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Based on observation, interviews with facility staff, document review and record review, the hospital's governing body, the legally responsible entity for the conduct of hospital operations, failed to provide oversight to the pharmaceutical, dietary, surgical, rehabilitation, and respiratory departments which resulted in the identification of systemic deficiencies in these areas. In addition, the governing body failed to ensure that the quality assessment and performances improvement program involved all hospital departments and services and reflected the complexity of the hospital's organization and services.

Findings:

1. The hospital failed to have an effective governing body and chief executive officer to effectively manage the entire hospital (Refer to A-0057).

2. The hospital failed to ensure that the quality assessment and performances improvement program reflected the complexity of the facility's organization and services, involved all departments and services, and focused on indicators related to improved health outcomes and the prevention and reduction of medical errors ( Refer to A-0263).

3. The hospital failed to track accurate quality data to measure and to analyze pharmacists' performance in reviewing physicians' medication orders. (Refer to A-0263).

4. The hospital failed to have a data-driven quality assessment program to assess pharmaceutical services provided in the hospital. The hospital failed to ensure that quarterly quality assurance reports were prepared by the contracted pharmacy provider and reviewed by the hospital administration. The quality assurance reports submitted by the contracted pharmacy provider did not have any measurable data relevant to pharmaceutical care provided in the hospital to facilitate the development of performance improvement plans. (Refer to A-0263)

5. The hospital failed to track accurate quality data to measure and to analyze pharmacists' performance in reviewing physicians' medication orders. (Refer to A-0492).

6. The hospital failed to have a data-driven quality assessment program to assess pharmaceutical services provided in the hospital. The hospital failed to ensure that quarterly quality assurance reports were prepared by the contracted pharmacy provider and reviewed by the hospital administration. The quality assurance reports submitted by the contracted pharmacy provider did not have any measurable data relevant to pharmaceutical care provided in the hospital to facilitate the development of performance improvement plans. (Refer to A-0492).

7. The failure to have the organizational framework and systems to function in accord with the requirements pertaining to General Acute Care Hospitals and the unique needs, given that the entity patient population is considered medically-stable upon admission and solely surgical. (A 619)

8. The failure to have a safe, healthful, sanitary and equipped food service operation to meet the nutritional needs of patients during regular and emergency/disaster conditions as well as to have the supervision, assignment, documentation and surveillance of the department to ensure effectiveness. (A 620)

9. The failure to have accurately documented prescribed therapeutic diets as well as tolerance to a specific diet order and the failure to have evaluated such diets for nutritional adequacy. (A 629)

10. The failure to have used current standards in the development of special diets as defined in the diet manual. (A 630)

11. The hospital's surgical service failed to package, handle, and store sterile equipment in a manner that ensured sterility so that all patients were protected from potential infections. (Refer to A-0951).

12. The hospital failed to ensure that the quality assessment and performance improvement program reflected the complexity of the facility's organization and services for rehab (Refer to A- 267).

13. The hospital failed to ensure that the quality assessment and performance improvement program reflected the complexity of the facility's organization and services for respiratory care (Refer to A- 267).

14. The hospital failed to ensure that the work performed by outside services pertinent to dietetic services had been safe and effective. (Refer to A - 84).

The cumulative effects of these systemic problems resulted in the failure of the hospital's governing body to ensure that its patients were provided with safe, effective, quality care.

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Based on interviews and document reviews the hospital failed to maintain an effective quality assessment and performance improvement program as evidenced by:

1. The hospital failed to track accurate quality data to measure and to analyze pharmacists' performance in reviewing physicians' medication orders.

2. The hospital failed to have a data-driven quality assessment program to assess pharmaceutical services provided in the hospital. The hospital failed to ensure that quarterly quality assurance reports were prepared by the contracted pharmacy provider and reviewed by the hospital administration. The quality assurance reports submitted by the contracted pharmacy provider did not have any measurable data relevant to pharmaceutical care provided in the hospital to facilitate the development of performance improvement plans.

3. The hospital failed to identify and involve other departments and services to identify systemic problems in the areas of: Dietary, surgery, rehabilitation, respiratory, and governing body.

Findings:

1. A review of Patient 1, 9 and 29 ' s clinical records showed that medication orders were not reviewed and approved by a pharmacist but were administered to the patients.

A review of patient 28 and 30 ' s clinical records showed that medication orders were reviewed and approved 20 hours and 17 hours respectively after the orders were written. Medications were administered before the orders were approved by the pharmacists.

A review of Patient 1 and 11 ' s clinical record showed that duplicated orders were not identified and clarified by the contracted pharmacy with the prescribing physician before approving the orders for administration.

During an interview at approximately 10:00 a.m. on 5/20/10, Staff A (Chief Nurse Officer) stated that the hospital conducted periodic random chart review to ensure that medication orders were faxed for review and that the faxes were returned by the pharmacist. Staff A also stated that, however, such chart reviews did not verify if the orders were reviewed in a timely manner to minimize treatment delay and that orders not written on pre-printed order forms were faxed to the contracted pharmacy provider for review. In addition, there were no quality assurance activities to ensure the quality of medication order reviews provided by the contracted provider.

2. A review of the hospital contract with the pharmacy provider dated 7/1/2007 showed that the contracted pharmacy provider should provide pharmaceutical services in accordance with accepted professional practices to patients in the hospital. The contract required the provider to submit, at least quarterly, a written report to the hospital ' s quality assurance committee on the status of the hospital ' s pharmaceutical services and staff performance. Such report shall include, but not limited to:

i. A review and assessment of compliance with any plan of action previously adopted by the hospital ' s quality assurance committee

ii. A review of and ongoing assessment of compliance with all federal, state and local laws, regulations and rules and all of the hospital ' s pharmaceutically related policies and procedures including, for example, that drugs are dispensed and labeled in compliance with federal and states laws, and provided on a prompt and timely basis.

iii. Recommendations, if any, for improving the delivery of Pharmaceutical Services with the goal of correcting or preventing instances of noncompliance and enhancing the resident care in the hospital.

A review of the quality assurance reports for the past 4 quarters showed that the 2nd, 3rd and 4th quarter reports for 2009 were all completed on 5/27/2010, after the date such reports were requested by the surveyor by telephone on 5/25/10. The 1st quarter of 2010 report was completed on 5/25/10. Each report was a one-page report. The reports for the 2nd, 3rd and 4th quarter of 2009 showed only bill payment and percentage of sleeping aid orders filled by the provider. The 1st quarter report for 2010 showed only drug returns and abnormal deliveries. There was no quality data reported in the quality assurance report.

During a telephone interview at approximately 2:00 p.m. on 5/28/10, Staff A stated that she requested for the reports with the contracted provider on 5/25/10 and the reports were then prepared by the contracted provider. Staff A agreed that the reports submitted by the contracted provider lacked quality data that the hospital can utilize to improve performance and further stated that the hospital was going to have a meeting with the provider to address the issue.

3. The hospital failed to have an effective governing body and chief executive officer to effectively manage the entire hospital (Refer to A 057 and A 0267).

4. The The hospital failed to ensure that the quality assurance program had encompassed patient care, hospital services and operations. By not having a comprehensive program in dietetic services, inclusive of outside services there was the potential for ineffective surveillance to preclude cross-contamination, food-borne illness and unsafe usage of equipment in a hospital with a licensed bed capacity for 16 patients.

5. The hospital failed to properly store and transport surgical instruments to the operating room (OR). (refer to A 0951.

6. The hospital did not have a policy regarding the sterilization and transportation of surgical instruments. (Refer to A 0951).

7. The hospital failed to have its governing body define the scope of the rehabilitation program requirements were met. (Refer to A 1124, 1132).

8. The hospital failed to have its governing body define the scope of the respiratory care services were met. (Refer to A 1152, 1160)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective quality assessment and performance improvement program in accordance with the statutorily-mandated Conditions of Participation for quality assessment and performance improvement.

Based on observation, staff interview and document review the hospital failed to ensure that the Condition of Participation: Food and Dietetic Services was met as evidenced by:

i)The failure to have the organizational framework and systems to function in accordance with the requirements pertaining to General Acute Care Hospitals and the unique needs, given that the entity patient population is considered medically-stable upon admission and solely surgical. (A 619)

ii)The failure to have a safe, healthful, sanitary and equipped food service operation to meet the nutritional needs of patients during regular and emergency/disaster conditions as well as to have the supervision, assignment, documentation and surveillance of the department to ensure effectiveness. (A 620)

iii )The failure to have accurately documented prescribed therapeutic diets as well as tolerance to a specific diet order and the failure to have evaluated such diets for nutritional adequacy. (A 629)

iv)The failure to have used current standards in the development of special diets as defined in the diet manual. (A 630)

The cumulative effects of these systemic problems resulted in the failure of the hospital's ability to improve health and safety outcomes for its patients.

Based on observation and interview, the hospital's surgical service did not package, handle, and store sterile equipment in a manner that ensured sterility so that all patients were protected from potential infections.

Findings:

1. The hospital failed to properly store and transport surgical instruments to the operating room (OR). Refer to A-0951.

2. The hospital did not have a policy regarding the sterilization and transportation of surgical instruments. Refer to A-0951.

The cumulative effects of these systemic problems resulted in the failure of the hospital to ensure safe and effective surgical care to its patients.

Based on observation, interview and document review, the hospital failed to have adequate staff to provide physical therapy rehabilitation services to patients who would benefit from the service. The hospital failed to develop its policy and procedure that would specify the scope of rehabilitation services offered to the patients.

Findings:

1. Provide policies and procedures approved by the medical staff that defined and verified the scope of rehabilitation services offered by the facility.

2. Provide a qualified director of rehabilitation services so as to supervise and administer the services.

The cumulative effects of these systemic problems resulted in the failure of the facility to organize and provide adequate staff to provide rehabilitation services to ensure the health and safety of patients. (Refer to A 1123, A 1124, A 1125, A 1132).

Based on observation, interview and document review, the hospital failed to meet the requirements to provide respiratory needs of patients in accordance to acceptable standards of practice.

