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800 MERCY DRIVE

COUNCIL BLUFFS, IA 51503

No Description Available

Tag No.: A0442

Based on observations, document review, and staff interviews, the facility failed to:

-Identify a system in which individuals were given access to certain locked areas of the hospital through use of their identification badge only when needed to do their work,
-Keep medical records safe from unauthorized access following current hospital policy, and
-Ensure medical records transported from an off-site record storage facility is done in a manner to prevent access by an individual with no need to do so.

Concerns were identified in 8 of 24 patient care areas as well as with the system of granting badge access to individuals who may not need access to areas where confidential patient medical information is kept and available.

The facility reported a current in patient census of 90 inpatients.

Electronic locks on some doors in the hospital unlock only when the individual ' s badge is programmed to unlock it, including those areas where patient records may be kept. These records contain confidential patient medical information which may include name, address, telephone number, medical insurance information, diagnoses, and results of tests and treatments which should not be accessible to individuals who do not require the need the information.

Failure to secure medical records of both inpatients and outpatients against unauthorized access could result in identity theft, theft of financial/insurance information, or unauthorized disclosure of a patient ' s personal medical information.

Findings include:

1. Review of the hospital policy titled "Information Security in the Work Area," last reviewed in 3/12, revealed in part, "V. Procedure A. Work Area . . . 4. All confidential information and personal health information (PHI) will be placed in a locked drawer or cabinet. . . ."

2. Observation during a tour of the diabetes education supply and medical record storage, on 8/28/12 at 4:00 PM, revealed the presence of patient medical records when Staff J, Diabetes Education Site Specialist, opened the top drawer of an unlocked file cabinet. Staff J reported she currently stored less than 20 charts in the file cabinet. Review of patient files found they included patient identification information, a certificate of medical necessity, plan of care, patient assessment information and lab results. Staff J reported the office was locked when unoccupied but the file cabinet was not always locked in her absence. Staff J further reported environmental services staff accessed the office to clean in her absence.

3. During a tour of the medical records department on 8/29/12 at 3:20 PM, Staff G, Operations Director - Medical Records, reported the main entrance into the department required a staff badge to be programmed to access the area (badge access).

Review of an undated, untitled document (received for review on 8/29/12) revealed a list of 576 individuals with badge access to the medical records department. This included catering associates.

During an interview on 8/30/12 beginning at 10:45 AM, Staff G reported a couple times a year he requested a report from security that listed the staff with badge access to the medical records department and reviewed the list for potential changes. He was unsure of the exact process of how the requests for badge access to specific areas were handled, but reported if there was a request for access to his department, he was involved in the approval process. During the interview, the surveyor reviewed a report of staff with badge access to medical records (the report was dated 7/24/12) and noted 27 of the approximately 576 names were highlighted in yellow. Staff G confirmed the highlighted names were medical records staff and these, along with security and plant operations (maintenance) staff, were identified to continue to have badge access to the medical records area while all others were to have their access discontinued.

During an interview on 8/30/12 at 12:10 PM, Staff I clarified the badge access report dated 7/24/12 was the last report Staff G had received and reviewed, but Staff I had made no changes for access to the medical records area since that time. Staff I reported the facility lacked a policy to address how it was determined that an individual needed badge access to the various areas within the hospital, but stated that the unwritten procedure involved human resources, approval from the director of the area for which access is requested, and security, which is the department that maintains the computer program for badge access.

5. During a tour of the medical records department on 8/29/12, beginning at 3:20 PM, Staff G reported Retrievex (a records management center) was used as an offsite medical records storage area for ancillary patient services records generated before they started the electronic medical record in July 2007. Staff G reported when a specific patient record is needed, Retrievex is contacted and given the box reference number containing the patient record. Retrievex staff delivered the entire box of records and a medical records staff person retrieved the specific record from the box, once delivered.

During an interview on 8/30/12, beginning at 10:45 AM, Staff G confirmed the records are transported in an unsealed, cardboard banker's box via a company vehicle.

