SAMDaily.us | SRCSGT | H | Testing of Sterile Compounding Areas

SAMDAILY.US - ISSUE OF OCTOBER 19, 2024 SAM #8362
SOURCES SOUGHT

H -- Testing of Sterile Compounding Areas

Notice Date: 10/17/2024 11:42:49 AM
Notice Type: Sources Sought
NAICS: 541380 — Testing Laboratories
Contracting Office: 242-NETWORK CONTRACT OFFICE 02 (36C242) ALBANY NY 12208 USA
ZIP Code: 12208
Solicitation Number: 36C24225Q0067
Response Due: 10/24/2024 9:00:00 AM
Archive Date: 11/23/2024
Point of Contact: Lee Kern, Contract Specialist, Phone: 228-523-5000
E-Mail Address: Lee.Kern@va.gov
(Lee.Kern@va.gov)
Awardee: null
Description: The Department of Veterans Affairs Network Contracting Office 2 is issuing this source sought synopsis as a means of conducting market research to identify parties having an interest in and the resources providing Testing of Sterile Compounding Areas at the Northport VAMC, 79 Middleville Road , Northport, NY 11768. The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 541380. The VA requires a 12-month base year, plus four 12-month options contract. This contract will be inclusive of all labor, materials, equipment, and travel (within 2 hours) to perform initial and recurring certification of the facility s sterile compounding areas. BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FOR SMALL BUSINESSES OR PROCURED THROUGH FULL AND OPEN COMPETITION. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. Submission Instructions: Interested parties who consider themselves qualified to perform the above listed services are invited to submit a response to this Sources Sought Notice by October 24, 2024, at 12:00PM EST. All responses under this Sources Sought Notice must be emailed to Lee.Kern@va.gov. Please see the below Statement of Work (SOW): STATEMENT OF WORK Testing of Sterile Compounding Areas INTRODUCTION United States Pharmacopeia (USP) establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of compounded sterile preparations (CSPs). To maintain compliance with these standards, Northport VAMC requires a Base plus four (4) year contract inclusive of all labor, materials, equipment, and travel (within 2 hours) to perform initial and recurring certification of the facility s sterile compounding areas. Certification and testing will consist of: testing all primary engineering controls [(PECs) e.g., biological safety cabinets (BSCs), laminar airflow workbenches (LAFWs), compounding aseptic containment isolators (CACI), and compounding aseptic isolators (CAI)] testing all secondary engineering controls (SECs), non-ISO rated controlled non-classified (CNC) rooms, and High-efficiency particulate air (HEPA) filtration devices. microbiological laboratory testing of collected viables samples. wipe sampling for environmental Hazardous Drug (HD) residue Testing and certification must be completed in accordance with the most currently published versions of USP Chapter , USP Chapter , Controlled Environment Testing Association (CETA) Application Guides for: CAG-003 Certification of Sterile Compounding Facilities for USP Compliance, CAG-002 Compounding Isolator Testing, CAG-008 Certification Matrix for Sterile & Nonsterile USP Compounding Facilities, CAG-009 Viable Environmental Monitoring for Sterile Compounding Facilities, CAG-014 Airflow Visualization Study, National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49 Biosafety Cabinetry, and Institute of Flow Clean Air Devices, IEST-RP-CC-002.4. All lab analysis of viable samples must be performed by a facility with ISO/IEC 17025 accreditation for microbial analysis. This environmental quality testing may not be performed under the laboratory s Clinical Laboratory Improvement Amendments (CLIA) license. The lab must attain ISO/IEC 17025 certification from an external accrediting body (e.g., American Association for Laboratory Accreditation ) to ensure quality and accuracy of the testing. BACKGROUND. Northport VAMC is pursuing a facility contract for certification of all PECs, SECs, CNC rooms, and HEPA filters must be performed pursuant to the most current version of USP Chapter and USP Chapter standards following CETA s standardized testing procedures which include (but is not limited to) CAG-003 CETA Certification Guide for Sterile Compounding Facilities for USP Compliance, CAG-002 CETA Compounding Isolator Testing Guide, CAG-014 Airflow Visualization Study, and CAG-009 Viable Environmental Monitoring for Sterile Compounding Facilities. Certification must be performed every 6 months. Recertification will be required after any servicing of facilities or equipment, post changes to the area that could affect airflow or air quality ( e.g., redesign, construction, replacement or relocation of any PEC, or alteration in the configuration of the room), and/or in response to identified problems or trends. Certification procedures defined in relevant CETA Application Guides must be performed no less than every 6 months by an individual who has the required CETA competencies and training related to the certification of primary and secondary engineering controls. Additionally, it is preferred that the on-site certification individual have received NSF accreditation for the field certification of Class II Biosafety Cabinets and are accredited through CNBT as a registered certification professional in the sterile compounding facility (RCP-SCF). Prior to