Findings:

1. Develop policies and procedures that defined and verified the scope of respiratory care by the facility.( A 1160)

2. Provide a qualified director of respiratory care services so as to supervise and administer the services.(A 1153)

The cumulative effects of these systemic problems resulted in the failure of the facility to organize and provide adequate staff for rehabilitation services to ensure the health and safety of patients.

Based on employee file review and interview, the facility failed to provide evidence that 1 of 5 sampled registered nurses (Staff L) had criminal background checks or verification of references and education prior to employment, as required by the facility's policy and procedure. A failure to obtain this information prior to employment is a potential risk for patient exposure to unsafe nursing care.

Findings:

Record review of employee files for five randomly selected registered nurses was conducted on 5/20/10.
Of these, three employee files had brown sealed envelopes containing verified criminal background checks, verified education, and evidence that employment references were checked in their files.

During record review of facility employees on 5/20/10, two registered nurses had no prior employment verification checks documented in their files (Staff L and Staff M). Staff L was hired on 3/9/09. There was no brown sealed envelope in Staff L's employee file, and no evidence of a verified criminal background check, verified education, or reference verification was found in the file. Staff M was hired on 4/1/06. There was was a brown sealed envelope in Staff M's file that contained only a physical fitness assessment form.

Review of the facility's policy and procedure, "Policy Guidelines on Employment Background Checks," found the facility recognized, "...the importance of employing qualified individuals who do not present a risk of harm to patients, employees, or its assets." The policy indicated, "...background check for all emplyees shall include: a. verification of employment by previous employers. b. Verification of licensure/certification where such is a requirement of the position. c. Criminal background checks... e. verification of educational credentials when deemed appropriate..."

In an interview on 5/20/10 at 4:15 PM, Staff A said she was sure the background checks, education and reference verification had been done. She said she thought they were filed somewhere else, possibly in human resources. She said she would obtain the information and provide it on 5/21/10.

In interview in mid-afternoon on 5/21/10, when Staff M's employee file was brought to the attention of Staff K, she said background and reference information should be found in the brown sealed envelopes in the employee files.

During interview on 5/21/10 at 3 PM, Staff A said new applicants were not issued letters offering employment unless the background check was cleared, but did not provide verification that background checks were done for Staff L or Staff M. On 5/25/10, Staff N provided Staff M's criminal background verification, prior employment checks and verification of education that was done on 10/18/05.

During a telephone interview with Staff N on 5/25/10 at approximately 3:30 PM, she said the facility had not located any verification of prior employment information for Staff L. Staff N said Staff L came to the facility from an agency, and they would have been responsible for obtaining the criminal background check, reference verification, and education verification.

Based on interview and document review, the hospital (Facility A) failed to have an effective governing body and chief executive officer to manage the entire hospital. The facility's failure to have an effective governing body resulted to multiple Conditions of Participation identified as noncompliant during the survey: Governing Body, Quality Assessment and Performance Improvement, Pharmacy, Dietary, Surgery, Rehabilitation, and Respiratory Services.

Findings:

During an interview on 5/21/10 at 3:04 PM, Staff K (Administrator) stated that Facility A's governing body was under Facility B which was under a different licensure from Facility A. When asked if Facility A had their own governing body, Staff K (CEO) stated they did not.

The facility's bylaws dated 5/1/09 ( laws or rules governing the internal affairs of an organization) titled, "Thirteenth Amendment and Restatement of Bylaws" was reviewed on 5/21/10. It was noted that Facility A and Facility B are using the same bylaws. In addition, these bylaws listed Facility A as part of a list of five other facilities that these bylaws governed (Facility B, C, D, E, and F).

The bylaws under Article V, Officers , number 2.2, page 8 stated, " The CEO shall be the Chief Executive Officer and the general manager and administrator of this Corporation (Facility H). The CEO shall be given the necessary authority and responsibility to operate this Corporation (Facility H) in all of its activities including without limitation, quality of service, cost effectiveness and economic performance and implementation ... "

Some of the general powers outlined in the bylaws for its governing body were the following (Article IV, Board of Directors, 1.2, page 3): " a. To supervise the Corporation's (Facility H) quality improvement activities, including all aspects of patient care evaluation, in accordance with guidelines established by the General Member (Facility G, the Parent Company), c. To review operations with management to ensure that services are necessary to the Corporation's mission (Facility H) ..., h. To approve the hiring of the CEO, i. To provide input in assessing the performance of the CEO as requested by the President of the General Member (Facility G, the Parent Company) ..., m. To establish a process for making decisions when a leadership group fails to fulfill its accountabilities, o. To be loyal to the Corporation (Facility H), its General Member (Facility G, the Parent Company) and (Facility I, an affiliate) , always furthering the interest of the Corporation (Facility H), its General Member (Facility G, the Parent Company) and (Facility I, an affiliate) in their pursuit of their missions, and complying with all laws (and) regulations ... "

In an interview on 5/21/10 at 4:00 PM, Staff O confirmed that Facility A's governing body was from Facility B and that Facility A did not have their own separate governing body.

Based on staff interview and document review the hospital failed to ensure that the work performed by outside services pertinent to dietetic services had been safe and effective. By not having ensured that services had been under the purview of the hospital ' s surveillance systems there was uncertainty regarding quality and efficacy.

Finding:

On 5/20/10 between 11:30 a.m. and 12:25 p.m. during review of contracts and the hospital-wide quality assurance program, there was no documented evidence that four companies providing services to the dietetic service department, e.g. for special equipment maintenance, dishmachine operations and pest control had been evaluated via the hospital's surveillance systems, including the quality assurance program. Additionally, there was no documentation available which related to the linen service which had been providing linen napkins to the dietetic service to have ensured the outside laundering had been conducted in a clean and sanitary environment and that items had been delivered under healthful conditions, free from potential cross-contamination during pick-ups and deliveries.

Further, as of 12:25 p.m. on 5/20/10 when both Nursing Manager 1 and Dietetic Service Manager 1 had been informed of these omissions as well as the failure to have had written language within contracts/agreements specific to term and administrative authority for the four services and the failure to have had co-signature on three of them, both stated that they had been unaware of need to have had the services evaluated. At 12:25 p.m. Dietetic Service Manager 1 stated that she " will have to check " the applicable standards regarding the linen service. Also, as of conclusion of interview with the Administrator at 5 p.m., she stated that: these outside services had been regarded as comparable to purchase orders; the relationship had been informal as to discussing any questions or concerns with service representatives; and there had not been integration of the evaluation of these outside services in the hospital ' s quality assurance program.

Based on record review and interview, the facility failed to ensure legibility of the medical record in accordance with its policy for 1 of 41 closed records (Patient 8), when a written entry was made in the schedule section of the medication administration record (MAR), but a number was written over the entry so that it could not be read; and, when entries made in the administration section of the MAR were scribbled out making it unclear and not legible. In addition, the facility failed to complete the written surgical post-operative reports for 9 of 41 sampled patients (Patients 2, 3, 8, 22, 23, 26, 27, 28, and, 31).The facility also failed to complete the " Preprinted Orders/Screening DVT/VTE Prophylaxis Therapy " form for 16 of 41 sampled patients (Patients 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, 21, 22, 23, 24, 30, and 31).

Findings:

1. On 5/18/10 Patient 8' s MAR (closed record) dated 4/15/10 was reviewed. It was noted that something was written in the schedule section of the Medication Administration Section (MAR) for Kefzol (an antibiotic), making the documentation unclear and could not be read. Only a letter G, a letter o, a number three, and a possible number four could be discerned, because the entry was written over boldly with the number 1400. In the administration section of the MAR for Colace (a stool softener) dated 4/15/10, something was written, circled, and scribbled out so that it could not be read. Error and initials were written above the scribbling, and the letter H was boldly written below.

In an interview on 5/18/10in mid-morning, Staff K reviewed Patient 8's MAR and said writing over an entry, or scribbling out an entry, were not in accordance with hopital policy.

Review of the facility's policy, "Corrections to the Medical Record," indicated under procedure: "A. Draw a single line through the incorrect data, in black ink. Write 'mistaken entry' above the incorrect data. B. Write the correct data below the lined out material. C. Sign and date the correction."





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2. Review of medical records on 5/18/10 and 5/19/10, it was noted that the
" Postoperative Notes " for patients 2, 3, 8, 22, 23, 26, 27, 28, and 31 were not completed for one or more of the following items on the pre-printed forms: description of findings, postoperative diagnosis, specimens submitted, disposition of each specimen, estimated blood loss, prophylactic antibiotics administered, fluids administered, complications, and patient's condition.

The facility's policy and procedure titled, " Documentation Requirements for Surgical, Invasive and Non-Invasive Procedures H-IM 7.003, section: Record Maintenance and Procedures, review/revision date: 01/08 " , page 1 or 2, stated the following: " Purpose: To describe the requirements for documentation of operative and other procedures. Policy: (described under letter " C " ) Postoperative Note is completed immediately after surgery. The Postoperative Note contains preoperative and postoperative diagnoses, surgeon, assistants (if any) and information concerning the procedure needed by the clinical team to treat the patient in the immediate post-operative period " .

During the same medical record review done on 5/18/10 and 5/19/10, it was observed that the " Preprinted Orders/Screening DVT/VTE Prophylaxis Therapy " forms for patients 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, 21, 22, 23, 24, 30, and 31 were not completed. In this form, there are three categories the physician was required to fill out by using check marks. These patients' forms were not completed for the first category titled, " Contraindications ". The instructions were: "Check one of the boxes below & state reason if VTE/DVT prophylaxis contraindicated " . The two choices for the physician to choose from were: 1. " VTE Prophylaxis contraindicated because of inability to use pharmacologic and mechanical prophylaxis, " or 2. " Pharmacologic Prophylaxis contraindicated in this patient (mechanical prophylaxis still indicated and will be used). " Also, in the same category, the physician was required to choose from the following statements to check: 1. " Patient hx of bleeding disorder " , 2. " Risk of bleeding from the procedure " , or 3. " other " .

For Patient 11, the DVT form was not filled out for any of the three categories on the preprinted form except for the physician's and nurse's signatures with the date and time. The other two categories were titled, " Recommendations for VTE Prophylaxis Selection by Surgery " , and, " Physician Order for Prophylaxis ".

