Joint Conference Committee (JCC) Regulatory Affairs Status Report: May 2017 (reporting period April 19, 2017 May 17, 2017

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1 Joint Conference Committee (JCC) Regulatory Affairs Status Report: May 2017 (reporting period April 19, 2017 May 17, 2017 I. PENDING SURVEYS A. American College of Surgeons- Commission on Cancer Survey scheduled for May 25, 2017 B. Joint Commission Triennial Accreditation Survey unannounced (survey window July 1, 2016 July 28, 2017) C. Joint Commission Clinical Laboratory Survey unannounced (survey window December 26, 2016 June 26, 2017) D. CDPH ZSFG Outpatient Clinics Survey (unannounced) II. COMPLETED SURVEYS A. FDA/State Mammography Quality Standards Act Inspection for Avon (April 20, 2017) no findings B. The Joint Commission Traumatic Brain Injury Intra- Cycle Monitoring Conference call ( May 11, 2017) No Requirements for Improvements III. PLANS OF CORRECTIONS: Reports & Updates A. Joint Commission Intra-Cycle Monitoring (ICM) Survey - Action plan submitted on March 8, 2017 Joint Commission Intra-Cycle Monitoring (ICM) Survey Action Items : Finding: There were no visual cues or landmarks in the physical environment for 4a SNF to assist residents with dementia to assist them in wayfinding in the clinical setting. Action Item: SNF NM created resident-specific visual identification signage for posting on bedroom doors of residents with dementia. Facilities created/installed permanent identifying signage on the Activity Room, Dining Room, and hallway shower doors. Page 1 of 11 Update(s): Monitoring: Ongoing weekly EOC rounds conducted by NM and/or designee to include checking to see that signage is maintained. 100% compliance for one consecutive quarter. Compliance 100 % ( April ) Target Completion Date: 100% compliance for one quarter. (June 2017)

2 Finding: There was no uncluttered, separate, dedicated area to perform IV admixture of emergency medications in the resuscitation room of the ED. Action: Appropriate signage was applied to the carts, indicating that the area is designated for med prep. Monitoring: ED Pharmacists conduct random checks of med prep areas in resuscitation bays found it had been designated to the top of nurses pre/iv cart Compliance 100 % ( April ) February 3,2017 Finding: Soiled pill cutter noted on unit; white powder residue noted on pill cutter. Action Item: Pill cutters were cleaned or replaced in real time in the clinical settings. Finding: A unit was found to have a range order for hydromorphone which did not include specific parameters for when it should be given; left to nurses discretion. Monitoring: Pharmacist to conduct audit of pill cutter 1x/wk in area to ensure cleanliness/no visible pill residue. Compliance - APRIL: Pill cutter found to be clean 3 of 4 times checked = 75%. 100% compliance for one consecutive quarter. ( June 2017) Action Item: Discussion: The issue is complex and a work-inprogress. The plan will address CPOE orders for now; paper orders will be addressed in the future. For now, a memo was sent to Nursing Depts. Regarding compliance. Discussions re range orders with physicians and Nursing, and how to approach is currently in-progress. Orders were audited on 30 patients who had prn pain medication orders with complex regimens. Consultative phone call with the Joint Commission Standards Interpretation group is scheduled for 4pm seeking guidance on corrective action plan to ensure compliance with the standard. Finding: the hospital failed to keep compromised medications unavailable for use when the hospital staff did not store "protect from light" medications appropriately Monitoring: To assure compliance to these changes, monthly auditing of the ADMs and listed storage areas in the Inpatient Pharmacy (HB792) were initiated. ADMS and pharmacy storage areas containing these medications will Page 2 of 11 ( June 2017)

