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Based on observation, staff interview and review of administrative records, policies and procedures, contracts, infection control and quality assurance documentation it was determined that the hospital failed to have an effective governing body responsible for the conduct of the hospital as evidenced by;
The governing body failed to consider the recommendations of the medical staff prior to appointing members to the medical staff, failed to ensure the governing body had approved the medical staff bylaws, and failed to assure written policies and procedure for the appraisal, initial treatment, and referral of emergencies was developed (Refer to A-046, A-048, A-093); the governing body failed to ensure contracted services, including but not limited to Dietary and Pharmacy, were monitored, evaluated and performed in a safe and effective manner (Refer to A-083, A-084, A-085, A-490, A-618);
The governing body failed to failed to ensure each patient's rights were protected and promoted, including participation in the development of plans of care, development of advance directives, assuring that each patient's personal belonging and monies were protected; the governing body failed to ensure restraint and seclusion orders were specific, complete and comprehensive, failed to ensure the death of a restrained, secluded patient was reported to CMS as required, and failed to ensure the CMS notification was documented in the patient's medical record (Refer to A- 115, A-130. A-132, A-142, A-164, A-214);
The governing body failed to ensure an organized nursing service was provided that met the needs of the patients, and that was integrated into the hospital's QAPI program; failed to ensure an adequate number of nursing staff were provided to meet the identified needs of the patients, failed to ensure that medications were given as prescribed, and that medication orders were clarified to ensure medications were administered as prescribed (A- 385, A-392, A-404);
The governing body failed to ensure that a ongoing, comprehensive quality assessment and performance improvement (QAPI) program was implemented and maintained, reflecting the complexity of the hospital services, focused on improving patient care and health outcome, such as Infection control, involving all departments, including those services furnished under contract or arrangement (Refer to A-263, A-490, A-385, A-618, A-756);
The governing body failed to ensure that Pharmaceutical Services met the needs of the patients served, that pharmacy policies and procedures, reflective of the hospitals services, were approved and implemented, that accurate accounting records of medications were kept and maintained, that a drug formulary was established, and that medication errors, including lost/missing medications were investigated (Refer to A-490, A-491, A-494, A-500, A-501, A-507, A-508, A-509, A-511);
The governing body failed to ensure that Dietary services were organized and staffed by adequate numbers of qualified personnel, that a diet manual and dietary policies and procedures were developed and implemented, that the dietary space and equipment was cleaned and maintained, and that the dietary services provided met the nutritional needs of the patients served (Refer to A-618, A-620, A-628,A-629, A-630, A-631);
The governing body failed to ensure the physical environment was maintained to ensure the safety of the patients, and that the hospital met the provisions of the Life Safety code of the the National Fire Protection Association, due to the potential for harm an immediate jeopardy was called on 1/11/11 at 2:55 p.m.. The IJ was abated on 1/12/11 at 9:08 a.m. (Refer to A-700, A-701, A-710);
The governing body failed to ensure a comprehensive on going, hospital wide infection control program and plan was developed and implemented to minimize infections and communicable diseases, failed to ensure that the assigned infection control officer was qualified, that infection control policies and procedures were reviewed, developed, and implemented, that the designation of the infection control officer was written into the infection control plan, and that a comprehensive log of incidents of infections was implemented, tracked and reviewed for improvement of patient care and services. (Refer to A-0747,A-748, A-749, A-750, A-756)

The cumulative effect of these systemic problems resulted in the hospitals inability to provide safe, quality patient care in a safe environment.

Based on interview with facility staff and review of documents the hospital failed to ensure that the governing body considered the recommendations of the medical staff prior to appointing members to the medical staff.

Findings:

Review of the current medical staff bylaws for the hospital revealed appointments to the medical staff were to be made by action of the governing board only after recommendation from the medical staff. In an interview on 1/12/11 at 10 a m. the medical director stated the Medical Practice Committee made recommendations for appointment to the medical staff to the governing body. However, review of the meeting minutes of the Medical Practice Committee did not show any documentation of their recommendations.

Based on review of documents and interview with facility staff the hospital failed to ensure that the governing body had approved the medical staff bylaws.

Findings:

Review of the medical staff bylaws for the hospital revealed they contained the statement that they had been approved by the governing board on 7/1/10. In an interview on 1/12/11 at 10 a.m. the medical director stated the medical staff bylaws had been approved by the governing body, but was unable to provide documentation of their approval.

Based on observation, staff interviews and review of hospital documents, the governing body failed to ensure that the food service and consultant dietitian contracts were executed in a manner that complied with conditions of participation for dietary services.

Findings:

Review of the hospital's contract for dietary services was done on 1/11/11. The contract was initially entered into on 12/15/2004. An attached "Exhibit A" which described the roles and responsibilities of the contractor was also reviewed. According to this document, the contracted service was to maintain a policy and procedure manual (P/P) that reflected the contractor's practices indicating how the contract would be executed.

According to the contract, meals were to be delivered at specified times. On 1/11/11 dinner arrived and was served before 4:30 p.m.. Hospital staff did not document the arrival time. The LN who served the meal stated that it arrived early and rather than let the food get cold he served it. Review of the dietary services contract revealed dinner was to be delivered at 4:45 p.m. and served at 5:00 p.m.. In an interview with the Program director on 1/11/11 at approximately 9:20 a.m., she identified the early delivery of patient food as one of the many issues that they have been working on with the contracted services. She explained that on weekends, the dinner meal is delivered about 1:00 p.m. because the cafe kitchen which produces the food closes at 12 (noon), and so they prepare cold sandwiches and put it on ice. A result of this early eating is that the patients are hungry and the hospital provides them additional snacks other than what is provided by the contracted service. This observation on 1/11/11 and interview with the program director revealed that this requirement was not always met (cross refer A630). These failures resulted in patients being served exceeding the community standards of the 14 hour span between dinner and breakfast the following day.

A tour of the contractor's kitchen showed an environment that was cluttered, and unsanitary. There was food service equipment that was not maintained in a working condition. Staff practices including food storage, were not in compliance with good food safety guidelines. There were refrigerators that did not have thermometers. Foods stored in all of the refrigerators were not labeled or dated. Some refrigerator temperature logs had not been maintained or checked since 11/1/10.

Six containers were found in one of the walk-in refrigerators on 1/10/11 at approximately 3:50 p.m.. According to the food service manager (FSM), this item was cream of wheat prepared ahead for the breakfast for another program. The temperature of the items varied from 120.1 degrees Fahrenheit to 156 degrees Fahrenheit. These items were not being monitored to ensure that it cools down appropriately. Improperly cooled foods left in the danger zone 41 to 135 degrees Fahrenheit for over 4 hours could result in food borne microorganisms that could cause food borne illness. The kitchen closes at about 5:00 p.m.; therefore no monitoring was done when the kitchen was closed.

Staff knowledge was inadequate in terms of dish washing and sanitizer testing. Two different staff members were interviewed on how they ensured that the dishes were properly sanitized. The contracted dietary services employee washing pots and pans in the three compartment sink, did not accurately identify the correct level of sanitizer in the sanitizing compartment of the sink. Although the strip read between 100 - 200 ppm (parts per million), he circled 200 on the log. The recommended level is 200 ppm or above.

The dietary services employee operating the dish machine on 1/10/11, at approximately 4:20 p.m. did not have the proper test strips to check the concentration of the sanitizer. The FSM stated at this time, his staff did not monitor the dish machine and only the service company who services the machine and sells them chemicals will check it when they come out once a month. Review of the county environmental health department inspection report dated 2/2/10, showed that the appropriate chemical test strips were not available during the inspection.

The hospital served meals at temperatures that were not palatable. It could not be determined whether the food was delivered at low temperatures or if the hospital staff were not maintaining the food at the proper temperature after delivery due to malfunctioning steam table (Cross refer A 620). The contracted dietary services staff stated that they do not record food temperatures prior to delivery at the facility.

The menu provided by dietary contracted service was posted in the kitchen in the hospital. There was no evidence that it was approved. An interview with the dietary contracted services RD could not be conducted for verification of her role in menu planning and approval. The January 2011 menu did have portion sizes. Hospital staff was sent serving utensils without instructions on how much to serve. The nutrition adequacy of the diet served could not be validated.

Review of the hospital menu for the month of January 2011 was reviewed. According to the menu, breakfast burrito and orange were items to have been served for breakfast on 1/10/11. But, the menu did not have portion sizes listed next to the items. Further review showed that none of the menu items for all three meals for the month had any portion sizes listed. Review of the lunch menu dated 1/10/11, showed BBQ chicken, macaroni and cheese, mixed vegetables, an orange, and milk for the lunch meal. The menu did not show portion sizes or scoop sizes. On 1/10/11, at approximately 11:50 a.m., on the steam table were BBQ chicken, green salad, macaroni and cheese, and cooked carrots and peas. The green salad was being served with a spaghetti spoon/server, macaroni and cheese and cooked carrots and peas were being both served with a six ounce (oz) spoodle, and the BBQ chicken was being served with a spatula.

The nutrition adequacy was unable to be validated due to lack of stated portion sizes of the meal items. No oranges were observed in the serving area. The menu did not state there would be a green salad served. A green salad would not be an equal substitute for an orange, on the basis of the green salad containing less vitamin C. The menu for the lunch meal on 1/11/11, showed pork loin, rice pilaf, mixed vegetables, dinner roll, fruit mix, and milk. The patients received lima beans instead of mixed vegetables and they did not receive a dinner roll. Patients also received the green salad that was not listed on the menu. The substitutions were made without being posted on the menu. There was no substitute provided for the missing dinner roll. RA1 served lima beans and rice pilaf with a six oz spoodle, pork loin (pre-sliced) with tongs. The portion sizes were not consistent for all the patients served. Some patients were served spoodle that was half-full; others were served 3/4th full. There were no cardex or patient diet cards instructing RA1 on what amount to serve each patient. It was unclear why each patient was not consistently served the same amount.

Concerns regarding a lack of portion sizes were shared with the contracted meal service provider manager (FSM). In an interview on 1/10/11, at approximately 2:30 p.m. he stated that in addition to the hospital's contract, the dietary contracted service also provides meals for children's program and a senior nutrition program. He indicated that the hospital menu is planned by a registered dietitian who was not housed in the office he was located. He further stated that the menu had a nutrient analysis. A call was placed to the dietary contracted services RD however, was not returned until after the surveyor had exited the hospital. (Cross refer 630)

The dietary contracted service did not consistently provide the hospital with all items as planned on the menu or made substitutions that were not documented prior to meal service. Meals were also delivered prior to scheduled meal times resulting in patients eating dinner very early requiring the hospital staff to provide snacks outside of the snacks provided by dietary contracted services. (Cross refer A629, A630)

There were refrigerators that were not working, thermometer gauges on warming carts that were not working, broken light fixtures above food preparation areas, roof leaks, walls and door of freezer with dark brown, black material etc. Interview with the FSM on 1/10/11 and 1/11/11 revealed attempts to resolve some of the issues with malfunctioning equipment. The FSM provided a copy of the emails dated 11/5/10 through 11/22/10 sent to the General Services Department requesting help in submitting work order request for repairs of kitchen equipment. He indicated that these issues had not been resolved.

In an interview with the registered dietitian (RD1) on 1/10/11 at approximately 4:30 p.m. revealed that she did not have any role in the food service operation. In a subsequent interview with RD1 on 1/13/11 she indicated that she did not monitor any quality improvement measures and does not generate any kind of report. Review of the RD1 ' s contract shows that she was contracted to assess the nutritional needs of patients at nutritional risk. There was no requirement for performance improvement in her contract. The current contract with RD1 was signed in 12/04.

There was no evidence that the county or hospital governing body ensured that the contracted meal provider met the requirements of the condition of participation.

Based on review of the hospital's Pharmacy and Therapeutic Committee (P&T) minutes, Medical Practice Committee minutes, and Quality Assurance Committee minutes the hospital failed to evaluate the services which were being provided by the contractor Pharmacy.

Findings:

Review of the facility's Pharmacy and Therapeutic Committee (P&T) minutes, Medical Practice Committee minutes, and Quality Assurance Committee minutes on 1/12/11 revealed that none of the hospital's Committees had reviewed or assessed the quality of services which were being provided by the facility's contracted Pharmacy. No indication of the hospital's satisfaction or disapproval with the Pharmacy's services could be found in any of the Committees minutes. No recommendations for change or modification of Pharmacy services were ever discussed in any of the above Committee minutes.

Based on review of documents and interview with facility staff the hospital failed to ensure a list of all contracted services was maintained.

Findings:

During an interview on 1/11/11 at 12:00 p.m. the medical director stated patients could be transferred to another facility through an agreement. Review of the list of contracted services revealed this agreement was not included on the list. In an interview on 1/12/11 at 10:30 a.m. the medical director discussed a contract for the purchase of medications, however, this contract was not included on the list of contracted services provided by the facility.

Based on review of documents and interview with facility staff the governing body failed to ensure that the medical staff had written policies and procedures for the appraisal of emergencies, initial treatment, and referral.

Findings:

The facility policy titled " Emergency Medical Policy " stated in case of emergency the facility staff was to call 911 for ambulance transport to an emergency room. The policy did not provide any guidance for appraisal or initial treatment of the patient. In an interview on 1/12/11 the DON stated it was the only policy for emergencies.

Based on observation, record and document review and staff interview the hospital failed to protect and promote patient rights. The hospital failed to ensure each patient was included in the development and implementation of their plans of care (Refer to A- 130). The hospital failed to ensure advanced directives were discussed and documented in the medical record for 2 of 11 patients reviewed (Refer to A-0132). The hospital failed to ensure patient's personal valuables were inventoried, monitored, and returned to patients timely, following their discharge. The facility failed to have a system in place to ensure patient monies were tracked, safe guarded and protected. (Refer to A-0142). The facility failed to ensure restraint and seclusion orders were comprehensive, complete and in compliance with facility policy and procedures (Refer to A-0164). The facility failed to report the death of a patient who expired while in restraints and seclusion to CMS, and to ensure this notification was documented in the patient's health record (Refer to A-214).

The cumulative effect of these systemic problems resulted in the hospital's inability to protect and promote patient's rights, and to provide quality patient care in a safe environment.

Based on interview and record review the hospital failed to ensure the right of 1 of 11 sampled patients (N3) to participate in the development and implementation of her plans of care.

Findings;

Review of N3's medical record on 1/11/11 at 12:10 p.m. revealed the patient was admitted on 5/3/10. Per the record the patient's medical problems included asthma, and the medication Flovent was ordered twice a day for the patient. On 5/6/10 a multidisciplinary treatment plan was developed and implemented for the patient's medical problem of asthma, however there was no documentation to indicate that the patient was involved in the development of her plan of care. Interview with LN 1 on 1/12/11 at 3:15 p.m. revealed that when a treatment plan is developed by the interdisciplinary team the identified problems are addressed with the patient by a member of the team.

There was no documentation to indicate the patient was involved in the development and implementation of her plans of care. This information was verified in an interview with staff on 1/11/11.

Based on policy and procedure review, medical record review and interview, the hospital failed to ensure that advanced directives were discussed and documented in the record for 2 of 11 sampled residents reviewed (N3, N4)

Findings:

Review of the policy and procedure titled" Patient Self-Determination Act" reflected the following, " When a patient is admitted to..., in such condition that it is not practical to provide information regarding advance directives at the time of admission, such information will be provided as soon as is reasonable after admission.

When a patient who lacks present decision making capacity (as determined by the admitting physician in consultation with the patient's family members and/or close friends) is admitted..., the person responsible for documenting the admission shall provide information regarding advance directives and ask for direct questions regarding the existence of an advance directive to a relative or friend accompanying the patient, if such a person is present. If the patient is unaccompanied, information on advance directives and inquiry into the existence of an advance directive shall be forwarded to the patient's surrogate decision maker, once a surrogate decision maker has been identified by the attending physician.

The admitting physician will decide whether a patient who is being admitted will be questioned regarding the existence of an advance directive. If the Patient's state of mental disability will be adversely impacted by the questioning then such questioning should not occur.

The person responsible for documenting the admission of the patient shall provide information regarding advance directives, and direct questions to a relative or friend accompanying the patient, if such a person is present. If the patient is unaccompanied, information on advance directives and inquiry into the existence of an advance directive shall be directed to the patient's surrogate decision maker."


1. Medical record review beginning on 1/11/11 at 11:45 a.m. reflected that N4 was admitted on 10/22/10. The nursing admission assessment dated 10/22/10, included an area for information regarding the patient's advanced directives, however, this area was blank.

Interview with LN 2 (licensed nurse) on 1/12/11 at 8 a.m. revealed that N4 was unable to answer the question on advance directives at the time of admission. The facility had no system in place to ensure this information was re-addressed with the patient once she was stabilized. The area was blank.

2. Medical record review beginning on 1/11/11 at 12:10 p.m. revealed N3 was admitted on 5/3/10. The information regarding the patient's advanced directives on the nursing admission assessment was blank.

Based on policy and procedure review, medical record review, staff interviews, facility inventory log and review of valuables in the lock box and safe, the hospital failed to ensure that each patient's personal valuables were consistently inventoried and monitored. Patient personal inventory lists were not consistently completed and signed by the patients and facility staff, for 2 of 11 patients (N1 and N4). Personal items, belonging to two patients N10 and N11, were not returned to the patients upon discharge and remained in the facility's lock box. Patient valuables exceeding $20, were found in the lock box, yet facility policy and procedure states that sums greater than $20.00 will be locked in the safe. (N6, N7, N8, N9). Personal items stored in sealed envelopes, for a patient who was transferred from another facility, were not verified and inventoried by the facility upon admission. (N5) There was no tracking or monitoring of personal monies that were locked in the lock box or the safe. There was no policy and procedure in place that addressed the use of a single key lock box in the medicine room.

Findings:

Review of the policy and procedure titled "Unit Safe", reflected the following," All sums of money greater than $20, credit cards, expensive jewelry, or other valuables, will be locked in the Unit safe. The Unit safe is located in the Medications Closet. 1. The safe lock requires two keys to enter. The team leader will have one key, and the Unit secretary will have the other key. At no time is one person to enter the safe. 2. Each time the safe is entered, an entry will be made in the safe logbook, with the day, time, purpose and signatures of the persons entering. 3. The safe will be checked daily by the Unit secretary."

1. Medical record review beginning on 1/10/11 at 2:10 p.m. reflected that the N1 was admitted on 1/3/11. The Patient Property List listed various articles of clothing, grooming items and a black billfold. The bottom of the form had a space for the patient's and staff signature. In addition it stated " I certify that the above is a correct list of my property and I assume entire responsibility for any articles I have retained in my possession" There was also a space that stated "If patient is unable to sign, please provide an explanation". There were two spaces for witnesses to sign. However, there were no signatures anywhere on the form.

N4 was admitted on 10/22/10. The Patient Property List dated 10/22/10 had four items of clothing listed. There was a staff signature dated 10/22/10, but, no patient signature, nor any explanation as to why there was no signature. On 11/23/10 and 1/6/11 there were additional items of clothing listed, however, there was no signature by staff or the patient which indicated that these valuables had been accepted by the patient.

2. Concurrent interview with LN6 ( licensed nurse) and a review of the valuables located in the lock box, stored in the medicine room, on 1/13/11 at 8:30 a.m., revealed two envelopes for patients N10 and N11. The envelope for N10 was blank. There was no information that indicated what was inside the envelope. Upon further inspection of the contents of the envelope, a wallet was found. LN6 stated that N10 was no longer a patient and had been discharged a few weeks ago. LN6 reviewed the safe log that was kept at the nursing station, there was no information to confirm the discharge of N10. Further review of discharge dates reflected that N10 was discharged on 12/16/10.

The envelope for N11 had a written note indicating that a case worker was to pick up the items on 7/9/10. Inside the envelope was a wallet and various credit and medical cards. N11 was discharged on 5/9/10, over 8 months ago.

3. Additional envelopes stored in the single key lock box contained the following:
Patient N6: A SSI check for $620.34.
Patient N7: A $25 gift card
Patient N8: A $100 paycheck
Patient N9: $54.12 cash

LN 6 stated that this lock box is for items or monies that are valued at $20 or less. The safe log is usually filled out and the monies are tallied daily. But, review of the log reflected it had not been done since 12/26/10. LN 6 confirmed that it was not being done. He stated that any staff can have access to keys for the lock box and safe. There was no single point person.

Inspection of the double key safe revealed two sealed envelopes labeled with another facility's name, and containing items that belonging to N5. LN 6 confirmed that the items were from a different facility, and that they (the facility) had not opened the contents of the envelopes to identify the contents and inventory N5's personal items.

Interview with the program director on 1/13/11 at 9:25 a.m. revealed that the contents in the single key lock box should be in the double key safe due to the amounts of the checks, credit cards and money that were found. The facility had no policies and procedure for the use of the single key lock box, and inventory lists. The current practice for the inventory lists, safe list and money tallies was inconsistent.

Based on observation, staff interview and record and document review, the hospital failed to ensure that the orders written for the use of restraints and/or seclusion, for 2 of 11 patients (N2 and N3), were comprehensive, complete and in compliance with the facility's policies and procedures. The restraint and seclusion orders written for N2 failed to describe, in specific behavioral terms, the patient's dangerous behavior justifying the intervention; failed to specify the type of restraint to be implemented; and failed to ensure the order for the use of the restraints was time limited. The restraint and seclusion orders written for patient N3 failed to specify the type of restraint to be implemented and failed to be time limited.

Findings;

A review of the facility's policy and procedures on 1/11/11 beginning at 9:00 a.m. revealed a policy entitled "Restraint and Seclusion" dated 12/5/04.

"Part 1. Definitions of terms .Mechanical restraint; Cuffs and belts which are well padded or soft ties consisting of cloth. Patient must be afforded the least restrictive restraint and the maximum freedom of movement while ensuring the physical safety of the person and other, and shall use the least number of restraint points."
" Part 4. "Environmental safeties and equipment.. 5-point locked leather restraint with padding, in secluding room with door locked under continuos one of one observation and monitoring. 4-point locked leather restraints walking ankle and waist restraints and in seclusion room with door locked under continous one to one observation and monitoring.
The facility's policy failed to include a definition of "5 point" locked, leather restraints.

Within the policy under Part 6 was "Procedures for Mechanical Restraint (cuffs and belts) and/or Seclusion.".....
"Physician"
1. RN/Physician assess that the patient is displaying behavior that presents a risk of great bodily harm to the patient or others and that less restrictive interventions have failed or are not feasible.
2. LNS/Physician (licensed nursing staff) documents any less restrictive intervention that were attempted but not effective on R (restraint) & S (seclusion) use form
3. Provide order R & S which includes time, date, and signature:describes in specific behavioral terms the dangerous behavior justifying intervention, specifies the types of restraints if applicable. Document this and orders on the R & S use form
5. Physician writes or RN obtains order for R & S. Describe in specific behavioral terms the dangerous behavior on the R & S Physician's orders form.....
6. Patient must be afforded the least restrictive restraint, and the maximum freedom of movement, while ensuring the physical safety of the person and others, and shall use the least number of restraint points.

Interview with three licensed nursing staff ( LN5, LN 2 and LN6) on 1/12/10 at 11:30 a.m. revealed that "an order" to place a patient in "restraints" means the patient is placed in 5 point locked leather restraints, in a bed, in the seclusion room. The seclusion room(s) are equipped with a surveillance camera, to facilitate observations of the patient by a staff person via a monitor located in the nursing station. Staff demonstrated that the placement of 5 point leather restraints consists of restraining the patient at the waist, and at each ankle and at each wrist.

1. Review of the medical record for N2 on 1/11/11 beginning at 11:35 a.m. revealed the patient was admitted to the hospital on an involuntary hold, at 4/28/10 at 21:45 (9:45 p.m.). The physician's orders of 4/28/10 at 2145 stated "may put pt. (patient) in seclusion and restraint."

The order for the use of "seclusion and restraints" was incomplete and did not reflect the facility's policy and procedure. The order failed to specify the dangerous behavior that justified the use of the most restrictive restraint intervention and the seclusion, failed to specify the type of the restraint(s) to be used, and failed to specify the use of the restraints and seclusion was time limited. There was no documentation to indicate the patient was afforded the least restrictive restraint and the maximum freedom of movement. There was no documentation in the patients record that identified that the patient required the use of 5 point locked leather restraints. There was no documentation in the record that identified the type of restraints that were used for the patient.

2. Review of the medical record for N3 on 1/11/11 beginning at 12:10 p.m. revealed the patient was admitted to the facility on 5/3/10. At 23:15 (11:15 p.m.) an order was written for "S (seclusion) & R (restraints) for SIB (self injurious behavior) pt's (patient's) safety." The order for the use of restraints and seclusion was incomplete. The order failed to describe in specific behavioral terms the dangerous behavior the patient was exhibiting that presented a risk of great bodily harm justifying this most restrictive intervention, failed to specify the type of restraint to be used and failed to specify that the use of the restraints and seclusion was time limited.

Further review of the patient's record revealed on 5/5/10 at 8:15 a.m. an order was written to "place pt. (patient) in seclusion and restraint for DTS/DTO (danger to self/danger to others)." The order for the use of restraints and seclusion failed to describe in specific behavioral terms the dangerous behavior that presented a risk of great bodily harm justifying the this most restrictive intervention, failed to specify the type of restraint(s) to be used and failed to specify the duration of the restraints and the seclusion.

Based on record and document review and staff interview, the hospital failed to report the death of a patient (N2), who expired while in restraints and seclusion on 4/29/10 to CMS, and failed to document the notification in the patient's medical record. Patient N2 was admitted to the facility on 4/28/10 at 21:45 (9:45 p.m.). Documentation indicates the patient was placed in restraints and seclusion at 21:45 (9:45 p.m.) upon admission to the facility, and remained in restraints and seclusion until the time of the patients death on 4/29/10 at 1:15 a.m., 3 hours and 15 minutes later. According to the IDN the patient was "noted to have no respirations at 0115" (on 4/29/10). " 911 called, CPR started. Paramedics arrived. Pt expired." There was no documentation to indicate CMS was notified of the patient's death, that occurred while the patient was in restraints and seclusion, and there was no documentation in the patients record to reflect that CMS was notified, as required.

Findings;

Review of the facility's "Restraint and Seclusion" policy and procedure dated 12/5/04, provided on 1/11/11 beginning at 9:00 a.m. revealed under Part 8 "Monitoring and Reporting".."Reporting Patient Death".. "Centers for Medicare and Medicaid (CMS) 42 CFR, Section 482.13(f)(7) requires that all certified hospitals report to CMS any patient death that occurs while a patient is restrained or in seclusion for behavior management..".

Interview with three licensed nursing staff (LN5, LN2, LN6) on 1/12/10 at 11:30 a.m. revealed that when patients are placed in "restraints" they are placed in 5 point locked leather restraints, in a bed, in the seclusion room. The seclusion room(s) have a camera mounted in the room so the patient can be constantly observed by staff, who are observing the camera monitor, which is located in the nursing station.

Review of N2's record on 1/11/11 beginning at 11:35 a.m. revealed the patient was admitted to the facility on 4/28/10 at 21:45 (9:45 p.m.) from the emergency room of an acute hospital, on an involuntary hold. The patient, who had been restrained while at the emergency room, remained restrained during the transfer via ambulance to the hospital for admission. The patient was admitted in restraints, and due to agitation, yelling, and uncooperative behaviors, the patient was placed in restraints (unspecified type), on a bed, in a seclusion room.

According to the restraint and seclusion flow sheet documentation, completed every 15 minutes, the patient continued to be agitated, to scream and yell at staff, and to pull at the restraints (unspecified type). At 22:30 (10:30 p.m.) the physician completed a face to face assessment of the patient, and the use of the restraints and seclusion continued. According to the medication administration record the patient received Zyprexa 10 mg IM for agitation and screaming at 22:15 (10:15 p.m.). with "no effect." At 24:10 (12:10 a.m.) the patient received Zyprexa 10 mg IM and Ativan 2 mg. IM for agitation again with "no effect." The final entry on the restraint and seclusion flow sheet was written at 01:00 (not dated). The entry states the patient was "pulling on restraints."

A review of the interdisciplinary progress notes in the record revealed a single entry dated 4/28/10 and timed as "admit 2145" (9:45 p.m.). According to the progress note the patient was admitted from an emergency room (ER) via ambulance on a gurney with restraints in place. The patient had been in restraints in the ER with 1:1 security. The patient was agitated, screaming, aggressive and combative to staff during the transfer from the gurney to the bed. Orders were received to admit the patient, to place the patient in seclusion and restraints, and to administer an antipsychotic medication (Zyprexa 10 mg.) IM (intramuscular). Documentation indicates the patient remained agitated and uncooperative, and was pulling at the restraints.

The physician was contacted and additional medication orders were received for Ativan (an antianxiety) and Zyprexa IM (intramuscular). The patient was offered water but refused. Attempts to provide care to the patient were unsuccessful due to the patient's refusal and agitation. The note continues stating the "Pt (patient) noted to have no respirations at + - 0115. 911 called, CPR started. Paramedics arrived. Pt expired. Supervisor notified." The note indicated that physician(s) were notified.

There was no documentation in the record to indicate CMS was notified of the patient's death that occurred while the patient was in restraints and in seclusion, as required.

A review of all of the hospital's documentation provided for review (related to the patient's death) on 1/11/11 at 12:00 p.m. revealed no documentation to indicate that CMS was notified of the restrained patient's death. Interview with the DON and LN5 on 1/11/11 at 2:00 p.m. verified that the hospital had not contacted CMS regarding the death of the restrained patient.

Based on staff interview and review of administrative records, policies and procedures, contracts, infection control and quality assurance documentation, the hospital failed to develop, implement and maintain an effective, ongoing, data driven, hospital wide quality assessment and performance improvement (QAPI) program, that incorporated infection control issues, and that measured, analyzed and tracked quality indicators, including adverse patient events (Refer to A-264, A-265, A-267, A-273, A-747). The hospital failed to have a QAPI program that included quality indicator data, focusing on high risk, high volume or problem prone areas; the hospital failed to ensure that results, summaries and trends of incident reports were shared with administrative hospital staff, and the facility failed to have system in place to implement improvement actions, and track performances; the hospital failed to ensure that ongoing performance improvement projects were conducted (Refer to A-283, A-288, A-291, A-297). The governing body failed to ensure the QAPI program reflected the hospital's services, involved all departments, including the contracted services of Pharmacy and Dietary, and focused on indicators to improve health outcome and provide quality patient care and services. (Refer to A-115, A-309, A-385, A-490, A-618, A-385, A-700)

The cumulative effect of these systemic problems resulted in the hospitals inability to ensure the provision of quality health care in a safe environment.

Based on interview and policy and procedure review, the hospital failed to ensure that an active, on going, comprehensive, facility wide, quality assessment and performance improvement program (QAPI) was enacted. There was no documentation to reflect that infection control issues were incorporated into a hospital wide QAPI program.

Findings:

Interview with the program director on 1/12/11 at 9:45 a.m. revealed that the infection control committee had not been reporting to the quality committee.

