SPS Questions 231201

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School

Arizona Western College *

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Course

BIO-299

Subject

Information Systems

Date

Jan 9, 2024

Type

docx

Pages

2

Uploaded by RustyShackleford007

Report
1. VISN SPS Lead mentioned several times to Tomah that they should seek a review by a water expert. PCG report makes the same recommendation on all courses of action recommended. 1. PCG was contracted to bring in a water expert to give the Tomah VA recommendations for RO water & systems. PCG consulted multiple experts including Dr Herb Kaiser (Steris Principal Scientist and co- author/contributor to ST-108 & AAMI TIR-34) to provide consultation. Contribution(s), consultation and/or review were provided by Dr. Kaiser. 2. Deionization unit is in the wrong position for proper function in the system as shown on the line diagrams. The unit should be located after the RO unit and before the water is circulated per ST108. This was confirmed with a discussion with HEFP. 1. PCG will correct - this was only a typing error. (it is on supply side) 3. PCG reports that other stations are sanitizing their systems before testing. What is the time delay from the end of sanitization to pulling samples at other VISN sites? Is this in compliance with ST108? 1. Time Delay is 30 minutes between flushing and pulling samples at Jesse Brown and Zablocki 2. AAMI TIR 34 indicates samples should always be taken prior to sanitization or disinfection (see AAMI TIR 34 section D.3.2). 3. AAMI TIR 34 D.3.2 also indicates if repeat cultures are performed after the system has been disinfected the system should be flushed completely before samples are collected. 4. Both approaches (items 2 & 3 above) are acceptable. 5. ST108 and/or AAMI TIR 34 do not specify any time delay requirement(s) after sterilization. 4. The SOW in the report mentions that PCG will Identify problems in the RO System such as dead legs, flow rates, piping materials, temperature, filters, and equipment. However, there is no mention as to the verification that there are no dead legs, that the proper material were used as well as the proper connections and construction methods. There are no flow rate measurements provided to verify that the system meets the ST108 requirements. 1. RO System was reviewed and depicted in single line diagrams (appendix 4.6) no issue found. a. No Dead Legs identified. b. Flow Rates per ST108 are being reviewed and will be amended to the PCG report. c. Piping materials - will be amended to the PCG report. d. Temperatures - ST108 does not specify but actuals are being reviewed and will be amended to the PCG report.
e. Filters - depicted in single line diagrams and "types" will be amended to the PCG report. f. RO system Equipment - no changes recommended. 5. The report mentions diagrams of the proposed system at 35%, 65%, and 95% design. Was a replacement system designed, if so, were the drawings provided? 1. This was a "Study" (not Design) the existing system was reviewed, and no changes were recommended. 2. This study was to recommend a Design Modification if needed and it was not. a. RO System - all items reviewed - "Production of RO water" - no change recommended. 6. There is no mention in the report as to verification that the testing ports are located in the correct locations required and identification of any extraneous ports, if any. 1. Test Port Location are recommended by ST108 to be near equipment (so this is subjective) a. PCG reviewed port locations and no recommendation to change was made. b. 7. PCG provides additional testing results in the report, yet these test are not marked as to whether the samples passed or failed. 1. Test results in the report were in a chart on p.17 appendix 4.1 (see note at bottom) a. On 8/23 (2) tests were done b. will be clarified in amendment to the PCG report. c. Note: PCG will be doing one more test yet 8. Recommendations in the report follow the three procedures provided by the interviewees, however, there is no verification that these recommended procedures comply with the ST108. 1. ST108 recommends processes to "Validate" and "Qualify" a system. a. PCG recommendation do follow ST108 process guidelines. 9. Additional concerns not addressed by the report. a. Minimum required steam pressure for the sterilizers are not being meet, Dave Martin was following up on this. The station nor the report mentions anything on the status of this issue. a. VA Tomah is planning to provide increased pressure as needed in a separate project. 1. This was not in scope of this study because PCG was focused on RO System NOTE: ST108 was just published, TIR34 was governing doc during this review
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