The facility's policy and procedure titled, " General Documentation Guidelines H-IM 7.002, section: Record Maintenance and Procedures, review/revision date: 1/08 " , stated the following, " Purpose: To provide guidelines for the initiation and maintenance of patient care information. Policy: (under number 3, letter I) To facilitate consistency and continuity in patient care, the medical record contains very specific data and information including: diagnostic and therapeutic orders, if any. "

On an interview on 5/19/10 at 10:52 am, the Staff A stated the physician was required to always complete category number one, " Contraindications " , and must select either category number 2, " Recommendations for VTE Prophylaxis Selection by Surgery " or category number 3, " Physician's Order for Prophylaxis " .

Based on observation, interviews and document reviews, the hospital failed to provide pharmaceutical services and care that met the needs of the patients.

Findings:

1. The hospital failed to track accurate quality data to measure and to analyze pharmacists' performance in reviewing physicians' medication orders.

2. The hospital failed to have a data-driven quality assessment program to assess pharmaceutical services provided in the hospital. The hospital failed to ensure that quarterly quality assurance reports were prepared by the contracted pharmacy provider and reviewed by the hospital administration. The quality assurance reports submitted by the contracted pharmacy provider did not have any measurable data relevant to pharmaceutical care provided in the hospital to facilitate the development of performance improvement plans.

3. the hospital failed to deliver pharmaceutical services to meet the needs of 16 patients (Patients 29, 9, 1, 28, 30, 11, 28, 29, 33, 34, 35, 36, 37, 39, 41, and 42) when medications were not controlled and distributed in accordance with standards of practice, federal and state laws. (Refer to A 500).

4. the hospital failed to remove expired or unusable medications or intravenous solutions out from the medication storage and not made available for patient use. (Refer to A 505).

The cumulative effects of these systemic problems resulted in the failure of the hospital's ability to improve health and Pharmaceutical safety outcome for it's patients and to prevent and reduce medication errors.

Based on interviews and record review, the hospital director of pharmacy failed to supervise all the activities of the pharmaceutical services in the hospital. Pharmaceutical services provided by contracted provider was not evaluated routinely and no quarterly quality assurance report was prepared by the contracted provider as required by the contract.

Findings:

During an interview at approximately 2:50 p.m. on 5/17/10, Staff B stated that he was the director of pharmacy for the hospital by contract. Staff B added that he worked about 15 to 20 hours in the hospital each week and was responsible for coordinating pharmaceutical services in the hospital. Staff B also stated that routine medication order review and medication supply for patient use were provided by a contracted pharmacy provider off site except that he was personally responsible for the medication supply for use in the operating rooms.

During an interview at approximately 10:00 a.m. on 5/20/10, Staff A stated that the hospital did not evaluate the performance of the contracted provider routinely in terms of quality of order review, timeliness of order review and timeliness in medication delivery.

A review of the hospital contract with the pharmacy provider dated 7/1/2007 showed that the contracted pharmacy provider should provide pharmaceutical services in accordance with accepted professional practices to patients in the hospital. The contract required the provider to submit, at least quarterly, a written report to the hospital ' s quality assurance committee on the status of the hospital ' s pharmaceutical services and staff performance. Such report shall include, but not limited to:

i. A review and assessment of compliance with any plan of action previously adopted by the hospital ' s quality assurance committee

ii. A review of and ongoing assessment of compliance with all federal, state and local laws, regulations and rules and all of the hospital ' s pharmaceutically related policies and procedures including, for example, that drugs are dispensed and labeled in compliance with federal and states laws, and provided on a prompt and timely basis.

iii. Recommendations, if any, for improving the delivery of Pharmaceutical Services with the goal of correcting or preventing instances of noncompliance and enhancing the resident care in the hospital.

A review of the quality assurance reports for the past 4 quarters showed that the 2nd, 3rd and 4th quarter reports for 2009 were all completed on 5/27/2010, after the date such reports were requested by the surveyor by telephone on 5/25/10. The 1st quarter of 2010 report was completed on 5/25/10. Each report was a one-page report. The reports for the 2nd, 3rd and 4th quarter of 2009 showed only bill payment and percentage of sleeping aid orders filled by the provider. The 1st quarter report for 2010 showed only drug returns and abnormal deliveries. There was no measurable data to evaluate quality reported in the quality assurance report.

During a telephone interview at approximately 2:00 p.m. on 5/28/10, Staff A stated that she requested for the reports with the contracted provider on 5/25/10 and the reports were then prepared by the contracted provider. Staff A agreed that the reports submitted by the contracted provider lacked measurable data that the hospital can utilize to evaluate and improve performance and further stated that the hospital was going to have a meeting with the provider to address the issue.

California Code of Regulations Title 22 70265 stipulates that a pharmacist shall have overall responsibilities for the pharmaceutical service. He shall be responsible for the procurement, storage, and distribution of all drugs as well as the development, coordination, supervision and review of pharmaceutical services in the hospital. The pharmacist shall be responsible to the administrator and shall furnish him written reports and recommendations regarding the pharmaceutical services within the hospital. Such reports shall be provided no less than quarterly.

The hospital director of pharmacy failed to assume the responsibility of supervising and reviewing the pharmaceutical services provided in the hospital.

Based on observation, interviews, and document review, the hospital failed to deliver pharmaceutical services to meet the needs of 16 patients (Patients 29, 9, 1, 28, 30, 11, 28, 29, 33, 34, 35, 36, 37, 39, 41, and 42) when medications were not controlled and distributed in accordance with standards of practice, federal and state laws as evidenced by:

1. Physicians ' medication orders were not reviewed by pharmacists prior to the first dose being administered in non emergent situations. In addition, the hospital failed to ensure that medication orders were reviewed by pharmacists timely to minimize delay in treatment.

2. Pharmacists failed to review medication orders for appropriateness. Order irregularities including duplication, use of range orders, unclear doses were not identified and clarified by the pharmacists with the prescribers.

3. Emergency drug supply was not readily available for the management of malignant hyperthermia.

4. Policies and procedures on medication orders were not consistently implemented. Range orders were used by physicians to order post-operative pain medications.

5. Failure to ensure the appropriate use of pre-printed order forms to minimize medication errors. Multiple narcotic pain medications were ordered by physicians on PACU (Post Anesthesia Care Unit) pre-printed order forms. Orders were not clarified with prescribers prior to the administration of the medications.

6. The hospital failed to develop policy and procedure to ensure the safe and effective use of high risk medications including fentanyl transdermal patches (a patch applied externally to relieve pain).

Findings:

1a. A review of Patient 29 ' s clinical record showed that medications that were ordered and administered to the patient from 4/16/10 to 4/18/10 were not reviewed by a pharmacist prior to or after the administration of the medications. The medication orders included:

4/16/10 at 7:30 a.m.:

Discontinue Estradiol (a hormone supplement)
Discontinue Amitiza ( a medication for chronic constipation)

4/16/10 at 6:55 p.m.:

Nitrofurantoin (an antibiotics) 50mg one capsule now - administered at 7:00 p.m. on 4/16/10

4/17/10 in the morning (no time documented):

Pepcid (a medication for heartburn or other digestive tract disorders) 20mg every 12 hours -- administered at 9:00 p.m. on 4/17/10

Methadone (a narcotic pain medication) 5mg by mouth every 12 hours

Percocet (a narcotic pain medication) 10mg by mouth every 4 hours as needed for pain

4/17/10 at 10:50 a.m.:

Discontinue Methadone

Percocet 10/325 one tablet by mouth every 4 hours as needed for pain level 1 to 5 and 2 tablets by mouth every 4 hours as needed for pain level 6 to 10 - administered at 12:20 p.m. , 6:00 p.m. and 11:00 p.m. on 4/17/10 and 3:00 a.m. and 7:00 a.m. on 4/18/10

4/17/10 at 5:50 p.m.:

Urecholine ( a medication for urinary retention) 25mg one tablet by mouth 3 times daily
Clear Liquid as tolerated - administered at 9:00 p.m. on 4/17/10 and 9:00 p.m. on 4/18/10

There was no evidence that the orders were faxed to the contracted pharmacy for review prior to the administration of the medications.

1b. A review of patient 9 ' s clinical record showed that medications ordered by the physician on 4/7/10 and 4/8/10 were not reviewed and approved by a pharmacist prior to administering to the patient. The medication orders included:

4/7/10 at 2:50 p.m.:

Ondansetron (a medication for post-operative nausea and vomiting) 4mg intravenously for one dose for nausea

4/8/10 at 11:10 a.m.:

Toradol (a pain relieving medication) 15mg intravenously every 6 hours as needed. Give one dose now.

There was no evidence that the orders were faxed to the contracted pharmacy for review prior to the administration of the medications.

1c. A review of Patient 1 ' s clinical record at approximately 9:30 a.m. on 5/18/10showed that Toradol (a pain relieving medication) 15mg intravenously every 6 hours for four doses was ordered at 7:00 am on 5/18/10 and was administered to the patient at 7:30 a.m. on 5/18/10. There was no record that a pharmacist reviewed the order prior to the administration of the medication.

During an interview at approximately 10:50 a.m. on 5/18/10, RN D stated that she forgot to fax Patient 1 ' s Toradol order to the contracted pharmacy for review.

1d. A review of Patient 28 ' s clinical record showed the medications ordered by physician on 4/22/10 at 12:40 p.m. were not reviewed and approved by the contracted pharmacy provider until 4/23/10 at 8:39 a.m. (20 hours later). Medications were administered to the patient prior to the review and approval of the orders by a pharmacist.

1e. A review of Patient 30 ' s clinical record showed that medications ordered by the physicians on 3/31/10 at 2:55 p.m. were not reviewed and approved by the contracted pharmacy provider until 4/1/10 at 8:44 a.m. (17 hours later). Medications were administered to the patient prior to the review and approval of the orders by a pharmacist.

During an interview at approximately 11:50 a.m. on 5/18/10, RN C stated that all medication orders should be faxed to the contracted pharmacy for review and that the medication should not be administered until the order was approved by a pharmacist.

