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Based on review of policies, procedures, water treatment documentation and staff interview, the facility failed to ensure the joint venture dialysis staff developed and implemented policies and procedures specific to the acute or inpatient dialysis water treatment system.

Written policies and procedures provide guidance and consistency among staff and provide a resource for the monitoring and use of the specific water treatment used in the acute or inpatient setting. The acute dialysis water treatment systems in this facility included both portable reverse osmosis (RO) that could connect at the patient's bedside for patients too ill to travel to the "Acute Room", and the "Acute Room" where a specific water treatment system provides dialysis quality water for up to 5 patients. Failure to develop and implement specific policies and procedures for the specific water system used could potentially cause staff to monitor and/or use the water treatment system equipment inappropriately and then potentially dialyze patients using water treatment systems that are not operating within acceptable parameters.

The dialysis staff reported a census of 26 acute dialysis patients at the time of the survey. Findings for review of 1 of 1 "Acute Room" water treatment system and 4 of 4 portable ROs (the portable equipment that connects to a water source at the bedside to provide dialysis quality water) include:

1. Upon entering the facility on 7/18/11 at 12:55 PM, the facility administrative staff received a list for requested information that included the dialysis policies and procedures for patient care and water and dialysate.

On 7/19/11, the Acute Coordinator, RN (Registered Nurse) DA provided policies and procedures in 2 separate binders. One binder contained clinical policies and procedures and 1 binder contained technical policies and procedures (this included equipment and water treatment policies and procedures).

2. Each portable RO and the "Acute Room" water treatment system had logs staff completed before using
these water treatment systems. The logs had specific checks and tests for staff to complete that would show this equipment fell within acceptable parameters and was safe for patient use. Review of each of these logs revealed documentation that failed to reflect an actual numerical result, results that fell outside of the acceptable parameters with no supporting documentation that showed the appropriate personnel were notified and communicated the equipment was safe for patient use, illegible documentation, and blank areas on the logs. (Refer to A724)

3. During an interview on 7/21/11 at 7:35 AM, the Acute Coordinator, RN DA and Mechanical Tech II, DJ reported the acute or inpatient dialysis staff had no specific technical policies to provide guidance in the use of the equipment and/or water treatment systems. RN DA and Mechanical Tech II, DJ went on to report that the clinical or direct patient care policies and procedures specific for inpatient dialysis patients had recently been issued, however the technical policies and procedures staff used were specific for the chronic dialysis unit. The chronic dialysis unit's water treatment system had different components and had the capability to dialyze up to 21 patients at 1 time, compared to the "Acute Room's" capability to dialyze up to 5 patients at 1 time.

At 7:40 AM, RN DA and Mechanical Tech II, DJ acknowledged the need for the water treatment policies and procedures to be specific to the equipment and water treatment components in the inpatient or acute setting.

Based on document review, observation, and staff interviews, the Hospital administrative staff failed to protect all confidential patient information from unauthorized access in the following departments:

Therapy department of the main hospital: The Therapy administrative staff identified a daily average of 200 inpatient visits, Physical Therapy (PT) 125 patient visits, Occupational Therapy (OT) 125 patient visits and Speech Therapy (ST) 50 patient visits

Radiology Mammography Department at Mercy Main Hospital: The administrator identified a weekly average of 182 outpatients

Nuclear Medicine Department at Mercy Main Hospital: The Director of Nuclear Medication identified a weekly average of 32 inpatients and 70 outpatients

Mercy Franklin: Medical records department

Mercy North Surgery Center: The Operating Room Coordinator stated the surgery center had an average of 100 patients per month.

Mercy Main Endoscopy: The Director stated the staff performed an average of 285 bronchoscopies per year, 300 specialty endocscopies per year, approximately 4,500 gastroscopies per year, and approximately 4,500 colonoscopies per year.

Imaging Services: The Director stated the staff performed an average of 182 outpatient mammograms per day.

Cardiac Rehabilitation: The Director stated the Cardiac Rehabilitation program had approximately 70 current patients.

Weight Loss Clinic: The Director stated the clinic staff saw approximately 140 patients per week.

Cardiovascular Services: The Vice President stated the Cardiovascular Testing clinic had an average of 30 patients per day.

Failure to secure medical records against unauthorized access could result in identity theft and/or unauthorized disclosure of personal medical information.

Findings include:

1. Review of the Hospital policy, "Health Records Information Department", dated 7/11, revealed in part, "...all medical records will be secured and maintained by the Health Records Information Department ...
Records are protected against loss, destruction, tampering and unauthorized access or use...
Access to patient information is restricted to those employees with a need to know as is necessary for the performance of their job duties...
The information contained in the medical record belongs to the patient, and it shall be the responsibility of the hospital to protect this information from unauthorized release..."

A. Observation during initial tour of the Therapy area, on 7/25/11 at 3:00 PM, Staff M, Physical Therapist, Director for in-patient therapy, stated staff stored Physician orders for Physical therapy (PT), Occupational Therapy (OT) and Speech Therapy (ST) in an open bin area. Staff M stated the Physician therapy orders remained in the open bin until staff assigned treatments to the various therapists.

i. During an interview on 7/25/11 at 3:00 PM, Staff M confirmed the PT and OT's bins held approximately 40 Physician orders and the ST's bin held approximately 30 Physician orders dated from 7/23-25/11. Staff M confirmed the orders contained personal (name/date of birth/address/phone number/etc) and medical information (diagnosis/treatment orders/procedures/etc). Staff M stated Environmental Services cleaned the therapy area after hours unsupervised and would have access to the information on the Physician orders.

ii. During an interview on 7/25/11 at 3:05 PM, Staff L, VP of Performance Improvement and Professional Services, confirmed Environmental Services cleaned the therapy area after hours unsupervised and would have access to the information on the Physician orders.


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B. Observation, during tour of the Radiology Department at Mercy Main Hospital, on 7/26/11 at 9:00 AM, with Staff U, Administrative Director of Radiology revealed approximately 25 patient medical records located in hanging files in the technologist work area. The medical records contained demographic patient information, (name, date of birth, social security number) along with procedures completed. The hanging files were open and could not be locked or secured.

During an interview on 7/26/11 at 9:00 AM, Staff Q, Mammography Technologist said the files were stored in the hanging files overnight and staff were unable to lock the hanging files. Staff Q said housekeeping staff cleaned the mammography department after department staff leave for the day and would have access to the patient medical records.

C. Observation, during tour of the Nuclear Medicine Department at Mercy Main Hospital, on 7/26/11 at 9:10 AM, with Staff R, Nuclear Medicine Manager revealed a file cabinet under the desk in the nuclear medicine main office. The file cabinet had a broken lock. The file cabinet contained approximately 200 patient medical records.

During an interview on 7/26/11 at 9:10 AM, Staff R stated the file cabinet had a broken lock and contained approximately 200 patient medical records. Housekeeping staff cleaned the office at night, unsupervised, and would have access to the patient medical files and information.


