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Based on observation, interview, and document review, the hospital failed to ensure there was a hospital wide Quality Assurance Performance Improvement (QAPI) program as evidenced by:

1. The failure to ensure audits were conducted for the glucometer quality control solution bottles (solution used to check if glucometer strips and machine are working properly) and other supplies; The failure to ensure audits were conducted for the fire watch monitoring process (fire watch an area that does not have automatic fire warning system); and The failure to ensure audits were conducted for an effective performance improvement program for the Checkpoint Monitoring Areas and Equipment. (Cross Reference A273).

2. The failure to ensure measurable improvements and timely interventions for patient food temperatures that were not within acceptable hospital developed parameters. (Cross Reference A297).

The cumulative effect of these systemic problems resulted in the hospitals' failure to meet statutorily mandated compliance with the Condition of Participation for Quality Assurance Performance Improvement.

Based on Administrative Staff interview and document review, the hospital failed to ensure:

1. An effective performance improvement program was developed for the facility's fire watch process that accurately reflected the compliance of departmental operations and

2. An effective performance improvement program for the Checkpoint Monitoring Areas and Equipment and

3. An effective perfomance improvement program for the glucometer quality control solution bottles and other supplies.

Failure to develop a comprehensive program that identifies opportunities for improvement may result in compromised patient outcomes in relationship to food and nutritional status and contracted services.

Findings:

1. The facility's Plan of Correction (POC) stated that they "complete 15 minute rounds of each department in the west wing building which surrounds the Dietary Department."

On 3/22/16 at 8:40 a.m., documentation provided titled "Fire Watch West Wing" indicated that the fire watch rounds of the first and second floors of the whole west wing were being covered hourly and that the fire watch log broke the different areas or departments inspected down into 15 minute increments. Many of the forms did not show which 15 minute increment in each area (department) was covered during the fire watch rounds. The original Field Visit (FV) report from OSHPD directed the facility to do the fire watch in accordance with OSHPD PIN 14 which designates an hourly fire watch round.

When interviewed at 8:40 a.m., Engineering Staff E stated that the facility was following the OSHPD fire watch procedure of hourly rounds and not 15 minute rounds. Staff stated that they were unsure how 15 minute rounds were added to the POC.

During an interview with Engineering Staff E on 3/22/16 at 11:15 a.m., he indicated the facility is not following the POC from 2/16/16 to present. He stated there was no quality assurance performance improvement measures in place to evaluate the Fire Watch West Wing for accuracy or completeness of the process. He stated the reporting structure for physical environment is through the Environment of Care Committee Safety Committee. He stated the committee met on 3/2/16. There was no indication during the review of the 3/2/16 agenda and committee minutes the Fire Watch West Wing was evaluated or discussed.

2. Review of undated hospital document titled "Checkpoint Monitoring Areas and Equipment" on 3/24/16 at 11:45 a.m., with Engineering Staff (ES) U revealed there were greater than 100 temperature monitoring sensors throughout the hospital. Concurrent review of the checkpoint inventory exhibited an alert threshold column. Some of the sensors had a value of 60 in this column, others were left blank. ES U stated that this designated when the alert system would trigger for engineering staff. Those marked 60 would trigger after 60 minutes and the blank ones would trigger after 120 minutes. Random review of 7 sensors revealed that 3 of the 7 exhibited instances where temperatures of refrigerators and freezers were out of range. It was also noted that there were no work orders generated for any of these instances. Additionally it was noted that food temperature ranges were not consistent. Not all food refrigerators were set to food holding standards of practice, rather were set to temperatures intended to hold medications. ES U stated that these ranges were long standing and that guidance for the temperature range was given by ES E.

During an interview with Engineering Staff E and Administrative Staff T on 3/24/16 at 10:30 a.m., Engineering Staff E and Administrative Staff T indicated the facility had not developed a quality assurance performance improvement process to evaluate the Checkpoint Monitoring System for all areas monitored by the Check Point System for the past two years and the Checkpoint Monitoring System had not been incorporated in the Environment of Care Committee or the hospital's Clinical Quality Committee.