Review of the Infection Control Manual, policy and procedures, reflected no current approval date of the policies. The Medical Director, Infection Control Practitioner and the facility Internist had not signed off on the policies. The form indicated that policies were reviewed annually for revision. The last revision date was noted to be in 5/2007. There was no mention of what infection control guidelines were to be utilized. The Infection Control Committee consisted of the Medical Director, Program Manager, Nurse Manager, Quality Improvement Manager, Infection Control Practitioner and the Internist.

Interview with the quality manager on 1/13/11 at 3:30 p.m. revealed that the infection control policies and procedures had not been reviewed recently nor were there any recent approval dates. The quality committee had not been proactively involved with the infection control process.

Based on interview with facility staff and review of documents the hospital failed to ensure that there was an ongoing quality assessment and performance improvement (QAPI) program.

Findings:

Review of the Compliance Committee (formerly the Utilization Review Committee) meeting minutes revealed the material reviewed at the meetings was related to utilization review not QAPI activities. In an interview on 1/11/11 at 11 a.m. the QA Manager stated medical care evaluation studies as required by Department of Mental Health were ongoing. In an interview on 1/12/11 at 3:15 p.m. a department business analyst stated there were two studies currently ongoing. One study was the re-hospitalization rates of the hospitals clients and the other was the utilization of hospital's bed days by jail clients. Review of the studies revealed both were utilization review studies concerned with length of stay at the hospital. There was no documentation of studies which used quality indicators for the improvement of health outcomes or the reduction of medical errors.

Based on document and medical record review the hospital failed to measure, analyze and track quality indicator, including adverse patient events and other aspects of performance that assess care and services. (Refer to A-164, A-747)

Findings;


Review of the documentation provided by the facility revealed there were no performance improvement activities which tracked medical errors and adverse patient events, analyzed their causes, and implemented preventative actions.

Document review revealed a patient expired while in restraints and seclusion on 4/29/10. There was no performance improvement documentation to indicate this adverse patient event was analyzed and/or tracked to assess care provided, and to identify improvement actions.

Review of the Infection Control Report dated 12/09-6/10 reflected three areas that were targeted: Employee Health, Environment and Infections. Under Infections there was a tally of 50 reported infections over a six month period. 40 were skin related, five were respiratory and five were for urinary tract infections. There was no breakdown of the data to ascertain what type of infections had been contacted, treatments utilized, treatment effectiveness, antibiotic choices based on the organism nor any analysis of the application/administration of ordered medications by facility staff.

Interview with LN 1, on 1/11/11 at 9:50 a.m. revealed that he has never attended an infection control meeting. He submits data that he collects and does not hear any more information. He has never had any input on any revisions to the policies and procedures. He had not attended an infection control committee meeting. He does not do any personal surveillance of employees, including handwashing techniques. He collects data on a quarterly basis and submits to the charge nurse. He did not know of any outcomes or decisions with the information that he submitted.

Interview with the program director on 1/12/11 at 9:45 a.m. revealed that the infection control committee had not been reporting to the governing board or the quality committee. She agreed that there was a lack of communication between committees and staff. Data collection, surveillance and monitoring had not been done on a proactive daily basis.




25764

Based on document review, interview and policy and procedure review, the hospital failed to develop quality indicators for performance improvement in infection control, pharmacy services,, nursing services and dietary services through out the hospital.

Findings:

1. Review of the Infection Control Report dated 12/09-6/10 reflected three areas that were targeted: Employee Health, Environment and Infections. Under Infections there was a tally of 50 reported infections over a six month period. 40 were skin related, five were respiratory and five were for urinary tract infections. There was no breakdown of the data to ascertain what type of infections had been contacted, treatments utilized, treatment effectiveness, antibiotic choices based on the organism nor any analysis of the application/administration of ordered medications by facility staff.

Interview with LN 1, on 1/11/11 at 9:50 a.m. revealed that he has never attended an infection control meeting. He submits data that he collects and does not hear any more information. He has never had any input on any revisions to the policies and procedures. He had not attended an infection control committee meeting. He does not do any personal surveillance of employees, including handwashing techniques. He collects data on a quarterly basis and submits to the charge nurse. He did not know of any outcomes or decisions with the information that he submitted.

Interview with the program director on 1/12/11 at 9:45 a.m. revealed that the infection control committee had not been reporting to the governing board or the quality committee. She agreed that there was a lack of communication between committees and staff. Data collection, surveillance and monitoring had not been done on a proactive daily basis.

Based on review of documents the facility failed to ensure that the QAPI program included quality indicator data such as patient care data.

Findings:

Review of the documentation provided by the facility revealed there was no data collection used to monitor the effectiveness and safety of services and quality of care.

Based on document review, the hospital failed to ensure that the QAPI program developed and incorporated quality indicators, including patient care data.

Findings:

Review of the documentation provided by the facility revealed there was no data collection used to monitor the effectiveness and safety of services and quality of care.

Based on interview and document review, the hospital failed to monitor the effectiveness of investigations pertaining to patient safety. There was no analysis or follow up of data collected to ensure that practices were targeted toward improvement.

Findings:

SUSAN.....need your data on incident reports......

Based on interview, the hospital failed to identify problem prone areas for improvement. There was no identification of issues related to patient rights, nursing services, pharmacy services, dietary services, life safety or infection control.
(Cross reference: A-0115, A-0385, A-0490, A-0618, A-0700, A-0747)

Findings:

Interviews conducted the week of 1/10/11 with the medical director, program director and the DON the hospital had not identified any trends or problem prone areas for improvement related to patient rights, nursing services, pharmacy services, dietary services, life safety or infection control.

Based on interview, the hospital failed to specify the frequency and detail of hospital wide data collection. There was no identification of specific data collection frequencies related to patient rights, nursing services, pharmacy services, dietary services, life safety or infection control.

(Cross reference: A-0115, A-0385, A-0490, A-0618, A-0700, A-0747)

Findings:

Interviews conducted the week of 1/10/11 with the medical director, program director and the DON revealed that the hospital had not specified the frequency nor details of the data to be collected on a hospital wide basis.

Based on review of documents the facility failed to ensure that the QAPI program focused on high-risk, high-volume, or problem-prone areas.

Findings:

Review of the documentation provided by the facility revealed there were no performance improvement activities which tracked medical errors and adverse patient events analyzed their causes, and implemented preventative actions.

Based on document and record review and staff interview, the hospital failed to ensure that performance improvement activities focused on high risk, high volume problem prone areas, that affect patient safety and quality of care. A review of the hospitals patient acuity system, which identifies staffing needs based on an assessment of the patients needs, and review of staffing records, revealed adequate numbers of licensed staff was not consistently provided to meet the needs of the patients, placing the patients and staff at risk for harm. There was no documentation to indicate the hospital had evaluated the effectiveness of their current patient acuity system for effectiveness. (Refer to A- 0392).

Findings;

A review of the facility's patient acuity/staffing policy and procedures on 1/11/11 at 10:00 a.m. revealed... " Nursing general policies. Acuity NG-2-0," effective 1/1/2000 and revised May 2006. According the policy the "daily nursing staff and requirement based on patient acuity as identified by levels of care. Patient acuity determination will be identified daily to identify, justify and guide the assignment of nursing staff. The total staffing requires the scheduling of at least one (1) registered nurse on each shift to provide assess, assign, direct, and/or supervise the care rendered by other nursing staff."

The facility utilizes patient criteria levels of 0 through 3.
A level 0 requires a 1:1 staff, patient is a high risk, in restraints or seclusion, or the patient continues to escalate despite frequent staff intervention.
A level 1 requires every 30 minutes observation and includes; a new admit within 24 hours, patient requires constant re-direction and limit setting.
A level 2 patient requires moderate assistance. may have a special medical treatment, seizure precautions, and may be verbally threatening or provocative but no physical threats.
A level 3 patient requires only minimal prompts, and is generally stable.

Interview with the Director of Nurses on 1/12/11 at 2:00 p.m. revealed that patient acuity assessments are completed daily at 11:30 a.m., and based on the assessment of each patient staffing needs are determined for the day. Most staff work 12 hour shifts ( 7a.m.-p.m. and 7 p.m. to 7 a.m.), but at times there is a staff who would work a variation of different hours, such as 1 p.m. -11 p.m. or 7 a.m.- 5 p.m..

The patient acuity assessments/staffing sheets for 4/26, 4/27,4/28, 4/29, 5/1, and 5/2/2010 were requested for review. A review of the six days revealed the facility failed to have an adequate number of staff to meet the patient needs, as identified on the acuity/staffing records, for all six of the days reviewed. The shortage of staff ranged from 1 to 4 staff.

On 4/26/10 the patient census was 16; (-2 staff)
1 patient was assessed at a level 0 and required a 1:1 staff;
2 patients were assessed at a level 1, and required constant redirection and every 30 minute observations.
13 patients were assessed at a level 2.
According to the staffing record although 12 staff were required to meet the acuti needs of the patients, only 10 staff were scheduled/provided for the 24 hours.

On 4/27/10 patient census was 17; (-4 staff)
2 two patients were assessed at a level 0, both requiring a 1:1 staff;
2 patients were assessed at level 1 and required every 30 minutes observations;
12 patients were at a level 2 (moderate assist); and
1 patient was a level 3 (stable).
According to the staffing record 14 staff were required to meet the needs of the patients, however, only 10 staff were scheduled/provided for the 24 hours.

On 4/28/10 patient census was 15; (-2 staff)
1 patient was a level 0 (1:1)
4 patients were assessed at a level 1, this included 2 new admissions and 2 potential admissions coming in ( require every 30 minutes observations);
9 patients at a level 2 (moderate assist); and
1 patient was a level 3 (stable).
According to staffing/acuity records 11.92 staff were required to meet the needs of the patients, however, only 10 staff were scheduled/provided for the 24 hours.

A review of the assignment sheets for 4/28/10 with LN5 verified that 3 staff worked the second shift (p.m.-a.m.). One of the 3 staff would be assigned to do the 1:1 patient observations, leaving the other two staff to complete the every 30 observations, and the other duties assigned to the shift, including the two new admissions. Staff interview on 1/12/11 at 2:30 p.m. with LN5 and LN2 verified that only 3 staff was not an adequate number of staff to meet all of the patients care needs and complete all of the duties required for the second shift.

On 4/29/10 patient census was 16;(-2 staff)
1 patient at a level 0;
2 patients were a level 1
12 patients were level 2
1 patient was a level 3. Per the daily acuity system 12 staff were needed for the patient's needs, however only 10 staff were scheduled/provided for the 24 hours.

On 5/1/10 patient census was 15; ( - 1.5 staff)
1 patient at a level 0
1 patient at a level 1 (new admit)
13 patients at a level 2. per the daily acuity system rating 10.66 staff were required, however only 9.41 staff were scheduled/provided for the 24 period.

On 5/2/10 patient census was 16; (-2.29 staff)
2 patients at a level 0 required 1:1
1 patient at a level 1 (new admit)
12 patients at a level 2 and
1 patient at a level 3. Per the daily acuity 12.42 staff were required to meet the needs of the patients, however, on 10.13 staff were scheduled/provided for the 24 hour period.

Interview with two licensed nursing staff (LN5 and Ln 2) on 1/12/11 at 2:00 p.m. verified that the acuity rating of the patients is done only once a day and if a patient's condition becomes more acute and the acuity changes additional staff can be called in. Both nurses verified that they are "frequently" asked to do overtime.

When asked if the current acuity/staffing system has been evaluated to ascertain if the system was still effective both nurses stated that there has been no evaluation or revision of the current system "for as long as I have been here" (over 8 years). Staff interview verified that no data was collected or analyzed to evaluate the current patient classification system/staffing to ensure it was effective in meeting the needs of the patients.

Based on hospital staff interview and review of the facility's Quality Assurance/ Utilization Committee minutes the hospital failed to ensure that the results and summaries and trends of reports were shared with administrative hospital staff. The sharing of this information would allow administrative staff to incorporate the information into opportunities for modifying the way that the hospital provides patient care.

Findings:

Review of the hospital's Quality Assurance/ Utilization Committee minutes on 1/13/11 revealed 15 to 20 reports that had been provided to the Committee, by the Acute Hospital during the 2010 year. No trending of the 15 to 20 specific incidents, could be found in the Quality Assurance/ Utilization Committee minutes, which required any type of action to be taken by the hospital. Interview with the Acute Hospital's DON (Director of Nursing Services) on 1/13/11 at 9:30 a.m. revealed that the reports for the Hospital, were collected by her and the Program Manager and then forwarded to Quality Assurance (QA) for analysis and trending. The DON also stated that unless QA brings back specific trends of events to the DON or the Program Manager, the DON and the Program Manager receive no information to assist them in modifying the way that the Hospital provides patient care. The hospital's DON and Program Manager confirmed that no information about the incidents which they send to QA have ever been brought back or shared with them by QA to assist with the modification in the way that patient care has been provided by the hospital.

Based on hospital staff interview, review of the facility's Quality Assurance/ Utilization Committee minutes and review of the facility's Medical Practice Committee minutes the hospital failed to ensure that the results, trends, and summaries of the incident reports were shared with administrative hospital staff. The hospital had no system in place to implement improvement actions, measure it's success and track performance to ensure improvements were maintained as a result of the data from the reports which had been gathered.

Findings:

Review of the hospital's Quality Assurance/ Utilization Committee minutes, Medical Practice Committee and administrative staff interview on 1/13/11 revealed that the facility had no system in place to implement improvement actions, measure any of it's success and track performance to ensure improvements as a result of the hospital's reports. Interview with the Acute Hospital's DON on 1/13/11 at 9:30 a.m. revealed that the reports for the Hospital are collected by her and the Program Manager and then forwarded to Quality Assurance (QA). The DON also stated that unless QA brings back specific trends or issues to the DON or the Program Manager, the DON and the Program Manager receive no information to assist them with modifying the way that the Hospital provides patient care. The hospital's DON and Program Manager confirmed that no information about the incidents that are sent to QA have ever been brought back or shared with them by QA. Interview with the QA Manager on 1/12/11 at 3:00 p.m. and again on 1/13/11 at 5:11 p.m. revealed that the hospital had not be aware of it's need to implement improvement actions, measure it's success with any system changes that had been implemented from the QA reports. The QA Manager also indicated that the hospital did not track performance improvements and ensure that any changes were maintained.

Based on review of documents the facility failed to ensure that performance improvement projects were conducted.

Findings:

Review of documents provided by the facility revealed the facility did not have documentation of quality improvement projects being conducted, reasons for conducting projects, or measurable progress from the projects.

Based on review of documents the hospital failed to ensure that the governing body, medical staff, and administrative officials were responsible and accountable for an ongoing Quality Assessment and Performance Improvement (QAPI) program to improve patient safety and patient care.

Findings:

Review of documents provided by the facility revealed there was no documentation that an ongoing program for quality improvement was defined, implemented, or maintained. There was no facility-wide QAPI program which addressed priorities for improved quality of care and patient safety including the reduction of medical errors.

Based on review of documents and interview with facility staff the hospital failed to ensure that the medical staff periodically conducted appraisals of its members.

Findings:

In an interview on 1/11/11 at 10 a.m. the medical director stated that the medical staff conducted peer review of its members. The medical director also stated that as part of the appraisal performance evaluations and chart reviews were performed. However, no documentation of these activities was provided.

Based on review of documents and interview with facility staff the hospital failed to ensure that the medical staff made recommendations to the governing body on the appointment of candidates.

Findings:

In an interview on 1/11/11 at 10 a.m. the medical director stated that the medical staff made recommendations to the governing body regarding the appointment of candidates. However, review of the Medical Practice Committee meeting minutes did not disclose any recommendations and no other documentation was provided.

Based on observation, document review and staff interview, the hospital failed to ensure that the medical staff enforced its bylaws by suspending members' privileges when medical records were not completed within the prescribed time period.

Findings:

The Medical Staff Bylaws, approved 7/1/10, were reviewed on 1/11/11. Section 6.3.5 states in part: "....A limited suspension in the form of withdrawal of admitting and other related privileges until medical records are completed, shall be imposed by the Chief of Staff...."

During an interview with medical records staff 1 (MR) on 1/10/11 beginning at 2:10 p.m., she stated that physicians are not suspended due to delinquent records (those not completed within 30 days after discharge). The medical records staff simply keep reminding physicians that records need to be completed. During a concurrent tour of the medical records office, a counter with a wire basket full of records and 3-4 stacks of records were observed. MR Staff 1 & 2 explained that these were records waiting for medical, nursing and allied health staff to complete.

An audit of the delinquent records was done on 1/11/11 and reviewed with MR Staff 1 on 1/12/11 at 9 a.m. There were 6 records lacking discharge summaries that needed to be completed by a member of the medical staff, dating back to 11/29/10 discharge date. There were a total of 60 delinquent records lacking signatures by other staff.

Based on review of documents and interview with facility staff the hospital failed to ensure that the medical staff bylaws were approved by the governing body.

Findings:

In an interview on 1/11/11 at 10 a.m. the medical director stated that the medical staff bylaws had been approved by the governing body. However, no documentation of their approval was provided.

Based on review of documents the hospital failed to ensure that the medical staff bylaws contained a requirement that a medical history and physical examination be completed and documented for each patient no more than 30 days before or 24 hours after admission.

Findings:

Review of the medical staff bylaws revealed no documentation to indicate a requirement for the completion of a medical history and physical examination of each patient within the prescribed timeframe.

Based on review of documents the hospital failed to ensure that the medical staff bylaws contained a requirement that an updated examination of the patient be completed, within 24 hours after admission, when the medical history and physical examination were completed within 30 days before admission.

Findings:

Review of the medical staff bylaws revealed that they did not contain a requirement for the completion of an updated examination of the patient within 24 hours after admission.

Based on staff interview and review of administrative records, policies and procedures, and quality assurance documentation it was determined that the hospital failed to ensure the hospital had an organized nursing service that had an adequate number of licensed registered nurses and other personnel to provide the necessary care and services to meet the identified needs of the patients, failed to ensure nursing services were integrated into a hospital wide QAPI program (Refer to A-392, A-263); the hospital failed to ensure an on- going assessment of N-3's was completed by a registered nurse (RN), and failed to ensure nursing plans of care were developed for N-4 Refer to A-395, A-396).; the hospital failed to ensure that a licensed nurse clarified stat (to be given now) medication orders for (N4, and failed to ensure the physician was notified by nursing or other authorized personnel, that a prescribed medication was not available for administration for N3 and N4 (Refer to A-405). The hospital failed to ensure all nursing care and treatments provided to N2 were accurately documented on the patient's medical record (Refer to A-438); and failed to ensure medications were transcribed accurately and administered as prescribed (Refer to 494).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the nusing needs of the patients were consistently met, and the provision of quality health care in a safe environment.

Based on staff interview, document and record review, the hospital failed to ensure an adequate number of licensed nursing staff were consistently available to provide the necessary care and services to meet the needs of the patients.

Findings;

A review of the facility's patient acuity/staffing policy and procedures on 1/11/11 at 10:00 a.m. revealed... " Nursing general policies. Acuity NG-2-0," effective 1/1/2000 and revised May 2006. According the policy the "daily nursing staff and requirement based on patient acuity as identified by levels of care. Patient acuity determination will be identified daily to identify, justify and guide the assignment of nursing staff. The total staffing requires the scheduling of at least one (1) registered nurse on each shift to provide assess, assign, direct, and/or supervise the care rendered by other nursing staff."

The facility utilizes patient criteria levels of 0 through 3.
A level 0 requires a 1:1 staff, patient is a high risk, in restraints or seclusion, or the patient continues to escalate despite frequent staff intervention.
A level 1 requires every 30 minutes observation and includes; a new admit within 24 hours, patient requires constant re-direction and limit setting.
A level 2 patient requires moderate assistance. may have a special medical treatment, seizure precautions, and may be verbally threatening or provocative but no physical threats.
A level 3 patient requires only minimal prompts, and is generally stable.

Interview with the Director of Nurses on 1/12/11 at 2:00 p.m. revealed that patient acuity assessments are completed once a day at 11:30 a.m., and based on the assessment of each patient, staffing needs are determined for the day. Most staff work 12 hour shifts ( 7a.m.-7p.m. and 7 p.m. to 7 a.m.), but at various times there is a staff who works a variation of different hours, such as 1 p.m. -11 p.m. or 7 a.m.- 5 p.m..

The patient acuity assessments/staffing sheets for 4/26, 4/27,4/28, 4/29, 5/1, and 5/2/2010 were requested for review. A review of the six days revealed the facility failed to have an adequate number of staff to meet the patient needs, as identified on the acuity/staffing records, for all six of the days reviewed.

On 4/26/10 the patient census was 16; (-2 staff)
1 patient was assessed at a level 0 and required a 1:1 staff;
2 patients were assessed at a level 1, and required constant redirection and every 30 minute observations.
13 patients were assessed at a level 2.
According to the staffing record, although 12 staff were required to meet the acuity needs of the 16 patients, only 10 staff were scheduled/provided for the 24 hours.

On 4/27/10 patient census was 17; (-4 staff)
2 two patients were assessed at a level 0, both requiring a 1:1 staff;
2 patients were assessed at level 1 and required every 30 minutes observations;
12 patients were at a level 2 (moderate assist); and
1 patient was a level 3 (stable).
According to the staffing record 14 staff were required to meet the needs of the patients, however, only 10 staff were scheduled/provided for the 24 hours.

On 4/28/10 patient census was 15; (-2 staff)
1 patient was a level 0 (1:1)
4 patients were assessed at a level 1, this included 2 new admissions and 2 potential admissions coming in ( require every 30 minutes observations);
9 patients at a level 2 (moderate assist); and
1 patient was a level 3 (stable).
According to staffing/acuity records 11.92 staff were required to meet the needs of the patients, however, only 10 staff were scheduled/provided for the 24 hours.

A review of the assignment sheets for 4/28/10 with LN 5 verified that 3 staff worked the second shift (p.m.-a.m.). One of the 3 staff was assigned the 1:1 patient observations, leaving the other two staff to complete the every 30 observations (on 4 patients), and the other patient care duties as assigned. Staff interviews on 1/12/11 at 2:30 p.m. with LN 5 and LN 2 revealed that 3 staff was not an adequate number of staff to meet all of the patient care needs, and complete all of the duties necessary for the second shift.

On 4/29/10 patient census was 16;(-2 staff)
1 patient at a level 0; required 1:1
2 patients were a level 1
12 patients were level 2
1 patient was a level 3. Per the daily acuity system 12 staff were needed for the identified patients needs, however, only 10 staff were scheduled/provided for the 24 hours.

On 5/1/10 patient census was 15; ( - 1.5 staff)
1 patient at a level 0; required 1:1
1 patient at a level 1 (new admit)
13 patients at a level 2. Per the daily acuity system rating 10.66 staff were required, however only 9.41 staff were scheduled/provided for the 24 period.

On 5/2/10 patient census was 16; (-2.29 staff)
2 patients at a level 0; required 1:1
1 patient at a level 1 (new admit)
12 patients at a level 2 and
1 patient at a level 3. Per the daily acuity 12.42 staff were required to meet the needs of the patients, however, on 10.13 staff were scheduled/provided for the 24 hour period.

Interview with two licensed nursing staff (LN 5 and LN 2) on 1/12/11 at 2:00 p.m. verified that the acuity rating of the patients is done only once a day, and if a patient's condition becomes more acute and the acuity changes, additional staff can be called in. Both nurses verified that they are "frequently" asked to do overtime.

A review of the acuity/staffing sheets for an additional 15 days with LN 5 on 1/12/11 at 3:00 p.m. (including 12/21, 12/22,12/23, 12/27, 12/28, 12/30/2010 and 1/2,1/4, 1/5,1/6, 1/7, 1/8, 1/9, 1/10 and 1/11/2011) revealed that on 7 of the 15 days reviewed the facility failed to have an adequate number of staff on duty to meet the needs of the patients. The staff shortage ranged from 1 to 3.5 staff.

When asked if the current acuity/staffing system had been evaluated to ascertain if the system was still effective, both nurses stated that there has been no evaluation or revision of the current system "for as long as I have been here" (over 8 years). Staff interview verified that no data was collected or analyzed to evaluate the current patient classification system/staffing to ensure it was effective in meeting the needs of the patients.

Based on record review and staff interview, the hospital failed to ensure an assessment of N3's medical problems was completed on an ongoing basis by a registered nurse (RN) to ensure the patient's needs were being met. (1 of 11 sampled patients).

Findings;

A review of the medical record for patient N3 on 1/11/11 beginning at 12:10 p.m. revealed the patient was admitted to the hospital on 5/3/10 at 3:16 p.m.. The patient's diagnoses included asthma and orthostatic hypotension (postural hypotension). The admission physician's orders included an order for Flovent twice a day (a medication given in the maintenance treatment of asthma), and an order for a prn (as needed) Albuterol inhaler (used to treat bronchial spasms).

Although the patient's asthma and orthostatic hypotension were identified identified medical problems for the patient there was no documentation in the record to indicate an ongoing assessment and evaluation of the patient's identified medical problems was completed. Interview with LN 1 on 1/12/11 at 10:30 a.m. revealed that an assessment of the patient's current medical problems should be documented in the the interdisciplinary progress notes. Review of the medical record with LN1 verified that the record contained no documentation to indicate the patient's medical conditions were assessed and evaluated on an ongoing basis.

Based on observation, document and record review and staff interview the hospital failed to ensure nursing plans of care were developed for N4 (1 of 11 sampled patients).

Findings

Medical record review beginning on 1/11/11 at 11:45 a.m. reflected N4 was admitted on 10/22/10. Admitting diagnoses included altered thought process, mood lability, bilateral leg edema, high blood pressure, hypothyroidism , history of breast cancer and a right mastectomy.

The nursing admission assessment dated 10/22/10 reflected that N4 had a "red" rash on both legs, poor nutrition, pain, high blood pressure, edema, and numbness and tingling in feet and hands.

There were no careplans initiated upon admission that addressed any of the above medical needs.

Interview with LN 2 (licensed nurse) on 1/12/11 at 8 a.m. revealed that N4 was admitted with a compression sleeve on her arm to assist with her arm edema. This information was not captured on any careplan nor documented in any progress notes. She did not have edema on her arm when admitted. N4 lost the compression sleeve, but, there was no way to determine the length of time the compression sleeve was lost, as there was no documentation . Over time N4 developed right arm lymphadema. A new compression sleeve was applied on 1/8/11. LN 2 agreed there were no care plans initiated upon admission that addressed the medical needs for N4. There was a lack of documentation and assessment of N4's right arm upon admission.

Based on medical record review, interview and policy and procedure review, the hospital failed to ensure that the licensed nurse clarified stat (to be given now) medication orders for 1 of 11 sampled patients (N4), and failed to ensure the physician was notified by nursing or other authorized personnel, that a prescribed medication was not available for administration and was not given as prescribed for 2 of 11 sampled patients (N3 and N4). (Refer to A-501)

Findings:

Review of the facility's policy and procedure titled "Drug Availability" reflected the following, in part,:" The Pharmacy Service shall be available 24 hours a day, seven days a week. If a physician orders a drug that is not available in the facility's Medication Room, the following procedure is to be observed:

Notify the attending physician or contact the on-call physician to see if an alternate medication can be used. If an alternate medication is acceptable the physician should give a new medication order. this mediation order must be signed by a physician within 24 hours. The decision to change medications should be documented in the nursing progress notes..."

1. Review of the the medical record for Patient N3 beginning on 1/11/11 beginning at 12:10 p.m. revealed the patient was admitted to the hospital on 5/3/10 with diagnoses including asthma and hypertension. The patient's admission physician's orders, written at 6:00 p.m., included the medication Flovent ( used in the maintenance treatment of asthma) to be given twice a day. The order was noted by nursing personnel, along with a notation that the Flovent medication would be delivered "tomorrow."

A review of the patients medication administration record revealed a notation that the Flovent was 'not available." There was no documentation to indicate the physician was notified that the patient's asthma medication was not available for administration as ordered.

2. Review of medical record for Patient N4 beginning on 1/11/11 at 11:45 a.m. reflected an admission date of 10/22/10. Admitting diagnoses included altered thought process, mood lability, bilateral leg edema, high blood pressure, hypothyroidism , history of breast cancer and a right mastectomy.

Physician orders dated 10/27/10 reflected " Give Ativan (anti-anxiety) 2 mg (milligram) and Abilify (antipsychotic) 15 mg IM (intramuscularly) Stat (right away)". The order was noted by nursing personnel and a notation reflected that the Abilify medication was not available from pharmacy.

The medication administration record (MAR) reflected that the Ativan was given at 2:50 p.m. However, a notation on the MAR indicated the Abilify was not available. There was no documentation to indicate the Abilify was ever administered or that communication with the physician took place to clarify the order and inform the physician the Abilify was not available.

Interview with LN 2 (licensed nurse) on 1/12/11 at 8 a.m. revealed that there was no indication that the order was ever clarified. Since the medication was not available, there should have been communication with the physician along with documentation to reflect the clarification.

Review of the policy and procedure titled "Drug Availability" reflected the following, in part,:" The Pharmacy Service shall be available 24 hours a day, seven days a week. If a physician orders a drug that is not available in the facility's Medication Room, the following procedure is to be observed:

Notify the attending physician or contact the on-call physician to see if an alternate medication can be used. If an alternate medication is acceptable the physician should give a new medication order. this mediation order must be signed by a physician within 24 hours. The decision to change medications should be documented in the nursing progress notes..."

Based on document review and staff interview, the hospital failed to ensure that the Medical Record Administrator had the qualifications as required by the job description; and that the medical record service's policies and procedures were approved and an accurate description of the current services.

Findings:

1. The job description for the Medical Record Administrator was reviewed on 1/11/11. The position requires either a Registered Health Information Administrator (RHIA) or a Registered Health Information Technician (RHIT) credential. During an interview with MR Staff 1 on 1/10/11 beginning at 2:10 p.m., she stated that she was an RHIT and she was asked for her most recent credential validation certificate. This certificate is evidence that an individual has obtained the minimum required number of hours of continuing education (CE) credits in a 2-year cycle, and it is required in order to retain the RHIT credential. The personnel file of MR Staff 1 was reviewed on 1/11/11 and no evidence of a current CE validation was in the file. On the afternoon of 1/12/11, she explained that she had not submitted her CE report for the last two cycles, resulting in a need to reinstate her credential.

2. The Medical Records Policy and Procedure (P&P) Manual was reviewed on 1/11/11. There was no evidence of annual approvals, as required by the administrative policy, "Review and Approval of Psychiatric Health Facility Policy and Procedures" (effective 6/4/08). The majority of the P&Ps were last reviewed in October, 2000 and were not reflective of current practices. For example, medical records were no longer stored with the off-site company as stated and there was no mention of the current record archives area. On 1/12/11 beginning at 9:30 a.m., during an interview with MR Staff 1, she stated that the P&P Manual had been reviewed and approved annually; however, no evidence was provided by the end of the survey.

Based on record review and staff interview the hospital failed to maintain accurately documented, and complete medical records for N2 and N3 (2 of 11 sampled patients) .

Findings;

1. A review of the medical record for patient N2 on 1/11/11 beginning at 11:35 a.m. revealed the patient was admitted to the hospital on 4/28/10 at 9:45 p.m. and expired on 4/29/10 at 1:45 a.m.. There was no primary admission diagnosis documented on the "Psychiatric admission orders" dated 4/28/10 at 2145 (9:45 p.m.).