3 Action Item: As an immediate response to this finding, Pharmacy Department staff inspected all medication storage areas within the pharmacy (e.g. HB792-F IVAC room, storage racks near Carousel 3 and the Anesthesia Tray preparation area) and identified all medications requiring light protection for storage. All such items not already in light-resistant manufacturer s packaging or stored protected from light were placed in re-sealable, amber, light-resistant bags. Further, both the shelving and the storage bins for these medications were labeled with Protect from Light tags to more readily identify the medications requiring such storage. Additionally, amber light-resistant bags were left in the medication storage bins for future needs to serve as a reminder to staff and to facilitate correct storage. be inspected monthly for compliance to the correct storage of medications requiring light protection. Compliance- April 100% Finding: a) A bronchoscopy was performed in the ICU in a room that did not have negative air pressure in relationship to the corridor. No documented risk assessment for TB had been performed prior to the procedure as recommended in the CDC s guidelines for prevention of TB transmission in hospitals. Action Item: a) 1) Implement a pre-bronchoscopy assessment that addresses level of infectiousness using CDC's "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005" for patient undergoing bronchoscopy if infectious TB has not already been ruled out. This assessment will address the following: TB history, current respiratory symptoms or lack of, e.g. cough, hemoptysis; diagnostic imaging reports, e.g. CXR and/or CT, and microbiology reports, e.g. AFB smears and/or GeneXpert, and will be documented in the patient's medical record. Monitoring: IC staff will perform chart review to verify a pre-bronchoscopy assessment is completed for 100% of patients who have bedside bronchoscopy performed at the bedside for a period of 3 Page 3 of 11

4 2) The Chief of Pulmonary Services will remind the providers regarding the requirement to perform and document a complete respiratory assessment prior to a bronchoscopy. b) Annual Infection Control Risk Assessment (ICRA) priority list was updated to include the risk of infection associated with Dialysis Services and devices requiring High Level Disinfection (HLD) : February 15, : February 15, FINDING: a) High Level Disinfection of the vaginal probes was not occurring in L&D. Staff were using a condom during the procedure. After the procedure, staff were wiping the probe and spraying it with Transeptic Cleaning Spray. b) Staff in the Woman s Option Clinic reported they transported the dirty ultrasound probes in a basin, covered with a pillow case, to the dirty utility room. c) Observed a vaginal forcep in a double peel pack. The corners of the inside peel pack were folded over itself. d) There was no documentation of quality checks for the past 4 months on the test strips for Resert solution used for high level disinfection of airway scopes in the Anesthesia room in the OR Action Items: a) 1) A special issue resolution was held and it was determined that the ED and the Family Ward were using the same process. The Radiology Department, Women's Health, and the Women's Option Unit were performing high level a) 1) ZSFG will purchase mobile Trophon HLD units for each of the areas that were without HLD processes. Upon receipt of the Trophon units, IC and each clinical area will develop a HLD patient tracking and quality control documentation process, in accordance with standards of care and manufacturer's requirements. a) 2) All identified staff will be educated and verified as competent prior to implementation of Trophon HLD system in each area. JC surveyor unannounced site visit on 4/27/17 for FHC and 5M Women s Clinic specific to high level disinfection practice for vaginal ultrasound probes. Surveyor had no Page 4 of 11 Purchase Orders have been placed for four Trophon HLD Units. (awaiting delivery)

5 disinfection after the probe was used. Leadership immediately revised the process; the probes were removed from the three areas and will be managed by Radiology until each of the 3 departments receive the GUS cleaning system. issues with practice standards and was very complimentary of staff. Compliance -100% 2) Staff who will perform HLD will be identified and educated on Trophon processes by qualified individual; documentation will be completed to include competency assessment form. 3) Leadership will conduct a risk assessment to determine what type of notification to physicians/patients, if any, may be needed. IC completed a chart review on 2/17/2017 for 68 unique patients (~35%) who had a transvaginal US performed with a probe that was cleaned and covered going back 2 years from time of finding (Jan Feb ) assessing for presence/possible transmission of 4 target organisms - no positive results found. Risk of transmission was determined to be minimal, no patient notification was deemed necessary. b) Effective 3/1/17, Women's Options Center staff are transporting dirty US probes to the dirty utility room using a basin placed inside of a biohazard bag. c) 1) On 3/8/17, SPD staff will be educated on the double peel pack protocol to include limiting double peel packs to only those items whose weight, size, structure require it; inner peel pack will be sized to avoid need for folding. 2) SPD Policy Prep 16.0: Acceptable Materials and Procedures for Sterile Packaging, Section 2.Paper-Plastic Peel Open Pouches b) WOC nurse manager/ designee will conduct weekly, random observations of the transport of dirty ultrasound probes by staff until c) 1) Sterile Processing Department (SPD)/ Nurse Manager or designee will check each double peel pack for the presence of folded inner peel pack prior to delivery for patient use in clinical area until 100% compliance is achieved for one month. Page 5 of 11 IC completed chart review on February 2, /8/17 100% compliance is achieved for one month. (May 2017)

