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Lessons Learned from Recent TJC Surveys

Lessons Learned from Recent TJC Surveys. Kurt Patton, MS, RPh Jennifer Cowel, RN, MBA John R. Rosing, MHA, FACHE Patton Healthcare Consulting. Medication Orders. Preprocedure medications/IVs and testing nurse-initiated protocols are now permitted

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Lessons Learned from Recent TJC Surveys

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  1. Lessons Learned from Recent TJC Surveys Kurt Patton, MS, RPh Jennifer Cowel, RN, MBA John R. Rosing, MHA, FACHE Patton Healthcare Consulting

  2. Medication Orders • Preprocedure medications/IVs and testing nurse-initiated protocols are now permitted • Caveats: (create a policy) “Standing Orders” • Must be approved by the medical staff, nursing (to affirm the practice is within the scope of license) and pharmacy (with respect to medications) • Must be based on nationally recognized and evidence based guidelines and recommendations • Include regular PI review to look for problems or improvement opportunities • Date, time, and authenticate per state regulation

  3. CPOE and the Pre-OP/Post-OP Order • CPOE signing of post-operative anesthesia or surgical orders pre-operatively now requires a risk assessment and policy to avoid a finding • Got away with it on paper; could fudge or omit the time and not be noticed • CPOE captures the time, so an easy observation • The LIP must either pend or plan the orders and log back in and sign/ release/initiate the orders post-OP, OR • Sign orders pre-OP and justify via risk assessment and policy having the RN reassess the patient and release/initiate the order based on the very nature of conditional/PRN orders

  4. CPOE Pre/Post-Op Orders • Physicians and staff seek ways to expedite patient flow by writing post procedure orders before the procedure starts (sometimes hours, days, weeks). This is noble! • EHR/CPOE systems allow organizations to build standard order sets or pre-printed orders to reduce/eliminate redundant work and expedite care. Also noble!

  5. CPOE Pre/Post-Op Orders • The organization must decide whether it will allowing practitioners to write post-procedure orders prior to the procedure; if yes, then… • Construct a risk assessment and policy that defends a process where conditional orders (i.e., if this, then that/PRN orders) may be entered/written ahead of time by the LIP and then allow licensed/competent PACU RN to review the order post-OP AND match the order to the assessed needs of the patient • The RN then initiates or activates the order or consults with the ordering LIP if patient condition warrants/changes

  6. Medication Orders • Intraprocedure verbal orders for meds administered by a nurse need to be countersigned by LIP • On paper – sign the OR flow sheet/ MAR • eFlow Sheet or eMAR and goes to LIP inbox for electronic signature

  7. Pharmacy Review of Orders • Applies in PACU! • Prior to administration a pharmacist must review all medication orders for contraindication, allergies, proper dosing • Long felt to be a “physician controlled environment” - no longer • CPOE and standardized order sets facilitates prompt review and profiling for ready retrieval from ADM • May still override ADM for urgent needs so long as retrospective review and evaluation occurs

  8. Medication/Fluid Integrity • IV bag fluids and Irrigation bottle fluids • Pharmacy should establish and oversee ongoing • Cannot exceed 104 degrees F, check manufacturer • Wise to record a daily temp reading • IV bag in outer pouch: 14 days, • label with new, “do not use beyond” date • All are single use (i.e., no opened bottles)

  9. Label All Medications(NPSG.03.04.01) Label all meds on and off the sterile field. All products, including sterile water/saline, disinfectants in a basin must be labeled. The safety goal includes bedside procedures as well as IR, cath lab, out patient Its an A element of performance Prelabeling??? OK if your policy permits it

  10. Sentinel Event Alert #49Safe Opioid Use - Risk Factors • Hx of sleep apnea or snoring • Smoker • Morbid obesity • Older age (>80 has almost 9X > risk) • No recent opioid use///opioid habituation • Concomitant use of benzodiazepines, antihistamines, sedatives or other CNS depressants • Post surgical, notably abdominal///thoracic • Longer anesthesia times • Pre-existing pulmonary or cardiac disease

  11. Safe Opioid Use • State Board of Medicine – Massachusetts • 27 incident reports since 2007 • 77% concomitant morphine or lorazepam • 23% of patients were obese • 19% had sleep apnea • 15% asthma • 15% some other chronic respiratory condition • > age 60, female, most likely on night shift

