bags, dates and types of all modifications, including any changes in component outdates, disposition of unit (transfused, discarded, quarantined, etc.)
  3. Units can be quarantined based on each of the above parameters to block release to and/or usage at all blood transfusion services/hospital blood banks.
  4. Upon request of the Division Head, Transfusion Medicine/LIS, designated Transfusion Medicine and HIIG staff have access to trace any of the above.
  5. All traceability incidents will be reported as variances and documented according to standard procedures.

References:

  1. Workflow processes for Medinfo HIIG, Current Versions
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA

Opinion: Outsider Access to Blood Bank Software

drzeyd

I designed my blood bank software Medinfo for use by my staff at all levels and positions to adhere to and facilitate compliance to the workflow processes.  Blood bank staff were restricted to access only those functions needed for their job duties.

Blood Donation records could not be viewed by outside staff for confidentiality reasons.  Blood donor records were not linked to patient records at all.

We did not allow access for Medinfo to non-Transfusion Medicine staff since the screens were designed to maximize efficiency of the work processes, not the viewing by outsiders of results.  Outsider access was made through the hospital information system HIS.

The separate hospital information system HIS interfaced to Medinfo for the following functions:

  • Ordering blood components
  • Ordering a limited number of tests from which algorithms would be generated on the blood bank side for further testing
  • Querying the status of the test or component orders (e.g. ordered, collected, in blood bank being processed, completed)
  • Viewing of completed tests and component requests

Even within the HIS ordering capabilities, there were additional restrictions:

  • Blood components:  outside doctors could order base blood components could be ordered, but special processing such as washing or irradiation followed internal blood bank rules.  Outside physicians could state their preferences in an order comment, but blood bank rules applied.  Any disagreements had to be discussed with the transfusion medicine physician.
  • Testing:  Only base tests such as ABO/D typing, antibody screen, direct antiglobulin test, transfusion reaction workup, and cord blood testing could be directly ordered by outside physicians, but further testing depended on the results of these tests as allowed by internal blood bank algorithms.  An outside physician could not directly order other tests but had to discuss his concerns with the transfusion medicine physician.

Results viewing in the HIS were subject to additional conditions as well:

Only certain results, not all results were viewable directed in the patient’s chart since showing all results may be confusing to the outside physicians and nurses.  The selected results were sent back into the HIS for viewing.  All these non-viewable results were retrievable for blood bank staff in Medinfo.

Another option, one I did not use at either HMC Doha or NGHA in Saudi Arabia, was to order tests and components by physicians directly into Medinfo.  Likewise, they could view test results directly in the system.  Special screens could be constructed to offer ordering and results retrieval.

Use of Expired Reagents

drzeyd

This is a sample document for use of expired reagents I wrote for HMC Qatar.

Principle:

Due to logistics issues including the long distance between suppliers in Europe and North America and Qatar and the importation/customs clearance of critical materials, Transfusion Medicine has developed a contingency variance policy to minimize disruption of the essential transfusion medicine testing and component preparation.  Approval for use of outdated reagents in special circumstances is not meant to be an excuse for untimely monitoring and improper ordering of supplies.

Definition:

Rare Reagent:  Any reagent that is either used uncommonly or is in short supply and difficult to obtain in a timely matter.

Policy:

  1. Maintain a minimum six (6) months’ supply of each reagent when feasible.
    1. This cannot be done for short-outdate reagents such as reagent red cells for panels and antibody screens.
  2. If an in-date reagent is not available for use, then an outdated reagent may be considered for use if:
    1. It passes an in-run quality control including negative and positive controls as applicable specific for the test in question.
    1. Supervisor reviews the results and approves their use:
      1. Results using such outdated reagents may only be used if they pass the validation rules in that procedure.
    1. The Division Head, Transfusion Medicine, or designate reviews the supervisor’s recommendations and approves their use.
  3. All such variances must be documented as follows:
    1. Variance document form
    1. In the comments for results within the Medinfo Hematos IIG software.

References:

Sections 1.3.2 and 7.0, Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA

Rules in Medinfo Hematos IIG Blood Bank Software

drzeyd

Medinfo Hematos IIG has an underlying framework of functionality.  It is flexible since it acts upon rules based on parameters (e.g. sex, age, diagnosis, test results, etc.)  You can change the processes in the system by changing the parameters without upsetting the underlying structure of the software.  This means you can make changes very simply and quickly without having to “hard-code.”