3. During a concurrent observation and interview with nursing staff from the Emergency Department, 2N Telemetry, Cath Lab, and 1S Med/Surg on 3/23/16, revealed one of six glucometer supply storage units (each housing unit contained two glucometer quality control solution bottles needed to perform a blood glucose test) contained bottles with a sticker dated and placed on the bottles. During the concurrent observations and interview with the staff, four of four nursing departments (Emergency Department, 2N Telemetry, Cath Lab, and 1S Med/Surg) were not aware of weekly inspections to ensure expirations dates are clearly marked, legible, and with in use date.

During a concurrent interview and document review with Administrative Staff W on 3/24/16 at 12:00, she indicated she had updated the nursing environment of care inspection sheets and had included the glucometer strips and solutions dated correctly. She stated she had not been provided audits by the four nursing departments (Emergency Department, 2N Telemetry, Cath Lab, and 1S Med/Surg) to demonstrate compliance with the plan of correction. She stated no information from the audits had been provided to the Clinical Quality Committee meeting on 3/9/16 as per the plan of correction.

The Plan of Correction submitted by the facility on 2/3/16 indicated the following: "Department managers from each department that utilizes a glucometer was instructed to directly observe and confirm Glucometer Control Solutions and glucose Stat Strips are correctly labeled with correct expiration dates. A. StatStrips were found without expiration dates after opening. Investigations identified that expiration dates written direction on the solution containers can sometimes rub off. Corrective actions were to obtain and place stickers with Glucometer supplies. Expiration dates are written on the sticker and the sticker is attached to the Glucometer Control Solution and Glucose Stat Strips. The written expirations date does not rub off of the sticker and remains clear an legible. B. Staff were informed via department meetings. Monitoring: Each nursing unit will inspect Glucometer Control Solution and Glucose Stat Strips containers weekly to ensure expirations dates are clearly marked, legible, and with in use date. Data will be reported to IC Committee and through QAPI structure to CQC/BOT."




17065

Based on dietetic services observations, dietary document review and dietary and administrative staff interview, the hospital failed to ensure measurable improvements and timely interventions for patient food temperatures that were not within acceptable hospital developed parameters.

Findings:

During meal distribution observation and concurrent interview with Dietary Staff (DS) Q, on 3/21/16 beginning at 12 p.m. a test tray was conducted. DS Q stated that she was the person responsible for completing weekly test trays. DS Q selected a different unit each week and evaluated meals for temperature, palatability and appearance as well as several other elements. The tray was evaluated at the time the last patient received their meal. She stated that since the hospitals' dishwasher was non-functional maintaining food temperatures problematic. DS Q described that the hospital changed to plastic plates from Styrofoam several weeks earlier; however after the change temperature regulation seemed to be more problematic. There was no current plan to go back to the Styrofoam despite better results.

In an interview on 3/24/16 beginning at 9 a.m., with Administrative Staffs (AS) A and H they were aware that the change to plastic plates did not maintain temperatures. While they were in the process of developing a proposal for administrative staff to place an external dishwashing trailer on the hospital campus, the document was still in the formulation and approval stages, it would require an unspecified timeframe for approvals and implementation. There were no intermittent plans developed. Administrative Staffs A and H also stated education was provided to nursing staff to ensure patient readiness prior to meal service; however there was no monitoring for the effectiveness of this intervention and whether or not patient readiness was a contributing factor of suboptimal food temperatures.

Weekly facility documents titled "Patient/Resident Tray Assessment" from 2/28 to 3/21/16 revealed that 8 of 8 meal evaluations did not meet expected parameters with relationship to food temperatures. Each tray had the possibility of receiving a maximum of 18 points. The results of the temperature evaluation ranged from 0 to 7 points, with the majority of the meal trays receiving 2-5 points.

Review of hospital document titled "Performance Improvement/Risk Management/Patient Safety Plan 2016" noted that the scope of the plan is organization wide and applies to all departments to provide a framework of optimal patient care.

Review of facility document titled "Statement of Deficiencies" dated 12/30/15 noted that hospitals' program will "...measure, analyze and track quality indicators for Food and Nutrition Services ...Such data will be reviewed on a routine basis ...implement appropriate corrective and improvement activities ..."