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D. Observation during initial tour of the Mercy Franklin Medical Records department, on 7/20/11 at 9:00 AM, revealed approximately 150 medical records stored on shelves. Each medical record contained confidential personal and medical information.

i. During an interview, on 7/20/11 at 9:05 AM, Staff W, Medical Record employee, stated housekeeping cleans the area after hours unsupervised and would have access to the medical records.

ii. During an interview, on 7/20/11 at 9:10 AM, Division Director of Mental Health, agreed housekeeping cleans the area after hours unsupervised and would have access to the medical records.


Surveyor: Dunn, Christopher
E. Observations during a tour of the Mercy North Operating Room on 7/25/11 at 10:15 AM, revealed 1 of 1 specimen log book sitting on the counter at the nurses' station. Review of the log book revealed the book contained approximately 332 entries. Each entry contained a patient's name, date of birth, the procedure performed, and the type of specimen sent to the lab. Observations also revealed 1 of 1 log book labeled "Signed Pathology Reports", that contained approximately 200 patient's names, and dates the facility received the pathology report.

During an interview at the time of the tour, the Mercy North Operating Room Coordinator stated the housekeeping staff cleaned the department after department staff had left for the day. The Mercy North Operating Room Coordinator acknowledged housekeeping staff had access to the patient information in the log books, and did not need the information to perform their duties.

F. Observations during a tour of the Mercy Main Endoscopy Center revealed 4 log books in the endoscope cleaning room. The log book labeled "Bronchoscope Cleaning Log", contained the patient's name, date of birth, procedure performed, date of service, and contained approximately 45 entries. The log book labeled "Gastroscope Cleaning Log" contained approximately 450 entries that included the patient's name, date of birth, procedure performed, and date of services. The log book labeled "Colonoscope Cleaning Log" contained approximately 360 entries that included the patient's name, date of birth, procedure performed, and date of services. The log book labeled "Specialty Endoscope Cleaning Log" contained approximately 360 entries that included the patient's name, date of birth, procedure performed, and the date of service.

During an interview at the time of the tour, the Endoscopy Director stated the housekeeping staff clean the department after the department staff had left for the day. The Endoscopy Director acknowledged the housekeeping staff had access to log books, and did not need access to the information to perform their job duties.

G. Observations during a tour of the Outpatient Mammography Site on 7/27/11 at 12:00 PM, revealed 1 small filing cabinet in the front office that contained approximately 15 medical reports. Each medical report contained the patient's name, results of the test, date of birth, address, date of service, and medical record number.

During an interview, at the time of the tour, the Director of Imaging Services stated the contracted cleaning service cleaned the office after the office staff left for the day. The Director also stated the contracted cleaning service staff had access to the medical records, and did not need access to the information to perform their job duties.

H. Observations, during a tour of the Cardiac Rehabilitation office, on 7/26/11 at 2:40 PM revealed 1 of 1 filing cabinet that contained approximately 5,000 medical screening forms. The medical screening form included the patient's name, date of birth, medical record number, and laboratory data. Further observations revealed a floor mounted cabinet that contained 34 medical records. The medical records contained the patient's name, date of birth, past medical history, and physician orders.

During an interview, at the time of the tour, the Director of Cardiac Rehabilitation stated a contracted cleaning service cleaned the Cardiac Rehabilitation office after the Cardiac Rehabilitation staff left for the day. The Director acknowledged the contracted cleaning staff had access to the medical records, and did not need access to the medical records to perform their job duties.

I. Observations, during a tour of the Weight Loss Clinic, on 7/26/11 at 10:50 AM revealed 1 of 1 unlocked filing cabinet in the dietician's offices. Further observation revealed the filing cabinet contained 19 medical records, which included the patient's name, date of birth, and medical history.

During an interview at the time of the tour, the Director of the Weight Loss Clinic stated a contracted cleaning service cleaned the clinic after the clinic staff had left for the day. The Director acknowledged the contracted cleaning service staff had access to the medical records, and did not need access to the medical records to perform their contracted job duties.

J. Observations, during a tour of the Cardiovascular Testing clinic on, 7/27/11 at 12:45 PM revealed 1 of 1 log book titled "Laurell Echo/STE"in the unlocked drawer of the Stress Echo room. Review of the "Laurell Echo/STE" log book revealed 30 entries that included the patient's name, diagnosis, procedure performed, and date of service.

i. Observations in the Vascular Room revealed 1 of 1 "Laurell Echo/PV" log book, located in an unlocked drawer. Review of the "Laurell Echo/PV" log book revealed approximately 2,400 entries that included the patient's name, diagnosis, procedure performed, and date of service.

ii. Observations in the Segmental Study room revealed 1 of 1 log book titled "Laurell PV/SEGS" located in an unlocked drawer. Review of the "Laurell PV/SEGS" log book revealed approximately 500 entries that included the patient's name, diagnosis, procedure performed, and date of services.

iii. During an interview, at the time of the tour, the Vice President of Cardiovascular Services stated housekeeping staff cleaned the Cardiovascular Testing clinic after clinic staff had left for the day. The Vice President acknowledged the housekeeping staff had access to the log books, and the housekeeping staff did not need access to the log books to perform their job duties.













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Based on observation, review of policies/procedures, documentation, and staff interview the hospital pain clinic staff failed to maintain a system to track and account for the receipt and distribution of sample drugs subject to oversight by the pharmacy. Problem identified in the Pain clinic supply cabinet. The Pain clinic unit coordinator identified an average daily census of approximately 20 patients.

Failure of pharmacy staff to provide oversight of sample medications could potentially result in theft of medication by unauthorized persons and/or patients receiving outdated and or recalled medications.

Findings include:

1. Tour of the Pain clinic Recovery Room on 7/26/11 at 3:15 PM, with Staff T, Unit Coordinator, revealed a sample medication cabinet. Staff T provided a "Sample Medication Log" document to compare with the medications in the cabinet.

a. The medication cabinet revealed 11 Lidoderm patches 5%, Staff T stated, "If I look at the log sheet it documents 13 patches, so someone forgot to sign 2 out."

b. The medication cabinet revealed 30 blister packs of Amrix 15 mg, Staff T stated, "I don't see this sample medication on the sample log sheet at all and they should be. These are not signed in or signed out. Staff are educated to sign sample medications in and to sign sample medications out."

c. The medication cabinet revealed 3 Flector 1.3% Patches, Staff T stated the log sheets are long by one patch.

d. The medication cabinet revealed 6 boxes of Cymbalta 30 ml tablets, Staff T stated, "The log sheets are long by 1 box."

e. The medication cabinet revealed 5 boxes of Cymbalta 60 ml tablets, Staff T stated, "the log sheets document 6 boxes. People are not documenting though if its 30 mg or 60 mg."

f. The medication cabinet revealed 3 Lyrica 75 mg bottles, Staff T stated, "The count is off by one bottle."
g. The medication cabinet revealed 10 Celebrex 200 mg blister packs, Staff T stated, "This is not going well, I know the count is off by 7 blister packs."

