Page 1 of 16 Attachment 2 Exhibit 351 INFECTION CONTROL ...

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Page 1 of 16 Attachment 2 Exhibit 351 INFECTION CONTROL ...

infection control practices comply with generally accepted standards of practice/national guidelines. If theASC neither selected any nationally recognized guidelines nor complies with generally accepted infectioncontrol standards of practice, then the ASC should be cited for a condition-level deficiency related to 42 CFR416.5117) Does the ASC have a licensed health care professional qualified through training in infection control anddesignated to direct the ASC’s infection control program?1 YES 2 NONOTE! If the ASC cannot document that it has designated a qualified professional with training (notnecessarily certification) in infection control to direct its infection control program, a deficiency relatedto 42 CFR 416.51(b)(1) must be cited. Lack of a designated professional responsible for infectioncontrol should be considered for citation of a condition-level deficiency related to 42 CFR 416.51.If YES,17a) is this person an: (check only ONE):1 ASC employee2 ASC contractor_____________________________________17b) Is this person certified in infection control (i.e., CIC) (Note: §416.50(b)(1) does not require thatthe individual be certified in infection control.)1 YES 2 NO17c) If this person is NOT certified in infection control, what type of infection control training has thisperson received? ___________________________________________________________17d) On average how many hours per week does this person spend in the ASC directing the infectioncontrol program? (Note: §416.51(b)(1) does not specify the amount of time the person mustspend in the ASC directing the infection control program, but it is expected that the designatedindividual spends sufficient time on-site directing the program, taking into consideration the sizeof the ASC and the volume of its surgical activity.)__________________________________________________________18) Does the ASC have a system to actively identify infections that may have been related to proceduresperformed at the ASC? 1 YES 2 NO18a) If YES, how does the ASC obtain this information? (Check ALL that apply)1 The ASC sends e-mails to patients after discharge2 The ASC follows-up with their patients’ primary care providers after discharge3 The ASC relies on the physician performing the procedure to obtain this information at afollow-up visit after discharge, and report it to the ASC4 Other (please specify):Page 4 of 16


18b) Is there supporting documentation confirming this tracking activity?1 YES 2 NONOTE! If the ASC does not have an identification system, a deficiency related to 42 CFR 416.44(a)(3)and 42 CFR 416.51(b)(3) must be cited.18c) Does the ASC have a policy/procedure in place to comply with State notifiable disease reportingrequirements?1 YES 2 NONOTE! If the ASC does not have a reporting system, a deficiency must be cited related to 42 CFR416.44(a)(3). CMS does not specify the means for reporting; generally this would be done by theState health agency.19) Do staff members receive infection control training? 1 YES 2 NOIf YES,19a) How do they receive infection control training (check all that apply)?1 In-service2 Computer-based training3 Other (specify):________________________________19b) Which staff members receive infection control training? (check all that apply):1 Medical staff2 Nursing staff3 Other staff providing direct patient care4 Staff responsible for on-site sterilization/high-level disinfection5 Cleaning staff6 Other (specify):________________________________19c) Is training:1 the same for all categories of staff2 different for different categories of staff19d) Indicate frequency of staff infection control training (check all that apply):1 Upon hire2 Annually3 Periodically/as needed4 Other (specify):________________________________19d) Is there documentation confirming that training is provided to all categories of staff listed above?1 YES 2 NOPage 5 of 16


NOTE! If training is not provided to appropriate staff upon hire/granting of privileges, with somerefresher training thereafter, a deficiency must be cited in relation to 42 CFR 416.51(b)and (b)(3). Iftraining is completely absent, then consideration should be given to condition-level citation in relationto 42 CFR 416.51, particularly when the ASC’s practices fail to comply with infection control standardsof practice.20) How many procedures were observed during the site visit: a 1 b 2 c 3 d 4 e OtherIf other, please specify the number:_____________________________Page 6 of 16