  12. Safe Opioid Use – Actions Taken • Eliminate range orders for dose and time • Lower dose hydromorphone purchased • Eliminate Pyxis override for hydromorphone • Educate staff on 8:1 dose conversion between morphine and hydromorphone • Specific privileging for hydromorphone ordering • Discourage hydromorphone use for outpatients • Closely monitor patients with known risk factors

  13. Safe Opioid Use - Key Recommendations • Use conversion support systems when converting from one opioid to another or one route of administration to another. • Use a sedation monitoring scale such as RASS, Pasero POSS or University of MI. • As with any SEA, have paper trail showing consideration of recommendations and actions taken, plus subsequent QAPI

  14. Laryngoscope Blades • Clean and (at least) high level disinfect them per manufacturer instructions for use • Store in manner that prevents recontamination • One blade per Zip-Lock bag if HLD, or • Peal pouch if steam • Consistent practice throughout the hospital • Look everywhere!!! • Testing light source? • Hand hygiene and/or use gloves • Place back into Zip-lock bag or peal pouch • Battery expiration dates!

  15. ET Tubes/Stylets • Video-assisted laryngoscope (e.g. GlideScope) re-usable stylets must be sterilized and packaged per manufacturer instruction • Often found unwrapped on cart ready for re-use • Check the ED and non-OR anesthetizing locations

  16. Disposable ET Tube and Stylet • Often found in/on an anesthesia cart ready for next case where the factory package is opened and stylet is inserted to save time in a STAT induction; package is not dated or timed with new expiration date/time.

  17. High Level Disinfection - Scopes • Follow manufacture recommendations • E.g., glutaraldehyde or OPA test strips • Date bottle of strips when opened – 90 days • QC run on a positive and negative solution • Requires 6 strips right from the start • Document the strip QC • Testing prior to each load, document QC

  18. Separation of Clean/Dirty • Scrutiny of scope cleaning room to determine if flow/practice prevents cross-contamination • Key: remove HLD scopes from sterilizer only when no other dirty scopes are in the room • Flawless QC and load record documentation • Proper PPE, eyewash station • GUS unit if ventilation is inadequate

  19. Scope Storage • Hang in a positive pressure vented cabinet • Avoid tip dragging on base • Avoid towels or other absorbent on base • Avoid cross-contamination (adjacent sink??) • 10-14 day shelf life? (August/2011 OR Manager) • Never store in foam mold in hard case

  20. Consistent Practice • How many TEE probes exist in the hospital? • How many nasogastric scopes? Where??? • In each area – are decontamination, testing, QC, HLD processing, load record-keeping steps performed consistently??? • Exact concentrations, soak times, handling? • Inventoried by Biomed/Clinical Engineering?

  21. Sterile Processing Tour • Attire: donned at the hospital, changed daily • Red line – no one enters without proper attire • No artificial nails, nail polish, jewelry, watches • Head AND facial hair covered at all times • In Decontamination: liquid-resistant garb, heavy-duty gloves, eye protections • WASH HANDS WHEN FINISHED • Eyewash station

  22. Immediate Use Sterilization • Important that staff can speak to the process without using the term “flash” • Follow manufacturer recommendations for sterilizer, pack, instruments, CI, BI • Covered, rigid containers even in sub-sterile • No pre-cleaning/decontamination in sub-sterile! • “A sterilized item intended for immediate use is not stored for future use, nor held from one case to another.” • “Instrument inventories should be sufficient to meet anticipated surgical volume and permit the time to complete all critical elements of reprocessing.” • Submit data to PI Committee /leadership to justify purchase

  23. SPD Facility • Easily cleaned walls, floors and ceiling • Daily housekeeping • No exposed pipes, etc. that collect dust • Maintain neg/pos pressure by keeping doors and windows closed; test pressures monthly • Sinks available for hand washing • Eye wash within 10 second travel time; single action lever, tepid water temperature to allow 15 minute flush time

  24. HVAC Temperature, Humidity, Storage • Monitor and record daily • Temp 68-73 in clean area of department • Temp 60-65 in decontamination • Humidity 20-60% in work areas • Proper # of Air Exchanges (>10, 2 fresh) • Pos/Neg pressure relationships • Humidity not > than 70% in sterile storage • 18 inch, 6 inch, 2 inch, solid lower shelf

