US Environmental Protection Agency Office of Pesticide Programs Office of Pesticide Programs Microbiology Laboratory Environmental Science Center, Ft. Meade, MD Standard Operating Procedure for Disinfectant Sample Login and Tracking SOP Number: COC-01-06 Date Revised: 06-18-12 ------- SOP No. COC-01-06 Date Revised 06-18-12 Page 1 of 17 EPA/OPP MICROBIOLOGY LABORATORY ESC, Ft. Meade, MD Standard Operating Procedure for Disinfectant Sample Login, Tracking, and Disposal SOP Number: COC-01-06 Date Revised: 06-18-12 Initiated By: Date: / / Print Name: Technical Review: QA Review: Approved By: Date: / / Print Name: Technical Staff Date: / / Print Name: QA Officer Date: / / Print Name: Branch Chief Date: / / Print Name: Safety, Health, and Environmental Management Office Effective Date: Controlled Copy No.: Withdrawn By: / / Date: / / ------- SOP No. COC-01-06 Date Revised 06-18-12 Page 2 of 17 TABLE OF CONTENTS Contents Page Number 1.0 SCOPE AND APPLICATION 3 2.0 DEFINITIONS 3 3.0 HEALTH AND SAFETY 3 4.0 CAUTIONS 3 5.0 INTERFERENCES 4 6.0 PERSONNEL QUALIFICATIONS 4 7.0 SPECIAL APPARATUS AND MATERIALS 4 8.0 INSTRUMENT OR METHOD CALIBRATION 4 9.0 SAMPLE HANDLING AND STORAGE 5 10.0 PROCEDURE AM) ANALYSIS 5 11.0 DATA ANALYSIS/CALCULATIONS 9 12.0 DATA MANAGEMENT/RECORDS MANAGEMENT 9 13.0 QUALITY CONTROL 9 14.0 NONCONFORMANCE AND CORRECTIVE ACTION 9 15.0 REFERENCES 9 16.0 FORMS AM) DATA SHEETS 9 ------- SOP No. COC-01-06 Date Revised 06-18-12 Page 3 of 17 1.0 SCOPE AND APPLICATION: 1.1 This protocol describes procedures used by the Microbiology Laboratory Branch for the login, tracking, and disposal of disinfectant samples. Documenting the receipt, storage, handling, use, and disposal of product samples is essential. Various chain-of-custody forms are used to document the movement of all product samples from sample collection through disposal. 2.0 DEFINITIONS: 2.1 Sample Custodian = Sample custodians are authorized to open shipping containers containing samples (including official samples and samples from sources other than official [inspector] collection, see 10.6), inspect a sample, place and remove samples from the sample storage area, record chain-of-custody information, prepare product dilutions, and return samples to the storage area. 2.2 PPE = Personal Protective Equipment 2.3 Date of sample disposal (Forms 16.3 and 16.5) = Date that the sample is removed from chain of custody and declared as waste. 2.4 Declare a sample as waste (section 10.15.5) = Place sample in secondary containment and clearly label the secondary containment bin as "waste". See section 10.15.5 for additional information. 3.0 HEALTH AND SAFETY: 3.1 Follow precautions for storage and handling as stipulated by the product manufacturer. 3.2 Flammable samples are stored in locked flammable storage cabinets (room B204). 3.3 Wear appropriate PPE (lab coat, gloves, and safety glasses) while handling samples. Refer to Chapter 3 of the Chemical Hygiene Plan for additional information on PPE. 4.0 CAUTIONS: ------- SOP No. COC-01-06 Date Revised 06-18-12 Page 4 of 17 4.1 Condition of the primary shipping container, the product sample, and the chain- of-custody seal must be noted on the appropriate form. 4.2 Samples should be logged in and transferred to the storage facility as soon as possible by an official OPP Microbiology Laboratory sample custodian. Sample custodians are responsible for signing out samples for testing and returning the samples to the storage area following procedures outlined in this SOP. 5.0 INTERFERENCES: 5.1 Insufficient chain-of-custody documentation, illegible entries by the inspectors, or incorrect entries of sample identity by the inspectors may interfere with completion of the sample login process. Illegible, missing, or incorrect entries that may interfere with the completion of the sample login process are addressed by contacting the inspector for clarification. Deficiencies are documented. A written explanation by the inspector may be required. 5.2 Samples which arrive in poor condition (e.g., leaking) will not be accepted for analysis. The sample is disposed of following the specified procedures and the sender notified. For officially-collected samples, the inspector and the Office of Enforcement and Compliance Assurance (OECA) are notified to send replacement samples. 6.0 PERSONNEL QUALIFICATIONS: 6.1 Sample custodians for the laboratory have been identified in Section 16.7 below. Personnel may not be designated as sample custodians unless they have received training on this SOP. Training is conducted and documented as per SOP ADM- 04, Training. Refresher training is provided as needed. 6.2 Documentation of training and familiarization with this SOP can be found in the training file for each sample custodian. 