testing, the contractor s technician(s) who conduct on-site certification will provide, to the COR, documentation of competency and training related to the certification of PECs and SECs. Procedures for air and surface sampling and evaluation must be compliant as per the most current USP Chapter 797 requirements for environmental air sampling, surface sampling (CAG-009), gloved fingertip testing (CAG-011), and media fill testing (CAG-013) following the appropriate CETA CAG application guide. Northport VAMC s sterile compounding areas and equipment must be compliant to The Joint Commission (TJC) and Food and Drug Administration (FDA) requirements. TJC Medication Compounding Requirements for Critical Access Hospitals and Hospitals, effective January 1, 2024, established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. The FDA has the authority to inspect VA medical facilities under the Food, Drug and Cosmetic Act, and evaluate based upon the guidance provided in the Insanitary Conditions at Compounding Facilities Guidance for Industry, November 2020 (or most current version). SCOPE Testing Frequency. The Northport VAMC has a requirement for onsite initial and reoccurring CETA certification and viable environmental sampling of the facility s Pharmacy-specific and non-Pharmacy specific areas and equipment as detailed within this Statement of Work (SOW). Testing and certification dates contained within this SOW are best documented; Contractor shall be responsible to confirm and/or adjust certification/testing requirements to ensure no lapse in requirements and thus no undesirable effect on the mission of the Northport VAMC. All pharmacy-specific equipment will minimally obtain CETA certification every six (6) calendar months from the date of the last certification/testing of BSCs, LAFWs, CAI, CACI, HEPA filters, and room spaces/environments in accordance with VHA Directive 1108.12 (see attachment A), and USP 797 (Attachment B) & 800 (Attachment C). Recertification may be required sooner if equipment is relocated/altered, or a major service is performed. Testing Locations. The following location shall be tested as per USP 797 and where applicable USP 800 standards as per respective CETA guide applications. Locations may be amended as per the facility s renovations and construction. Building 200, Unit 31 Cleanroom suite(s) Primary Space(s) and equipment ISO-8 Anteroom(s): Two ceiling mounted HEPA filters ISO-7 Buffer room(s) Two ceiling mounted HEPA filters One ISO-5 LAWF: Baker Edgegard 5252 LAWF Building 200, Inpatient: One ISO-5 Compounding Aseptic Isolator (CAI): Baker SS-500 Building 200, New pavilion 2F, E2-49 HD negative pressure storage room: One ceiling mounted HEPA filter CNC HD negative pressure C-SCA One ceiling mounted HEPA filter One ISO-5 HD negative pressure Compounding Aseptic Containment Isolator (CACI): Baker CS-500 GermFree Trailer (adjacent to building 11) - This location will be covered under this contract for monthly viable sampling and hazardous drug wipe sampling. Note: There is a separate contract which covers the semiannual CETA testing and viable sampling of the trailer. Testing Requirements of PECs. Biological safety cabinet (BSC): On-site certifications of the BSCs shall be tested to manufacturer specifications in accordance with the most recent version of NSF/ANSI Standard 49 Biosafety Cabinetry (as per CETA CAG-003:2022 section 8.2. through 8.2.5 application guide and CETA CAG-005:2007 (or most current versions) Compounding Aseptic Isolator (CAI) and Compounding Aseptic Containment Isolator (CACI): The contractor shall test and certify all CAIs and CACIs as per CETA CAG-003 sections 8.3 through 8.3.5 and in accordance with CETA CAG-002 guide application. Laminar Air Flow Workbench (LAFW): The contractor shall test and certify all LAFW as per CETA CAG-003:2022 section 8.4. through 8.4.6 application guide (or most current version) The contractor shall test and certify all PECs in accordance with the most current version of The Institute of Environmental Sciences and Technology (IEST)-RP-CC002 (Unidirectional Flow Clean-Air Devices), CETA CAG-003, and the manufacturer's specifications. The contractor shall record each individual face velocity reading and the average of those readings, the downstream concentration reading of the HEPA filter leak test and the results of the induction leak test and back streaming test All equipment used to certify PECs must be calibrated in accordance with IEST-RP-CC013 or manufacturer's recommendation and be NIST traceable where possible. Where applicable the list of tests for PECs includes, where applicable but not limited to the following: Air flow velocity profile Air flow visualization profile: dynamic smoke pattern testing (video recorded and provided to us on a thumb drive or made available for download on a secure website) for all primary engineering controls. Tester must utilize sufficient smoke to demonstrate unidirectional airflow at critical sites and sweeping action over and away from preparations. Prefilter check HEPA/ULPA filter leak integrity testing (must be performed upon installation and as part of certification) Induction leak integrity test and patching if necessary Electrical leakage and ground circuit resistance and polarity tests Preparation ingress and egress test where applicable Chamber pressure test Total airborne non-viable