According to the guidelines on Minimum Standard for Pharmacies in Hospitals published by the American Society of Health-System Pharmacist, all prescribers ' medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed. Any questions regarding the order must be resolved with the prescriber at this time, and a written notation of these discussions must be made in the patient ' s medical record or pharmacy copy of the prescriber ' s order. Information concerning changes must be communicated to the appropriate health professional.

A review of the hospital policy and procedure " Drug Distribution, Dispensing Medication Management " indicated that all physicians ' medication orders should be immediately faxed to the contracted pharmacy for review and approval. Nursing staff should not administer the medication to the patient until (s)he has received a faxed confirmation that the medication is acceptable to administer to the designated patient. The faxed confirmation should be placed in the patient ' s medical record.


2a. A review of Patient 1 ' s clinical record showed that 2 medications were ordered on 5/17/10 for nausea and vomiting as follow:

Phenergan 12.5mg intravenously for mild nausea or 25mg intramuscularly every 4 hours as needed for moderate nausea and vomiting.

Reglan 10mg intravenously or orally every 6 hours as needed for nausea and vomiting.

There was no record that the contracted pharmacy provider identified this therapeutic duplication as an irregularity. There was also no record that the contracted pharmacy provider contacted the prescribing physician to clarify the order.

A review of Patient 11 ' s clinical record showed that 2 medications were ordered on 3/31/10 for insomnia as follow:

Halcion 0.125 mg orally at bedtime as needed. May repeat one time after 30 minutes if no effect

Ambien 5mg orally at bedtime as needed for insomnia. May repeat X1 in 30 minutes if no relief.

Both Halcion and Ambien are medications for insomnia. The concurrent use of both medications may cause oversedation.

There was no record that the contracted pharmacy provider identified this therapeutic duplication as an irregularity. There was also no record that the contracted pharmacy provider contacted the prescribing physician for clarification.

2b. A review of patients ' records from 5/17/10 to 5/20/10 showed that Patient 28, 29, 34, 35, 36, 37, 39, 41, 42 had ambiguous PACU orders on pre-printed order forms for narcotic pain medications. The orders showed that 2 different narcotic pain medications, fentanyl and morphine were listed for the physicians to select for 2 different levels of pain, mild to moderate and moderate to severe. The physicians in these cases had selected both fentanyl and morphine for one or both levels of pain. There were no further instructions written by the prescribing physicians to instruct nursing staff on which medication to give first and under what circumstances should the other medication be given. There was no record that such unclear orders were identified and clarified by the pharmacists with the prescriber. (See number 5 below)

2c. A review of Patient 9 and Patient 33 ' s clinical record showed that range orders were used by physicians ' to order post-operative pain medications. There was no record that the range orders for Patient 9 and 33 were clarified with the prescriber by the pharmacist or nursing staff prior to administration. ( See number 4 below)

3. During a tour of the workroom of the surgical department with Staff E (Operating Room Manager) at approximately 2:00 p.m. on 5/18/10, the emergency supply for the management of malignant hyperthermia was inspected. No cold intravenous saline solution was found in the Malignant Hyperthermia (MH) cart or the medication storage refrigerator. A review of the hospital malignant hyperthermia supply log at the same time of the inspection showed that no cold saline solution was listed. Staff E acknowledged that cold intravenous saline solution was missing from the MH cart and stated that he would communicate with hospital management to have the problem corrected.

Malignant hyperthermia is a life-threatening condition that is triggered by the exposure to certain drugs used for general anesthesia during surgeries. In susceptible patients, adverse reactions will develop after exposure to the agents including a drastic and uncontrolled increase in skeletal muscle metabolism, which overwhelms the body ' s capacity to supply oxygen, remove carbon dioxide, and regulate body temperature leading to circulatory collapse and death if not treated timely.

The Emergency Therapy for Malignant Hyperthermia published by the Malignant Hyperthermia Association of the United States recommended that cold intravenous saline solution be available for the management of malignant hyperthermia to lower the patient ' s temperature as an acute phase treatment.

The hospital failed to ensure that emergency medication supply is readily available for the management of malignant hyperthermia.

4. A review of Patient 9 and Patient 33 ' s clinical record showed that range orders were used by physicians ' to order post-operative pain medications. Patient 9 had the following Post Anesthesia Care Unit (PACU) orders:

For Mild to Moderate Pain:

Fentanyl 25 - 50 mcg (micrograms) I.V. (intravenously) every 10 minutes prn (as needed). Repeat to a maximum dose of 100.

For Moderate to Severe Pain:

Morphine 1-2 mg (milligrams) I.V. every 10 minutes prn. Repeat to a maximum dose of 10.

Patient 33 had the following PACU orders:

For Mild to Moderate Pain:

Morphine 1-3 mg I.V. every 10 minutes prn. Repeat to a maximum dose of 20.

For Moderate to Severe Pain:

Fentanyl 25 mcg I.V. every 5 minutes prn. Repeat to a maximum doe of 200.

There was no record that the range orders for Patient 9 and 33 were clarified with the prescriber by the pharmacist or nursing staff prior to administration.

A review of the hospital Policy and Procedure on Medication Orders indicated that range orders (such as 1 -2 tablets every 4 to 6 hours prn) are considered unclear and therefore unacceptable. Such medication orders must be clarified prior to dispensing and administration.

5. A review of patients ' records from 5/17/10 to 5/20/10 showed that Patient 28, 29, 34, 35, 36, 37, 39, 41, 42 had ambiguous PACU orders on pre-printed order forms for narcotic pain medications. The orders showed that 2 different narcotic pain medications, fentanyl and morphine were listed for the physicians to select for 2 different levels of pain, mild to moderate and moderate to severe. The physicians in these cases had selected both fentanyl and morphine for one or both levels of pain. There were no further instructions written by the prescribing physicians to instruct nursing staff on which medication to give first and under what circumstances should the other medication be given.

During an interview at approximately 10:25 a.m. on 5/19/10, Patient 29 ' s PACU orders as follow were reviewed with RN G:

For Mild to Moderate Pain:

Morphine 2mg IV every 10 minutes prn. Repeat to a maximum dose of 10.

Or

Fentanyl 25 mcg IV every 10 minutes prn. Repeat to a maximum dose of 200.

For Moderate to Severe Pain:

Morphine 2mg IV every 10 minutes prn. Repeat to a maximum dose of 10.

Or

Fentanyl 25 mcg IV every 10 minutes prn. Repeat to a maximum dose of 200.

Patient 29 ' s PACU order showed the same medications at the same dose were ordered for different levels of pain. In addition, 2 different medications were ordered for each level of pain.

RN G was asked by the surveyor which medication she would give to the patient if the patient reported a pain level of 3 (mild pain). RN G answered that she would select a medication based on the patient ' s condition, for example, if the patient was going to be discharged the same day, she would choose to give fentanyl 25 mcg first and if the patient was going to stay in the hospital overnight, she might consider giving morphine first. When being asked what would she give the patient if the patient reported a pain level of 8 (severe pain), RN G answered that she would give fentanyl 25 mcg first if the patient was going to stay in the hospital overnight, she might consider giving morphine first. When being asked if she noticed that the physician ordered the same dose of medication for mild to moderate and moderate to severe pain, RN G responded that she would need to check with the prescriber.

During an interview at approximately 10:50 a.m. on 5/20/10, Patient 29 ' s PACU orders were reviewed with Staff Y. RN Y stated that he would probably give morphine first depending on which anesthesiologist wrote the order. RN Y further stated that he might call the prescriber if he did not feel comfortable selecting which medication to give.

During an interview at approximately 4:05 p.m. on 5/19/10, Staff A (CEO) stated that it was the hospital expectation that nursing staff to clarify orders with the prescribers before adminitration if the PACU orders were unclear.

A review of the hospital policy and procedure " Pharmacist Review of Medications " on 5/19/10 showed that retrospective review of all PACU orders would be done as soon as the pharmacist was available. All PACU orders would be screened for appropriate drug utilization, therapeutic duplication, potential drug interactions and potential adverse effects. There was no evidence in the patients ' records indicating that any irregularities were identified by the pharmacist from the retrospective reviews (Patient 28, 29, 34, 35, 36, 37, 39, 41, 42)


6a. During an inspection of the workroom of the surgical department with Staff E at approximately 2:00 p.m. on 5/18/10, 2 bags of Potassium Chloride 20mEq (milliequivalents)/100ml intravenous solution were observed being stored in Pyxis (an automated dispensing cabinet). A warning was on the outer wrapping of the solution: " Highly concentrated 20 mEq total in 100 ml Whenever possible, use central line. " When asked how the potassium chloride should be administered, Staff E stated that he was not too sure and he would give the bag of intravenous solution to the anesthesiologist who ordered it.

During an interview at approximately 10:30 a.m. on 5/19/10, RN F stated that patients in the hospital were administered potassium chloride mostly by peripheral line. RN F further stated that she had handled a potassium chloride order in the past and she recalled that no reference on the proper administration of the medication was available for her to refer to and consequently she had to contact the hospital CNO and pharmacist for instructions on administration. When asked if the hospital had policy and procedure or guidelines on the administration of intravenous potassium chloride, RN F stated that there was no such policy and procedure or guidelines after looking through the hospital policy and procedure binder.

According to the Institute for Safe medication Practice (ISMP), intravenous potassium chloride was one of the most frequently implicated medication errors that led to patient death. Such errors were often related to administering potassium chloride at an unsafe concentration or at an unsafe rate. Potassium is an electrolyte in the body which is vital in maintaining normal rhythm and contraction of the heart. Potassium chloride must not be administered in a concentrated form and must be administered slowly. Generally, potassium concentration for infusion should not exceed 40 mEq/L and the rate of administration should not exceed 10 mEq/hour for peripheral administration to minimize vein (blood vessel) irritation and serious side effect of the heart.


6b. A review of the hospital pre-printed order forms on 5/17/10 showed that fentanyl transdermal patch was on one of the post-operative pre-printed order form for post-operative pain control.

During an interview at approximately 2:30 p.m. on 5/17/10, Staff B (Director o Pharmacy) stated that all pre-printed order forms must be approved by Pharmacy and Therapeutics Committee before it can be used in the hospital. Staff B also stated that fentanyl patch was on the pre-printed order form for only one surgeon who usually had more complicated patient cases. When asked what safeguards were in place in the process of reviewing fentanyl patches orders to ensure the safe use of the patch, Staff B stated that he was not too sure and he would have to check with the contracted provider.