PART 2 – INFECTION CONTROL & RELATED PRACTICESInstructions:• Circle the applicable response, as well as information on the manner in which information wasobtained• Unless otherwise indicated, a “No” response to any question below must be cited as a deficientpractice in relation to 42 CFR 416.51(a).• If N/A is circled, please explain why there is no associated observation, or why the question is notapplicableI. Hand HygieneAdditional Instructions:• Observations are to focus on staff directly involved in patient care (e.g., physicians, nurses,CRNAs, etc.). Hand hygiene should be observed not only during the case being followed, but alsowhile making other observations in the ASC throughout the survey. Interviews are used primarily toprovide additional evidence for what the surveyor has observed, but may in some cases substitutefor direct observation to support a citation of deficient practice.Practices to be AssessedA. All patient care areas have:Note: 42 CFR 416.51(a) should be citedonly if the answer to both a and b is “No.”a. Soap and water availableb. Alcohol-based hand rubsavailableI. If alcohol-based hand rub isavailable in patient careareas, it is installed asrequiredB. Staff perform hand hygiene:a. After removing glovesb. After direct patient contactc. Before performing invasiveprocedures (e.g., placing an IV)d. After contact with blood, body fluids,or contaminated surfaces (even ifgloves are worn)Was practiceperformed?1 Yes 2 No1 Yes 2 No1 Yes 2 No1 Yes 2 No 3 N/A1 Yes 2 No 3 N/A1 Yes 2 No 3 N/A1 Yes 2 No 3 N/AManner of confirmation4Observation 5Interview 6Both4Observation 5Interview 6BothThere are LSC requirementsat 42 CFR 416.44(b)(5) forinstallation of alcohol-basedhand rubs4Observation 5Interview 6Both4Observation 5Interview 6Both4Observation 5Interview 6Both4Observation 5Interview 6BothPage 7 of 16


C. Regarding gloves, staff:a. Wear gloves for procedures thatmight involve contact with bloodor body fluidsb. Wear gloves when handlingpotentially contaminated patientequipmentc. Remove gloves before moving tothe next task and/or patient1 Yes 2 No 3 N/A1 Yes 2 No 3 N/A1 Yes 2 No 3 N/A4Observation 5Interview 6Both4Observation 5Interview 6Both4Observation 5Interview 6BothD. Additional breaches in hand hygiene,not captured by the questions abovewere identified (If YES, please specifyfurther in comments)Comments:1 Yes 2 No 3 N/A 4Observation 5Interview 6BothII. Injection Practices (injectable medications, saline, other infusates)Additional Instructions:Observations are to be made of staff who prepare and administer medications and performinjections (e.g., anesthesiologists, certified registered nurse anesthetists, nurses)..Practices to be AssessedWas practiceManner of confirmationperformed?A. Needles are used for only one patient 1 Yes 2 No 3 N/A 4Observation 5Interview 6BothB. Syringes are used for only onepatientC. Medication vials are always enteredwith a new needleD. Medication vials are always enteredwith a new syringeE.. Medications that are pre-drawn arelabeled with the time of draw, initials ofthe person drawing, medication name,strength, and expiration date or timeNote: A “No” answer should result incitation as a deficient practice in relationto 42 CFR 416.48(a), Administration ofDrugs1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6BothPage 8 of 16


F.a. Single dose (single-use)medication vials are used for onlyone patient (A “No” responsemust be cited in relation to 42CFR 416.48(a).)1 Yes 2 No 3 N/A4Observation 5Interview 6Bothb. Manufactured prefilled syringesare used for only one patient1 Yes 2 No 3 N/A4Observation 5Interview 6Bothc. Bags of IV solution are used foronly one patient1 Yes 2 No 3 N/A4Observation 5Interview 6Bothd. Medication administration tubingand connectors are used for onlyone patient1 Yes 2 No 3 N/A4Observation 5Interview 6BothG. List all injectable medications/infusates that are in a vial/container used for more than one patient:Name of MedicationAverage number of patients per vial/containerH. Multi-dose injectable medications areused for only one patient (Note: a “No”answer here is not necessarily a breachin infection control and does not result ina citation. However, a “No” response tothe related questions I – K should becited.Circle N/A if no multi-dosemedications/infusates are used.)If YES, please skip to “L”If NO, please answer “I-K”:I. The rubber septum on a multidosevial used for more than onepatient is disinfected with alcohol prior toeach entry1 Yes 2 No 3 N/A1 Yes 2 No 3 N/A4Observation 5Interview 6Both4Observation 5Interview 6BothPage 9 of 16