Based on medical record review, nursing and administrative staff interview, the hospital failed to ensure effective procedures to ensure that verbal orders were not used as part of routine day to day operations in 3 (Patients 29, 30 and 31) records reviewed for clinical nutrition care. The use of verbal orders as routine communication may result in increased errors during order implementation with the potential to further compromise patient medical status.

Findings:

Verbal orders are those which are communicated in the presence of the physician, are intended to be used infrequently in emergent situations where it is impossible or impractical for the ordering physician to enter their own order without delaying the treatment of the patient (Code of Federal Regulations Section 482.23 (c)(3)(i)).

Patient 29 was admitted on 3/20/16 with diagnosis that included swelling, weakness and difficulty walking. Medical record review was conducted on 3/23/16 beginning at 11 a.m. Admission diet order for 3/20/16 was NPO (nothing by mouth). Follow up order dated 3/21/16 was for initiation of tube feeding (liquid feeding through a tube placed through the nose into the stomach). A comprehensive nutrition assessment was conducted on 3/21/16 at 8:19 a.m. The assessment resulted in recommendation for Novosource Renal at 50 cc/hour. The order was entered into the electronic medical record by the Registered Dietitian on 3/21/16 at 11:33 a.m. as a verbal order. The physician authenticated the order on 3/22/16 at 7:13 a.m. In a concurrent interview with Registered Nurse (RN) V she stated that based on the timing of the order it was likely that the order was finalized as part of the daily rounds in the intensive care unit. In a concurrent interview with Administrative Staff (AS) H she stated that she developed the verbal order guidance in accordance with language in the State Business and Professions code for Registered Dietitian. She was unaware of Federal regulatory guidance in relationship to verbal orders.

Food and Nutrition Policy titled "Telephone and Verbal Orders" dated 9/14 guided staff that all nutrition related orders would be entered into the electronic medical record and supported the use of verbal order terminology. The policy did not incorporate Federal regulatory guidance. Similarly the hospital policy titled "Medication Orders-Required Elements" dated 10/13 described the elements required for a valid medication order as well as guidance to " ...minimize the use of verbal and telephone orders ..." The policy did not describe situations in which verbal orders may be used; provide a mechanism to verify the identity and authority of the issuing practitioner; describe the elements required for inclusion of a verbal order or establish procedures for effective communication and authentication of verbal orders.

Additional medical record review on 3/23/16 at beginning at 2 p.m. revealed that verbal orders were also utilized in providing nutrition care for Patients 30 and 31.

Based on foodservice observations, dietary staff interview and dietary document review the hospital failed to ensure the provision of food and nutrition services as evidenced by lack of:

1. An effective system to monitor dietetic services refrigerators/freezers to ensure identification of non-functional equipment in a timely manner (Cross Reference A724);

2. A comprehensive preventative maintenance program for dietetic services food storage equipment (Cross Reference A724);

3. Effective infection control practices during food production and/or storage activities (Cross Reference A749);

4. Development of departmental policies and procedures and lack of effective oversight of food production activities (Cross Reference A620);

5. Timely interventions for issues identified during performance improvement activities (Cross Reference A297) and;

6. Development of a procedure that described the required elements for use of verbal orders in accordance with the standard of practice (Cross Reference A407).

The cumulative effects of these systemic problems resulted in the hospitals' inability to provide food and nutrition services in a safe and effective manner in accordance with the statutorily mandated Conditions of Participation for Dietetic Services.

Based on food production observations, administrative staff interview and dietary document review, the hospital failed to ensure:

1) The comprehensive development of operational procedures that fully reflected the depth and scope of dietetic services as evidenced by the lack of written/approved policies and procedures related to food production practices associated with foodborne illness;
2) The lack of an implementation plan when issues were identified in relationship to the hospitals' style of meal delivery;
3) The lack of actions when the department performance improvement plan that identified opportunities for improvement.

Findings:

1. Hazard Analysis Critical Control Plan (HACCP) plans are the key to regulatory compliance in relationship to food services. HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product (Food Code 2013). It would be the responsibility of organizations to individually evaluate operations and develop policies and procedures based on operations as guidelines for staff.

