(X2) MULTIPLE CONSTRUCTION A. BUILDING: STREET ADDRESS, CITY, STATE, ZIP CODE 757 WESTWOOD PLAZA LOS ANGELES, CA E 000 E347

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1 California Deoartment of Publi Health STATEMENT OF DEFCENCES AND PLAN OF CORRECTON NAME OF PROVDER OR SUPPLER RONALD REAGAN UCLA MEDCAL CENTER (X4)1D PREFX. (X1) PROVDER/SUPPLER/CUA DENTFCATON NUMBER: SUMMARY STATEMENT OF DEFCENCES (EACH DEFCENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC DENTFYNG NFORMATON) (X2) MULTPLE CONSTRUCTON A. BULDNG: STREET ADDRESS, CTY, STATE, ZP CODE PROVDER'S PLAN OF CORRECTON (EACH CORRECTVE ACTON SHOULD BE CROSS-REFERENCED TO THE APPROPRATE DEFCENCY) PRNTED: 07/08/2013 (X3) DA TE SURVEY 02/ E 000 nitial Comments E 000 The following reflets the findings of the Department of Publi Health during an entity reported inident investigation. Complaint ntake# CA Substantiated The inspetion was limited to the speifi entity reported inident investigated and does not represent the findings of a full inspetion of the faility, Representing the Department of Publi Health: Evaluator D# 31335, RN, HFEN () Health and Safety Code Setion 1280 For purposes of this setion. "mmediate Jeopardy means a situation in whih the liensee's nonompliane with one or._more requirements of liensure has aused, or likely to ause, serious injury or death to the patient. E 347 T22 DV5 CH1 ART (b)(2) Surgial Servie General Requirements (b) A ommittee of the medial staff shall be assigned responsibility for: (2) Development, maintenane and implementation of written poliies and proedures in onsultation with other appropriate health professionals and administration. Poliies shall be approved by the governing body. Proedures shall be approved by the administration and medial staff where suh is appropriate. This Statute is not met as evidened by: 1 Based on reord review and interview, the faility Liensing and Certifiation Division ~ Af\. A / LABORATORY DRECTOR'S OR PROVDER/SUPPLER REPRESENTATVE'S ;G~TU~ 6899 ~v V 7/ Sine this inident in 2011, our faility has taken many measures to ensure the safety of our patients. Our plans of ation inlude: 8/1/2011 The faility introdues our yearly Failure Mode Effetiveness Analysis (FMEA} topi: Surgiount nitiative. Surgiount is a bar oding system using RFD sponge tehnology as an adjunt system to assist with surgial sponge ount pratie. The FMEA inluded a review of the new system as well as the development of an anagram that desriptively inludes the new proess mapping. R (X6) 7-'22. (_) 30L311 f ontinuation sheet 1 Of 5

2 California Deoartment of Publi Health STATEMENT OF DEFCENCES AND PLAN OF CORRECTON NAME OF PROVDER OR SUPPLER RONALD REAGAN UCLA MEDCAL CENTER (X4) D PREFX. (X1) PROVDERSUPPLER/CLA DENTFCATON NUMBER: SUMMARY STATEMENT OF DEFCENCES (EACH DEFCENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC DENTFYNG NFORMATON) (X2) MULTPLE CONSTRUCTON A. BULDNG: B.\l\llNG STREET ADDRESS, CTY, STATE, ZP CODE D PREFX. PROVDER'S PLAN OF CORRECTON (EACH CORRECTVE ACTON SHOULD BE CROSS-REFERENCED TO THE APPROPRATE DEFCENCY) PRNTED: 07/08/2013 ()(3) SURVEY E 347 Continued From page 1 failed to implement its written poliy and proedure on ounting sponges used for Patient 1 's surgial proedure whih resulted in retention of a foreign objet (lap sponge) in the patient's abdomen. On- 2011, Patient 1 underwent an Exploratory Laparotomy (a laparotomy s a large inision made into the abdomen, and is used to visualize and examine the strutures inside of the abdominal avity), Choleystetomy (surgial removal of the gallbladder), and a resetion of tumor mass anterior body of panreas. A lap sponge was left in the patient's left lower abdominal whih required a seond surgial proedure under general anesthesia to remove a retained sponge. The faility's failure plaed the patient at risk for possible additional ompliations [e.g. bleeding, infetion, shok, adhesions, ileus (paralysis of the bowel), hanges in blood pressure, heart rate or heart rhythm and allergi reation to general anestheti mediine]. Findings: On February 14, 2013, an unannouned visit was made to the faility to investigate an entity reported inident on a retained foreign objet (lap sponge) after a surgial proedure on Patient 1. A review of the Disharge Summary for Patient 1 dislosed the patient was admitted to the faility on- 2011, and disharged on The admitting diagnosis was hepati flexure olon aner, (Hepati flexure is a bend in the olon that onnets the asending and transverse olon.) The disharge diagnoses inluded hepati flexure olon aner and retrained foreign body. Aording to the Operative Reord dated , Patient 1 underwent an Exploratory (Continued from page 1) OR dept safety talk 8/ Topi: Safe and Quality Care; The mportane of Communiation and Culture. This OR safety talk ontinued until all staff involved has reeived the talk. Responsible Party: Diretor of Peri Operative Servie FMEA - Surgiount nitiative 5/ /1/2011 FMEA subgroup meets weekly to disuss the progress of implementation of the Surgiount nitiative. This group was primarily responsible for the poliy standardization and revision aross the health systerr. This group was responsible for ensuring that staff eduation was provided lo all targeted areas throughout the UCLA Health System. Responsible Party: Diretor of Peri Operative Servie Notifiation of Medial Staff 8/8/2011 nformational letter sent out to all Medial Staff from Surgiount representative staff. Responsible Party: Diretor of Peri Operative Servie Blast to all involved staff 8/24/2011 blast to all staff from the Diretor of Perioperative servies was sent. The blast inlude the pilot kik off shedule, as well as eduation on the Surgiount system, the letter that was sent to the Medial Staff, and a reent artile from the Joint Commission of the Journal on Quality and Patient Safety. Responsible Party: Diretor of Peri Operative Servie mplementation of "Surgi-ount" 9n12011 Staff Eduation/n-servie was provided and reviews of the pilot kik-off shedule of the new program surgi-ount". Responsible Party: Diretor of Peri Operative Serive Liensing and Certifiation Division 30L311 f ontinuation sheet 2 of 5

3 California Deoartment of Publi Health STATEMENT OF DEFCENCES AND PLAN OF CORRECTON NAME OF PROVDER OR SUPPLER RONALD REAGAN UCLA MEDCAL CENTER (Xi) PROVDER/SUPPLER/CUA DENTFCATON NUMBER: (X2} MULTPLE CONSTRUCTON A BULDNG: STREET ADDRESS, CTY, STATE, ZP CODE PRNTED: 07108/2013 (X3} SURVEY 02/22/2013 (X4) D PREFX SUMMARY STATEMENT OF DEFCENCES (EACH DEFCENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC DENTFYNG NFORMATON) D PREFX PROVDER'S PLAN OF CORRECTON (EACH CORRECTVE ACTON SHOULD BE CROSS-REFERENCED TO THE APPROPRATE DEFCENCY) E 347 Continued From page 2 E 347 (Continued from Page 2) Laparotomy, Choleystetomy, and a resetion of tumor mass anterior body of panreas. The Operating Room Nursing Reord for Patient 1 dated- 2011, dislosed thatthe preliminary ount was onduted by Employee 1 and Employee 3 and it was orret. The first ount and the final ounts were done by Employee 2 and Employee 4, and they were orret. However; aording to the Disharge Summary, on the fourth post-operative day a Gastrogaffin study (swallowing of ontrast follow by an x-ray) was done to assess for duodenal (the first part of the small intestine) leak, whih did not show any leak. nstead, the study showed the ribbon like strutures in the left lower abdominal. The repeat KUB (an x-ray of the kidneys, ureter, and bladder) was ompleted and again it showed the same image of the objet. A review of Patient 1 's X-ray of the abdomen dated 2011, indiated "one or two ribbon like densities projeting over the left abdomen are unhanged and likely lap pad markers." A review of the Operating Room Reord for Patient 1 dated 2011, dislosed Patient 1 underwent a seond surgery of an exploratory laparotomy to remove a foreign body under general anesthesia. The Operating Room Reord indiated a preoperative and postoperative diagnosis of retained lap sponge. During an interview on February 22, 2013 starting at 1:05 p.m., Employee 1 (Cirulating Nurse) stated that there were three (3) sponge ounts, the preliminary ount was done before the first inision, the first ount was done before the i losing of the body avity, and the final ount was Liensing and Certifiation Division The in-room trails begin 9/23/2011 The pilot inluded trialing the system in (5) rooms of the main OR.The system was trialed in five OR Suitei. The trial ontinues daily for 12 hours at a time. The trial lasts from through 9/ Administrative Nurse 1 meeting An update of the patient safety initiative was provided to this group. Roles and responsibilities hanges targeted ~o this group were also disussed. Grand Rounds presentation 2115/2012 Surgiount eduation.data review.and implementatior information was disussed with the group. Responsible Party: Diretor of Medial Staff Surgial Faulty Group presentation 4/5/2012 Surgiount eduation.data review,and implementatior information was disussed with the group. Poliy revision 7/3/2012 The Health System Count Poliy final draft submitted for leadership approval. {applies to perioperative servies and labor & delivery in the UCLA Health System) Surgiount Team on site for go live ramp up and staff training. n-servie 7111/2012 Count poliy hanges and overview and Surgiount training with staff. Data Review 7/12/ reports were reviewed by leadership and seleted staff. 30L311 f ontinuation sheet 3 of 5

