The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

MENTAL HEALTH INSTITUTE 1251 NORTH CEDAR LOOP CHEROKEE, IA 51012 June 19, 2013
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observations, document review and staff interviews, the facility failed to develop and implement a system that ensured Reduced Oxygen Packaged (ROP) vacuum packaged foods, for patient consumption, were packaged and stored in accordance with accepted standards of practice for infection control and safety. The facility failed to:

-ensure dietary staff followed the Food Code guidelines specific to ROP which increased the risk of the packaged food growing potentially foodborne causing illness and/or death; (Refer to A-749)

-ensure a system was in place that assured dietary staff reported concerns, related to the improper use of the ROP system, identified by the Siouxland District Health Department inspector in 12/12 and 5/13, to management and the qualified dietitian for review and remedial action. (Refer to A-749)

The cumulative effect of these systemic failures and deficient practices resulted in the facility's inability to guarantee the safety of ROP vacuum packaged foods.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observations, document review and staff interviews, the facility failed to follow the Food and Drug Administrations (FDA) Food Code, considered a standard of practice in the food industry, for Reduced Oxygen Packaging (ROP - a food packaging process where the oxygen content is controlled to a level below that normally found in the atmosphere and includes vacuum packaging). The facility also failed to develop Hazard Analysis and Critical Control Points (HACCP) plans for ROP (a food safety plan to achieve control of foodborne illness risk factors to safely use ROP). The Food Production Manager reported the facility served approximately 60 to 108 patient meals daily. All patients served were potentially affected by the deficient practice.

Failure to follow the Food Code guidelines specific to ROP, including developing HACCP plans, increases the risk of the packaged food growing potentially foodborne causing illness and/or death.

Findings include:

1. Review of the manual for the Hobart vacuum packing machine, dated 4/1991, revealed in part "the machines ... are designed to remove air from the package. The package is then sealed to create a vacuum package ... The FDA has made recommendations and established guidelines for vacuum packaging. Some state and local governments have rules which cover the proper use of vacuum packaging equipment. Check with your local health department for the rules in effect in your location...fish and fish products (except frozen product) may not be packaged in reduced oxygen containers...All refrigerated reduced oxygen packaged product must be given a maximum fourteen day shelf life...."

Review of the 2005 and 2009 editions of the Food Code, published by the Food and Drug Administration and considered a standard of practice for the food service industry, states a food establishment that packages potentially hazardous food (require time/temperature control for food safety) using a reduced oxygen packaging method shall control the growth and toxin formation of Clostridium botulinum (a bacteria that is a frequent cause of food poisoning from preserved meats, fruits, or vegetables that have not been properly sterilized before canning) and Listeria monocytogenes (a bacteria linked to food-borne diseases especially associated with meat and dairy products).

The Food Code also requires the facility to:
- develop a HACCP plan;
- limit the refrigerated shelf life to no more than 14 calendar days from packaging to consumption, or the original manufacturer's "sell by" or "use by" date, whichever occurs first;
- develop operational procedures which describe the training program that ensures that the individual responsible for the ROP operation understands the process;
- refrain from the use of ROP for fish, except for fish that is frozen before, during, and after packaging;
- place foods in a package with an oxygen barrier and seal either before cooking, or sealed immediately after cooking and before reaching a temperature below 57?Celsius (135?Fahrenheit); and
- hold packaged foods in a refrigeration unit that is equipped with an electronic system that continuously monitors time and temperature and is visually examined for proper operation twice daily.

The required elements of a HACCP plan, as defined by the Food Code include:
- categorization of the types of potentially hazardous foods specified on the menu;
- a flow diagram by specific food or category type identifying critical control points;
- food employee and supervisory training plan that addresses the food safety issues;
- standard operating procedures identifying critical control points and critical limits for each;
- method and frequency of monitoring of each critical control point;
- method and frequency used to routinely verify employees are following the standard operating procedures;
- actions taken if critical control points are not met; and
- records maintained to demonstrate that the HACCP plan is properly managed.

2. Observations during the initial kitchen tour on 6/17/13, beginning at 1:15 PM, accompanied by the Food Production Manager and the Business Manager, revealed the following:

Packaged sliced ham, sliced turkey ham and flaked tuna stored in a walk-in cooler labeled "meat thaw." During an interview at the time, the Food Production Manager reported the products are purchased in bulk and the portion not used, at the time it appears on the menu, is divided into smaller amounts, packaged with the Hobart vacuum packaging machine and labeled with a 45-day expiration date. She was unable to explain the basis for an extended 45-day expiration date and indicated that's the procedure used, which came from the Food Service Director, who was currently on vacation.