particle count testing in all classified areas performed under dynamic operating conditions For each PEC passing the required certification tests, the contractor supplies each unit with a certification tag or sticker displaying the following information: Company name and contact information. Unit make, model and serial number. Report number Location (e.g., building, room number, area identification) Certification date Recertification date Technician name and signature Any PEC that fails to meet CETA specifications shall be clearly marked with signage which alerts compounding personnel that the unit is out of order until further notice. Testing Requirements of SECs. The contractor will provide comprehensive cleanroom testing and certification services every 6 months, in the event of an environmental or engineering control excursion/exceedance or sooner if there are changes to the area such as redesign, construction, replacement or relocation of any PEC, or alteration in the configuration of the room that could affect airflow or air quality or if a cleanroom(s) did not meet compliance. Certification tests for rooms within a cleanroom suite include, but are not limited to: Airflow testing: HEPA filter(s) air volumes and velocities will be measured and documented as per CETA CAG-003:2022 section 8.1.1 application guide (or most current version) Airflow testing is performed to determine acceptability of the air velocity, the room air exchange rate, and the room pressure differential in doorways between adjacent rooms to ensure consistent airflow and that the appropriate quality of air is maintained under dynamic operating conditions. The contractor shall calculate the total room area and volume for each buffer room, anteroom, Containment segregated compounding area (C-SCA), and hazardous drug storage room. The ISO classification and a sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The report provided will specify flow rates detailing returns and supply that were obtained during the testing. The contractor shall calculate air changes per hour (ACPH) for each buffer and anteroom and include their findings in the report. ACPH for HVAC, ACPH contributed from PEC, and the total ACPH. Comparison of ACPH will be completed both for USP 797 standards as well as those referenced in the VHA HVAC Design Manual (Attachment D or earlier version if available), which are further stringent than USP Chapter 797. ISO Classified Turbulent Airflow Area Reporting and Documentation Record all airflow measurements and their corresponding filter or diffuser locations or grid identifications on a diagram Calculate and report room volume Calculate and report the average total room airflow volume Calculate and report the total air changes per hour of the room (include LAFW and/or Non-ducted BSC HEPA exhaust to room, where applicable) Report any correction factors used or deviations from the primary method Name of test (e.g., Room Airflow Analysis) Report acceptance criteria Provide a Pass or Fail statement based on the results of the test Non-ISO Classified Negative Pressure Turbulent Airflow Area Testing Procedure including ACPH requirements for containment segregated compounding areas and hazardous drug storage areas, must be a minimum of 12 exhaust ACPH. Because these rooms/areas are not ISO classified airflow measurements should be taken on the exhaust of negative pressure differential rooms. Non-ISO Classified Negative Pressure Turbulent Airflow Reporting and Documentation must include: Record all airflow measurements and their corresponding exhaust filter or exhaust grill locations Calculate and report room volume Calculate and report the average total room airflow volume Calculate and report the total air changes per hour of the room Report any correction factors used or deviations from the primary method Name of test (e.g., Unclassified Negative Pressure Room Airflow Analysis) Report acceptance criteria Provide a Pass or Fail statement based on the results of the test SEC HEPA filter integrity testing performed as per CETA CAG-003:2022 section 8.1.2 application guide (or most current version) Record upstream aerosol challenge concentration List method used to report concentration (measured or calculated) Record maximum leak penetration in percent Name of test (HEPA Filter Leak Test) Report acceptance criteria Provide a Pass or Fail statement based on the results of the test SEC Room Pressure Differential/Room Pressurization as per CETA CAG-003:2022 section 8.1.3 application guide (or most current version) The contractor shall include in their report differential pressure readings from each buffer room, anteroom, C-SCA, and Hazardous Drug (HD) storage rooms to all surrounding areas. The report shall indicate whether the area is required to be a negative or positive pressure location as per USP 797 and/or USP 800. All readings and acceptance criteria shall be documented to at least one thousandths of an inch water gauge or water column (e.g., 0.020 w.g. and not 0.02 w.g.) or one tenth of a pascal (e.g., 5.0 Pa). Pressure differentials will be reflected on a report showing the sketch of the room(s). SEC Room Pressure Reporting and Documentation Report room pressure differential relative to an adjacent room/space Report and compare performance of room pressure monitor Report whether smoke dispersed at entry doors follows