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-09-06 Date Revised: 08-09-13 ------- SOP No. QC-09-06 Date Revised 08-09-13 Page 1 of 11 SOP Number QC-09-06 Title Establishment of Control Numbers and Tracking of Laboratory Supplies Scope This protocol describes the methods used to establish the control numbers for tracking chemicals, media, reagents and laboratory materials. 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Name: Quality Assurance Unit Print Name: Branch Chief Print Name: Date SOP issued: Controlled copy number: Date SOP withdrawn: ------- SOP No. QC-09-06 Date Revised 08-09-13 Page 2 of 11 TABLE OF CONTENTS Contents Page Number 1.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 7 ------- SOP No. QC-09-06 Date Revised 08-09-13 Page 3 of 11 1. Definitions 1. OMLIMS = OPP Microbiology Laboratory Information Management System 2. Chemicals = Includes materials such as acids, bases, alcohols, disinfectants, stains, 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. Laboratory materials = Includes organisms, test kits, and pre-sterilized supplies that have expiration dates (e.g., pipettes, tips, filter units). Pre- sterilized items that do not have expiration dates are not tracked in OMLIMS. 2. Health and Safety 1. Chemicals, media, reagents, and laboratory materials are handled 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. Chemicals, media, reagents, and laboratory 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 (see 14.1). 7. Interferences 1. Chemicals, media, reagents, and laboratory materials (see section 1.5) 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 1. In the event that a control number was incorrectly assigned or entered incorrectly into OMLIMS, the analyst should correct the control number ------- SOP No. QC-09-06 Date Revised 08-09-13 Page 4 of 11 Data on the item and in the database immediately as per section 12.4.a. 9. Data Management 1. Data will be archived consistent with SOP ADM-03, Records and Archives. 10. Cautions 1. To maintain consistency and accuracy in the OMLIMS database, it is preferable to limit access to one or two staff members. 11. Special Apparatus and Materials 1. The OMLIMS is written in Microsoft Access with the data and system stored on the G: drive (G:\Data\Shared\MLB\Omlims) at the Environmental Science Center, Fort Meade, MD. 12. Procedure and Analysis Chemicals, media, reagents, and laboratory materials (see section 1.5) are logged into the OMLIMS upon receipt and assigned a control number. 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) (see 14.1). 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 10-31-13 has a manufacturer-assigned expiration date of 12-2016 (no day given so last day of the month is used), assign the control number R103113E123116-01. c. For additional items received on the same day, assign a control number with a consecutively-increasing suffix (e.g., -02, -03, etc.). 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 10-31-13 consisted of three identical containers of dehydrated media X, same lot and expiration date of 12/31/16, the control numbers assigned ------- SOP No. QC-09-06 Date Revised 08-09-13 Page 5 of 11 would be R103113E123116-01 A, R103113E123116-01B, andR103113E123116-01C. ii. The second items received on 10-31-13, consisting of two identical (i.e., same lot and expiration date of 05/31/14) containers of an alcohol, would be assigned the control numbers R103113E053114-02A and R103113E053114-02B. 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. 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 chemical, media, reagent or 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., 12/31/16). In this case, a control number is assigned using the current date (e.g., R103113E123116-04). 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 Numbers a. In the event that a control number was incorrectly assigned or entered incorrectly into OMLIMS, analyst(s) with OMLIMS access should 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 ------- SOP No. QC-09-06 Date Revised 08-09-13 Page 6 of 11 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. 