HospitalInspections.org

Based on review of the hospital's brochure that informs patients/families of their rights and how to place a grievance, and employee interview, the hospital failed to provide a working phone number to which the patients/families can report a grievance to Missouri Department of Health and Senior Services (MO DHSS), Health Services Regulation. This potentially affects all 207 current patients.

Findings include:

Review of the hospital's brochure titled "Welcome to Children's Mercy" revealed that the brochure includes patient rights and how to file a grievance with addresses and phone numbers to contact different entities including the MO DHSS, Hospital Licensing and Certification. However, the phone number listed is a non-working number.

Interview with Registered Nurse (RN) Staff OOOOO, Director of Emergency Nursing Services, on 5/11/10 at 4 p.m. confirmed the brochure titled "Welcome To Children's Mercy" is the document given to all patients/families hospital-wide to inform them of the patient rights and how to file a grievance. The "Patient Advocate" section of the brochure includes phone number 573-751-6302 for the Missouri Department of Health, Hospital Licensing and Certification. However, this employee called the number two different times and confirmed receiving an operator telephone recording stating the number is a non-working number.

Based on observation, interviews, and policy review, the facility failed to administer medications as ordered. This failure has the potential to effect all the patients in the facility. The Patient census was 207.

Findings include:

1. Observation/interview on 05/11/10 at 8:15 a.m. to 11:20 a.m. in the Intensive Care Nursery (ICN) revealed the following:

At approximately 8:15 a.m. Registered Nurses Staff YYY and Staff ZZZ started administering medications to Patient #59. According to the electronic MAR (Medication Administration Record) all scheduled medications were to be administered to the patient at 9:00 a.m. Registered Nurse, Staff ZZZ, stated that if the medications couldn't be given within the 60 minutes before or 60 minutes after the ordered administration time then he/she could just call pharmacy and get the time changed.

Observation of a medication pass for Patient #59 on 05/11/10 at 11:20 a.m. revealed that two medications ordered for 9:00 a.m. administration had not been given 2-hours and 20-minutes after planned. Observation did not find that staff called pharmacy or the physician.

During an interview on 05/11/10 at approximately 2:33 p.m. in the ICN, Staff XXX, Registered Nurse (RN), Director of Critical Care Nursing Services and acting ICN Manager, stated the medication administration policy was 60 minutes before and 60 minutes after the ordered time of the MAR.

During an interview on 05/12/10 at 9:04 a.m., Staff UUU, RN, BSN, Director of Utilization Review and Regulatory Readiness stated the hospital's current standard of practice was 60 minutes before and 60 minutes after the ordered medication administration time. Staff UUU did state that training earlier in the year had made he/she aware of the 30 minute standard but the facility failed to act upon it.

During an interview on 05/12/10 at approximately 1:30 p.m., Staff UUUU, Director of Pharmacy, stated that 60 minutes before and 60 minutes after the ordered medication time was not acceptable and a 30 minute window before and after the ordered medication time was an acceptable window of medication administration.

2. Review of the "Medication Management Policy", Med. 01, not dated or revised, revealed in part:
Administering
2.e. Verify that the medication is being administered at the proper time, in the prescribed dose and by the correct route.
However, the document included no direction to staff regarding the acceptable standard of practice for the time allowed for administering the medication before and after the planned time for medication administration.

Based on observation, interview and record review facility staff failed to demonstrate compliance with the requirements under the Condition of Participation for Medical Records Service through the following:

-The failure to maintain confidentiality of electronic medical records by granting 575 non-staff persons in 95 separate offices or clinics in the city plus 328 non-staff persons in 55 clinics outside the city and 291 non-staff persons in 66 clinics in a neighboring state active electronic access to patient medical information and the failure to develop routine monitoring of any access done by these 1194 non-staff (refer to A 0441);

-The failure to maintain security of paper patient medical records by ensuring accurate author identification and accuracy of the electronic medication administration record (refer to A 0438);

-The failure to maintain security of paper medical records in the main file room and during transport to and from clinic locations (refer to A 0442);

-The failure to ensure paper patient medical records with physician orders were timed as required (refer to A 0454);

-The failure to ensure authentication of physician verbal orders within forty-eight hours (refer to A 0457);

-The failure to ensure authentication and completion of patient history and physicals within twenty-four hours of admission (refer to A 0458);

The cumulative effect of these systemic failures result in overall noncompliance with the Condition of Participation for Medical Records Services CFR 482.24.

Based on observation, record review, and interview, the facility:
- failed to accurately record the time of medication administration and uses an electronic record keeping system that defaults to the time the medication is ordered rather than the time the actual medication administration occurs. This failure has the potential to effect all patient records in the facility; and
- failed to develop and maintain policies and procedures for verification of author identification for paper records ensuring integrity of the authentication. The facility census was 207 patients.

Findings included:

1. Observation on 05/11/10 of a printout of the electronic MAR showed all medications given to Patient #59 were given at 9:00 a.m. However, direct observation of the medication pass revealed medications were administered from 8:15 a.m. to 11:20 a.m. and two ordered medications had still not been administered to the patient.

2. Observation on 05/11/10 at approximately 11:20 a.m. on a print out of the "Children's Mercy Hospital MAR" for Patient #59 revealed all medications given to Patient #59 were administered at 9:00 a.m. as ordered by the physician. Direct observation of the medication pass revealed medications being given from 8:15 a.m. through 11:20 a.m.

3. During an interview on 05/11/10 at approximately 11:20 a.m. ICN Staff XXX, Registered Nurse (RN), Director of Critical Care Nursing Services and acting ICN Manager, stated the default time for the electronic system is the ordered time of the administration - in this case all medications defaulted to the ordered administration time of 9:00 a.m.
4. During an interview on 05/12/10 at 9:04 a.m., Staff UUU, RN, BSN, Director of Utilization Review and Regulatory Readiness stated he/she was unaware of the default in the electronic MAR system.
5. During an interview on 05/12/10 at approximately 1:30 p.m., Staff UUUU, M.S., R. Ph., Director of Pharmacy, stated he was not aware of the default in the electronic system and did not monitor medication administration times except for those at risk medications requiring constant blood monitoring such as Heparin (is an anticoagulant medication. It is used to treat or prevent clots in the veins, arteries, lungs, or heart. It stops clots from forming or getting bigger).
6. During an interview on 05/13/10 at 10:00 Staff UUUU, M.S., R. Ph., Director of Pharmacy, telephoned, Staff RRRR, IT for Pharmacy. Staff RRRR verified the electronic MAR did default to the time of the medication order unless changed by the person administering the medication.