Packaged diced bacon stored in the #1 walk-in freezer. During an interview at the time, the Food Production Manager reported leftover bacon is cooled in the blast chiller and packaged with the Hobart vacuum packaging machine and labeled with a 45-day expiration date.

Packaged individual servings of turkey, roast beef, pork and chicken in a reach-in freezer labeled "special diets." During an interview at the time, the Food Production Manager reported these items are prepared in bulk, divided into individual portions for patients on special diets, packaged with the Hobart vacuum packaging machine and labeled with a 45-day expiration date.

3. Following the initial kitchen tour on 6/17/13, ending at 3:00 PM, which identified the facility utilized reduced oxygen packing (ROP), surveyor requested the HACCP plans for the vacuum packaged food items and all policies and procedures related to the process. The Food Production Manager, the person designated in charge in the absence of the Food Service Director, provided a notebook labeled "HACCP" and a notebook labeled "Reduced Oxygen Packaging" and reported the notebooks contained the information requested.

Review of the HACCP notebook revealed documentation of past temperature monitoring logs for the coolers, freezers, blast chiller and food temperatures from meal service. However, the documentation the facility identified as HACCP plans did not include the required elements as delineated in the Food Code.

The required elements of a HACCP plan, as defined by the Food Code include:
- categorization of the types of potentially hazardous foods specified on the menu;
- a flow diagram by specific food or category type identifying critical control points;
- food employee and supervisory training plan that addresses the food safety issues;
- standard operating procedures identifying critical control points and critical limits for each;
- method and frequency of monitoring of each critical control point;
- method and frequency used to routinely verify employees are following the standard operating procedures;
- actions taken if critical control points are not met; and
- records maintained to demonstrate that the HACCP plan is properly managed.

Review of the ROP notebook revealed a cover sheet that identified steps in the packaging process which included, in part, equipment temperatures are taken 2 times a day, vacuum packaged bags are sealed and the product may then be kept 45 days in the refrigerator. The notebook contained logs labeled "Write in Items that get vacuum packed" and "CMHI (Cherokee Mental Health Institute) Food Safety Control Checklist," dated back to 4/24/13, which identified the food items packaged. The notebook contained other documents related to proper food handling including a chart titled "Cherokee Mental Health Institute HACCP Monitoring," a list of definitions and material covering hand washing, receiving, food storage, food preparation, etc.

Review of the "HACCP" and "ROP" notebooks revealed the notebooks lacked policies and procedures specific to the vacuum packaging process. For example, review of the Food and Nutrition Services policy and procedure manual (last reviewed and revised 8/2010) revealed the manual lacked policies and procedures related to vacuum packaging of food using the ROP method. Missing policies and procedures relevant to Food Code HACCP did not address: the food employee and supervisory training programs, basic infection control practices, HACCP plans outlining the process to be followed, the method and frequency for monitoring the process is followed, and maintenance of records. The index for Section VI, titled "Quality Assessment & Performance Improvement Program" included Infection Control/Food Safety. Review of this section revealed in part "... The provision of wholesome foods includes: The preparation of food in accordance with accepted food handling and processing techniques. The holding and serving of the finished products in a manner designed to control bacterial growth ... A manual containing all HACCP policies and procedures has been developed..."

4. During a staff interview on 6/18/13 at 12:10 PM, Staff A, cook, said she was not familiar with the notebook pages, behind the logs, and thought they were probably something the Food Service Director covered with some of the staff, but acknowledged the information had not been reviewed with her.

During an interview on 6/19/13 at 10:13 AM, the Food Production Supervisor reported she was not familiar with the notebook pages, behind the logs, and said it was probably something the Food Service Director covered with some of the staff, but confirmed the information had not been reviewed with her.

5. Observation of the facility's inventory of vacuum packaged foods on 6/18/13, beginning at 10:30 AM, the Food Production Supervisor, Business Manager and Staff A, Cook II, verified the inventory of vacuum packaged foods identified by the facility as being items served to patients.

Walk-in cooler labeled "meat thaw:"
7 packages of flaked tuna packaged on 6/10/13 with an expiration date of 8/4/13
9 packages of sliced ham packaged on 5/23/13 with an expiration date of 7/7/13
1 package of sliced turkey bologna packaged on 6/9/13 with an expiration date of 7/24/13
2 packages of sliced turkey ham packaged on 6/16/13 with an expiration date of 7/31/13
3 packages of sliced turkey packaged on 6/13/13 with an expiration date of 7/28/13
1 package of sliced turkey packaged on 6/2/13 with an expiration date of 7/17/13

Additional observation in the walk-in cooler revealed 1-11 pound Cobblestreet ham stored in the cooler with a received date of 6/11/13. During an interview at the time, the Food Production Manager said the ham would be sliced and vacuum packaged, as needed, with no scheduled date at the time. The Food Production Manager was unable to verify the manufacturer's recommended "use by" date for any of the sandwich meats. The Food Production Manager reported the sliced meats were used for patient sandwiches every Sunday night and occasionally other times when sandwiches appeared on the menu. She clarified her statement to include the fresh meat is used when sandwiches appear on the menu and leftovers are vacuum packaged and used to feed clients other than patients 99% of the time.