A review of N2's "Routine assessment of Patient Progress", an assessment to be completed upon admission, revealed the assessment was incomplete. The assessment was not dated or signed by the person who completed the assessment.

2. A review of the facility's policy and procedure titled "Restraint and Seclusion" dated 12/5/04 included the use of "emergency involuntary medications." According to the facility policy and procedure.."the use of emergency involuntary medication" requires a physician's order. "The order is to include the symptoms for which the medication is to be given", and a "statement" that the patient is a "danger to self and/or others."

According to medical record documentation N2 was admitted to the hospital in restraints on 4/28/10 at 2145 (9:45 p.m.). Physician's orders received at that time stated.."put pt (patient) in seclusion and restraints", and "Give Zyprexa 10 mg IM now." A subsequent physician's order written on 4/28/10 at 2355 (11:55 p.m.) stated, "Give Zyprexa 10 mg IM now, one time order" and "Give Ativan 2 mg. IM now one time order."

The two orders written for the use of emergency medications were incomplete, and did not reflect the facility's policy and procedures. The orders failed to specify the symptoms for which the medications were to be given, and failed to identify whether the patient was a danger to self and/or others.

3. According to facility's policy and procedure titled "Event of Patient Death" effective Feb. 1998, Revised May 2006.....
#1. Only a physician may pronounce a patient deceased.
#2. The physician should notify the deceased patient's family of the patient death, and determine from them which mortuary is to be called.
#3. When an autopsy is desired, the physician or social worker must obtain consent.
#9. The nursing observation should include the time respiration ceased, the time the physician pronounced the patient dead, which physician, which member of the family was notified, the disposition of the body, the property and the valuables. If resuscitation was attempted, include all measures taken.

The patient's record contained one interdisciplinary progress note (IDT)dated "4/28/10" and timed only as "admit 2145." According to the documentation the patient was admitted from an acute hospital emergency room (ER), on an involuntary hold, via ambulance. The patient was transported to the hospital in restraints and remained in restraints (type was not specified) and seclusion following admission to the facility. The patient was described as "agitated and screaming at staff." The patient remained restraints, in seclusion, in an observation room. The nursing interdisciplinary progress notes described the patient as "yelling" and "screaming" at staff and "pulling at the restraints." Per the notes the patient was uncooperative with staff during attempts to provide personal care.

The interdisciplinary progress note documentation states "4/28/10 admit. Pt (patient) noted to have O (no) respiration at + - 0115. 911 called, CPR started, Paramedics arrived. Pt. expired. Supervisor notified. Dr. M.., Dr. F... LZ notified."

The record contained no documentation describing what "CPR" interventions were implemented, what care was provided to the patient, when and by whom. There was no documentation to reflect the patient's responses to the interventions and care provided.

The record stated "paramedics arrived." However, there was no documentation to indicate when they arrived and what care, treatment and interventions were initiated. There was no documentation in the patients record to indicate what the patient's response was, if any, to interventions implemented by the paramedics.

Per the IDT documentation by the licensed nurse... "Pt. (patient) expired." The documentation was incomplete, not timed and failed to reflect the facility's policy and procedure. There was no documentation in the patients record that a physician pronounced the patient deceased, per policy. The record contained no documentation to indicate a physician attempted to notify the deceased patient's family of the patient death, and determine from them which mortuary is to be called. There was no documentation in the record to indicate if an autopsy was desired, or if the physician or social worker obtained consent. The nursing observations failed to include the time respiration ceased, the time the physician pronounced the patient dead, which physician, which member of the family was notified, the disposition of the body, the property and the valuables. If resuscitation was attempted, there was no documentation to include all the measures taken.

4. A review of the medical record for patient N3 on 1/11/11 at 12:10 p.m. revealed the patient was admitted on 5/3/10 at 3:16 p.m.. A review of the admission record, completed by the on-call psychiatrist, revealed the form was incomplete. The form was not dated, timed, or signed. The history and physical, completed on the patient on 5/4/10 indicated the patient had "no allergies", yet the admission physicians orders state the patient has allergies to "Ativan, latex, codeine, demerol, geodon and allerall."

Based on medical record review and staff interview, the facility failed to ensure that medical record entries were complete (with time, date and patient identifier) in 4 of 4 records reviewed (R1,R2, R3, R4).

Findings:

Records R1 through R4 were reviewed 1/12/11. The following findings were confirmed with MR Staff 1 on1/12/11 beginning at 9:30 a.m.:

1. Physician progress notes that did not document the time the notes were written, as required by the pre-printed area on the form (R 1, 2, 3, 4). Physician orders were not timed (R1, 3, 4).
2. The Admission Evaluations did not state the date the evaluation was performed (R2, 3, 4).
3. The Informed Consent for Psychotropic Medications was not dated when signed by the physician (R1); and not dated when signed by the patient (R2).
4. The Psychiatric Admission Assessment contained abbreviations (DTS, OD, CPT, SA) that were not on the approved list (RI).
5. The Daily Nursing Assessment Flowsheet did not contain any patient identification on the back sides of the forms (R1, 2, 3, 4).
6. A discharge summary had been electronically signed by the physician; however the facility did not have an acknowledgement statement signed by the physician to ensure that the individual is indeed the one who electronically authenticated the report. (R1).
7. The Admission Evaluation did not document the actual date the evaluation was performed (R2, 4).
8. A telephone order was not dated and timed when the physician signed it (R2).

Based on observation, interview, and document review the hospital failed to ensure that Pharmaceutical Services met the needs of all of it's patients as evidenced by failure to:

1. To ensure that the Pharmacy services were administered in accordance with the facility's policy and procedures and that the facility's Medical Staff Committees had approved the facility's Pharmacy policy and procedure manual. (Refer to A-491).

2. To ensure that the facility administered drugs and biologicals in accordance with Federal and State laws and regulation, and in accordance with approved medical staff policies and procedures. (Refer to A-405)

3. To ensure patient safety with the distribution of drugs in accordance with standards of practice (including the facility's own policies and procedures). (Refer to A-500).

4. To ensure that medications were dispensed under the supervision of a pharmacist and consistent with Federal laws. (Refer to A-501).

5. To ensure that outdated and mislabeled drugs were not available for patient use. (Refer to A-505).

6. To ensure that medications were renewed in compliance with the facility's stop order policies and procedures. (Refer to A 507).

7. To ensure that all medication errors were reported to the attending physician and the hospital-wide quality assurance program. (Refer to A-508).

8. To ensure that any losses of controlled substances were reported to the individual responsible for pharmaceutical service and to the chief executive officer. (Refer to A-509).

9. To ensure that the facility had established a formulary system for the hospital and it's staff to use. (Refer to A-511).

10. Evaluate the services that were being provided by the facility's contracted Pharmacy service. (Refer to A- 84).

11. To analyze medication errors, to implement preventive actions, and mechanisms which included feedback and learning for the hospital and it's employees. (Refer to A-288).

12. To ensure that systems were in place to implement improvement actions, measure the success of these improvement actions, measure success, track performance, and to ensure that any success obtained as a result, were maintained. (Refer to A-291).

The cumulative effect of these systemic problems resulted in the inability of the hospital to provide pharmaceutical services and ensure client safety in such a manner that the pharmaceutical needs of the patients were met in accordance with the facility's own policies and procedures, Federal law, and applicable standards of practice.

Based on review of the hospital's Medical Staff Committee minutes, interview with the hospital's Medical Director, and the Program Manager, the hospital failed to ensure that the hospital's Pharmacy Policy and Procedure manual was approved by any of the hospital's medical staff committees. The hospital failed to ensure that the contracted Pharmacy provider was able to provide all the necessary services which are required for an Acute Care Hospital. The hospital failed to ensure that policies and procedures which are outlined in this manual were being implemented into the hospital's practices. Review of the hospital's only medication refrigerator log, the Pharmacist medication regimen review and facility staff interview revealed that the hospital failed to ensure that the medication refrigerator was maintained between 36 and 46 degrees Fahrenheit, and that actions were taken by staff when the refrigerator was out of range. The facility's administrative staff also failed to take corrective actions when this issue of refrigerator temperatures being maintained out of range, was brought to administrations attention on several occasions by the hospital's Pharmacist, this could alter the integrity of the refrigerated drugs.


Findings:


1. Inspection of the hospital's Pharmacy Policy and Procedure manual on 1/11/11, which was labeled: "Nursing Care Center Pharmacy Policy and Procedure Manual", contained a document entitled:" Pharmacy Policies and Procedures Annual Authorization". The document read: "The nursing care center's Pharmacy Services Subcommittee/Pharmaceutical Services Committee/Quality Assessment and Assurance Committee/ or its equivalent, on this the day of...hereby approve and adopt the following policies and procedures as amended by the nursing care center in accordance with nursing care center standards and state and federal regulations. The hospital's failure to address these out of range refrigerator temperatures may have altered the integrity of all of the facility's refrigerated drugs and biologicals.

All medical, nursing and pharmacy staff shall be inserviced on and have access to this manual." Not only does this facility not have any of the Committees identified above, but the facility's Medical Staff Committees had no oversight on any approval of this Pharmacy policy and procedure manual. The remainder of the Authorization page had signature lines for the following administrative staff: Administrator, Director of Nursing, Medical Director or physician designee, and the Consultant Pharmacist. This page was completely blank, indicating that this policy and procedure had not been reviewed by the facility's administrative staff or the Consultant Pharmacist. Interview with the hospital's Program manager on 1/11/11 at 10:35 a.m. revealed that this manual was the hospital's official Pharmacy policy and procedure manual. Interview with the hospital's Medical Director on 1/12/11 at 11:15 a.m. revealed that no one could provide proof that this policy and procedure had been reviewed by any of the hospital's administrative staff or any of the facility's Medical Staff Committee's prior to its' use in the facility. The blank copy of the facility's "Pharmacy Policies and Procedures Annual Authorization form had accurately reflected the hospital's failure to approve this Pharmacy policy and procedure manual.

2. Review of the hospital's Pharmacy policy and procedure manual introduction page stated the following information indicating that this Pharmacy provider only services "Long Term Care" facilities: "XXXX (the Pharmacy's name was removed) Corporation specializes in long-term care pharmacy, providing medications, consulting programs, regulatory assistance and related services to long-term care residents in skilled nursing, sub-acute and assisted living settings nationwide....XXXXX (the Pharmacy's name was removed) Corporation has compiled this collection of policies and procedures as a basic practice guideline for pharmaceutical services for the professional nurse in a long-term care setting....The responsibility for ensuring the accuracy of any provision and updating of the procedures for compliance within your nursing care center remains with you."

The introduction in this manual confirms that this Pharmacy does not provide services for a facility certified as an Acute Care Hospital, which this hospital is currently certified as. As a result of this information, the hospital's Pharmaceutical services were not the same as the Pharmaceutical services which are being provided at other Acute Hospitals. Interview with the facility's Program Manager and the facility's Director of Nurses on 1/13/11 at 5:10 p.m. confirmed that the services that the facility was receiving from the Pharmacy provider above, were not meeting the hospital's expectations and needs.

3. Review of the hospital's Pharmacy policy and procedure manual on 1/13/11 at 2:00 p.m. revealed a policy and procedure entitled:"Black Box Warning Medications". The policy states:"...1. Nursing Staff shall refer to "Black Box" Warning Monitoring Guidelines...". No such monitoring guidelines could be provided by the facility. Interview with LN5 on 1/13/11 at 2:15 p.m. revealed that about one year ago, nursing staff were provided with medication side effect and other important drug information documents which could be given to patients who were being discharged from the facility. LN5 went on to say during the interview that she would provide any patient with the information that she remembered about each drug.

Interview with LN2 on 1/13/11 at 2:18 p.m. revealed that she too would do the same, in regards to providing her patient drug information based on her memory of the drugs which were being dispensed. Nursing staff indicated that the information about the drugs which was shared with the patients at the time of discharge, would not always be consistent from nurse to nurse. LN5 indicated that the facility's Pharmacy use to send the facility standardized drug information sheets for reference and to be provided to the discharge patient for the sake of consistency. Both Nursing staff indicated that they missed the fact that Pharmacy was no longer providing them with these standardized drug information sheets, for the nurses to share this information with the patients at discharge for consistency.

4. Review of the facility's Pharmacy policy and procedure manual on 1/12/11 revealed a policy and procedure entitled: "Emergency Pharmacy Service and Emergency Kits", which read:"....Emergency needs for medication are met by using the nursing care center's approved emergency medication supply or by special order from the provider pharmacy...". The hospital did not have an approved list of emergency drugs for use. The same Pharmacy policy and procedure goes on to say:" 3. The provider pharmacy supplies emergency or "stat" medications/items according to the provider pharmacy agreement...".

The hospital's pharmacy agreement states:"Services to be provided by Contractor: A. Check and replenish "stock" medications and emergency box". Interview on 1/12/11 at 3:50 p.m. with one of the hospital staff nurses revealed that the only emergency supplies that the facility had for Diabetic emergencies was oral glucose tubes, which could not be administered for an unconscious patient. The pharmacies policy and procedure manual did not indicate what emergency drugs should be present in the facility.

5. The hospital's Nursing policy and procedure entitled: "Nursing -Medications", reads: "A refrigerator will be housed in the Medication Room for the storage of medications. The temperature of the refrigerator will be maintained between 2.2 degrees C (36 degrees F) and 7.7 degrees C (46 degrees F)....B. The refrigerator will be defrosted and cleaned monthly by the evening shift. C. The temperature of the medication refrigerator will be checked daily and a log maintained of daily temperatures noted. The log will be kept on top of the medication refrigerator. The refrigerator temperature shall be between 2.2 degrees C (36 degrees F) and 7.7 degrees C (46 degrees F)."
Review of the hospital's Pharmacy policy and procedure entitled: "Medication Storage", reads: "...11. Medications requiring "refrigeration" or "temperatures between 2 degrees C (36 degrees F) and 8 degrees C (46 degrees F)" are kept in a refrigerator with a thermometer to allow temperature monitoring....".


Review of the hospital's refrigerator temperature log on 1/12/11 at 4:00 p.m. revealed that following recorded temperatures below 36 degrees Fahrenheit between April 2010 to January 2011: 1) on 4/4/10 and 4/5/10 the temperature was recorded as 34 degrees Fahrenheit without any corrective action being documented on the log, 2) on 4/9/10 the temperature was recorded as 34 degrees Fahrenheit without any corrective action being recorded on the log, 3) on 4/10/10, 4/11/10, 4/14/10, 4/19/10, 4/24/10 and 4/28/10 no refrigerator temperatures were recorded on the log, 4) between 4/21/10 to 4/26/10 (for at least 5 days) the refrigerator temperatures were documented as 34 degrees Fahrenheit, 5) on 5/1/10, 5/4/10, 5/6/10, 5/15/10, and 5/17/10 no refrigerator temperatures were recorded on the medication refrigerator's temperature log, 6) on 5/3/10 and 5/10/10 the temperature was recorded as 35 degrees Fahrenheit and on 5/5/10 the refrigerator temperature was recorded as 32 degrees Fahrenheit (which is freezing), 7) for the remainder of 5/10, the refrigerator temperature was recorded at 34 degrees Fahrenheit for 8 days, 8) for 6/10 the refrigerator temperature was recorded below 36 degrees Fahrenheit for 5 days,
9) for 7/10, the refrigerator temperature was recorded below 36 degrees Fahrenheit for 6 days and no temperature was documented during this month for an additional 5 days that month, 10) for 8/10, the refrigerator temperature was recorded below 36 degrees Fahrenheit for 8 days and no temperature was documented on the refrigerator log for an additional 6 days that month,11) for 9/10, the refrigerator temperature was recorded below 36 degrees Fahrenheit for 11 days and no temperature was documented on the refrigerator log for an additional 10 days that month, 12) for 10/10, the refrigerator temperature was recorded below 36 degrees Fahrenheit for 13 days and no temperature was documented on the refrigerator log for an additional 7 days that month, 13) for 11/10, the refrigerator temperature was recorded below 36 degrees Fahrenheit for 6 days and no temperature was documented on the refrigerator log for an additional 4 days that month, 14) for 12/10, the refrigerator temperature was recorded below 36 degrees Fahrenheit for 4 days (with temperatures documented as low as 30 degrees) and no temperatures were documented on the refrigerator log for numerous days that month, and 15) for 1/1/11 to 1/12/11 the refrigerator temperature was recorded below 36 degrees Fahrenheit for 2 of 12 days and no temperature was documented on the refrigerator log for an additional 4 of 12 days that month.


Nursing staff failed to ensure that the medication refrigerator temperatures were maintained in accordance with the hospital's policies and procedures. Hospital staff failed to document on the refrigerator temperature log daily, as indicated in the facility's policy and procedure. Review of the facility's Pharmacy and Nursing polices or procedures, provided the facility staff with direction or guidance as to what they should do when refrigerator temperatures were not maintained between 36 F to 46 F. Interview with at least three of the facility's day shift nursing staff on 1/12/11 at 4:00 p.m. revealed that none of the staff knew how to adjust the medication refrigerator's temperature or what to do when the refrigerator might be in need of repair.

Review of the hospital's Pharmacist monthly medication report on 1/13/11 at 3:00 p.m. revealed that the Pharmacist had reported to the facility in 4/10 that there was ice in the Insulin (a drug used to treat diabetes) storage box, in the same report the Pharmacist reported that the refrigerator temperature was 32 degrees Fahrenheit and that she had asked the hospital's administrative staff to correct the refrigerator's freezing temperature.

Again in 8/10, the hospital's Pharmacist reported that the insulin 70/30 (which had been stored inside the refrigerator) was encased in ice. The Pharmacist also noted at that time that there was ice build up in the refrigerator for a second time, and requested that administrative staff take action to correct this issue. In the Pharmacist's report dated 9/10, the Pharmacist stated that the refrigerator temperature was again 32 degrees Fahrenheit and that this was her second time in the last month for requesting administrative staff to correct the freezing temperature of the medication refrigerator. The freezing temperatures of this medication refrigerator continued into 1/11 without any correction, or action being taken by the hospital's administrative staff.

Based on review of the hospital's Narcotic Control form, review of the hospital's unusual occurrence reports, and interview with facility administrative staff, the hospital failed to utilize medication error data from their reports, to change or modify the way that the hospital provides services.

Findings:

Review of a hospital report on 1/12/11 involving Vicodin (a scheduled narcotic) revealed that the facility had concluded that the loss of a tablet was due to "Overcrowding" in the narcotic storage area and because medications were being stored inside of large bubble packs. Interview with facility nursing staff on 1/12/11 at 2:10 p.m. revealed that the facility has had a difficult time with controlled drugs falling out of the backs of the narcotic bubble packs for a while. Facility staff also indicated that the loss of narcotics from this supply (the narcotic cabinet), had occurred on a regular frequency. Review of the hospital's reports did not reveal any trends with the facility's loss of controlled substances. Review of the facility's monthly Consultant Pharmacist report also failed to identify any concerns about the facility's loss of controlled substances.

A Narcotic Control form was reviewed on 1/12/11 for Vicodin (a scheduled narcotic) and the sheet indicated that on 12/23/10 at 4:40 p.m. a dose of Vicodin was going to be administered to a patient, but it was wasted. The dose of Vicodin which had been wasted only had one signature on the narcotic control form, contrary to the hospital's policy and procedure. Interview with one of the medication nurses on 1/12/11 at 2:05 p.m. revealed that the facilities policy and procedure was for two different nurses to sign the Narcotic Control form when a dose of a controlled substance was to be wasted.

Based on clinical record review, document review, and hospital staff interview the facility failed to ensure that all patient discharge orders were written clearly and discharge orders clarified as needed. The Pharmacy provider was unable to provide discharge medications for all the hospital's patients in a timely manner. The hospital also failed to ensure that all drugs and biologicals were accurately accounted for. The hospital staff provided patients with discharge medications, house stock medications were not approved by the hospital's P&T Committee, the list of house supply medications was incomplete, the facility failed to develop a system for the tracking of the house supply medications.

Findings:

1. Inspection of the facility's Drug Room and drug storage area on 1/12/11 at 2:15 p.m. revealed that the facility had established an unapproved list of drugs which the facility referred to as "House Supply". This "House Supply" was for Controlled drugs as well as non-controlled prescription and nonprescription medications. This included injectable drugs and consisted of more than 70 different types of medications. The list of drugs in both "House Supplies", had never been approved for use by any of the facilities Medical Staff oversight committees. Facility staff and the DON indicated that the DON had decided at some point in time, which medications the facility would need to have in stock. For the non-controlled prescription and over the counter drugs, the quantities on hand did not match the quantities which were indicated on the master "House Stock" medication list.

Facility staff indicated that any one who had access to this drug supply could walk out of the building and go home with pockets full of these medications and no one would miss them because the quantities were not being monitored. Review of the Controlled "House Supply" on 1/12/11 at 2:15 revealed the following drugs were not on the facility's "House Supply" list, but despite not being on the facility's list, they were still present in the facility's narcotic locker: 1) Ambien 5 mg, 9 tablets, 2) Xanax 0.5 mg, 16 tablets, 3) Phenobarbital (which on the facility's list stated:"Do not Order", 32.4 mg 4 tablets, 4) Norco 10-325 mg, 13 tablets, 5) Darvocet N-100, 13 tablets, 6) Dalmane 30 mg, 6 tablets, 7) Tylenol #3, 16 tablets, and 8) Librium 10 mg, 10 tablets. The facility also had Chloral Hydrate 500 mg Softgels 10, on the list, but none were available for administration in the narcotic cabinet.

2. Review of the hospital's controlled substance drug storage area on 1/12/11 at 4:15 p.m. revealed that almost 1/3 of the all of the controlled substance bubble packs had tape on the back of them. During an interview with LN 5 on 1/12/11 at 4:15 p.m. the nurse was asked why so many of the bubble packs had tape on the back of them. LN 5 responded that nursing staff would find the medication hanging out of the back of the card (almost ready to fall out of the card), or the medication had already fallen out of the bubble pack and into a bin or the counter space inside the narcotic cabinet. Nursing staff would put these tablets back into the bubble packs and resealing the medications back into the bubble packs using tape. The use of the tape to reseal the bubble packs did not conform with standards of professional practice.

Based on review of the hospital's policy and procedure and interview with the facility's Medical Director, the hospital failed to establish policies and procedures which were reflective of the facility's operational practices. The hospital staff provided patients with discharge medications, house stock medications were not approved by the hospital's pharmacy and therapeutics (P&T) Committee, the list of house supply medications was incomplete, and the facility failed to develop a system for the tracking of its house supply medications and the distribution of these medications for 1 of 5 patients (P-5).

Findings:

1. Review of the clinical record for patient P-5 on 1/13/11 at 11:00 a.m. revealed the following physician's order written on 12/30/10 at 10:05 a.m. :"Discharge home with own medications and house stock medications". This medication order was never clarified by nursing. Interview with hospital nursing staff on 1/13/11 at 10:30 a.m. revealed that when a patient is discharged from the facility, the patient is provided (not directly unless they are being discharged home) with a 7 day supply of the current medications that they were receiving during the patient's stay in the hospital. Several facility nursing staff also indicated that they have been asked to provide the patients with the patient's own bubble pack of medications which may have been mislabeled, (as the directions for use on the label of the bubble pack may not reflect the directions for use that the patient is currently taking). Facility nursing staff also indicated that they have had to give patients "House Supply" medications on discharge in order to ensure that patients are able to take with them a 7 day supply of medications on discharge from the hospital.

Facility nursing staff also indicated that patients are usually discharged from the facility around "Probable Cause Hearings", which usually take place between 1:30 p.m. and 2:30 p.m. during any given date. Based on the outcome of these hearings, the facility may need to fax the patient's medication orders for discharge to the Pharmacy. The contracted Pharmacy's location is approximately 40 miles south of the hospital's location. Delivery of the patient's medications from the Pharmacy has taken up to 4 hours (6:00 p.m. in the evening) after the orders have been faxed to the Pharmacy by the hospital. By the time that the ordered medications arrives at the facility (6:00 p.m. in the evening), almost 90% of the patients who have been discharged as a result of the "Probable Cause Hearings" have already left the facility without the medications, and there is usually no sure way for these medications to get to the patients or their caregivers once the patients have left. Nurses were dispensing medications outside of their scope of practice.


2. Review of the hospital's policies and procedures on 1/12/11 revealed a policy and procedure entitled: "#50 Dispensing Sample Medications". The policy and procedure reads as follows: "It is the policy of the XXXXXXXXXXXX that sample medications will be recorded, stored and dispensed in accordance with relevant State and Federal requirements as well as standards of clinical practice." The policy goes on to say: "Pharmaceutical samples will only be dispensed by Medical Staff to a patient as directed by a written prescription or other order signed by a Physician. 2. A single dose of a sample medication may be dispensed to a patient by Medical Staff....".

Interview with the facility's Medical Director on 1/13/11 at 3:10 p.m. revealed that this policy did indeed pertain to the hospital, but in practice, the hospital did not permit sample medications to be dispensed to the hospital's patient's. During the interview, the Medical Director indicated that he understood how someone reviewing the facility's policy and procedure, could accept this policy as being a part of the hospital's every day practice. The Medical Director also indicated that many of the facility's policies and procedures had not been reviewed by any of the hospital's administrative staff in order to determine if this policy and procedure reflected the hospital's everyday practices.

Based on inspection of the hospital's drug storage room, the hospital and the Pharmacist failed to ensure that all medications were labeled correctly with expiration dates, and failed to ensure that expired medications were not available for administration.

Findings:

Review of the facility's Pharmacy policy and procedure manual states under the section entitled:" House Supplied (Floor Stock) Medications:"...4. The manufacturer's or pharmacy's label shall include the following elements: ....f. expiration date."

Inspection of the facility's "House Supply" on 1/12/11 at 2:30 p.m. revealed the following expired drugs were available for administration, and had not been removed from the facility' drug supply by the facility's Pharmacist:
1) Provigil 100 mg, 16 tablets with an expiration date of 12/10.
2) Ambien 12.5 mg, 7 tablets with an expiration date of 12/10.

Inspection of the same drug supply revealed one bubble pack of Ativan 1 mg, tablets 10, without an expiration date being provided by the facility's Pharmacy, contrary to the facility's Pharmacy contract which states in Exhibit D under compliance requirements J: "All drugs obtained by prescription are labeled in compliance with all pertinent State and Federal standards, specifically: 1. All drugs obtained by prescription are labeled in compliance with Federal and State laws....". California Business and Professions Code section 4076 states: "A pharmacist shall not dispense an prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following:.....9. The expiration date of effectiveness of the drug dispensed.....".

Based on review of the hospital's clinical records, review of the hospital's Pharmacy policy and procedure manual, and interview with the Medical Director, the facility failed to ensure that the facility's medication stop order policy was implemented for 1 of 5 patients (P2).

Findings:

Review of the hospital's Pharmacy policy and procedure manual under section entitled: "Stop Orders for Acute Conditions", reads:"...1. The following classes of medications will not be automatically refilled after the indicated number of days, unless the prescriber specifies a different number of doses or duration of therapy to be given or in cases where the automatic discontinuation of a medication may lead to an adverse outcome....e. Steroids (10 days)...".

Review of the clinical record for patient P2 on 1/12/11 at 10:15 a.m. revealed a physician's order for Advair Diskus (a corticosteroid combination drug) 250/50 one puff twice a day for inhalation. The Advair Diskus was originally order for this patient on 9/17/10 and it was reordered on 9/21/10 (4 days later). On 10/10/10 the Advair was reordered 19 days after the last reorder, then on 12/5/10 (55 days after the last reorder) the Advair Diskus was renewed. Then on 1/4/11 the Advair Diskus inhaler was renewed again, 31 days after the last renewal of this medication.

The Advair was not renewed as outline in the facility's Pharmacy policy and procedure.

Based on review of clinical records and interview with hospital administrative staff the hospital failed to have an effective system in place to identify and report medication errors for 4 of 6 patients (P1, P3, P4, P6) in an effort to reduce or prevent reoccurrences. The medications recorded on the physicians Discharge Summary for P3 was inaccurate, creating a potential for the patient to receive the wrong medications. Two drug administration errors were not identified and/or reported for P1. A medication prescribed for P4 was not given as ordered, and an unsampled patient (P6) received an incorrect dose of a prescribed medication which was not reported to the physician. The facility was unable to provide documentation that the medication errors were identified and sent to QA.

Findings:

1. Review of the clinical record for P-3 on 1/11/11 revealed that a Physician's Discharge Summary had been created for this patient. The Discharge Summary indicated that this patient had been discharged from the hospital on an anti-arrhythmic drug called Amiodarone at a dose of 800 mg by mouth three times daily. Review of th patient's clinical record revealed that the patient was never on Amiodarone during her stay at the facility.

The Discharge Summary is very important and needs to be accurately completed. This Discharge Summary is sent out with the patient to the next facility (or place of discharge), so that anyone who is to provide subsequent care to this patient has accurate information on what medications the patient should be taking, and the events which took place during the patient's hospitalization. The Discharge Summary is also used to obtain medical information when the patient is readmitted to the hospital and medical treatment decisions need to be made on how to handle the patient's medical care. Interview with the facility's Medical Director on 1/11/11 at 11:00 a.m. and review of the patient's medical record with the Medical Director revealed that the Amiodarone was not a medication that P-3 had received during any point of her hospitalized stay at the hospital.

2. Review of the clinical record for patient P-1 on 1/11/11 at 3:00 p.m. revealed a physician's order, written on 1/7/11 about 6:45 p.m. for the patient to receive Zydis (a behavior modifying medication) 10 mg by mouth twice daily. The medication nurse transcribed this order onto the patient's Medication Administration Record (MAR) on 1/7/11 as Zydis 10 mg every evening by mouth.

The first dose of this medication was given on 1/7/11 at 9:00 p.m. The next dose that was attempted to be administered to the patient was on 1/8/11 at 9:00 p.m. but the patient refused, so no Zydis was given to this patient on 1/8/11. The medication was ordered by the physician to be administered twice a day, so a second dose should have been offered to the patient at some other point during 1/8/11. The second dose was not administered/ offered as prescribed resulting in a medication error of a missed dose. On 1/9/11, no dose at 9:00 a.m. was administered as originally ordered by the patient's physician, but the next dose was administered at 9:00 p.m.

On 1/10/11, three days after the physician's original order for this medication was received, one of the facility's nursing staff re-transcribed the physician's order onto the MAR correctly for twice daily administration and administered a 9:00 a.m. dose on 1/10/11. No medication error report was created for these medication errors, and the facility failed to identified these errors in their medication error data.

3. Review of the same clinical record for P-1 on 1/11/11 at 3:15 p.m. revealed a physician's order, written on 1/9/11 for Primidone (an anti-seizure medication) 250 mg by mouth four times daily. This medication was documented on the patients medication administration record (MAR) to be given at the following times daily: 9:00 a.m., 1:00 p.m., 5:00 p.m., and 9:00 p.m. Review of the hospital's MAR for 1/10/11 revealed that the 5:00 p.m. dose of the medication, which was suppose to have been administered to the patient, had not been documented on the patient's MAR, and the facility was unable to provide documentation that the medication had been given to the patient as ordered.