correct direction Name of test (Room Pressure Differential Test) Report acceptance criteria Provide a Pass or Fail statement based on the results of the test Total airborne particle count testing (0.5 micron and larger) in all classified areas performed under dynamic operating conditions as per CETA CAG-003:2022 section 8.1.5 application guide (or most current version). Reporting shall be completed following ISO 14644-01 [2015] section 5.4 Test report and shall include the following: The name and address of the testing organization, and the date on which the test was performed The number and year of publication of this part of ISO 14644 (i.e., ISO 14644 1:2015) A clear identification of the physical location of the cleanroom or clean zone testing (including reference to adjacent areas if necessary), and specific designations for coordinates of all sampling locations (a diagrammatic representation can be helpful) The specified designation criteria for the cleanroom or clean zone, including the ISO Class number, the relevant occupancy state(s), and the considered particle size(s) Details of the test method used, with any special conditions relating to the test, or departures from the test method, and identification of the test instrument and its current calibration certificate The test results, including particle concentration data for all sampling locations Report acceptance criteria Provide a Pass or Fail statement based on the results of the test SEC Airflow Visualization Studies (AVS) - Visual Smoke Studies per CETA CAG-014 guide application SEC General Temperature and Moisture Tests to verify accuracy of monitoring devices as per CETA CAG-003:2022 section 8.1.7 application guide (or most current version) SEC Viable Sampling as per CETA CAG-003:2022 section 8.1.6 and CAG-009:2020 application guides Viable Sampling Testing All viable sampling will conform to USP 797 requirements and performed as per CETA CAG-009 application guide Viable Environmental Monitoring for Sterile Compounding Facilities Environmental Air Sampling. Biannually (every six months) the collection of environmental air samples will be performed by the contractor s CETA technician during certification and during negatively impactful incidents which require repeat air sampling as follows: whenever there is a change to the placement of equipment in the room or any other alteration within the cleanroom suite that affects the quality of the air. in response to identified problems and trends. in response to changes that could impact the sterile environment (changes in cleaning agents). Viable air sampling will be performed utilizing a calibrated high-volume impaction sampler during dynamic operating conditions Single plate TSA media which supports growth of both bacteria and fungi will be used to sample. A sufficient volume of air (1000 liters) shall be tested at each location to maximize sensitivity (samples of less than 1000 liters will not be acceptable) Positive and negative control plates will be included with sampled plates submitted by the contractor for analysis. Environmental Surface Sampling. Biannually (every six months) the collection of environmental surface samples will be performed by the contractor s CETA technician and during repeated CETA testing. Upon the request of the facility, the contractor will repeat surface sampling as follows: whenever, there is a change to the placement of equipment in the room or any other alteration within the cleanroom suite that affects the quality of the air. in response to identified problems and trends. in response to changes that could impact the sterile environment (changes in cleaning agents). Surface samples will be collected in each room, the interior of each PEC, passthrough chambers connecting to classified areas, and frequently touched surfaces (e.g., door, tables, carts, stools, benches, etc.) Surface sampling will be performed at the end of the largest CSP activity of the day but before area has been cleaned and disinfected. Single plate TSA media supplemented with neutralizing additives (e.g., lecithin and polysorbate 80) to neutralize the effects of any residual disinfecting agents will be used. Routine monthly surface sampling will be performed by an appointed trained Northport VAMC personnel. The collected samples will be shipped to the laboratory service employed by the contractor for incubation and microbiological analysis. As needed, appointed trained Northport VAMC personnel will collect surface samples within the PEC as a part of the competency assessment for assigned personnel. The collected samples will be shipped to the laboratory service employed by the contractor for incubation and microbiological analysis. Personnel Viable Sampling. The collection of personnel viable samples for competency testing will be performed by an appointed trained Northport VAMC personnel. The samples will be shipped to the laboratory service employed by the contractor for incubation and microbiological analysis when it is required for personnel competency assessment sampling as follows: Gloved Fingertip and Thumb (GFT) Testing Upon initial assignment compounding staff will be assessed, post hand hygiene and garbing, utilizing GFT samples in triplicate (three samples/hand) for analysis. Every six (6) months and thereafter compounding staff will be assessed, post hand hygiene and