2. Review of hospital policy, Drug Samples and Complimentary Medications ", effective 2/2003, revealed in part, "...it is the responsibility of that area to maintain the necessary documentation for the samples.
It is the responsibility of each of these departments to, maintain the supply of the sample cabinet ...

3. A log reflecting the date the samples are dispensed, the physician, the name of the drug, the strength of the drug, the quantity dispensed, the expiration date and the lot number must be maintained by the department ...
It is the responsibility of Mercy Pharmacy Department to: inspect sample medications as part of the medication storage inspection and remove out of date or unauthorized samples..."

4. During an interview on 7/27/2011 at 11:05 AM, Staff V, Director of Pain and Palliative Services, stated the Pain clinic followed the Drug Samples and Complimentary Medications policy and "the unit coordinator and the pharmacist are responsible for oversight of sample medications and we have been negligent of this." Staff V verified the drug sample policy provides direction to nursing staff regarding maintaining a perpetual inventory of sample medications received and dispensed from the pain clinic to patients. Staff V stated pain clinic nursing staff received education when hired and in yearly competencies.

Staff V confirmed the Pharmacy and unit coordinator failed to oversee sample medications in the pain center. Staff V stated, "From now on the pharmacy and unit coordinator will complete monthly checks of sample medications."

5. During an interview on 7/28/11 on 10:05 AM, Staff X, Director of Pharmacy, stated "There is a Pharmacist assigned to conduct quarterly inspections of sample medications in the pain center. Staff X stated, "They do review for outdates and the intent is to review for perpetual inventory and proper logging of medications." Staff X confirmed inspection reports for the last two inspections lacked documentation of "anything unusual with sample meds" and "I was not aware the count was off for medications prior to yesterday."
Staff X acknowledged the pain clinic nursing staff "needed to improve record keeping for logging sample medications" and pharmacist inspections "should include monitoring for outdates" and verifying perpetual inventories of all sampled medications. Staff X stated, "If there is a drug recall, our current system would not pick up the sample meds given to patients in the pain clinic."

I. Based on observation, document review, and staff interview, the hospital's pharmacy administrative staff failed to ensure operating room (OR) staff documented a shortened expiration date after removing paralytic medications from refrigerated storage, in accordance with manufacturer's directions in 2 of 3 operating room sites (Mercy North and Mercy Downtown). The hospital operating room administrative staff identified an average of 40 surgeries per month that used general anesthesia at Mercy North, and an average of 750 surgeries per month that used general anesthesia at Mercy Downtown.

Failure to document a shortened expiration date after removing paralytic medications from the refrigerator could potentially result in staff using ineffective medications for patient care.

Findings include:

1. Observations, during a tour of the Mercy North Operating Rooms, on 7/25/11 at 10:15 AM, revealed 1 small bin that contained 5 vials of Atracurium, 3 vials of Succinylcholine, and 2 vials of Rocuronium in the medication refrigerator. The vials lacked documentation of the date staff initially removed the vials from the refrigerator.

2. During an interview, at the time of the tour, the Mercy North OR Coordinator stated anesthesia staff removed the medications in the small bin at the start of the day, and kept the medications at room temperature until they finished the last surgical procedure of the day. The Mercy North OR Coordinator stated the medications could stay at room temperature for up to 6 hours. After the last surgical procedure of the day, the anesthesia staff returned the bin to the refrigerator. The Mercy North OR Coordinator acknowledged the medications would reach room temperature if anesthesia staff left the medications out of the refrigerator for up to 6 hours. The Mercy North OR Coordinator stated the OR staff did not document a shortened expiration date on the medication vials, despite the medication vials reaching room temperature during the day.

3. Observations during a tour of the Mercy Main Operating Rooms, on 7/26/11 at 7:00 AM, revealed 1 medication refrigerator at the entrance to the operating rooms. Further observations of the medication refrigerator revealed 2 small bins containing paralytic medications. The first bin contained 3 vials of Succinylcholine, 2 vials of Atracurium, 2 vials of Rocuronium, and 2 vials of Cisatracurium. The second bin contained 1 vial of Succinylcholine, 2 vials of Atracurium, 1 vial of Cisatracurium. The vials lacked documentation of the date staff initially removed the vials from the refrigerator.

4. Observations during a tour of the Mercy Main Operating Room #1, on 7/26/11 at 8:15 AM, revealed a small bin sitting on a cart in the operating room. The bin contained 4 vials of Rocuronium, 1 vial of Succinylcholine, 1 vial of Atracurium, and 1 vial of Cisatracurium. The vials lacked documentation of the date staff initially removed the vials from the refrigerator.

5. During an interview at the time of the tour, the Director of Peri-Operative Services stated anesthesia staff removed the bins from the refrigerator before the first operative procedure of the day. The anesthesia staff kept the bin in the operating room during the day, and returned the bins to the refrigerator at the end of their shift. The Director of Peri-Operative Services stated the anesthesia staff could keep the bins out of the refrigerator for up to 8 hours. The Director of Peri-Operative Services stated the medications in the bins would reach room temperature if anesthesia staff kept them out of the refrigerator for up to 8 hours.

6. Review of the manufacturer's directions for Atracurium, revised 5/04, revealed in part, "Upon removal from refrigeration to room temperature storage conditions ... use Atracurium ... within 14 days even if refrigerated."

7. Review of the manufacturer's directions for Succinylcholine, revised 5/04, revealed in part, "The ... vials are stable for up to 14 days at room temperature without significant loss of potency."

8. Review of the manufacturer's directions for Rocuronium, no revision date, revealed in part, "Upon removal from refrigeration to room temperature storage conditions ... use rocuronium ... within 60 days."

9. Review of the manufacturer's directions for Cisatracurium, revised 11/10, revealed in part, "Upon removal from refrigeration to room temperature storage conditions ... use [Cisatracurium] within 21 days, even if refrigerated."

10. During an interview on 7/27/11 at 3:30 PM, the Director of Pharmacy stated that without documenting the date staff initially removed the medications from the refrigerator, they could not guarantee staff used the medications before the shortened expiration date. The Director of Pharmacy also stated the pharmacy lacked a policy requiring the OR staff to document the date they initially removed the medications from the refrigerator.

Based on observation, document review and staff interviews, the Consultant Dietitian at Mercy Franklin failed to plan the adult patient menu to meet the general diet requirements outlined in the facilities diet manual and dietary staff failed to serve the menu as planned to the pediatric patients. The Manager for Food and Nutrition at Mercy Franklin reported dietary staff provided approximately 45 meals daily.

Failure to provide and serve a planned menu could potentially result in a patient's nutrient needs not being met.

