US Environmental Protection Agency Office of Pesticide Programs Office of Pesticide Programs Microbiology Laboratory Environmental Science Center, Ft. Meade, MD Standard Operating Procedure for Establishment of Control Numbers and Tracking of Laboratory Supplies SOP Number: QC-09-07 Date Revised: 12-12-16 ------- SOP No. QC-09-07 Date Revised 12-12-16 Page 1 of 6 SOP Number QC-09-07 Title Establishment of Control Numbers and Tracking of Laboratory Supplies Scope This protocol describes the procedure used to establish the control numbers for tracking chemicals, media, reagents, biological materials and disposable test carriers. Application Tracking supplies from date of receipt is an essential quality control practice. Approval Date SOP Developer: Print Name: SOP Reviewer Print Name: Quality Assurance Unit Print Name: Branch Chief Print Name: Date SOP issued: Controlled copy number: Date SOP withdrawn: ------- SOP No. QC-09-07 Date Revised 12-12-16 Page 2 of 6 TABLE OF CONTENTS Contents Page Number 1. DEFINITIONS 3 2. HEALTH AND SAFETY 3 3. PERSONNEL QUALIFICATIONS AND TRAINING 3 4. INSTRUMENT CALIBRATION 3 5. SAMPLE HANDLING AND STORAGE 3 6. QUALITY CONTROL 3 7. INTERFERENCES 3 8. NON-CONFORMING DATA 3 9. DATA MANAGEMENT 4 10. CAUTIONS 4 11. SPECIAL APPARATUS AND MATERIALS 4 12. PROCEDURE AND ANALYSIS 4 13. DATA ANALYSIS/CALCULATIONS 6 14. FORMS AND DATA SHEETS 6 15. REFERENCES 6 ------- SOP No. QC-09-07 Date Revised 12-12-16 Page 3 of 6 1. Definitions 1. OMLIMS = OPP Microbiology Laboratory Information Management System 2. Chemicals = Includes materials such as acids, bases, alcohols, disinfectants, stains, test kits, and media components (e.g., sodium chloride, Tween 80, etc.). 3. Media = Includes powder (e.g., Letheen Broth), solid (e.g., Trypticase Soy Agar plates; purchased already prepared), and liquid media (e.g., Minimum Essential Medium; purchased already prepared) used for the growth of microorganisms and cell cultures. 4. Reagents = Includes materials such as buffer and saline solutions. 5. Biological materials = Microorganisms purchased from appropriate vendors or received from other federal agencies for special studies, tracked per SOP MB-02, Tracking of Test Microorganisms, and biological indicators. 6. Disposable test carriers. 2. Health and Safety 1. Handle tracked materials according to the manufacturer's instructions or information stated in the Safety Data Sheets (SDS). 3. Personnel Qualifications and Training 1. Refer to SOP ADM-04, OPP Microbiology Laboratory Training. 4. Instrument Calibration Not Applicable 5. Sample Handling and Storage 1. Tracked materials are handled and stored in the appropriate cabinet or refrigerator according to the manufacturer's recommendation or as noted in the SDS. 6. Quality Control 1. For quality control purposes, enter supply receipt information (e.g., received date, expiration date, vendor, catalog number, lot number, status, room number, etc.) into OMLIMS. 7. Interferences 1. Tracked laboratory materials must have a control number in order to be used by the laboratory. 2. If an item is found in the laboratory which does not have a control number, and the control number cannot be created by determining the date of receipt (see section 12.3), then discard the item. 8. Non- conforming Data 1. In the event that a control number was incorrectly assigned or entered incorrectly into OMLIMS, the analyst should correct the control number on the item and in the database immediately as per section 12.4.a. ------- SOP No. QC-09-07 Date Revised 12-12-16 Page 4 of 6 9. Data Management 1. Data (i.e., OMLIMS reports) will be archived consistent with SOP ADM- 03, Records and Archives, in secured file cabinets in room D217. 10. Cautions 1. To maintain consistency and accuracy in the OMLIMS database, it is preferable to limit access to one or two staff members. 2. It is analysts' responsibility to check the expiration date of all pre- sterilized materials purchased for use in the lab (e.g., plastic loops, pipet tips, filter units, etc.) to ensure expired materials are not in use. 11. Special Apparatus and Materials 1. The OMLIMS is written in Microsoft Access with the data and system stored on the G: drive (G:\MLB\Omlims and ATP Tracking) at the Environmental Science Center, Fort Meade, MD. 12. Procedure and Analysis 1. Tracked laboratory materials are logged into the OMLIMS upon receipt and assigned a control number. 2. The analyst must verify and document on their test paperwork that pre- sterilized items are within the manufacturer's expiration date prior to their use. See Cautions, section 10. 12.1 Purpose of OMLIMS a. The OMLIMS is used to track supplies and contain important information such as vendor, catalog number, lot number, control number, expiration date, sterility requirements, storage conditions and supply status categories (i.e., Full, In Use, Discarded, Expired or Sent Out). 