During evaluation of the hospitals' foodservice operational processes on 3/21 and 3/23/16 there were identified issues surrounding the lack of comprehensive identification of operational processes (Cross Reference A749). On 3/23/16 beginning at 9 a.m., the food and nutrition policy/procedure manual was reviewed. It was noted that while a manual was established the policies/procedures consisted primarily of personnel policies, such as calling in sick and annual leave, as well as those related to clinical nutrition care. Examples of draft policies included cleaning work surfaces, food storage, defective food containers and menu planning. There were no procedures that provided standardized guidance to staff on food production operations.

In an interview on 3/23/16 at 3:30 p.m. with Administrative Staff (AS) A, he stated that the contracted foodservice had written operational policies/procedures; however they would need to be approved by the hospital. In an interview on 3/24/16 at 11 a.m., with AS T she stated that it would be the responsibility of individual departments to present policies and procedures to hospital administration for committee approvals. While there were some policies that were pending approval by the hospitals' administrative bodies, the policies were related primarily to deficient practices of the Centers for Medicare and Medicaid Survey (CMS) dated 12/30/15 rather than based on an assessment of the hospitals' operational procedures.

Review of hospital document titled "Statement of Deficiencies" dated 12/30/15 noted that it was the responsibility of departmental management staff to "...implement policies that will ensure improved and effective oversight of food production activities ..."

2. During meal plating and test tray observation on 3/21/16 beginning at 12 p.m., it was noted that patients who received mechanically altered diets did not receive the same entrée as residents with regular diet orders. Rather than receiving rice pilaf as the starch, residents with pureed diet orders received cream of rice cereal. In a concurrent interview with Dietary Staff (DS) Q she stated that she was responsible for completing weekly test trays. She also stated that the tray for today would be a dysphagia II diet (a mechanically altered diet for patients with swallowing disorders). The test tray process consisted of temperature monitoring in addition to tasting the foods. The taste test was conducted on 3/21/16 at 12:30 p.m. While the regular tray was flavorful the cream of rice on the dysphasia diet was watery and flavorless. In a concurrent interview with DS Q she acknowledged that the flavor was bland and stated that that was the way "it always tasted."

Review of hospital document titled "Patient/Resident Tray Assessment" dated 3/21/16 documented the quality of the tray to be unsatisfactory. Review of recipe titled "Cream of Rice" consisted of water and cream of rice, flavors and/or ingredients that would not be similar or consistent with rice pilaf. Review of additional weekly test tray assessments beginning 2/28-3/21/16 noted that all of the assessments were considered to be unsatisfactory. While the trays were routinely tested there was no documentation evaluating the palatability of the food in relationship to taste.

3. In an interview on 3/24/16 beginning at 9 a.m., with Administrative Staffs (AS) A and H they were aware that the change to plastic plates did not maintain temperatures. While they were in the process of developing a proposal for administrative staff to place an external dishwashing trailer on the hospital campus, the document was still in the formulation and approval stages, it would require an unspecified timeframe for approvals and implementation. There were no intermittent plans developed. Administrative Staffs A and H also stated education was provided to nursing staff to ensure patient readiness prior to meal service; however there was no monitoring for the effectiveness of this intervention and whether or not patient readiness was a contributing factor of suboptimal food temperatures.

Weekly facility documents titled "Patient/Resident Tray Assessment" from 2/28 to 3/21/16 revealed that 8 of 8 meal evaluations did not meet expected parameters with relationship to food temperatures. Each tray had the possibility of receiving a maximum of 18 points. The results of the temperature evaluation ranged from 0 to 7 points, with the majority of the meal trays receiving 2-5 points.

Review of hospital document titled "Performance Improvement/Risk Management/Patient Safety Plan 2016" noted that the scope of the plan is organization wide and applies to all departments to provide a framework of optimal patient care.

Review of facility document titled "Statement of Deficiencies" dated 12/30/15 noted that hospitals' program will"...measure, analyze and track quality indicators for Food and Nutrition Services ...Such data will be reviewed on a routine basis ...implement appropriate corrective and improvement activities ..."

Based on observations, interviews, and document reviews, the hospital failed to ensure a safe physical environment for patients, visitors and staff as evidenced by the following:

1. Failed to protect its Kitchen/Cafeteria corridor separation wall by not following its kitchen project interim Life Safety procedures. (Cross Reference A710 [K17]).