Findings include:

1. Review of the facility menu, signed by Staff J, Consultant Dietitian, on 3/9/11, showed the menu failed to define a portion size for the planned food items. Review of the Mercy Nutrition Care Manual, updated and approved on 1/20/11, showed the General Diet guidelines included in part ... "Adequacy: This diet meets the Recommended Dietary Allowances for all nutrients". The guidelines further included the following suggested meal pattern:

Breakfast: Fruit or juice 1/2 cup, Cereal, whole grain 1/2 cup, 1 egg per day, Toast, whole grain 1 slice, Margarine 1 teaspoon, Milk, low fat 1 cup, Beverage as desired, Condiments as desired.
Lunch: Meat or substitute 2-3 ounces, Potato or substitute 1/2 cup, Vegetable or Salad 1/2 cup, Bread, whole grain 1 slice, Margarine 1-2 teaspoon, Fruit or Dessert 1/2 cup, Milk or Beverage, low fat.

Dinner: Soup or juice 1/2 cup, Meat or substitute 1/2 cup, Potato or substitute 1/2 cup, Vegetable or Salad 1/2 cup, Bread, whole grain 1 slice, Margarine 2 teaspoon, Fruit or Dessert 1/2 cup, Milk, low fat 1 cup, Beverage as desired, Condiments as desired.

2. During an interview on 7/20/11 at 10:35 AM, Staff I, Lead Foodservice Worker, did not know how staff knew what portion to serve. According to the lead foodservice worker, Staff used a #12 scoop to serve the taco meat. However, Staff I was unable to verify why they used this serving size or that the serving size was recorded anywhere stating, " that ' s just what we have always used. "

3. During an interview on 7/20/11 at 10:40 AM, Staff J, referred to a document titled "Entree/Sides Portion Sizes. Review of the document showed it included portions sizes for some food items. Staff J admitted the document lacked guidelines for items such as fruit, eggs and potatoes but believed the designated 1/2 cup (#8 scoop) for side dishes would cover many items.

4. The facility's pediatric menu, signed by Staff J on 5/18/11, identified 1 burrito, tater tots, 1/2 cup mixed vegetables, 1/2 cup peaches and 1/2 cup chocolate pudding planned for lunch on 7/20/11.

5. Observation of lunch meal service on 7/20/11 at 11:25 AM, showed Staff K, foodservice worker, used a slotted spoon to serve an unmeasured amount of mixed vegetables. Staff K confirmed staff used the slotted spoon to serve vegetables.

I. Based on review of policies, procedures, manufacturer's information, joint venture dialysis provider documentation, and staff interview, the facility administrative staff failed to ensure the dialysis staff documented actual numerical values, acted upon values that fell outside the acceptable parameters, documented legibly, and documented the completion of all water tests on the water treatment logs.

Hemodialysis treatments cleanse the blood of accumulated waste products for people with renal failure. Hemodialysis treatments require special machines and use treated water for those treatments, often referred to as dialysis quality water. To provide dialysis quality water, water flows through several components to remove unsafe contaminants. Dialysis equipment, including the water treatment components require staff to monitor and ensure all components function within the acceptable parameters. Failure to provide documentation that shows the water treatment components were safe for patient use, could potentially cause patients' exposure to unsafe water, which could cause severe illness or even death.

The dialysis staff reported a census of 26 acute dialysis patients at the time of the survey. Findings for review of 1 of 1 "Acute Room" water system and 4 of 4 portable ROs (reverse osmosis) (RO #1, #2, #3, and #4) include:

1. The "Acute Room" water treatment system had 2 different operating logs used to monitor the functions of all the components.

a. The log titled "WATER SOFTENER LOG" identified multiple functions for staff to monitor. The water softener removes calcium and magnesium from the water and minimizes the possible accumulation of these minerals on the RO membrane. If calcium and magnesium ions accumulated on and fouled the RO membrane, this could potentially delay the dialysis patients' treatments. Each day staff dialyzed patients in the "Acute Room" staff documented on the log. On 7/19/11 at 7:55 AM, PCT (Patient Care Technician) DH reported staff should notify Mechanical Tech II, DJ when any results fell outside the identified parameters. Review of this log from March 1, 2011 through May 31, 2011 revealed the following:

Staff documented the outlet pressures. The parameters identified this result should read less than 15 psi (pounds per square inch) of the inlet pressure. The documentation reflected readings greater than 15 psi for 38 of the 85 dates reviewed. These elevated readings ranged from 16 to 30 psi greater than the inlet pressures. Further review failed to show any documentation that reflected any notification to the appropriate personnel.

During an interview on 7/21/11 at 7:35 AM, Mechanical Tech II, DJ reported the elevated readings reflected high delta pressures, which could show a congested or clogged area in the water softener. Mechanical Tech II, DJ acknowledged staff should notify the appropriate personnel when results fell outside the identified parameters.

Staff completed water hardness tests twice daily. When the water tests results reflected less than 10 ppm (parts per million), this showed the water softener was operating within the specified guidelines. Review of the logs showed 68 of 85 entries had no numerical value documented, only a zero with a line drawn through it.

During an interview on 7/21/11 at 7:25 AM, Mechanical Tech II DJ and Acute Coordinator, RN DA acknowledged a zero with a line drawn through it did not reflect a numerical result.

b. Review of the log title "R.O. Machine Log for MRO 3" for the "Acute Room" from March 1, 2011 through April 30, 2011 revealed the following:

The dialysis staff monitored the reject flow of the RO and documented the results on the RO logs. The RO rejects water that does not meet the dialysis quality water requirements. The logs identified the acceptable parameters as greater than 1.8 GPM (gallons per minute). Review of the logs revealed the documentation reflected results less than 1.8 GPM on 6 of 54 entries, however, no documentation reflected any notification to the appropriate personnel.

The area on the logs where staff documented the pH following the carbon tank showed the parameters identified as 6.5 to 8.5. On 49 of the 54 entries, the dialysis staff identified the pH readings as greater than 8.5, however, no documentation reflected any notification to the appropriate personnel that these readings fell outside of the acceptable parameters.

During an interview on 7/21/11 at 7:25 AM, Mechanical Tech II, DJ reported the corporate personnel had set the pH parameters and that the water source pH remained higher than the identified parameters. Mechanical Tech II, DJ agreed the selected parameters should alert staff when to notify the appropriate personnel, and that the selected parameters should be specific to the water source. Mechanical Tech II, DJ went on to report a high PH could potentially deplete the carbon tanks that remove chloramines from the water to protect the dialysis patients from hemolysis (the breakdown of red blood cells that could cause severe illness and/or death).