6. Observation on 8/29/12 at 11:00 AM, during tour of the Surgery area (including pre- and phase II post-operating areas) with Staff Q, Team Lead - Surgery, and Staff L, Team Lead Peri-Op/Recovery Room, revealed patient medical records for the next day's cases stored on an unlocked cart, in an open area without doors, near the medication/dictation room.

During an interview on 8/29/12 at 11:00 AM, Staff Q and Staff L stated an average of 25 surgical patient medical records were kept overnight in the unsecured area.

The space within the surgery area where records are stored overnight lacked a mechanism to lock or keep secure the patient medical records from persons with unauthorized access or a need to know.

Review of an undated, untitled document received 9/5/12 listed 1044 employees with badge access to the surgery area. This included 47 environmental services employees, 11 maintenance employees, and 65 security employees, none of whom would likely need information found in medical records to perform their job.

7. Observation on 8/29/12 at 12:40 PM, during tour of the Invasive Cardiology area with Staff M, Team Lead - Invasive Cardiology area, revealed two 3-ring binders with patient names and tests performed from 1/2011 to present. Review of an undated, untitled document, received 9/5/12, found it listed over 1000 individuals with badge access to the Invasive Cardiology area. These included 48 environmental services employees, 11 maintenance employees, 14 volunteers, and 64 security employees, none of whom would likely need information found in medical records to perform their job.

8. Observation on 8/30/12 at 8:15 AM, during tour of the Non-Invasive Cardiac and Vascular area with Staff N, Operations Director Non-Invasive Cardiac and Vascular, revealed patient medical records with physician orders for tests to be performed. These records were stored in an unlocked file cabinet located in the central area.

When interviewed at this time, Staff N acknowledged presence of the unlocked patient medical records stored in the central area and verified the patient information was available to the housekeeping staff that cleaned the area when non-invasive cardiology staff were not present. Staff N acknowledged the housekeeping staff do not have the need to know nor need to have access to the confidential patient medical record information.

Review of an undated, untitled document received 9/5/12 listed 272 employees with badge access to the Non-Invasive Cardiology. This included 48 environmental services employees, 13 maintenance employees, 1 courier services driver employee, 1 materials handler employee, 2 catering associate employees, and 66 security employees, none of whom would likely need information found in medical records to perform their job.

9. Observation on 8/30/12 at 10:40 AM, during tour of the Medical Access Center - Downstairs office with Staff P, Team Lead - Medical Access Center, revealed 27 patient medical records stored in 1 drawer of a 5 drawer unlocked vertical file cabinet. Also, a one page document was posted on the front of the vertical file cabinet with 7 patient names and birth dates. Staff P verified two folders that contained approximately 25 special procedures to be scheduled that included patient information stayed on the staff's desk unsecured after staff left for the day.

Observation on 8/30/12 at 11:05 AM, during tour of the Medical Access Center - Upstairs office with Staff P revealed a 2 drawer unlocked file cabinet with approximately 660 medical records of patients who had surgical and total joint replacements. Also present, was an open cart with 28 patient medical records of those patients scheduled for future medical procedures.

During an interview on 8/30/12 at 11:05 AM, Staff P acknowledged the unlocked patient medical records stored in the Medical Access Centers - Downstairs and Upstairs office and verified the patient information was available to the housekeeping staff that cleaned the area when staff were not present. Staff P stated Medical Access Center - Downstairs and Upstairs office staff and housekeeping staff are required to use a key to unlock the doors to the areas. Staff P acknowledged the housekeeping staff do not have the need to know nor need to have access to the confidential patient medical record information.

During an interview on 9/5/12 at 8:50 AM, Staff L, Campus Operations Leader, acknowledged the undated, untitled document, received 9/5/12, included a list of employees with job titles with badge access to Surgery, Invasive Cardiology, and Non-Invasive Cardiology.

DIETS

Tag No.: A0630

Based on clinical record review, policy review, other document review and staff interviews, the hospital nursing staff failed to ensure the diet ordered by the physician was communicated correctly to the Food and Nutrition Department. The administrative staff reported a census of 90 inpatients. The Operations Director of Food and Nutrition Services reported approximately 55 patient meals served each meal period.