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7. During an interview on 05/10/10 at 2:20 p.m. the Director of Medical Records, Staff A, stated the following:
-The Medical records department did not have a policy and procedure for author identification for the paper medical records documenting outpatient visits to offsite clinic locations.
-The facility Appointment and Credentialing Policy may outline author identification and verification of signatures.

However, record review of the facility Appointment and Credentialing Policy, dated 04/20/10, provided during the survey revealed no discussion of author identification or verification of signatures.

8. Record review of the facility Medical Staff Rules and Regulations, Article VI. Medical Records, paragraph 1, dated 04/20/10 directed members shall be responsible for the preparation of a complete, legible medical record for each patient seen in an inpatient or outpatient setting. All written documentation including orders must be completed and signed in the Hospital's electronic Health Information System (HIS) except for services not yet automated or during periods of system downtime.

9. During an interview on 05/11/10 at 9:51 a.m. the Director of Medical Records, Staff A, stated the following:
-Again confirmed the facility failed to establish written policy and procedure for ensuring authentic, accurate signatures on hand written paper documentation in patient medical records.
-Medical Records staff maintained a list of some of the physician's signatures for verification of questionable entries on paper documents.
-Most of the medical record entries were now electronic signatures so, Medical records staff had not been maintaining the signature list.
-Did have a very few signatures on file.

Record review of the hand written list of physician names with a sample of their individual signatures revealed twenty one names adjacent to a corresponding signatures (some almost illegible).

Based on interview and record review, the facility failed to ensure confidentiality of patient electronic medical records by granting access to 1,194 non-staff persons in 216 clinics and offices in the city, outside the city and in a neighboring state without structured, routine monitoring of any accesses to identify and prevent breaches of confidentiality. The facility census was 207 patients.

Findings included:

1. Record review of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L. 104-191), Title II Administrative Simplification (AS) revealed provisions addressed the security and privacy of health data and established rules including the Privacy Rule and the Security Rule.

Further review revealed the Privacy Rule, effective 04/14/03 regulated use and disclosure of Protected Health Information (PHI, any information held regarding health status and provisions of health care). The Privacy Rule further directed PHI may be disclosed for treatment or health care if the patient provided authorization to disclose and the facility disclosed only the minimum necessary information.

The Security Rule, effective 04/21/03 complemented the Privacy Rule and specifically directed electronic PHI be maintained with safeguards including; Administrative Safeguards consisting of policies and procedures to show how the facility will comply, Physical Safeguards consisting of how physical access (to hardware, software, work stations) were controlled and Technical Safeguards consisting of how information systems were protected from intrusion, erasure, alteration; how facilities authenticate entries with which they communicate, documented HIPAA compliance, policies and procedures regarding access of records and documentation of risk analysis and risk management.

2. Record review of the facility policy titled Resolving HIPAA Administrative Simplification Breaches and Complaints; revised 07/14/05 directed, in part, the following:
-All workforce members must comply with federal, state and local laws and regulations as well as all hospital policy related to the components on the HIPAA Administration Simplification.
-Failure to do so will result in counseling, up to and including termination of employment or affiliation with the hospital.
-The policy does not address non-staff members with access to patient electronic medical records.

Record review of the facility standard form provided to each patient, parent/guardian of each patient who was admitted to the facility, titled Consent for Examination and Medical/Dental Treatment, #8071-051 MR 08/06, paragraph titled "Release of Information" directed the signee attested authorization of release of information concerning the current visit {admission to the hospital} to the primary care physician, family physician or referring physician. The form does not have a section for signee attestation authorizing release of information of previous hospitalizations and does not grant access to patient information to non-physicians.

Record review of the facility policy titled, Access to Data and Information, revised 10/08 directed, in part, the following:
-Access to patients' protected health information was given on a "need to know" basis.
-External access: All outside requests for access to patient information must be made through a valid authorization, filed in the patients' medical record.
-When external access to patient data and information was appropriate, it was provided through a copy of the original document.
-Identified community physicians, primary care physicians and referring physicians have access to patient electronic records and will access the record of their specific patient.
-Failure to comply with limiting access to their patients will result in counseling and up to termination of their access.

Record review of the facility policy titled Confidentiality; revised 09/09 directed, in part, the following:
-All patient information will be held in the strictest confidence and not release without proper authorization.
-Patient information was any clinical, financial or demographic information about a patient whether oral, written, printed images or electronically stored data.
-Concerns regarding potential breaches of confidentiality by any hospital staff member should be reported to the Privacy Officer.

2. During an interview on 05/10/10 at 2:15 p.m. the Director of Medical Records, Staff A, stated the following:
-Some physicians have access to patient electronic medical records from their homes and offices.
-The Medical Records department did not have a confidentiality policy that addresses physician access to patient electronic medical records from home or office.
-He/she felt the facility Privacy Officer would have a policy addressing the confidentiality of patient electronic medical records from home or office.

3. During an interview on 05/11/10 at 9:31 a.m. the Privacy Officer stated the following:
-He/she had been in position since 1996.
-Staff were granted access to patient electronic medical records by job title.
-The Manager of the staff person initiated the request for staff access.
-With a change in position, the new manager would request a different access level for the staff person.
-Access was granted to staff such as physicians, nurses, schedulers and clerical.
-Some clerical and support staff had access and were restricted to view only, some can be edit and add, and some were no access.
-The accesses were granted on "a job needs" of the staff person.
-Job needs were determined by the manager and the Information Technology Security Analysts.
-All physicians have access to all patient medical records (not limited just their own patients).
-The Privacy Officer stated he/she knew Centers for Medicare/Medicaid Services had objection to allowing all physicians access to all patient medical records.
-The facility also allowed limited access to some community physicians including laboratory results and radiology results.
-No routine auditing of staff accesses was currently being done.
-Audits of staff accesses were conducted on a complaint basis (complainant suspected patient information was compromised and complain to the facility).
-Audits of staff accesses were also conducted on high profile media cases/patients.

