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Based on interviews and review of Quality Assurance and Performance improvement documents, Medical Staff Bylaws, medical Executive Committee meeting minutes, Peer Review Log, and patient records, it was determined the governing body failed to provide sufficient oversight and management over the hospital to ensure compliance with all the CoPs. This resulted in the inability of the facility to provide safe and appropriate care and services to patients. Findings include:

1. Refer to A049 as it relates to the failure of the governing body to ensure a medical review process was developed and implemented and that medical staff were accountable to the governing body for the quality of care provided to patients.

2. Refer to A083 as it relates to the failure of the governing body to ensure contracted services were incorporated into the hospital ' s Quality Assessment and Performance Improvement Program.

3. Refer to A263 Condition of Participation on Quality Assessment and Performance Improvement Program and related standard level deficiencies as they relate to the failure of the governing body to ensure the hospital ' s Quality Assessment and Performance Improvement Program was integrated into all of the hospital ' s departments.

4. Refer to A338 Condition of Participation on Medical Staff and related standard level deficiencies as they relate to the failure of the governing body to ensure a medical review process was developed and implemented and that medical staff were accountable to the governing body for the quality of care provided to patients and did not admit medically unstable patients.

5. Refer to A385 Condition of Participation on Nursing Services and related standard level deficiencies as they relate to immediate jeopardy to patient health and safety (abated 6/21/10) and the failure of the governing body to ensure nursing services were provided to meet patients ' needs.

The cumulative effect of these systemic negative practices resulted in the inability of the facility to provide care of adequate scope and quality.

Based on staff and patient interviews and review of Quality Assurance and Performance Improvement documents, medical Staff bylaws, Medical Executive Committee meeting minutes, Peer Review log, and patient records, it was determined the governing body failed to ensure the medical staff was held accountable to the governing body and assumed full responsibility for the quality of medical care provided to patients. This resulted in a lack of Medical Staff peer review of the medical care provided by general medicine physicians. Findings include:

1. The hospital's Medical Staff Rules and Regulations, dated 5/07, stated at 20.2, that all members of the active Medical Staff were required to participate in Monthly Peer Review Procedures or as otherwise mandated by the Medical Director. Qualifying Peer Review guidelines for cases to be reviewed under the peer review process, included, but were not limited to, patients leaving AMA (Against Medical Advise), patients who experienced adverse drug reactions, patients transferred to acute care ED's, and patients who experienced critical events.

On 6/22/10 starting at 12:00 PM, a group interview was conducted. In attendance were the consulting General medicine Physician, a NP, a PA, and the Chief of Medicine. The Chief of medicine stated that no processes were developed to include Peer Review process for General Medical Physicians.

Review of the hospital's Peer Review Log, from July 2009 to June 1020, showed that no records underwent peer review that included services provided by General Medicine Physicians.

The governing body failed to ensure processes were developed and implemented to thoroughly and effectively assess the quality of care provided by the hospital's General Medical Physicians.

2. Refer to A338 Condition of Participation on Medical Staff and related standards level deficiency, as they relate to the failure of the hospital to ensure Medical Staff assumed full accountability for the medical care provided to patients.

Based on Quality Assurance and Performance improvement documents, hospital policies and procedures, and staff interview, it was determined the governing body failed to ensure of 3 of 4 (laboratory, dietary, pharmacy) contracted departments were integrated into the hospital's Quality Assurance and Performance Improvement Program. This negatively impacted 2 of 9 current patients (#16 and #17) whose records were reviewed. The failure of the governing body's oversight resulted in missed opportunities to improve patient care and outcomes. Findings include:

1. A review of the hospital's contract titled Professional Services Agreement - Stat Clinical Laboratory Services, did not state who was going to collect data for or address Performance Improvement Projects.

The hospital's Director of Performance Improvement and Risk Management was interviewed on 6/24/10 starting at 2:30 PM. She stated she had not implemented quality assessment and performance improvement program for the hospital's laboratory services.

During a tour of the hospital on 6/17/10, beginning at 8:40 AM, surveyors found the following expired laboratory equipment:

* Adult Unit-1 grey top blood collection tube that expired on 12/08, 3 grey top blood collection tubes that expired on 6/09, and 2 grey top blood collection tubes that expired on 12/09.

* ICU Overflow Medication Room-a vial of sterile water for parenteral administration that expired on 4/10, 2 viral transport kits that expired on 5/09, 3 viral transport kits that expired on 6/09, 3 viral transport kits that expired on 8/09, and 7 viral transport kit that expired on 9/09.