Failure to provide a patient with the correct therapeutic diet as ordered by the patient's physician or other qualified and privileged staff could potentially result in complications for the patient including gastrointestinal intolerance, texture intolerance, and inadequate or excess nutrient intake which could lead to weight loss, fluid imbalance, electrolyte imbalance, choking, aspiration, nausea or vomiting.

Findings for 6 of 20 open medical records reviewed (Patients #1 - #6) include:

1. Review of the medical record for Patient #1 revealed a diet order, written on 8/25/12 at 2:50 PM, for the patient to receive a pureed cardiac American Diabetes Association (ADA) diet. Review of the Sorian (facility electronic medical record system) diet order entry, revealed an entry for a puree consistent carbohydrate on 8/25/12 at 2:52 PM.

-Review of a document titled "Diet Order Roster Report" (diet order sheet printed from Computrition, the facility foodservice company), dated 8/27/12 2:06 PM, used by the Food and Nutrition Department for patient meal service, revealed a diet order of puree consistent carbohydrate.

-Staff C, Clinical Nutrition Manager, reported the ADA portion of the diet translated to a consistent carbohydrate diet but confirmed the diet order entered into Sorian did not match the physician order and lacked the cardiac diet restriction, which would add a cholesterol and 2 gram (gm) sodium (Na) restriction.

2. Review of the medical record for Patient #2 revealed an order, dated 8/26/12 at 9:00 AM, titled "Routine Admission to Labor and Delivery," that included a clear liquid diet as part of the order set. A subsequent order set, dated 8/27/12 at 2:00 PM, titled "Routine Postoperative for Cesarean Delivery" included an order for a clear liquid diet, advance as tolerated to a regular diet.

-Review of the Sorian diet order entries, revealed an entry for a clear liquid consistent carbohydrate on 8/26/12 at 7:52 AM and on 8/27/12 at 1:05 PM. Review of a document titled "Diet Order Roster Report" dated 8/27/12 at 2:06 PM, used by the Food and Nutrition Services Department for patient meal service, revealed a diet order of clear consistent carbohydrate.

-During an interview on 8/27/12 at 4:00 PM, Staff F, unit secretary, reported she knew the patient had a diagnosis of diabetes and entered the diet order as a clear consistent carbohydrate diet because she felt it to be appropriate.

3. Review of the medical record for Patient #3 revealed a diet order, written on 8/24/12 at 4:00 PM, of ADA 2000 calories.

-Review of the Sorian diet order entry, revealed an entry for a 2000 calorie 2 gram sodium consistent carbohydrate on 8/24/12 at 4:38 PM.

-Review of a document titled "Diet Order Roster Report" dated 8/27/12 2:06 PM, used by the Food and Nutrition Services Department for patient meal service, revealed a diet order of 2000 calorie consistent carbohydrate 2 gm Na. Staff C, present at the time of the review, confirmed the medical record lacked a documented physician order for the 2 gm Na restriction.

4. Review of the medical record for Patient #4 revealed a diet order, written on 8/22/12 at 3:33 PM, of mechanical soft.

-Review of the Sorian diet order entries revealed an entry for NPO (nothing by mouth) on 8/25/12 at 7:16 AM. However, review of the medical record revealed the record did not contain an order for NPO.

During an interview at the time of the review, Staff D, Team Lead Critical Care Unit (CCU) recalled the physician thought the patient might need surgery and believed the patient may have been made NPO as a result. However, Staff D failed to locate a documented diet order for the change to NPO or documentation in progress notes to address the reason for the change to NPO.

-Review of a document titled "Diet Order Roster Report" dated 8/28/12 1:39 PM, revealed a diet order of mechanical soft (ground or mashable, soft foods).

5. Review of the medical record for Patient #5 revealed a diet order, written on 8/22/12 at 10:00 PM, of No Added Salt (NAS).