According to the manufacturer ' s prescribing information, fentanyl patch is contraindicated in the management of post-operative pain. A boxed warning (Black Box Warning) was issued on fentanyl patches which indicated that (1) fentanyl patch is indicated for management of persistent, moderate to severe chronic pain. (2) fentanyl patch should ONLY be used in patients who are receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/hr. Patient who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60mg of morphine daily, or at least 30 mg of oxycodone daily, or at least 8mg of oral hydromorphone daily or an equianalgesic dose of another opioid. (3) Fentanyl transdermal system is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid-tolerant patients may lead to fatal respiratory depression.

A review of the hospital policy and procedure titled " Fentanyl Patch Procedure " showed that the appropriate use of the patch in opioid tolerant patients was not addressed. The policy did not require the prescribing physician, the dispensing pharmacist or the nursing staff to ensure that fentanyl patch orders were appropriate and consistent with the boxed warning issued by FDA.

The hospital failed to ensure that safeguards were in place to ensure the safe and effective use of fentanyl transdermal patches.

Based on observation and interview, the hospital failed to remove expired or unusable medications or intravenous solutions out from the medication storage and not made available for patient use.

Findings:

1. During an inspection of the medication storage area in the PACU with Staff A (Chief Nurse Officer) at approximately 9:30 a.m. on 5/17/10, five 1-liter bags of 0.9% sodium chloride with expiration date of March 01, 2010 were found being stored in the medication storage refrigerator. Staff A stated that the refrigerated solution was for intravenous use to lower the patient ' s temperature in the event of a patient developed malignant hyperthermia. Staff A further stated that the expired cold solution was not suitable for patient use.

During the same inspection, one 250-ml bag of 0.9% sodium chloride was found being stored in an overhead cabinet. Staff A stated that the expired intravenous solution was not suitable for patient use and should have been removed from the medication storage cabinet.

2. During an inspection of the supply room with Staff A at approximately 9:55 a.m. on 5/17/10, one 1-liter bag of Potassium Chloride 20 mEq in Latated Ringer and 5% dextrose with no protective outer wrapping was found being stored on a shelf. There was no indication as to when the bag was removed from its protective outer wrapping. Staff A stated that products should be dated upon removal from the outer wrapping and that the identified product was not suitable for patient use.

Based on staff interview and document review, the hospital failed to have an organized dietetic service to carry-forth nutrition care and foodservice operations. By not having an organizational framework for scheduling, training, inter-departmental coordination, screening, storage, preparation, distribution, service and disposal as well as surveillance of systems and services. There was potential and actual non-adherence to standards. Further, there was probable unhealthful, unsafe disruptions during regular and emergency/disaster conditions in a hospital which had a licensed bed capacity for 16 patients.

Findings:

1.On 5/20/10 between 10 a.m. and 10:30 a.m. concurrent review of documents and interview of both Dietetic Service Manager 1 and Nursing Manager 1 revealed that the failures to have had an organizational framework comparable to general acute care hospitals in the community was attributed to size, uniqueness in having a medically stable patient population admitted for surgical procedures, short duration of stay and dependence upon affiliate healthcare for administrative consultation, staffing and related services. Further, on 5/21/10 at 3:45 p.m. having concluded not only document review, inclusive of the hospital ' s organizational structure, but foodservice inspection and medical record reviews related to nutrition care, identifying systemic failures, the Administrator stated that because of size, specialization and history of affiliation, she would " need to look at how the dietetic service department operates " .

2.On 5/21/10 at 3:12 p.m. having found deficient practices and conditions in regards to infection control within the dietetic service department, Registered Dietitian 1 stated that her responsibilities to the dietetic service department had been primarily " clinical " and " consultative " -given her current schedule. According to Registered Dietitian 1, it was clear that there needed to be " more specific training " developed and presented by her as well as guidance to Dietetic Service Manager 1 and dietetic service staff regarding foodservice storage, preparation, distribution and service to patients for food safety, healthful meals and nourishments as well as adherence to the special dietary needs of patients during duration of stay as well as for specific diet plans upon discharge.

Based on observation, staff interview and document review the hospital failed to ensure that the director, responsible for the daily management of the dietetic services had reviewed the policies and procedures and had related training that addressed food safety, special dietary needs, emergency/disaster plans, documentation and other support items so as to have a dietetic service department conforming to standards of practice. Two residents (30 and 6) who had cosmetic surgery had Physician orders for "Advance Diet" as tolerated, but had no specific subsequent diet ordered for this specific type of surgery (e.g. liquid diet, soft diet). The facility had no documented alternative plan for a dietary manager or designee if there was an admission on weekends to provide dietary needs of patients.

Findings:

1.On 5/20/10 between 10 a.m. and 10:30 a.m. review of the departmental documents revealed that: there was no signed approval page for policies and procedures; a failure to have a list of substitutes/alternates for therapeutic and modified texture diets as well as a specific list of substitutes/alternatives for breakfast for all types of diets; and the failure to have an approved, written nourishment schedule and offering, e.g. for HS (night) snacks for patients without restrictions. On 5/20/10 between 10:15 a.m. and 10:30 a.m. Dietetic Service Manager 1 stated that she: could not locate the signed approval page; had not consulted with Registered Dietitian 1 regarding the development of a complete list of substitutes/alternates to include in the approved policies and procedures; and did not know why there had been a failure to have a written nourishment schedule in departmental policies and procedures.

2.On 5/20/10 between 10:25 a.m. and 10:30 a.m. Dietetic Service Manager 1 stated
that weekend admission of patients was " rare " and that because of this, neither she nor another member of the dietetic service was responsible for oversight of the foodservice then unless she was " called in " . Dietetic Service Manager 1 stated that Registered Dietitian 1 was available by phone for consultation and that she (Dietetic Service Manager 1) " could come in " if contacted by nursing staff. However, there was no documentation to demonstrate what would occur if neither she nor Registered Dietitian 1 were available. However, at 10:30 a.m. Nursing Manager 1 stated that if Registered Dietitian 1 " is not available " nursing staff would contact their affiliate healthcare facilities for utilization of a substitute registered dietitian and that if there was a delay in the arrival of Dietetic Service Manager 1 that nurses (who are to assigned only for nursing care) " might be asked to step in " to help in food distribution in the interim. As stated, this utilization could be problematic in terms of scheduled patient care, potential for cross-contamination as well as performing duties delineated to the authorized, oriented and trained Dietetic Service Manager 1.

3.On 5/20/10 between 10:30 a.m. and 11:20 a.m. review of departmental documents
revealed that there was no formalized training for physicians and nurses conducted by a registered dietitian in the past year; no training by a registered dietitian for dietetic service staff since 4/09; and the acceptance of physician-prescribed " Diet as Tolerated " orders modified by nursing staff without requiring accuracy and correlation to the hospital diet manual diet titles. The latter was of concern subsequently on 5/21/10 between 3:20 p.m. and 3:45 p.m. as closed medical record review of three patients who had been discharged the day following admission revealed that two patients (Patient 30 and Patient 6) had physician-prescribed diet orders for " Advance diet as tolerated " with no subsequent diet order by a physician indicating specific diet (i.e. Clear Liquid Diet, Full Liquid Diet, etc).

For Patient 30, a five feet five inch, 150 lbs female admitted 3/31/10 and
discharged 4/1/10 who had a history of gastric bypass surgery and had a cosmetic
surgery procedure, there was no record of what types of food and/or beverages had
been consumed during hospitalization. Also, for Patient 6, a five feet seven inch
205 lbs female admitted on 5/18/10 for cosmetic surgery, then discharged on
5/19/10 there was neither documentation as to what had constituted " tolerance "
and " intolerance " nor a plan upon discharge identifying how the diet was to be
advanced.

On 5/20/10 between 11:20 a.m. and 11:30 a.m. Registered Dietitian 1 stated there had only been informal " usually periodic and weekly " patient-specific discussions with physicians with discussion at rounds and when there was hospitalization with length of stay beyond five days. Additionally, there was no scheduled, on-going training for nurses by Registered Dietitian 1 and dependence upon Dietetic Service Manager 1 for training dietetic service staff in the past year.

Between 1 p.m. and 1:10 p.m. Registered Dietitian 1, Dietetic Service Manager 1 and Nursing Manager 1 stated that non-specific " Diet as tolerated ' and " Advance diet as tolerated " physician orders had been " on-going " , modified by nursing staff " as needed " and tolerance was dependent upon bowel sounds, absence of nausea and subjective determination by the patients and nursing staff. The latter was of concern based upon patients ' post-surgical reliability, communication and potentially varying criteria for intolerances and thresholds on the part of not only patients, but healthcare staff.

3.On 5/20/10 between 11:30 a.m. and 12:25 p.m. review of departmental documents revealed that for four companies providing services for: specific equipment maintenance; dishmachine operations and pest control that there had been the failure to have contracts denoting term and administrative authority of the hospital. Further, only one of the four documents had co-signature, one had not been on the hospital ' s list of contracts and none of the four had been part of the hospital ' s quality assurance program in the past year. Additionally, it remained uncertain as to how an outside linen service providing laundered napkins had been evaluated.

On 5/20/10 between 12:20 p.m. and 12:25 p.m. Nursing Manager 1 stated that both she and the Administrator would " look into these 'contracts' " and " update them as needed. " At 12:25 p.m. Dietetic Service Manager 1 stated that she had not been aware of the need to have completed contracts/agreements for outside services pertinent to the dietetic service department and to have had them integrated in the hospital-wide quality assurance program. Additionally, between 4:50 p.m. and 5 p.m. the Administrator added that while there had been the informal process of addressing concerns " with anything, if it is a concern with any thing purchased or agreed upon " , there had been the failure to have had " complete " contracts and the services evaluated through the hospital ' s quality assurance program.

4.On 5/20/10 between 1:10 p.m. and 1:30 p.m. review of the departmental documents revealed that with the exception of 96 hour sustainability which was pertinent to foodservice operations, there had been no quality assurance projects specific to clinical nutrition care issues. At 1:30 p.m. Dietetic Service Manager 1 stated that she would have to check with Registered Dietitian 1 to determine what clinical nutrition care issues could be addressed.