Rules are based on parameters which are entered into the system by the user or the results of previous action.  I am listing here some examples of parameters used to define processes in my Medinfo installations:

  • Demographics (e.g. age, sex, nationality, address)
  • Diagnosis
  • Ordering Physician
  • Project (e.g. research project)
  • Location (e.g. hospital ward or clinic)
  • Procedure (e.g. apheresis, surgical)
  • Test results (ABO typing, DAT, marker testing, control values)

Based on these parameters, the system may require:

  • Specific selection of component, derivative
  • Special processing of component
  • Selection of specific test methodology
  • Discard of blood component
  • Invalidation of test rests (e.g. positive D control)

Examples:

  • Restrict use of CCP if SARS-CoV-2 antibody titer is low
  • Discard component if HBsAb quantitation below a threshold (e.g. 100 IU/liter)
  • Hematology ward patients only to receive irradiated blood components
  • Patients in research project to have special testing always done
  • Patients with unexplained hemolysis to have special DAT performed (IgG, IgA, IgM, C3c, C3d)
  • If anti-Kell present, only use K-negative blood—if Kell positive or Kell untested, block allocation
  • If female donor, whole blood only to be processed for RBCs
  • Reflex testing (if HBcAb reactive, then HBsAb must be performed)

Overriding rules:

One can also define if the rules can be overridden by someone with appropriate credentials:

  • Use antigen-incompatible RBCs (e.g. C-positive in a patient with anti-C)
  • Use of non-irradiated RBCs if irradiator is broken

On the other hand, rules can be specified to prohibit overriding:

  • Use of group O RBCs in a patient with anti-H

Validation of Reporting Formats

drzeyd

The attached PDF illustrates a sample validation of reporting formats for transfusion service testing.  The validation criteria are explicitly stated.  The evidence, in forms of screen shots, is attached to the PDF.  The data is reviewed and then accepted by me as the Division Head, Laboratory Information Systems.

Please note in this sample, no actual patient data was used.  All testing was done in a non-production environment.

Here are the embedded screenshots:

Opinion: Software Permissions for Blood Bank Staff

drzeyd

In my career, I have worked with many different hospital and laboratory computer systems.  One of my greatest frustrations has been providing software permissions to staff at all levels, from clerical, nursing, technical, and medical—inside and outside the blood bank.

The software permissions that I am specifically referring to are those with the blood bank software.  These I directly controlled as Division Head of Transfusion Medicine and Laboratory Information Systems.  I am not talking about virtual private networks or Citrix or cloud-based software controlled by the hospital IT department.

Here are some examples of inappropriate permissions:

  • All staff share the same access, regardless of position or department
  • Technical staff, including non-blood bank staff have global access to all functions
  • Non-blood bank staff can modify test results or comments

The golden rule is to only give access that is needed for each staff’s job designation.  Staff must sign an agreement not to access the system except for work and not release anything to non-designated personnel.

I recommend separating privileges by:

  • Blood bank vs non-blood bank staff
  • Blood bank section and location
  • Technical privileges by rank:  trainee vs base technologist vs senior technologist vs supervisor vs technical director
  • Medical privileges by rank:  residents/fellows, junior medical staff, senior staff, head of sections/directors

Permissions within a test category may include test ordering, result entry, verification/authorization, and/or purging.  In the donor center, it may include registration, donor qualification, collection, donor marker testing, donor immunohematology, component processing, component modification, and/or inter-depot transfer of components.  Management tools included in the software may also be restricted to high-level staff.

In this time of COVID and staffing shortages, we may be training new staff to work in the blood bank.  During their training, these trainees can be competency assessed and be given access to limited functions.  In Medinfo Hematos IIG, you can give staff custom permissions test-by-test so for example, if they are deemed competent for ABO/D typing, you could restrict their access to only those tests as an interim measure.

Having customized access for each employee can be nightmare for the systems administrators so this granular special access must be kept to a minimum.  However, it is good to know that you do have this capability if needed.

Teaching Document: Variances in Transfusion Medicine

drzeyd

Principle:

In accordance with AABB Standards, all actions contrary to the standard operating procedures and policies of Transfusion Medicine must be specifically approved by the Head, Transfusion Medicine or designate.

Documentation of variances must be organized in a system for ready retrieval for analysis.  They should not be entered into a system that is cumbersome to find the entered variances.

Examples include but are not limited to:  Rh(D)-incompatible transfusions, least-incompatible crossmatch, extension of expired rare reagents, etc.

If the same variance is occurring frequently, it should be determined if modifications in the underlying documentation (policies, processes, procedures) should be made.

Policy:

  1. Whenever there is need for a variance in the policies and procedures in Transfusion Medicine, the Division Head, Transfusion Medicine or designate must be informed.
  2. The Division Head or Designate will review and accept/reject the request.
  3. If accepted, the variance must be documented in writing by any of the following:
    1. A paper form (pre-blood bank computer system implementation) that can ultimately be scanned or an electronic version stored in Transfusion Medicine.
    2. A comment in an appropriate field in the Medinfo computer system
  4. All verbal authorizations for a variance (e.g. telephone call to Transfusion Medicine physician at night) must be recorded on a form and submitted to the responsible TM physician for review and signature.
  5. All variance documentation must be readily retrievable for analysis.
  6. All variances must be collated and assessed as part of the monthly quality review.

References:

  1. Technical Manual, Current Edition, AABB, Bethesda, MD, USA
  2. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA