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Based on interview and record review, the facility failed to document experience in the privileges requested for 2 of 10 sampled credentials files (refer to A-945).

20245

Based on observation, interview, and document review, the hospital failed to ensure an effective quality plan was implemented to evaluate cold food holding systems for potentially hazardous foods (Cross reference 749), and failed to develop an effective tool to monitor accuracy of diet orders provided by food and nutrition services.

Findings:

1a. At 10:00 a.m. on 3/15/11 during initial tour, the single door reach-in refrigerator (R6) used in the pediatric room service area was observed to have temperature 45 ? F (Fahrenheit) and contained assorted potentially hazardous foods including meat sandwiches, desserts, puddings and cottage cheese and fruit plates. Dietary Staff U took the temperature of a random turkey sandwich dated 3/15 and it was 49.5?F and a pudding also dated 3/15 was 41.3?F.
At 3:20 p.m. on 3/15/11 the same refrigerator temperature was observed to be 46?F and a turkey sandwich labeled 3/15 had temperature of 49?F and puree fruit labeled 3/15 had temperature 45?F (Cross Reference A749).
1b. At 10:25 a.m. on 3/15/11, in the cold production refrigeration (R-22) it was noted there were several potentially hazardous foods with temperatures above 41?F (Cross Reference A749).

During an interview on 3/17/11 at 12:30 P.M., Staff 101 stated Nutrition and Food Service had developed key performance indicators in November 2010 to report to the quality committee and provided surveyors Appendix A, revised December 2010. Review of the quality indicators revealed no evaluation of the systems used for ensuring safe food holding of cold foods, although that had been identified as a problem in a prior survey. Additionally, for the key indicators listed, there was no compliance threshold expected by the medical executive board. Staff 101 stated the committee had not requested a threshold for compliance but could do so in the future. The accepted standard for quality is to identify compliance thresholds.

On 3/17/11 at 1:20 p.m. during an interview regarding the quality program for food and nutrition services, DMS A stated he had determined that a Food Safety Inspections done quarterly by an outside resource was a good tool to determine whether food safety standards were met on a daily basis and stated he was satisfied with the process. DMS A provided the report completed 1/13/11 by the outside resource and "Inspection Type" indicated it was done biannually (twice a year) for the production kitchen.

2. On 3/16/11 and 3/17/11 during clinical record reviews, it was observed that 2 of 5 patients did not receive the therapeutic diet ordered by the physician. (Cross reference A629).

During an interview on 3/17/11 at 1:00 p.m., Dietary Management Staff DD stated incorrect diet delivery of "complex" diets where the physician "free-texted" the diet order rather than choose from a pre-determined drop down menu on the computer, had been identified as a problem for food and nutrition services in a previous survey.

DMS DD stated the food and nutrition department had identified "NPO or Incorrect Diet Orders" as a key quality indicator. The indicator goal was "Patient would have a correct diet order and meals provided will match that order." During an interview with DMS DD, it was noted that the Daily Diet Request document was produced from the transcription of the nurse reading the physician's orders, and was not the actual written order. Therefore, comparing the diet with the DDR would not ensure physician's orders were followed.
DMS DD acknowledged the comparison of the diet with the Daily Diet Request was not the correct comparison to ensure the physician's orders were followed.

Based on interview and record review, the facility failed to document recent experience in each of the requested privileges before deciding whether to renew them for 2 of 10 sampled credentials files (refer to A-945).

14545

Based on record review and interview, the facility failed to ensure all medical records were complete and signed for 2 of 18 sampled patients (Patients 14 and 19), when Patient 14 had a pre-procedure history and physical completed that was not signed by the physician, and Patient 19 had conscious sedation for a procedure and the post procedure record did not indicate level of consciousness or his disposition at the end of the procedure.

Findings:

1. Record review on 3/17/11 at 1:20 PM, indicated Patient 14 was scheduled for procedures including liver biopsy. Patient 14's history and physical (H&P) form was completed by hand on 3/16/11, but was not signed by the physician and there was no way to tell who had completed it.

During interview with Director of Regulatory Affairs (DRA) on 3/18/11 at 11 AM, she acknowledged the 3/16/11 history and physical form for Patient 14 was not signed. The DRA said an H&P form had been completed for Patient 14 on 3/14/11 for another procedure and was still within the timeframe required for pre procedure H&Ps.

2. Record review on 3/18/11 indicated Patient 19 had an IVC (inferior vena cava) filter placed under conscious sedation on 3/7/11. Post procedure documentation was recorded in the Sedation Record dated 3/7/11, which indicated Patient 19's blood pressure, pulse, respirations, oxygen administration and oxygen saturation were obtained at 9:45 AM and 10 AM. The section designated for level of alertness was left blank. The note under transfer instructions indicated report to Nina/B/C, RN. No transfer time was noted, there was no indication of where the patient went after the procedure, and no indication of who accompanied the patient when transferred.

During interview with the DRA on 3/21/11 at 10:30 AM, she reviewed Patient 19's Sedation Record and was unable to determine his level of consciousness after the procedure, and could not tell where the patient had gone after the procedure. She said level of consciousness is usually indicated in a designated space toward the end of the post procedure section of the Sedation Record, but it was left blank. A section at the end of the Sedation Record had a designated space to note where the patient went after the procedure and who accompanied him, but it was not filled out.

Based on observation, interview, and document review, the hospital failed to control medications in accordance with standard of practice as evidence by:

1. The hospital failed to provide medications in single-unit packages and in a ready-to-administer form when bulk vials of 30 ml Heparin (a high-alert medication) were found in the IR Pyxis machines.

2. The hospital failed to ensure emergency medications were accurately calculated when two of four nurses in the NICU did not accurately calculate the correct doses for Epinephrine and Atropine.

3. The hospital failed to ensure sterility of the chemotherapy compounding area when pressures were not monitored and documented daily for CACIs (compounding aseptic containment isolators aka IV chemo hood).

Findings:

1. According to the American Society of Health Systems Pharmacists, a nationally recognized professional organization, in the titled document ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals section Medication Distribution and Control indicates "Whenever possible, medications shall be available for inpatient use in single-unit packages and in a ready-to-administer form. Manipulation of medications before administration (e.g., withdrawal of doses from multidose containers, labeling containers) by final users should be minimized."

During observation on 03/17/11 at 4:18 pm, in the Neuro Interventional Radiology, there were several bulk vials of Heparin (blood thinner) 1000 u/ml 30 ml vials in the Pyxis machine (madication dispensing machine). The Heparin 30 ml bulk vials were in the Pyxis drawers.

An interview on 03/17/11 at 4:18 pm, the Interventional Radiologist stated he used the 1000 u/ml of Heparin. He also stated that the procedures done in Neuro Interventional Radiology would usually use less then 10 ml of the Heparin.

During an Interview on 03/21/11 at 1:30 pm, the Anesthesiologist stated the Anesthesiologists used the 1000 u/ml of Heparin. He also stated that for the Neuro Interventional Radiology cases they did not use more then 10 ml of Heparin. He said that more then 10ml of Heparin was not necessary.

A review of the clinical records indicated 3 of 3 patients used less then 10 ml of the Heparin 1000u/ml during their Interventional Radiology (IR) procedure. Patient 37, Patient 38, and Patient 39's Neuro IR procedure records indicated the 7.5 ml, 7ml, 5.6 ml of Heparin 1000u/ml were administered respectively.

According to the Institute of Safe Medication Practices (ISMP), a nationally recognized medication error prevention resource, in the entitled document ISMP's List of High-Alert Medications indicates "High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. We hope you will use this list to determine which medications require special safeguards to reduce the risk of errors. This may include strategies like ...limiting access to high-alert medications." Heparin is listed as a High-alert medication.

The pharmacy provided bulk vials of Heparin (30 ml) for hospital staff use. The availability of bulk vials of Heparin increased the risk for excessive Heparin dosing which could result in devastating consequences (death).

2. According to the hospital policy dated last approved 08/07 entitled Emergencies (Code Blue and Medical Emergencies) indicated "Code Blue Team Roles and Responsibilities ...Bedside Nurse ...Initiate Code Blue alarm ...Initiate resuscitation ...Relay pertinent patient history to code team physician ...Administer medications as directed. "

A review of the Intensive Care Nursery Emergency Medication Sheet indicated calculated doses for emergency medications which included Epinephrine (concentration 0.1 mg/ml). The Sheet indicated the initial dose of Epinephrine for a 1.4 kg child was 0.14 ml.

During an interview on 03/18/11 at 10:06 am in the intensive care nursery nurse, RN 1 was asked what would be the initial dose of Epinephrine (concentration 0.1 mg/ml) for a 1.4 kg child. RN 1 stated the dose would be 1.4 ml.

A review of the Intensive Care Nursery Emergency Medication Sheet indicated calculated doses for emergency medications which included Atropine (concentration 0.1 mg/ml). The Sheet indicated the initial dose of Atropine for a 1.7 kg child was 1 ml.

In an interview on 03/18/11 at 10:15 am, intensive care nursery nurse RN 2 was asked what would be the initial dose of Atropine (concentration 0.1 mg/ml) for a 1.7 kg child. RN 2 stated the dose would 0.06 ml.

RN 1's dose of 1.4ml was 10 times higher then the correct Epinephrine dose of 0.14ml. RN 2's dose 0.06 ml was more then 16 times lower then the correct Atropine dose of 1ml. Had these doses been administered during an emergency situation these patients would have been substantially over and under-dosed.

3. Compounding Aseptic Containment Isolators (CACIs) are used to compound chemotherapy. CACIs (aka Chemo IV hood) are primarily used for making intravenous chemotherapy.

During an interview on 03/23/11 at 10:53 am the CACI Manufacturer representative stated that CACI pressure gauges on the outside of the CACI were used to monitor pressures. He also stated that when pressures were to low this would compromise the sterile field.

A review of the report dated 02/08/11 entitled Visit Report prepared for UCSF Medical Center by Clinical IQ a consultant report evaluating UCSF's intravenous (IV) hoods indicated the following recommendation "The pressures on the minihelic gauges on isolators need to be read and documented daily ...The manufacturer provides recommended values."

An interview on 03/18/11 at 9:55 am the DOP stated that the pressures were not documented and monitored daily.

The hospital did not provide any documentation of consistent monitoring of pressures for any CACIs throughout the hospital.


26985




27000

20245

Based on observation, interview and document review, the hospital failed to ensure an effective quality plan was implemented to evaluate cold food holding systems for potentially hazardous foods (Cross reference 749), and failed to develop an effective tool to monitor accuracy of diet orders provided by food and nutrition services.

The cumulative effect of these systemic problems resulted in the hospital's failure to meet statutorily mandated compliance with the Condition of Participation for Food and Dietetic Services.


Findings:

At 10:00 a.m. on 3/15/11 during initial tour, the single door reach-in refrigerator (R6) used in the pediatric room service area was observed to have temperature 45 ? F (Fahrenheit) and contained assorted potentially hazardous foods including meat sandwiches, desserts, puddings and cottage cheese and fruit plates. Dietary Staff U took the temperature of a random turkey sandwich dated 3/15 and it was 49.5?F and a pudding also dated 3/15 was 41.3?F.
At 3:20 p.m. on 3/15/11 the same refrigerator temperature was observed to be 46?F and a turkey sandwich labeled 3/15 had temperature of 49?F and puree fruit labeled 3/15 had temperature 45?F (Cross Reference A749).

At 10:25 am on 3/15/11, in the cold production refrigeration (R-22) it was noted there were several potentially hazardous foods with temperatures above 41?F (Cross Reference A749).

During an interview on 3/17/11 at 12:30 P.M. Staff 101 stated Nutrition and Food Service had developed key performance indicators in November 2010 to report to the quality committee and provided surveyors Appendix A, revision December 2010. Review of the quality indicators revealed no evaluation of the systems used for ensuring safe food holding of cold foods, although that had been identified as a problem in a prior survey. Additionally, for the key indicators listed, there was no compliance threshold expected by the medical executive board. Staff 101 stated the committee had not requested a threshold for compliance but could do so in the future. The accepted standard for quality is to identify compliance thresholds.

2. On 3/16/11 and 3/17/11 during clinical record reviews, it was observed that 2 of 5 patients did not receive the therapeutic diet ordered by the physician. (Cross reference A629).

During an interview on 3/17/11 at 1:00 p.m., Dietary Management Staff DD stated incorrect diet delivery of "complex" diets where the physician "free-texted" the diet order rather than choose from a pre-determined drop down menu on the computer, had been identified as a problem for food and nutrition services in a previous survey.

During the same interview, DMS DD stated the food and nutrition department had identified "NPO or Incorrect Diet Orders" as a key quality indicator. The indicator goal was "Patient would have a correct diet order and meals provided will match that order." During concurrent interview DMS DD, stated the Daily Diet Request, document was produced from the transcription of the nurse reading the physicians' orders, and was not the actual written order. Therefore, comparing the diet with the DDR would not ensure physician's orders were followed.
DMS DD acknowledged the comparison of the diet with the Daily Diet Request was not the correct comparison to ensure the physician's orders were followed.

20245

Based on observation, interview, and document review, the hospital failed to ensure an effective quality plan was implemented to evaluate cold food holding systems for potentially hazardous foods (Cross reference 749), and failed to develop an effective tool to monitor accuracy of diet orders provided by food and nutrition services.

Findings:

1a. At 10:00 a.m. on 3/15/11 during initial tour, the single door reach-in refrigerator (R6) used in the pediatric room service area was observed to have temperature 45 ? F (Fahrenheit) and contained assorted potentially hazardous foods including meat sandwiches, desserts, puddings and cottage cheese and fruit plates. Dietary Staff U took the temperature of a random turkey sandwich dated 3/15 and it was 49.5?F and a pudding also dated 3/15 was 41.3?F.
At 3:20 p.m. on 3/15/11 the same refrigerator temperature was observed to be 46?F and a turkey sandwich labeled 3/15 had temperature of 49?F and puree fruit labeled 3/15 had temperature 45?F (Cross Reference A749).
1b. At 10:25 am on 3/15/11, in the cold production refrigeration (R-22) it was noted there were several potentially hazardous foods with temperatures above 41?F (Cross Reference A749).

During an interview on 3/17/11 at 12:30 P.M. Staff 101 stated Nutrition and Food Service had developed key performance indicators in November 2010 to report to the quality committee and provided surveyors Appendix A, revision December 2010. Review of the quality indicators revealed no evaluation of the systems used for ensuring safe food holding of cold foods, although that had been identified as a problem in a prior survey. Additionally, for the key indicators listed, there was no compliance threshold expected by the medical executive board. Staff 101 stated the committee had not requested a threshold for compliance but could do so in the future. The accepted standard for quality is to identify compliance thresholds.

On 3/17/11 at 1:20 p.m. during an interview regarding the quality program for food and nutrition services, DMS A stated he had determined that a Food Safety Inspections done quarterly by an outside resource was a good tool to determine whether food safety standards were met on a daily basis and stated he was satisfied with the process. DMS A provided the report completed 1/13/11 by the outside resource and "Inspection Type" indicated it was done biannually (twice a year) for the production kitchen.

2. On 3/16/11 and 3/17/11 during clinical record reviews, it was observed that 2 of 5 patients did not receive the therapeutic diet ordered by the physician. (Cross reference A629).

During an interview on 3/17/11 at 1:00 p.m., Dietary Management Staff DD stated incorrect diet delivery of "complex" diets where the physician "free-texted" the diet order rather than choose from a pre-determined drop down menu on the computer, had been identified as a problem for food and nutrition services in a previous survey.

DMS DD stated the food and nutrition department had identified "NPO or Incorrect Diet Orders" as a key quality indicator. The indicator goal was "Patient would have a correct diet order and meals provided will match that order." During interview DMS DD, it was noted that the Daily Diet Request document was produced from the transcription of the nurse reading the physician's orders, and was not the actual written order. Therefore, comparing the diet with the DDR would not ensure physician's orders were followed.
DMS DD acknowledged the comparison of the diet with the Daily Diet Request was not the correct comparison to ensure the physician's orders were followed.

20245

Based on food production observations, dietary staff interview, and dietary document review the hospital failed to ensure competency in cleaning food production equipment for 1 staff member. Failure to ensure staff competency in position associated tasks may result in patients being placed at risk for foodborne illness. Foodborne illness may result in gastrointestinal distress, further compromise in clinical condition and in severe instances may result in death.

Findings:

During general food production observations on 3/15/11 at 10:50 am, it was noted that DS Z was using a large floor mounted steam kettle. In a concurrent interview he was asked to describe the cleaning process. He stated that he would wash the item with water and a detergent that he obtained from the manual dishwashing area after he would rinse the item with water. He then stated that the kettle was "good to go for the next round." The surveyor confirmed with DS Z the process he described. He acknowledged that this was his normal process for cleaning in-place equipment.

In a concurrent interview with DMS B she stated that DS Z was hired sometime in 2009. In an interview on 3/16/11 at 10 am, with DMS H he stated that to his knowledge the department did not have procedures related to cleaning the steam kettles. DS H was also asked how the hospital ensured that staff was competent in position related skills. He replied that competency was determined through an employee orientation checklist that included testing and guidelines for specific position related tasks. The surveyor requested documentation of DS Z's checklist. In a follow up interview on 3/17/11 at 2 pm, with DMS A he stated that they were unable to locate any orientation/competency documentation for DS Z

20245

Based on observation, nursing staff interview and medical record review the hospital failed to ensure that 2 patients (Patients 29 and 32) in a sample of 5 patients reviewed for nutrition care received their physician ordered nutritional intervention. Failure to provide for identified nutritional needs may result in further compromise of medical status.

Findings:

*1. Patient 32 was admitted with diagnoses including diabetes and vomiting. Medical record review was conducted on 3/16/11 beginning at 1:30 pm. Current diet order, dated 3/10/11, was Cardiac Diet, with 1.5 L FR (liter fluid restriction.) During a concurrent interview with RD W, it was revealed the dietary department had been sending 2000 Calorie, 1.25L FR, 2 gram sodium diet. RD W acknowledged the diet served was not the one ordered for the patient and stated "it (the diet order) should have been clarified; it's not the right diet. The patient had been receiving a more complex diet previously." RD W stated the department policy did not include registered dietitian verification of the written physician's order.

*2. Patient 29 was admitted with diagnosis including abdominal pain. Admission diet order dated 3/11/10 was noted to be a 2 gram cardiac diet. Additional diet orders were as follows: 3/12-low sodium, diabetic, 2000 calorie diet; 3/13-clear liquid diabetic diet; 3/14-clear liquid diabetic 2,000 calorie diet; 3/15-mechanical soft low sodium, diabetic diet; 3/15 regular low sodium diabetic diet.

In an interview on 3/16/11 at 10 am, with RD V she stated that a standard ADA (American Diabetes Association) diet would have 1800 calories. She also stated that it would be impossible for the department to offer a 2,000 calorie clear liquid, diabetic diet. She also stated that these conflicting orders should have had physician clarification.

Review of the dietary department's daily diet requisitions from 3/12-3/16/11 revealed that on 3/12/11 the dietary department sent a low sodium, ADA diet rather than the physician ordered low sodium, 2000 calorie diet. Similarly on 3/14/11 the physician ordered a 2,000 calorie diet, clear liquid diet. The daily diet requisition noted that a clear liquid diet was sent. Review of hospital communications from the nursing staff to the dietary department revealed that the orders were entered as per the physician's orders.

Based on interview and document review, the hospital failed to ensure a pre-planned written disaster menu with in-house food inventory that could be implemented during a disaster. This would put critically ill patients at risk of inadequate nutrition during an event that required the hospital to be self sufficient and shelter in place

Findings:

On 3/16/11 beginning at 2:30 p.m. DMS B discussed the hospital's seven day disaster menu and plan and provided Policy 09.100.01 Emergency Management Plan, revised December 2009. DMS B stated the hospital had identified most of the foods that would be served to patients on regular diets, but had still not determined which special pediatric formulas would be appropriate, and had not finished the "spread sheet" to indicate foods that would be served to patients on therapeutic diets, nor developed and purchased and stored the inventory for the entire menu. Additionally, DMS B stated the hospital had not located areas to store the foods for the menu. DMS B stated the department had submitted to the hospital disaster emergency preparedness committee, estimates of the number of people to prepare for and that estimate had been approved. At 3:15 pm. DMS A confirmed the department was "working on it (the disaster menu and inventory)." He stated "we hope to have it done within the next six weeks."

Based on food storage observations, dietary staff interview, and dietary document review, the hospital failed to ensure the maintenance of all essential equipment as evidenced by elevated food temperatures for 2 refrigeration units with potentially hazardous foods held in them. Failure to ensure effective functioning of essential equipment may put patients at risk of foodborne illness.

Findings:

*1. At 11:30 a.m. on 3/15/11 meal preparation activities were observed in the "Blue Room," (pediatric room service).

The single-door reach in refrigerator (R6) was observed to have temperature 45 ? F (Fahrenheit) and contained assorted sandwiches, desserts, puddings and cottage cheese and fruit plates. Dietary Staff U took the temperature of a random turkey sandwich dated 3/15 and it was 49.5?F and a pudding also dated 3/15 was 41.3?F. DS U returned the foods to the refrigerator for service.

At 3:20 p.m. on 3/15/11 the same refrigerator temperature was observed to be 46?F.

On 3/16/11 at 4:15 p.m. refrigerator R6 was observed to have a sign on it "Do Not Use". During an interview at 4:30 p.m. DS FF stated he had observed the refrigerator to be 45?F at noon this day and stopped the staff from using it.

*2. On 3/15/11 at 10:37 a.m., the freezer temperature of the ice cream freezer in the dry goods storeroom was observed to have three different thermometers, variously reading 9?, 16? and -4?F. The ice cream inside was not firm to touch. During an interview at 10:44 a.m., Dietary Staff D stated he was responsible for monitoring temperatures of the freezer but did not monitor that one because it wasn't on his list. During a concurrent interview, DMS A stated not all refrigerators/freezers were monitored by hand, and that the freezer in question was monitored by an electronic system.

On 3/17/11 at 10:45 a.m. the hospital provided electronic monitoring reports that revealed the freezer was not on an electronic system and the temperature was not monitored.

Review of Food and Nutrition Policy 05.510.08 directed "All active cold temperature units ( ...freezers ...) will be designated to be monitored by the automated temperature monitoring system or manually in the Nutrition and Food Services Master Active Temperature List." On 3/17/11 at 10:46 a.m., DS FF stated the freezer with the ice cream had just been added to his list to monitor since the survey observations on 3/15/11 at 10:37 a.m. that the ice cream was soft and the temperature not monitored.

*3. During the initial tour on 3/15/11 at 10:25 am, in the cold production refrigeration (R-22) there were several potentially hazardous foods with temperatures above 41?F (Cross Reference A749). Concurrent observation also noted that the thermometer in the refrigerator, which was placed along the back wall of the unit, was 34?F. It was also noted that there was an additional temperature probe mounted to the interior right hand side of the unit.

In an interview on 3/13/11 at 10:30 a.m. with DMS B, she stated refrigerator temperatures were monitored by supervisory staff at the beginning of each day. On 3/16/11 at 4 pm, in an interview with DMS A he stated that the temperature of the unit was monitored via a remote system. In a follow up interview on 3/17/11 at 1 pm, DMS A stated that while the refrigerator was monitored on a remote system the department did not utilize the system because it was inaccurate. He further stated that in place of the automated monitoring he instructed supervisory staff to check refrigerator temperatures every morning.

Review on 3/17/11 at 2 pm, of dietary documents titled "HACCP Refrigerator Freezer Temperature Log" from 3/11-3/16/11 revealed that staff was taking temperatures once daily, between the hours of 8 and 9:45 a.m. and consistently recorded refrigerator temperatures of 38?F or below. Concurrent review of remote temperature recording print-out noted that the remote system recorded a minimum of 84 temperatures during a 24-hour timeframe. It was also noted that for the timeframe of 3/14/11 at 11 pm through 3/16/ 11 am, many of refrigerator temperatures, including those that were recorded after 7 pm, were consistently above 41?F. On 3/15/11 at 10:30 am, the remote system recorded a temperature that was between 44.5 and 51.9?F.

Dietary policy 05.510.08, revised 2/10, for temperature monitoring of refrigerators/freezers outlined a procedure that all active refrigerators would be monitored by the automated temperature monitoring system. The policy also noted that when units were out of compliance for 30 consecutive minutes the system would send a phone or text notification to the designated food service supervisor. There was no documentation of implementation of an effective system of equipment monitoring to ensure food safety.

Based on observation, interview and document review, the facility failed to develop and implement safe food storage and food preparation systems to avoid sources and transmission of infections as evidenced by:

1. Failure to provide safe/effective dietetic services as evidenced by findings of unsafe food storage and handling practices (Cross Reference A620 and A749).

2. Failure to provide a hospital wide infection control program to conduct effective surveillance that would prevent the transmission of food borne infections in the dietary department (Cross Reference A 749)

The cumulative effect of these systemic problems resulted in the hospital's failure to meet statutorily mandated compliance with the Condition of Participation for Infection Control.

Findings:

During an interview at 11:15 a.m. on 3/17/11, Infection Control Staff EE stated food and nutrition services had developed some matrices due to food safety issues identified during a previous survey and provided two Nutrition and Food Service Quarterly Reports presented to the quality committee; one on 12/2/10 and one on 2/3/11. Both reports identified the "Surveyor Finding: cold foods in prep area for peds (pediatric room service) were held at temperatures greater than 41?F." The quarterly reports both stated the corrective action for the finding was "cold preparation units are continuously monitored by the Awarepoint Temperature Monitoring system to notify supervisors of issues". During a concurrent interview, Staff EE stated she was satisfied any food safety issues were addressed.

During an interview at 1:15 p.m. DMS A stated he was in error when he provided the information that cold food refrigeration for peds was continuously monitored. He stated the refrigerators were monitored manually once a day in the a.m. and that although some refrigerators were hooked to the continuous system, the reach in refrigerator in the pediatric room service area was not one of them and never had been.



14545




26985

Based on food production observations, staff interviews and document reviews, the hospital failed to ensure dietary management staff provided effective oversight into food services as evidenced 1) lack of effective monitoring system for foods held in refrigerated storage; 2) lack of a comprehensive system to ensure cooldown monitoring of potentially hazardous foods; 3) lack of an sanitation per manufacturer's guidance of the hospital's ice machines; 4) lack of effective air gaps of food production equipment; 5) lack of effective ware washing of utensils and equipment; and 6) lack of flushing enteral feeding supplies prior to the addition of new enteral formula. Failure to ensure effective systems to prevent the transmission of hospital acquired infections such as foodborne illness may result in further compromising patients' clinical condition and in severe instances may result in death.

Findings:

Food Service

*1. During initial tour on 3/15/11 at 10:25 am, in the cold production refrigeration (R-22) it was noted there was a metal pan labeled as taco chicken that was dated 3/13/11, the temperature of the item was noted to be 45?F. An additional pan of ham also dated 3/13/11 had a temperature of 43?F. In a concurrent interview with DS Y he stated that he had not used any of the chicken and to his knowledge it was placed in the refrigerator on 3/13. He further stated he was unsure of when the ham was placed in the refrigerator. Concurrent observation also noted that the thermometer, along the back wall of the unit, which read 34?F. It was also noted that there was a remote (electronic reading/recording performed at an alternate location) temperature probe mounted to the interior right hand side of the unit.

In an interview on 3/15/11 at 10:30 am, with DMS B she stated refrigerator temperatures were monitored by supervisory staff at the beginning of each day. In an interview on 3/16/11 at 10:10 am, with DMS H he acknowledged that food holding temperatures should be 41?F or below. On 3/16/11 at 4 pm, in an interview with DMS A he stated that the temperature of the unit was monitored via a remote system. In a follow up interview on 3/17/11 at 1 pm, with DMS A he stated that he was mistaken and that the refrigerator's remote monitoring system was not utilized because the system was inaccurate. He further stated that in place of the automated monitoring he instructed supervisory staff to check refrigerator temperatures every morning.

Review on 3/17/11 at 2 pm, review of remote temperature recording print-out noted that the system recorded that on 3/15/11 at 10:30 am, the electronic log noted a temperature that was between 44.5 and 51.9?F which was consistent with the temperature of the of the chicken and ham taken on 3/15/11 at 10:25 am. While the hospital was recording refrigerator temperatures on a daily basis, the recorded temperatures did not accurately reflect food temperatures.

Dietary policy 05.530.34 titled "Holding Food Temperatures" revised 1/11 noted that food holding temperatures "will always meet or exceed the California Retail Food code standards for cold meats 36?-41?F."

*2. During general food storage observations on 3/15/11 at 11 am, it was noted that in the cooks refrigerator there was chopped sausage dated 3/15 with a temperature of 80?F and penne pasta dated 3/14. In addition in the cold production refrigerator there was taco chicken dated 3/13, all of which were potentially hazardous foods (PHF's). PHF's are those foods capable of supporting bacterial growth associated with foodborne illness (Food Code, 2009). In an interview on 3/15/11 at 3:25 pm, with DS J the surveyor asked him to describe how he ensured leftover PHF's were safe to use at a later time. He stated that after the items were cooked he would put the item in either the blast chiller or in the cooks' refrigerator. He further stated that he would monitor the temperatures with the expectation that the food reached 70?F within 2 hours and 41?F or lower within an additional 4 hours. A follow up observation on 3/15/11 at 3:30 pm, noted that the temperature of the sausage was 49?F.

Review on 3/15/11 at 3:35 pm, of hospital document titled "Blast Chiller Temp Log" dated 3/2-3/13/11 and concurrent interview with DS E revealed that there were no documented entries of the observed items. DS E, who had supervisory responsibility for food production activities, she stated she did not have any logs past 3/13/11. She stated that on 3/14/11 a construction project was initiated and the construction crew covered the blast chiller entrance with a plastic tarp. She also stated that while she was working on 3/14/11, she was unaware that the construction project was started. DS E also stated that the hospital did not monitor the cooldown of pasta items since they rinsed the item with cold water.

In a follow up interview on 3/16/11 at 10 am, with DMS H he confirmed that the plastic was put up on 3/14/11. He also acknowledged that to his knowledge supervisory staff did not provide any guidance for cooldown of PHF's in the absence of the blast chiller. The standard of practice would be ensure that all previously cooled PHF's would be monitored for cooldown, regardless of cooking method.

Review on 3/16/11 at 4 pm of departmental in-service dated 11/20/10 intended for food service managers and supervisors noted that the training addressed standard operating procedures ensuring safe food handling procedures. While supervisory staff was trained in the basic principles of safe food handing practices there was no evidence that the hospital fully developed consistent procedures relative to the types of foods that were prepared in the department. Dietary policy 05.530.34 titled, "Food Cooling Procedures" revised 1/11 guided staff that foods would be to 70?F within 2 hours and to 41?F or less within an additional 4 hours. The procedure also guided staff to use the blast chiller whenever possible; however did not guide staff on procedures when the blast chiller was unavailable.

3. On 3/15/11 starting at 10:00 a.m. during the initial kitchen observations, eight six inch deep quarter steam table pans were observed on a cart in the walk-in freezer. The pans were each individually covered with plastic wrap, labeled "meat sauce" and dated 3/15 , 3/18." Temperatures of three of the pans were obtained and were 102?, 120?, and 110?F. During a concurrent interview DMS A revealed Dietary Staff AA had prepared the sauces that morning.
At 10:15 a.m. during an interview, Dietary Staff X stated he had prepared the meat sauce that morning. He stated "the blast chiller is down" so he asked the supervisor, Dietary Staff E, who told him to put it in the freezer "about 9:00 a.m."

On 3/17/11 at 10:45 a.m. Dietary Staff H provided the Production Worksheets Report for 3/15/11 that revealed the meat sauce temperature was 175? when prepared, however time of preparation was not indicated. A hand written note on the report "cool temp from freezer 2:30 p.m. 39?". During a concurrent interview DS H stated this was the only place the temperature was recorded for the meat sauce on 3/15.
Review of the hospital Food Cooling Procedures, Policy 05.530.34, revised January 2011 provided the guidance: The rate of cooling from 135 to 70 within 2 hours and from 70 to 41 or less within 4 hours. During an interview on 3/17/11 DS H acknowledged additional temperatures should have been taken two hours into the cooling process to ensure food safety, and stated "we need to have procedures to follow for when the blast chiller doesn't work." Additionally, DS H stated he would have expected that temperatures of all pans of food would have been taken.

4. At 11:30 a.m. on 3/15/11 meal preparation activities were observed in the "Blue Room," (pediatric room service) where during a concurrent interview; DMS A stated "We serve all the pediatric units all day room service from here. 7 a.m. - 7 p.m. We don't stop".

The single-door refrigerator was observed to have temperature 45 ? F (Fahrenheit) and contained assorted potentially hazardous foods including meat sandwiches, desserts, puddings and cottage cheese and fruit plates. Dietary Staff U took the temperature of a random turkey sandwich dated 3/15 and it was 49.5? and a pudding also dated 3/15 was 41.3?F.
At 3:20 p.m. the same refrigerator temperature was observed to be 46? and a turkey sandwich labeled 3/15 had temperature of 49? and puree fruit labeled 3/15 had temperature 45?. No prepared food items had time of preparation listed. Concurrent interview with Dietary Management Staff (DMS) B revealed the refrigerator was in constant use with the door opened and closed, and re-stocked as needed throughout the day with identical looking prepared food items labeled by date.

On 3/17/11/ at 9:00 a.m. the hospital provided temperature monitoring reports from 3/15/11 for the Blue Room that revealed on 3/15 cold food temperatures were taken for breakfast between 6:28 a.m.-6:34 a.m. and for lunch at 12:28 p.m. During an interview at 10:30 a.m. DMS B stated the cold food temperatures had not been taken at any other time; temperatures would not be anywhere else and acknowledged the sandwiches and other items were labeled with date only and it was not possible to determine how long any given sandwich or cold item had been in the refrigerator and at the observed temperatures.

On 3/17/11 at 9:15 a.m. DMS B stated the temperature of the refrigerator (R6) was taken once a day and provided the document titled PFS Refrigeration Temperature Log that revealed two temperatures were recorded twice per day at unspecified time. Temperature ranged from 23? to 40?F during the period 3/13/11-3/17/11.

On 3/17/11 at 12:00 p.m. review of Policy 12.100.2 Room Service Temperature Monitoring issued October 2010 provided the guidance refrigerator temperatures were to be monitored twice a day at 6:00 a.m. and 4:00 p.m., cold food temperatures would be recorded at the beginning of each meal, and milk and cold meat sandwiches will be rechecked after two hours during meal service. The hospital failed to ensure foods were held at 41 degrees F. during service, or that foods held at greater than 41 degrees were discarded after four hours.

*5. On 3/15/11 at 1:35 pm, the hospitals' procedure for cleaning ice machines was reviewed with Engineering Staff (ES) A. He stated that on a quarterly basis he "sanitized" the machines. He stated that he used a powered cleaner in the condenser unit and a sanitizer in the ice holding bin. He also stated that he used an identical process in all of the hospitals' ice machines.

Review on 3/15/11 at 3 pm, of the products used revealed that the powder was an ice machine cleaner and the liquid was an ice machine sanitizer. Concurrent review of the manufacturers' guidance revealed a recommended semi-annual cleaning of the ice making system. The specifications described the cleaning of the ice machine with the powdered ice machine cleaner using a solution temperature of at least 120?F and allowing the solution to circulate through the ice producing mechanism. The manufacturer's guidance also included removal of some of the internal hoses. Similarly the instructions guided staff to fill the reservoir with the sanitizing solution. The guidance also specified the cleaning and sanitizing of the ice storage dispenser. While the hospital was using the manufacturers' recommended chemicals, the procedures implemented were not consistent with the manufacturers' guidance, specifically the hoses were not removed, the ice producing mechanism was not sanitized and the cleaning solution was not used in the ice holding bin.

Review on 3/17/11 at 9 am, of hospital procedure titled " Market Forge Unit " (the brand of ice machine) guided staff to clean the condensing unit with an ice machine cleaner and to disinfect the ice bin and rinse. While the hospital developed procedures to for preventive maintenance of the ice machines, the procedures were not consistent with the manufacturers' guidance.

*6. During general food production observation on 3/15/11 beginning at 10 am, it was noted that the food production sink in the cold food production area had a direct plumbing connection into the waste water system. In an interview on 3/15/11 at 10:45 am, with DS Y he was asked where he would wash fruits/vegetables that were not washed prior to packaging. He indicated he would use the 2 compartment sink in the cold production area. In a follow up interview with DMS C on 3/15/11 at 12:45 pm, he stated that the 2-compartment sink was previously located along the wall in the food production area, but was recently moved to the center of the room. In a concurrent interview with Administrative Staff B he acknowledged that the sink was not installed with the required air gap. It would be the standard of practice to install food production equipment through the use of an air gap to prevent contamination of equipment in the event of waste water backflow (Food Code, 2009).

*7a. During general food production observation on 3/15/11 at 10:45 am, it was noted that DS AA was chopping parsley. Upon completion of the task he was observed rinsing the knife off with water and placing in the holder. In a follow up interview on 3/15/11 at 11 am, the surveyor described the observation to DS AA and asked if this was his usual method of knife storage after chopping the parsley. He replied that it was.

Dietary policy 05.520.20 titled "Food Contact Surface Cleaning and Sanitizing" guided staff that all utensils should be effectively cleaned and sanitized between uses.

*7b. During general food production observations on 3/15/11 at 10:50 am, it was noted that DS Z was using a large floor mounted steam kettle. In a concurrent interview he was asked to describe the cleaning process. He stated that he would wash the item with water and a detergent that he obtained from the manual dishwashing area after he would rinse the item with water. He then stated that the kettle was "good to go for the next round." The surveyor confirmed with DS Z the process he described. He acknowledged that this was his normal process for cleaning in-place equipment.

In an interview on 3/16/11 at 10 am, with DMS H he stated that to his knowledge the department did not have procedures related to cleaning the steam kettles.

It would be the standard of practice to ensure that all equipment is effectively cleaned, rinsed, and sanitized, after use (Food Code, 2009). The knife was rinsed with water only before re-use, not cleaned with detergent, rinsed and sanitized; the kettles were only cleaned with detergent and rinsed, but not sanitized before re-use.

*8. On 3/15/11 at 3:45 pm, cafeteria food storage practices were reviewed. It was noted that there was a salad bar area that had 3 separately refrigerated table-top units. It was also noted that each of the units had an externally mounted temperature gauge. The 1st and 3rd units displayed temperatures of 22 and 24?F respectively; however the 2nd unit displayed a temperature of 40?F. This 2nd unit contained several potentially hazardous foods including tomatoes at a temperature of 43?F and cut carrots-56?F. The first unit with a temperature of 22?F had boiled eggs at a temperature of 43?F. A follow up observation on 3/16/11 at 4 pm, revealed that in the 2nd salad bar unit there were carrots at a temperature of 56?F and beets at 49?F. It was also noted that the temperature display for this unit was 39?F.

In an interview on 3/15/11 at 3:50 pm, with DMS A and RD BB, they stated that she monitored cafeteria food temperatures. She described a system where temperatures were taken at the beginning of breakfast lunch and dinner meal service. DMS A also described a system where some lunch and dinner items were the same for these 2 meals. DMS A and RD BB were asked to demonstrate the length of time that the identified items were in service. They stated that they were unsure but thought that the items may have been replaced during the course of meal service. DMS A also stated that the hospital recently moved into the newly renovated cafeteria space and that DMS C had a punch list of items that needed to be addressed. He also stated he was unsure if the hospital identified that the salad bar unit was not maintaining cold food temperatures. In a follow up interview on 3/17/11 at 4 pm, DMS A acknowledged that the current system evaluated temperatures at the beginning of meal service for a specific point-in time, rather than evaluation of temperatures over the continuum of meal service.

Review on 4/17/11 at 1:30 pm, of the dietary document titled "UCSF Cafeteria Punchlist" failed to identify that the #2 salad bar was not maintaining cold food temperatures. It would be the standard of practice for safe food handling that foods be monitored for time/temperature control. While it may be possible to monitor foods based only on time as the public health control the standard of practice would be to develop a system that indicated the point at which 4 hours passed (Food Code, 2009). The hospital was unable to demonstrate the existence of a system that either ensured either time/and or temperature a public health control measure.

Nutrition Care

Patient 36 was admitted with diagnoses including respiratory failure. An observation on 3/16/11 at 2:15 pm, noted that the patient was receiving feeding through a gastrostomy tube (a tube in the stomach, Medline 2011). It was noted that the feeding was running at 65 cc's/hour with approximately 125 cc's left in the bag. It was also noted that the bag was hung on 3/15/11 at 2:30 pm and there was approximately 125 cc's of feeding remaining in the bag.

In a concurrent interview with RN CC the surveyor asked him to describe the process for handling the enteral feeding. He stated that Patient 36 was on a combination feeding of equal volumes of Promote and 2 Cal/HN. He also stated that prior to hanging the feeding he would check the physicians' order to be sure he had the correct feeding, verify the feeding and route and make sure that the product was not expired. He also stated that he filled the bag with enough feeding to cover a 4-hour period and stated that as the bag became empty it would be refilled. He further stated that the bag and tubing was changed every 24 hours. There was no indication that nursing staff flushed the enteral feeding bag with water prior to adding additional formula. The safest practice to ensure the prevention of bacterial contamination of the enteral feeding would be to flush the system with sterile water prior to the addition of feeding during the 24 hour timeframe for administration sets and bags (American Society for Enteral and Parenteral Nutrition, 2007).

Medical record review was conducted on 3/16/11 beginning at 2:30 pm. Physician diet order dated 3/14/11 noted an order for equal volumes of feeding of promote and 2Cal/HN starting at a rate of 20 cc's/hour and advancing by 15 cc's every 8 hours until a goal rate of 65 cc's. Review of hospital document titled "Adult Critical Care Flowsheet" noted that the feeding was started on 3/14/11 at 11 am at a rate of 15 cc's. It was noted that from 3/14-3/16/11, nursing staff would have added feeding to existing formula from one to three times per 24 hour shift depending on the amount of feeding delivered/hour.




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Cold Food Storage on Patient Units

1. During initial tour observation of the 6-long pediatric unit on 3/15/11 at 10:04 AM, while accompanied by RN 4, the pantry patient food refrigerator thermometer registered 50 degrees Farenheit (F), and there was no log of temperature checks for the refrigerator on the unit. The refrigerator shelves were fully stocked with a variety of food items.

When concurrently interviewed, RN 4 said the refrigerator was electronically monitored and may have been recently stocked so that the temperature would be lower.

Record review on 3/17/11 of the Awarepoint electronic monitoring record for the 6-long pantry refrigerator indicated that during the 24-hour period of 3/15/11, hourly temperatures averaged between 47.3 and 53.1 from 9 AM through 10 PM (13 hours of the 24-hour period). The actual temperatures during these 13 hours ranged between 50.6 and 53.4 degrees F. The 3/15/11 Awarepoint graph for the 6-long refrigerator indicated temperatures "out of range with immediate correction required" for the hours between 9 AM and 10 PM.

Review of blank food requisition reports used by 6-long, indicated foods that were stored in the pantry refrigerator included 8-ounce cartons of chocolate, low fat, and whole milk, chocolate and vanilla puddings, and beef and chicken baby food.

2. Observation on 3/15/11 at 10:15 AM, while accompanied by RN 5, found the patient refrigerator on the bone marrow transplant (BMT) unit had a thermometer that registered 50 degrees F.

According to Stanford Medicine Bone Marrow Transplantation, "... After infusion (of bone marrow), the patient may ...be very susceptible to infection... Infections are likely in the patient with severe bone marrow suppression. Bacterial infections are the most common. Viral and fungal infections can be life threatening. Any infection can cause an extended hospital stay, prevent or delay engraftment (donated cells make their way to the marrow and begin producing new cells), and/or cause permanent organ damage." (http://cancer.stanford.edu/blood/leukemias/bmt.html, 2011, p 6, 7).

During concurrent interview with RN 5, he said the BMT patient refrigerator was electronically monitored.

Record review on 3/16/11 of the facility's "Awarepoint" electronic monitoring system records for the BMT refrigerator indicated that during the 24 hour period of 3/15/11, the BMT refrigerator's lowest temperature was 50.6 degrees F. Its highest temperature was 53.4 degrees F. The hourly average temperatures for the 24-hour period ranged between 51 and 51.6 degrees F. The report graph indicated the BMT refrigerator was, "out of range with immediate correction required" for the entire 24-hour period.

Review of the food requisition list for the BMT refrigerator included 8-ounce cartons of chocolate, low fat, and whole milk.

During interview with RN 5 on 3/17/11 at 1:40 PM, he said the BMT refrigerator was pulled out of use on 3/16/11. RN 5 said one yogurt,one carton of milk and juices were removed from the refrigerator and discarded.




26917

Based on interview and record review, the facility failed to document recent experience in the privileges requested in 2 of 10 sampled credentials files (Practitioners 4 and 5). The deficient practice had the potential to allow medical staff to be privileged to perform procedures in which they had not had recent experience.

Findings:

Review of the facility's medical staff bylaws dated 8/31/10 indicated that privileges would be determined on the basis of current clinical competence, and that factors to be considered included experience and "performance of a sufficient number of procedures each year to develop and maintain the member['s]... skills and knowledge..."

Review of the agenda for the credentials committee meeting on 3/15/11 indicated that Practitioners 4 and 5 were being considered for reappointment to the facility's medical staff on that date.

Review of Practitioner 4's credentials file on 3/16/11 indicated that she had requested special privileges in interventional radiology which included radioembolization with yttrium-90 and image guided percutaneous thermal or chemical tumor ablation. The privileges form indicated that the facility's criteria for renewing these privileges included performance of at least two of each procedure in the last two years. No notations were present in the credentials file indicating that any of Practitioner 4's requested privileges had been denied. Review of data in Practitioner 4's credentials file regarding her activity at the facility indicated that they included all ICD9 (diagnosis) codes for inpatient and outpatient, but the CPT codes (for the services performed) were truncated after the top ten codes by volume for inpatient and the top ten for outpatient. Review of both listings indicated that there was no documentation Practitioner 4 had performed two radioembolizations and two tumor ablations in the past two years.

In an interview on 3/16/11 at 11:16 a.m., Staff 101 stated that the facility had expanded the listing of the ICD9 codes but that the CPT codes would go on forever. In an interview on 3/16/11 at 12:22 p.m., Staff 102 stated that Practitioner 4 was not certified to do radioembolizations because she hadn't been to the course but that he was certain Practitioner 4 had performed tumor ablations and could print out the procedure notes to prove it.

Review of Practitioner 4's procedure notes subsequently provided by the facility indicated that she had performed more than two tumor ablations in the last two years.

Review of Practitioner 5's credentials file on 3/16/11 indicated that she had requested special privileges in radiation oncology which included central nervous system (CNS) brachytherapy and that the department's medical director had recommended the request be approved. The privileges form indicated that CNS brachytherapy required "additional training and/or experience". No notations were present in the credentials file indicating that any of Practitioner 5's requested privileges had been denied. Review of data in Practitioner 5's credentials file regarding her activity at the facility indicated that they included all ICD9 codes but only the top ten CPT codes for inpatient as well as the top ten CPT codes for outpatient. Review of both listings indicated that Practitioner 5 had treated patients with CNS diseases, but did not document Practitioner 5's recent experience in CNS brachytherapy.

In an interview on 3/16/11 at 1:29 p.m., Staff 103 stated that the codes for CNS brachytherapy were not included in the listing in Practitioner 5's credentials file but that she could have the data manager pull the number of cases Practitioner 5 had done.

Review of a price list and activity report for Practitioner 5 subsequently provided by the facility indicated that the CPT code for CNS brachytherapy was 77778 and that Practitioner 5 had not provided that service since 1/1/09.

Based on interview and record review, the facility failed to apply national standards and its own nursing policies regarding surgical counts to its interventional radiology (IR) service. The IR policies provided no mechanism of accounting for guidewires in procedures where the incision was less than 2 centimeters (cm). Two of 8 IR patients (Patients 13 and 22) whose records were reviewed had procedures in which guidewires were used but no documentation of either surgical counts or radiographic confirmation that there were no unintentionally retained foreign objects (RFO's). The deficient practice resulted in a missed opportunity to prevent RFO's.

Findings:

1. Review of the facility's undated policy on "Interventional Radiology Sponge and Instrument Accountability" indicated that the facility would review final radiographs for the detection of RFO's on "procedures involving an incision greater than 2 cm." The policy did not address procedures with an incision less than 2 cm.

Review of the facility's nursing policy on "Counts: Instruments, Sponges, Needles, and Small Items" indicated that the facility's policy was to count all instruments "on all procedures in which the likelihood exists that they could be retained".

Review of the Centers for Medicare & Medicaid Services (CMS) interpretive guidelines for hospitals indicated that alteration or transposition of human tissue with probes and needles as well as injection of diagnostic substances (other than injections by nursing ordered by a physician) were considered surgery and that recommendations promoted by surgical organizations therefore applied and were considered standards of practice.

Review of the Association of periOperative Registered Nurses (AORN) "Recommended Practices for Prevention of Retained Surgical Items" indicated that the recommendations were "intended as guidelines adaptable to various practice settings. These practice settings include... radiology departments..." The recommended practices further indicated that "Instruments should be accounted for in all procedures in which the likelihood exists that an instrument could be retained."
Review of the article "Preventing the Retention of Foreign Objects during Interventional Radiology Procedures" (Pennsylvania Patient Safety Advisory, Vol. 5, No. 1 - March 2008, pp. 24-27, accessed at http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2008/Mar5(1)/Pages/24.aspx) revealed that the Pennsylvania Patient Safety Authority had received a report of a retained guidewire following lower extremity angiography. The article stated that retained surgical items were possible in IR and that surgical counts should therefore be done in IR.



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2. Record review on 3/17/11 indicated Patient 13 had an IR procedure for placement of a transjugular intrahepatic portosystemic shunt (TIPS) to treat recurrent ascites on 3/8/11. The procedure report made seven references guidewires that were used at various times during the procedure, as follows:
* A 0.018 inch microwire was placed in the superior vena cava;
* A 0.035 inch "LLT" guidewire was passed into the "IVC (inferior vena cava)" and was, "...left in to function as a safety wire;"
*A "Terumo" guidewire was placed in the middle hepatic vein and later withdrawn;
*An "Amplatz" guidewire was inserted in the right hepatic vein;
*A "Bentson" guidewire was put down the main portal vein into the splenic vein;
*"...the Bentson was exchanged for an Amplatz...;" and
* "...The guidewire was placed into the IVC...a cordis catheter was placed over the wire into the SVC (superior vena cava)... It was secured to the neck with suture..." "

There was no record of a pre-procedure or post-procedure count of the guidewires used, and no documentation of their length, or whether or not they were straight. The procedure report did not indicate all of the guidewires were removed. On 3/9/11, the physician ordered an abdominal ultrasound by doppler (an imaging procedure that is not a radiograph) to evaluate the TIPS for Patient 13. Review of the ultrasound report dated 3/9/11, found the liver, gallbladder, pancreas, abdominal aorta, and urinary bladder were described. The TIPS and the hepatic vessels were described as patent with normal flow. The IVC was described as patent. The ultrasound report gave no indication in the description or in the impression that it had checked for unintentionally retained guidewires, or that the "LLT" guidewire that was left in for safety was identified.

3. Record review on 3/21/11 indicated Patient 22 had an IR procedure for a cholangiogram and tube removal. Review of the procedure report dated 3/16/11 indicated an "Amplatz" guide wire was passed through a hole in the patient's drainage catheter and the catheter was cut and removed over the guidewire. The report did not indicate the guidewire was removed. There was no record that the guidewire was counted before or after the procedure. There was no post-procedure radiographic image obtained to rule out a retained guidewire.

During interview on 3/21/11 at 11:10 AM with Staff 105, she said during a procedure, a cart containing all the available equipment and supplies is brought into the room and the proceduralist would ask for the wire or other equipment he needs. Usually the technician obtains the requested item from the cart and gives it to the proceduralist. The packaging wrapper that covers each item is placed aside on a table when the item is opened, whether or not it is used.

Staff 105 said no count of items used (such as guidewires) was done before or after a procedure. She said at the end of the procedure, all the packaging wrappers are scanned into the inventory Pixis machine by the technologist for billing purposes only. The nurse was present during a procedure to support the patient.

Review of Perioperative Standards and Recommended Practices, 2011 Edition (PSRP), indicated under Recommendation I, page 264, "...A consistent multidisciplinary approach for preventing RSIs (retained surgical items) should be used during all surgical and invasive procedures... that accounts for all items opened and used during a procedure... all items need to be accounted for at the end of a procedure so that all team members can be sure that a surgical item is not left in the patient..." Under Recommendation III. b., page 269, the PSRP indicated, "...Counts of sharps and miscellaneous items should be performed: before to establish baseline... when new items added to the the field... at skin closure at the end of procedure..." Under III.b.1., the PSRP indicated, "Miscellaneous items that should be accounted for include but are not limited to... vascular inserts..." (aornesubscription.org)

Review of the facility's policy and procedure, Interventional Radiology Sponge and Instrument Count (P&P), indicated under policy, "...Keeping track of the location of items used in and around the sterile field is a shared responsibility between proceduralists, technologist and nursing personnel. Items that are percutaneously inserted and removed will be inspected for intactness..." Under Procedure C., the P&P indicated, "1. Throughout the procedure, the physician will visually and manually inspect all percutaneous catheters, wires, instruments, and devices, which are inserted and removed from the patient to ensure intactness."

The P&P's procedure for wires did no include a multidisciplinary approach. There was no baseline of the number or kind of wires used, and the P&P addressed only inspection of wires removed. It did not specify a multidisciplinary verification that all wires were removed.



21223

Based on interview and record review, the facility failed to require a complete medical history and physical examination (H&P) on every patient having surgery. The facility's medical staff rules and regulations required complete H&P's on patients having anesthesia but more limited H&P's on patients having moderate sedation, minimal sedation, or local anesthetics. One of 5 gamma knife patients whose medical records were sampled after completion of their procedure (Patient 17) had an H&P which did not include examination of the heart and lungs. The deficient practice sidestepped an opportunity to identify relevant health information prior to invasive procedures.

Findings:

Review of the facility's medical staff rules and regulations (revised 4/5/10) indicated that there were four categories of requirements for H&P's. Category 2 was for "Surgical or other invasive diagnostic or therapeutic procedures performed under the care of an anesthesiologist... or deep sedation performed under the care of a non-anesthesiologist" and cross-referenced another section (II.D) which required an H&P that included "Examination of at least 9 elements from the 7 Body Areas or 13 Organ Systems". Category 3 was for "Procedures performed under moderate sedation" and required "a directed" H&P for which the physical exam requirements were "- Cardiovascular and Respiratory assessment and - An assessment of the system or body part undergoing intervention." Category 4 was for "Procedures where minimal sedation and/or local anesthetic are used"; the physical exam requirements were "An assessment of the system or body part undergoing intervention".

Review of the facility's Governance Advisory Council (GAC) minutes indicated that the GAC had approved revisions to the bylaws and medical staff rules and regulations delineated in a bylaws committee report to the Executive Medical Board (EMB) dated 2/22/11. Review of the Bylaws Committee Report to the EMB dated 2/22/11 indicated, "It should be noted that the CMS Conditions of Participation for Surgical Services only require a 'complete' examination for those surgeries or procedures in which anesthesia services are required... It is only for Category 2 (surgical or other invasive diagnostic or therapeutic procedures requiring anesthesia) that a 'complete or comprehensive' examination is required." The approved revisions to the bylaws modified two references to "complete history and physical examination" by eliminating the word "complete". The approved revisions to the rules and regulations modified Category 2 of the H&P requirements to apply to "Surgical or other invasive diagnostic or therapeutic procedures performed under anesthesia (regional and/or general anesthesia, monitored anesthesia care (MAC) or deep sedation..." but retained the cross-reference to section II.D requiring examination of 9 elements. The revisions also modified Category 3 to require a "focused" rather than a "directed" H&P, but did not modify the delineation of the required components. The revisions did not modify Category 4. The revisions also modified section II.D to clarify that they applied to "a Category 2 surgery or other invasive diagnostic or therapeutic procedure..."

In an interview on 3/15/11 at 4:07 p.m., Staff 104 (the chief medical officer) stated that the facility's intent was to require varying degrees of H&P's based on the level of anesthesia, that category 2 required a higher level H&P and category 3 required a lower level H&P.

In an interview on 3/17/11 at 10:41 a.m., the surveyor told Staff 104 that the surveyor instructions were to interpret the regulations as requiring a complete H&P before any surgical procedure, not only those requiring anesthesia. Staff 104 then stated that the facility had also interpreted their policy that way, and that he was mistaken on 3/15 when he had stated otherwise. Staff 104 did not explain the apparent discrepancy between his revised comments, the bylaws committee report which emphasized the limited circumstances in which the H&P had to be complete and which proposed deletions of the word "complete" in the bylaws, and the text of the rules and regulations which specified varying degrees of completeness depending on the level of sedation used.

In an interview on 3/17/11 at 2:15 p.m., Staff 101 stated that the apparent contradiction between Staff 104's statements was because he was not knowledgeable on the topic. Staff 101 did not explain why the chief medical officer would not be knowledgeable about medical staff policies or why the facility had sent him to discuss topics with the survey team of which he had no knowledge. Review of the facility's plan of correction dated 3/2/11 in response to a survey completed 10/21/10 indicated that, contrary to Staff 101's statement, Staff 104 had been the person responsible for implementing the changes in the bylaws and rules and regulations regarding H&P's.




14545

Patient 17's record was reviewed on 3/17/11. Patient 17 had radiosurgery for trigeminal neuralgia on 3/10/11. The Patient Intake Form dated 3/7/11, indicated under the section, "Do you currently have or have you had any of the following illnesses/complaints?" that Patient 17 checked yes for asthma/bronchitis/emphysema."

Review of the first page of Patient 17's Consult Service form dated 3/9/11, indicated under the list of systems to be checked off as normal or abnormal that neurological was abnormal. The other systems included in the list, such as cardiovascular and respiratory, were not checked off as either normal or abnormal. The handwritten commentary associated with the list of systems addressed neurological signs and symptoms only. The third page of the 3/9/11 Consult Service form was titled Physical Examination. It had spaces designated for body systems in a head to toe physical examination including "cardiovascular" and "respiratory/chest," but only the blood pressure, heart rate, respiratory rate, oxygen saturation, general appearance, eyes, and neurologic sections had notations by the consultant. The cardiovascular and respiratory portions were blank.

Review of Patient 17's printed history and physical (H&P) dated 3/9/11 indicated, "Neurologic: Trigeminal neuralgia pain." The past medical history included asthma. Under physical exam, the H&P indicated Patient 17's blood pressure, heart rate, respiratory rate, and oxygen saturation, and that she was in no distress. The physical exam included the extraocular muscles, alertness, orientation, speech, facial sensation and gait, all parts of a neurological examination. There was no examination of the heart or lungs. There was no physical examination of Patient 17's heart or lungs that had been completed within the thirty days prior to her radiosurgery found in the record.

During interview on 3/17/11 at 11:55 AM, Staff 103 reviewed Patient 17's record and acknowledged examination of the heart and lungs was not included. She said the radiation therapist was responsible for checking to see that the history and physical was complete, but there was no pre-procedure checklist used by the radiation therapist.