4. Review of the clinical record for patient P-4 on 1/11/11 at 4:40 p.m. revealed a physician's order, written on 11/18/10 about 7:00 p.m. for Zantac (an ulcer medication) 150 mg by mouth twice daily. According to documentation on the patient's MAR, the medication was not available for administration on 11/19/10 when the first dose was due.

5. Review of a hospital report on 1/12/11 revealed that an unsampled patient (P-6) received a dose of Ativan 2 mg, rather than the 1 mg dose, which had been ordered by the patient's physician. The only corrective action identified in the hospital's summary report indicated that the employee had been counseled about the incident. There was no documentation to indicate the patient's physician had notified of the medication administration error.

Based on review of the facility's Narcotic Control form, review of the hospital's report forms, and interview with facility administrative staff, the hospital failed to provide documentation that an incident involving a lost controlled narcotic (Darvocet N-100) tablet had been reported as an incident for documentation and investigation to facility administrative staff for the purpose of tracking and trending of medication related events. The hospital failed to implement their policy and procedure for the loss of controlled substances.

Findings:

1. Review of the hospital's policy and procedure entitled: "Controlled Drug Storage", states: "Any discrepancy in controlled substance medication counts is reported to the director of nursing immediately. The director of nursing or designee investigates and makes every reasonable effort to reconcile all reported discrepancies while nurses remain on duty. The director of nursing, in a report to the administrator, documents irreconcilable discrepancies".


Review of the hospital's Narcotic Control form on 1/12/11 at 2:00 p.m. revealed that a controlled drug (Darvocet N-100) came up missing on 9/3/10 during a shift count. Vicodin (a schedule IV narcotic) had also come up missing on 11/12/10 according to one of the hospital's reports, indicating that the facility had multiple incidents of controlled drugs being lost in the facility. The hospital was unable to provide documentation that the Darvocet N-100 loss was ever reported by staff to administration as an incident which needed to be investigated. Review of the facility's policy and procedure entitled: "Controlled Drug Storage", states: "Any discrepancy in controlled substance medication counts is reported to the director of nursing immediately. The director of nursing or designee investigates and makes every reasonable effort to reconcile all reported discrepancies while nurses remain on duty. The director of nursing, in a report to the administrator, documents irreconcilable discrepancies". Interview with the DON on 1/13/11 at 5:00p.m. revealed that the DON was unable to remember this specific incident, she was unable provide any documentation of any action that had been taken, or provide any evidence that a report had been generated and sent to the facility administrator (Program Manager).

Based on interview with hospital staff and review of what the hospital thought was their drug formulary, the hospital failed to ensure that it had established an actual drug formulary for the hospital. The hospital's medical staff failed to establish a drug formulary for the hospital.

Findings:

Interview with three of the hospital's nursing staff on 1/13/11 at 10:00 a.m. revealed that none of the three staff could find a copy of the hospital's drug formulary. When no one could find a copy of a drug formulary, one of the facility nurses went to her computer and printed a copy of the institutions formulary (not the hospital's formulary) and brought it to me for review. After reviewing the institution's formulary and identifying that drugs which were being used by the hospital (such as Risperdal and Zyprexa to mention a few), were not on the formulary which I had received. One of the nursing staff members involved in the interview had worked at the hospital for over 16 years and indicated that he had never called the facility's pharmacy and been told that any drug of the drugs that he had requested was not on the drug formulary.

Further interview with the three nursing staff revealed that the hospital did not have a drug formulary. Interview with the facility's DON and Medical Director on 1/13/11 at 5:10 p.m. revealed that the Acute Hospital did not have a drug formulary. The DON and Medical Director confirmed that any drug which the facility ordered from the Pharmacy would be sent to the facility irregardless of its cost or availability. They also confirmed that the hospital did not have any type of official or unofficial drug formulary.

Based on interview, the hospital failed to ensure the application of a laboratory waiver (CLIA) for the use of a glucometer (machine that checks blood sugar level) in the facility.

Findings:

Interview with the program director on 1/11/11 revealed that the staff test patient blood sugars with an accuchek (glucometer) machine. They had not obtained a waiver for the testing of blood specimens with this machine within the hospital.

Based on observation, review of clinical records, hospital documents and staff interviews, the hospital failed to ensure that the dietary services met the needs of all patients as evidenced by failure to:

1. Provide organized dietetic services as evidence by failure to hire a full-time employee who was responsible for the daily management of the dietary services, this resulted in a food service operation that was unorganized, space that was dirty and cluttered, and the use of dirty food service equipment. Staff, that were inadequately trained, a menu that was not consistently followed, and food storage practices that were not reflective of current community standards, i.e.. poor food quality due to poor dating and labeling practices (Refer to A-620).

2. Ensure that the contracted dietitian had adequate hours to meet the nutritional needs of the patients and provide adequate oversight for the food services. Failed to ensure the diet manual and dietary policies and procedures were approved and implemented. (Refer to A-621)

3. Ensure that menus met the needs of the patients. This failure resulted in the inability of the hospital to evaluate the nutritional adequacy of meals provided (Refer to A- 628).

4. Ensure that the therapeutic diets of two of three clinical records reviewed (D1, D2) were ordered by their physicians. These failures resulted in a delay of medical nutrition therapy (Refer to A-629).

5. Ensure the nutritional needs of the patients were met in accordance with recognized dietary practices, and in accordance with the orders of the physicians. This failure resulted in patients not receiving therapeutic diets. Other patients received food that may be inadequate or exceed their nutrient needs, and meal times that were not in accordance with accepted community standards (Refer to A-630).

6. Ensure that a current diet manual was maintained and was readily accessible to the physician, nursing staff and food service personnel. This failure had the potential of patients being served diets not consistent with the orders of the physician (Refer to A-631)

7. Develop performance improvement activities that reflected the scope and nature of services provided (Refer to A-263, A-276 ).

Based on observation, staff interviews and review of hospital documents, the hospital failed to hire a full-time employee who is responsible for the daily management of the dietary services. This resulted in a food service operation that was unorganized, space that was cluttered, unclean; food service equipment that was dirty, food storage practices that were below community standards and could result in growth of microorganisms that could result in food borne illness; poor food quality due to poor dating and labeling practices. In addition, these failures resulted in staff that were inadequately trained, a menu that was not consistently followed resulting in patients not receiving adequate food as planned on the menu.

Findings:

During the initial tour of the kitchen on 1/10/11 at approximately 10:00 a.m. the following observations were made:

*Three breakfast burritos wrapped in foil and left in the steam table which was not plugged in;

*One toaster with a build up of bread crumbs visible through top openings and in tray;

*One toaster oven with a build up of black burnt material coated on rack and tray, bottom tray with black hard coating along with discolored sesame seeds. The window had a brown and yellowish film covering it and up the top of toaster oven;

*Three drawers containing various food items including: knives, spoons, were stored directly on paper lined drawers that had visible food debris and dark brown stains;

*On the top shelf of one the cupboards was a silver metal container that was firmly stuck onto shelf;

*Other cabinets were cluttered with various items including: hairnets, gloves, condiments, aprons, and low sodium packets;

*One cabinet with a stack of bowls, approximately seven of the bowls were wet and contained approximately one tablespoon of water in them;

*Freezer with no visible thermometer. A build up of ice through out shelves and a solid build up on door ice shute (outlet by which ice dispenses into a container from the ice maker inside the freezer to the dispenser on the exterior door);

*Refrigerator:
A 46 fluid ounce metal can of prune juice with the side bent and bulging on top with approximately one to two inch sliced opening with old juice thick residue around the opening. There was no date on can of prune juice indicating when it was opened;

Two, four ounce styrofoam containers filled with mandarin oranges were stored in the refrigerator with no date to indicate when it was stored;

Approximately 10 by 10 inch metal pan containing cottage cheese that showed evidence of being previously served with no date to indicate when it was stored or when it needed to be discarded;

One plastic bag containing sliced meat which was not sealed and contained no label to indicate what kind of meat it was and no date to indicate when it was placed in the refrigerator or when it needed to be discarded;

One 10 ounce container of sliced white mushrooms opened with rubber band wrapped around package. The package contained a date of packaging for 12/27.

Hand washing

On 1/11/11, at approximately 11:40 a.m. RA 1 was observed entering kitchen. Next, she used a hand sanitizer before putting on gloves prior to serving the lunch meal. At the conclusion of the meal, she returned to the hand sanitizer dispenser after taking off her gloves.

Review of the basic kitchen policy and procedures, showed to "always wash hands at the beginning of a shift,...., before putting on gloves, and at any time necessary to prevent the spread of food borne bacteria". The policy also showed to wash hands whenever you change gloves.

Meal observation

Review of the lunch menu dated 1/10/11, showed BBQ chicken, macaroni and cheese, mixed vegetables, an orange, and milk for the lunch meal. The menu did not show portion sizes or scoop sizes. On 1/10/11, at approximately 11:50 a.m., the steam table contained BBQ chicken, green salad, macaroni and cheese, and cooked carrots and peas. The nutrition adequacy was unable to be determined due to lack of stated portion sizes of the meal items. The green salad was being served with a spaghetti spoon/server, macaroni and cheese and cooked carrots and peas were being both served with a six-ounce (oz) spoodle, and the BBQ chicken was being served with a spatula.

No oranges were observed in the serving area. The menu did not state there would be a green salad served. A green salad would not be an equal substitute for an orange, on the basis of the green salad containing less Vitamin C.

Further observation revealed the steam table was turned on; there were three knobs that controlled the heat to each of the wells. The well where the macaroni and cheese was placed, the knob was turned to "2" (out of 10); the well where the cooked carrots and peas were placed, the knob was turned to "9"; and the well where the BBQ chicken was placed, the knob was turned between the 9 and 10.

Review of the written instruction titled, Weekend Standards for hospital's Meal Delivery, showed staff should "verify temperatures are at least at 160 for hot food - 40 or below for cold food". Food temperatures were taken by the surveyor which revealed the macaroni and cheese was 90.4 degrees Fahrenheit (F), cooked carrots and peas was 116.7 F, and the BBQ chicken was 128.5 F. On 1/10/11 at approximately 12:05 p.m. an interview was conducted with RA 2. RA 2 stated temperatures should be taken prior to meal service but she had forgotten to take today since she has not worked in the kitchen in awhile.

Review of the daily temperature log dated January 2011, showed no food temperatures recorded for the lunch meal or the previous meal on the 10th. Further review of the same log, showed no temperatures (blanks) for the lunch meal on the 2nd, blanks for the breakfast meal on the 3rd, blanks for the dinner meal on the 4th, blanks for the breakfast and dinner meal on the 7th, blanks for lunch and dinner meal on the 8th, and blanks breakfast and lunch meal on the 9th. The daily temperature log only accounts for one food item for each meal. It is unclear what item should be or had been recorded. This log did not have instructions on what the procedure should be and the facility did not have any policies or procedures to direct the staff on the correct procedures on the taking and recording of temperatures.

On 1/11/11 at approximately 11:45 a.m. the steam table was observed containing pork loin, rice pilaf, green salad (with tomatoes, red bell peppers, red onions, and cucumbers), and cooked lima beans. RA 1, who was the nurse responsible for meal service, took the temperature of pork loin which read 124.1 F and took no other food temperatures. The surveyor took the temperatures of the lima beans and rice pilaf which read 104.8 F and 128.2 F, respectively.

Review of the menu for the lunch meal on 1/11/11 showed, pork loin, rice pilaf, mixed vegetables, dinner roll, fruit mix, and milk for the lunch meal. The patients received lima beans instead of mixed vegetables and they did not receive a dinner roll. Patients also received the green salad that was not listed on the menu. The substitutions were made without being posted on the menu. There was no substitute provided for the missing dinner roll.

RA1 was observed on 1/11/11 serving lima beans and rice pilaf with a six oz spoodle, and pork loin (pre-sliced) with tongs. The portion sizes were not consistent for all the patients served. Some patients were served spoodle that was half-full; others were served 3/4th full. There were no cardex or patient diet cards instructing RA1 on what amount to serve each patient. It was unclear why each patient did not receive the same amount.

An interview was conducted with RA1 on 1/11/11, at approximately 11:55 a.m. In a response to concerns about food sufficiency, because some food items were completely utilized for sixteen patients with none leftover at the end of service before patients had consumed their meals, thereby leaving no opportunity for seconds when requested. RA 1 stated that sometimes there is not enough food for the patients. She stated that they send enough food for 18 patients for the entree or meats and for other items they send a pan.

On 1/11/11, at approximately 12:00 p.m. after all the patients had been served, an interview was conducted with RA 1 regarding the missing dinner roll and equivalent substitute. RA 1 stated she did not notice the dinner rolls were missing since they have not been provided for about the last week. When one of the patients asked for a roll, RA 1 preceded to hand him a slice of bread from a loaf that had been stored in the cabinet. Thereafter, other patients were observed asking and receiving bread slices. RA 1 was not observed to offer other patients a slice of bread since the dinner roll was missing from the initial meal served.

An observation at the end of meal service on 1/11/11, was of two plates with food, covered with aluminum foil and placed in the pan on the steam table well. An interview was conducted with RA1 at approximately 12:10 p.m. regarding these items. RA1 stated that they were being saved for two patients who did not want to eat at the time lunch was being served. She further stated, these plates will be saved for the patients with their names written on it. It will stay in the kitchen steam table until they request the meal because the "steam table will keep the food warm". If the food is not requested by snack time (approximately 2-1/2 hours later) the food will be discarded.

RA 1 was then asked why the food was not stored in the refrigerator and reheated in the microwave when the patients request for their food, she stated she had not thought of putting it in the refrigerator. This practice of storing food in the steam table well at room temperature had been observed the day before. Food stored at room temperature (danger zone is 41 degrees Fahrenheit to 135 degrees) could result in the growth of microorganisms that could result in food borne illness.

Training

RA 1 was interviewed on 1/11/11, at approximately 12:00 p.m. regarding the training she had received for patient meal service. She indicated that she was hired approximately a year and half before and had "shadowed" (followed and observed) another employee but had not received any formal training from the registered dietitian or contract food service operator.

Policies and Procedures

There were no policy and procedure manuals in the kitchen for use of the hospital staff. There was only written instructions on the wall regarding hand washing and taking food temperatures but no other policies. A review of the food service contract dated 12/15/04 was conducted. Included in the responsibilities of the food service contractor was "generate, maintain and distribute a policy and procedure manual which defines methods and practices by which the contractor will comply with the terms of the agreement and compliance with regulatory requirements. The contractor shall ensure that the policy and procedure manual is maintained in a current, complete and timely manner reflecting actual practices". The lack of a P/P resulted in staff practices there were inconsistent and in some cases, had the potential to cause harm.

The program director (PD) of the hospital was interviewed on 1/10/11, at approximately 9:20 a.m. regarding the lack of a full time person responsible for food service operation. She acknowledged that the food temperatures were an on-going problem and that the hospital does not have anybody in the position to coordinate the activities of the department because of food production being contracted out. The PD stated that there were not specific policies for dietary services.

The failure of the hospital to have a full -time person responsible for the operation of the dietary services department has resulted in a food service space that is cluttered, unclean; food service equipment that was dirty, food storage practices that were below community standards and could result in poor food quality and growth of microorganisms. In addition, these failures resulted in staff that were inadequately trained, menu that was not consistently followed resulting in patients not receiving adequate food as planned on the menu; there were also no policy and procedure manual.

Based on observation, review of hospital documents, clinical record review and staff interviews, the hospital failed to ensure that the contracted dietitian had adequate hours to ensure the nutritional needs of the patients were met and to provide oversight for the food services. The limited frequency of consultation and lack of oversight resulted in two patients not receiving therapeutic diets and therefore the delay of medical nutrition therapy. In addition, it resulted in the lack of collaboration with medical staff, unapproved diet manual and lack of performance improvement activities in the dietary services department.

Findings:

The contract with the registered dietitian (RD 1) was effective 7/1/10 through 06/30/11. A review of the contract, revealed RD 1 was contracted to provide a 2 hour weekly visit to the facility to assess the nutritional status of patients at nutritional risk. The contract attachment identified what these nutritional risks were including malnutrition, diabetes, <80% or >130 % of IBW (Ideal Body Weight), hypertension, etc and how to refer to the RD. It stated that a daily diet sheet would be faxed to the dietitian.

Review of the clinical records revealed the hospital did not have a written policy and procedure to screen patients to determine their nutritional risk and referral to RD 1. The rationale behind screening is that medical nutrition therapy will be provided in a timely manner. None of the patients reviewed were assessed sooner than RD 1's scheduled Monday visits to the hospital. There was an average of five days lag time in nutrition assessments for patients considered at high nutritional risk.

Nutrition Care
1. Patient D1 was admitted to the hospital on 8/11/10 with diagnoses including diabetes mellitus, hypothyroidism and COPD (chronic obstructive pulmonary disease). She was 5' 6" tall and weighed 186 lbs on admission. A nutrition assessment was conducted by the registered dietitian (RD 1) on 8/16/10. RD 1 recommended a DM diet (diabetic diet). There was no documented evidence that this recommendation was communicated to the patient's physician.

On 10/4/10, RD 1 conducted a follow up assessment, she documented Patient D1 gained 16 lbs in six weeks, therefore weighed 202 lbs. Patient D1 had developed a foot ulcer and RD1 recommended a DM high protein, no extra portions except high protein food diet to promote healing of foot ulcer. There was no documented evidence that this recommendation was communicated to the patient's physician.

On 11/15/10 after the foot ulcer had healed, RD 1 recommended "continue ADA hi protein diet to prevent foot ulcer re-infection". Review of the clinical record for Patient D1 did not show any diet order for any of the diets recommended by RD 1. There was no documented evidence that this recommendation was communicated to the patient's physician.

During meal observations on 1/10/11 and 1/11/11 all the patients were served the same foods. There was a white board that had Patient D1's name with the word "diabetic" next to it but there was no observed change made specifically to her plate in terms of amount or kind of food served.

In an interview with LN 7 on 1/11/11 at approximately 3:40 p.m. she explained the process by which RD1's recommendations are communicated to the hospital staff. She stated that RD1 writes her recommendations and nursing goals on the Consultant Dietitian Report. She stated that the charge nurse or team leader will make a copy of the report and give it to the staff member working in the kitchen. That staff member will then write the recommendations/nursing goals on a white board in the kitchen, for example if patients cannot have seconds. Review of the Consultant Dietitian Reports from 1/10 to 1/10/11 showed no recommendations for Patient D1 during the months that RD 1 made those recommendations.

Further review of Patient D1's clinical record showed that on 1/1/11 hospital staff documented on the interdisciplinary team Treatment Plan problem list "Resistant to ADA diet". Patient D1 was not provided with the diet that was recommended and RD 1 believed she was on it and was not clear how she was resistant to a diet that was never served.

2. Patient D2 was admitted on 1/5/11 with diagnoses including hypertension, broken jaw, and detached retina. He was 6'1" and weighed 300 lbs on admission and was placed on a regular diet.

A nutrition assessment was conducted by RD 1 on 1/10/11. She recommended a weight loss diet, secondary (due to) obesity. She did not however, specify a caloric level. The nursing goals were "no extra portions except vegetables and salads". It is unclear how long it takes the hospital staff to communicate diet recommendations to the physician and when nursing plans are implemented when physicians concur with RD's recommendations.

Policy and Procedures and Diet Manuals
The hospital did not have a dietary services policy and procedure manual. The hospital staff was observed not practicing proper food storage procedures. Items in the refrigerator were not properly labeled or dated. Dry food and storage areas in which they were stored were not maintained in a sanitary manner. The toaster and toaster ovens were not cleaned. There were no written policies to determine the frequency of cleaning and who was responsible.

The diet manual had not been approved or used by the hospital staff for an undermined length of time. The program director stated, at approximately 4:00 p.m. on 1/10/11, that they could not find the diet manual, and would ask the registered dietitian (RD) where it was located. The hospital diet manual is a reference tool that describes the different types of therapeutic diets that is available to be ordered in the hospital. It describes the framework (including definition and nutrient adequacy) of all diets and under what conditions all diets are ordered.

Observations during meal times on 1/10/11 and 1/11/11 and lack of portion sizes that resulted in questions of nutrient adequacy could have been verified using the diet manual. During interview with the RD on 1/10/11 at approximately 4:30 p.m. she stated that the hospital had a diet manual but does not remember the last time she saw it. She indicated that she had not been invited to any Pharmacy and Therapeutics Committee (P & T) since been hired about 12 years ago. The P & T committee or similar committee is the avenue used in hospitals to approve diet and patient care manuals, present or resolve care issues that affect patients.

On 1/14/11, the program director found the diet manual in a shelf in her office. The face sheet was blank and therefore could be determined whether it was ever approved by the dietitian or medical staff. The length of the time that it took to locate the diet manual and the fact that the RD indicated that she could not remember the last time she saw it, would result in the conclusion that the hospital staff did not have access to it.

Food service
The RD had no role in ensuring that the nutritional needs of the patients were met. She stated in an interview that her role was clinical and did not participate in menu planning. Review of the contract with the meal service provider revealed a provision stating that their registered dietitian was to approve menus only. However, there has been no communication between the contracted meal service provider and RD 1. RD 1, who has had no responsibilities with the food service, is unable to share concerns with contracted dietary staff. Some of these concerns include food palatability, improper food delivery times, substitutions, and poor hand washing.

Review of the menu for the lunch meal on 1/11/11, showed pork loin, rice pilaf, mixed vegetables, dinner roll, fruit mix, and milk for the lunch meal. The patients received lima beans instead of mixed vegetables and they did not receive a dinner roll. Patients also received the green salad that was not listed on the menu. The substitutions were made without being posted on the menu. There was no substitute provided for the missing dinner roll.

RA 1 was observed on 1/11/11 serving lima beans and rice pilaf with a six ounce spoodle, and pork loin (pre-sliced) with tongs. The portion sizes were not consistent for all the patients served. Some patients were served a spoodle that was half-full; others were served 3/4th full. There were no cardex or patient diet cards instructing RA 1 on what amount to serve each patient. It was unclear why each patient did not receive the same amount. During this meal several of the patients asked for seconds but did not receive any because the food had run out. Due to a lack of a credible nutrient analysis and portion sizes on the menu, it could not be determined whether the menu was meeting the patients' needs.

Training
An interview was conducted with RA 1 on 1/11/11, at approximately 12:00 p.m. regarding the training she had received for patient meal service. She indicated that she was hired approximately a year and half before and had "shadowed" (followed and observed) another employee but had not received any formal training from the registered dietitian or contract food service operator. RD 1 stated that she has provided some training to nursing staff but did not indicate the last time she had provided such training.

At the end of the meal service, there were two plates of food covered with aluminum foil placed in the pan on the steam table well. RA 1 stated in an interview conducted on 1/11/11 at approximately 12:10 p.m. they were being saved for two patients who did not want to eat at the time. She further stated at this time, these plates will be saved for the patients with their names written on it. It will stay in the kitchen steam table until they request the meal because the "steam table will keep the food warm". If the food is not requested by snack time (approximately 2-1/2 hours later) the food will be discarded.

When RA 1 was asked why the food was not stored in the refrigerator and reheated in the microwave when the patients request for their food, she stated she had not thought of putting it in the refrigerator. This practice of storing food in the steam table well at room temperature had been observed the day before. Food stored at room temperature (danger zone is 41 degrees Fahrenheit to 135 degrees) could result in the growth of microorganisms that could result in food borne illness. There has been no training provided to hospital staff on the proper storage of food.

In the interview with RD 1 on 1/10/11 at 4:30 p.m. she stated she felt the hours she was contracted for was sufficient. These limited consultation hours has resulted lapses observed in areas of patient care and food service.

Based on observation, review of hospital menu and staff interviews, the hospital failed to ensure that menus met the needs of its patients. This failure has resulted in the inability of the hospital to evaluate the nutritional adequacy

Findings:

Patient D1 was admitted to the hospital on 8/11/10 with diagnoses including diabetes mellitus, hypothyroidism and COPD (chronic obstructive pulmonary disease). She weighed 186 lbs and was 5 ' 6 " tall. A nutrition assessment was conducted by the registered dietitian (RD 1) on 8/16/10. She recommended a DM diet. Patient D1 weighed 202 lbs, gained 16 lbs in 6 weeks.

On 10/4/10, RD1 conducted a follow up assessment and recommended a DM high protein, no extra portions except high protein food diet to promote healing of foot ulcer. On 11/15/10 after the foot ulcer had healed RD1 recommended continue ADA high protein diet to prevent foot ulcer re-infection. Review of clinical record for patient D1 did not show any diet order for any of the diets recommended by RD1. The copy of the posted menu did not include any therapeutic diet or a diabetic or high protein diet. Patient D1 was not provided with the diet that was recommended and RD1 believed she was on.

A tour of the kitchen on 1/10/11 at approximately 9:47 a.m. revealed three large foil wrapped item stored in an unheated steam table. The item was later described as breakfast burrito left over from breakfast. Each breakfast burrito was approximately six inches long, weighing approximately 12 ounces.

Review of the hospital for the month of January 2011 was reviewed. According to the menu, breakfast burrito and orange were items to have been served for breakfast on 1/10/11. But, the menu did not have portion sizes listed next to the items. Further review showed that none of the menu items for all three meals for the month had any portion sizes listed.

Review of the lunch menu dated 1/10/11, showed BBQ chicken, macaroni and cheese, mixed vegetables, an orange, and milk for the lunch meal. The menu did not show portion sizes or scoop sizes. On 1/10/11, at approximately 11:50 a.m., on the steam table were BBQ chicken, green salad, macaroni and cheese, and cooked carrots and peas. The green salad was being served with a spaghetti spoon/server, macaroni and cheese and cooked carrots and peas were being both served with a six ounce (oz) spoodle, and the BBQ chicken was being served with a spatula. The nutrition adequacy was unable to be determined due to lack of stated portion sizes of the meal items.

No oranges were observed in the serving area. The menu did not state there would be a green salad served. A green salad would not be an equal substitute for an orange, on the basis of the green salad containing less Vitamin C.

The menu for the lunch meal on 1/11/11, showed pork loin, rice pilaf, mixed vegetables, dinner roll, fruit mix, and milk. The patients received lima beans instead of mixed vegetables and they did not receive a dinner roll. Patients also received the green salad that was not listed on the menu. The substitutions were made without being posted on the menu. There was no substitute provided for the missing dinner roll.

RA1 served lima beans and rice pilaf with a six oz spoodle, pork loin (pre-sliced) with tongs. The portion sizes were not consistent for all the patients served. Some patients were served spoodle that was half-full; others were served 3/4th full. There were no cardex or patient diet cards instructing RA1 on what amount to serve each patient. It was unclear why each patient did not receive the same amount.

Concerns regarding the lack of portion sizes were shared with the contracted meal service provider manager (FSM) in an interview on 1/10/11, at approximately 2:30 p.m.. In addition to the hospital's contract he stated, the contracted meal service provider also provided meals for children ' s program and a senior nutrition program. He indicated that the facility's menu is planned by a registered dietitian who was not housed in the office where he was located. He further stated that the menu had a nutrient analysis. A call was placed to the meal services providers RD at this time, and was not returned until after the surveyor had exited the hospital.

The FSM provided a document that he stated was the nutrient analysis for hospital menus. The document titled " Dec 1, 2010 thru Dec 31, 2010 Spreadsheet-Portion values " . The nutrient analysis was for the previous month not for January 2011. According to this spreadsheet the breakfast burrito portion size was one and contained 213 calories each. The breakfast burrito was significantly large and would contain more calories than was stated in the nutrient analysis. Closer review of the spreadsheet revealed that the analysis was conducted on a program for children. The portion sizes analysis would therefore be based on children's not adult daily requirements. For example, the total calories for a meal that included breakfast burrito were analyzed as 377 calories, and satisfying 68 % of the allocated need of 554 calories for breakfast.

The information was based on the caloric requirements of a School Breakfast Program, not the recommended daily allowances (RDA) for an adult. The nutrient analysis that was provided, did not examine the nutrient adequacy of the meal for adults. The FSM was asked for a copy of the recipe used to prepare the breakfast burrito, neither he nor the cook in the kitchen were able to produce the recipe.

Based on observation, review of clinical records and staff interview, the hospital failed to ensure that the therapeutic diets of two of three clinical records reviewed (D1, D2) were ordered by their physicians. These failures resulted in a delay of medical nutrition therapy.

Findings:

1. Patient D1 was admitted to the hospital on 8/11/10 with diagnoses including diabetes mellitus, hypothyroidism and COPD (chronic obstructive pulmonary disease). She was 5' 6" tall and weighed 186 lbs on admission. A nutrition assessment was conducted by the registered dietitian (RD 1) on 8/16/10. RD1 recommended a DM diet (diabetic diet). There was no documented evidence that this recommendation was communicated to the patient's physician.

On 10/4/10, RD1 conducted a follow up assessment she documented that Patient D1 gained 16 lbs in six weeks, therefore weighed 202 lbs. Patient D2 had developed a foot ulcer and RD1 recommended a DM high protein, no extra portions except high protein food diet to promote healing of foot ulcer. There was no documented evidence that this recommendation was communicated to the patient's physician.

On 11/15/10 after the foot ulcer had healed RD1 recommended, "continue ADA hi protein diet to prevent foot ulcer re-infection". Review of the clinical record for patient D1 did not show any diet order for any of the diets recommended by RD1. There was no documented evidence that this recommendation was communicated to the patient's physician.

During meal observations on 1/10/11 and 1/11/11, all the patients were served the same foods. There was a white board that had Patient D1's name with the word "diabetic" next to it but there was no observed change made specifically to her plate in terms of amount or kind of food served.

An interview was conducted with LN 7 on 1/11/11, at approximately 3:40 p.m., she explained the process by which RD1's recommendations are communicated to the hospital staff. She stated that RD1 writes her recommendations and nursing goals on the Consultant Dietitian Report. She stated that the charge nurse or team leader will make a copy of the report and give it to the staff member working in the kitchen. That staff member will then write the recommendations/nursing goals on a white board in the kitchen, for example if patients cannot have seconds. Review of the Consultant Dietitian Reports from 1/10 to 1/10/11 showed no recommendations for Patient D1 during the months that RD1 made those recommendations.

An interview was conducted with the FSM on 1/11/11, at approximately 12:30 p.m. regarding production of special diets for the hospital. He stated that he had been in his position for approximately a year and a half and does not remember sending any special diets to the facility except vegetarian and vegan diets. The copy of the posted menu did not include any therapeutic diets, diabetic or high protein diet. There were no special instructions on modifying the regular diet to any special diet.

Further review of Patient D1's clinical record showed that on 1/1/11 hospital staff documented in the interdisciplinary team Treatment Plan problem list "Resistant to ADA diet". Patient D1 was not provided with the diet that was recommended and RD1 believed she was on it was not clear how she was resistant to a diet that was never served. The hospital failed to provide a therapeutic diet as recommended by the RD.

2. Patient D2 was admitted on 1/5/11 with diagnoses including hypertension, broken jaw, and detached retina. He was 6'1" and weighed 300 lbs on admission and was placed on a regular diet.