Freezer #1:
1 package of diced bacon packaged on 6/14/13 with an expiration date of 7/29/13
4 packages of diced bacon packaged on 6/7/13 with an expiration date of 7/20/13

Special diets freezer:
1 package chicken leg packaged on 6/10/13 with an expiration date of 7/25/13
8 packages of pork packaged on 5/3/13 with an expiration date of 6/18/13
21 packages of turkey packaged on 6/14/13 with an expiration date of 7/29/13
17 packages of roast beef with no label to indicate when it was packaged or the expiration date

During an interview, at the time of the inventory, the Food Production Supervisor reported the facility used vacuum packaging because the packaging method resulted in better food quality and to help manage the purchasing and production of large quantities of food items that could be packaged and used later in smaller quantities.

The Food Production Supervisor and Business Manager verified on 6/18/13 at 11:30 AM, the walk-in cooler labeled "meat thaw," walk-in Freezer #1 and the special diets freezer had digital temperature read-outs on the outside of the units and lacked an electronic monitoring system that would continuously monitor the time and temperature. The Food Production Manager reported there was a daily check of the digital read-out in the morning and recorded on a log. During a follow-up interview on 6/19/13 at 10:13, the Food Production Supervisor reported dietary staff checked the unit temperatures twice daily but only recorded the readings once per day.

6. During staff interviews on 6/18/13, from 11:45 AM to 12:25, Staff B, Staff C, and Staff A, respectively, reported each had several years of experience at the facility and received training on the vacuum packaging process from another cook. They were unaware of any written policies and procedures specific to vacuum packaging and had never received, nor had any knowledge of, a defined training program specific to vacuum packaging. Staff B, Staff C, and Staff A confirmed sandwich meats, available for patient use, were vacuum packaged and labeled with a 45-day expiration date and leftovers were vacuum packaged after being chilled.

During an initial interview on 6/17/13 at 3:20 PM and follow-up interviews on 6/18/13 at 1:45 PM and 6/19/13 at 10:13 AM, the Food Production Supervisor reported the Siouxland District Health Department conducted 2 inspections related to the children's school program and raised concerns regarding the vacuum packaging process. The Food Production Manager believed the inspector told the Food Service Director (FSD) she needed HACCP plans for the process in December of 2012. The Food Production Supervisor reported the Food Service Director began working on new forms, but when the inspector came back in May 2013, the inspector determined their packaging process still did not meet safety standards due to the lack of HACCP plans. Review of the Siouxland District Health Department report from 5/10/13 revealed the inspector had requested the HACCP plans be provided to her, following state approval. The Food Production Supervisor believed the inspector gave the FSD the name of a person to call to consult on the requirements for vacuum packaging and HACCP plans, but had no knowledge if the person had been contacted. The Food Production Supervisor reported they posted the Siouxland District Health Department inspection reports in the kitchen for dietary staff to review but was unaware if management received a copy of the reports. The Food Production Supervisor reported the Food Service Director initiated the documents for vacuum packaged foods, located in the ROP notebook, 1 to 2 months ago. However, she was not included in the development of a defined vacuum packaging process, training for the process or policy and procedure development and confirmed the facility lacked policies and procedures specific to the process and had no defined training program. The Food Production Supervisor lacked knowledge of the details regarding the concerns the Siouxland inspector communicated to the Food Service Director, lacked knowledge of the elements required by the Food Code for the ROP process, and lacked knowledge of the required elements of a HACCP plan.

During an interview on 6/18/13 at 3:25 PM, the Business Manager reported he had a background in infection control as well as public health and acknowledged he became alarmed during the initial kitchen tour when he heard staff held the vacuum packaged sandwich meats for 45 days. He reported he checked with the dietary staff after the tour to confirm they actually held the products for 45 days. Dietary staff informed him they used the foods well before the expiration date. The Business Manager believed the intention of vacuum packaging was to improve product quality, not to extend the shelf life, and therefore was not subject to the same requirements as set forth in the Food Code. He acknowledged he was not aware of how the 45-day expiration date came about, but did not believe they should keep any food in refrigeration for 45 days.