Record review of the list of the number of known Compliance Cases with Access to PHI, provided by the Privacy Officer during the survey revealed the following:
-In 2008, there were only ten investigations {prompted by complaint or high profile media status} and two were found substantiated (inappropriate access).
-In 2009, there were only ten investigations {again prompted by complaint or high profile media status} and four were found substantiated (inappropriate access).
-During the first months of 2010, there were three investigations with one found substantiated.
-One investigation concerned the parent of a patient (a staff member) who inappropriately accessed the patient's medical record 74 times between 09/01/09 and 09/02/09 (two days).
-One investigation concerned the parent of a patient (a staff nurse) who inappropriately accessed the patient's medical record 36 times between 01/02/10 and 02/05/10.

4. Record review of an undated copy of the list of community non-staff persons with access revealed the following:
-575 persons in 95 clinics and offices in and around the city. The list of job titles included not only physicians and nurses but also office receptionist, office manager, medical assistants, referral person, information technology specialist, hospital record tracker, patient relations co-ordinator, business manager, scheduler, secretary, chart preparer, billing and coding, quality assurance manager, administrative assistant, insurance clerk, interpreter, data specialist and some without credentials or job title listed.
-Plus 328 persons in 55 other clinics and offices in the state. Their list of job titles included not only physicians and nurses but also front office supervisor, site supervisor, receptionist, technician, medical assistant, insurance, clinic tech, program manager, echo/steno, EKG tech, transcriptionist, front desk, certified medication aide and triage clerk.
-Plus 291 persons in 66 clinics and offices outside the state. Their list of job titles included not only physicians and nurses but also office manager, billing clerk, certified nurse aide, medical assistant, outreach co-ordinator, administrative assistant, tumor registrar, site supervisor, and receptionist.
-The total number of non-staff persons with active access status was 1194 in 216 different locations.

Record review of the list of documents (provided by the Privacy Officer during the survey) revealed each non-staff person with access in an office or clinic could read (and possibly print or transfer a copy) of the following for any patient referred from their clinic:
-Daily progress notes.
-Clinic reports and notes.
-Discharge reports.
-History and physicals.
-Lab results.
-Procedure and test reports.
-Radiology reports.
-Past and future appointment information.
-Patient demographic and insurance information.

5. During an interview on 05/11/10 at 1:45 p.m. the Privacy Officer stated he/she did not perform routine audits of access by the estimated four hundred plus community non staff.

Based on observation and interview, the failed to ensure paper patient medical records stored in the main file room of the Medical Records department were secured against unauthorized access and paper patient medical records documenting outpatient clinic visits (at offsite locations) were transported to and from the clinics in a secured manner. The facility census was 207 patients.

Findings included:

1. During an interview on 05/10/10 at 2:05 p.m. the Director of Medical Records, Staff A stated the following:
-Inpatients medical records were mostly electronic.
-Outpatient medical records documenting patient visits to offsite clinics were maintained on paper.
-Eighteen months of paper medical records were retained in the Medical Records file room.
-Doors to the Medical Record department were locked to limit unauthorized access.

2. Observation on 05/10/10 at 2:50 p.m. revealed the following:
-An unsecured door #0404.22 (entrance from a hallway) led into the file room.
-No Medical Records staff were working in the area.
-No Medical Records staff had direct line of sight from other parts of the department where staff was working.
-Multiple floor to ceiling metal shelves with numerous paper patient medical records.

During an interview on 05/10/10 at 2-50 p.m. the Director of Medical records stated the door should have been locked and was not.

Observation on 05/12/10 at 9:29 a.m. revealed staff stored approximately 2,000 paper patient medical records on the metal shelving and nearby carts with no direct line of sight of five or six Medical Records staff.

3. During an interview on 5/11/10 at 4:15 P.M. at the Northland Annex, Staff HHHHHH, said medical records for patients are always placed in door boxes and in boxes facing the wall so no one can see a patient's name as they are escorted down the corridor to an examination room. She said that after passing through the door from the waiting room into the examination/treatment area of the facility, patients are always escorted by staff to prevent potential violations of patient privacy, and never left alone to wander or loiter behind the nurse's desk. She said all their patient records are pulled daily at the hospital and sent by courier up to the Northland annex, which provides outpatient treatment. She said at the end of the day, most of the records are returned via courier back to the main hospital's possession for secure storage. She said, occasionally a patient's file would be retained overnight at the clinic to be examined for follow up appointment the next day or lab work, then returned to the main campus by courier the next day.

During an interview on 05/12/10 at 10:01 a.m. Teen Clinic Manager, Staff KKK, stated all patient medical records were sent to the main Medical Records department at the end of the clinic work day.

4. During an interview on 05/13/10 at 3:00 p.m. the Medical Records Supervisor, Staff VVVVV, stated the following:
-He/she had been in position for approximately fourteen years.
-Six days a week a contract courier service transported patient medical records to and from the offsite clinic locations.
-The couriers came to the main Medical Records department at 6:00 a.m. and picked up a gray bin of paper patient medical records assembled for transport by Medical records staff.
-The couriers returned to the main Medical Records department at 6:30 p.m. with patient medical records in the gray bin.
-Staff VVVVV did not know if the patient medical records were transported in a car or van or if the vehicle had identifying marking signifying it as a courier vehicle.
-The bins had no locking mechanism.
-The bins had never been locked for transport.

Observation on 05/13/10 at 3:00 p.m. revealed Medical Records staff used the following:
-A gray colored hard plastic bin measuring approximately fifteen inches by twenty two inches and approximately twelve inches deep.
-The top of the bin had an interlacing two section fold over cover.
-The end of the cover had a hole big enough to insert a lock.
-No lock was present.


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Based on interview and record review, the facility failed to ensure patient's physician's orders were timed as required in one (Patient #75) of four current patient medical records reviewed for timed orders. The facility census was 207 patients.