A nutrition assessment was conducted by RD1 on 1/10/11. She recommended a weight loss diet, secondary (due to) obesity. She did not however, specify a caloric level. The nursing goals were "no extra portions except vegetables and salads". It is unclear how long it takes the hospital staff to communicate diet recommendations to the physician and when nursing plans are implemented when physicians concur with the RD's recommendations.

During lunch on 1/11/11, Patient D2 was observed asking for seconds, he was offered bread because there was no more entree. Patients D2's name was not observed on the white board in the kitchen.

The hospital failed to ensure that its patients receive therapeutic diets as recommended by the RD.

Based on observation, review of hospital documents and staff interviews, the hospital failed to ensure that nutritional needs were met in accordance with recognized dietary practices and in accordance with the orders of the physicians. This failure resulted in patients not receiving therapeutic diets, other patients receiving food that may be inadequate or exceed their nutrient needs and meal times that are in accordance with community standards.

Findings:

1. Patient D1 was admitted to the hospital on 8/11/10 with diagnoses including diabetes mellitus, hypothyroidism and COPD (chronic obstructive pulmonary disease). She was 5' 6" tall and weighed 186 lbs on admission. A nutrition assessment was conducted by the registered dietitian (RD1) on 8/16/10. RD1 recommended a DM diet (diabetic diet). There was no documented evidence that this recommendation was communicated to the patient's physician.

On 10/4/10, RD1 conducted a follow up assessment she documented that Patient D1 gained 16 lbs in six weeks, therefore weighed 202 lbs. Patient D1 had developed a foot ulcer and RD1 recommended a DM high protein, no extra portions except high protein food diet to promote healing of foot ulcer. There was no documented evidence that this recommendation was communicated to the patient's physician.

On 11/15/10 after the foot ulcer had healed RD1 recommended, "continue ADA hi protein diet to prevent foot ulcer re-infection". Review of clinical record for patient D1 did not show any diet order for any of the diets recommended by RD1. There was no documented evidence that this recommendation was communicated to the patient's physician.

During meal observations on 1/10/11 and 1/11/11 all the patients were served the same foods. There was a white board that had Patient D1's name with the word "diabetic" next to it but there was no observed change made specifically to her plate in terms of amount or kind of food served.

In an interview with LN 7 on 1/11/11, at approximately 3:40 p.m. she explained the process by which RD1's recommendations are communicated to the hospital staff. She stated that RD1 writes her recommendations and nursing goals on the Consultant Dietitian Report. She stated that the charge nurse or team leader will make a copy of the report and give it to the staff member working in the kitchen. That staff member will then write the recommendations/nursing goals on a white board in the kitchen, for example if patients cannot have seconds. Review of the Consultant Dietitian Reports from 1/10 to 1/10/11 showed no recommendations for Patient D1 during the months that RD1 made those recommendations.

An interview was conducted with the FSM on 1/10/11, at approximately 3:00 p.m. regarding production of special diets for the hospital. He stated that he had been in his position for approximately a year and a half and does not remember sending any special diets to the facility except vegetarian and vegan diets. The copy of the posted menu did not include any therapeutic diets, diabetic or high protein diet. There were no special instructions on modifying the regular diet to any special diet.

Further review of Patient D1's clinical record showed, that on 1/1/11 hospital staff documented in the interdisciplinary team Treatment Plan problem list "Resistant to ADA diet". Patient D1 was not provided with the diet that was recommended and RD1 believed she was on. It was not clear how Patient D1 was resistant to a diet that was never served. The hospital failed to provide a therapeutic diet as recommended by the RD.

2. A tour of the kitchen on 1/10/11 at approximately 9:47 AM revealed three large foil wrapped item stored in an unheated steam table. The item was later described as breakfast burrito left over from breakfast. Each breakfast burrito was approximately six inches long, weighing approximately 12 ounces.

Review of the hospital menu for the month of January 2011 showed, a breakfast burrito and orange were items to have been served for breakfast on 1/10/11. But, the menu did not have portion sizes listed next to the items. Further review showed that none of the menu items for all three meals for the month had any portion sizes listed.

Review of the lunch menu dated 1/10/11, showed BBQ chicken, macaroni and cheese, mixed vegetables, an orange, and milk for the lunch meal. The menu did not show portion sizes or scoop sizes. On 1/10/11, at approximately 11:50 AM, on the steam table were BBQ chicken, green salad, macaroni and cheese, and cooked carrots and peas. The green salad was being served with a spaghetti spoon/server, macaroni and cheese and cooked carrots and peas were being both served with a six ounce (oz) spoodle, and the BBQ chicken was being served with a spatula. The nutrition adequacy was unable to be validated due to lack of stated portion sizes of the meal items.

No oranges were observed in the serving area. The menu did not state there would be a green salad served. A green salad would not be an equal substitute for an orange, on the basis of the green salad containing less vitamin C.

The menu for the lunch meal on 1/11/11, showed pork loin, rice pilaf, mixed vegetables, dinner roll, fruit mix, and milk. The patients received lima beans instead of mixed vegetables and they did not receive a dinner roll. Patients also received the green salad that was not listed on the menu. The substitutions were made without being posted on the menu. There was no substitute provided for the missing dinner roll.

RA1 served lima beans and rice pilaf with a six oz spoodle, pork loin (pre-sliced) with tongs. The portion sizes were not consistent for all the patients served. Some patients were served spoodle that was half-full; others were served 3/4th full. There were no cardex or patient diet cards instructing RA1 on what amount to serve each patient. It was unclear why each patient was not consistently served the same amount.

Concerns regarding a lack of portion sizes were shared with the contracted meal service provider manager (FSM). In an interview on 1/10/11, at approximately 2:30 PM, he stated that the in addition to the hospital's contract, the contracted meal service provider provides meals for children's program and a senior nutrition program. He indicated that the hospital's menu is planned by a registered dietitian of the contracted meal service provider who was not housed in the office he was located. He further stated that the menu had a nutrient analysis. A call was placed to the contracted meal service's RD however, was not returned until after the surveyor had exited the hospital.

The FSM provided a document that he stated was the nutrient analysis for hospital's menus. The document titled "Dec 1, 2010 thru Dec 31, 2010 Spreadsheet-Portion values". The nutrient analysis was for the previous month not for January 2011. According to this spreadsheet the breakfast burrito portion size was one and contained 213 calories each. The breakfast burrito was significantly large and would contain more calories than was stated in the nutrient analysis. Closer review of the spreadsheet revealed that the analysis was conducted on a program for children. The FSM confirmed in an interview on 1/10/11 at approximately 3:00 p.m. that this was the program used for nutrient analysis. The portion sizes analysis would therefore be based on children's not adult's daily requirements. For example, the total calories for a meal that included breakfast burrito were analyzed as 377 calories, and satisfying 68 % of the allocated need of 554 calories for breakfast.

The information was based on the caloric requirements of the School Breakfast Program not the recommended daily allowances (RDA) for an adult. The nutrient analysis provided did not examine the nutrient adequacy of the meal for adults. FSM was asked for a copy of the recipe used to prepare the breakfast burrito, neither he nor the cook in the kitchen were able to produce the recipe.

3. The community standard is that no greater than 14 hours lapse between dinner and breakfast the following day. On 1/11/11 dinner arrived and was served before 4:30 p.m. Hospital staff did not document the arrival time. The LN who served the meal stated that it arrived early and rather than let the food get cold he served it.

Review of the contract with the contracted meal service revealed dinner was to be delivered at 4:45 p.m. and served at 5:00 p.m In an interview with the Program director on 1/11/11, at approximately 9:20 a.m. she identified the early delivery of patient food as one of the many issues that they have been working on with the contracted service. She explained that on weekends, the dinner meal is delivered about 1:00 p.m. because the cafe kitchen which produces the food closes at 12 (noon) and so they prepare cold sandwiches and put it on ice. A result of this early eating is that the patients are hungry and the hospital provides them additional snacks other than what is provided by the contracted meal service.
The program director further explained that some of the medications cause weight gain and diabetes. However, it is unclear what role the added snacks and calories if any, may be contributing to weight gain in some of the patients. Patient D1 gained 16 lbs in six weeks after her initial admission to the hospital. Patient D2 already weighs over 300 lbs. The nutrient analysis of the menu has been determined to be incorrect (cross refer A629). The hospital failed to provide patients' food according to community standards due to early delivery of dinner meals including weekends and poor functioning food temperature maintenance equipment (steam table). (Cross refer A620).

Based on staff interviews and review of hospital diet manual, it was determined that the hospital failed to ensure that it maintained a current diet manual that was readily accessible to the physician, nursing staff and food service personnel. This failure had the potential of patients being served diets not consistent with the orders of the physician.

Finding:

During the entrance interview on 1/10/11, the diet manual was one of the documents requested for review. The program director stated, at approximately 4:00 p.m. on 1/10/11, that they could not find the diet manual and would ask the registered dietitian (RD) where it was located. The hospital diet manual is a reference tool that describes the different types of therapeutic diets that is available to be ordered in the hospital. It describes the framework (including definition and nutrient adequacy) of all diets and under what conditions all diets are ordered.

Observations during meal times and lack of portion sizes that resulted in questions of nutrient adequacy could have been verified using the diet manual. During interview with the RD on 1/10/11, at approximately 4:30 p.m. she stated that the hospital had a diet manual but does not remember the last time she saw it. She indicated that she had not been invited to any Pharmacy and Therapeutics Committee (P&T) since been hired about 12 years ago. The P&T Committee or similar committee is the avenue used in hospitals to approve diet and patient care manuals, present or resolve care issues that affect patients.

On 1/14/11, the program director found the diet manual in a shelf in her office. The face sheet was blank and therefore could be determined whether it was ever approved by the dietitian or medical staff. The length of the time that it took to locate the diet manual and the fact that the RD indicated that she could not remember the last time she saw it, would result in the conclusion that the hospital staff did not have access to it.

Based on observation, staff interview, and inspection of the building, it was determined that the hospital failed to be maintained to ensure the safety of the patients. This was evidenced by no records for testing the complete fire alarm system, the failure of the tamper alarm, and by the failure to test the generator under load as required by NFPA 99 Health Care Facilities, and NFPA 110, Standard for Emergency and Standby Power Systems.
The facility did not meet the provisions of the 2000 edition of the Life Safety Code 101 of the National Fire Protection Association.
(Refer to A-710)

The Program Manager was notified that immediate jeopardy (IJ) was identified on 1/11/11, at 2:55 p.m. The immediate jeopardy was due to no records for required testing of the complete fire alarm system, by the failure of the tamper alarm to activate after closing the O S & Y valve, and by the failure to test the generator under load. The O S & Y valve controls the water supply to the sprinkler system. The tamper alarm is activated when the water supply is turned off. (See K52, K61 and K144 of the Life Safety Code survey document).

On 1/12/11 at 9:08 a.m., the IJ was abated after repairs and testing of the fire alarm system were scheduled, a Fire Watch for the fire alarm system was initiated, and load testing of the generator was successfully completed. The Program Manager was notified that IJ had been abated.

NFPA (National Fire Protection Association) manuals are the basis for the regulations and standards for building construction, exits, and fire safety features in various occupancies.
NFPA 99 Health Care Facilities - 1999 edition, addresses fire related problems in and about health care facilities.
NFPA 110 Standard for Emergency and Standby Power Systems - 1999 edition, addresses the installation, and performance of electrical power systems to supply critical and essential needs during outages.

The facility failed to ensure the facility is protected from fire, and that all building construction, fire protection systems and emergency electrical sources are maintained and tested as required. The results of the survey are cross referenced to the CMS 2567 representing the K tags for the Life Safety Code. (Refer to A710 in the Health Survey and K52, K61 and K144 of the LSC survey document).

1. During record review and interview with staff on 1/11/11, no current records for monthly activation and annual inspection and testing of the fire alarm system were provided.

2. During the facility tour and alarm testing on 1/11/11, the tamper alarm failed to activate when the O S & Y valve was closed.

3. During record review and interview with staff on 1/11/11, the facility failed to provide generator records for 30 minute testing under load, and for weekly inspections for 29 of 52 weeks.
During an interview at 10:07 a.m., Maintenance Staff 2 reported the generator is not tested under load.


The cumulative effect of the systemic problems identified during the Life Safety Code (LSC) portion of the recertification survey resulted in the facility's inability to ensure the provision of quality health care in a safe environment. The condition of participation for Physical Environment was Not Met.

Based on observation and staff interview the condition of the hospital physical environment was not maintained in a manner that the safety and well being of the patient was assured.

Findings;

The hospital provides services to acute, inpatient psychiatric patients on voluntary and involuntary holds. The locked unit, where the safety of the patients, is a concern. Observation rooms, equipped with cameras, are used to monitor patients who require the use of restraints and/or seclusion. During an environmental tour of the unit on 1/12/10 at 11:10 a.m. with nursing staff the following safety concerns were observed.

A window in the hallway, outside room 111, was cracked and broken at the top. Staff stated that the broken window had been reported, but not yet repaired.

An empty camera box was observed mounted on the wall in patient room 134. The wooden box was broken and could be used as a leverage tool for a patient with suicidal ideations.

Throughout the unit patient rooms were equipped with protruding stationary knobs that were not break away, creating a possible leverage tool and a safety concern for at risk suicidal patients.

Based on observation, facility staff interviews, document review and generator and fire alarm system inspections, the facility did not meet the provisions of the 2000 edition of the Life Safety Code 101 of the National Fire Protection Association. The facility failed to maintain and test the complete fire alarm system annually, failed to inspect and test the generator in accordance with NFPA 99 and NFPA 110, and the facility failed to ensure the sprinkler system tamper alarm initiated an alarm when the O S & Y valve was closed. These failures affected 13 of 13 patients on 1/11/11 and 15 of 15 patients on 1/12/11. This could result in a failure of the fire protection system, an increased risk of fire, or the spread of smoke and fire.

Findings:

During the facility tour, facility staff interviews, document review and the generator area inspection, on 1/11/11 and 1/12/11, the facility was found not to be in compliance with the 2000 edition of the Life Safety Code 101 of the National Fire Protection Association. The results of the survey are cross referenced to the CMS 2567 representing the K tags for the Life Safety Code. The deficiencies written were as follows: K52, K61, and K144.

1. During record review with staff on 1/11/11, no current records for annual inspection and testing of the fire alarm system were provided. The records indicated the last inspection was completed in 2008.

During the facility tour on 1/11/11, at 10:14 a.m., the fire alarm control panel, in the reception area, indicated a Supervisory trouble signal. At 2:30 p.m., a faxed report, dated 1/11/11, provided a list of fire alarm signals received during the last 12 months by the monitoring company. The report "System Event Report," indicated the system had been in Trouble since 12/10/10.

2. During the facility tour and alarm testing with facility staff on 1/11/11, the tamper alarm was tested at the sprinkler system riser.
At 1:45 p.m., the O S & Y valve was closed. There was no audible alarm or trouble signal received at the fire alarm panel after the valve was closed.
At 1:48 p.m., the O S & Y valve was closed. There was no audible alarm or trouble signal received at the fire alarm panel after the valve was closed.
An alarm is required to activate at the panel when the valve is closed.

3. During record review and interview with staff on 1/11/11, the generator records were reviewed. There were no records for 30 minute testing under load for 12 of 12 months. There were no records for weekly generator inspections for 4 of 4 weeks in January 2010 and in November 2010. There were no records for weekly inspections for 2 of 4 weeks during the other 10 months in 2010.

During an interview on 1/11/11, at 10:07 a.m., Maintenance Staff 2 reported the generator is not tested under load. He stated there were no other records for generator inspection or testing.

Based on observation, staff interview and review of facility documentation, the hospital failed to develop, implement and maintain a comprehensive on going infection control program to minimize infections and communicable diseases. The hospital failed to ensure that the assigned infection control officer was qualified in infection control. Policies and procedures in infection control had not been reviewed, developed nor implemented. The designation of the infection control officer was not written into the over all infection control plan. (Refer to A-0748). The hospital failed to develop a comprehensive infection control program for the identification, investigation, reporting, prevention, evaluation and control of infections. (Refer to A-049) The hospital failed to maintain a comprehensive log of infections and incidences for patients and personnel. (Refer to A-0750) The hospital failed to ensure infection control issues were incorporated into the facility wide quality assurance program and that training programs were developed targeting infection control issues. (Refer to A-0756).

The cumulative effect of these systemic failures resulted in the hospital's inability to maintain an ongoing infection control program to minimize infections and communicable diseases and provide quality patient care in a safe and sanitary environment.

Based on interview, personnel file review and facility forms review, the hospital failed to ensure that the assigned infection control officer (LN 1) was qualified in infection control. There were no specific infection control responsibilities assigned to LN 1. Policies and procedures in infection control had not been reviewed, developed nor implemented by LN 1. The designation of the infection control officer was not written into the over all infection control plan.

Findings:

Interview with LN 1 (licensed nurse) on 1/11/11 at 9:50 a.m. revealed he had been the infection control nurse for over 15 years. He had never addressed the policy and procedures related to infection control. He had not had any training in infection control beyond what all employees receive as a part of their job. He had never been given a job description related to the infection control duties.

Review of LN 1's personnel file on 1/13/11 at 9:30 a.m. revealed that he had worked at the facility since 1997. An Annual performance report, dated 2/10/10 reflected part of the work objectives were to "Continue to function as the Infection Control Nurse". There was no further delineation as to what that objective required.

Subsequent interview with the Director of Nursing (DON), revealed that the work objective related to being the infection control nurse had been written into each of LN 1's performance evaluations. There had never been specific duties assigned that would encompass infection control issues. The designation of the infection control nurse had not been addressed in writing as part of the over all infection control plan, nor had it been approved by any committee, including the quality committee and the governing board.

Review of the facility's organizational chart reflected no indication who had been designated as the infection control officer.

Based on interview, policy and procedure review and observation, the hospital failed to develop a comprehensive infection control program for the identification, investigation, reporting, prevention, evaluation and control of infections. 1. Contracted environmental cleaning services were not included in the over all infection control plan. The cleaning solutions and procedures had not been adopted and approved by the facility. 2. There was no on going active surveillance of personnel in infection control practices, nor any current areas identified for improvement. There was no analysis of data collected. 3. The medicine room had an air duct in the ceiling that was covered in debris, resembling dust. The nurses station sink had a faucet and handles with a build up of gray/green sediment deposits. The counter tops were discolored with a white coating. 4. There was no monitoring of the cleaning of the accucheck machine (used for checking patient's blood sugar). 5. Policies and procedures related to infection control were not approved and did not meet current standards of practice.

Findings:

1. Interview with LN 3 (licensed nurse) on 1/11/11 at 8:30 a.m. revealed that no licensed staff were assigned to any custodial duties. Information about infections is put on a white board and sometimes they are available on-line as a part of their yearly training. There have been no employee staff meetings in many years.

Interview with the Job Coach on 1/11/11 at 9:30 a.m. revealed that he supervises the housekeeping staff. They leave at around 4:15 p.m. weekdays, with an evening crew that comes in at 5:30, but they clean multiple buildings, not just this facility. On weekends the crews leave at 1:30 p.m. so, the next cleaning that is done is not until Monday morning at 8:30 a.m. The crew uses universal precautions. The nurses don't always relay information regarding patient conditions, so they will have to ask before they enter rooms. They will clean rooms only when they are not occupied. Linens are not changed daily. Beds are cleaned when patient's are discharged. The medicine room is cleaned now and then. He did not know what the nurses do if any cleaning needed to be done after they were gone.

Interview with LN 1, on 1/11/11 at 9:50 a.m. revealed that if staff needed to clean the rooms after the cleaning crew left they would use bleach. There was no policy and procedure for this scenario.

Interview with the program director on 1/12/11 at 9:45 a.m. revealed that the contract for environmental cleaning and subsequent cleaning policy and procedures, had not been approved as a part of the facility's infection control committee, governing body or quality improvement.

2. Review of the Infection Control Report dated 12/09-6/10 reflected three areas that were targeted: Employee Health, Environment and Infections. Under Infections there was a tally of 50 reported infections over a six month period. 40 were skin related, five were respiratory and five were for urinary tract infections. There was no breakdown of the data to ascertain what type of infections had been contacted, treatments utilized, treatment effectiveness, antibiotic choices based on the organism nor any analysis of the application/administration of ordered medications by facility staff.

Interview with LN 1, on 1/11/11 at 9:50 a.m. revealed that he has never attended an infection control meeting. He submits data that he collects and does not hear any more information. He has never had any input on any revisions to the policies and procedures. He had not attended an infection control committee meeting. He does not do any personal surveillance of employees, including handwashing techniques. He collects data on a quarterly basis and submits to the charge nurse. He did not know of any outcomes or decisions with the information that he submitted.

Interview with the program director on 1/12/11 at 9:45 a.m. revealed that the infection control committee had not been reporting to the governing board or the quality committee. She agreed that there was a lack of communication between committees and staff. Data collection, surveillance and monitoring had not been done on a proactive daily basis.

3. Observation of the handwashing sink in the nurses station, on 1/12/11 at 9:30 a.m., revealed a faucet and handles with a build up of gray/green sediment deposits. The deposits were at the tip of the faucet, where water pours out and at the base of the faucet and the handles. The counter tops were discolored with a white embedded coating. Subsequent interview with LN 1 revealed that the cleaning crew will clean the area when asked by nursing. He agreed that the area did not look clean and the sediment on the faucet was stuck and unable to be removed.

Observations noted on 1/13/11 at 2:40 p.m. in the medicine room revealed a ceiling vent with a build up of material, resembling an accumulation of lint and dust. Subsequent interview with LN 2 revealed she had no idea when it was last cleaned. There was no documentation of cleaning or monitoring of this area found.

4. Review of the policy and procedure titled " Accuchek Machine Maintenance' reflected in part,"..The machine will be checked nightly comparing the "Check Strip". Record as Okay with a check mark on the log sheet. Initial. The machine will be checked weekly, (Sunday), using HI and LO solutions to record variances. Initial...."

Review of the accuchek "Quality Control Log" for the year 2010 indicated the following number of nights that nightly checks were missing for each month:
January: 12
February: 19
March: 16
April 19
May: 14
June: 16
July: 17
August: 19
September: 23
October: 16
November: 21
December: 16

Subsequent interview with LN 1 revealed that no one oversees this process. He agreed the log is inconsistent and the policy was not being followed.

5. Review of the Infection Control Manual, policy and procedures, reflected no current approval date of the policies. The Medical Director, Infection Control Practitioner and the facility Internist had not signed off on the policies. The form indicated that policies were reviewed annually for revision. The last revision date was noted to be in 5/2007. There was no mention of what infection control guidelines were to be utilized. The Infection Control Committee consisted of the Medical Director, Program Manager, Nurse Manager, Quality Improvement Manager, Infection Control Practitioner and the Internist.

Interview with the program director on 1/12/11 at 9:45 a.m. revealed that the policies and procedures had not been reviewed or revised recently and there were no recent approval dates.

Based on facility document review and interview, the hospital failed to maintain a comprehensive log of incidences of infections for patients and personnel. The patient log utilized was incomplete and did not allow for the tracking of diagnoses, organisms, or even isolation precautions, if required. No log of employee infections or incidences had been developed or monitored by the infection control designee.

Findings:

Review of the Infection Control Log dated 12/1/10 through 12/31/10, reflected a computerized print out of patient names and antibiotics prescribed.

Subsequent interview with LN 1 (licensed nurse) revealed that the list comes from pharmacy. He concurred it was lacking in specific information and there was no way of knowing the diagnoses. He had not been tracking organisms or the efficacy of the antibiotics that were prescribed. He had not been tracking the number of times isolation had been used or why. He does not get information on employee illness. No log had been developed that tracked employee infections or incidences that could potentially be an infection control concern.

Based on interview and policy and procedure review the hospital failed to ensure infection control issues were incorporated into the facility wide quality assurance program. Training programs for staff, targeting infection control, were not developed, as there was no identification of any infection control issues.

Findings:

Interview with LN 1 (licensed nurse), on 1/11/11 at 9:50 a.m. revealed that he has never attended an infection control meeting. He submits data that he collects and does not hear any more information. He has never had any input on any revisions to the policies and procedures. He had not attended an infection control committee meeting. He does not do any personal surveillance of employees, including handwashing techniques. He collects data on a quarterly basis and submits to the charge nurse. He did not know of any outcomes or decisions with the information that he submitted.

Interview with the program director on 1/12/11 at 9:45 a.m. revealed that the infection control committee had not been reporting to the governing board or the quality committee. Training specific to any infection control issues had not been implemented.

Review of the Infection Control Manual, policy and procedures, reflected no current approval date of the policies. The Medical Director, Infection Control Practitioner and the facility Internist had not signed off on the policies. The form indicated that policies were reviewed annually for revision. The last revision date was noted to be in 5/2007. There was no mention of what infection control guidelines were to be utilized. The Infection Control Committee consisted of the Medical Director, Program Manager, Nurse Manager, Quality Improvement Manager, Infection Control Practitioner and the Internist.

Interview with the quality manager on 1/13/11 at 3:30 p.m. revealed that the infection control policies and procedures had not been reviewed recently nor were there any recent approval dates. The policies had not been approved by the governing body. The Quality Improvement committee had not been proactively involved with the infection control process. As a result, there had been no training programs developed specific to any infection control issues.

Based on record review, observation and interviews, the facility failed to:

I. Provide physician directed Master Treatment Plans for 3 of 9 active sample patients (5, 7 and 15). The treatment plans for these patients were left blank where the physician was to document the diagnosis, patient assets, physician interventions and physician signature. This failed practice results in the treatment team developing plans of care for patients without physician leadership or input. (Refer to B118)

II. Provide a treatment program during morning hours to patients on the unit; patients were noted to be idle at that time. In addition, the facility failed to provide alternative active treatment for 6 of 9 active sample patients (4, 5, 7, 11, 14 and 15) who refused to participate in the scheduled active treatment program. These failures result in the potential for delaying improvement of the patients' level of function and their subsequent discharge. (Refer to B125-I)

III. Assure that staff followed hospital policy related to the use of seclusion and restraint to ensure a safe and therapeutic environment for 1 of 9 active sample patients (#4) and 1 of 3 non- sample patients chosen for having multiple episodes of seclusion (S-1). This failed practice results in a failure to ensure that patients are free from excessive use of seclusion and restraints.
(Refer to B125-II)

IV. Assure that staff protected 1 of 9 active sample patient's (#5) right to dignity and privacy through the failure to provide clothing that did not identify the patient's status as a prisoner. Staff allowed the sheriff who had jurisdiction over jailed patients admitted to the hospital to direct that Patient 5 was required to wear an orange jail jumpsuit, which identified his legal status. In addition, because it was the only article of clothing he had, the jumpsuit was not laundered. The patient was singled out for demeaning treatment by not having street clothing available to wear. (Refer to B125-III)

Based on record review, policy review and interview, the facility failed to provide a social work assessment for 1 of 9 active sample patients (#5). Failure to provide social work assessments can result in a lack of professional social work treatment services being available for patients and a lack of discipline specific information being available for the treatment team.

Findings include:

A. Record Review

Patient 5 (admitted 7/28/11). A Social Service Progress Note dated 7/29/11 stated, "Neither patient or his mother could provide us with reliable or accurate social history. Request extension of Psychosocial Assessment/Discharge Plan until 8/1/11." There were no further social service progress notes nor a psychosocial evaluation in the patient's record as of the afternoon of 8/2/11 (5 days after admission).

B. Policy Review

Psychiatric Health Facility Policies and Procedures, A-7.2/NG-2.2, titled "Assessments" last revised 9/1/10 noted, "a psychosocial assessment will be completed within 72 hours (after admission)."

C. Interview

In an interview on 8/2/11 at 2:15PM, the Director of Social Services acknowledged the findings.

Based on record review and interview, it was determined that the psychiatric evaluations of 8 of 9 active sample patients (1, 2, 4, 5, 7, 10, 14 and 15) failed to report memory functioning and/or intellectual functioning in measurable, behavioral terms which clearly reflected the patient's ability to function in those areas. The tests used to measure these functions also were not identified. This failure compromises the database from which diagnoses are determined and from which changes in response to treatment interventions may be measured.

Findings include:

A. Record Review

1. Patient 1: In an admission Psychiatric Evaluation dated 7/15/11, under the section titled Mental Status Examination, memory and intellect were described as "Long term and short term memory appear intact, intelligence appears average." There was no description in the report that noted how these findings were determined.

2. Patient 2: In an admission Psychiatric Evaluation dated 7/29/11, under the section titled Mental Status Examination, memory and intellect were described as "Long term and short term memory appear intact, intelligence appears average." There was no description in the report that noted how these findings were determined.

3. Patient 4: In an admission Psychiatric Evaluation dated 7/31/11, under the section titled Mental Status Examination, there was no information noted that related to memory or intellectual function.

4. Patient 5: In an admission Psychiatric Evaluation dated 7/29/11, under the section titled Mental Status Examination, memory and intellect were described as "[#5] comes across as being developmentally delayed. Memory tested briefly was normal." There was no description in the report that noted how these findings were determined.

5. Patient 7: In an admission Psychiatric Evaluation dated 7/27/11, under the section titled Mental Status Examination, there was no information noted that related to memory or intellectual function.

6. Patient 10: In an admission Psychiatric Evaluation dated 5/17/11, under the section titled Mental Status Examination, there was no information noted that related to memory or intellectual function.

7. Patient 14: In an admission Psychiatric Evaluation dated 7/20/11, under the section titled Mental Status Examination, memory and intellect were described as "Long term and short term memory appear intact, intelligence appears average." There was no description in the report that noted how these findings were determined.

8. Patient 15: In an admission Psychiatric Evaluation dated 7/27/11, under the section titled Mental Status Examination, there was no information noted that related to memory or intellectual function.

B. Interview

During an interview on 8/2/11 at 3:30PM with the Medical Director, samples of the eight records noted above were reviewed. The Medical Director acknowledged the findings.

Based on record review and interview, the facility failed to provide psychiatric evaluations for 3 of 9 active sample patients (5, 7 and 15) that described patient assets/strengths that would be used in treatment in descriptive terms. Lack of information on patient assets/strengths hinders the physician's ability to guide the team in developing a plan of care that utilizes strengths that the patient brings to treatment.

A. Record Review

In the Psychiatric Evaluations (PEs) for the following three patients, there was no description of assets or strengths: Patient 5 (PE dated 7/29/11); Patient 7 (PE dated 7/27/11) and Patient 15 (PE dated 7/27/11).

B. Interview

In an interview on 8/2/11 at 3:30PM, when shown the three records noted above, the Medical Director agreed with the findings.

I. Based on record review and interview, the facility failed to provide a physician directed Master Treatment Plan for 3 of 9 active sample patients (5, 7 and 15). The Master Treatment Plans for these patients were left blank where the physician was to document the diagnosis, patient assets, physician interventions and physician signature. This failed practice results in the treatment team developing plans of care for patients without physician leadership or input.

Findings include:

A. Record Review

1. The facility's form titled "Multidisciplinary Treatment Plan" (Master Treatment Plan) contains an entire page (page 2 of the 7 page document) for the psychiatrist to complete. Page 3 has a signature line for the "M.D." to sign.