During an interview on 6/19/13 at 10:13 AM, the Business Manager reported he had not received a copy of the Siouxland District Health Department inspection reports from December and May and was not aware the inspector had identified concerns with the vacuum packaging process.

7. Review of the Food and Nutrition Services Quality reports from 4/2012 through 5/2013 revealed the department had not identified any problems with their vacuum packaging process.

8. During an interview on 6/19/13 at 8:00 AM, the Infection Control (IC)/Quality Assurance (QA) registered nurse (RN) verified dietary reports quality improvement/assurance findings to the Business Manager and these findings are reported to Medical Executive and the Performance Improvement Committee on a quarterly basis. The IC/QA RN verified she was unaware of the reduced oxygen packaging system and procedures to follow to maintain safety of the system.
VIOLATION: QUALIFIED DIETITIAN Tag No: A0621
Based on document review and staff interviews, the facility failed to ensure their contracted qualified consultant dietitian, with knowledge and expertise beyond that of the Food Service Director, provided the Food and Nutrition Services Department necessary professional support and consultation related to their reduced oxygen packaging (ROP) system. The facility identified a census of 7 child/adolescent patients and 18 adult patients, all of whom were affected.

Failure to provide necessary support and consultation of a qualified dietitian related to food safety and Food Code requirements when using this reduced oxygen packaging system potentially contributed to food service staffs' failure to package and store foods in accordance with the Food Code and the manufacturer's directions, or recognize the increased potential for foodborne illness related to inappropriate use of the system.

Findings include:

1. During the entrance interview on 6/17/13 at 12:15 PM, the Superintendent reported the facility's current contracted dietitian did not come on-site and completed all communication and documentation electronically.

2. Review of a contract titled "Dietician Consultant," with a start date of 10/1/11 and renewed in May 2012, revealed the contracts purpose was to provide the facility with a consultant dietitian for the Food Service Department. The contract stipulated the dietitian would be available by phone, email or fax. The contract failed to delineate the dietitian's responsibilities regarding oversight and consultation related to provision of food service and safe food handling practices.

Review of written communication between the consultant dietitian and the Food Service Department, from 7/2012 through 6/2013, revealed communication was limited to menu development and approval. The communication lacked any documentation regarding food production topics, food safety topics, or any communication regarding the lack of Hazard Analysis and Critical Control Points (HACCP) plans (a food safety plan to achieve managerial control of foodborne illness risk factors), as required by the Food and Drug Administration Food Code, for ROP. A Siouxland District Health Department inspector had identified problems with their ROP and notified the dietary staff of the problems related to the ROP on 12/21/12 and 5/10/13.

3. During an interview on 6/18/13 at 1:45 PM, the Food Production Manager reported the consultant dietitian did not make onsite visits and the majority of communication with the dietitian was through email and occasional phone calls. She was not sure if the Food Service Director had spoken to the consultant dietitian about the Siouxland District Health Department inspector's concerns (identified in 12/12 and 5/13) regarding the vacuum packaging process and lack of HACCP plans, but did not think so.

The facility is also surveyed by The Joint Commission for regulations comparable to Federal hospital regulations. During an interview on 6/19/13 at 9:30 AM, the Administrative Assistant reported in 2/2013 the Joint Commission tracer process (evaluation method to assess compliance with standards) identified standards for dietitian involvement were not met and the facility lacked information to adequately evaluate the fulfillment of her duties. The facility determined on-site visits were needed to increase communication between the medical staff and the dietitian. During a follow-up interview at 12:15 PM, the Administrative Assistant reported all contracts are reviewed annually and, in the process of reviewing the Joint Commission tracers and the consultant dietitian's contract in 2/2013, the facility identified a problem with completion of required duties and determined the need for on-site visits.

During an interview on 6/18/13 at 3:25 PM, the Business Manager reported the current consultant dietitian has been under contract with the facility for approximately 1 1/2 years, with the understanding she would not be onsite and would perform her duties electronically. He said the facility determined on-site visits were needed to adequately fulfill the responsibilities of the contract and has a new person contracted to start on 7/1/13, who will be available on site approximately 16 hours/week. The Business Manager reported the consultant dietitian's primary involvement was with menu management and special diets and had no involvement on the food service side.

The surveyor attempted to contact the consultant dietitian by telephone on 6/18/13 at 2:00 PM, 2:20 PM and 7:45 PM and received no answer and the calls did not provide the option for leaving a message. The surveyor sent an email to the consultant dietitian at 2:53 PM requesting she contact this surveyor as soon as possible. However, the surveyor received no reply to the email by the time of the complaint exit on 6/19/13.

(Refer to A-0749 for additional qualified dietitian information)