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 sections 14.2 through 14.4) can be generated from the OMLIMS database. The analyst in charge of entering information into OMLIMS will generate all necessary reports. b. Generate a report at the end of each month to identify all items received during the month (see 14.2). c. Generate a report at the end of each month to identify supplies by control numbers that have expired so that they will be discarded (see 14.3). d. Generate a report monthly to identify supplies by control number that will expire in the next 30 days. This report assists the laboratory in identifying supply items that may have to be ordered to keep the supply item in stock when existing stock expires (see 14.4). 13. Data Analysis/ Calculations None 14. Forms and Data Sheets Excerpts from OMLIMS: 1. Supply Data (OMLIMS) 2. Laboratory Supplies Received Report 3. Laboratory Supplies Which Expired On or Before a Particular Date 4. Laboratory Supplies Which Will Expire Within 30 Days of a Particular Date ------- SOP No. QC-09-06 Date Revised 08-09-13 Page 7 of 11 15. References None ------- SOP No. QC-09-06 Date Revised 08-09-13 Page 8 of 11 16.1 Supply Data (OMLIMS) D Supplies ~ _ H X Supply Ammonium Hydroxide Sterility ~ Storage RI v Order MoreAmt. Unit of Measure bottles) Stock M " 1 4 ~ ~1 Add Supply Delete Supply Save Supply Ex* Rec. Date Exp .Date R/H-88 Control No. Vendor Catalog No. lot No Amt. Storage Status Chim Room 3/8/1999 I 3/8/2009 R v 07 Sigma Aldrich A-6899 2SH3445 RT v Empty 602 B203 5/3/1999 5/3/2009 R v 02 Fisher Scientific NA 669-212 RT v Discarded @203 5/19/1999 5/19/2009 R v 04A Sigma Aldrich 22,122-8 09728LS RT v Discarded 8189 8203 5/19/1999 5/19/2009 R v 048 Sigma Aldrich 22,122-8 09728LS RT v Discarded v 8190 8203 3/9/2009 3/9/2019 R v 07A Sigma Aldrich 221228 02621LH RT v Full v 11234 8203 3/9/2009 3/9/2019 R v 078 SigmaAldrich 221228 02621LH RT v Full v 11235 8203 7/10/2013 7/11/2023 R v 002 H 4 ~ ~ 1 Add Stock Delete Stock Duplicate Stock Save Stock Record: h 1 o( 6 ~ N > Record: H < 27 of 613 ~ H t Search Search ------- SOP No. QC-09-06 Date Revised 08-09-13 Page 9 of 11 16.2 Laboratory Supplies Received Report OFF Microbiology Laboratory Supplies Received Control No. titppij VftiK&or Name Catalog; Mo. Lot NO. Room Storage CtHfTI •TO0713C06 3016-01 Pseycsomonss ¦= \ : r : = i ATCC 15*42 5® 134321 B204 Rr •i* R06aT13£015115-02 staphs to coccus ajseus ATCC 65-35 53-534359 S204 R~ m H051213EQ33111-01 PCS Pfiette CslisellonKl A lei PCS-60Q 32842 B202 RT K RQ&1213E033114-02 PCS Buk KR A«et PCS-211 39557 B2Q2 RT K H061313£®C6 13-01 Bran neat! r^js-ten Agar - ==:-=: =:= ns A&-6463 1$61 ©463 B201 RT C ¦R051713C043017-01A : -:'c - ¦=: = = = = t433*-600G 0000169162 B206 RT 0 13061713£Q43Q 17-016 Synineifc Brotv Klmedta = : : 5; M334-600G 0000169162 B206 RT 0 HOS2113E 022815-01 = "= = 5: SV30031 01 ^130011 6201 FR 0 RCH24135053115-01 - new 2.5^ = = = ---=-.- 3715-32 2305A91 mm RT 14054 ------- SOP No. QC-09-06 Date Revised 08-09-13 Page 10 of 11 16.3 Laboratory Supplies Which Expired On or Before a Particular Date OPP Microbiology Laboratory Supplies Which Have Expired Control Nb twp>plf vwMtor Nam* Qtlalof fto, Lot If®. Room Stewf® culm S«073'?E0F0F13-C)i 1 : :: :: : c::?-e i a;s22-25G (ammss Bim S.F 9«i ------- SOP No. QC-09-06 Date Revised 08-09-13 Page 11 of 11 16.4 Laboratory Supplies Which Will Expire Within 30 Days of a Particular Date GPP Microbiology Laboratory Supplies Which Will Expire Within 30 Days Control m. i-cc V Yindsr Hit® CiU :g Mr1 tut h: Rooci Glim «on: S050I Sffil : SOsli C-. " t ¦ SMpfBWtX Ptos XLOAgar ftnaerote Systems & fisher Selsnlfte e ~ = rfss In SoilEMbS HtW Pessue Se Cutum '=? i: e SC\1691049 AS-6463 35-6 02490 0d1 .if 'jq Od 1^ Fteher Scieril!»3 8201 ST MOSS -ciejcs 5201 ST C B2S4 = - 0 :::: :E B20i ft? 0 Sft 8204 SF J1G1B 5206 ST - B202 sr ;:¦ : ¥«34« BS06 ST 21600? 7 5207 ST 0 11*3516 B20* =E = 0 B20* SF 0 E82312 «22 13 3204 ST M:2€ =3:: : ¦: :: ST •i)r =i:i : ::: : ST : ¦.::: : ST '-.1: : :::: ST 14030 ------- |