2. Review of the sample patients' treatment plans revealed that for the following patients, Page 2 of the Multidisciplinary Treatment Plan (dates in parentheses) was blank; the physician signature line on Page 3 also was left blank: Patient 5 (7/29/11); Patient 7 (7/29/11); Patient 15 (7/29/11).

B. Interviews

1. In an interview on 8/2/11 at 2:00PM with the Program Manager, the three examples of the Master Treatment Plans were shown to her. The Program Manager agreed with the findings.

2. In an interview on 8/2/11 at 3:30PM, after reviewing the three examples of the Master Treatment Plans, the Medical Director agreed with the findings and stated, "I know what happened here, this should have been done by the doctor covering."

Based on record review and interview, the facility failed to provide Master Treatment Plans for 8 of 9 active sample patients (1, 2, 5, 7, 10, 11, 14 and 15) that identified strengths and abilities on which to base treatment interventions. Failure to identify individual patient strengths and abilities for the treatment team to use in treatment planning can compromise treatment effectiveness and delay discharge.

Findings include:

A: Record Review (MTP dates in parentheses)

On the Multidisciplinary Treatment Plan (MTP) forms for each of the following 8 sample patients, the section titled "Assets (How can the patient help? Consider his/her knowledge base, employment, education, aptitude, personal attributes)" was left completely blank: Patient 1(7/29/11); Patient 2 (7/29/11); Patient 5 (7/29/11); Patient 7 (7/29/11); Patient 10 (5/19/11); Patient 11 (7/11/11); Patient 14 (7/22/11); Patient 15 (7/29/11).

B. Interviews

1. In an interview on 8/2/11 at 2:00PM, when shown the Master Treatment Plans of these active sample patients, the Program Manager agreed with the findings.

2. In an interview on 8/2/11 at 3:30PM, when shown the Master Treatment Plans of these active sample patients, the Medical Director agreed with the findings and stated, "The doctors should be filling this out."

Based on record review and interview, the master treatment plans failed to include a diagnosis that served as the primary focus of treatment planning for 3 of 9 active sample patients (5, 7 and 15). This deficient practice compromises the staff's ability to deliver clinically focused treatment based on the patient's illness.

Findings include:

A. Record Review (MTP dates in parentheses)

On the Multidisciplinary Treatment Plan (MTP) forms for each of the following three patients the section titled "Admitting Diagnosis: Axis I; Axis II; Axis III; Axis IV (with eight check boxes); Axis V: Global Assessment" was left completely blank: Patient 5 (7/29/11); Patient 7 (7/29/11); Patient 15 (7/29/11).

B. Interviews

1. In an interview on 8/2/11 at 2:30PM with the Program Manager, the three examples of the Master Treatment Plans were shown to her. She agreed with the findings.

2. In an interview on 8/2/11 at 3:30PM with the Medical Director, the three examples of the Master Treatment Plans were shown to him. He agreed with the findings and stated, "The doctors should be filling this out."

Based on record review and staff interview, the facility failed to develop Master Treatment Plans that consistently identified patient-related objectives (short-term goals) for 5 of 9 active sample patients (1, 5, 7, 11 and 15), and long term goals for 2 of 9 active sample patients (Patients 5 and 15), stated in observable, measurable, behavioral terms. In one instance, the short term goals did not relate to the identified problem (Patient 7). These failures result in master treatment plans that fail to identify expected treatment outcomes in a manner that can be understood by treatment staff and the patient.

Findings include:

A. Record Review

1. Patient 1: In a Master Treatment Plan dated 7/18/11, for Problem #1: "Altered Thought Processes," the following short term goals were noted: "Medication compliant with prescribed meds x 3 consecutive [sic]" and "will be able to differentiate between reality and delusions perceptions 75% of the time x 3 consecutive days." The long term goal was noted as "verbalize insight into legal issues and agree to cooperate with attorneys." None of these goals were measurable as stated.

2. Patient 5: In a Master Treatment Plan dated 7/29/11 there were no short term or long term patient goals recorded.

3. Patient 7: In a Master Treatment Plan dated 7/28/11, for Problem #1: "Ineffective Coping," the following short term goals were noted as: "will verbally communicate daily for 3 consecutive days...attend 1 group daily x 3 days. Medication compliant x 3 consecutive days." It wasn't clear how these goals related to the problem of ineffective coping.

4. Patient 11: In a MTP dated 7/11/11, for Problem #1: "Disturbed Thought Process," the short term goals were noted as "medication compliant x 3 consecutive days. Be able to differentiate between reality and delusions 75% of the time for 3 consecutive days. Attend 2 snacks and 3 meals daily with 75% intake." The MTP did not document how the terms "reality" and "delusions" would be determined.

5. Patient 15: In a MTP dated 7/29/11, under Problem #1: "Ineffective Coping, Self Care Deficit," the following short term goals were noted: "Establish routine for ADLs (activities of daily living) by changing clothes each day and eating 75% of each meal for 3 consecutive days. Report and demonstrate less depressed mood and increase socialization by 50% for 3 consecutive days." The long term goal was stated as "participate in treatment plan and make plans consistent with personal strengths and goals during 1:1 each week." The long term goal appeared to be a short term goal; the short goals did not include measurable baselines that could be used to determine improvement.

B. Interviews

1. In an interview on 8/2/11 at 2:45PM, the Director of Social Services was shown examples of the sample patients' MTPs, and the short term goals and long term goals were discussed. The Director of Social Services agreed that it was difficult to measure improvement without adequate baseline information, and that the goals needed to be more specific.

2. In an interview on 8/2/11 at 3:30PM, when shown examples of the sample patients' MTPs, the Medical Director agreed that the treatment plan goals needed to be more specific.

Based on record review and staff interview, the facility failed to provide Master Treatment Plans for 8 of 9 active sample patients (1, 2, 4, 5, 7, 10, 11 and 15) that included interventions that were individualized and patient-oriented. The listed interventions lacked focus or were stated as routine discipline functions that would be expected for any patient. In addition, for Patients 5, 7 and 15, the MTPs were missing interventions by some disciplines. These deficiencies result in treatment plans that fail to provide guidance to staff in delivering consistent and focused treatment for patients' identified problems.

Findings include:

A. Record Review

1. Patient 1

In a Master Treatment Plan dated 7/15/11, for Problem #1: "Altered Thought Process," the following discipline specific interventions were noted:

Psychiatric: "I tried to change from Thorazine but [patient] declined. So continue Thorazine and Depakote to decrease symptoms."

Nursing: "Safety checks every 15 minutes daily, prompt for meds, med. Education."

Social Work: "Assess for mental status, readiness for discharge, aftercare needs. Complete psychosocial assessment and discharge plan."

Activities Therapy: "I will prompt pts attendance based on a daily assessment- Pt can interrupt the group by speaking tangentially and controlling the group."

2. Patient 2

In a Master Treatment Plan dated 7/29/11, for Problem #1: "Disturbed Thought Process," the following discipline specific interventions were noted:

Psychiatric: "Continue Depakote, change antipsychotic to Risperidone."

Nursing: "Safety checks every 15 minutes daily, medication education."

Social Work: "Assess for mental status, readiness for discharge, aftercare needs. Complete psychosocial assessment and discharge plan."

Activities Therapy: "Groups to promote sober leisure lifestyle."

3. Patient 4

In a Master Treatment Plan dated 08/02/11, for Problem #1 "Risk for Violence-Directed at Others," the nursing interventions included "Staff checks q 15 daily, 1:1 LOS (length of stay) to prompt, monit (monitor) appropriate behaviors as ordered (unreadable) and prompt for 2 groups daily, medication education daily." These interventions were generic tasks that would be conducted for any patient.

4. Patient 5

In a MTP dated 7/29/11, there was an intervention listed for activities therapy that stated, "Community meeting and wrap up groups daily to orient to unit milieu and facilitate social interaction." There were no psychiatric, nursing or social work interventions on the MTP

5. Patient 7

In a MTP dated 7/29/11, for Problem #1: "Ineffective Coping," there were no psychiatric or activities therapy interventions noted. The other interventions (listed below) were generic tasks.

Nursing: "Safety checks every 15 minutes daily, one to one daily assessment, prompt for groups/milieu."

Social Work: "patient will be assisted to find appropriate shelter in the community and referred back to clinic for follow up."

6. Patient 10

In a Master Treatment Plan dated 5/19/11, for Problem #1: "Disturbed Thought Process," the following discipline specific interventions were noted:

Psychiatric: "Start meds, refer to appropriate groups, work on discharge plans."

Nursing: "Safety checks every 15 minutes daily, prompt for meds, medication education, prompt for groups."

Activities Therapy: "Groups as patient can tolerate to work on coping skills, medication education and to facilitate appropriate social and leisure involvement."

7. Patient 11

In a Master Treatment Plan dated 7/11/11, for Problem #1: "Disturbed Thought Process," the following discipline specific interventions were noted:

Psychiatric: "Rx Prolixin and Cogentin, including Prolixin Dec [sic]."

Nursing: "Safety checks every 15 minutes daily, prompt for meds, med. Education. Vital signs daily."

Social Work: "Assess for mental status, readiness for discharge, aftercare needs. Complete psychosocial assessment and discharge plan."

Activities Therapy: "Offer groups daily that teach coping skills, about community resources and relapse prevention."

8. Patient 15

In a Master Treatment Plan dated 7/29/11, for Problem #1: "Ineffective Coping," the following discipline specific interventions were noted:

There were no psychiatric interventions noted.

Nursing: "Safety checks every 15 minutes daily, prompt for meds, med. Education."

There were no Social Work interventions noted.

Activities Therapy: "Approach daily to develop trust and rapport. Encourage groups as highlighted for social interaction (there were no groups highlighted on the patient schedule)."

B. Interviews

1. In an interview on 8/2/11 at 2:00PM, the Activities Therapy manager reviewed the activities therapy interventions noted in the Master Treatment Plans and agreed that the interventions were not specific enough for patients. She stated, "...actually all patients are expected to attend all of the groups."

2. In an interview on 8/2/11 at 3:00PM, the Director of Social Work reviewed the master treatment plans of the active sample patients and agreed that the social work functions were generic role functions, not individualized interventions for patients.

3. In an interview on 8/2/11 at 3:30PM, the Medical Director agreed that the psychiatric interventions in the active sample patient's master treatment plans were "not sufficient" and could not explain why some patients' Master Treatment Plans did not list any psychiatric interventions.

4. In an interview on 8/2/11 at 4:15PM, the Director of Nursing agreed that the nursing functions in the active sample patient's master treatment plans were generic roles and not patient specific interventions.

Based on observation, interviews and record review, the facility failed to:

I. Provide a treatment program during morning hours to patients on the unit; patients were noted to be idle at that time. In addition, the facility failed to provide alternative active treatment for 6 of 9 active sample patients who refused to participate in the scheduled active treatment program (4, 5, 7, 11, 14 and 15). These failures result in the potential for delaying improvement of patients' level of function and their subsequent discharge.

II. Assure that staff followed hospital policy related to implementation of Seclusion and Restraint, thus failing to provide a safe and therapeutic environment for 1 of 9 active sample patients (#4) and 1 of 3 non sample patients (S-1) chosen for seclusion review who was identified as having multiple episodes of seclusion. This failed practice resulted in a failure to ensure that patients are free from excessive use of seclusion and restraints.

III. Protect patients' rights through the provision of clothing that promoted dignity and respect. Patient 5 was maintained in an orange jail jumpsuit at the direction of the sheriff who had jurisdiction for the jail from which the patient came, and staff reported this was a routine procedure which they followed when directed to do so by the sheriff. This failure resulted in 1 of 9 active sample patients (#5) having to wear a single orange jail jumpsuit, and with no opportunity to have it laundered, thus being denied dignity and privacy by not having street clothing available to wear.

Findings include:

I. Failure to provide Active Treatment

A. Observation

During observations on the inpatient unit the morning of 8/1/11 between 9:15AM and 12PM, approximately 10 or 11 patients (including all 9 active sample patients) were observed lying in their beds, walking the hallways or sitting in the day room watching television at various times during the observation. Staff was observed walking around carrying clipboards and recording 15 minute safety checks. There was little or no patient-staff interaction during this time- period. The unit schedule showed no scheduled activities for patients during this time- frame other than smoking breaks.

B. Interview

1. In an interview on 8/1/11 at 10:45AM, the unit activity therapist stated, "Patients don't do much in the mornings because groups would interfere with the doctor visits and treatment team meetings." The activity therapist stated that this open, unstructured time- period between 9 AM and noon occurred daily.

2. In an interview on 8/1/11 at 11:15AM, RN1 confirmed the statements made by the activities therapist noted above.

C. Specific Patient Findings

1. Patient 4, admitted on 07/30/11, was not assigned to any group interventions on the MTP dated 08/02/11. The Activity Therapist note on the Multidisciplinary Individualized Treatment Plan of 08/02/11 stated, "(patient name) is refusing groups at this time and is on a 1:1. Will be seen 2:1 (1:1 nursing staff and AT) to pursue leisure interests as able."

In an interview with the Activity Therapist 1(AT1) on 08/02/11 at 12 PM, she stated she "did not think the patient was ready to meet with her."
There were no treatment notes which indicated any alternative treatment was provided.

2. Patient 5, admitted on 7/28/11, was assigned to all group interventions on the patient unit schedule per the MTP dated 7/29/11.There were no group progress notes in the patient's record between 7/28/11 and 8/2/11(in the interview noted above with AT, she stated that if there wasn't a group note, then the patient didn't attend the group). There were no alternative therapies noted in the patient's Master Treatment Plan dated 7/29/11, and none of the daily MTP updates listed any new interventions for the patient.

In an interview on 8/1/11 at 10:30AM, Patient 5 stated, "I don't go to groups. I just sleep and watch TV."

3. Patient 7, admitted on 7/26/11, was assigned to all group interventions on the patient unit schedule per an MTP dated 7/29/11. There were no group progress notes in the patient's record between 7/26/11 and 8/2/11. Patient 7 was selectively mute per the psychiatric admission note dated 7/27/11; the MTP dated 7/29/11 did not include any individualized interventions related to the mutism.

In an interview on 8/2/11 at 11:45AM, Patient 7 communicated via a writing tablet and wrote "There's nothing to do here. I sit on the couch and watch TV. No one tries to talk to me since I've been here. I want to go home."

During an observation on 8/3/11 at 9:15AM, Patient 7 met with the treatment team; the attending physician carried out an interview with the patient via a writing tablet. The attending physician focused on contacting the patient's family to arrange discharge. The treatment team did not review the treatment plan and did not discuss Patient 7's lack of engagement in treatment in the milieu.

4. Patient 11, admitted 07/08/11, was assigned to "groups daily that teach coping skills, about community resources and relapse prevention" per the MTP dated 7/11/11. According to the Group Therapy/Progress Notes in the patient's medical record, from her admission through the date of the survey, the patient attended 7 of the 24 groups available. Review of the Master Treatment Plan, last updated 07/24/11, revealed no identification of the patient's lack of participation as a treatment issue. During the survey, the patient was observed sitting around, walking around, or lying in bed most of the time.

5. Patient 14, admitted 07/19/11 was not assigned to any group interventions on the MTP dated 07/22/11. The Activity Therapist note on the Master Treatment Plan of 07/22/11 stated, "(patient name) will be assessed daily for group participation-pt. is currently too disorganized and preoccupied."

Review of the Master Treatment Plan, last updated 07/28/11, identified intervention modalities as "education, groups and discharge planning." Review of the patient's medical record on 8/02/11 revealed only one documented attendance in a group. The group was a "Wrap-up and Leisure group"; according to the notes, the patient attended the group for "five minutes."

In an interview on 08/02/11 at 1PM, Patient 14 stated, "There's nothing to do here, they're not helping me, they just walk around and look at me....There are no activities, the few they have don't mean anything to me....I have so much anger and depression and sadness but no one will listen, can you help me?...Sometimes I ' ll smoke a cigarette just to do something....I like to read and write. I try to keep busy doing that, there's nothing much more to do here."

On 08/01/11 from 2PM to 2:40PM, there were six patients in the dayroom (sample patients #10, #11 and #14 in addition to 3 non-sample patients). There was no observed interaction between staff members and the patients. Patient #14 sat alone, talking out loud to no one, occasionally looking at a book s/he held. The patient periodically got up and walked about the room gesturing.

6. Patient 15, admitted 07/27/11, on the MTP dated 07/29/11 was assigned to groups "social interaction and orientation to unit milieu." Review of the medical record showed documentation that the patient only attended one community meeting (on 08/03/11). The Master Treatment Plan, written on 07/27/11, failed to be revised by the time of the survey to identify the patient's lack of participation as a treatment issue.

During the survey day of 08/01/11-08/03/11 the patient was observed out of bed three times: on 08/01/11 and 08/02/11 at approximately 3PM the patient was seen walking with a walker; on 08/03/11 the patient was present in the dayroom during community meeting. At other times s/he was noted to be in bed.

II. Failures related to Seclusion and Restraint

A. Patient 4

1. This patient was re-admitted to the facility on 7/30/11, having had a previous two month stay from 11/2010 to 01/2011. According to the Seclusion & Restraint Form dated 08/01/11the patient was placed in seclusion on 8/2/11. The reasons noted were, "became belligerent (without) provocation, yelling (with) food servers, making racist comments to staff, ...threw food and plates on floor, escorted to seclusion (without) incident." There was a notation on a form for Preventative Measures that listed: "establish rapport" "asked to return to room" "would not follow instructions."

2. During an interview on 8/2/11 at 3PM, the Medical Director said the patient had had a consultation with a Psychologist during the previous admission that provided a behavioral plan to reduce/eliminate the use of seclusion and restraints.

3. The MTP dated 08/02/11 did not include the problem of the patient's frequent S & R during the prior admission. There was no notation in the MTP of a previous behavioral plan which had been adopted for this patient to reduce the use of seclusion or restraints. The current medical record for this patient did not include this behavioral plan

4. In an interview on 8/3/11 at 10AM, the DON stated she was not aware of a behavioral plan for Patient 4. The absence of the behavioral plan resulted in a failure to ensure that de-escalation that may have been identified in the behavioral plan would be used prior to use of seclusion or restraint when there is a danger to self or others.

5. The Nursing Section of the Multidisciplinary Individualized Treatment Plan dated 08/02/11 had only generic interventions for Problem #1: "Risk for Violence-Directed at Others," including: "Safety checks q.15, daily LOS (line of sight), 1:1 LOS to promote appropriate behaviors...Prompt for 2 group's daily, medication education daily." There were no individualized interventions specific to the prevention of seclusion and/or non-physical responses to manage the patient's potential behavioral emergency.

6. The facility policy for Restraint and Seclusion, effective date 4/6/11 includes, "identify and use alternative interventions to prevent dangerous behaviors."

B. Patient S-1

1. A review of the facility's restraint log for the prior three (3) months, (April, May and June, 2011) showed that patient S-1 had five (5) episodes of seclusion and/or restraints; a record review for this patient's seclusion and restraint episodes included two (2) additional episodes in March, 2011. The episodes were on 3/27/11, 3/31/11, 4/15/11, 4/19/11, 4/20/11, 4/29/11 and 4/30/11.

a. According to a review of the documentation tools used by the facility for seclusion and restraint monitoring, on 3/27/11, patient S-1 was placed in seclusion. The "Required Monitoring" record stated that the patient continued to be in seclusion for one and half (1?) hours while sleeping.

In an interview on 8/3/11 at 10AM, the DON stated that it was not necessary to keep patients in seclusion while sleeping.

The Facility Policy for Restraint and Seclusion, effective date of 4/6/2011, states "...(patients at the PHF) are free from the harm of excessive physical restraint, isolations, excessive medication and abuse or neglect."

Keeping the patient in seclusion for an excessive amount of time resulted in a denial of the patient's right to freedom from isolation and unwarranted seclusion.

b. A review of the documents for seclusion and restraints in the patient's medical record showed that on 4/15/11, patient S-1 was placed in Seclusion and 5 point Restraints. The Debriefing documentation stated that a Treatment Plan Modification had been completed, yet the "Interdisciplinary Team: Daily Treatment Plan Update" for 4/15/11 indicated no change: a box was checked that there were no notable changes on a 24 hour behavior evaluation, and there were no new interventions checked; there was a checkmark for "continue interventions per daily and weekly treatment plan updates."

In an interview on 8/3/11 at 10AM, the DON stated this treatment plan update did not assist the staff in making any intervention changes that would assist in reducing or eliminating the patient's need for seclusion or restraint.

This failed practice resulted in a failure to ensure that patients are free from excessive use of seclusion and restraints.

c. On 4/19/11, patient S-1 was placed in Seclusion. The Debriefing documentation stated that a Treatment Plan Modification had been completed, yet the "Interdisciplinary Team: Daily Treatment Plan Update" for 4/19/11 indicated no change: a box was checked that there were no notable changes on a 24 hour behavior evaluation. and there were no new interventions checked. There was a checkmark for "continue interventions per daily and weekly treatment plan updates."

In an interview on 8/3/11 at 10AM, the DON stated this treatment plan update did not assist the staff in making any intervention changes that would assist in reducing or eliminating the patient's need for seclusion or restraint.

This failed practice resulted in a failure to ensure that patients are free from excessive use of seclusion and restraints.

d. A review of the documentation for seclusion and restraint in the patient's medical record included a notation that on 4/20/11, patient S-1 was placed in Seclusion. Review of the Required Monitoring record revealed no documented monitoring of the patient for one hour and fifteen minutes -- from "1445" (2:45p.m.) to "1600" (4:00p.m.).

The facility's Restraint and Seclusion policy, effective date 4/6/2011, states in the Nursing Care and Monitoring section that documentation of the patient's status and a determination of whether the patient meets release criteria is to be done every 15 minutes.

In an interview on 8/3/11 at 10AM, the DON acknowledged that the hospital policy is to be followed in all instances of seclusion and restraint.

This failed practice resulted in a failure to ensure that the patient was physically and emotionally safe from harm.

e. A review of the documentation for seclusion and restraint in the patient's medical record included a notation that on 4/30/11, patient S-1 was placed in Seclusion and 5 point Restraints. The Interdisciplinary Progress Note written on 4/30/11 by RN 3 stated, "...[patient] was escorted by two male staff to room 116 and placed in restraints to prevent any further self harm. Pt. (patient) was cooperative and did not resist staff."

In an interview on 8/3/11 at 10AM, the DON stated that it would appear the patient no longer required restraints if he was cooperative.

This failed practice resulted in a failure to ensure that patients are offered the least restrictive methods to ensure their safety from danger to self or others.

C. Record reviews revealed that for all of the identified episodes of seclusion or restraints for patients 4 and S-1, the "Face to Face Evaluation in Presence of PHF Staff" documentation form was present and the section for recommendations from the physician was blank.

D. In an interview on 8/3/11 at 10AM, the DON acknowledged that the section of the "Face to Face Evaluation in Presence of PHF Staff" for identification of recommendations by the physician is never completed.

E. The facility's Restraint and Seclusion policy, effective date 4/6/11, states in the Debriefing section: "Help treatment team staff devise treatment interventions to address the root cause of the incident consequences and to modify the treatment plan [sic]."

These failed practices resulted in a failure to reduce the use of seclusion and restraints for these patients.

III. Patient Right to Dignity and Privacy Issues

A. Observations

During an observation on 8/1/11 between 9:15AM and 10:30AM, Patient 5 was observed pacing the hallways wearing an orange jumpsuit that had printed on it in white letters "Santa Barbara County Jail." Patient 5 was also observed later in the afternoon of 8/1/11 pacing the hallways in the same orange jumpsuit. Patient 5 was wearing the same orange jumpsuit on 8/2/11 at 10:30AM while in his/her bedroom.

B. Interviews

1. In an interview on 8/1/11 at 10AM, the Program Manager stated that Patient 5 was an inmate at the jail and had been admitted to the facility on a "5150 (involuntary 72 hr hold)." The Program Manager stated, "the Sheriff ordered the patient to be in the orange jumpsuit and even wanted us to block visitors and phone calls. The Sheriff also ordered us to not let [Patient 5] out onto the patio for fresh air breaks." She further explained that there had been a long history of disagreement regarding this practice of jailed patients being in "oranges" between the Patient Advocate Office and the Sheriff.

2. In an interview on 8/1/11 at 10:30AM, Patient 5 stated, "I don't like this jumpsuit; I've been in it for 4 days now and it's dirty, they won't let me take it off to wash it." Patient 5 also stated, "I feel weird here since everyone gets to wear regular clothes; my mom could bring me clothes. I want to be here, it's better than jail."

3. In an interview on 8/2/11 at 3:30PM, the Medical Director reiterated that the Sherriff demands that adjudicated prisoners remain in jail clothing when they are in the sheriff's custody.

4. In an interview on 8/3/11 at 9:15AM with Licensed Psychiatric Technician 1(LPT1), the jail clothing was discussed. LPT1 stated, "It's not fair to the patient to have to wear the outfits and I think it (the jail clothing) scares the other patients to stay away from [Patient 5]."

Based on record review and interview, the facility failed to provide a discharge summary that summarized all the treatment received in the hospital and the patient's response to treatment other than medication for 4 of 5 discharged patients whose records were reviewed (DC1, DC3, DC4 and DC5). This failure compromises the effective transfer of the patient's care to the next care provider by not providing information that identifies effective and/or ineffective treatment strategies for the individual patient.

Findings include:

A. Record Review

1. Patient DC1: In a Discharge Summary dated 6/17/11, under the "Hospitalization Course," the summary noted that the patient's sleep hours were "average" and that the patient had taken "several doses of Lithium." There was no information about the patient's response to treatment or the effect of other forms of treatment during the hospitalization.

2. Patient DC3: In a Discharge Summary dated 6/21/11, the entire summary was limited to one type-written page that included information on "Hospitalization course; Discharge Diagnoses; and Discharge Medications." The "Hospitalization Course" noted the patient's delusions and the use of Restoril (a sedative hypnotic) for the psychosis as evidenced by the statement "On the Restoril four hours, the patient has not been showing these symptoms (referring to the delusions), at least not verbalizing it [sic]." The "Discharge medications" included Trileptal (a mood stabilizing anticonvulsant) and Zydis (an antipsychotic); the discharge summary had no more information about these medications or the patient's response to treatment.

3. Patient DC4: In a Discharge Summary dated 6/14/11, under the section titled "Hospitalization Course," the physician noted the previously known findings (on physical examination) of a hernia and knee repair, and then noted "We began the LPS Conservatorship process on [patient] and it was in process when he was released on 6/8/11 to go to [skilled nursing facility], remaining on 1370.01 PC status (incompetent to stand trial code), still being incompetent to stand trial. The court consented to this placement." There was no discussion of psychiatric symptoms or the patient's response to treatment or the milieu in the summary. The patient was discharged on Risperidone and Seroquel (antipsychotic medications) and Sertraline (antidepressant medication).

4. Patient DC5: In a Discharge Summary dated 7/26/11 there was no review of the hospital course.

B. Interview

In an interview on 8/2/11 at 3:30PM, the Medical Director was shown the discharge summaries noted above in Section A; he agreed with the findings and stated, "This is not acceptable."

Based on record review and interview, the facility failed to ensure that discharge summaries contained psychiatric recommendations related to anticipated problems and suggested means of intervention after discharge for 5 of 5 discharged patients whose records were reviewed (DC1, DC2, DC3, DC4 and DC5). This failure results in a lack of critical clinical information about the patient's level of psychiatric symptomatology and risk being available to aftercare providers.

Findings include:

A. Record Review

1. Patient DC1: In a Discharge Summary dated 6/17/11, there was no section that contained information related to psychiatric recommendations for anticipated problems after discharge.

2. Patient DC2: In a Discharge Summary dated 6/24/11, there was no section that contained information related to psychiatric recommendations for anticipated problems after discharge.

3. Patient DC3: In a Discharge Summary dated 6/21/11, there was no section that contained information related to psychiatric recommendations for anticipated problems after discharge.

4. Patient DC4: In a Discharge Summary dated 6/14/11, there was no section that contained information related to psychiatric recommendations for anticipated problems after discharge.

5. Patient DC5: In a Discharge Summary dated 7/25/11, there was no section that contained information related to psychiatric recommendations for anticipated problems after discharge.

B. Interview

In an interview on 8/2/11 at 3:30PM, the Medical Director was shown the discharge summaries noted above in Section A; he agreed with the findings and stated "This is not acceptable."

Based on record review, interview, policy review and observation, the Medical Director failed to:

I. Ensure that physicians provided a complete physical examination for patients admitted to the facility from another facility. For 3 of 9 active sample patients (2, 14 and 15), the facility used a practice of countersigning physical examinations performed at outside facilities within 30 days of admission to the facility. For 3 other active sample patients (4, 7 and 10), the physician failed to complete physical examinations when the patients either refused the initial attempt by the physician to do a physical examination, or had cursory examinations on admission. These failures place patients at risk for missing important medical diagnosis and treatment while in the hospital.

Findings include:

A. Record Review

Physical Examinations completed at another facility

1. Patient 2

Patient 2, admitted to the facility on 7/28/11, had a previous physical examination on 7/25/11 at an outside hospital. The following handwritten note regarding the previous physical examination was written on 7/29/11 by the facility's internal medicine physician: "a/w (agree with) above, rx (treatment) for asthma, labs reviewed." There was no evidence that a complete physical examination was performed by a facility staff physician for the patient's current hospitalization.

2. Patient 14

Patient 14, admitted to the facility on 7/19/11, had a previous physical examination on 7/14/11 at an outside hospital. The following handwritten note regarding the previous physical examination was written on 7/20/11 by the facility's internal medicine physician: "a/w (agree with) above, will rx (treat) for acne." There was no evidence that a complete physical examination was performed by a facility staff physician for the patient's current hospitalization.

3. Patient 15

Patient 15, admitted to the facility on 7/27/11, had a previous physical examination on 6/28/11 at an outside hospital. The following handwritten note regarding the previous physical examination was written on 7/28/11 by the facility's internal medicine physician: "a/w (agree with) above, would like to limit narcotics if possible." There was no evidence that a complete physical examination was performed by a facility staff physician for the patient's current hospitalization.

Incomplete physical examinations

1. Patient 4, admitted to the facility on 7/31/11, had a handwritten report of a physical examination (PE) that noted, "refused PE, appears fit." There were no progress notes that showed any further attempt to complete the physical examination from 8/1/11 through 8/3/11.

2. Patient 7, admitted to the facility on 7/26/11, had a handwritten report of a physical examination (PE) that was limited to exam of the lungs, heart, abdomen, extremities. The neurological exam was limited to "Neuro awake alert follows commands move all extremities, ambulates without difficulty [typed as written]." There were no progress notes that showed any further attempt to complete the examination from 7/27/11 through 8/3/11.

3. Patient 10:,admitted to the facility on 7/8/11, had a handwritten report of a physical examination (PE) that was limited to exam of the lungs, heart, abdomen, extremities. Neurological exam was limited to: "Neuro awake alert oriented x 3 [typed as written]." There were no progress notes that showed any further attempt to complete the examination from 7/8/11 through 8/3/11.