12.2 Control Number Assignment a. The control number consists of four parts: 1) The first digit identifies items as purchased with OPP funds ( R) or items purchased with funds from other organizations (H); 2) the next six digits represent the date the item was received: MMDDYY where MM=month, DD= day, and YY=the last two digits of the calendar year; 3) the next seven digits represent the expiration date of the item: EMMDDYY where E=expiration, MM=month, DD=day, and YY=the last two digits of the calendar year; and 4) the suffix where the digits after the dash act as a counter for the number of items received on the same date. b. For example, if the first item received and logged in on 10-31-16 has a manufacturer-assigned expiration date of 12-2018 (no day given so last day of the month is used), assign the control number R103116E123118-01. c. For additional items received on the same day, assign a control number with a consecutively-increasing suffix (e.g., -02, -03, etc.). ------- SOP No. QC-09-07 Date Revised 12-12-16 Page 5 of 6 d. If multiple quantities of the same item are received on the same day, add an alphabetical character to the suffix to differentiate the items. i. For example, if the first item received on 10-31-16 consisted of three identical containers of dehydrated media X, same lot and expiration date of 12/31/18, the control numbers assigned would be R103116E123118-01 A, R103116E123118-01B, andR103116E123118-01C. ii. The second items received on 10-31-16, consisting of two identical (i.e., same lot and expiration date of 05/31/18) containers of an alcohol, would be assigned the control numbers R103116E053118-02A and R103116E053118-02B. e. If an item does not have a manufacturer-assigned expiration date, assign an expiration date that is not greater than 5 years from the date the item was received. i. Test carriers (e.g., stainless steel discs or penicylinders, glass slides, etc.) are the exception to the expiration date requirement. Assign an expiration date of "E000000" to test carriers. A shipment of glass slides received on 11/30/16 would be assigned the control number R113016E000000-01. f. Record the control number directly on the item or its packaging, or record it on a label and affix it to the item. 12.3 Items Found in Laboratory with No Control Number a. If a tracked laboratory material is discovered to have no control number, an attempt should be made to assign one. b. Begin by searching vendor packing slips, purchase records, or other information to identify the date the item was received. c. If a date received is established, assign a control number to the item using this information. Determine the expiration date and suffix components of the control number as per section 12.2. d. If no date received information is available, the item may be used if it is labeled with a manufacturer-assigned expiration date (e.g., 12/31/18). In this case, a control number is assigned using the current date (e.g., R103116E123118-04). Make a note of the control number assignment and place it in the notebook containing the current packing slips. The item may be used until the expiration date. e. If no date received or expiration date can be determined, the item is discarded. 12.4 Changes to Control a. In the event that a control number was incorrectly assigned or entered incorrectly into OMLIMS, analyst(s) with OMLIMS access should ------- SOP No. QC-09-07 Date Revised 12-12-16 Page 6 of 6 Numbers correct the control number on the item and in the database immediately upon discovery of the error. b. Items for which there is no manufacturer-assigned expiration date (see section 12.2.e) may be evaluated once the laboratory-assigned expiration date is reached. If the laboratory determines that the quality of the item is not compromised (e.g., not damaged, no precipitate or color change evident, etc.) and further use of the item is anticipated, analysts may change the control number to assign a new expiration date, as long as the newly assigned expiration date is not greater than five years after the date that the item was received. Change the control number on both the item and in OMLIMS. i. Test carriers (e.g., stainless steel discs or penicylinders, glass slides, etc.) are the exception to the five-year maximum expiration date. The expiration date for these items may be extended as needed for testing purposes. c. When changing control numbers recorded on items, strike through the portion of the old number which has changed and write the new set of numbers above it. Write the analyst's initials next to the new set of numbers to document the originator of the change to the control number. 12.5 Monthly OMLIMS Reports a. Reports containing information on items received, expired, and soon- to-be expiring (see section 14) can be generated from the OMLIMS database if required for inventory management. b. The analyst in charge of entering information into OMLIMS will, at a minimum, generate and archive the Laboratory Supplies which Will Expire Within 30 Days of a Particular Date report for the purpose of inventory management. 13. Data Analysis/ Calculations None 14. Forms and Data Sheets Examples of Reports: Laboratory Supplies Received Report Laboratory Supplies Which Will Expire Within 30 Days of a Particular Date 15. References None ------- |