  25. Relative Humidity to 20% • CMS finally agreed to lower the minimum acceptable humidity level from 30% to 20% • Requires an “internal” waiver • You need not submit a waiver request to CMS or TJC, but simply discuss at a committee of record (e.g., EOC, IC, OR Operations, etc.) and conclude and memorialize in minutes that you have adopted the 20% minimum acceptable

  26. Reduce Risk of Infection • Surveyors will observe staff as they process dirty equipment • Surveyors will check manufacturer instructions for use (IFU) for three things: the device/instrument, the sterilizer itself, and the packaging (i.e., blue wrap or flash pan.) • Check your policy, check staff understand and follow both. Create a recipe book or OneSource • Will observe proper use of PPE

  27. Eye Wash • Study MSDS: Corrosive? Irreversible Tissue damage? Immediate 15 minute rinse? • An eyewash is likely needed – risk assess • Within 10 seconds (50 feet) • In the same room • Single action lever • Tepid water – 60-100 degrees F • Consider wall mount/self contained system

  28. Loaner Equipment • Clear policy and procedure, penalties for noncompliance; ripe for short-cuts • Mandate 48 hour lead-time??? • Follow manufacture recommendations • Staff should blow whistle if uncertain • Don’t be bullied

  29. New Topic: 2011 ASA IP Guidelines • Recommendations for Infection Control for the Practice of Anesthesiology (Third Edition) • Great Explanation of Hand hygiene • Ditto Safe Injection Practices • Expiration Dating of Medications • (Propofol = 6 hours) • Catheter Insertion

  30. Tissue Management TS.03.01.01 • EP 1 Assign responsibility for tissue • EP 2 Policy for acquisition, receipt, storage, issuance • EP 3 Confirm FDA registration, have current paperwork • EP 4 Spread process throughout hospital • EP 5 Use manufacturer instructions for transporting, handling, storing and using tissue (verify that vendor keeps records per lot # in event of RCA) • EP 6 document receipt of tissue(TS.03.02.01 EPs 3 &6) • EP 7 at receipt, package integrity and temp control is verified (TS.03.02.01 EP 6)

  31. TS.03.01.01 Continued • EP 8 Daily record of temperature for ambient, refrigerated, frozen, or liquid nitrogen (TS.03.02.01 EP 5) • EP 9 Continuous monitoring for refrigerated, frozen, or liquid nitrogen • EP 10 Functional 24/7 alarm for refrigerated, frozen, or liquid nitrogen • EP 11 If you are a tissue supplier, you need FDA registration. • “If a hospital sends tissue for use at another physical location or building that is not on the same campus, even if under the same management, that establishment is considered a distributor and must register.” • http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.3

  32. TS.03.02.01 • EP 1 Bi-directional tracing including discarded (FAQ ‘10) • EP 2 Written materials/instructions to prepare or process (FAQ TJC) • EP 3 date/time/name of staff involved at receipt/ acceptance, preparation, and issuance. “During tracer activities, it was found that the organization had not been recording times at the following points: 1. Receipt at the warehouse which was located off site; 2. Receipt by the surgical personnel upon arrival to OR; 3. Time placed in refrigerator or freezer, and 4. Time removed from the refrigerator or freezer.”

  33. Preparation “While doing a surgical tracer in the main operating room staff was asked how tissue receipt, storage and use documentation would be done if the patient needed a tissue transplant. Staff said that reconstitution diluents or fluids such as normal saline that were used to reconstitute the tissue would not have the diluents’ lot number recorded. Further discussion revealed that the form used to track tissue transplants had all the required prompts for information except one for lot numbers of the fluid used to reconstitute tissue. During the survey staff updated the form to include a field for lot numbers, and when the form is implemented this standard will be met.”

  34. TS.03.02.01 (con’t) • EP 4 document in MR tissue type and unique identifier • EP 5 retain records on temperatures, outdated procedures, manuals, and publications for 10 years (TS.03.01.01 EP 2 & 8) • EP 6 records on distribution, transplantation, disposition, or expiration for 10 years • Name of supplier • Original numeric/alphanumeric donor and lot • Name of recipient and final disposition • The expiration dates of all tissue (TS.03.01.01 EP 6&7) • EP 7 complete tissue cards and return to supplier

  35. TS.03.03.01 (all are “A” EPs) • EP 1 written procedure to investigate adverse events, disease transmission or complication • EP 2 conduct investigation • EP 3 report to supplier ASAP • EP 4 sequester compromised tissue or tissue implicated by a supplier • EP 5 inform patients