2. When the surveyor questioned the Acute Coordinator and the Mechanical Tech II if a policy or procedure provided any guidance or direction to staff on the process used to complete the logs and when to notify staff of any results that fell outside the identified parameters, they both reported the joint venture dialysis staff had not developed or implemented any technical policies or procedures specific for the acute or inpatient equipment and used the same policies and procedures utilized in the chronic dialysis unit. Mechanical Tech II, DJ agreed the water treatment system used in the chronic was specific to that unit and did not compare to the systems used in the inpatient setting. (Refer to A 0083)

3. The dialysis staff had portable ROs that provided the water treatment for the bedside dialysis treatments. Beside dialysis occurred when patients were too ill for transport to the "Acute Room" for dialysis. The joint venture dialysis staff used "Better Water" portable ROs. Review of the portable RO manufacturer information titled "Better Water, Inc", dated July 2, 2007 revealed the optimal water temperature was 77 degrees Fahrenheit for the ROs performance.

Review of the portable RO logs titled "Acute Portable RO Start Up Checklist& Water Quality" for RO #1, #2, #3, and #4 from 3/28/11 through 6/18/11 revealed the following:

a. RO #1:

The logs had an area for dialysis staff to document the pump PSI (pounds per square inch). The logs listed the parameters for the pump psi as 120-160. Review of the logs showed staff documented a pump psi of 110 on 4/5/11 and 4/18/11.

The logs had the filter in and filter out pressure parameters listed as 25 to 60 psi. Review of the logs for RO #1 revealed that for 5 of 32 entries for the filter in pressures and 7 of the 32 entries for the filter out pressures, the documentation reflected filter in and out pressures outside the identified acceptable parameters.

Review of the logs showed 5 entries where the staff had left sections blank. The blank areas included water temperature, pH, and water flow. Lack of monitoring for these functions could potentially cause staff to use equipment that was not functioning optimally.

The logs identified the temperature parameters as 65-85. Eleven of the 32 entries had temperatures documented that reflected readings outside the acceptable parameters. The logs identified acceptable parameters of 0-30 for the product PSI. Five of the 32 entries had documentation that reflected results that fell outside the acceptable parameters.

The logs listed acceptable limits for the water hardness tests as less than 0.3 grains per gallon. Three entries reflected either a zero with a line drawn through it or less than zero. Review of the "HACH STERICHEK SENSITIVE LOW-RANGE WATER HARDNESS REAGENT STRIPS" used by the dialysis staff to perform the water hardness tests showed no values less than zero.

b. RO #2:

The logs listed the filter in and filter out pressure parameters as 25 to 60 psi. Review of the logs for RO #2 revealed that for 4 of 21 entries for the filter in pressures and 6 of the 21 entries for the filter out pressures, the documentation reflected filter in and out pressures outside the identified acceptable parameters.

The logs identified the temperature parameters as 65-85. Eight of the 21 entries had temperatures documented that reflected readings outside the acceptable parameters. The logs identified acceptable parameters of 0-30 for the product PSI. Ten of the 21 entries had documentation that reflected results that fell outside the acceptable parameters.

The logs listed the acceptable limits for the water hardness tests as less than 0.3 grains per gallon. Two entries reflected a zero with a line drawn through it.

c. RO#3:

The logs had an area for dialysis staff to document the pump PSI (pounds per square inch). The logs listed the parameters for the pump psi as 120-160. Review of the logs showed staff documented a pump psi of 112 on 5/31/11.

The logs listed the filter in and filter out pressure parameters as 25 to 60 psi. Review of the logs for RO #3 revealed that for 3 of 47 entries for the filter in pressures and 8 of the 47 entries for the filter out pressures, the documentation reflected filter in and out pressures outside the identified acceptable parameters.

Review of the logs showed 3 entries where the staff had left sections blank. The blank areas included water temperatures. Failure to monitor water temperature could potentially cause staff to use an RO where the water temperature was too cold or too hot. Water with temperatures above the acceptable parameter of 85 could potentially damage the RO membrane. Damage to the RO membrane could cause delays to the dialysis treatments. The RO produces less dialysis quality water when the water temperature falls too low. Less dialysis quality water production could potentially cause delays to the dialysis treatment.
The logs identified the temperature parameters as 65-85. Fifteen of the 47 entries had temperatures documented that reflected readings outside the acceptable parameters. The logs identified acceptable parameters of 0-30 for the product PSI. Twenty of the 47 entries had documentation that reflected results that fell outside the acceptable parameters.

The logs listed the acceptable limits for the water hardness tests as less than 0.3 grains per gallon. Four entries reflected a zero with a line drawn through it. Review of the logs showed on 4/13/11, 5/27/11, 6/2/11 and 6/3/11, the water hardness test results fell outside the acceptable limits. During an interview on 7/20/11 at 9:42 AM, RN (registered nurse) DD reported when the water hardness tests results fell outside the acceptable parameters staff should recycle the softener before the RO produced the dialysis quality water for another patient's dialysis treatment. RN DD showed the surveyor that staff should document this on the log in a section that read "Softener Recycled". Further review of the logs showed no documentation that reflected staff had recycled the softener following the water hardness test results that fell outside the acceptable parameters on 4/13/11, 5/27/11, 6/2/11 and 6/3/11.

Review of the water temperature documented on 6/3/11 showed the documentation as illegible. Closer inspection of the documentation showed staff had documented a temperature and then written another value over the original entry.

Review of the log for RO #3 showed staff had documented the date of 3/29/11 for both Tuesday and Wednesday.

d. RO #4:

The logs listed the filter in and filter out pressure parameters as 25 to 60 psi. Review of the logs for RO #4 revealed that for 3 of 33 entries for the filter in pressures and 3 of the 33 entries for the filter out pressures, the documentation reflected filter in and out pressures outside the identified acceptable parameters.

Review of the logs showed 3 entries where the temperature results remained blank. The logs identified the temperature parameters as 65-85. Eight of the 33 entries had temperatures documented that reflected readings outside the acceptable parameters. The logs identified acceptable parameters of 0-30 for the product PSI. Nineteen of the 32 entries had documentation that reflected results that fell outside the acceptable parameters.

The logs listed the acceptable limits for the water hardness tests as less than 0.3 grains per gallon. Three entries reflected either a zero with a line drawn through it or less than zero. Review of the "HACH STERICHEK SENSITIVE LOW-RANGE WATER HARDNESS REAGENT STRIPS" used by the dialysis staff to perform the water hardness tests showed no values less than zero.

4. Continued review of the logs for RO #1, #2, #3, and #4, failed to show any documentation that reflected notification to the appropriate personnel when the readings for the water treatment system fell outside the acceptable parameters.

5. Review of the total chlorine logs showed the documentation on 5/4/11 reflected the total chlorine test results as less than zero. Dialysis staff perform total chlorine tests to ensure the removal of chloramines from the water used for the dialysis treatments has occurred. Exposure to water with chloramines during the dialysis treatment, could cause hemolysis (rupture of red blood cells, which could cause severe illness and/or death) to the dialysis patients. During an interview on 7/20/11 at 11:35 AM, the Acute Coordinator, RN DA acknowledged, the strips used to test the total chlorine did not show any values below zero. The Acute Coordinator agreed a result documented as less than zero did not accurately reflect the test result.