2. Failed to protect its Kitchen/Cafeteria area by not following its kitchen project interim Life Safety procedures. (Cross Reference A 710 [K69]).

3. Failed to ensure that the physical environment of dietetic services was maintained in a safe and sanitary manner. (Cross Reference A724).

The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation for Physical Environment to ensure that a safe environment was provided to all patients, visitors, and staff.

31201


K17
Based on observation, interview, and document review the facility failed to protect its Kitchen/Cafeteria corridor separation wall by not following its kitchen project interim Life Safety procedures. This was evidenced by a lack of documentation provided for the Interim Life Safety Measure (ILSM) Evaluation dated 2/11/16, by incomplete documentation in its fire watch logs, by discrepancies in its fire watch procedures, and by not displaying a notice to the public that a fire watch was in progress. This could result in a delay in notification in the event of a fire and affected all patients, visitors, and staff in the west wing.

Findings:
1. The Plan of Correction (POC) stated that " An Interim Life Safety Measure form has been filled out and submitted to the Fire Marshal on 2/11/16. "
On 3/23/16 at 8:57 a.m., the formal Interim Life Safety Measure form dated 2/11/16 referenced in the POC was not provided upon request. An Interim Life Safety Measure form dated 9/2/15 was, however, provided. When interviewed on 3/23/16 at 8:57 a.m., Engineering Staff E stated that the Interim Life Safety Measure form had been submitted to the Fire Marshall when the fire watch was implemented in September of 2015.
2. The facility ' s POC stated that they " complete 15 minute rounds of each department in the west wing building which surrounds the Dietary Department. "
On 3/22/16 at 8:40 a.m., documentation provided titled " Fire Watch West Wing " indicated that the fire watch rounds of the first and second floors of the whole west wing were being covered hourly and that the fire watch log broke the different areas or departments inspected down into 15 minute increments. Many of the forms did not show which 15 minute increment in each area (department) was covered during the fire watch rounds. The original Field Visit (FV) report from OSHPD directed the facility to do the fire watch in accordance with OSHPD PIN 14 which designates an hourly fire watch round.
When interviewed at 8:40 a.m., Engineering Staff E stated that the facility was following the OSHPD fire watch procedure of hourly rounds and not 15 minute rounds. Staff stated that they were unsure how 15 minute rounds were added to the POC.
3. The POC stated that a notice to the public that a Fire Watch is in progress is displayed in the Cafeteria.
During a tour of the Cafeteria on 3/22/16, between 10:41 a.m., and 10:46 a.m., no public notification of a fire watch in progress was observed inside the cafeteria or on either of the two entrances to the cafeteria. When interviewed, at 10:41 a.m., Administrative Staff 1 stated that the fire watch sign was usually on the window of the doors.

K69
Based on observation, interview, and document review, the facility failed to protect its Kitchen/Cafeteria area by not following its kitchen project interim Life Safety procedures. This was evidenced by a lack of documentation provided for the Interim Life Safety Measure (ILSM) Evaluation dated 2/11/16, by incomplete documentation in its fire watch logs, by discrepancies in its fire watch procedures, and by not displaying a notice to the public that a fire watch was in progress. This could result in a delay in notification in the event of a fire and affected all patients, visitors, and staff in the west wing.

Findings:
1. The POC stated that " An Interim Life Safety Measure form has been filled out and submitted to the Fire Marshal on 2/11/16. "
On 3/23/16 at 8:57 a.m., the formal Interim Life Safety Measure form dated 2/11/16 referenced in the POC was not provided upon request. An Interim Life Safety Measure form dated 9/2/15 was, however, provided. When interviewed on 3/23/16 at 8:57 a.m., Engineering Staff E stated that the Interim Life Safety Measure form had been submitted to the Fire Marshall when the fire watch was implemented in September of 2015.
2. The facility ' s POC stated that they " complete 15 minute rounds of each department in the west wing building which surrounds the Dietary Department. "
On 3/22/16 at 8:40 a.m., documentation provided titled " Fire Watch West Wing " indicated that the fire watch rounds of the first and second floors of the whole west wing were being covered hourly and that the fire watch log broke the different areas or departments inspected down into 15 minute increments. Many of the forms did not show which 15 minute increment in each area (department) was covered during the fire watch rounds. The original Field Visit (FV) report from OSHPD directed the facility to do the fire watch in accordance with OSHPD PIN 14 which designates an hourly fire watch round.
When interviewed at 8:40 a.m., Engineering Staff E stated that the facility was following the OSHPD fire watch procedure of hourly rounds and not 15 minute rounds. Staff stated that they were unsure how 15 minute rounds were added to the POC.