garbing, utilizing single collection of GFT samples (one sample/hand) will be collected for analysis post hand hygiene and garbing. Initially and every six (6) months thereafter compounding staff will be assessed for GFT during aseptic manipulations, utilizing single collection of GFT samples (one sample/hand) post media fill testing (MFT). Media Fill Test (MFT) Upon initial assignment and every six months thereafter, compounding staff will be assessed for aseptic manipulations utilizing USP 797 compliant media fill testing kits. Other Viable Sampling Requirements. The laboratory service employed by the contractor must be able to provide the following: Microbial growth media plates which are USP 797 compliant and include certificates of analysis (COA) from the manufacturer that verify the plates meet the expected growth promotion, pH, and sterilization requirements consistent with USP Chapter 797 contain TSA supplemented with neutralizing additives (lecithin and polysorbate 80) have a raised convex surface support both bacterial and fungal growth on the same plate for single media incubation Media fill testing (MFT) kits compliant to USP 797 and designed to simulate medium complexity (Category 2) sterile IV compounding. simulate low complexity (Category 1) sterile IV compounding. A chain of custody documenting each sample collected must be created and provided to the Northport VAMC . During self-sampling, which is performed by Northport VAMC, the contracted lab is responsible for providing a prepaid mailer for properly sending samples to the laboratory for testing. All samples shipped to the laboratory service must be incubated in accordance with current USP Chapter 797 requirements for duration and temperature. Additional Requirements for PECs and/or SECs Testing Any PEC or SEC that fails to meet CETA specifications shall be immediately reported directly to the site-identified point(s) of contact (POC) or appointed ad hoc. Areas where hazardous drug handling occurs will be tested by Environmental Wipe Sampling for Hazardous Drug (HD) Residue: Every 6 months, or more frequently as needed to verify contaminant, environmental wipe sampling for HD residue will be performed by an appointed trained Northport VAMC personnel. The collected samples will be shipped to the contractor s laboratory service for HD residue analysis. The kits used to complete HD wipe sampling must be verified prior to use to ensure the sensitivity and validity of the methods and reagents used to recover a specific percentage of known marker drugs. The hazardous drugs (HDs) to be tested will be determined by the facility and may include, but are not limited to: Cyclophosphamide Ifosfamide Fluorouracil Gemcitabine Methotrexate Platinum-containing drugs Taxane-based drugs On average 14 surface environmental HD wipe samples will be collected per testing date. The facility can elect to adjust the quantities of samples submitted as needed during investigative remediation. Routine environmental HD wipe sampling will include, at minimum, the following areas: Interior of containment primary engineering control (C-PEC) and any equipment contained inside the C-PEC. Pass-through chambers. Surfaces in staging or work areas near C-PEC. Areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging, and dispensing area). Areas immediately outside the hazardous drug buffer room or C-SCA. Areas designated for pharmacist end product verification (checking) / workstations. Hazardous drug storage areas (including refrigerators). Hazardous drug receiving areas. Patient administration areas. Competency of Technician Performing Testing CETA testing must be performed by a CNBT individual/company accredited to perform this work. The technician/contractor shall provide a copy of the individuals CETA credentials at time of offer. If, during the contract, a different individual(s) is designated by the contractor, the CETA certification credentials of the assigned individual(s) must be provided to the POC, CO, and COR prior to the start of work. To ensure accurate and reproducible sampling results, environmental viable sampling should be performed by a CETA CNBT technician or a trained technician competent in air and surface sampling procedures. Prior to sampling the contractor must provide the facility documentation records for the individuals training and competencies to perform sampling. Additional Contracting Requirements Certification periodicities shall be confirmed by contractor, post award, and adjusted as necessary to meet the needs of the Northport VAMC. Certification and testing shall conform to USP and OSHA standards. Technician will disinfect and sanitize all equipment brought into the cleanroom suite or segregated compounding area prior to entry (with PreEmpt® or Peridox® (or facility approved disinfectant cleaner), followed by sterile 70% isopropyl alcohol or as per current standard operating procedure for the cleanroom suite). Contractor will follow Northport VAMC s protocols for use of PPE in the classified spaces and understands the risks associated with facilities and equipment designed for storage and preparation of hazardous drugs. The contractor shall comply with Federal, State, and Local Laws, plus and federal regulations as applicable to the performance of this contract; to include USP Chapter 797 and USP Chapter 800. Contractor must obtain all