  36. H&P and Update • An H&P is done no more than 30 days prior to admission or within 24 hours of admission. • If the H&P is done anytime in the 30 days prior to admission you must update it within 24 hours of admission, or prior to an invasive procedure on the day of the procedure, whichever comes first. • Must document: the patient was examined, and the H&P was reviewed, changes___ or no changes. CMS mandate • In EMR – use a SmartText: e.g., .no changes or .changes

  37. HISTORY AND PHYSICAL • MS.03.01.01, EP 6, A,D – “The organized medical staff specifies the minimal content of medical histories and physicals, which may vary by setting, level of care, tx and services”. • Problem: a long form, short form or “ad hoc” form is spotted which doesn’t meet your requirements • CMS now prohibits anything but a “comprehensive H&P” for ASC; Hospitals?

  38. HISTORY AND PHYSICAL • EP 7, A – “The medical staff monitors the quality of H+P’s”. • Surveyors score failure to obtain within 24 hours of admission or prior to surgery, then look for actions taken by MEC to improve. • If quality data indicates that indeed sometimes there are performance gaps, what do the minutes show for actions?

  39. Sample H&P Bylaw Language A medical history and physical examination be completed and documented for each patient by a hospital practitioner with appropriate privileges no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.  An updated examination of the patient, including any changes in the patient's condition, be completed and documented within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration.

  40. Informed Consent • Physician responsibility • Paper form needs date and time for all signatures • CMS requires patient to sign, date, time • May need to have them re-initial, date, time on day of surgery • Form may include potential use of blood • Process includes discussion of likelihood of desired outcome • Anesthesia consent is usually in anesthesia record • Sedation consent is on presedation assessment • RN confirms patient understanding, advocate

  41. Document Operative & High Risk Procedures (RC.02.01.03) • H&P in record before procedure (EP 3) • Post op/post procedure report is written or dictated before transfer to next level (EP 5) • (Unless a post op/post procedure note is entered immediately [see EP 7], if so, report may be written or dictated per policy) • The post operative/procedure report includes: name of LIPs, procedure name and description, findings, EBL, specimens, post op diagnosis (EP 6 - Top Scorer)

  42. Document Operative & High Risk Procedures (RC.02.01.03) • If report is delayed, an immediate post procedure note is entered and includes LIP, assistants, procedure(s) performed and finding(s), ANY EBL, ANY specimens, Post op diagnosis (EP 7 top scorer). Check your policy. • No premature Post-OP notes!!! • Medical record includes the LIP release order or approved DC criteria (EP 9) • Medical record includes the use of DC criteria/pt readiness (EP10)

  43. CMS/TJC Anesthesia 1/11 Changes • Post-Anesthesia assessment must occur (and be documented) within 48 hours of recovery. • No premature Post-Anesthesia Evals!!! • May be based on data collected by a nurse (as in the case of SDS where discharge is by RN using criteria approved by the medical staff.) • No requirement for an LIP post-sedation assessment. • All entries to medical record are dated/timed

  44. Elements of Post Anesthesia Eval • Remember required elements should conform to current standards of anesthesia care including respiratory function, rate, airway patency and O2 sat, CV function including pulse and BP, mental status, temp, pain, N+V, post-operative hydration.

  45. Telemedicine MS.13.01.01 - 3 Options • Originating site fully credentials and privileges the LIP. • Originating site privileges the LIP using the credentialing information from a TJC accredited organization. The LIP needs a license in the originating hospital’s state. • Originating site uses the credentialing and privileging decision of the distant site if: • The distant site is TJC accredited • The LIP has the privilege(s) at the distant site • The distant site must share the full list of LIP privileges • The originating site collects FPPE/OPPE data and shares with distant site (including adverse outcomes and complaints)

  46. Telemedicine LD.04.03.09 • If either Option 2 or 3 is chosen, there must be a written agreement and EP 4 and 23 apply • EP 4 Leaders monitor performance expectations • EP 23 the agreement must • Label the distant site as a contractor • Specify that distant site will follow MS.06.01.01 – 06.01.13 • Specify that distant site complies with CMS CoP • Note that originating site governing body grants privileges based on originating site medical staff recommendation based on information provided by the distant site • Also, the medical staff bylaws must include a provision permitting such reliance on the distant site.

  47. QUESTIONS? JohnRosing@PattonHC.com JenCowel@PattonHC.com Kurt@PattonHC.com Please visit and bookmarkwww.pattonhc.com

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