3. The POC stated that a notice to the public that a Fire Watch is in progress is displayed in the Cafeteria.
During a tour of the Cafeteria on 3/22/16, between 10:41 a.m., and 10:46 a.m., no public notification of a fire watch in progress was observed inside the cafeteria or on either of the two entrances to the cafeteria. When interviewed, at 10:41 a.m., Administrative Staff 1 stated that the fire watch sign was usually on the window of the doors.

Based on dietetic services observations, dietary staff interview and dietary document review, the hospital failed to ensure an effective program that addressed the operational needs of dietetic services equipment as evidenced by 1) lack of effective system for remote temperature monitoring of the hospitals' refrigeration equipment; and 2) lack of a system that ensured dietetic services equipment, whose lifespan was exceeded, was replaced in a timely manner. Failure to ensure a comprehensive preventative maintenance program that may contribute to equipment failure, puts patients at risk for foodborne illness which can compromised medical status and in severe instances may result in death.

Findings:

1. During review of hospital operations on 3/21/16 beginning at 11:30 a.m., it was noted that the hospital experienced a failure of the dietetic departments' main refrigeration/freezer system affecting the departments' foodservice operations. Hospital document dated 3/19/16 submitted to the Department noted on 3/17/16 at 5:30 a.m., Supervisory Staff (SS) B notified the hospitals' engineering department of the issue. The affected units were designated by the hospitals' temperature monitoring system as K3 and K4 which were refrigerators as well as K5, a freezer.

In an interview on 3/21/16 beginning at 1:40 p.m., with Engineering Staff (ES) U he describe a remote temperature monitoring system that consisted of temperature sensors throughout the hospital, including multiple refrigeration units within dietetic services. He stated that if the sensor detected temperatures that were either higher or lower than the programmed parameters it would send an electronic alert to a computer screen in the Engineering Department. This screen was monitored 24 hours/day, 7 days/week. In the event an alert was detected Supervisory Staff (SS) B was the primary contact and Administrative Staff (AS) A was the secondary contact for dietetic services. In a follow up interview on 3/21/16 at 2 p.m., with ES E and ES U they stated that if the temperature sensor alarm goes off a work order is created and maintained within the system until the problem is resolved. They also stated that the problem was due to an ice build-up that was chiseled off, puncturing the line that supplied the refrigerant.

In an interview on 3/22/16 at 9 a.m., with ES E he stated that the procedure for temperature monitoring was not followed. In an interview on 3/22/16 at 10 a.m., with SS B she stated that she was not notified of the elevated refrigeration temperatures; rather she notified Engineering. She also stated that there has been no issue with ice build-up as the units were new. In a concurrent interview with AS A he also stated he was not notified of the refrigeration failure.
In an interview on 3/23/16 at 11:30 a.m., with AS A he stated he was not consulted in terms of which units would benefit from remote monitoring. Concurrent review of the hospitals café revealed that that there were no remote monitoring units, despite documented remote graphic monitoring sheets provided by ES E for the grab and go and soda refrigerator. In a concurrent interview with Dietary Staff (DS) S she stated someone from engineering removed these units 45 minutes earlier. Concurrent observation of K2 unit contained protein based products which would require temperature control for food safety.

In an interview on 3/23/16 at 1:30 p.m., with ES U he was unaware of the removal of the unit. In an interview on 3/24/16 at 10 a.m., with AS J she stated she was told by Engineering Staff (ES) E that the unit was removed 18 months earlier when the hospital moved to the new pavilion to be used in another area. In an interview with ES E on 3/24/16 beginning at 10 a.m., he stated that the monitoring unit was removed because it routinely demonstrated elevated temperatures since it was an open grab and go unit. He was unable to explain how removal of the remote temperature monitoring unit would ensure that foods were held at safe food temperatures.