Findings included:

1. Record review of the facility Medical Staff Rules and Regulations, Article VI. Medical Records paragraph 1 g. Orders and Verbal Orders, dated 04/20/10 directed, in part, all orders shall be documented in the patient's medical record, signed, dated and timed by the authorized person who gave the order and the responsible Member of the Medical Staff.

During an interview on 05/10/10 at 2:30 p.m. the Director of Medical Records, Staff A, stated the staff were directed to complete legible, dated, timed and authenticated entries in all patient medical records.

2. Record review of current Patient #75's admission history and physical revealed staff admitted the patient on 02/23/10 with diagnosis including juvenile myelomonocytic leukemia (cancer) and bone marrow transplant (bone marrow is soft, fatty tissue inside bones. Transplant delivers healthy bone marrow stem cells, cells that can make any blood cells, to the patient.)

Record review of the patient's physician's orders revealed the following:
-Untimed six page order set (each page was untimed) for admission dated 02/23/10.
-Untimed two page order set (each page was untimed) for bone marrow transplant conditioning regimen dated 02/23/10
-Untimed three page order set (each page was untimed) for Allogeneic (bone marrow stem cells from a donor) conditioning regimen dated 04/06/10.
-Untimed single page for Fludarabine (chemotherapy) and anti nausea medications dated 04/06/10.
-Untimed single page for Rituximab (chemotherapy), other medications and vital signs monitoring dated 04/08/10.
-Untimed single page for Rituximab (chemotherapy), other medications and vital signs monitoring dated 04/15/10.
- Untimed single page for Rituximab (chemotherapy), other medications and vital signs monitoring dated 04/21/10.
-Untimed two page order set (each page was untimed) for Allogeneic conditioning regimen, chemotherapy and total body radiation dated 04/29/10.

Further record review of the overprinted forms used for the patient's orders revealed a prompt in the column specifically directing "time order written".

Based on record review and interview, the facility failed to develop a mechanism for physician's to authenticate verbal orders and staff failed to ensure that verbal orders were authenticated within 48-hours as required for two (Patient #42 and #75) of four open medical records reviewed for authenticated verbal orders. The facility census was 207 patients.

Findings included:

1. Record review of the facility Medical Staff Rules and Regulations, Article VI. Medical Records paragraph 1 g. Orders and Verbal Orders, dated 04/20/10 directed, in part, the following:
-All orders shall be documented in the patient's medical record, signed, dated and timed by the authorized person who gave the order and the responsible Member of the Medical Staff.
-All verbal orders in the patient's medical record must be authenticated by the practitioner within forty eight hours after the order is entered.
-Verbal orders shall be identified as such, signed by the person to whom given with the name of the authorized person who gave the order.

Record review of the facility Medical Records policy titled Analysis Deficiency Rules, paragraph labeled Verbal Orders Completion Criteria, revised 12/09 directed, in part, the following:
-All verbal orders and telephone orders require a signature and date when the order was signed by the ordering care provider.
-In this state, all verbal orders must be signed and dated within forty eight hours of the date and time given.

During an interview on 05/10/10 at 2:30 p.m. the Director of Medical Records, Staff A, stated the Medical Records department did not have a policy and procedure directing authentication of physician electronic verbal orders for current admissions, but deferred to the facility Medical Staff Rules and Regulations.

2. Record review of current Patient #42's admission history and physical revealed staff admitted the patient on 04/12/10 with diagnoses including abdominal distention and large abdominal mass, probable neuroblastoma (cancer). Further record review of the admission history and physical revealed the physician's assessment and plan included to maintain the patient NPO (nothing by mouth), kept on intravenous fluids in preparation for a bone marrow procedure and monitor intake and output closely.

Record review of the physician's orders revealed an unauthenticated order to provide the patient with a regular diet dated 04/12/10.

During an interview on 05/13/10 at 10:29 a.m. Pharmacist, Staff B, reviewed the unauthenticated verbal order and stated the following:
-There was an electronic order entered by the physician to hold the patient NPO dated 04/12/10.
-Nursing staff had entered the order for regular diet on 04/12/10.
-The physician had not authenticated the order for oral diet.
-In order to check the authentication for any electronic order, staff would have to review each (open each) individual order.

During an interview on 05/13/10 at 10:42 a.m. Resource Nurse, Staff UUUUU, stated the following:
-The order for regular diet entered by nursing staff was a verbal order.
-The order for regular diet was not authenticated by a physician.
-The diagnosis of abdominal distention and mass may or may not be an indicator for nursing staff to hold an oral diet.
-The nursing staff should obtain an authenticated physician's order for diet for a patient with abdominal problems.

3. Record review of current Patient #75's admission history and physical revealed staff admitted the patient on 02/23/10 with diagnosis including juvenile myelomonocytic leukemia (cancer) and bone marrow transplant (bone marrow is soft, fatty tissue inside bones. Transplant delivers healthy bone marrow stem cells, cells that can make any blood cells, to the patient.)

Record review of the patient's physician's orders revealed the following:
-An unauthenticated verbal clarification order (changing the amount of albumin, a protein in a total parenteral nutritional, intravenous nutrition mixture from one gram to twenty five grams) dated 03/14/10.
-An unauthenticated verbal clarification order (changing the amount of lipids, fats in a total parenteral nutrition mixture from forty three and two tenth grams to two grams per kilogram per day) dated 03/20/10.

During an interview on 05/13/10 at 10:30 a.m. Pharmacist, Staff B, reviewed the unauthenticated intravenous nutrition verbal clarification orders and stated the two orders were not authenticated by the physician (a third verbal order clarification form dated 03/30/10 was corrected by a new written order from the Physician Assistant).

Based on interview and record review, the facility failed to ensure patient admission history and physicals were completed and authenticated within 24-hours for five (Patients #40, #75, #37, #38, #39) of eight patient medical records reviewed for authenticated admission history and physicals. The facility census was 207 patients.

Findings included:

1. Record review of the facility Medical Staff Rules and Regulations, Article VI. Medical Records, paragraph 1 b. History and Physical, dated 04/20/10 directed, in part, the following:
-All inpatient histories and physical examinations shall be performed within twenty-four hours after inpatient admission to the hospital.
-The admitting attending physician must sign the history and physical examination.

