AUTOMATED SORTATION DEVICE. To establish quality assurance measures for automated sortation devices.

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Deirdre Ross
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1 UTMB CMC PHARMACY DEPARTMENTAL POLICY AND PROCEDURE Effective 10/16/00 NUMBER: Revised: 4/16/18 Page 1 of 9 Reviewed: 4/16/18 AUTOMATED SORTATION DEVICE SUBJECT: PURPOSE: POLICY: AUTOMATED SORTATION DEVICE To establish quality assurance measures for automated sortation devices. Each of the automated sortation devices shall have scheduled maintenance and periodic quality assurance checks to verify dispensing accuracy. All designated personnel will be trained prior to operating the system. PROCEDURES: I. The Assistant Director of Systems and Regulatory Compliance will ensure that preventive maintenance is performed on each sorter twice a year. A. The maintenance visit and inspection will be conducted by an authorized Solutions Net System (SNS) representative. B. Repairs and modifications will be made as deemed necessary. C. A written summary of the maintenance performed will be provided by SNS after each visit and copies will be distributed to the Warehouse Operations Supervisor and Assistant Director of Systems and Regulatory Compliance. A copy should also be ed to the Director of Pharmacy and Associate Vice President for Pharmacy Services for inclusion in the 340B audit files. II. III. IV. The Warehouse Operations Supervisor will ensure that routine maintenance is performed on each sorter every 30 days according to manufacturer recommendations. Maintenance will be documented using the form in Attachment A (Sorter Monthly Maintenance Check List). Forms must be kept in chronological order for one year. A. Chain operation Inspection and oil when necessary B. Cylinder Arms Check for proper functioning C. Paddles Observe diverting action D. Regulator/Water Trap/Filter checked and cleaned. E. Compressor Observe for visible signs of damage (e.g. unusual noise or vibration). F. Cameras Clean accumulated dust G. Lexan panels (reclamation sorter) Should be dusted frequently. Do not use alcohol as a cleaning agent. H. Belts All issues or problems associated with an automated sortation device will be immediately reported to the Warehouse Operations Supervisor and documented on the Daily Assessment/Issue Log (Attachment B). Each of the three automated sortation devices shall have its own Daily Assessment/Issue Log. The Warehouse Operations Supervisor will conduct a daily assessment of the operational performance of each of the three sorters. The assessment shall consist of: A. Conducting a visual inspection of production area and pertinent equipment to ensure optimum operational compliance (e.g. area is clean, no perceived hazards, and equipment appears to be in good working order).

2 UTMB CMC PHARMACY DEPARTMENTAL POLICY AND PROCEDURE Effective 10/16/00 NUMBER: Revised: 4/16/18 Page 2 of 9 Reviewed: 4/16/18 AUTOMATED SORTATION DEVICE B. Reviewing each sorter s Error Log (Attachment B). At each sorter location shall be a clipboard with the noted form. The form shall be utilized by all staff (stores clerks, senior technologists, and pharmacist) to record production equipment issues (e.g. making a strange noise at lane 22, cylinder on lane 40 seems to be leaking, etc.). Outstanding issues shall be immediately reported to the Assistant Director of Systems and Regulator Compliance. Completed forms must be kept in chronological order for one calendar year. C. Reviewing the previous day s General Statistics Summary Report to assess overall performance and/or potential areas of concern (e.g. Product Count vs. Percentage Successful, Induct Errors, Verify Errors, etc.). V. The Warehouse Operations Supervisor will ensure that a quality assurance audit is performed weekly for all distribution sorters. A. Shipping containers from each sorter will be selected and visually inspected for errors by a designated stores clerk. B. The weekly quality assurance audit will be documented using Attachment C. C. One shipping container for each sorter will be selected and one tote must be for a non-340b unit (e.g., Texas Tech, county jails). If the shipping container selected does not contain a minimum of 25 prescriptions each, additional containers must be selected until the minimum is reached. D. Shipping containers for different units and waves should be selected each week. E. At a minimum the audit will include: 1. The correct tote plate label was placed on the shipping container. 2. The correct delivery manifest (i.e., packing slip) was placed inside the shipping container. 3. The contents of shipping container match the delivery manifest. 4. The correct inventory (i.e., 340B versus non-340b) was used to fill each medication order. F. The audit form (Attachment C) should be turned in to the Warehouse Operations Supervisor who will take action to resolve any problems. A copy of the audit should also be ed to the Director and AVP for Pharmacy Services for inclusion in the 340B audit files. G. All issues related to 340B program compliance will be immediately referred to the Director of Pharmacy, Assistant Director of Systems and Regulatory Compliance and Finance Manager. H. The results of audit will also be discussed with the stores clerks during quality assurance meetings and other area personnel as needed I. The weekly audits will be filed and kept in chronological order per the record retention schedule. V. Reclamation Sorter A. The Warehouse Operations Supervisor will ensure that a quality assurance audit is performed monthly on the reclamation sorter. B. A minimum sample of medication orders will be processed where a specified sample of cards will be reclaimed according to business rules and a specified sample of cards will be destroyed according to business rules. C. The completed audit form (Attachment D) will be turned in to the Warehouse Operations Supervisor who will take action to resolve any problems. D. The monthly audit form will be filed and kept in chronological order per the record retention schedule.