-Review of the Sorian diet order entry, revealed an entry for a Low Cholesterol 2 gm Na (Cardiac Diet) on 8/22/12 at 10:51 PM. Review of a document titled "Diet Order Roster Report" dated 8/28/12 1:39 PM, used by the Food and Nutrition Services Department for patient meal service, revealed a diet order for a cardiac diet.

-Staff C, present at the time of the review, confirmed the diet order entered into Sorian did not match the physician ordered diet. Staff C reported a NAS diet did not restrict cholesterol and included a 4 gm Na restriction, rather than 2 gm.

6. Review of the medical record for Patient #6 revealed a diet order, written on 8/27/12 at 10:00 PM, of Cardiac 1800 cal ADA diet. However, review of the Sorian diet order entry, revealed an entry for an 1800 calorie 2 gm Na Consistent Carbohydrate diet on 8/27/12 at 10:34 PM.

-Review of a document titled "Diet Order Roster Report" dated 8/28/12 1:39 PM, used by the Food and Nutrition Services Department for patient meal service, revealed a diet order of 1800 calorie consistent carbohydrate 2 gm Na diet.

-Staff C, present at the time of the review, confirmed the diet order entered into Sorian lacked the cholesterol restriction, which is part of a cardiac diet, and did not match the order documented by the physician.

7. Review of a Patient Food Services policy titled "Diet Orders," dated 12/11, revealed in part, "Polices: Diets are ordered in writing by the responsible physician prior to the service of the diet. Procedures: Physician - Writes diet order in medical record/information system. . . . Writes a diet order for 'NPO' when a patient is not allowed oral intake. Writes a new diet order to resume oral intake for patients who have been NPO. . . . "

-Review of a Patient Food Services policy titled "Communication of Patient Information and Requests:", dated 1/12, revealed in part, "Procedures: Nursing - Transcribes physician order exactly as written by MD . . . ."

-Review of a Nursing Services policy titled "Receiving, Clarifying, Transcribing and Reviewing (Chart Audits) of Physician's Orders:," dated 1/11, revealed in part, "II. Policy Statement . . . D. A 24-hour audit will be completed by the night shift nurse to verify that the physician orders have been correctly processed. . . . III. Procedure . . . D. Review Orders (Chart Audit) 1. The chart audit is done to verify that the orders have been: a. processed, implemented, or completed. b. Transcribed correctly onto the MAR/EMAR (Electronic Medication Administration Record). 2. The 24-hour chart audit is done by the nurse during the night shift. . . ."

8. During an interview on 8/27/12 beginning at 2:00 PM, Staff C reported the department recently completed a year-long quality improvement project and reported on the project earlier this month. Staff C relayed the project included chart audits to compare the diet order documented by the physician to the diet order in the electronic record. Staff C reported improvement had been noted, but there continued to be room for improvement and the chart audits would continue.

-During an interview on 8/27/12 at 4:20 PM, Staff E, Operations Director - Post Critical Care Unit (PCCU) and 2nd floor, reported the unit secretary should enter the diet orders as written by the physician and if there is a question about the diet, he/she would expect the nurse to contact the physician for clarification.

-During an interview on 8/28/12, as part of the medical record review for nutrition screening and assessment, beginning at 8:30 AM, Staff C reported the clinical dietitians should compare the diet order documented by the physician to the diet order entered into the electronic record to ensure they match.

-During an interview on 8/30/12 at 8:50 AM, Staff E reported a 24 hour chart audit is completed by the nurse each night and included verification of the accuracy of physician orders entered into the electronic medical record and would be an opportunity for the nurse to realize the diet order on the paper chart did not match the order entered into the electronic system. Staff E further reported if the diet order entered into the electronic medical record did not match the order written by the physician, she expected the nurse to make the appropriate correction in the system.

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on observation, review of documentation, and staff interview, the facility failed to ensure current safety inspection of 2 of 2 steam sterilizers, used to sterilize all surgical instruments for surgery, in the only sterile processing area. The facility reported approximately 8 loads of patient care supplies sterilized per day in the 2 steam sterilizers.