During an interview on 05/10/10 at 2:30 p.m. the Director of Medical Records, Staff A, stated the department did not have a policy and procedure directing physicians to authenticate the patient's history and physicals within 24-hours, but did defer to the Medical Staff Rules and Regulations which directs that the patient history and physicals were to be authenticated and on the patient medical records within 24-hours of admission.

2. Record review of current Patient #40's admission history and physical revealed staff admitted the patient on 04/21/10 with diagnoses including hypoxia (deprived of actual oxygen) and increased productive cough (can expel mucous). Review of the patient's admission history and physical revealed the Nurse Practitioner authenticated the document on 04/23/10 and the attending physician authenticated the document on 05/04/10.

3. Record review of current Patient #75's admission history and physical revealed staff admitted the patient on 02/23/10 juvenile myelomonocytic leukemia (cancer). Review of the patient's admission history and physical revealed the physician authenticated the document on 02/28/10.

4. Record review of closed Patient #37's admission history and physical revealed staff admitted the patient on 04/26/10 with diagnoses including right temple rhabdomyosarcoma (cancer). Review of the patient's history and physical revealed the physician failed to authenticate the document.

5. Record review of closed Patient #38's admission history and physical revealed staff admitted the patient on 05/04/10 with respiratory distress/impending failure likely due to viral versus bacterial infection. Review of the patient's history and physical revealed the physician authenticated the document on 05/06/10.

6. Record review of closed Patient #39's admission history and physical revealed staff admitted the patient on 04/28/10 with diagnoses including severe heart failure and need for ventilator support. Review of the patient's history and physical revealed the attending physician authenticated a history and physical progress notes on 04/30/10.

Based on observation, the facility failed to secure 1 of 2 emergency carts filled with medications and supplies on the Pediatric Intensive Care Unit (PICU). This failure effected 56 of 56 patients in the unit. The facility census was 207.

Findings included:

1. During an observation on 05/12/10 at 3:12 p.m. the drawer to the emergency medical cart opened freely throwing the green lock tab to the floor.
2. During an interview on 05/12/10 at 3:15 p.m., Staff AAAAA, RN, BSN, stated the lock tabs were faulty and had not been replaced.

Based on observation, interview and record review, the facility failed to have a system in place that ensured the nutritional needs of each patient was met in accordance with recognized dietary standards and practices. The facility census was 207 patients.

Findings included:

1. Record review of the Dietary Reference Intake (DRI) revealed a system of nutrition recommendations from the Institute of Medicine (IOM) of the United States National Academy of Sciences with application for the daily nutrient intake for the general public and health professional to use when planning diets. The DRI was introduced in 1997 to broaden the Recommended Dietary Allowances (RDAs, a set of daily nutrient intake recommendations) which were guidelines meant to provide good nutrition for the general public.

2. During an interview on 05/11/10 at 3:20 p.m. the Director of Nutrition, Staff UU stated the following:
-The facility did not have a policy and procedure for a dietitian to review and approve the nutrient content (calories, grams of protein, carbohydrate, and fat, International Units of vitamins or milligrams of minerals) for any therapeutic diets used with patients.
-Patients were provided a selective form listing all possible foods that could be ordered from which they chose what they would recieve at their meals.
-Patients were allowed to self select any quantity and/or combination of foods without assistance of guidelines or a template to prompt food selections that might meet the DRIs.
-The facility did not have a systematic method of ensuring each patient was receiving foods that were at or near a nutritionally adequate diet.

3. During an interview on 05/13/10 at 10:16 a.m. the Director of Nutrition, Staff UU stated the nutrition assistants (not clinical professional dietitians) were assigned to complete nutrition screening within the first twenty four hours of the patient's admission. If the nutrition assistant did not find a nutrition problem the clinical dietitian would complete a nutrition assessment by the fifth day of admission (even though during the first through fifth days the patient could be self selecting an inadequate amount or type of food).

4. On 05/13/10 at 11:35 a.m., Dietitian Staff E showed the surveyor a computer screen listing of the foods selected by a patient. Further observation revealed the computer screen showed a single meal quantification of the nutrients from the food selected. Staff E stated the following:
-The computer screen showed a single meal's worth of foods and the nutritional values of those foods.
-The computer program did not show a daily intake of foods for the patient.
-If a daily composite nutrient intake was needed, he/she would have to add all the nutrient values together based on the foods selected.
-There was no generic diet to show the totals or composite nutrient values of foods selected.

5. During an interview on 05/13/10 at 11:41 a.m. the Director of Nutrition, Staff UU stated the staff dietitians used the DRIs (a daily composite quantification of nutrients) to meet the nutritional needs of the patients and not all menus served in the facility met the DRI guidelines.

Based on observation, interview and record review, the facility failed to ensure a current therapeutic diet manual, approved by the dietitian and the medical staff, was readily available to all medical, nursing and food service personnel. The facility census was 207 patients.

Findings included:

1. Record review of an approval cover page dated 10/02/03 revealed the president of the Medical Staff approved the content of the electronic copy of the Nutrition Care Manual (no edition number or date of publication to know if the diet manual reflected current therapeutic practices) as the diet manual. The approval page did not have an authentication by an approving dietitian.

Record review of a letter dated 05/04/10 directed that the president of the Medical Staff approved the facility Nutrition Department web page (not pages) as the official diet manual (no edition number or date of publication). The approval page did not have an authentication by an approving dietitian.

2. During an interview on 05/10/10 the Director of Dietary, Staff D stated the facility used the Children's Mercy Diet Manual as a therapeutic diet manual and copies were available on the facility internal computer system called "Scope".

3. During an interview on 05/11/10 at 11:46 a.m. Nurse Staff M looked for a diet manual in a cabinet then stated he/she had been in position for four years and if needed staff had room service menus that provided menu ingredients.

4. During an interview on 05/12/10 at 2:55 p.m. Nurse Staff BBB stated he/she had been in position since 1998 and was not aware of a diet manual for use in ordering patient diets.

5. During an interview on 05/13/10 at 10:06 a.m. Nurse Staff UUUUU stated he/she would look for the facility diet manual on the facility internal computer system named "Scope".

Observation on 05/13/10 at 10:06 a.m. revealed Nurse Staff UUUUU gained access to the facility computer system "Scope", then selected "food services" and opened a general diet menu (a list of multiple foods a patient could select).

During an interview on 05/13/10 at 10:06 a.m. when asked to find a specific diet and the protein content of the diet, Staff UUUUU stated he/she could try to find it on "Scope" but did not feel the "Scope" entry would list the amount of protein in the diet.

6. During an interview on 05/13/10 at 10:55 a.m. Nurse Staff TTTTT had been in position for one and a half years and would have to look at "Scope" to see if the facility had a diet manual.

7. A diet manual provides a list of diets that can be served to patients in the hospital. For each diet, the description typically includes a meal pattern, a list of foods allowed and those not allowed on the diet, a meal pattern of foods with the serving size for each food, and if the diet will or will not provide nutrients needed to maintain health.

Observation on 05/13/10 at 11:35 a.m. in the Dietary department diet office revealed Dietitian Staff E demonstrated use of the "Scope" system to find a single meal on a specific diet. This included several foods that would comprise a meal for that diet, but the Dietitian was unable to find a description of the foods served on the diet with a list of nutrients those foods and, therefore, the diet would provide to keep a person healthy.

Review of the facility internal computer system called "Scope" revealed a number of selective menus from which patients could choose. (A selective menu is like a restaurant menu since it lists a variety of foods from which to choose a main dish, vegetable, salad, etc.) Although the selective menus were for some specific diets, information did not include guidelines for serving specific foods or food groups and amounts of foods to address a nutritional problem, or estimated amounts of daily intake of any nutrients (protein, carbohydrate, fat, Vitamin C, Vitamin A) per default selection of foods on any diet.

During an interview on 05/13/10 at 11:40 a.m. the Director of Dietary Staff D stated any of the cooks who serve patient meals could access dietary information on the computers in the diet office. However, interview on 05/13/10 at 11:41 a.m. with Cook Staff I, he/she stated that he/she did not know how to access anything on the computers in the diet office.

During an interview on 05/13/10 at 11:41 a.m. Cook, Staff J stated he/she did not know anything about the computers in the diet office and did not care to learn how to access the information.

Based on observation, interview and record review, the facility's staff:

- failed to clean and maintain equipment and surfaces in the dietary department to prevent cross contamination of foods and supplies stored and used for patient meal service;
- failed to periodically calibrate to maintain accuracy of a scale used in preparation of infant formulas;
- failed to ensure intravenous fluids were not avilable for use for patients after the expiration date labeled on the container; and
- failed to ensure mattresses in treatment areas were clean and in good repair.

The facility census was 207 patients.

Findings included:

1. Record review of the United States Department of Health and Human Services, Public Health Service, Food and Drug Administration, 2005 "Food Code" directed in part the following:
-Chapter 3-302.12 Storage containers, identified with common name of food. Working containers holding foods removed from original packages shall be identified with the common name of the food.
-Chapter 3-304.12 Dispensing utensils shall be stored with the handles above the surface of the food.
-Chapter 3-305.11 Food shall be protected from contamination by storing the food in a clean dry location not exposed to dust or other contaminants and at least six inches above the floor.
-Chapter 3-305.12 Food may not be stored in locker rooms, dressing rooms, or under other sources of contamination.

a. Observations on 05/10/10 at 3:15 p.m. revealed dietary staff failed to store foods in a safe, sanitary manner to protect against cross contamination including:
-An opened, undated, partial one gallon container of cherry flavored shake syrup with sticky, heavily soiled exterior surface (of the container) stored on a shelf in the dry food storeroom.
-Heavily soiled, spilled food and dust ladened shelving in the dry food storeroom where staff stored foods used for patient service.
-A partial, opened to air paper sack of lentils stored on a lower shelf.
-A partial, opened to air sack of cornmeal stored on a lower shelf.
-A plastic bag of split peas labeled use by 04/16 (the month and date).
-An undated, opened partial bag of spiral pasta stored on a soiled shelf.
-An undated, opened partial bag of rotini stored on a soiled shelf.
-An undated, opened partial bag of elbow macaroni stored on a soiled shelf.
-An undated, opened partial bag of marshmallows.
-Three sticky, food crumb and unknown soil covered three tiered carts used to transport foods from the storeroom.
-A jacket (outer wear) hung on a shelf post where staff stored dry foods.

During an interview on 05/10/10 at 3:16 a.m. the Director of Dietary, Staff D stated hanging a jacket on the shelf post where foods were stored was not within the food storage standards of the hospital's dietary department and the staff who owned the jacket had been counseled against that practice in the past.

b. Observations on 05/10/10 at 3:20 p.m. in the paper supply room revealed dietary staff failed to store paper supplies used in food service in safe, sanitary conditions including:
-Five cases of supplies on the floor of the storeroom.
-A sleeve of soufflé cups with torn exterior plastic exposing the cups to air and contaminants.
-A heavily soiled, food and unknown debris ladened cart used to transport individual use packets of condiments.

c. Observations on 05/10/10 at 3:30 p.m. in the refrigeration units revealed staff failed to store refrigerated and frozen foods in a safe, sanitary manner to protect against cross contamination including:
-An undated, opened to air bag of frozen French fries stored on a shelf in the walk-in freezer.
-An unlabeled, undated, opened to air bag of pork fritters stored on top of cases of frozen foods in the walk-in freezer.
-An unlabeled, undated, open to air bag of vegetable burgers stored on top of cases of frozen foods in the walk-in freezer.
-A pan of sliced tomatoes precariously stored on top of containers of cheese on a shelf in a walk-in milk refrigerator.
-An opened partial case of lettuce stored on the soiled floor of a walk-in refrigerator.
-An uncovered half pan of lettuce stored in a mobile cart in the walk-in refrigerator.
-A second uncovered full pan of lettuce stored in a mobile cart in the walk-in refrigerator.
-A heavily soiled fan blade guard over a refrigerator condenser soiled with tendrils of dust and debris blowing air and debris onto uncovered foods in the walk-in refrigerator.

During an interview on 05/10/10 at 3:30 p.m. the Director of Dietary, Staff D, stated the following:
-The pan of sliced tomatoes should not be stored on top of the containers of cheese.
-The two uncovered pans of lettuce were intended for use on the cafeteria salad bar.
-The department policy directed staff to cover, label and date all foods in storage.

d. Observation on 05/10/10 at 3:31 p.m. in the food preparation area of the dietary department revealed staff failed to clean and maintain a table-mounted can opener with metal can shavings behind the blade and partially imbedded into blackened, tarry food debris encrusted over the blade, gears and over the holster and mounting plate attached to the table.

During an interview on 05/10/10 at 3:31 p.m. the Director of Dietary, Staff D stated the following:
-The department did not have a policy and procedure for routine cleaning of the table-mounted can openers.
-The can openers were on the food safety inspection sheets periodically completed by dietary supervisors.
-This can opener had not been sufficiently cleaned or adequately checked by the dietary supervisors.

e. Observation on 05/10/10 at 3:35 p.m. in the patient tray assembly area revealed staff stored a soiled 24-ounce plastic bottle of chocolate syrup out on a counter. Further observation of the bottle of chocolate syrup revealed the manufacturer's label directed "refrigerate after opening".

f. Observation on 05/11/10 at 10:50 a.m. revealed staff stored an opened one gallon container of barbecue sauce on a lower shelf in under the cook's table. Further observation of the opened, partial gallon of barbecue sauce revealed the manufacturer's label directed "refrigerate after opening". During an interview on 05/11/10 at 10:50 a.m. Cook, Staff J stated the barbecue sauce was normally stored on the lower shelf under the cook's table.

g. Observation on 05/11/10 at 10:21 a.m. revealed staff stored a scoop in a twelve quart container of brown rice with the handle touching the surface of the food. During an interview on 05/11/10 at 10:21 a.m. the Director of Dietary stated staff should not store the scoop in the brown rice with the handle touching the surface of the food.

h. Observation on 05/11/10 at 10:47 a.m. revealed staff stored a scoop in the bulk flour bin with the handle touching the flour, staff stored a scoop on the bulk sugar bin with the handle touching the sugar and staff stored a scoop in the bulk bread crumbs bin with the handle touching the bread crumbs.

i. During an interview on 05/11/10 at 10:21 a.m. Diet Aide, Staff K stated the following:
- He/she had been in position for thirty five years.
- His/her current primary assignment was infant formula preparation.
- He/she used one of three digital scales to measure various quantities of powdered infant formula products to mix with sterile water to feed specific patients.
- He/she used the scales daily.
- He/she was not aware of any calibration that had ever been done on any of the scales.

Observation on 05/11/10 at 10:21 a.m. revealed no preventive maintenance stickers (visual indicators that periodic biomedical checks had been done to ensure safe, accurate operation of the equipment) on the scales.


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2. Observation on 05/1310 at 3:25 p.m. of the anesthesia cart in operating room number 12 revealed an out dated IV (intravenous line used to administer medication and fluids into a vein.) solutions. The following were noted: three Plasmalyte-148, 500 ml. (milliliter) expired on October 2008; one Plasmalyte-148, 500 ml. expired August 2009; one Normal Sialine 0.9% Sodium, 1000 ml. expired September 2009; and one Normal Saline 0.9% Sodium, 1000 ml. expired November 2009.

During Interview immediately following discovery of each outdated solution, Staff AAAAAA, Assistant Director of Operating Room, and Staff BBBBBB, Assistant Manager of Operation Room, stated these were the correct dates and each IV solution was outdated.


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3. Observation on 5/11/10 at 10:15 p.m.showed a film of old tape residue on the vinyl cover of a mattress pad in a treatment room located on 3-Henson, in the ICN department, near the Skytron. The tape residue covered a four-inch long by eight-inch wide area at the head of the mattress, and approximately 12-inches wide by 20-inches long on the lower (thigh and buttocks area) portion of the mattress. A small, one-inch long cut in the center portion of the mattress exposed the foam interior beneath the vinyl covering, a substance that cannot be cleaned or disinfected if it becomes soiled.

During an interview on 5/11/10 at 10:20 a.m., Staff GGGGGG, said they usually have a sheet on the mattress and never lay patients directly on the mattress without first covering it with a sheet. She said she would look for something that would dissolve and remove the tape residue or turn in a work order on the mattress to have it cleaned or replaced.

4. Observation on 5/11/10 at 4:00 p.m. of the outpatient clinic located on Barry Road revealed a mattress on a treatment table damaged with a one-inch cut through the vinyl surface material. Several one-quarter inch spots that looked like an oily residue were observed under the pillow at the head of the mattress.

During an interview on 5/11/10 at 4:20 p.m., Staff HHHHHH said she would turn in a work order on the mattress to have it cleaned and the cut repaired, or have the whole thing replaced.

Based on observation and interview and record review, the facility:

- failed to secure tubing above the floor to minimize the potential for infection for one patient (Patient #59) out of 21 patients in the Intensive Care Nursery (ICN);
- failed to assure that staff followed appropriate infection prevention practices in the care of Patient's #4 and #78 to prevent and/or minimize transmission of infectious agents from the known or unknown infected patient to susceptible patient, personnel and visitors; and
- failed to develop a system to identify and control food handling practices in the Dietary department that prevented cross-contamination of foods and possible food borne illness, potentially affecting all patients who consumed food by mouth.

The facility census was 207 patients.

Findings included:

1. Observation on 05/11/10 at approximately 11:00 a.m. revealed a large suction tube exiting from Patient #59's abdomen and resting on the floor beneath the baby bed. (The floor is considered a source of infectious microorganisms that could potentially adhere to any thing that comes in contact with the floor and be transmitted into the patient, causing an infection.) This was brought to the attention of Staff YYY, (Registered Nurse) RN, who responded, "Oh, it's just a drainage tube." Staff ZZZ, RN, inquired as to what the conversation was about and nodded in agreement with Staff YYY, RN. However, the nurses made no attempts to report or to remove the tubing from the floor.