B. Interviews

1. In an interview on 8/2/11 at 10:30AM, the internal medicine physician acknowledged that he had not completed physical examinations for Patients 4, 7 and 10. He also stated that he countersigned the physical examinations from other facilities "if I know the doctor." He then stated, "Sometimes I'm pressed for time and don't repeat a physical if I think someone is healthy."

2. In an interview on 8/2/11 at 3:45PM, the Medical Director concurred with the information provided by the internal medicine physician, and stated that the facility's policy was to accept physical examinations from "certain other hospitals" if the PE was completed within 30 days. The Medical Director agreed the three physical examinations (Patients 2, 14 and 15) were completed by physicians who were not staff at the surveyed facility. He also agreed that the three physical examinations (Patients 4, 7 and 10) were incomplete.

C. Policy Review

Psychiatric Health Facility Policies and Procedures, titled "Medical Care for Patients", C-1.2, Effective 10/01/1997, revised May 2006 notes the following: "Physical Examination on all new patients who have not had a physical within the past 30 days, within 24 hours of admission. Patients who are readmitted within 30 days will have their history and physical reviewed and updated appropriately."

II. Assure that the psychiatric evaluations of 8 of 9 active sample patients (1, 2, 4, 5, 7, 10, 14 and 15) included a report of memory functioning and/or intellectual functioning which clearly reflected patients' abilities to function in these areas. This failure compromises the database from which diagnoses are determined and from which changes in response to treatment interventions may be measured. (Refer to B116)

III. Assure that the psychiatric assessments of 3 of 9 active sample patients (5, 7 and 15) identified patient assets/strengths in descriptive, not interpretive terms. Lack of this information hinders the physician's ability to guide the team in developing a plan of care that builds on patient assets/strengths. (Refer to B117)

IV. Assure that a physician directed Master Treatment Plan was developed for 3 of 9 active sample patients (5, 7 and 15). The Master Treatment Plans for these patients were left blank where the physician was to document the diagnosis, patient assets, physician interventions and physician signature. This failure results in the treatment team developing a plan of care for patients without physician leadership or input, potentially leading to ineffective and/or unsafe treatment. (Refer to B118)

V. Assure that treatment staff provided sufficient alternative active treatment interventions for 6 of 9 active sample patients who refused to participate in the scheduled active treatment program (#4, 5, 7, 11, 14 and 15). These failures result in the potential for delaying improvement of the patients' level of function and their subsequent discharge. (Refer to B125-1)

VI. Assure that staff followed hospital policy to ensure a safe and therapeutic environment through appropriate use of seclusion and restraint for 1 of 9 active sample patients (4) and 1 of 3 non sample patients (S-1). This failed practice resulted in a failure to reduce the use of seclusion and restraints for these patients. (Refer to B125-II)

VII. Assure that staff protected a patient's right to dignity through the provision of clothing that promoted dignity and respect. This failure resulted in 1 of 9 active sample patients (5) having to wear an orange jail jumpsuit, thus feeling demeaned by having not street clothing available to wear. All of the other patients on the unit were able to wear street clothing at all times. (Refer to B125-III)

VIII. Assure that physicians provided a discharge summary that summarized all the treatment received in the hospital and the patient's response to treatment other than medication for 4 of 5 discharged patients whose records were reviewed (DC1, DC3, DC4 and DC5). This failure compromises the effective transfer of the patient's care to the next care provider by not providing information that identifies effective and/or ineffective treatment strategies for the individual patient. (Refer to B133)

IX. Assure that physicians completed discharge summaries that contained psychiatric recommendations related to anticipated problems, and that suggested interventions after discharge for 5 of 5 discharged patients whose records were reviewed (DC1, DC2, DC3, DC4, and DC5). This failure results in a lack of critical clinical information about the patient's level of psychiatric symptomatology and risk being available to aftercare providers. (Refer to B135)

Based on record review and interview, it was determined that the Director of Nursing failed to provide adequate oversight to ensure standards of nursing care. Specifically, the DON failed to:

I. Ensure that the Master Treatment Plans of 5 of 9 active sample patients (2, 4, 11, 14 and 15) clearly delineated the role of nursing in the care of the patient. The listed nursing interventions on the patients' treatment plans were generic nursing tasks, not individualized interventions for the patients. This deficiency results in lack of guidance to staff in providing individualized nursing care.

Findings include:

A. Record Review

1. Patient #2: In a Master Treatment Plan dated 07/29/11, for Problem #1 "Disturbed Thought Process," the nursing interventions were listed as: "Safety checks q. 15 LOS, medication education with each med pass daily, LOS, redirection to encourage appropriate behaviors." These interventions were generic tasks that would be performed for any patient.

2. Patient #4: In a Master Treatment Plan dated 08/02/11, for Problem #1 "Risk for Violence-Directed at Others," the nursing interventions were listed as: "Staff checks q 15 daily, LOS, 1:1 LOS to prompt, monit (monitor) appropriate behaviors as ordered (unreadable) and prompt for 2 groups daily, medication education daily." These interventions were generic tasks performed for any patient.

3. Patient #11: In a Master Treatment Plan dated 07/11/11, for Problem #1 "Disturbed Thought Process," the nursing interventions was listed as: "Safety checks q 15 for LOS, Prompt for meds, v/s groups & milieu daily, LOS, daily nsg mental health assessment, LOS." These interventions were generic tasks performed for any patient.

4. Patient #14: In a Master Treatment Plan dated 07/22/11, for Problem #1 "Disturbed Thought Process," the nursing interventions were listed as: "teach about illness, relapse prevention, treatment options each day, LOS, reality feedback daily as appropriate, LOS, Safety checks daily q 15 LOS." These interventions were generic tasks that would be performed for any patient.

5. Patient #15: In a Master Treatment Plan dated 07/29/11, for Problem #1 "Ineffective Coping, Self Care Deficit," the nursing interventions were listed as: "Safety Checks q 15, Mont (monitor) and prompt for milieu, groups, Bid nursing assessment- LOS Medication education, Provide article for ADL's- Daily LOS." These interventions were generic tasks that would be performed for any patient.

These deficiencies resulted in treatment plans that failed to provide direction to the nursing staff in providing individualized nursing care for each patient.

B. Staff Interview

In an interview on 08/02/11 at 2PM, LPT1 stated, "I have no involvement with the Treatment Plans for my patients; all of them are written by a RN who is in charge, I don't know what's in them, they (treatment plans) are not helpful or needed for me to give care."

II. Ensure that the treatment plan specify individualized interventions that nursing staff could provide in the care of patients who had been secluded and/or restrained for 1 of 9 active sample patient (#4) and one non sample patient (S-1). For Patient #4, the MTP dated 08/02/11 did not include the history/problem of the patient's frequent S & R during a prior admission, nor any notation in the MTP of a previous behavioral plan which had been developed for this patient at the prior admission to reduce the use of seclusion or restraints. This deficiency results in the absence of documented direction to RN staff to reduce the use of S& R. For patient S-1, the Director of Nursing failed to ensure that the nursing staff secluded and restrained the patient in such a way that patient rights were maintained. For details of the failed practices, refer to B125, Part II.

III. The DON failed to protect patients' rights through the provision of clothing that promoted dignity and respect.

Findings include:

Patient 5 was maintained in an orange jail jumpsuit at the direction of the sheriff who had jurisdiction, and staff reported this was aroutine procedure they followed if directed to do so by the sheriff. This failure resulted in 1 of 9 active sample patients (5) having to wear an orange jail jumpsuit, thus being denied dignity and privacy by not having street clothing available to wear. Refer to B125 Part III for details of this failed practice.

Based on record review and interview, The Director of Social Services failed to ensure:

I. Ensure that social work staff provided a social work assessment for 1 of 9 active sample patients (#5). This failed practice can result in lack of professional social work treatment services being available for a patient, and lack of discipline specific information being available for the treatment team.

Findings include:

A. Record Review

Patient #5: Admitted 7/28/11 noted in a Social Service Progress Note dated 7/29/11; "Neither patient or his mother could provide us with reliable or accurate social history. Request extension of Psychosocial Assessment/Discharge Plan until 8/1/11."

There were no further social service progress notes or a psychosocial evaluation in the patient's record prior to discharge in the afternoon on 8/2/11 (5 days after admission).

B. Policy Review

Psychiatric Health Facility Policies and Procedures, A-7.2/NG-2.2, titled "Assessments" last revised 9/1/10 noted that "a psychosocial assessment will be completed within 72 hours."

C. Interview

In an interview on 8/2/11 at 2:15PM, the Director of Social Services agreed with the findings.

II. Assure that psychosocial evaluations completed by staff in the social work department who were not trained in social work were reviewed by a masters level social worker for 7 of 8 active sample patients whose records had completed psychosocial evaluations (1, 2, 4, 10, 11, 14 and 15).

Findings include:

A. Record Review

1. Patient 1: Psychosocial Assessment was completed on 7/16/11 by an MFT (Marriage and Family Therapist). There was no evidence that the assessment had been reviewed or countersigned by a master's level social worker.

2. Patient 2: Psychosocial Assessment was completed on 7/29/11 by an MFT (Marriage and Family Therapist). There was no evidence that the assessment had been reviewed or countersigned by a master's level social worker.

3. Patient 4: Psychosocial Assessment was completed on 7/30/11 by an MFT (Marriage and Family Therapist). There was no evidence that the assessment had been reviewed or countersigned by a master's level social worker.

4. Patient 10: Psychosocial Assessment was completed on 5/18/11 by an MFT (Marriage and Family Therapist). There was no evidence that the assessment had been reviewed or countersigned by a master's level social worker.

5. Patient 11: Psychosocial Assessment was completed on 7/14/11 by an MFT (Marriage and Family Therapist). There was no evidence that the assessment had been reviewed or countersigned by a master's level social worker.

6. Patient 14: Psychosocial Assessment was completed on 6/1/11 by an MFT (Marriage and Family Therapist). There was no evidence that the assessment had been reviewed or countersigned by a master's level social worker.

7. Patient 15: Psychosocial Assessment was completed on 7/28/11 by an MFT (Marriage and Family Therapist). There was no evidence that the assessment had been reviewed or countersigned by a master's level social worker.

B. Interview

In an interview on 8/2/11 at 2:30PM, the Director of Social Work was shown the psychosocial evaluations noted in Section A. She was asked if she reviewed the work of non-master's level social workers and she stated that she "looked at 2 records a month." The Director of Social Work acknowledged that she did not review all of the psychosocial evaluations that were performed by staff not trained as social workers.

Based on record review and interview, it was determined that the facility failed to regularly implement a structured program of therapeutic/leisure activities on weekends for the inpatient population, including the 9 of 9 active sample patients (1, 2, 4, 5, 7, 10, 11, 14 and 15). Failure to provide adequate structured therapeutic groups/activities to assist the patients in meeting their treatment goals can delay patient progress and prolong hospitalizations.

Findings include:

A. Interviews

In an interview on 8/2/11 at 2:30 PM, AT 2 stated, "There are no activities currently on Sundays; no Activity Therapists are working on Sundays. We work every other Saturday and essentially everyone sleeps in; we get a late start and have some leisure time....If there are no group notes, then the patient did not attend."

In an interview with patient #14 on 08/02/11 at 1PM s/he stated, "There's nothing to do here, they're not helping me, they just walk around and look at me (referring to staff)....There are no activities, the few they have don't mean anything to me....I have so much anger and depression and sadness but no one will listen, can you help me?...Sometimes I'll smoke a cigarette just to do something....I like to read and write. I try to keep busy doing that, there's nothing much more to do here."

B. Record Review

A review of the medical records for the 9 active sample patients for the two weekends prior to the survey revealed no activity/group notes for Sundays on 7/24/11 and 7/31/11.

Based on observation, staff interviews and review of hospital documents, the governing body failed to ensure that the food service and consultant dietitian contracts were executed in a manner that complied with conditions of participation for dietary services.

Findings:

Review of the hospital's contract for dietary services was done on 1/11/11. The contract was initially entered into on 12/15/2004. An attached "Exhibit A" which described the roles and responsibilities of the contractor was also reviewed. According to this document, the contracted service was to maintain a policy and procedure manual (P/P) that reflected the contractor's practices indicating how the contract would be executed.

According to the contract, meals were to be delivered at specified times. On 1/11/11 dinner arrived and was served before 4:30 p.m.. Hospital staff did not document the arrival time. The LN who served the meal stated that it arrived early and rather than let the food get cold he served it. Review of the dietary services contract revealed dinner was to be delivered at 4:45 p.m. and served at 5:00 p.m.. In an interview with the Program director on 1/11/11 at approximately 9:20 a.m., she identified the early delivery of patient food as one of the many issues that they have been working on with the contracted services. She explained that on weekends, the dinner meal is delivered about 1:00 p.m. because the cafe kitchen which produces the food closes at 12 (noon), and so they prepare cold sandwiches and put it on ice. A result of this early eating is that the patients are hungry and the hospital provides them additional snacks other than what is provided by the contracted service. This observation on 1/11/11 and interview with the program director revealed that this requirement was not always met (cross refer A630). These failures resulted in patients being served exceeding the community standards of the 14 hour span between dinner and breakfast the following day.

A tour of the contractor's kitchen showed an environment that was cluttered, and unsanitary. There was food service equipment that was not maintained in a working condition. Staff practices including food storage, were not in compliance with good food safety guidelines. There were refrigerators that did not have thermometers. Foods stored in all of the refrigerators were not labeled or dated. Some refrigerator temperature logs had not been maintained or checked since 11/1/10.

Six containers were found in one of the walk-in refrigerators on 1/10/11 at approximately 3:50 p.m.. According to the food service manager (FSM), this item was cream of wheat prepared ahead for the breakfast for another program. The temperature of the items varied from 120.1 degrees Fahrenheit to 156 degrees Fahrenheit. These items were not being monitored to ensure that it cools down appropriately. Improperly cooled foods left in the danger zone 41 to 135 degrees Fahrenheit for over 4 hours could result in food borne microorganisms that could cause food borne illness. The kitchen closes at about 5:00 p.m.; therefore no monitoring was done when the kitchen was closed.

Staff knowledge was inadequate in terms of dish washing and sanitizer testing. Two different staff members were interviewed on how they ensured that the dishes were properly sanitized. The contracted dietary services employee washing pots and pans in the three compartment sink, did not accurately identify the correct level of sanitizer in the sanitizing compartment of the sink. Although the strip read between 100 - 200 ppm (parts per million), he circled 200 on the log. The recommended level is 200 ppm or above.

The dietary services employee operating the dish machine on 1/10/11, at approximately 4:20 p.m. did not have the proper test strips to check the concentration of the sanitizer. The FSM stated at this time, his staff did not monitor the dish machine and only the service company who services the machine and sells them chemicals will check it when they come out once a month. Review of the county environmental health department inspection report dated 2/2/10, showed that the appropriate chemical test strips were not available during the inspection.

The hospital served meals at temperatures that were not palatable. It could not be determined whether the food was delivered at low temperatures or if the hospital staff were not maintaining the food at the proper temperature after delivery due to malfunctioning steam table (Cross refer A 620). The contracted dietary services staff stated that they do not record food temperatures prior to delivery at the facility.

The menu provided by dietary contracted service was posted in the kitchen in the hospital. There was no evidence that it was approved. An interview with the dietary contracted services RD could not be conducted for verification of her role in menu planning and approval. The January 2011 menu did have portion sizes. Hospital staff was sent serving utensils without instructions on how much to serve. The nutrition adequacy of the diet served could not be validated.

Review of the hospital menu for the month of January 2011 was reviewed. According to the menu, breakfast burrito and orange were items to have been served for breakfast on 1/10/11. But, the menu did not have portion sizes listed next to the items. Further review showed that none of the menu items for all three meals for the month had any portion sizes listed. Review of the lunch menu dated 1/10/11, showed BBQ chicken, macaroni and cheese, mixed vegetables, an orange, and milk for the lunch meal. The menu did not show portion sizes or scoop sizes. On 1/10/11, at approximately 11:50 a.m., on the steam table were BBQ chicken, green salad, macaroni and cheese, and cooked carrots and peas. The green salad was being served with a spaghetti spoon/server, macaroni and cheese and cooked carrots and peas were being both served with a six ounce (oz) spoodle, and the BBQ chicken was being served with a spatula.

The nutrition adequacy was unable to be validated due to lack of stated portion sizes of the meal items. No oranges were observed in the serving area. The menu did not state there would be a green salad served. A green salad would not be an equal substitute for an orange, on the basis of the green salad containing less vitamin C. The menu for the lunch meal on 1/11/11, showed pork loin, rice pilaf, mixed vegetables, dinner roll, fruit mix, and milk. The patients received lima beans instead of mixed vegetables and they did not receive a dinner roll. Patients also received the green salad that was not listed on the menu. The substitutions were made without being posted on the menu. There was no substitute provided for the missing dinner roll. RA1 served lima beans and rice pilaf with a six oz spoodle, pork loin (pre-sliced) with tongs. The portion sizes were not consistent for all the patients served. Some patients were served spoodle that was half-full; others were served 3/4th full. There were no cardex or patient diet cards instructing RA1 on what amount to serve each patient. It was unclear why each patient was not consistently served the same amount.

Concerns regarding a lack of portion sizes were shared with the contracted meal service provider manager (FSM). In an interview on 1/10/11, at approximately 2:30 p.m. he stated that in addition to the hospital's contract, the dietary contracted service also provides meals for children's program and a senior nutrition program. He indicated that the hospital menu is planned by a registered dietitian who was not housed in the office he was located. He further stated that the menu had a nutrient analysis. A call was placed to the dietary contracted services RD however, was not returned until after the surveyor had exited the hospital. (Cross refer 630)

The dietary contracted service did not consistently provide the hospital with all items as planned on the menu or made substitutions that were not documented prior to meal service. Meals were also delivered prior to scheduled meal times resulting in patients eating dinner very early requiring the hospital staff to provide snacks ou

Based on interview and policy and procedure review, the hospital failed to ensure that an active, on going, comprehensive, facility wide, quality assessment and performance improvement program (QAPI) was enacted. There was no documentation to reflect that infection control issues were incorporated into a hospital wide QAPI program.

Findings:

Interview with the program director on 1/12/11 at 9:45 a.m. revealed that the infection control committee had not been reporting to the quality committee.

Review of the Infection Control Manual, policy and procedures, reflected no current approval date of the policies. The Medical Director, Infection Control Practitioner and the facility Internist had not signed off on the policies. The form indicated that policies were reviewed annually for revision. The last revision date was noted to be in 5/2007. There was no mention of what infection control guidelines were to be utilized. The Infection Control Committee consisted of the Medical Director, Program Manager, Nurse Manager, Quality Improvement Manager, Infection Control Practitioner and the Internist.

Interview with the quality manager on 1/13/11 at 3:30 p.m. revealed that the infection control policies and procedures had not been reviewed recently nor were there any recent approval dates. The quality committee had not been proactively involved with the infection control process.

Based on interview with facility staff and review of documents the hospital failed to ensure that there was an ongoing quality assessment and performance improvement (QAPI) program.

Findings:

Review of the Compliance Committee (formerly the Utilization Review Committee) meeting minutes revealed the material reviewed at the meetings was related to utilization review not QAPI activities. In an interview on 1/11/11 at 11 a.m. the QA Manager stated medical care evaluation studies as required by Department of Mental Health were ongoing. In an interview on 1/12/11 at 3:15 p.m. a department business analyst stated there were two studies currently ongoing. One study was the re-hospitalization rates of the hospitals clients and the other was the utilization of hospital's bed days by jail clients. Review of the studies revealed both were utilization review studies concerned with length of stay at the hospital. There was no documentation of studies which used quality indicators for the improvement of health outcomes or the reduction of medical errors.

Based on document and medical record review the hospital failed to measure, analyze and track quality indicator, including adverse patient events and other aspects of performance that assess care and services. (Refer to A-164, A-747)

Findings;


Review of the documentation provided by the facility revealed there were no performance improvement activities which tracked medical errors and adverse patient events, analyzed their causes, and implemented preventative actions.

Document review revealed a patient expired while in restraints and seclusion on 4/29/10. There was no performance improvement documentation to indicate this adverse patient event was analyzed and/or tracked to assess care provided, and to identify improvement actions.

Review of the Infection Control Report dated 12/09-6/10 reflected three areas that were targeted: Employee Health, Environment and Infections. Under Infections there was a tally of 50 reported infections over a six month period. 40 were skin related, five were respiratory and five were for urinary tract infections. There was no breakdown of the data to ascertain what type of infections had been contacted, treatments utilized, treatment effectiveness, antibiotic choices based on the organism nor any analysis of the application/administration of ordered medications by facility staff.

Interview with LN 1, on 1/11/11 at 9:50 a.m. revealed that he has never attended an infection control meeting. He submits data that he collects and does not hear any more information. He has never had any input on any revisions to the policies and procedures. He had not attended an infection control committee meeting. He does not do any personal surveillance of employees, including handwashing techniques. He collects data on a quarterly basis and submits to the charge nurse. He did not know of any outcomes or decisions with the information that he submitted.

Interview with the program director on 1/12/11 at 9:45 a.m. revealed that the infection control committee had not been reporting to the governing board or the quality committee. She agreed that there was a lack of communication between committees and staff. Data collection, surveillance and monitoring had not been done on a proactive daily basis.




25764

Based on document review, interview and policy and procedure review, the hospital failed to develop quality indicators for performance improvement in infection control, pharmacy services,, nursing services and dietary services through out the hospital.

Findings:

1. Review of the Infection Control Report dated 12/09-6/10 reflected three areas that were targeted: Employee Health, Environment and Infections. Under Infections there was a tally of 50 reported infections over a six month period. 40 were skin related, five were respiratory and five were for urinary tract infections. There was no breakdown of the data to ascertain what type of infections had been contacted, treatments utilized, treatment effectiveness, antibiotic choices based on the organism nor any analysis of the application/administration of ordered medications by facility staff.

Interview with LN 1, on 1/11/11 at 9:50 a.m. revealed that he has never attended an infection control meeting. He submits data that he collects and does not hear any more information. He has never had any input on any revisions to the policies and procedures. He had not attended an infection control committee meeting. He does not do any personal surveillance of employees, including handwashing techniques. He collects data on a quarterly basis and submits to the charge nurse. He did not know of any outcomes or decisions with the information that he submitted.

Interview with the program director on 1/12/11 at 9:45 a.m. revealed that the infection control committee had not been reporting to the governing board or the quality committee. She agreed that there was a lack of communication between committees and staff. Data collection, surveillance and monitoring had not been done on a proactive daily basis.

Based on document and medical record review the hospital failed to measure, analyze and track quality indicator, including adverse patient events and other aspects of performance that assess care and services. (Refer to A-164, A-747)

Findings;


Review of the documentation provided by the facility revealed there were no performance improvement activities which tracked medical errors and adverse patient events, analyzed their causes, and implemented preventative actions.

Document review revealed a patient expired while in restraints and seclusion on 4/29/10. There was no performance improvement documentation to indicate this adverse patient event was analyzed and/or tracked to assess care provided, and to identify improvement actions.

Review of the Infection Control Report dated 12/09-6/10 reflected three areas that were targeted: Employee Health, Environment and Infections. Under Infections there was a tally of 50 reported infections over a six month period. 40 were skin related, five were respiratory and five were for urinary tract infections. There was no breakdown of the data to ascertain what type of infections had been contacted, treatments utilized, treatment effectiveness, antibiotic choices based on the organism nor any analysis of the application/administration of ordered medications by facility staff.

Interview with LN 1, on 1/11/11 at 9:50 a.m. revealed that he has never attended an infection control meeting. He submits data that he collects and does not hear any more information. He has never had any input on any revisions to the policies and procedures. He had not attended an infection control committee meeting. He does not do any personal surveillance of employees, including handwashing techniques. He collects data on a quarterly basis and submits to the charge nurse. He did not know of any outcomes or decisions with the information that he submitted.

Interview with the program director on 1/12/11 at 9:45 a.m. revealed that the infection control committee had not been reporting to the governing board or the quality committee. She agreed that there was a lack of communication between committees and staff. Data collection, surveillance and monitoring had not been done on a proactive daily basis.




25764

Based on document review, interview and policy and procedure review, the hospital failed to develop quality indicators for performance improvement in infection control, pharmacy services,, nursing services and dietary services through out the hospital.

Findings:

1. Review of the Infection Control Report dated 12/09-6/10 reflected three areas that were targeted: Employee Health, Environment and Infections. Under Infections there was a tally of 50 reported infections over a six month period. 40 were skin related, five were respiratory and five were for urinary tract infections. There was no breakdown of the data to ascertain what type of infections had been contacted, treatments utilized, treatment effectiveness, antibiotic choices based on the organism nor any analysis of the application/administration of ordered medications by facility staff.

Interview with LN 1, on 1/11/11 at 9:50 a.m. revealed that he has never attended an infection control meeting. He submits data that he collects and does not hear any more information. He has never had any input on any revisions to the policies and procedures. He had not attended an infection control committee meeting. He does not do any personal surveillance of employees, including handwashing techniques. He collects data on a quarterly basis and submits to the charge nurse. He did not know of any outcomes or decisions with the information that he submitted.

Interview with the program director on 1/12/11 at 9:45 a.m. revealed that the infection control committee had not been reporting to the governing board or the quality committee. She agreed that there was a lack of communication between committees and staff. Data collection, surveillance and monitoring had not been done on a proactive daily basis.

Based on document review, the hospital failed to ensure that the QAPI program developed and incorporated quality indicators, including patient care data.

Findings:

Review of the documentation provided by the facility revealed there was no data collection used to monitor the effectiveness and safety of services and quality of care.

Based on interview and document review, the hospital failed to monitor the effectiveness of investigations pertaining to patient safety. There was no analysis or follow up of data collected to ensure that practices were targeted toward improvement.

Findings:

SUSAN.....need your data on incident reports......

Based on interview, the hospital failed to identify problem prone areas for improvement. There was no identification of issues related to patient rights, nursing services, pharmacy services, dietary services, life safety or infection control.
(Cross reference: A-0115, A-0385, A-0490, A-0618, A-0700, A-0747)

Findings:

Interviews conducted the week of 1/10/11 with the medical director, program director and the DON the hospital had not identified any trends or problem prone areas for improvement related to patient rights, nursing services, pharmacy services, dietary services, life safety or infection control.

Based on interview, the hospital failed to specify the frequency and detail of hospital wide data collection. There was no identification of specific data collection frequencies related to patient rights, nursing services, pharmacy services, dietary services, life safety or infection control.

(Cross reference: A-0115, A-0385, A-0490, A-0618, A-0700, A-0747)

Findings:

Interviews conducted the week of 1/10/11 with the medical director, program director and the DON revealed that the hospital had not specified the frequency nor details of the data to be collected on a hospital wide basis.

Based on document and record review and staff interview, the hospital failed to ensure that performance improvement activities focused on high risk, high volume problem prone areas, that affect patient safety and quality of care. A review of the hospitals patient acuity system, which identifies staffing needs based on an assessment of the patients needs, and review of staffing records, revealed adequate numbers of licensed staff was not consistently provided to meet the needs of the patients, placing the patients and staff at risk for harm. There was no documentation to indicate the hospital had evaluated the effectiveness of their current patient acuity system for effectiveness. (Refer to A- 0392).

Findings;

A review of the facility's patient acuity/staffing policy and procedures on 1/11/11 at 10:00 a.m. revealed... " Nursing general policies. Acuity NG-2-0," effective 1/1/2000 and revised May 2006. According the policy the "daily nursing staff and requirement based on patient acuity as identified by levels of care. Patient acuity determination will be identified daily to identify, justify and guide the assignment of nursing staff. The total staffing requires the scheduling of at least one (1) registered nurse on each shift to provide assess, assign, direct, and/or supervise the care rendered by other nursing staff."

The facility utilizes patient criteria levels of 0 through 3.
A level 0 requires a 1:1 staff, patient is a high risk, in restraints or seclusion, or the patient continues to escalate despite frequent staff intervention.
A level 1 requires every 30 minutes observation and includes; a new admit within 24 hours, patient requires constant re-direction and limit setting.
A level 2 patient requires moderate assistance. may have a special medical treatment, seizure precautions, and may be verbally threatening or provocative but no physical threats.
A level 3 patient requires only minimal prompts, and is generally stable.

Interview with the Director of Nurses on 1/12/11 at 2:00 p.m. revealed that patient acuity assessments are completed daily at 11:30 a.m., and based on the assessment of each patient staffing needs are determined for the day. Most staff work 12 hour shifts ( 7a.m.-p.m. and 7 p.m. to 7 a.m.), but at times there is a staff who would work a variation of different hours, such as 1 p.m. -11 p.m. or 7 a.m.- 5 p.m..

The patient acuity assessments/staffing sheets for 4/26, 4/27,4/28, 4/29, 5/1, and 5/2/2010 were requested for review. A review of the six days revealed the facility failed to have an adequate number of staff to meet the patient needs, as identified on the acuity/staffing records, for all six of the days reviewed. The shortage of staff ranged from 1 to 4 staff.

On 4/26/10 the patient census was 16; (-2 staff)
1 patient was assessed at a level 0 and required a 1:1 staff;
2 patients were assessed at a level 1, and required constant redirection and every 30 minute observations.
13 patients were assessed at a level 2.
According to the staffing record although 12 staff were required to meet the acuti needs of the patients, only 10 staff were scheduled/provided for the 24 hours.

On 4/27/10 patient census was 17; (-4 staff)
2 two patients were assessed at a level 0, both requiring a 1:1 staff;
2 patients were assessed at level 1 and required every 30 minutes observations;
12 patients were at a level 2 (moderate assist); and
1 patient was a level 3 (stable).
According to the staffing record 14 staff were required to meet the needs of the patients, however, only 10 staff were scheduled/provided for the 24 hours.

On 4/28/10 patient census was 15; (-2 staff)
1 patient was a level 0 (1:1)
4 patients were assessed at a level 1, this included 2 new admissions and 2 potential admissions coming in ( require every 30 minutes observations);
9 patients at a level 2 (moderate assist); and
1 patient was a level 3 (stable).
According to staffing/acuity records 11.92 staff were required to meet the needs of the patients, however, only 10 staff were scheduled/provided for the 24 hours.

A review of the assignment sheets for 4/28/10 with LN5 verified that 3 staff worked the second shift (p.m.-a.m.). One of the 3 staff would be assigned to do the 1:1 patient observations, leaving the other two staff to complete the every 30 observations, and the other duties assigned to the shift, including the two new admissions. Staff interview on 1/12/11 at 2:30 p.m. with LN5 and LN2 verified that only 3 staff was not an adequate number of staff to meet all of the patients care needs and complete all of the duties required for the second shift.

On 4/29/10 patient census was 16;(-2 staff)
1 patient at a level 0;
2 patients were a level 1
12 patients were level 2
1 patient was a level 3. Per the daily acuity system 12 staff were needed for the patient's needs, however only 10 staff were scheduled/provided for the 24 hours.

On 5/1/10 patient census was 15; ( - 1.5 staff)
1 patient at a level 0
1 patient at a level 1 (new admit)
13 patients at a level 2. per the daily acuity system rating 10.66 staff were required, however only 9.41 staff were scheduled/provided for the 24 period.