7.0 SPECIAL APPARATUS AND MATERIALS: 7.1 Rooms B204 and D204 at EPA's Environmental Science Center have been designated as the secured storage sites for product samples. Flammable samples are stored in the locked flammable storage cabinet in room B204. All other samples are stored in room D204. The temperature and relative humidity of sample storage rooms are monitored by the computer-based Environmental Monitoring and Alarm System (see SOP QC-05, Monitoring Environmental Parameters.) ------- SOP No. COC-01-06 Date Revised 06-18-12 Page 5 of 17 8.0 INSTRUMENT OR METHOD CALIBRATION: Not applicable 9.0 SAMPLE HANDLING AND STORAGE: 9.1 Product samples are handled and maintained for testing per the conditions outlined below in the "Procedure and Analysis" section. 9.2 All samples must be in secondary containment. 9.3 Wear appropriate PPE while handling samples (see section 3.3). 10.0 PROCEDURE AND ANALYSIS: 10.1 Product samples are shipped to the Microbiology Laboratory to the attention of Michele Cottrill, USEPA, Environmental Science Center (ESC), 701 Mapes Road, Ft. Meade, MD 20755-5350. 10.2 Upon arrival at the ESC loading dock, loading dock personnel receive the sample and deliver it to the recipient. In the absence of the recipient, the package may be signed for by another staff member. However, only a sample custodian may open the box and initiate chain of custody forms. Loading dock personnel are required to date and initial the Shipping and Receiving Record for Disinfectant Products (see 16.1) in the appropriate block. 10.3 For a current list of sample custodians for the laboratory, see section 16.7. After each addition to or deletion from the list, an updated electronic copy of the list is be filed in the shared directory with the other forms associated with this SOP. 10.4 Each shipping container is inspected by a sample custodian for external structural damage, tampering, and evidence of leaks or spills. Any sign of damage, tampering, or leaks or spills is documented on the Shipping and Receiving Record for Disinfectant Products (see 16.1) and any chain-of-custody forms provided by the inspector. See section 5.2. A photograph is taken of the shipping container. 10.5 The shipping container is opened and the contents are inspected. The plastic bag and the chain-of-custody seals, if the product was received under seal, are closely inspected for damage or signs of tampering. Individual samples are inspected for leakage or damage by a sample custodian. The sample custodian will review the chain-of-custody documentation sent by the inspector, and if necessary apply signature and date of receipt. The sample custodian will review all paperwork ------- SOP No. COC-01-06 Date Revised 06-18-12 Page 6 of 17 sent by the inspector to identify any pertinent information such as lot number (see 10.7.11), sample expiration date, storage conditions, etc. Then, the sample custodian will initiate a History of Official Sample Form (EPA Form 3540-17) (see 16.2). A photograph is taken of the product sample. 10.6 For product samples which arrive from sources other than official inspector collection (for example, products purchased from the internet, direct shipment from the registrant, etc.), initiate chain of custody documentation beginning with the Shipping and Receiving Record for Disinfectant Products (section 10.2) through the History of Official Sample Form (section 10.7). Fill out the appropriate sections of the form. Take a photograph of the shipping container prior to opening. Take a photograph of the product sample after inspection. Place the sample container in a plastic bag, and seal. Fill out the official seal. 10.7 Correct and complete entry of information on the History of Official Sample Form is an essential component to the chain-of-custody documentation. One form is used per unique product sample number. The sample custodian who received the shipment may request another sample custodian to complete the History of Official Sample Form, as long as the sample custodian completing the Form performs the actual inspection of the shipping container and sample. For clarification purposes, follow the guidance for data entry for the specified fields listed below; fields #l-#4 are self-explanatory: 10.7.1 #5. DATE RECEIVED: Enter the date the shipment was received by the laboratory. This date is the same as the date entered on the Shipping and Receiving Record for Disinfectant Products. 10.7.2 #6. RECEIVED BY: The signature of the sample custodian responsible for receiving the shipment from the loading dock personnel is required; date of signature is also required. The sample custodian signing as the sample receiver may not necessarily be the individual who completes the History of Official Sample Form. 10.7.3 #7. RECEIVED FROM: Record the name of the ESC loading dock personnel and the person who actually shipped the package to the ESC (inspector, administrative assistant). 