During an interview on 05/13/10 at 1:15 p.m., Staff WWWWW, M.D., Section Chief of Infection Control (IC), Chairperson, Infection Prevention and Control Committee; Staff XXXXX, RN, CIC; and Staff YYYYY, RN, IC, agreed that a tube connected to a patient should not touch the floor regardless of the type of tubing and that hospital staff had been trained in infection control prevention of transmission.

Record review of the "INFECTION PREVENTION AND CONTROL MANUAL", revised 11/2006, found in Section 2 THE INFECTIOUS DISEASE PROCESS - PREVENTION OF TRANSMISSION 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, and 2.7 that it states the process of infection by agent, source, portals of escape, routes of transmission, portals of entry, susceptible host, and important facts.


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2. Observation on 05/11/10 at approximately 8:45 a.m. Staff V, RN, entered room and picked IV (intravenous - tubing used to administer medication and fluids into a vein) tubing off the floor. She/he wiped the IV port with an alcohol wipe and connected Normal Saline (salt water solution 0.9% 1000 ml [milliter]). Staff RN V laid the IV tubing on Patient 4's bed, but the tubing fell back to the floor. Staff RN V did not pick the tubing up off the floor. The floor is considered a contaminated surface where people walk. Debris and bacteria can adhere to the tubing and potentially spread to cause a patient to acquire an infection.

3. Observation on 05/11/10 at approximately 9:00 a.m. of Patient #4 found dirty hospital linens on the floor of the bathroom and around the bed. Immediately after the observation, interview of Patient #4 revealed the dirty linen has been laying on the floor since admission , which was three (3) days before.

Review of the hospital's "Infection Prevention and Control Manual", revised 11/06, found section 3.6 Miscellaneous Items number 3 b. states, "All used linen is considered contaminated, handled to minimize agitation, and placed in leak proof linen bags."

4. Observation on 05/11/10 at 2:30 p.m. found Patient #78 was in contact isolation. Staff FFF entered and knelt beside bed to give medication SoluMedrol Intravenous (IV) bolus (directly inject the medication into the vein) over five (5) minutes. While administering the medication, Staff FFF picked up trash off the floor and did not change gloves.


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5. Record review of the United States Department of Health and Human Services, Public Health Service, Food and Drug Administration, 2005 "Food Code" directed the following:
-Chapter 2-301.14 Food employees shall clean their hands and exposed portions of their arms immediately before engaging in food preparation including working with exposed food, clean equipment and utensils, after touching bare human body parts or disposable tissue, using tobacco, eating, or drinking; during food preparation, as often as necessary to remove soil and contamination and to prevent cross contamination when changing tasks; after engaging in other activities that contaminate the hands.
-Chapter 2-402.11 Food employees shall wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair, that are designed and worn to effectively keep their hair from contacting exposed food; clean equipment, utensils.
-Chapter 3-304.15 Gloves, Use Limitation. Single-use gloves shall be used for only one task, used for no other purpose, and discarded when damaged or soiled, or when interruptions occur in the operation.
-Chapter 3-501.16 Food holding temperatures shall be at or above 135 degrees Fahrenheit and below 41 degrees Fahrenheit.
-Chapter 5-501.113 Receptacles and waste handling units for refuse shall be covered when they are not in continuous use.

a. Record review of the facility contract food service company's policy and procedure titled "Food Service Dress Code", updated 05/09 directed, in part, faces should be clean shaven or facial hair should be trimmed low and neat. Further review revealed the directive contradicted itself and was contrary to the existing USDA Food Code.

b. Observation on 05/10/10 at 3:30 p.m. revealed staff failed to cover partially filled trash containers in the food preparation area. During an interview on 05/10/10 at 3:30 p.m. Diet Aide, Staff F stated he/she had been in position for approximately two months and there had been no covers for the trash cans in those two months.

c. Observations on 05/11/10 from 10:10 a.m. through 11:21 a.m. revealed staff failed to wash hands at appropriate times including:
-Diet Aide, Staff G, placed hands to hair then, failed to wash hands prior to touching surfaces in the food preparation area.
-Diet Aide, Staff H, placed the back of his/her hand on the face then without hand washing handled individual bags of potato chips.
-Cook, Staff J, applied gloves without hand washing and portioned foods on patient meal trays.
-Diet Aide, Staff L, touched both hands to the back of slacks, scratched his/her shirt in the stomach area (contaminating the hands) then, without hand washing placed patient meal trays on a cart for lunch meal service.

During an interview on 05/11/10 at 11:21 a.m. stated he/she could not recall a dietary department in-service on hand washing or gloving.

d. Observations on 05/11/10 from 10:47 through 11:19 a.m. revealed Diet Aide, Staff EEEEEE, prepared foods for patient lunch meal service and failed to wear an effective hair restraint; and Cook, Staff I, and Diet Aide, Staff L, with facial hair failed to wear a beard cover.

e. Observation on 05/13/10 at 11:30 a.m. revealed Diet Aide, Staff FFFFFF with facial hair failed to wear a beard cover. During an interview on 05/13/10 at 11:30 a.m. Diet Aide, Staff FFFFFF was assigned in the diet office, however, he routinely walked to and through the food production and service areas of the kitchen.

f. During an interview on 05/10/10 at 3:01 p.m. the Director of Dietary, Staff D stated the Infection Control department staff rounded through the Dietary department periodically but could not recall the last date of that activity.

During an interview on 05/13/10 at 1:15 p.m. the Section Chief of Infectious Disease, Staff WWWWW, Infection Control Nurse, Staff XXXXX and Infection Control Data Analyst, Staff YYYYY stated the following:
-Infection Control staff have contact with the Dietary staff by being the "back-up" educators.
-The Director of Dietary was assigned to provide food sanitation in-service training.
-Facility staff including the Infection Control staff provide environmental rounds to look for infection control issues in the area of the building where Dietary department is housed.
-Environmental rounds were not specifically focused on food sanitation or Dietary department specific issues.
-Environmental rounds were scheduled for twice a year.
-Staff XXXXX could not recall the last time Environmental rounds were conducted through Dietary department.
-The last in-service for the Dietary staff focused around flu education.
-Infection Control staff had taught hand washing and gloving to Dietary staff in the past.
-The Infection Control staff do not routinely have input into Dietary department policies and procedures.