3 UTMB CMC PHARMACY DEPARTMENTAL POLICY AND PROCEDURE Effective 10/16/00 NUMBER: Revised: 4/16/18 Page 3 of 9 Reviewed: 4/16/18 AUTOMATED SORTATION DEVICE IV. All designated personnel will be trained prior to operating the distribution sorters and reclamation sorter (Attachment E).

4 Attachment A Sorter Monthly Maintenance Check List 88-Lane Distribution Sorter Performance Summary of Problem Detected Chain Cylinder Arms Paddles Regulator/Water Trap/Filter Compressor Sorter Scanners (Dust) Comments: 40-Lane Distribution Sorter Performance Summary of Problem Detected Chain Cylinder Arms Paddles Regulator/Water Trap/Filter Compressor Sorter Scanner (Dust) Comments:

5 Reclamation Sorter Performance Summary of Problem Detected Chain Cylinder Arms Paddles Regulator/Water Trap/Filter Compressor Camera (Dust) Lexan Panels (Clean) Comments: Take-Away Conveyor Performance Summary of Problem Detected Chain Problem Detected Belts Problem Detected Comments:

6 Attachment B Sorter Error Log Date Name Lane # Issue / Problem Date of Repair Fix Notes (what was done)

7 Attachment C Weekly Distribution Sorter Quality Assurance Audit Note: Two shipping containers should be selected and one tote must be for a non-340b unit (e.g., Texas Tech). If the shipping containers do not contain a minimum of 25 prescriptions each, additional containers must be selected until the minimum is reached. Supervisor: 88-Lane Sorter: Unit: Wave: Tote Plate #: 340B Eligible Unit (circle one): Yes or No Manifest #: Number of RXs: Question Answer Comments Correct tote plate placed on shipping container? (i.e., unit tote plate = unit listed on orders) Correct manifest placed inside shipping container? (i.e., unit on manifest = unit listed on orders) Contents of shipping container match the delivery manifest? (i.e., are there drugs in the tote that are not listed on manifest) Any missing medications? (i.e., are there drugs listed on manifest but not in the shipping container) Any medications with the incorrect price plan? (i.e., 340B used for 340B eligible unit and WAC used for non- 340B unit) Were there other issues discovered during the audit? (If yes, list in comments) 40-Lane Sorter: Unit: Wave: Tote Plate #: 340B Eligible Unit (circle one): Yes or No Manifest #: Number of RXs: Question Answer Comments Correct tote plate placed on shipping container? (i.e., unit tote plate = unit listed on orders) Correct manifest placed inside shipping container? (i.e., unit on manifest = unit listed on orders) Contents of shipping container match the shipping manifest? (i.e., are there drugs in the tote that are not listed on manifest) Any missing medications? (i.e., are there drugs listed on manifest but not in the shipping container) Any medications with the incorrect price plan? (i.e., 340B used for 340B eligible unit and WAC used for non- 340B unit) Were there other issues discovered during the audit? (If yes, list in comments) CC: Warehouse Operations Supervisor Director of Pharmacy Services

8 ATTACHMENT D Monthly Reclamation Sorter Quality Assurance Audit Supervisor: Question Answer Comments Number of cards reclaimed correct? Reclamation label for each reclaimed card correct? Number of cards destroyed correct? Number of cards diverted to the error tote correct? Were any cards diverted off the end of the belt? (If yes, list quantity in comments) Were there other issues discovered during the audit? (If yes, list in comments)

9 Attachment E Stores Clerk (Sorter/Line) Training Check List Note: Completed check list should be given to the supervisor for signature and placement in the employee s personnel file. Stores Clerk Trainer Learn the following activity/items: Acquire a sign-on for the sorters. General description of sorter process. Safety around sorters and E-Stop. Error lanes: Purpose of lanes 1,3,5,7. Purpose and placement of tote plates. Proper labeling and sealing of boxes and plastic totes. Start and Stop the sorters. Process and log refrigerated medications. Wave cut off times. Set up line for a Distribution Wave Run. Set up line for a Reclamation Wave Run. Scan products. Scan tote plates and lanes. Know what to do with reports and manifests. Stage boxes and plastic totes properly for courier pick-up. Stage boxes properly for shipping by mail carrier. Hand sort and dump wave totes from racks to boxes/plastic totes. Identify the mail carrier units and the courier units. Attach Courier Manifests to appropriate boxes/totes. Start, feed and stop the Take-away-Conveyor Clean area and prepare for the next day. Other items discussed: (List) Date Trained Supervisor:

RETURNED MEDICATIONS AND RECLAMATION PROCESSING

Page 1 of 14 SUBJECT: PURPOSE: POLICY: Returned medications and reclamation processing To define the process for handling products returned to the Pharmacy to ensure that medications are properly destroyed