10.7.4 #8. SENT VIA: Enter the name of the shipping company and type of delivery. 10.7.5 #9. SAMPLE CONDITION: Record as Good or Poor; if Poor, describe the condition in detail in #15 REMARKS. ------- SOP No. COC-01-06 Date Revised 06-18-12 Page 7 of 17 10.7.6 #10. CONDITION OF SEALS: Record as Good, Poor, or No Seals (products from sources other than official collection); if Poor, describe the condition in detail in #15 REMARKS. 10.7.7 #11. SEALED BY: Enter the name which appears on the seals (the name should also appear on inspector's chain-of-custody paperwork). 10.7.8 #12. DATE SEALED: Enter the date taken from the seals. The seal date must be the date of collection specified on the inspector's chain-of- custody paperwork. If a sample was sealed on a date other than the date of collection, contact OECA for guidance. 10.7.9 #13. PIECES RECEIVED: Enter the number of seals and the number and type of product containers per seal. 10.7.10 #14. PLACE STORED: Enter the official sample storage room (B204 flammable cabinet for flammable samples or D204 for all others). 10.7.11 #15. REMARKS: Record notable items such as damaged samples, labeling clarification, special sample storage requirements, name of the sample custodian completing the History of Official Sample Form (if different from the individual in #6), and lot number. (Note: For official samples, record lot number on the History of Official Sample Form only if the inspector has recorded a lot number on his paperwork. Do not assume that codes imprinted on containers are lot numbers. If the inspector failed to record a lot number on his paperwork, the sample lot number is considered to be unknown. For samples received from sources other than official inspector collection, the lot number may be extrapolated from the labeling, paperwork accompanying the sample, sticker affixed to bottle, etc. as long as the number recorded is clearly a lot number.). 10.8 Sample collection and chain-of-custody information is maintained in the Disinfectant Product Field Chain-of-Custody Documentation from Inspector notebook. Deficiencies in paperwork accompanying the shipment (i.e. lack of field chain-of-custody papers) are documented. 10.9 Complete the Comprehensive Sample Log form (see 16.5). This log is stored in a notebook in room D217. Place the sample in the designated sample storage area. All samples must be in secondary containment. ------- SOP No. COC-01-06 Date Revised 06-18-12 Page 8 of 17 10.10 Prior to testing, a sample custodian initiates a Laboratory Chain-of-Custody Form (see 16.3) and a Chain-of Custody Seal Log (see 16.4) for each product sample received. 10.11 The Laboratory Chain-of-Custody Form is filled out whenever a product sample is removed from storage. 10.12 The product label is photocopied or photographed directly from a product container; a copy is filed in the Disinfectant Product Field Chain-of-Custody Documentation from Inspector notebook. In addition, sample numbers found on the product containers are photocopied; copies are filed in the Disinfectant Product Field Chain-of-Custody Documentation from Inspector notebook. 10.13 Broken chain-of-custody seals are retained on a Chain-of-Custody Seal Log (see 16.4). A new chain-of-custody seal is established on the sample as per the directions in the Pesticides Inspection Manual (see ref. 15.1). 10.14 The entire inventory of disinfectant samples is evaluated at the end of each quarter to determine the integrity of the COC seals, to inspect the sample containers for leakage, and assess samples for further retention. Replace any COC seal if it becomes compromised (e.g., torn or lack of adhesiveness) - archive the original COC seal in the seal log. Document the date of inspection, location of samples, the name of the person inspecting the samples, and findings/action items on the inspection log (see 16.6). 10.15 Consult with MLB management prior to sample disposal to ensure that all testing and client needs have been met. Process and dispose of samples that have expired, are leaking, or are no longer required to be maintained, according to the ESC's waste disposal practices. 10.15.1 For products to be disposed, remove the COC seal from the product, initial and date in the appropriate box, and place the seal in the Chain-of- Custody Seal Log. 10.15.2 Complete the "Product Disposal Information" section on the Laboratory Chain-of-Custody Form. Make an entry on the form to indicate that the sample was removed from storage room as in section 10.11, but note in the "Purpose of Removal" block that the sample was removed for disposal. 10.15.3 Note the date of disposal on the Comprehensive Sample Log. ------- SOP No. COC-01-06 Date Revised 06-18-12 Page 9 of 17 10.15.4 If the sample is in a plastic bag, remove the sample and discard the bag, if not compromised. 