5.On 5/20/10 between 1:30 p.m. and 2 p.m. review of the emergency/disaster plans with Nursing Manager 1 for foodservice revealed that allocations for food, water and support materials had been based upon the number of beds that could be readily occupied (12) and for which the hospital planned staff, rather than what was identified on the license (16). At 2 p.m. Nursing Manager 1 attributed the discrepancy in number of beds and related calculations to utilization of four patient rooms for " outpatient needs ' and " office space " . Also, there had been the failure to have the types and amounts of containers for dispensed tank water and to have the approved, policy and procedure for three-step (wash, rinse and sanitize) manual dishwashing in the plan. At 2 p.m. Dietetic Service Manager 1 added that they would review the plans to be sure that the plans cover all the patients, staff and possible visitors.

6. On 5/20/10 between 2 p.m. and 2:20 p.m. review of the job descriptions for Dietetic Service Manager 1 and Registered Dietitian 1 and respective personnel documents revealed that for Dietetic Service Manager 1 (who met State qualification standards for dietetic supervisor) she was to have had a related Bachelor ' s degree, but did not and for Registered Dietitian 1 (who was a registered dietitian) there had not been the specification of having registration with the American Dietetic Association Commission on Dietetic Registration. Also, additional review revealed that there was no job description and/or formal agreement defining the duties and responsibilities of registered dietitians from affiliate healthcare facilities who may substitute when Registered Dietitian 1 is on leave.

7. On 5/20/10 between 4:45 p.m. and 5 p.m. review of the diet manual revealed reliance upon outdated (1989) RDA ' s (Recommended Dietary Allowances) and that there was lack of current guidance regarding the varied caloric and nutritional requirements of an identified actual and potential surgical population, adolescents of varied ages and needs relative to stage of growth.

8. On 5/20/10 between 5 p.m. and 5:10 p.m. review of the diet manual and available standardized recipes (i.e. for two soups) revealed that there was incomplete guidance and lack of standardized recipes for preparation of foods and beverages that could be served to patients on the Full Liquid Diet. As such, there was uncertainty as to desired, safe consistency, appropriateness of added ingredients, appeal, nutritional adequacy and conformance to the diet as described the hospital diet manual.

9. On 5/21/10 between 9:45 a.m. and 10 a.m. review of the departmental policies and diet manual revealed that there was no dietary guidance pertaining to patients identified as having Latex allergy and for whom specific foods (e.g. avocadoes, chestnuts, eggplant, kiwis, bananas and/or other assorted fruits and vegetables) could be contraindicated. This omission posed a medical risk due to the concomitant connection between these food allergies and Latex with the potential for reactions, inclusive of life-threatening anaphylaxis.

On 5/21/10 at 1 p.m. review of the nursing policy, " Latex Allergy " revealed that there were no considerations mentioned for diet. Also, the policy did not specify the need
for screening patients for potentially related food allergies upon admission and alerting the dietetic service department. The latter was of concern as the dietetic service department did not screen for this specific potential, had not developed a reciprocal alert for nursing staff should it be learned that there were specific food allergies indicating potential allergy to Latex and had no plans or materials for patient education. Additionally, the nursing policy specifically addressed Latex allergy to be of such concern that if known to occur in asthmatic patients, the anesthesiologist on-call was to be notified and that such patients might not be suitable for admission due to the risk of severe reaction.

As contraindicated foods were available on the menus as well as potentially available for patient service either by planned substitution or patient request and there was no documentary evidence of interdepartmental correspondence indicating that this risk was known, surgical patients with known allergies were potentially subject to adverse reactions. In the 2006 edition of " Medical-Surgical Nursing " , ' Critical Thinking for Collaborative Care " by D. Ignatavicius and M. Workman recommendations are made to " assess " Latex allergies, especially as Latex-induced anaphylaxis accounts for ten-percent of anaphylaxis reactions occurring during surgery and there are potential non-food concerns as hospital materials, equipment and devices may contain Latex. Additionally, this text referenced sources which reported that as of 2000, the incidence of Latex allergy had increased.

10.On 5/21/10 at 2:10 p.m. inspection of the outdoor premises for kitchen refuse disposal revealed that there was an uncovered dumpster filled to the brim with full bags. Previously, on 5/20/10 between 10:15 a.m. and 10:30 a.m. Dietetic Service Manager 1 stated that in addition to patient foodservice breakfast and lunch service was available for " about thirty to forty staff a day " and that this accounted for " so much going on " . As of 3:10 p.m. there was no explanation for why there was lack of prompt containment when identified and corresponding additional pick-up scheduled so as to prevent unsightliness, odors and the attraction of pests.

Based on medical record and document review as well as staff interview the hospital failed to ensure that: prescribed therapeutic diets were accurate; there was documentation related to tolerance of such order; and had been evaluated for nutritional adequacy. By not having specific diet orders, documentation of tolerance and evaluation of nutritional adequacy, there was the failure to have ensured that the nutritional needs of patients had been met in a hospital with a licensed bed capacity for 16 patients. Additionally, there was uncertainty as to the evaluation of diet for a patient with a history of gastric bypass surgery. (Patient 30).

Findings:

On 5/20/10 between 10:30 a.m. and 11:20 a.m. Dietetic Service Manager 1 and Nursing Manager 1 stated there had been a long-standing acceptance of physician orders which were non-specific as to type of diet. At 1:10 p.m. Nursing Manager 1 stated that nursing staff needed to " modify " these types of orders based upon presence of bowel sounds, absence of nausea and subjective evaluations by both the patients and the nursing staff. As such, per this report and document review conducted on 5/21/10 between 3 p.m. and 3:10 p.m., it appeared that " tolerance " had been based upon few criteria and had not considered other factors--e.g. safe chewing and swallowing capacity, normal metabolic processes/presence of enzymes, return of normal intestinal, bowel and colon function, absence or type of pain, percent-intake and/or subjective, qualitative evaluations of food provided by the dietetic service.

Further, on 5/21/10 between 3:20 p.m. and 3:45 p.m. closed medical record review of Patient 30 ' s care revealed that while admitted on 3/31/10 for cosmetic surgery, the post surgical diet order of Advance Diet as Tolerated " was non-specific and there was no documented evidence of clarification and evaluation of tolerance to the diet provided. The latter was of concern, given that Patient 30 had previously had gastric-bypass surgery and this typically has many considerations, including discomfort with moderate to large volumes of food, risk for diarrhea and needed, nutritional supplementation. On 5/21/10 at 3:45 p.m. Nursing Manager 1 stated that there would need to be review to ensure accuracy in diet orders and to have consistent, complete means to determine and document " tolerance " . She added that Registered Dietitian 1 needs to " help with this " .

Based on medical record and document review as well as staff interview the hospital failed to ensure that the nutritional needs of patients had been met in accordance with recognized dietary practices, current national standards, professional practice and specific
patient needs. By not having had both policies and procedures as well as a
diet manual with updated reference to current nutritional guidelines there was
the on-going inability to evaluate the dietary regimens of two patients (Patients 60 and 6).

Finding:

On 5/20/10 between 10:30 a.m. and 11:20 a.m. as well as on 5/21/10 between 3 p.m. and 4 p.m. interview with Dietetic Service Manager 1 as well as document and medical record reviews of two of three patient medical records (Patient 60 and Patient 6) revealed that there were departures from standards of practice and a failure to have updated support materials, e.g. policies and procedures and diet manual. This included: the allowance for "as tolerated " diets rather than specific diet orders; not having updated references for caloric and nutrient needs of patients (e.g. adolescents and those who have had gastric bypass surgery); not having current standards relative to Latex and contraindicated foods; a lack of guidelines/standardized recipes for the preparation of the Full Liquid Diet; and the failure to have developed a schedule for nourishments as well as complete lists for food substitutes and alternates.

On 5/21/10 at 4:25 p.m. the Administrator and Nursing Manager 1 stated that they would " work with dietary on all of these things."

Based on observation, interview, and record review, the facility failed to provide equipment for 4 out of the 16 beds it was licensed to furnish as general acute care beds.

Findings:

Record review on 5/21/10 showed that the facility's license granted by the California Department of Public Health effective 5/01/10 thru 4/30/11 for bed classifications and services were for 16 general acute care beds.

In an interview on 5/21/10 at 3:55 PM, Staff A stated there are four rooms (Rooms 21, 22, 35, and 36) that are currently not equipped as acute beds and that about six years ago, someone from the Department had spoken to the facility about obatining a bed conversion waiver for the four rooms. When asked if they have a conversion letter from the Department that allowed the facility to use these four rooms other than the intended acute beds granted on their license, Staff A stated they will try to locate it and send it to the Department. The facility was not able to present a letter to the Department requesting a waiver for the specified rooms.

Record review on 5/21/10 showed facility plans for room reconversions. One document titled, "Reconversion Plans for Rooms 21 and 22" (undated), stated the following:
1. Facilities will be contacted and asked to convert rooms 21 and 22 back into patient rooms.
2. Standard patient room cleaning procedures will be completed.
3. Confidential 4 drawer file cabinet (locking) and 2 drawer file cabinet will be moved to Library (lockable).
4. Computers from Rooms 21 and 22 will be set up in the library as needed or will go to storage temporarily.
5. Items such as linens and crutches stored in room 21 and 22 will be relocated temporarily to other locations.
6. Facilities will take all desks furniture from 21 and 22 to storage facility that are not able to be used as patient furniture.
7. All patient room furniture will be brought from storage by facilities and set up in the rooms. If additional beds or other furniture are needed, Mills Peninsula Health services will be contacted for items needed on a loan basis.