On 5/2/10 patient census was 16; (-2.29 staff)
2 patients at a level 0 required 1:1
1 patient at a level 1 (new admit)
12 patients at a level 2 and
1 patient at a level 3. Per the daily acuity 12.42 staff were required to meet the needs of the patients, however, on 10.13 staff were scheduled/provided for the 24 hour period.

Interview with two licensed nursing staff (LN5 and Ln 2) on 1/12/11 at 2:00 p.m. verified that the acuity rating of the patients is done only once a day and if a patient's condition becomes more acute and the acuity changes additional staff can be called in. Both nurses verified that they are "frequently" asked to do overtime.

When asked if the current acuity/staffing system has been evaluated to ascertain if the system was still effective both nurses stated that there has been no evaluation or revision of the current system "for as long as I have been here" (over 8 years). Staff interview verified that no data was collected or analyzed to evaluate the current patient classification system/staffing to ensure it was effective in meeting the needs of the patients.

Based on hospital staff interview and review of the facility's Quality Assurance/ Utilization Committee minutes the hospital failed to ensure that the results and summaries and trends of reports were shared with administrative hospital staff. The sharing of this information would allow administrative staff to incorporate the information into opportunities for modifying the way that the hospital provides patient care.

Findings:

Review of the hospital's Quality Assurance/ Utilization Committee minutes on 1/13/11 revealed 15 to 20 reports that had been provided to the Committee, by the Acute Hospital during the 2010 year. No trending of the 15 to 20 specific incidents, could be found in the Quality Assurance/ Utilization Committee minutes, which required any type of action to be taken by the hospital. Interview with the Acute Hospital's DON (Director of Nursing Services) on 1/13/11 at 9:30 a.m. revealed that the reports for the Hospital, were collected by her and the Program Manager and then forwarded to Quality Assurance (QA) for analysis and trending. The DON also stated that unless QA brings back specific trends of events to the DON or the Program Manager, the DON and the Program Manager receive no information to assist them in modifying the way that the Hospital provides patient care. The hospital's DON and Program Manager confirmed that no information about the incidents which they send to QA have ever been brought back or shared with them by QA to assist with the modification in the way that patient care has been provided by the hospital.

Based on hospital staff interview, review of the facility's Quality Assurance/ Utilization Committee minutes and review of the facility's Medical Practice Committee minutes the hospital failed to ensure that the results, trends, and summaries of the incident reports were shared with administrative hospital staff. The hospital had no system in place to implement improvement actions, measure it's success and track performance to ensure improvements were maintained as a result of the data from the reports which had been gathered.

Findings:

Review of the hospital's Quality Assurance/ Utilization Committee minutes, Medical Practice Committee and administrative staff interview on 1/13/11 revealed that the facility had no system in place to implement improvement actions, measure any of it's success and track performance to ensure improvements as a result of the hospital's reports. Interview with the Acute Hospital's DON on 1/13/11 at 9:30 a.m. revealed that the reports for the Hospital are collected by her and the Program Manager and then forwarded to Quality Assurance (QA). The DON also stated that unless QA brings back specific trends or issues to the DON or the Program Manager, the DON and the Program Manager receive no information to assist them with modifying the way that the Hospital provides patient care. The hospital's DON and Program Manager confirmed that no information about the incidents that are sent to QA have ever been brought back or shared with them by QA. Interview with the QA Manager on 1/12/11 at 3:00 p.m. and again on 1/13/11 at 5:11 p.m. revealed that the hospital had not be aware of it's need to implement improvement actions, measure it's success with any system changes that had been implemented from the QA reports. The QA Manager also indicated that the hospital did not track performance improvements and ensure that any changes were maintained.

Based on hospital staff interview, review of the facility's Quality Assurance/ Utilization Committee minutes and review of the facility's Medical Practice Committee minutes the hospital failed to ensure that the results, trends, and summaries of the incident reports were shared with administrative hospital staff. The hospital had no system in place to implement improvement actions, measure it's success and track performance to ensure improvements were maintained as a result of the data from the reports which had been gathered.

Findings:

Review of the hospital's Quality Assurance/ Utilization Committee minutes, Medical Practice Committee and administrative staff interview on 1/13/11 revealed that the facility had no system in place to implement improvement actions, measure any of it's success and track performance to ensure improvements as a result of the hospital's reports. Interview with the Acute Hospital's DON on 1/13/11 at 9:30 a.m. revealed that the reports for the Hospital are collected by her and the Program Manager and then forwarded to Quality Assurance (QA). The DON also stated that unless QA brings back specific trends or issues to the DON or the Program Manager, the DON and the Program Manager receive no information to assist them with modifying the way that the Hospital provides patient care. The hospital's DON and Program Manager confirmed that no information about the incidents that are sent to QA have ever been brought back or shared with them by QA. Interview with the QA Manager on 1/12/11 at 3:00 p.m. and again on 1/13/11 at 5:11 p.m. revealed that the hospital had not be aware of it's need to implement improvement actions, measure it's success with any system changes that had been implemented from the QA reports. The QA Manager also indicated that the hospital did not track performance improvements and ensure that any changes were maintained.

Based on review of documents the hospital failed to ensure that performance improvement projects were conducted.

Findings:

Review of documents provided by the facility revealed the facility did not have documentation of quality improvement projects being conducted, reasons for conducting projects, or measurable progress from the projects.

Based on review of the hospital's Medical Staff Committee minutes, interview with the hospital's Medical Director, and the Program Manager, the hospital failed to ensure that the hospital's Pharmacy Policy and Procedure manual was approved by any of the hospital's medical staff committees. The hospital failed to ensure that the contracted Pharmacy provider was able to provide all the necessary services which are required for an Acute Care Hospital. The hospital failed to ensure that policies and procedures which are outlined in this manual were being implemented into the hospital's practices. Review of the hospital's only medication refrigerator log, the Pharmacist medication regimen review and facility staff interview revealed that the hospital failed to ensure that the medication refrigerator was maintained between 36 and 46 degrees Fahrenheit, and that actions were taken by staff when the refrigerator was out of range. The facility's administrative staff also failed to take corrective actions when this issue of refrigerator temperatures being maintained out of range, was brought to administrations attention on several occasions by the hospital's Pharmacist, this could alter the integrity of the refrigerated drugs.


Findings:


1. Inspection of the hospital's Pharmacy Policy and Procedure manual on 1/11/11, which was labeled: "Nursing Care Center Pharmacy Policy and Procedure Manual", contained a document entitled:" Pharmacy Policies and Procedures Annual Authorization". The document read: "The nursing care center's Pharmacy Services Subcommittee/Pharmaceutical Services Committee/Quality Assessment and Assurance Committee/ or its equivalent, on this the day of...hereby approve and adopt the following policies and procedures as amended by the nursing care center in accordance with nursing care center standards and state and federal regulations. The hospital's failure to address these out of range refrigerator temperatures may have altered the integrity of all of the facility's refrigerated drugs and biologicals.

All medical, nursing and pharmacy staff shall be inserviced on and have access to this manual." Not only does this facility not have any of the Committees identified above, but the facility's Medical Staff Committees had no oversight on any approval of this Pharmacy policy and procedure manual. The remainder of the Authorization page had signature lines for the following administrative staff: Administrator, Director of Nursing, Medical Director or physician designee, and the Consultant Pharmacist. This page was completely blank, indicating that this policy and procedure had not been reviewed by the facility's administrative staff or the Consultant Pharmacist. Interview with the hospital's Program manager on 1/11/11 at 10:35 a.m. revealed that this manual was the hospital's official Pharmacy policy and procedure manual. Interview with the hospital's Medical Director on 1/12/11 at 11:15 a.m. revealed that no one could provide proof that this policy and procedure had been reviewed by any of the hospital's administrative staff or any of the facility's Medical Staff Committee's prior to its' use in the facility. The blank copy of the facility's "Pharmacy Policies and Procedures Annual Authorization form had accurately reflected the hospital's failure to approve this Pharmacy policy and procedure manual.

2. Review of the hospital's Pharmacy policy and procedure manual introduction page stated the following information indicating that this Pharmacy provider only services "Long Term Care" facilities: "XXXX (the Pharmacy's name was removed) Corporation specializes in long-term care pharmacy, providing medications, consulting programs, regulatory assistance and related services to long-term care residents in skilled nursing, sub-acute and assisted living settings nationwide....XXXXX (the Pharmacy's name was removed) Corporation has compiled this collection of policies and procedures as a basic practice guideline for pharmaceutical services for the professional nurse in a long-term care setting....The responsibility for ensuring the accuracy of any provision and updating of the procedures for compliance within your nursing care center remains with you."

The introduction in this manual confirms that this Pharmacy does not provide services for a facility certified as an Acute Care Hospital, which this hospital is currently certified as. As a result of this information, the hospital's Pharmaceutical services were not the same as the Pharmaceutical services which are being provided at other Acute Hospitals. Interview with the facility's Program Manager and the facility's Director of Nurses on 1/13/11 at 5:10 p.m. confirmed that the services that the facility was receiving from the Pharmacy provider above, were not meeting the hospital's expectations and needs.

3. Review of the hospital's Pharmacy policy and procedure manual on 1/13/11 at 2:00 p.m. revealed a policy and procedure entitled:"Black Box Warning Medications". The policy states:"...1. Nursing Staff shall refer to "Black Box" Warning Monitoring Guidelines...". No such monitoring guidelines could be provided by the facility. Interview with LN5 on 1/13/11 at 2:15 p.m. revealed that about one year ago, nursing staff were provided with medication side effect and other important drug information documents which could be given to patients who were being discharged from the facility. LN5 went on to say during the interview that she would provide any patient with the information that she remembered about each drug.

Interview with LN2 on 1/13/11 at 2:18 p.m. revealed that she too would do the same, in regards to providing her patient drug information based on her memory of the drugs which were being dispensed. Nursing staff indicated that the information about the drugs which was shared with the patients at the time of discharge, would not always be consistent from nurse to nurse. LN5 indicated that the facility's Pharmacy use to send the facility standardized drug information sheets for reference and to be provided to the discharge patient for the sake of consistency. Both Nursing staff indicated that they missed the fact that Pharmacy was no longer providing them with these standardized drug information sheets, for the nurses to share this information with the patients at discharge for consistency.

4. Review of the facility's Pharmacy policy and procedure manual on 1/12/11 revealed a policy and procedure entitled: "Emergency Pharmacy Service and Emergency Kits", which read:"....Emergency needs for medication are met by using the nursing care center's approved emergency medication supply or by special order from the provider pharmacy...". The hospital did not have an approved list of emergency drugs for use. The same Pharmacy policy and procedure goes on to say:" 3. The provider pharmacy supplies emergency or "stat" medications/items according to the provider pharmacy agreement...".

The hospital's pharmacy agreement states:"Services to be provided by Contractor: A. Check and replenish "stock" medications and emergency box". Interview on 1/12/11 at 3:50 p.m. with one of the hospital staff nurses revealed that the only emergency supplies that the facility had for Diabetic emergencies was oral glucose tubes, which could not be administered for an unconscious patient. The pharmacies policy and procedure manual did not indicate what emergency drugs should be present in the facility.

5. The hospital's Nursing policy and procedure entitled: "Nursing -Medications", reads: "A refrigerator will be housed in the Medication Room for the storage of medications. The temperature of the refrigerator will be maintained between 2.2 degrees C (36 degrees F) and 7.7 degrees C (46 degrees F)....B. The refrigerator will be defrosted and cleaned monthly by the evening shift. C. The temperature of the medication refrigerator will be checked daily and a log maintained of daily temperatures noted. The log will be kept on top of the medication refrigerator. The refrigerator temperature shall be between 2.2 degrees C (36 degrees F) and 7.7 degrees C (46 degrees F)."
Review of the hospital's Pharmacy poli

Based on observation, staff interviews and review of hospital documents, the hospital failed to hire a full-time employee who is responsible for the daily management of the dietary services. This resulted in a food service operation that was unorganized, space that was cluttered, unclean; food service equipment that was dirty, food storage practices that were below community standards and could result in growth of microorganisms that could result in food borne illness; poor food quality due to poor dating and labeling practices. In addition, these failures resulted in staff that were inadequately trained, a menu that was not consistently followed resulting in patients not receiving adequate food as planned on the menu.

Findings:

During the initial tour of the kitchen on 1/10/11 at approximately 10:00 a.m. the following observations were made:

*Three breakfast burritos wrapped in foil and left in the steam table which was not plugged in;

*One toaster with a build up of bread crumbs visible through top openings and in tray;

*One toaster oven with a build up of black burnt material coated on rack and tray, bottom tray with black hard coating along with discolored sesame seeds. The window had a brown and yellowish film covering it and up the top of toaster oven;

*Three drawers containing various food items including: knives, spoons, were stored directly on paper lined drawers that had visible food debris and dark brown stains;

*On the top shelf of one the cupboards was a silver metal container that was firmly stuck onto shelf;

*Other cabinets were cluttered with various items including: hairnets, gloves, condiments, aprons, and low sodium packets;

*One cabinet with a stack of bowls, approximately seven of the bowls were wet and contained approximately one tablespoon of water in them;

*Freezer with no visible thermometer. A build up of ice through out shelves and a solid build up on door ice shute (outlet by which ice dispenses into a container from the ice maker inside the freezer to the dispenser on the exterior door);

*Refrigerator:
A 46 fluid ounce metal can of prune juice with the side bent and bulging on top with approximately one to two inch sliced opening with old juice thick residue around the opening. There was no date on can of prune juice indicating when it was opened;

Two, four ounce styrofoam containers filled with mandarin oranges were stored in the refrigerator with no date to indicate when it was stored;

Approximately 10 by 10 inch metal pan containing cottage cheese that showed evidence of being previously served with no date to indicate when it was stored or when it needed to be discarded;

One plastic bag containing sliced meat which was not sealed and contained no label to indicate what kind of meat it was and no date to indicate when it was placed in the refrigerator or when it needed to be discarded;

One 10 ounce container of sliced white mushrooms opened with rubber band wrapped around package. The package contained a date of packaging for 12/27.

Hand washing

On 1/11/11, at approximately 11:40 a.m. RA 1 was observed entering kitchen. Next, she used a hand sanitizer before putting on gloves prior to serving the lunch meal. At the conclusion of the meal, she returned to the hand sanitizer dispenser after taking off her gloves.

Review of the basic kitchen policy and procedures, showed to "always wash hands at the beginning of a shift,...., before putting on gloves, and at any time necessary to prevent the spread of food borne bacteria". The policy also showed to wash hands whenever you change gloves.

Meal observation

Review of the lunch menu dated 1/10/11, showed BBQ chicken, macaroni and cheese, mixed vegetables, an orange, and milk for the lunch meal. The menu did not show portion sizes or scoop sizes. On 1/10/11, at approximately 11:50 a.m., the steam table contained BBQ chicken, green salad, macaroni and cheese, and cooked carrots and peas. The nutrition adequacy was unable to be determined due to lack of stated portion sizes of the meal items. The green salad was being served with a spaghetti spoon/server, macaroni and cheese and cooked carrots and peas were being both served with a six-ounce (oz) spoodle, and the BBQ chicken was being served with a spatula.

No oranges were observed in the serving area. The menu did not state there would be a green salad served. A green salad would not be an equal substitute for an orange, on the basis of the green salad containing less Vitamin C.

Further observation revealed the steam table was turned on; there were three knobs that controlled the heat to each of the wells. The well where the macaroni and cheese was placed, the knob was turned to "2" (out of 10); the well where the cooked carrots and peas were placed, the knob was turned to "9"; and the well where the BBQ chicken was placed, the knob was turned between the 9 and 10.

Review of the written instruction titled, Weekend Standards for hospital's Meal Delivery, showed staff should "verify temperatures are at least at 160 for hot food - 40 or below for cold food". Food temperatures were taken by the surveyor which revealed the macaroni and cheese was 90.4 degrees Fahrenheit (F), cooked carrots and peas was 116.7 F, and the BBQ chicken was 128.5 F. On 1/10/11 at approximately 12:05 p.m. an interview was conducted with RA 2. RA 2 stated temperatures should be taken prior to meal service but she had forgotten to take today since she has not worked in the kitchen in awhile.

Review of the daily temperature log dated January 2011, showed no food temperatures recorded for the lunch meal or the previous meal on the 10th. Further review of the same log, showed no temperatures (blanks) for the lunch meal on the 2nd, blanks for the breakfast meal on the 3rd, blanks for the dinner meal on the 4th, blanks for the breakfast and dinner meal on the 7th, blanks for lunch and dinner meal on the 8th, and blanks breakfast and lunch meal on the 9th. The daily temperature log only accounts for one food item for each meal. It is unclear what item should be or had been recorded. This log did not have instructions on what the procedure should be and the facility did not have any policies or procedures to direct the staff on the correct procedures on the taking and recording of temperatures.

On 1/11/11 at approximately 11:45 a.m. the steam table was observed containing pork loin, rice pilaf, green salad (with tomatoes, red bell peppers, red onions, and cucumbers), and cooked lima beans. RA 1, who was the nurse responsible for meal service, took the temperature of pork loin which read 124.1 F and took no other food temperatures. The surveyor took the temperatures of the lima beans and rice pilaf which read 104.8 F and 128.2 F, respectively.

Review of the menu for the lunch meal on 1/11/11 showed, pork loin, rice pilaf, mixed vegetables, dinner roll, fruit mix, and milk for the lunch meal. The patients received lima beans instead of mixed vegetables and they did not receive a dinner roll. Patients also received the green salad that was not listed on the menu. The substitutions were made without being posted on the menu. There was no substitute provided for the missing dinner roll.

RA1 was observed on 1/11/11 serving lima beans and rice pilaf with a six oz spoodle, and pork loin (pre-sliced) with tongs. The portion sizes were not consistent for all the patients served. Some patients were served spoodle that was half-full; others were served 3/4th full. There were no cardex or patient diet cards instructing RA1 on what amount to serve each patient. It was unclear why each patient did not receive the same amount.

An interview was conducted with RA1 on 1/11/11, at approximately 11:55 a.m. In a response to concerns about food sufficiency, because some food items were completely utilized for sixteen patients with none leftover at the end of service before patients had consumed their meals, thereby leaving no opportunity for seconds when requested. RA 1 stated that sometimes there is not enough food for the patients. She stated that they send enough food for 18 patients for the entree or meats a

Based on observation, review of hospital documents, clinical record review and staff interviews, the hospital failed to ensure that the contracted dietitian had adequate hours to ensure the nutritional needs of the patients were met and to provide oversight for the food services. The limited frequency of consultation and lack of oversight resulted in two patients not receiving therapeutic diets and therefore the delay of medical nutrition therapy. In addition, it resulted in the lack of collaboration with medical staff, unapproved diet manual and lack of performance improvement activities in the dietary services department.

Findings:

The contract with the registered dietitian (RD 1) was effective 7/1/10 through 06/30/11. A review of the contract, revealed RD 1 was contracted to provide a 2 hour weekly visit to the facility to assess the nutritional status of patients at nutritional risk. The contract attachment identified what these nutritional risks were including malnutrition, diabetes, <80% or >130 % of IBW (Ideal Body Weight), hypertension, etc and how to refer to the RD. It stated that a daily diet sheet would be faxed to the dietitian.

Review of the clinical records revealed the hospital did not have a written policy and procedure to screen patients to determine their nutritional risk and referral to RD 1. The rationale behind screening is that medical nutrition therapy will be provided in a timely manner. None of the patients reviewed were assessed sooner than RD 1's scheduled Monday visits to the hospital. There was an average of five days lag time in nutrition assessments for patients considered at high nutritional risk.

Nutrition Care
1. Patient D1 was admitted to the hospital on 8/11/10 with diagnoses including diabetes mellitus, hypothyroidism and COPD (chronic obstructive pulmonary disease). She was 5' 6" tall and weighed 186 lbs on admission. A nutrition assessment was conducted by the registered dietitian (RD 1) on 8/16/10. RD 1 recommended a DM diet (diabetic diet). There was no documented evidence that this recommendation was communicated to the patient's physician.

On 10/4/10, RD 1 conducted a follow up assessment, she documented Patient D1 gained 16 lbs in six weeks, therefore weighed 202 lbs. Patient D1 had developed a foot ulcer and RD1 recommended a DM high protein, no extra portions except high protein food diet to promote healing of foot ulcer. There was no documented evidence that this recommendation was communicated to the patient's physician.

On 11/15/10 after the foot ulcer had healed, RD 1 recommended "continue ADA hi protein diet to prevent foot ulcer re-infection". Review of the clinical record for Patient D1 did not show any diet order for any of the diets recommended by RD 1. There was no documented evidence that this recommendation was communicated to the patient's physician.

During meal observations on 1/10/11 and 1/11/11 all the patients were served the same foods. There was a white board that had Patient D1's name with the word "diabetic" next to it but there was no observed change made specifically to her plate in terms of amount or kind of food served.

In an interview with LN 7 on 1/11/11 at approximately 3:40 p.m. she explained the process by which RD1's recommendations are communicated to the hospital staff. She stated that RD1 writes her recommendations and nursing goals on the Consultant Dietitian Report. She stated that the charge nurse or team leader will make a copy of the report and give it to the staff member working in the kitchen. That staff member will then write the recommendations/nursing goals on a white board in the kitchen, for example if patients cannot have seconds. Review of the Consultant Dietitian Reports from 1/10 to 1/10/11 showed no recommendations for Patient D1 during the months that RD 1 made those recommendations.

Further review of Patient D1's clinical record showed that on 1/1/11 hospital staff documented on the interdisciplinary team Treatment Plan problem list "Resistant to ADA diet". Patient D1 was not provided with the diet that was recommended and RD 1 believed she was on it and was not clear how she was resistant to a diet that was never served.

2. Patient D2 was admitted on 1/5/11 with diagnoses including hypertension, broken jaw, and detached retina. He was 6'1" and weighed 300 lbs on admission and was placed on a regular diet.

A nutrition assessment was conducted by RD 1 on 1/10/11. She recommended a weight loss diet, secondary (due to) obesity. She did not however, specify a caloric level. The nursing goals were "no extra portions except vegetables and salads". It is unclear how long it takes the hospital staff to communicate diet recommendations to the physician and when nursing plans are implemented when physicians concur with RD's recommendations.

Policy and Procedures and Diet Manuals
The hospital did not have a dietary services policy and procedure manual. The hospital staff was observed not practicing proper food storage procedures. Items in the refrigerator were not properly labeled or dated. Dry food and storage areas in which they were stored were not maintained in a sanitary manner. The toaster and toaster ovens were not cleaned. There were no written policies to determine the frequency of cleaning and who was responsible.

The diet manual had not been approved or used by the hospital staff for an undermined length of time. The program director stated, at approximately 4:00 p.m. on 1/10/11, that they could not find the diet manual, and would ask the registered dietitian (RD) where it was located. The hospital diet manual is a reference tool that describes the different types of therapeutic diets that is available to be ordered in the hospital. It describes the framework (including definition and nutrient adequacy) of all diets and under what conditions all diets are ordered.

Observations during meal times on 1/10/11 and 1/11/11 and lack of portion sizes that resulted in questions of nutrient adequacy could have been verified using the diet manual. During interview with the RD on 1/10/11 at approximately 4:30 p.m. she stated that the hospital had a diet manual but does not remember the last time she saw it. She indicated that she had not been invited to any Pharmacy and Therapeutics Committee (P & T) since been hired about 12 years ago. The P & T committee or similar committee is the avenue used in hospitals to approve diet and patient care manuals, present or resolve care issues that affect patients.

On 1/14/11, the program director found the diet manual in a shelf in her office. The face sheet was blank and therefore could be determined whether it was ever approved by the dietitian or medical staff. The length of the time that it took to locate the diet manual and the fact that the RD indicated that she could not remember the last time she saw it, would result in the conclusion that the hospital staff did not have access to it.

Food service
The RD had no role in ensuring that the nutritional needs of the patients were met. She stated in an interview that her role was clinical and did not participate in menu planning. Review of the contract with the meal service provider revealed a provision stating that their registered dietitian was to approve menus only. However, there has been no communication between the contracted meal service provider and RD 1. RD 1, who has had no responsibilities with the food service, is unable to share concerns with contracted dietary staff. Some of these concerns include food palatability, improper food delivery times, substitutions, and poor hand washing.

Review of the menu for the lunch meal on 1/11/11, showed pork loin, rice pilaf, mixed vegetables, dinner roll, fruit mix, and milk for the lunch meal. The patients received lima beans instead of mixed vegetables and they did not receive a dinner roll. Patients also received the green salad that was not listed on the menu. The substitutions were made without being posted on the menu. There was no substitute provided for the missing dinner roll.

RA 1 was observed on 1/11/11 serving lima beans and rice pilaf with a six ounce spoodle, and pork lo

Based on observation, review of hospital documents and staff interviews, the hospital failed to ensure that nutritional needs were met in accordance with recognized dietary practices and in accordance with the orders of the physicians. This failure resulted in patients not receiving therapeutic diets, other patients receiving food that may be inadequate or exceed their nutrient needs and meal times that are in accordance with community standards.

Findings:

1. Patient D1 was admitted to the hospital on 8/11/10 with diagnoses including diabetes mellitus, hypothyroidism and COPD (chronic obstructive pulmonary disease). She was 5' 6" tall and weighed 186 lbs on admission. A nutrition assessment was conducted by the registered dietitian (RD1) on 8/16/10. RD1 recommended a DM diet (diabetic diet). There was no documented evidence that this recommendation was communicated to the patient's physician.

On 10/4/10, RD1 conducted a follow up assessment she documented that Patient D1 gained 16 lbs in six weeks, therefore weighed 202 lbs. Patient D1 had developed a foot ulcer and RD1 recommended a DM high protein, no extra portions except high protein food diet to promote healing of foot ulcer. There was no documented evidence that this recommendation was communicated to the patient's physician.

On 11/15/10 after the foot ulcer had healed RD1 recommended, "continue ADA hi protein diet to prevent foot ulcer re-infection". Review of clinical record for patient D1 did not show any diet order for any of the diets recommended by RD1. There was no documented evidence that this recommendation was communicated to the patient's physician.

During meal observations on 1/10/11 and 1/11/11 all the patients were served the same foods. There was a white board that had Patient D1's name with the word "diabetic" next to it but there was no observed change made specifically to her plate in terms of amount or kind of food served.

In an interview with LN 7 on 1/11/11, at approximately 3:40 p.m. she explained the process by which RD1's recommendations are communicated to the hospital staff. She stated that RD1 writes her recommendations and nursing goals on the Consultant Dietitian Report. She stated that the charge nurse or team leader will make a copy of the report and give it to the staff member working in the kitchen. That staff member will then write the recommendations/nursing goals on a white board in the kitchen, for example if patients cannot have seconds. Review of the Consultant Dietitian Reports from 1/10 to 1/10/11 showed no recommendations for Patient D1 during the months that RD1 made those recommendations.

An interview was conducted with the FSM on 1/10/11, at approximately 3:00 p.m. regarding production of special diets for the hospital. He stated that he had been in his position for approximately a year and a half and does not remember sending any special diets to the facility except vegetarian and vegan diets. The copy of the posted menu did not include any therapeutic diets, diabetic or high protein diet. There were no special instructions on modifying the regular diet to any special diet.

Further review of Patient D1's clinical record showed, that on 1/1/11 hospital staff documented in the interdisciplinary team Treatment Plan problem list "Resistant to ADA diet". Patient D1 was not provided with the diet that was recommended and RD1 believed she was on. It was not clear how Patient D1 was resistant to a diet that was never served. The hospital failed to provide a therapeutic diet as recommended by the RD.

2. A tour of the kitchen on 1/10/11 at approximately 9:47 AM revealed three large foil wrapped item stored in an unheated steam table. The item was later described as breakfast burrito left over from breakfast. Each breakfast burrito was approximately six inches long, weighing approximately 12 ounces.

Review of the hospital menu for the month of January 2011 showed, a breakfast burrito and orange were items to have been served for breakfast on 1/10/11. But, the menu did not have portion sizes listed next to the items. Further review showed that none of the menu items for all three meals for the month had any portion sizes listed.

Review of the lunch menu dated 1/10/11, showed BBQ chicken, macaroni and cheese, mixed vegetables, an orange, and milk for the lunch meal. The menu did not show portion sizes or scoop sizes. On 1/10/11, at approximately 11:50 AM, on the steam table were BBQ chicken, green salad, macaroni and cheese, and cooked carrots and peas. The green salad was being served with a spaghetti spoon/server, macaroni and cheese and cooked carrots and peas were being both served with a six ounce (oz) spoodle, and the BBQ chicken was being served with a spatula. The nutrition adequacy was unable to be validated due to lack of stated portion sizes of the meal items.

No oranges were observed in the serving area. The menu did not state there would be a green salad served. A green salad would not be an equal substitute for an orange, on the basis of the green salad containing less vitamin C.

The menu for the lunch meal on 1/11/11, showed pork loin, rice pilaf, mixed vegetables, dinner roll, fruit mix, and milk. The patients received lima beans instead of mixed vegetables and they did not receive a dinner roll. Patients also received the green salad that was not listed on the menu. The substitutions were made without being posted on the menu. There was no substitute provided for the missing dinner roll.

RA1 served lima beans and rice pilaf with a six oz spoodle, pork loin (pre-sliced) with tongs. The portion sizes were not consistent for all the patients served. Some patients were served spoodle that was half-full; others were served 3/4th full. There were no cardex or patient diet cards instructing RA1 on what amount to serve each patient. It was unclear why each patient was not consistently served the same amount.

Concerns regarding a lack of portion sizes were shared with the contracted meal service provider manager (FSM). In an interview on 1/10/11, at approximately 2:30 PM, he stated that the in addition to the hospital's contract, the contracted meal service provider provides meals for children's program and a senior nutrition program. He indicated that the hospital's menu is planned by a registered dietitian of the contracted meal service provider who was not housed in the office he was located. He further stated that the menu had a nutrient analysis. A call was placed to the contracted meal service's RD however, was not returned until after the surveyor had exited the hospital.

The FSM provided a document that he stated was the nutrient analysis for hospital's menus. The document titled "Dec 1, 2010 thru Dec 31, 2010 Spreadsheet-Portion values". The nutrient analysis was for the previous month not for January 2011. According to this spreadsheet the breakfast burrito portion size was one and contained 213 calories each. The breakfast burrito was significantly large and would contain more calories than was stated in the nutrient analysis. Closer review of the spreadsheet revealed that the analysis was conducted on a program for children. The FSM confirmed in an interview on 1/10/11 at approximately 3:00 p.m. that this was the program used for nutrient analysis. The portion sizes analysis would therefore be based on children's not adult's daily requirements. For example, the total calories for a meal that included breakfast burrito were analyzed as 377 calories, and satisfying 68 % of the allocated need of 554 calories for breakfast.

The information was based on the caloric requirements of the School Breakfast Program not the recommended daily allowances (RDA) for an adult. The nutrient analysis provided did not examine the nutrient adequacy of the meal for adults. FSM was asked for a copy of the recipe used to prepare the breakfast burrito, neither he nor the cook in the kitchen were able to produce the recipe.

3. The community standard is that no greater than 14 hours lapse between dinner and breakfast the following day. On 1/11/11 dinner arrived and was served before 4:30 p.m. Hospital staff did not docum