Failure to ensure current safety inspections of the steam sterilizers could potentially mean the sterilizers may not perform as intended to kill bacteria on patient care supplies, including instruments used during surgery, and could result in surgical infections to patients. In addition, the lack of safety inspection of the pressure vessel could potentially result in harm to the operator if the steam sterilizer would malfunction.

Findings include:

During tour of the sterile processing area on 8/29/12 at 1:45 PM, Staff Q, Team Lead Surgery, acknowledged the boiler certificates for 2 of 2 steam sterilizers had expired on 6/2011. Staff Q was not aware of the location of the steam sterilizer boiler certificates until asked by the surveyor to look for them. Staff Q then called Staff O and inquired about current steam sterilizer boiler certificates.

During an interview and review of documentation on 8/29/12 at 3:25 PM, Staff O, Director of Engineering, provided documentation that showed 2 of 2 steam sterilizers with inspection expiration dates of 6/2012. Staff O stated he was not aware the steam sterilizer inspections had expired 6/2012.

EMERGENCY GAS AND WATER

Tag No.: A0703

Based on document review and staff interview, the facility failed to provide documented evidence of a current written plan for the necessary fuel and potable/unpotable water to meet the needs of the patients and staff, in the event of an emergency. The administrative staff reported a census of 90 patients.

Failure to have a plan for emergency fuel and water may result in a disruption in services to patients and staff which could result in discomfort, exacerbation of illness and harm.

Findings include:

1. During an interview, as part of the hospital environment tour, on 8/29/12 beginning at 1:30 PM, Staff H, Operations Director of Facilities, reported the hospital had written contracts for fuel and water supplies in the event of an emergency disruption in their existing supply.

2. Review of an undated document from Sapp Brothers Petroleum, Inc. revealed a lack of signatures from either party and no date to indicate the period for which the document was in force.

-Review of a document dated 12/6/10 from Pure Water revealed the party agreed to provide an unspecified amount of bottled water. Staff H reported the contract for unpotable water had been entered into verbally last summer with a nearby city, and confirmed he lacked any agreement in writing.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observation, record review and facility policy review, the facility failed to implement a system to test OPA Cidex disinfectant solution prior to each use as directed by the manufacturer's guidelines and facility policy for 1of 1 (Ultrasound) rooms using Cidex as a disinfectant. The facility reported an average of 20-25 procedures a week completed in Ultrasound requiring the use of Cidex as a disinfectant.

Failure of staff to test OPA Cidex disinfectant solution prior to each use could potentially cause cross-contamination of an infection between patients if the effectiveness of the Cidex decreases with use.

Findings include:

1. An observation during the tour of the Ultrasound department on 8/29/12 at 9:55 AM, with Staff A (Operations Director of Radiology), revealed Cidex disinfectant solution located by the sink in the Ultrasound room where staff completed pelvic exams. The Cidex Test Strip Check List hung on the wall next to the Cidex Test Solution. The ultrasound staff documented testing the solution 1x a day.

2. During an interview on 8/29/12 at 9:55 AM, Staff B, (Sonographer) confirmed staff tested the Cidex Solution once a day and did not test the solution prior to each use.

3. Review of the manufacturer's guidelines for Cidex OPA Solution disinfectant found it stated in part, "4. Test. It is recommended the Cidex OPA Solution be tested before each usage with Cidex OPA Test Strips to verify that the appropriate concentration of ortho-phthalaldehyde is present."

Review of the facility policy titled "Cleaning, Disinfection and Sterilization of Patient Care Items and the Emvironment" found it stated in part:

"...IIIA 2. High Level Disinfection: Sterility is somewhat critical (or semi-critical) for items that will touch mucous membranes.
a. Such items include some respiratory equipment, endoscopy equipment and vaginal ultrasound probes.
2. High level disinfectants will be used on these items (i.e., Cidex OPA).
4e. Follow manufacturer's instruction for exposure and contact times..."