4 California Deoartment o Publi Health STATEMENT OF DEFCENCES AND PLAN OF CORRECTON NAME OF PROVDER OR SUPPLER RONALD REAGAN UCLA MEDCAL CENTER (X4)1D PREFX (X1) PROVDER/SUPPLJER/CLA DENTFCATON NUMBER: SUMMARY STATEMENT OF DEFCENCES (EACH DEFCENCY MUST BE PRECEDEQ BY FULL REGULATORY OR LSC DENTFYNG NFORMATON) (X2) MULTPLE CONSTRUCTON A BULDNG: STREET ADDRESS. CTY. STATE. ZP CODE D PREFX PROVDER'S PLAN OF CORRECTON (EACH CORRECTVE ACTON SHOULD BE CROSS-REFERENCED TO THE APPROPRATE DEFCENCY} PRNTED: 07/08/2013 (X3) SURVEY 02/ E 347 Continued From page 3 done before losing of the skin. Employee 1 stated as sponges were added or removed from the field they were separated and put on eah finger of one hand, followed by 2 staff members verifying the ount of the sponges. Employee 1 also stated that he was unsure of how a sponge was missed. Employee 1 further stated Employee 2 (Cirulating Nurse). Employee 3 (Srub Nurse). and Employee 4 (Srub Teh) verified the proedures on ounting sponges. Employee 1 added that if a dotor used a sponge for paking and leaves it in the body avity, they were to inform the nurses in the OR and that ount would be inluded in the ount. None of the employees were able to explain how a sponge was left in the patient when the doumentation indiated the ount was orret. A review of the faility's poliy and proedure titled, "Counts, Sponges and Sharps, Mis.. nstruments" dated June indiated the purpose was to provide guidelines for sponges, sharps, misellaneous. and instrument ounts during a surgial proedure to ensure patient safety. The poliy indiates: (1) Mandatory ounts are performed visually and audibly by the srub person and irulating nurse. ( ) The srub person and irulating nurse must be independent pratitioners in their designated role. ( ) Sponges, sharps and misellaneous items are ounted at the initial ount - prior to the start of the proedure, first ount - prior to the losure of the body, and final ount - skin losure. ( ) Srub person and irulating nurse ount all instruments on thorai, abdominal, retroperitoneal, and pelvi surgial proedures. The faility's failure to implement its poliy and L1ens1ng and Cert1fiabon Division (Continued from page 3) mplementation Health System wide 7/16/2012 Go Live with Surgiount sanning at RR & SMN Main Operating Rooms and Labor and Delivery rooms. Morbidity & Mortality Review topi: Preventing RFOs 7/23/2012 A presentation was made to the group that disussed the FMEA. Surgiount proess. Health System poliy and proedure hanges as a related to the implementation of Surgiount. Responsible Party: Diretor of Anesthesia 30L311 f ontinuation sheet 4 of 5

5 California Deoartment of Publi Health STATEMENT OF DEFCENCES AND PLAN OF CORRECTON NAME OF PROVDER OR SUPPLER RONALD REAGAN UCLA MEDCAL CENTER ()(4) D PREFX ()(1) PROVDER/SUPPUER/CLA DENTFCATON NUMBER: SUMMARY STATEMENT OF DEFCENCES (EACH DEFCENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC DENTFYNG NFORMATON) (X2) MULTPLE CONSTRUCTON A. BULDNG: B. Vv1NG STREET ADDRESS, CTY, STATE, ZP CODE D PREFX PROVDER'S PLAN OF CORRECTON (EACH CORRECTVE ACTON SHOULD BE CROSS-REFERENCED TO THE APPROPRATE DEFCENCY) PRNTED: 07/08/2013 (X3) SURVEY , E 347 Continued From page 4 proedure to prevent retention of a lap sponge during a surgial proedure for Patient 1 is a defiieny that has aused, or likely to ause, serious injury or death to the patient, and therefore onstitutes and immediate jeopardy within the meaning Health and Safety Code Setion Liensing and Cert1fiat1on Division 30L311 i f ontinuation sheet 5 Of 5