In an interview on 3/23/16 beginning at 11:45 a.m., with the repair vendor he stated that the problem which was reported on 3/15/16 was due to a leak in the refrigerant line at the welding point, possibly due to expansion and contraction. He stated the first contact from the facility was on 3/15/16 at 6:08 a.m. He also stated the refrigeration units were manufactured and installed by the vendor he represented. The vendor also recommended routine preventive maintenance of the units. To his knowledge the hospital did not establish a contract for preventive maintenance services.

In an interview on 3/24/16 at 8 a.m., with ES U he stated that there were no preventive maintenance requirements for the refrigeration units.

Review of remote temperature monitoring graphs from 3/8 - 3/21/16 for K3 refrigerator revealed an elevation of temperatures beginning on 3/14/16 at 12 p.m. There was no work order despite a continued temperature elevation over the next 18 hours. Monitoring graphs for K4 refrigerator also noted daily, multiple temperature elevations from 3/8 through 3/15/16. There were no documented work orders for these dates. Similar elevations and lack of work orders were also noted for K5 (a freezer) on 3/10/16 and again beginning on 3/14/16 beginning at 6 a.m., with continued elevations above hospital parameters for the next 72 hours. Work orders were not generated until 3/19/16 after the unit was under repair. Lack of monitoring and work order initiation was seen for K9, a refrigeration unit in the basement. The unit demonstrated elevated temperatures beginning on 3/14/16 with multiple elevations through 3/17/16.

Review of draft hospital policy revised 1/16, titled "Checkpoint Temperature and Humidity Monitoring" noted that monitoring will occur for "...refrigerators, freezers ..." The policy describes what were defined as 5 rich client hosting application areas that included the engineering watch room, biomedical department, pharmacy, lab and nursing. Dietetic services was not included in these locations, despite the multiple refrigerators/freezers within the department. The policy also describes a visual alarm will notify the watch engineer, if the alarm does not clear itself the engineer will notify the department and create a work order.

Review of undated hospital document titled "Checkpoint Monitoring Areas and
Equipment" on 3/24/16 at 11:45 a.m., with ES U revealed there were greater than 100 temperature monitoring sensors throughout the hospital. Concurrent review of the checkpoint inventory exhibited an alert threshold column. Some of the sensors had a value of 60 in this column, others were left blank. ES U stated that this designated when the alert system would trigger for engineering staff. Those marked 60 would trigger after 60 minutes and the blank ones would trigger after 120 minutes. Random review of 7 sensors revealed that 3 of the 7 exhibited instances where temperatures were out of range. It was also noted that there were no work orders generated for any of these instances. Additionally it was noted that food temperature ranges were not consistent. Not all food refrigerators were set to food holding standards of practice, rather were set to temperatures intended to hold medications. ES U stated that these ranges were long standing and that guidance for the temperature range was given by ES E.

2. During initial tour on 3/21/16 beginning at 11:30 a.m., the K2 pass-through refrigerator was non-functional. The interior thermometer read 58°F. In a concurrent interview with SS B she stated that while the unit functioned for 1 or 2 days during March 2016 it has been essentially non-functional for multiple months. She also stated that while the unit was serviced, it was not effective. In a concurrent interview with AS A he stated that the interior thermometer and exterior temperature recording devices were not consistent. Review of the refrigerator log for February and March 2016 revealed that the unit was non-functional from 2/1 through 3/10/16. The unit was functional from 3/11 through 3/12/16 at which time it required service. Undated facility document titled "Kitchen Risk Assessment Report" noted the unit was 41 years old. The assessment for the useful life for this piece of equipment was not established. It was also noted that the equipment risk assessment was not comprehensive, accurate or complete. As an example, there were no small kitchen wares such blenders or mixers, all of which were observed in the kitchen, as part of the assessment. Similarly there were multiple pieces of equipment that were designated as a high risk for failure; however there was no plan developed to address the issue. The K2 refrigerator was listed as high risk of failure, despite that it was not functional. The facility steam kettle was designated as at high risk for failure, despite that it was a new piece of equipment.