6. During an interview on 7/21/11 at 7:35 AM, the Acute Coordinator, RN DA and Mechanical Tech II, DJ both reported staff should notify Mechanical Tech II, DJ when staff identified any readings and/or test results outside the acceptable parameters. The Acute Coordinator and Mechanical Tech II, DJ acknowledged no log audits to identify illegible, inaccurate or missing documentation had occurred. In addition, neither Acute Coordinator, RN DA nor Mechanical Tech II, DJ had reviewed the logs to ensure staff notified the appropriate personnel if readings or test results fell outside the acceptable parameters.

II. Based on review of manufacturer's information, joint venture dialysis staff documentation and staff interview, the facility administrative staff failed to ensure all documentation regarding disinfection of the water treatment system reflected the presence and negative residual for the disinfectant.

Failure to complete the procedure to ensure the disinfectant is present in the water system at the beginning of this procedure could potentially cause staff to complete the disinfection process without the disinfectant. Lack of disinfectant for this procedure could then allow bacterial growth. Patient exposure to water with a high amount of bacterial contaminants could cause severe illness and/or death.

Failure to complete the final residual disinfectant procedure prior to use of the dialysis equipment could cause inadvertent patient exposure to the disinfectant, which could then cause severe illness and/or death.

The dialysis staff reported a census of 26 inpatient or acute patients at the time of the survey. Findings for review of the disinfection logs for 1 of 1 water treatment system for the "Acute Room" and 3 of 4 of the portable ROs (RO #1, #3, and #4) include:

1. The RO used to produce the dialysis quality water used for the dialysis treatments in the "Acute Room" had a label that read "AmeriWater". Review of the manufacturer's information for the "AmeriWater" RO revealed staff should rinse out all the disinfectant at the end of the disinfection process to ensure no patients are exposed to the disinfectant during the dialysis treatments.

Review of the logs used to document the disinfection of the "AmeriWater" RO from 1/16/11 through 7/17/11 showed the following:

a. On 5/11/11, the documentation failed to reflect the water treatment system tested negative for disinfectant at all test points. The log had an area where staff should circle yes or no. Staff had not circled either yes or no.

b. On 7/17/11, the documentation failed to reflect a positive test result for the disinfectant at the beginning of the disinfection procedure. The log had an area where staff should circle yes or no. Staff had not circled either yes or no.

2. The portable ROs used to provide the dialysis quality water at the bedside had a label that read "Better Water". Review of the manufacturer's information for the "Better Water" portable ROs revealed no disinfectant should remain in the system prior to use for a dialysis treatment.

Review of the logs used to document the disinfection of the "Better Water" portable ROs from 1/10/11 through 7/14/11 showed the following:

a. RO #1:

i. On 3/7/11, the documentation failed to reflect the water treatment system tested negative for disinfectant at the end of the disinfectant procedure. The log had an area where staff should circle yes or no. Staff had not circled either yes or no.

b. RO #3:

i. On 2/7/11, the documentation did reflect the water treatment system tested negative at the end of the disinfection, however staff had not circled yes or no for the negative disinfectant check at the end of 30 minutes.

c. RO #4:

i. On 5/11/11, the documentation failed to reflect the water treatment system tested negative for disinfectant at the end of the disinfectant procedure. The log had an area where staff should circle yes or no. Staff had not circled either yes or no.

3. During an interview on 7/21/11 at 7:35 AM, Mechanical Tech II, DJ acknowledged the importance to document the presence and negative residual for the disinfectant during and at the completion of the disinfection procedure. Mechanical Tech II, DJ verified the documentation on the disinfection logs did not always reflect the presence and negative residual for the disinfectant.

I. Based on review of policies, procedures, CDC (Centers for Disease Control and Prevention) MMWR (Morbidity and Mortality Weekly Report) Recommendations and Reports, observation and staff interview, the facility staff failed to ensure the joint venture dialysis staff separated clean supplies from the contaminated fluid disposal area.

Failure to maintain a distinct separation of clean supplies and/or personal protective equipment from the area where potentially contaminated fluids were disposed of could potentially allow the clean supplies to become contaminated. If used for the dialysis treatment, the contaminated supplies could then expose patients and staff to those contaminants.

The dialysis staff reported an inpatient dialysis patient census of 26 during the course of the survey, with 18 patients that received hemodialysis treatments in the "Acute Room". Findings for observation of 1 of 1 room where contaminated fluid disposal occurred (7/18/11) include:

1. Review of the dialysis policy titled "Infection Control Overview", FMS-CS-IC-II-155-060A, with a revision date of October 10, 2008, included in part, "...The nature of dialysis, with frequency exposure to blood and body fluids, close proximity of patients and staff, and the immunocompromised status of dialysis patients, makes a dialysis clinic a high risk for spreading infectious disease. The Centers for Disease Control (CDC) has recommended specific infection control practices for dialysis centers that have been shown of reduce and prevent the spread of infectious disease. CDC guidelines and incorporated into FMC policies, processes and procedures. ..."

Review of the dialysis policy titled "Dialysis Precautions", FMS-CS-IC-II-155-070A, with a revision date of October 10, 2008 revealed the patient treatment rooms should have designated clean and dirty areas. The policy defined the "dirty" area as an area where a potential for contamination could occur. Further review of the policy showed only contaminated or used supplies should be stored in "Dirty" areas.

Review of the policy titled "FMS Clinical Services", FMS-CS-IC-II-155-070A, with a revision date of October 10, 2010, revealed clean areas should be clearly separated from contaminated areas where used supplies, equipment or blood samples are stored.

2. Review of CDC MMWR Recommendations and Reports titled "Recommendations for preventing Transmission of Infections Among Chronic Hemodialysis Patients", dated April 27, 2001 included in part, "...Infection Control Precautions FOR Outpatient Hemodialysis Settings Compared with Inpatient Hospital Settings...In addition to standard precautions, more stringent precautions are recommended for hemodialysis... Additional measures to prevent contamination of clean or sterile items include...not handling or storing contaminated (i.e. used) in areas where ... clean (i.e. unused) equipment and supplies are handled..."

3. During a tour of the facility on 7/18/11 at 1:20 PM, observation showed patients receiving dialysis treatments in 2 rooms. The dialysis staff referred to these 2 rooms as the "Acute Room". Observation showed 3 patients receiving hemodialysis in 1 room and 2 patients receiving hemodialysis in the room just to the west. Further observation showed a cut out opening in a wall between the 2 rooms. The opening was approximately 3 feet wide by 3 feet long. Both dialysis rooms had signs posted to delineate the "clean" and "dirty" areas. The room that had 3 patients receiving hemodialysis treatments had 2 sinks, 1 labeled "clean" and 1 labeled "dirty". During the tour of the room where 2 patients were receiving hemodialysis treatments, RN (Registered Nurse) DE showed the surveyor a sink labeled "clean". RN E reported using the "clean" sink for only clean procedures, such as hand washing. When the surveyor questioned RN DE where staff would dispose of contaminated fluids, RN E opened a door and pointed to a toilet. Observation showed a toilet, equipment labeled "AmeriWater Clean", a tool box that contained tools and water fittings, a fan, a booster pump (often used to increase the flow of purified water used for dialysis treatments and enables the purified water to flow throughout a dialysis room where multiple hemodialysis treatments are performed), and a box that contained several plastic encased white rolls of fiber.