6 will be updated to identify which types of items require double peel package. d) On 2/17/17, Anesthesia technicians were educated on the need to log QC checks for every Resert test strip bottle opened. Resert test strip quality control log was moved from the back of a binder and placed at eye level at the Resert work station to provide a visual cue for this low volume work process. d) Anesthesia workroom manager or designee will audit the test strips quality control log weekly to ensure staff follow the process and completing the log until 100% compliance is achieved for 3 continuous months. ( July 2017 Findings: In the Cardiac ICU, a blanket warmer was set at 141 degrees Fahrenheit and contained patient gowns with metal snaps. Hospital policy stated that the blanket warmer temperature should not exceed 130 degrees Fahrenheit. A blanket warmer in the surgery ICU was set at 143 degrees Fahrenheit when the instructions on the cabinet indicated a maximum temperature of 130 degrees. Action Items: The blanket warmer temperature control unit was pre-set and locked at 130 degrees F, disabling the manual manipulation of higher temperatures/ greater than the maximum allotted temperature. As part of routine EOC rounds on the unit, the temperature of the blanket warmer will be checked to ensure compliance with pre-set and locked temperature of 130 degrees F. Finding: the facility failed to implement their policies and procedures when: A physician's order was not obtained prior to application of a restraint for one of 30 (Patient 8) sampled patients. Action Item/s: 1) Following the survey, the ZSFG Chief Medical Officer (CMO) and Chief of Staff developed a presentation to Monitoring: 1) The Nurse Manager or designee of the designated Intensive Care Unit will conduct standard work validation of the Restraint Flow sheet review on a monthly basis. The standard work validation will be ongoing with each manager validating a minimum of 10 instances of Page 6 of 11

7 educate the providers regarding the requirement to conduct and document a face to face evaluation of patients ordered on restraints for self- destructive behavior. The presentation will be distributed to Chiefs of Service and will be required for all providers to complete. restraint or 25% of total instances. The goal is to validate all staff. The presentation is included as part of resident orientation. CMO & Chiefs of Service will develop a plan for ongoing monthly orientation of new resident providers to restraint requirements. Following receipt of the 2567 the SICU nurse manager reminded the staff of the requirement that the orders for restraint be obtained following a face to face evaluation by the ordering provider, as stated in ZSFG Admin policy restraints and seclusion. Nursing Leadership implemented standard work for the review of 100% of restraint instances during change of shift hand-off. The oncoming/off going nurses will review the restraint orders and monitoring documentation to ensure the face-to-face evaluation by the medical providers is documented and orders are in place. In the event orders are incomplete or missing the provider with be contacted and any issues will be corrected in real time. Restraint skill and education station has been included to provide education to all Critical Care Nurses at the Annual Critical Care Education Day. Finding: the hospital failed to follow and execute its own policy regarding consent to medical and surgical procedures as Page 7 of 11

8 evidenced by a procedure performed for one of 30 sampled patients (Patient 9) without full disclosure as to why the responsible party cannot provide written consent prior to surgery. Action/s: Re-education was provided to the attending on the emergency exception criteria and ZSFG required policy documentation. A memo outlining the Consent: Emergency Exception Criteria Language and ZSFG policy requirements - forwarded to all surgical attendings. Monitoring: A random sampling of 30 charts of Trauma/Surgical patients lacking capacity or ability to consent who are taken for surgery, based on emergency exception, will be audited to ensure required documentation elements in accordance with the policy. The audit results will be reported to the ZSFG Medical Executive Committee, if necessary an action plan will be implemented to ensure compliance with the standard. During the April Medical Executive Meeting, Risk Management will present information on the CONSENT: Emergency Exception Criteria and ZSFG policy requirements. B. CDPH/CMS Skilled Nursing Facility Long-Term Care Relicensing/Recertification Survey (February 27-March 2, 2017): Plan of Correction submitted on March 27, 2017, CDPH/CMS Skilled Nursing Facility Long-Term Care Relicensing/Recertification Survey Action Items : Finding: the facility failed to follow its policy to ensure "appropriate safety and operational standards" of patient care equipment when the "condition and function" of the newly acquired Stow-A-Weigh wheelchair scale was not tested, inspected and evaluated prior to use. Update(s): Monitoring: On an annual basis, ZSFG Biomedical Engineering will conduct an inspection of all patient equipment items present on 4A to ensure maintenance is performed as required by manufacturer's guidelines. Compliance: 100% Target Completion Date: Page 8 of 11