10.15.5 Once the COC paperwork is completed and the seal removed, place the sample in secondary containment, declare it as "waste", and contact the ESC Safety, Health and Environmental Management (SHEM) manager (x52681) or facility waste contractor (x52857) to request and arrange for a waste pick up and disposal. 11.0 DATA ANALYSIS/CALCULATIONS: None 12.0 DATA MANAGEMENT/RECORDS MANAGEMENT: 12.1 Data are recorded promptly, legibly, and in indelible ink on all forms. Completed forms are archived in notebooks kept in secured file cabinets in room D217. Only authorized personnel have access to the secured files. Archived data is subject to OPP's official retention schedule contained in SOP ADM-03, Records and Archives. 13.0 QUALITY CONTROL: 13.1 Timely, accurate, and legible sample information recorded in ink is required on all chain-of-custody documentation. 13.2 For quality control purposes, the required information is documented on the appropriate forms (see 16.0). 14.0 NONCONFORMANCE AND CORRECTIVE ACTION: 14.1 Any deviation from the protocol is documented. 14.2 Entry errors or entry omissions are corrected immediately upon discovery. 15.0 REFERENCES: 15.1 Pesticides Inspection Manual (Chapter 9) 2002. See http://www.epa.gov/oecaerth/resources/publications/monitoring/fifra/manuals/fifr amanual.pdf. 16.0 FORMS AND DATA SHEETS: 16.1 Shipping and Receiving Record for Disinfectant Product Samples Form ------- SOP No. COC-01-06 Date Revised 06-18-12 Page 10 of 17 16.2 History of Official Sample Form (EPA Form 3540-17) 16.3 Laboratory Chain-of-Custody Form 16.4 Chain-of-Custody Seal Log 16.5 Comprehensive Sample Log 16.6 Sample Inspection Log 16.7 Sample Custodians for the Laboratory ------- SOP No. COC-01-06 Date Revised 06-18-12 Page 11 of 17 16.1 Shipping and Receiving Record for Disinfectant Product Samples Form OPP Microbiology Laboratory Shipping and Receiving Record for Disinfectant Product Samples Loading Dock Personnel (Date/Initials): Loading Dock Personnel (Date/Initials): Shipping Container # of Date and Lime Received: Shipping Container # of Date and Lime Received: Received Bv: Received Bv: Received Lrom: Received Lrom: Lvpe of Delivery: Lvpe of Delivery: Lracking Number (if available): Lracking Number (if available): Sample Custodian (Date/Initials): Sample Custodian (Date/Initials): Condition of Primary Shipping Container: Product Name(s): Condition of Primary Shipping Container: Product Name(s): EPA Reg. No.(s): EPA Reg. No.(s): Sample Numbers: Sample Numbers: ------- SOP No. COC-01-06 Date Revised 06-18-12 Page 12 of 17 16.2 History of Official Sample Form (EPA Form 3540-17) PAGE 1 OF UNITED STATES 1. SAMPLE NO. 2, REGISTRATION NO. ENVIRONMENTAL PROTECTION AGENCY OEPA HISTORY OF OFFICIAL SAMPLE - 3. PRODUCT LABORATORY 4. LABORATORY 5. DATE RECEIVED 6. RECEIVED BY 7. RECEIVED FROM 8, SENT VIA 9. SAMPLE CONDITION 10. CONDITION OF SEALS 11, SEALED BY 13 PieCES RECEIVED 14, PLACE STORED IS. REMARKS EPA FORM 3540-17 (01-01) ------- SOP No. COC-01-06 Date Revised 06-18-12 Page 13 of 17 16.3 Laboratory Chain-of-Custody Form OPP Microbiology Laboratory Laboratory Chain of Custody Form Product Information: Product Disposal Information: EPA Rcs>. #: Date of Disposal: Product Name: Sample Custodian Initials: Sample #: Amount Disposed: Lot #: Reason for Disposal: Date Received: Date/Time Removed Sample Custodian Initials Removed From Purpose of Removal Amount Used (mL) Returned To Sample Custodian Initials Date/Time Returned ------- SOP No. COC-01-06 Date Revised 06-18-12 Page 14 of 17 16.4 Chain-of-Custody Seal Log OPP Microbiology Laboratory Chain-of-Custody Seal Log Product Information: Product EPA Reg. #: Product Name: Sample #: Date Product Received: / / Date/Initials Apply Seals Below (1 seal per row) ------- SOP No. COC-01-06 Date Revised 06-18-12 Page 15 of 17 16.5 Comprehensive Sample Log OPP Microbiology Laboratory Comprehensive Log for Samples Received or Purchased by Laboratory Calendar Year: Date Received Sample Custodian Initials * Name of Product Number of Containers EPA Reg. No. Control or Sample # Storage location **Program Date Disposed/ Initials * Add the Suffix P for Purchased Items ** ATP=Antimicrobial Testing Program, B=Biofilm, HS=Homeland Security, VTP=Virucidal Testing Program ------- SOP No. COC-01-06 Date Revised 06-18-12 Page 16 of 17 16.6 Sample Inspection Log OPP Microbiology Laboratory Sample Inspection Log Date of Inspection Location Initials of Person Inspecting Samples Findings/Action Items ------- 16.7 Sample Custodians for the Laboratory OPP Microbiology Laboratory 1. Michele Cottrill 2. Jason Duncan 3. Jafrul Hasan 4. Knoxley Japal 5. Rebecca Pines 6. Luisa Samalot-Freire 7. Stephen Tomasino 8. Kiran Verma 9. Michele Wingfield SOP No. COC-01-06 Date Revised 06-18-12 Page 17 of 17 ------- |