Continued observation showed several personal protective gowns and face protecting shields that hung on the inside portion of the bathroom door. Upon closing the bathroom door, the distance between the gowns and shields to the toilet was approximately 1 foot.

4. During an interview on 7/18/11 at 3:05 PM, the Acute Coordinator, RN DA reported the toolbox, "AmeriWater Clean" equipment, fan and booster pump was all equipment no longer used for the dialysis treatments. the Acute Coordinator went on to report no knowledge regarding the plastic encased filters. The Acute Coordinator acknowledged the protective gowns and shields stored so close to the "dirty" fluid disposal could potentially allow contaminated fluids to splash on those gowns and shields. Staff could then wear these gowns and shields to deliver care to the immunosuppressed dialysis patients without the knowledge of exposing those patients to contaminated gowns and shields.

5. During an interview on 7/21/11 at 7:35 AM, Mechanical Tech II DJ acknowledged using the "dirty" area to store equipment. Mechanical Tech II DJ then stated the plastic encased filters replaced the filters for the water treatment system that purified the dialysis quality water used for the hemodialysis treatments. Mechanical Tech II, DJ then agreed clean supplies should not be stored in a "dirty" area.


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II. Based on observation, policy review and staff interviews, the hospital dietary staff failed to maintain a sanitary kitchen environment. The Director of Food and Nutrition reported the dietary staff at Mercy Main provided approximately 2500-2800 patient meals daily. The Manager for Food and Nutrition at Mercy West Lakes reported dietary staff provided approximately 240 meals daily. The Manager for Food and Nutrition at Mercy Franklin reported dietary staff provided approximately 45 meals daily.

Failure to maintain the kitchen environment in a sanitary manner could potentially result in the contamination of the patient's food.

Findings include:

1. Observation during the kitchen environment tour at Mercy Main, on 7/18/11 beginning at 1:30 PM, revealed the following:

a. A KitchenAid mixer, located in the bakery area and covered with a plastic bag, had a greasy golden brown substance and dried food debris on the underside head of the mixer. In addition, a Hobart Mixer, located in the nourishment room and covered with a plastic bag, had a greasy golden brown substance and dried food debris on the underside head of the mixer. During an interview, at the time of the environment tour, Staff D, Executive Chef/Production Supervisor, reported staff were trained to clean the mixer after each use and cover with a plastic bag. He/She concurred the mixers were not clean.

b. Observed 3 of 3 yellow, 1 of 1 each red, green and cream colored plastic cutting boards, in the bakery area, and 1 of 1 green plastic cutting board, in the vegetable prep room, contained multiple surface cuts and a worn unsanitizable surface. In addition, the pizza counter and salad/deli plastic cutting board counters had multiple surface cuts, stains and a worn unsanitizable surface. During an interview at the time of the environment tour, Staff D acknowledged the worn condition of the cutting boards and reported she would have them replaced.

2. Observation during the kitchen environment tour at Mercy West Lakes, on 7/19/11 at 1:10 PM, revealed 3 of 6 white plastic cutting boards contained multiple surface cuts and a worn unsanitizable surface.

3. Observation during the kitchen environment tour at Mercy Franklin, on 7/20/11 at 10:10 AM, revealed the following:

a. A KitchenAid mixer, covered with a plastic bag, had dried food debris on the underside of the mixer head. Staff S, Manager of Food and Nutrition at Mercy West Lakes and Franklin, confirmed the presence of the debris and reported staff were trained to clean the mixer after each use and cover with a plastic bag.

b. The east wall contained metal shelving units that showed multiple areas of worn paint and surface rust, covered with paper taped to the surface. The south unit of shelving stored food preparation equipment upside down. The food contact surfaces of a muffin tin, a large pot, a 4-inch steamtable pan, pot lids and a large colander touched the paper surface. Staff S concurred a paper-covered surface lacked the ability to be effectively cleaned and sanitized.

4. Review of the hospital policy titled "Cleaning and Sanitization of Equipment and Utensils", effective date of August 2009, revealed in part ... "2. All utensils, counters, shelves and equipment shall be kept clean; maintained in good repair; and shall be free from breaks, corrosion, opens seams, cracks and chipped areas. 4. Nonfood-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue and other debris."

III. Based on observation, policy review, document review and staff interviews, the hospital dietary staff failed to maintain sanitary practices during observed meal service at Mercy Main. The Director of Food and Nutrition reported dietary staff provided approximately 2500-2800 patient meals daily.

Failure to maintain sanitary practices during meal service could potentially result in a foodborne illness.

Findings include:

1. Observation of meal service on 7/19/11 from 8:08 AM to 8:20 AM, showed Staff E, cook, and Staff F, cook, stationed at the hot food side of patient meal trayline with gloved hands. Both staff handled serving utensils, plates, plate covers and tray tickets in addition to pancakes, sausage patties and omelets with the same gloved hands. Observation showed Staff E removed their gloves once but failed to wash their hands before donning clean gloves. Staff F wore the same pair of gloves during the entire observed meal service.

2. Observation of meal service on 7/20/11, from 7:30 AM to 7:58 AM, showed Staff E, Staff G, cook, and Staff H, cook, stationed at the hot food side of the patient meal trayline with gloved hands. Observation showed Staff G, with gloved hands, opened the steamer, freezer and handled the fryer basket handle, then without changing gloves, continued with patient meal service serving pancakes, sausage patties, bacon, orange slice garnishes and a biscuit with the same contaminated gloves.

Staff H opened the microwave, freezer, cooler and pushed garbage down in a garbage can, then without changing gloves or sanitizing hands, continued with patient meal service serving pancakes, french toast slices, sausage patties, bacon, orange slice garnishes and cheese slices with the same contaminated gloves.

Staff E used gloved hands to place tray tickets, pick up pancakes, sausage patties, bacon, orange slice garnishes, omelets and sauteed green onions and peppers. Observation showed Staff E removed their gloves once but failed to wash their hands before donning clean gloves.

Staff G and Staff H wore the same pair of gloves during the entire observed meal service.