J. Multi-dose medications used formore than one patient are dated whenthey are first opened and discardedwithin 28 days of opening or according tomanufacturer’s recommendations,whichever comes first1 Yes 2 No 3 N/A4Observation 5Interview 6BothK. Multi-dose medications, usedfor more than one patient, are notstored or accessed in the immediateareas where direct patient contact occursL. All sharps are disposed of in apuncture-resistant sharps containerM. Sharps containers are replaced whenthe fill line is reachedN. Additional breaches in injectionpractices, not captured by the questionsabove were identified (If YES, pleasespecify further in comments)Comments:1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6BothIII. Single Use Devices, Sterilization, and High-level DisinfectionAdditional instructions:Pre-cleaning must always be performed prior to sterilization and high-level disinfectionSterilization must be performed for critical equipment (i.e., instruments and equipment that enternormally sterile tissue or the vascular system, such as surgical instruments)High-level disinfection must be performed for semi-critical equipment (i.e., items that come intocontact with non-intact skin or mucous membranes such as reusable flexible endoscopes,laryngoscope blades)Observations are to be made of staff who perform equipment reprocessing (e.g., surgicaltechs), unless these activities are performed under contract or arrangement off-site from theASC.Page 10 of 16


SINGLE-USE DEVICESPractices to be AssessedWas practiceperformed?A. If single-use devices are reprocessed,they are devices that are:a. Approved by the FDA for1 Yes 2 No 3 N/AreprocessingManner of confirmation4Observation 5Interview 6Bothb. Reprocessed by an FDA-approvedreprocessor.(Choose N/A if single-use devices arenever reprocessed and used again)(Surveyor to confirm there is a contractor other documentation of anarrangement with a reprocessing facilityby viewing it)1 Yes 2 No 3 N/A4Observation 5Interview 6BothSTERILIZATIONPractices to be AssessedWas practiceManner of confirmationperformed?A. Critical equipment is sterilized 1 Yes 2 No 3 N/A 4Observation 5Interview 6BothB. Are sterilization proceduresperformed on-site?1 Yes 2 No 3 N/A 4Observation 5Interview 6Both(If NO, Skip to “F”)(A “No” answer does not result in acitation, since ASCs are permitted toprovide for sterilization off-site, under acontractual arrangement.)(Surveyor to confirm there is a contractor other documentation of anarrangement for off-site sterilization byviewing it)IF YES,Please indicate method of sterilization,Steam autoclavePeracetic acidOther (specify): _______________C. Items are pre-cleaned according tomanufacturer’s instructions or evidencebasedguidelines prior to sterilization1 Yes 2 No 3 N/A 4Observation 5Interview 6BothPage 11 of 16


D.a. Medical devices andinstruments are visuallyinspected for residual soil andre-cleaned as needed beforepackaging and sterilization1 Yes 2 No 3 N/A4Observation 5Interview 6Bothb. A chemical indicator is placed ineach load1 Yes 2 No 3 N/A4Observation 5Interview 6Bothc. A biologic indicator is performedat least weekly and with allimplantable loads1 Yes 2 No 3 N/A4Observation 5Interview 6Bothd. Each load is monitored withmechanical indicators (e.g., time,temperature, pressure)1 Yes 2 No 3 N/A4Observation 5Interview 6Bothe. Documentation for each piece ofsterilization equipment ismaintained and up to date andincludes results from each loadE. Items are appropriately contained andhandled during the sterilization processto assure that sterility is notcompromised prior to useF. After sterilization, medical devicesand instruments are stored in adesignated clean area so that sterility isnot compromisedG. Sterile packages are inspected forintegrity and compromised packages arereprocessedH. Additional breaches in sterilizationpractices, not captured by the questionsabove were identified (If YES, pleasespecify further in comments)Comments:1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6BothPage 12 of 16