On the same record review on 5/21/10, another document titled, "Reconversion Plan for Rooms 35 and 36" (undated), stated the following:
1. Facilities will be contacted and asked to convert rooms 35 and 36 back into patient rooms.
2. Standard patient room cleaning procedures will be completed.
3. Confidential Medical Record file cabinet (1) will be moved to MD dictation room (lockable). Current patient's charts that may be needed will be kept in small file in fax room (lockable).
4. Employee files cabinet (1) will be moved to MD dictation room.
5. Confidential Quality file cabinet (1) and binders will be moved to CEO office.
6. Back Office staff file cabinets and bookcase will be temporarily moved to Library and/or storage facility.
7. Medical records copy machine and printer will be temporarily moved to library.
8. Two computers can be set up in the library as needed, one can be set up in the MD dictation room as needed, the rest will go to storage temporarily.
9. Facilities will take all desks and other furniture from 35 and 36 to storage facility.
10. All patient room furniture will be brought from storage by Facilities and set up in the rooms.
11. Back office staff will access laptop computers as necessary or available computers throughout the facility.

During the tour of the facility on 5/21/10 at 3:55 PM, Rooms 21 and 22 were furnished with patient beds and cabinets but according to Staff A, these rooms were being used for outpatient admissions and discharges. Rooms 35 and 36 were furnished as offices with desks and bookshelves. Room 35 was used as the medcial records office and room 36 was shared with the education department and the chief nursing officer. According to Staff A, the facility would be able to convert these four rooms to acute patient rooms within 24 hours.

Based on observation, interview, and record review, the hospital failed:
1. to ensure that it had maintained infection control standards in the dietetic service department and in a staff dining area. By not having maintained standards, there was the potential for not identifying, reporting and remediating an unsafe, unsanitary foodservice and a dining condition which could contribute to the development of cross-contamination and foodborne illness in a hospital with a licensed bed capacity for 16 patients.

2. to prevent potential infections when: they mounted soap dispensers above paper towel dispensers so that wet dirty hands reaching for the soap could drip onto clean paper towels; a fold down shower seat had a large tear on the vinyl covering the side of the foam cushion; toiletries including toothbrushes and washcloths were spread out next to the sink where they could be splashed and contaminated by someone using the sink to wash their hands.

Findings:

1. On 5/21/10 between 2:10 p.m. and 3:10 p.m. inspection of the kitchen and kitchen areas revealed unsanitary, cross-contaminating conditions and practices. These were: in dry storage--two moldy onions retained in a bin; in a food preparation area-four scratched, stained cutting boards; in a cold food preparation area counter--a box of salad dressing which had an oily exterior of uncertain origin and in a cleaning/dishwashing area-usage of undated test strips to determine potency of the sanitizing solution used on counters and equipment surfaces. At 2:15 p.m. Dietetic Service Manager 1 discarded the moldy onions, but there was no direction to dietetic service staff regarding cleaning and sanitizing the bin as well as discarding the onions that had been stored adjacent to the observably moldy onions. Also, at 2:40 p.m. both Dietetic Service Manager 1 and Registered Dietitian 1 acknowledged that the dietetic service staff needed to use clean, sanitary and reliable equipment and supplies.

2. On 5/20/10 at 10:40 a.m. Dietetic Service Manager 1 had stated that Registered Dietitian 1 had little or no participation in the Infection Prevention Committee which met quarterly as well as two other hospital organizations for evaluation, Safety Rounds and Environment of Care discussion and surveillance. On 5/21/10 between 3 p.m. to 3:10 p.m. upon conclusion of the inspection of the kitchen and kitchen areas Registered Dietitian 1 stated she had been " a little surprised " at the conditions. Additionally, Registered Dietitian 1 stated that she thought that the dietetic service needed " monitoring ' and that dietetic service staff needed " training. "

3. On 5/21/10 between 2:30 p.m. and 2:50 p.m. inspection of the kitchen revealed there were problematic plumbing and sink conditions. In the cleaning/dishmachine area there were two drainage spigots near the floor which lacked sufficient air gaps to prevent splashing contaminated water into pipes. At one sink there was a missing spigot to ensure operability of the third sink for three-step manual dishwashing for regular and emergency/disaster use and there was a lack of designated (separate, sole use) preparation sink. At 3 p.m. Dietetic Service Manager 1 stated that she was " concerned " about the conditions and that the lack of preparation sink required washing, then sanitizing a sink basin that had been designated for part of the manual dishwashing process preceding sanitization. The later was of concern given the risk for splashing contaminants and ineffective sanitization of a dual-usage sink which could lead to unsafe, unsanitary food preparation and distribution during both regular and emergency/disaster conditions.

4. On 5/21/10 between 2:40 p.m. and 2:45 p.m. while in the kitchen cleaning/dishmachine area Dietetic Service Staff 1 stated he could not locate the QAC (Quaternary Ammonium Chloride) test strips that were to be used to test the sanitizing solution that was to be applied to kitchen counters and equipment. Upon leaving the area at 2:40 p.m. and returning within two minutes, he used a strip from an undated container and stated that he did not know how long the strip was to be submerged in solution. At 2:45 p.m. when Dietetic Service Staff 1 read the manufacturer ' s label directions, he found that he had not been testing for the specified time and that one of the two solutions tested was not of the anticipated potency. Further, at 3:10 p.m. Dietetic Service Manager1 stated that there was no documentation of having tested the sanitizing solutions routinely

5. On 5/17/10 at 2:40 p.m., the sink in patient room 34 was noted to have a pump bottle of Hibiclens? soap mounted above a paper towel dispenser that was flush with the sink counter and to the left of the sink. To the right of the sink were small bottles of toiletries including a toothbrush and a washcloth.

The patient, visitor, or staff member who used this sink to wash their hands had the potential to contaminate the clean paper towels when they reached for the Hibiclens? soap after wetting their hands. The hospital's policy, Hand Hygiene Technique, number 10.170 indicated in F. 3., "Moisten hands well before applying any antimicrobial soap." The toothbrush along with the rest of the toiletries the patient may use had the potential to be contaminated from splashes during hand washing.

6. On 5/17/10 at 2:40 p.m., the shower seat cushion in room 34 was noted to have a large tear in the vinyl exposing the foam cushion. The exposed foam cannot be cleaned between patients. The facility is a surgical hospital so many of the patients could be expected to have drainage including blood from their surgical wounds. There is potential for contamination of the foam in the shower seat which could lead to infections in patients.

7. On 5/19/10 at 2:05 p.m., the isolation room (a room for highly contagious patients) which was not in use, and room 34 were observed with the Infection Control Nurse. There were Hibiclens? soap dispensers mounted over the paper towel dispensers in both rooms. The Infection Control Nurse said the nurses use the sinks to wash their hands and that the soap could drip onto the paper towels. She then took the Hibiclens? soap dispenser out of the holder mounted on the wall and placed it next to the sink. She stated there were several other rooms with this same problem. She also said if the toothbrush was left on the washcloth on the sink counter it could get splashed when someone washed their hands in the sink.

8. On 5/21/10 at 11:19 a.m., in room 26, the housekeeper explained how she thoroughly cleaned patient rooms. There was a Hibiclens? soap dispenser mounted over the paper towel dispenser in this room and toiletries on the other side of the sink. She said that soap frequently drips onto the clean paper towels and that she also notices splashes where the toothbrush and washcloth were placed.

The hospital failed to protect their patients from potential infections when they allowed paper towels, toiletries, and a shower seat cushion to be exposed to sources of contamination.


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Based on observation, document review, and interview, the hospital failed to follow recommended practices in preparing and transporting surgical instruments when instruments which had been sterilized for use were taken uncovered back through a sterilization room and a hallway crowded with open carts of dirty surgical instruments to the operating room (OR). This practice potentially contaminated the surgical personnel and the sterile equipment which would then enter the OR potentially contaminating the patient and causing infection.

Findings:
On 5/20/10 at 10:30 a.m., the areas where surgical instruments were cleaned and processed were observed with the OR Manager. This area was adjacent to an operating room. The first room was where dirty surgical instruments were taken to be washed in a sink. This area was overflowing out into the hallway with steel carts with open shelves containing dirty surgical instruments. One cart was touching the oxygen tank apparatus on the crash cart (a cart containing equipment and medications used in medical emergencies like cardiac arrest).
The hallway then opened into the second room where special machines are used to remove all remaining microorganisms (sterilization). The last room was where sterile instruments that had been placed in special paper wraps were stored on shelves. While exiting the area near the dirty sink room, a staff member was asked to move a cart of dirty instruments to enable passage through the hallway.
In an interview with the OR Manager at 3:25 p.m. on 5/20/10, he stated the sterile packages were not wrapped in plastic, and were transported on uncovered carts past the sterilization machines and the dirty sink room. He stated there were no hospital policies nor procedures for the cleaning, sterilization, and transportation of surgical instruments. The OR Manager said the only pathway to take the sterile packages of instruments from the last room where they were stored to the operating room was through the second (sterilization) room and through the hallway where the carts of dirty instruments were.
The Association of periOperative Registered Nurses (AORN) sets standards and recommendations for surgical nursing care. In the 2008 edition of Perioperative Standards and Recommended Practices under "Recommended Practices for Sterilization in the Perioperative Practice Setting," Recommendation I, 1.a. stated "Functional workflow patterns should be established to create and maintain physical separation between the decontamination and sterilization areas." It further indicated under 1.a.2., that functional workflow patterns should be established from potentially high contamination (dirty) areas to cleaning, decontaminating, sterilizing, sterile storage, and clean distribution - in that order. This recommendation was not followed by the hospital when they transported their sterile instruments through dirty areas.
Recommendation I, 1.a.3 indicated, "Traffic patterns should be established that define access restrictions, movement of personnel, and appropriate attire . . . to protect personnel, equipment, supplies, and instrumentation from sources of potential contamination."

Based on interview and document review, the facility failed to develop policies and procedures to verify the scope of the rehabilitation services that the facility offers.

Findings:

During an interview on 5/21/10 at 1:55 PM, the Chief Nurse Officer and Administrator stated the facility offered physical therapy to their patients through contract agreements from another facility but had never required to use the service. Both facility staffs stated they offered physical therapy " in case it was ever needed " .

When asked to review their policy and procedures for the physical therapy services, the Chief Nursing Officer and Administrator stated there was none.

Based on interview and document review, the facility failed to employ a qualified director of rehabilitation services to ensure supervision and administration of the rehab services. The facility's failure to have a director of rehabilitation to manage and supervise the rehabilitation services is a potential risk that could cause inadequate treatment for patients who may need the services.