3. During an interview on 7/20/11 at 9:30 AM, Staff G reported that dietary staff had trained him/her to wear gloves for food service. The training included washing hands and changing gloves when the gloves become contaminated such as touching face, oven or refrigerator handle.
4. During an interview on 7/20/11 at 9:32 AM, Staff H reported that dietary staff had trained him/her to wear gloves when performing the majority of food-related tasks. The training included changing gloves and washing hands when the gloves became contaminated. Staff H reiterated the importance of washing hands and changing gloves when something dirty is touched, like garbage.
5. During an interview on 7/20/11 at 9:35 AM, Staff E reported that dietary staff had trained him/her to wear gloves with food handling and preparation. The training included the need to change gloves when they became contaminated after things such as scratching face, sneezing or coughing and touching something like an oven or refrigerator handle.

6. Review of the hospital policy titled "Prevention of Contamination", effective date of August 2009, revealed in part ... Policy: All food while being stored, prepared, displayed, served or sold at foodservice establishments, or during transportation between such establishments, shall be protected from contamination. ... 14. If used, single-use gloves shall be used for only one task such as working with ready-to-eat food or with raw animal food, used for no other purpose, and discarded when damaged or soiled, or when interruptions occur in the operation."

7. During an interview on 7/20/11 at 8:15 AM, Staff A, Director of Food and Nutrition, Staff B, Manager of Food and Nutrition at Mercy Main, Staff C, Chief Clinical Dietitian and Staff D, concurred with observed concern of cross-contamination during meal service. Staff D reported all dietary staff received training on food safety and sanitation. Employees completed the training titled "Rapid Regulatory Compliance" within 45 days of hire and annually thereafter. The training included a section on infection control, hand washing and glove use. In addition, all dietary employees completed the "Serve Safe Starter Employee Guide" for additional training on food handling. Staff D reported staff received training that included wearing gloves with direct food contact, wash hands before donning and after removing gloves and to change gloves when contaminated.

8. Review of the manual titled "ServSafe Starters Employee Guide", showed pages 6 and 7 included a section titled "When to Wash Your Hands". It stated in part, ... before putting on gloves." Page 9 included a section titled "Use Gloves the Right Way" and included in part, ... Wash your hands before putting on gloves and when changing to a new pair, ... before beginning a different task".

9. Review of material presented in the mandatory staff training titled "Rapid Regulatory Compliance: Clinical II" showed Lesson 4 covered the topic of infection control. The material included in part "... The single most important factor for preventing the spread of infection is proper hand hygiene. ... Hand hygiene should also occur after gloves are removed."

10. Review of dietary department personnel files revealed the following:

a. Staff E completed the mandatory staff training titled "Rapid Regulatory Compliance: Clinical II" on 2/2/10 and 9/18/10 and received a certificate of completion for "ServSafe Employee Food Safety Training" dated January 2010.

b. Staff F completed the mandatory staff training titled "Rapid Regulatory Compliance: Clinical II" on 4/2/09 and 9/16/10 and received a certificate of completion for "ServSafe Employee Food Safety Training" dated April 27-28, 2009.

c. Staff G completed the mandatory staff training titled "Rapid Regulatory Compliance: Clinical II" on 9/25/10 and received a certificate of completion for "ServSafe Employee Food Safety Training" dated 1/5/08 and April 27-28, 2009.

d. Staff H completed the mandatory staff training titled "Rapid Regulatory Compliance: Clinical II" on 5/21/09 and 6/23/11 and received a certificate of completion for "ServSafe Employee Food Safety Training" dated January 2008 and April 27-28, 2009.

11. Review of staff inservice records showed Staff D conducted an inservice on 7/19/11 titled "Glove Use in Retail Foodservice Establishments". The material presented included in part "... Improper handling of food and poor personal hygiene of food handlers are leading causes of foodborne illness outbreaks. ... Observational research has found improper glove use can be as big a problem as poor hand hygiene. For gloves to provide an effective barrier between food and food handler, hands should be properly washed ... before putting gloves on or changing gloves. Pathogens on hands can be transferred to the exterior of the gloves when gloves are removed from the box. Bacteria and other contaminants on the hands are now on the gloves and will be transferred to food upon contact. ... Gloves should be changed before handling different types of foods, after touching anything that could contaminate hands (such as refrigerator doors or trash containers) ..." The attendance list for the inservice included Staff E, Staff F and Staff H.

IV. Based on policy review, document review and staff interviews, the hospital dietary staff failed to measure and record the hot and cold temperatures for all food served to patients in accordance with hospital policy. The Director of Food and Nutrition reported the dietary staff, at Mercy Main, provided approximately 2500-2800 patient meals daily.

Failure to ensure dietary staff measure and record hot and cold food temperatures could potentially result in a foodborne illness.

Findings include:

1. Review of Mercy Main documents titled "Temperature Log Sheet - Steamtable" and "Temperature Log Sheet - Cook's Cold Side" for June and July 2011 revealed the dietary staff failed to follow hospital policy for food temperatures as noted below:

a. Breakfast - In June 2011, the 6th, 11-12, 17th and 25-26 and in July 2011, the 9-10, 15th and 18th showed no temperatures recorded. In addition, the 3rd and 20th in June 2011 and the 4th in July 2011 revealed incomplete temperature logs.

b. Lunch - In June 2011, 2-3, 6-12, 16th, 20-22 and 25-26 and in July 2011 the 1st, 4th and 9-16 showed no temperatures recorded. In addition, the 1st, 4-5, 13-15, 17-20, 23-24 and 27-30 in June 2011 and 2-3, 5-8 and 17-19 in July 2011 revealed incomplete temperature logs.

c. Supper - In June 2011, 1-4, 6-12, 14th, 16-22 and 24-26 and in July 2011, 1-7 and 9-17 showed no temperatures recorded. In addition, the 29th in June 2011 and the 18th in July 2011 revealed incomplete temperature logs.

2. Review of the hospital policy titled "Food Temperatures", effective date of May 2011, revealed in part ... "Food temperatures are to be taken, read accurately and recorded on approved department temperature logs every two hours of service."

3. Review of the hospital policy titled "Quality Control Procedures for Temperature/Sanitation", effective date of August 2009, revealed in part ... "Policy: Quality control procedures will be established to prevent foodborne illness and assure food safety. ... B. Recording and auditing of food storage and service temperatures will occur daily. ... C. 1. ... Food and Nutrition Supervisors are responsible to monitor the temperature forms daily to ensure compliance. ... Temperature inspections will be completed as follows: ... iii. Daily - food temperature audits in room service area."

4. Review of the hospital policy titled "Food Production, Service, and Distribution Standards", review date of January 2011, revealed in part ... F. 2. ... Temperatures of hot foods are checked with a thermometer prior to the food reaching the serving line. ... G. 2. Temperatures are monitored daily by Supervisors or designee staff".

5. During an interview on 7/20/11 at 2:00 PM, Staff A and Staff B confirmed food temperature records were not completed per facility policy. Staff A and Staff B reported the task of measuring and recording food temperatures was assigned to a specific person and staff failed to reassign the task in the absence of that person.