9 Action/s: ZSFG Biomedical Engineering responded in real-time to inspect, test, and evaluate the Stow-A-Weigh wheelchair scale. A Bio-Med sticker with the date of inspection was applied at this time No negative patient outcomes were associated with the lack of preventive maintenance performed on the wheelchair scale. C. CDPH GACH (General Acute Care Hospital) Relicensing Survey (February 14-17, 2017): Plan of Correction submitted on April 10, 2017, reporting to begin at ALCC meeting on May 25, CDPH GACH (General Acute Care Hospital) Relicensing Survey Action Items : Findings: the facility failed to implement preventative interventions for skin impairment in accordance with the patient's plan of care for one of 30 sampled patients. Action Items: Upon discovery of the dry and flaky skin on Patient 10's feet, moisturizing lotion was applied and the patient's heels were floated. Clinical Nurse Specialists (CNSs) are now placing their wound care notes in the electronic Kardex to facilitate staff nursing Page 9 of 11 Update(s): Monitoring: Staff nurses are reviewing care plans at change of shift to ensure all interventions are being carried out. In the event of missing activated intervention(s), the Nursing Care Plan will be updated in real time. Target Completion Date: Inititiated April 10,2017 & Ongoing

10 access to wound care recommendations. In addition, staff nurses are reviewing care plans at change of shift to ensure all interventions are being carried out. The nurse manager or designee will conduct random reviews of nursing handoffs to ensure compliance with patient's care plan is occurring. An educational protocol has been developed by the Wound Care CNS to clearly explain standard work for any patient determined to be at risk for pressure injuries. Staff education about this protocol is being disseminated during staff huddles. staff distribution lists and informational flyers. Finding: the hospital failed to develop and implement policy and procedures for establishment of safe administration of medications when the hospital nurses did not rotate the site for injection for 1 of 30 sampled patients (Patient 5) on subcutaneous (SC-injection given under the skin) Enoxaparin (blood thinner), and did not inject into the abdomen in accordance to manufacturer. Action Item/s: The patient's care plan was updated to include the patient education and their subsequent refusal of enoxaparin administration in abdomen due to complaints of pain. ZSFG Pharmacy I.T. has added a note in the electronic medication administration system (MAK) to remind nursing staff to inject Enoxaparin in the abdomen area and to rotate injection sites. Nursing policy 17.5: Administration of Medications has been updated to include language detailing the need to rotate subcutaneous injection site. Monitoring: Pharmacy IT, in collaboration with Nursing IT will generate a monthly report of subcutaneous Enoxaparin injections administered in the inpatient settings. This report will be reviewed by the managers or designee of each clinical setting to ensure site rotation is appropriate. The audit results will be reported monthly for one quarter Page 10 of 11

11 Finding: the hospital staff stored medications not in an orderly manner when a Radiology medication bin had various medications that were stored in a crowded container. This failure increases the risk of administering the wrong drug. Action Item/s: Upon immediate discovery of the comingling of medications, the Director of Radiological Services corrected the situation by separating each medication: Sodium Bicarbonate, Lidocaine and Sodium Chloride, into their appropriately labelled bins in room HB452A. All Radiology staff were made aware of the problem at an allstaff meeting and were trained in how to properly store medications. Photos of properly and improperly labelled medication bins were shown and discussed. Monitoring: This medication room will be monitored by the Radiology Staff as part of their daily equipment and supply checks. The Pharmacy Department continues to conduct their monthly standard medication room inspections, including Radiology. IV. SITE VISITS No site visits during this period. Page 11 of 11

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