HIGH-LEVEL DISINFECTIONPractices to be AssessedWas practiceManner of confirmationperformed?A. Semi-critical equipment is high-level 1 Yes 2 No 3 N/A 4Observation 5Interview 6Bothdisinfected or sterilizedB. Is high-level disinfection performedon-site?1 Yes 2 No 3 N/A4Observation 5Interview 6Both(If NO, Skip to “F”)(A “No” answer does not result in acitation, since ASCs are permitted toprovide for high-level disinfection off-site,under a contractual arrangement.)(Surveyor to confirm there is a contractor other documentation of anarrangement for off-site sterilization byviewing it)If YES,Please indicate method of high-leveldisinfection,4Observation 5Interview 6Both1 Manual2 Automated3 Other (specify): _______________C. Items are pre-cleaned according tomanufacturer’s instructions or evidencebasedguidelines prior to high-leveldisinfection1 Yes 2 No 3 N/A 4Observation 5Interview 6BothPage 13 of 16


D.a. Medical devices andinstruments are visuallyinspected for residual soil andre-cleaned as needed beforehigh-level disinfection1 Yes 2 No 3 N/A4Observation 5Interview 6Bothb. High-level disinfection equipmentis maintained according tomanufacturer instructions1 Yes 2 No 3 N/A4Observation 5Interview 6Bothc. Chemicals used for high-leveldisinfection are:I. Prepared according tomanufacturer instructions1 Yes 2 No 3 N/A4Observation 5Interview 6BothII. Tested for appropriateconcentration according tomanufacturer’s instructions1 Yes 2 No 3 N/A4Observation 5Interview 6BothIII. Replaced according tomanufacturer’s instructions1 Yes 2 No 3 N/A4Observation 5Interview 6BothIV. Documented to have beenprepared and replacedaccording to manufacturer’sinstructions1 Yes 2 No 3 N/A4Observation 5Interview 6Bothd. Instruments requiring high-leveldisinfection are:I. Disinfected for the appropriatelength of time as specified bymanufacturer’s instructions orevidence-based guidelines1 Yes 2 No 3 N/A4Observation 5Interview 6BothII. Disinfected at the appropriatetemperature as specified bymanufacturer’s instructions orevidence-based guidelines1 Yes 2 No 3 N/A4Observation 5Interview 6BothE. Items that undergo high-leveldisinfection are allowed to dry before useF. Following high-level disinfection,items are stored in a designated cleanarea in a manner to preventcontaminationG. Additional breaches in high leveldisinfection practices, not captured bythe questions above were identified (IfYES, please specify further in comments)1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6BothPage 14 of 16


Comments:IV. Environmental Infection ControlAdditional Instructions:Observations are to be made of staff who perform environmental cleaning (e.g., surgicaltechnicians, cleaning staff, etc.)Practices to be AssessedA. Operating rooms are cleaned anddisinfected after each surgical or invasiveprocedure with an EPA-registereddisinfectantB. Operating rooms are terminallycleaned dailyC. High-touch surfaces in patient careareas are cleaned and disinfected withan EPA-registered disinfectantD. The ASC has a procedure in place todecontaminate gross spills of bloodE. Additional breaches in environmentalcleaning not captured by the questionsabove were identified (If YES, pleasespecify further in comments)Comments:Was practiceManner of confirmationperformed?1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6BothV. Point of Care Devices (e.g., blood glucose meter)Additional instructions:Observations are to be made of staff who perform fingerstick testing (e.g., nurses)If N/A is circled, please clarify why it was not applicable or not observed.Page 15 of 16


Practices to be AssessedDoes the ASC have a blood glucosemeter?1Yes___ 2 No___ (If NO, STOP HERE)Was practiceperformed?Manner of confirmationA. A new single-use, auto-disablinglancing device is used for each patientB. The glucose meter is not used onmore than one patient unless themanufacturer’s instructions indicate thisis permissible.C. The glucose meter is cleaned anddisinfected after every use.D. Additional breaches in appropriateuse of point of care devices (like glucosemeters) not captured by the questionsabove were identified (If YES, pleasespecify further in comments)Comments:1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6Both1 Yes 2 No 3 N/A 4Observation 5Interview 6BothPage 16 of 16

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