Review of facility document titled "Statement of Deficiencies" dated 12/30/15 noted that a risk assessment was completed on all kitchen equipment and submitted to the Chief Operating Officer as well as reviewing the list with the Capital Equipment Request Committee and reporting progress to the Environment of Care (EOC)/Safety Committee. Review of hospital document titled "Capital Steering Committee" dated 1/21/16 failed to include any information regarding a risk assessment of kitchen equipment. Similarly the EOC Safety Committee meeting minutes dated 3/2/16 did not include any information on the risk assessment of kitchen equipment.

Based on observation, staff interview and record review, the hospital failed to ensure that a infection control program was implemented to provide the prevention, transmission and investigation of infectious disease process when:

Sanitary practices and a sanitary environment may result in practices associated with foodborne illness as well as promoting practices that may lead to cross contamination of food and food preparation surfaces. Foodborne illness may result in compromising medical conditions and in severe instances may result in death and which could lead to an ineffective hospital infection control program in preventing the spread of infectious diseases to patients and staff if problems were not identified. (Cross Reference A749).

The cumulative effect of these systemic problems resulted in the hospitals' inability to maintain an effective infection control program, in accordance with accepted professional standards of practice.

Based on dietetic services observations, dietary staff interview and dietary document review, the hospital failed to ensure food production activities were implemented in a safe and effective manner as evidenced by:

1) The thawing raw meat utilizing water in the absence of time/temperature monitoring and 2) retention of leftover foods in the absence of cooldown monitoring.

Failure to ensure comprehensive monitoring of foods during food production activities may result in practices associated with foodborne illness.

Findings:

1. Potentially hazardous foods are those that require time/temperature control for food safety. Protein based foods such as meat, whether they be cooked or raw, require time/temperature control. The standard of practice for thawing of meats may include running water provided time/temperature parameters are maintained and monitored. When thawing utilizing running water the following parameters must be met: 1) completely submerged under running water; 2) with sufficient water velocity to float off loose particles and for a period of time 3) that does not allow thawed portions, whether cooked or raw, to rise above 41 degrees Fahrenheit (°F) for a cumulative timeframe of greater than 4 hours including the time that is required for preparation/cooking or the time required to decrease the temperature to 41°F if being held for later use (Food Code, 2015).

During initial tour on 3/21/16 beginning at 11:30 a.m., walk in K04 there was a stainless steel pan with approximately 20 pounds of thawed, raw chicken dated 3/20/16. In a concurrent interview with Administrative Staff (AS) A and Dietary Staff (DS) AA they confirmed that the product was purchased frozen and was pulled from the freezer on 3/20/16. Administrative Staff A was unable to explain how this quantity of chicken was fully thawed in less than 24 hours. In a follow up interview on 3/22/16 at 11 a.m., with DS G he stated that the meat was pulled on 3/20/16 after which it was placed in a sink with running water and returned to the walk in to be prepared on 3/21/16 for the evening meal. He stated he thawed the meat for about 30 minutes but did not record elapsed time and/or temperature. In an interview on 3/23/16 at 11:45 a.m., with AS A he stated that while staff may use running water as a method to thaw meat, there was no monitoring system for time/temperature control. The hospital was unable to provide documentation of training for staff on thawing foods utilizing water.

Review of hospital document titled "Comprehensive Food Safety Self-Inspection" dated 2/12/16 documented that the operation was in compliance with thawing frozen foods.

2. The standard of practice would be to ensure that cooked PHF ' s are monitored for time/temperature control. Cooked foods should be cooled to 70°F or below within 2 hours and to 41°F within an additional 4 hours (Food Code, 2013). During food storage observation on 3/23/16 beginning at 8:30 a.m., in refrigerator K04 there was previously cooked roast beef. The surveyor asked AS A to review time/temperature monitoring for this item. He stated that this item was prepared by DS R and there was no monitoring as dietary staff were instructed not to keep leftover foods.

Review of facility document titled "Statement of Deficiencies" dated 12/30/15 noted that the facility was previously cited for lack of cooldown monitoring. The document also indicated that it was the standard of practice within the hospital to ensure effective cooldown monitoring.





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