Findings:

During an interview on 5/21/10 at 1:55 PM, Staff A and Staff K stated there was no director of the rehabilitation services in their facility. They stated physical therapy was the only service offered and that it was never required by any patient in the facility.

During a document review on 5/21/10, the facility ' s organizational chart dated 9/30/08 had the physical therapy within the " Therapy Services " department and did not have a delineated qualified director of rehabilitation.

Based on interview and document review, the facility failed to develop policies and procedures to verify the scope of the respiratory therapy services the facility offered.

Findings:

Review of the contract between the hospital and the Therapy Services with an agreement date of 01/01/09 indicated that the contracted Therapy Services "Review of Hospital's patient care policies with respect to the Rehabilitation Services and the implementation of such changes or amendments to those policies as are necessary to conform to the Hospital's policies to all applicable state and federal regulations and accepted professional practices."

During an interview on 5/21/10 at 9:18 AM, the Director of Nursing (Staff A) and Administrator (Staff K) stated the facility offered respiratory therapy to their patients through contract agreements from another facility but had never required to use the service. Staff A and Staff K stated they offered respiratory therapy " just in case it was ever needed " . They also stated that their nurses and physicians were certified in Advanced Cardiac Life Support (ACLS) and were capable of treating a patient who was in respiratory distress before transferring the patient to a local hospital for further management. Staff A and Staff K also stated that if a patient required more extensive respiratory treatments on a regular basis, the patient would be evaluated initially by the anesthesiologist and most likely may not be admitted to the facility.

When asked to review their policy and procedures for the Therapy Services, Staff A and Staff K stated there was none.

Based on interview and document review, the facility failed to employ a qualified director of respiratory care services to ensure supervision and administration of the respiratory services.

Findings:

During an interview on 5/21/10 at 9:18 AM, Staff A and Staff K stated there was no director of the respiratory care services in their facility. Respiratory Therapists were employed by contract agreement through another facility and that respiratory therapy was never required yet by a patient.

During a document review on 5/21/10, the facility ' s organizational chart dated 9/30/08 had the respiratory therapy within the " Therapy Services " department and did not have a delineated qualified director of respiratory care.

By not having a designated Director of Respiratory Services, there was no administrative oversight of the respiratory department to ensure the overall delivery of care was being instituted.

Based on interview and document review, the facility failed to develop policies and procedures approved by the medical staff to verify the scope of the respiratory care services the facility offered.

Findings:

During an interview on 5/21/10 at 9:18 AM, the Chief Nurse Officer (CEO A) and The Administrator (Staff K) stated the facility offered respiratory care therapy to their patients through contract agreements from another facility but had never required to use the service. Staff A and Staff K stated they offered physical therapy " just in case it was ever needed " .

When asked to review their policy and procedures for the physical therapy services, CEO A and Staff K stated there was none. (Refer to A 1151, 1152, 1153, 1160).

Based on document review and staff interview the hospital failed to ensure that the quality assurance program had encompassed patient care, hospital services and operations by not complying with the following: 1) By not having a comprehensive program in dietetic services, inclusive of outside services there was the potential for ineffective surveillance to preclude cross-contamination, foodborne illness and unsafe usage of equipment in a hospital with a licensed bed capacity for 16 patients and 2) By not having one effective governing body and quality assurance committee for Facility A.

Findings:

1. On 5/20/10 between 11:30 a.m. and 12:25 p.m. review of contracts and the hospital-wide quality assurance program revealed that four companies providing services to the dietetic service department, e.g. for special equipment maintenance, dishmachine operations and pest control that there had not been surveillance of the conditions and practices by hospital staff. Also, at 12:27 p.m. upon concurrent review and interview, Dietetic Service Manager 1 stated that in addition to not being familiar with the need to have these outside services pertinent to her department " evaluated ", she was unfamiliar with the standards for evaluating the safety of the linen service providing napkins. Further, in addition to this lack of surveillance, there had not been any documented integration within the hospital ' s quality assurance program and as of 5 p.m. the Administrator, having consulted with Nursing Manager 1 and Dietetic Service Manager 1 as well as stating she had checked with other hospital and affiliate representatives throughout the day stated, " This can get fixed " .

2. On 5/20/10 between 1:10 p.m. and 1:30 p.m. Dietetic Service Manager 1 stated
unless she was informed " differently " by Registered Dietitian 1, there were " no
clinical nutrition items " in the quality assurance program within the past year. However, in the course of the survey on 5/20/10 and 5/21/10 there were actual and potential shortcomings for patients ' nutrition care. These were not having: complete lists for substitutes/alternates; sufficient references and recipes for preparation of foods for the Full Liquid Diet; planned and evaluated training for physicians and nurses; assessed the accuracy, tolerance, nutritional adequacy and possible need for specific supplementation of physician prescribed " as tolerated " diets; conducted retrospective studies of diets prescribed and provided within the first five days of stay of sub-group patient populations and what diets were recommended upon discharge; determined effectiveness of any orientation and coverage conducted by any substituting registered dietitians; evaluated the diet manual for current, accurate reference and application, given the outdated enclosure, the 1989 RDA ' s (Recommended Dietary Allowances); and not having addressed special patient needs, e.g. adolescents and those with potential concerns for some surgical patients regarding food allergies and condition, i.e. reaction to use of Latex and concomitant foods..

On 5/21/10 at 3:20 p.m. both Nursing Manager 1 and Registered Dietitian 1 discussed the need to evaluate and prioritize actual and potential nutrition care problems. At 3:20 p.m. Nursing Manager 1 stated, " Now it 's clear what we can do " .


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2.During an interview on 5/21/10 at 3:04 PM, Staff K stated that Facility A ' s governing body was under Facility B which was under a different licensure from Facility A. When asked if Facility A had their own governing body, Staff K stated they did not. In addition, Staff K stated Facility A shared half of its quality assurance committee with that of Facility B.

During another interview on 5/21/10 at 4:00 PM, Staff O also confirmed that Facility A ' s governing body was from Facility B and that Facility A did not have their own separate governing body and confirmed that the Quality Assurance Committee comprised half of Facility A and the other half with facility B.

During a document review on 5/21/10, Facility A's bylaws ( laws or rules governing the internal affairs of an organization) were stated in Facility B's bylaws which was titled, "Thirteenth Amendment and Restatement of Bylaws of ( Facility B) " , dated May 01, 2009.

The bylaws stated the following on pages 14 to 16, under Quality Committee (for Facility H, the Corporation): "12.2 a. Oversee the development and implementation of the Corporation's (Facility H) policy for quality management and continuous quality improvement in the hospitals and facilities owned or operated by the Corporation (Facility H); 12.2 g. Give support, guidance, and counsel to the Chief Executive Officers or administrators from the hospitals and facilities owned or operated by this Corporation (Facility H) and the respective Cheifs of Staff in the performance of their respective functions and activities; 12.2 i. Conduct appropriate monitoring and oversight to ensure that the quality functions delegated to the Professional and Medical Staffs of the hospitals and facilties are being consistently and effectively performed so as to enhance the quality of patient care and assure patient safety; 12.2 n. Review and monitor hospital and facility programs from a quality of care standpoint, including adequacy of staffing, equipment, facilities and other factors."

The bylaws for Facility A stated the following on pages 20 to 21, under (Facility A) Quality Committee: "16.1 Purpose : a. To ensure that the Corporation's facilities (Facility H), caregivers, resource allocation and process of care are responsive to the care delivery and health status needs of the ..... community; 16.3 Responsibilities h. Review and make recommendations regarding compliance with applicable standards and recommendations for licensure, certification and accreditation..."

3. During an interview on 5/21/10 at 9:18 AM, Staff A and Staff K stated the hospital offered respiratory therapy to their patients through contract agreements from another hospital but had never required to use the service. Staff A and Staff K stated they offered respiratory therapy " just in case it was ever needed " . They also stated that their nurses and physicians were certified in Advanced Cardiac Life Support (ACLS) and were capable of treating a patient who could develop respiratory distress before transferring the patient to a local hospital for further management. Staff A and Staff K also stated that if a patient required more extensive respiratory treatments on a regular basis, the patient would be evaluated initially by the anesthesiologist and most likely may not be admitted to the facility.

When asked to review their policy and procedures for the physical therapy services, Staff A and Staff K stated there was none.

The physical therapy service was evaluated in their quality assurance meeting via a document titled, " Performance Expectations ". This document had a rating scale of the service from: " A = Services meet and frequently exceed expectations, B = Services usually meet expectations, C = Services do not meet expectations; improvement needed - see action plan". Since the facility did not use this service, the document stated, " Not used " , and it was signed by Staff K dated 4/01/10.

Additionally, during an interview on 5/21/10 at 9:18 AM, Staff A and Staff K stated there was no director of the respiratory care services in their facility. Respiratory Therapists were employed by contract agreement through another facility and that respiratory therapy was never required yet by a patient.

During a document review on 5/21/10, the facility's organizational chart dated 9/30/08 had the respiratory therapy within the " Therapy Services " department and did not have a delineated qualified director of respiratory care.

4. During an interview on 5/21/10 at 1:55 PM, Staff A and Staff K stated the facility offered physical therapy to their patients through contract agreements from another facility but had never required to use the service. Staff A and Staff K stated they offered physical therapy "just in case it was ever needed ".

When asked to review their policy and procedures for the physical therapy services, Staff A and Staff K stated there was none.

The physical therapy service was evaluated in their quality assurance meeting via a document titled, " Performance Expectations " . This document had a rating scale of the service from: " A = Services meet and frequently exceed expectations, B = Services usually meet expectations, C = Services do not meet expectations; improvement needed - see action plan". Since the facility did not use this service, the document stated, " Not used " , and it was signed by Staff K dated 4/01/10.

Furthermore, during an interview on 5/21/10 at 1:55 PM, Staff A and Staff K stated there was no director of the rehabilitation services in their facility. They stated physical therapy was the only service offered and that it was never required yet by a patient.

During a document review on 5/21/10, the facility's organizational chart dated 9/30/08 had the physical therapy within the " Therapy Services " department and did not have a delineated qualified director of rehab.