necessary licenses and/or permits required to perform the work herein. Reporting Results for CETA Testing (including Viable Sampling) A General Report Documentation for all CETA test results must be provided via email directly to the COR (Contracting Officer Representative), Chief of Facility Management Services, Chief of Pharmacy Service, and to the Designated Compounding Pharmacist no later than one week after the testing is performed. The CETA report will be a comprehensive informative report of the certification process which will include a statement of compliance or non-compliance regarding the requirements and guidelines outlined respective to CETA Application Guide. The formal report will include as a minimum, but not limited to, the following items: Name, address, and contact information for the certifying organization also listing key personnel with appropriate accreditations including the name of CETA-certified technician performing the testing. Confirming remark that facility/equipment was tested in accordance with CETA CAG-003:2022 (or most current version) and any other applicable performance testing standard followed. The most current version of this CAG must be referenced. Note: USP 797 is not a certification specification. Explanation of test procedure used for data collection and justification for any deviations from established industry practices encountered during the certification process. A list of test equipment utilized in data collection. List shall include make, model, serial number, and calibration date. A copy of the current calibration documentation for each piece of equipment must be provided when requested. Required reporting values listed in each test section Type, make, model and serial number for each PEC tested Each PEC and SEC nonviable particulate counts (including sample volume and time) and ISO classification Measured air velocity data for PEC, including air flow in CFM, average and standard deviation of air velocity measurements and acceptance criteria PEC blower setting and pressure gauge reading (if any) For BSCs: measured downflow air velocity data, acceptance criteria and pass/fail result measured exhaust damper acceptance criteria and pass/fail result inflow velocity test method, measurements, and results Documentation of results for the video of the airflow smoke pattern test documenting unidirectional flow at critical sites in the PEC. Total Air Changes Per Hour (ACPH) for each SEC, with indication of ACPH supplied by the PECs Pressure differentials between each SEC and the anteroom/pharmacy Results of HEPA leak tests for all filters tested, as well as the results of any patching that was performed If leaks were detected and sealed, include a diagram showing approximate location of sealed leaks Prefilter type, size, and condition for each PEC SEC temperature and relative humidity Video recording of all smoke pattern testing (airflow and dynamic) Alarm test results (if any) A diagram of the areas tested, noting the approximate location of air and surface particle counts Any recommendations for HEPA replacement/HEPA lifespan Microbiological lab analysis reports must meet the following: The laboratory performing microbial analysis must be an American Association for Laboratory Accreditation (A2LA)-accredited laboratory with ISO/IEC 17025 certification for microbiological testing. All viable and non-viable analyzed sampling results must be provided via email directly to the Chief of Facility Management Services, Chief of Pharmacy Service, and to the Designated Compounding Pharmacist no later than 2 weeks after sampling is performed. At a minimum, the provided lab analysis report must include: The manufacturer, lot number, and expiration date for each media lot analyzed. Date and time sampling was performed. Comments indicating sampling under dynamic conditions. Sampling location(s), with a Site Map sketch identifying location of each sample obtained. Sampling type and incubation dates, temperature, and duration intervals. Quantitative number of discrete colonies of microorganisms on each media device as colony forming units (CFUs) of bacterial/fungal isolates. Results equal to or greater than the action level will require immediate notification to the facility s the POC(s). Recovered organisms identified to the genus level (The pharmacy must be notified of any microbial growth immediately after it is identified (no later than 48 hours after the report is received by the contractor from the laboratory). Determination of whether lab findings are actionable (e.g., acceptable/unacceptable as per USP 797). Response-Travel- Expense Considerations Response Time- The Contractor shall use commercially reasonable efforts to: Provide technical support via telephone to Northport VAMC on a 24/7, 365 days a year schedule. Respond by telephone to any report of a malfunction requiring repair within one hour of notification. Provide on-site support within 2 hours of notification unless prevented by unforeseen circumstanc...
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Place of Performance: Address: Department of Veteran Affairs Northport VAMC 79 Middleville Road, Northport, NY 11768, USA; Zip Code: 11768; Country: USA
Record: SN07243647-F 20241019/241017230115 (samdaily.us)
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H -- Testing of Sterile Compounding Areas