* Medication room of the Adolescent Unit-3 grey top blood collection tubes that expired on 12/08, 3 expired grey top blood collection tubes that expired on 6/09, and 3 grey top blood collection tubes that expired on 12/09.

* Adolescent North Unit-1 grey top tube that expired on 6/09.

* New Start Unit-5 grey top tubes that expired on 6/09.

All items and expiration dates were observed and confirmed by the DNS during the tour.

The hospital's governing body failed to ensure the equipment was not expired.

2. The hospital's Director of Performance Improvement and Risk Management was interviewed on 6/24/10 starting at 2:30 PM. She stated the contracted dieticians were not included within the hospital's Quality Assessment and Performance Improvement Program.

The hospital's Dietician Consultant Description of Services form, that was not dated, stated the contracted dietician service would "Complete the Following QA (Quality Assurance) audits monthly ..."; Dining room observations, sanitation survey, tray-line observation, test tray. The form stated the contracted dietitians would "Complete the Following QA audits quarterly;" Diet card accuracy check, tube feeding evaluation, and management review.

The Dietician Consultation Director was interviewed on 6/23/10 starting at 10:30 AM. She stated she had not been involved in the hospital's Quality Assessment and Performance Improvement Program and did not have any aggregated data.

3. The hospital's Dietician Consultant Description of Services form, that was not dated, stated the dietician would help develop patients' Plans of Cares. This was not done. Examples include:

a. Patient #16 was a 61-year-old male, who was admitted to the hospital on 6/14/10 for treatment of opiate detoxification. According to Patient #16's medical record, he had a long history of Diabetes Mellitus and was insulin dependent. Patient #16 was a current patient as of 6/18/10.

Patient #16's record contained a Nursing Assessment, dated 6/14/10 that was not timed. The assessment included an evaluation of Patient #16 BMI. The assessment stated Patient #16 was 5 foot 10 inches tall and weighted 125 pounds. This resulted in a BMI of less than 19 (normal 19-24) which placed Patient #16 in the underweight category.

Patient #16's record contained a verbal physician's order, dated 6/14/10 at 11:55 AM. The order included a dietary consult and an ADA diet for Patient #16. An ADA diet is set forth by the American Diabetes Association to help diabetics control BG levels by eating a consistent amount of carbohydrates distributed throughout the day and reduce calories to less than 2000 per day.

A Nursing note, dated 6/15/10 at 5:05 AM, stated Patient #16 had a history of gastroparesis resulting in a 25 pound weight loss and he was described as looking emaciated.

On 6/15/10 at 11:10 AM, the NP wrote orders for Patient #16. These orders included a second dietary consult referral and instructed nursing to provide a can of Ensure between meals and at bedtime. This would total 3 to 4 cans a day. Ensure has 250 calories per can and 60 grams of carbohydrates, 3 cans of ensure would provide 750 calories out of a 1500-2000 calories ADA diet and 180 grams of carbohydrates of the 250-275 grams of carbohydrates for the ADA diet.

A History and Physical assessment, written by a NP, dated 6/15/10 at 12:28 PM, stated Patient #16 was malnourished and had poor nutritional status.

Patient #16's record contained a dietary Nutritional Assessment, completed by a contracted Dietician, dated 6/16/10, that was not timed. The assessment did not include an assessment of Patient #16's calorie or carbohydrate intake. The assessment did not state how much of his meals he was eating or how many cans of Ensure Patient #16 was drinking. The assessment did not state what Patient's #16's BMI was or what his normal weight was. The assessment stated Patient #16 had a weight loss, but did not define how much weight he lost and in what period of time. The assessment did not include Patient #16's current and past dietary compliance or snacking habits. The assessment documented the Dietician recommended to encourage Patient #16 to decrease his Ensure as he began to eat more food. The assessment did not include recommendations such as, monitoring Patient #16's oral intake, monitoring Patient #16's compliance with the ADA diet, providing healthy snacks and weighing Patient #16 each week or at more frequent routine interval.

Patient #16's Plans of Cares, dated 6/14-6/16/10, did not include Patient #16's poor nutritional status and his malnutrition. Patient #16's Plans of Cares did not document the Dietician had reviewed and contributed to the development of the Care Plans. The above findings were confirmed by the Dietician Consultation Director on 6/23/10 during an interview that started at 10:30 AM.

b. Patient #17 was 36-year-old female admitted to the hospital on 6/11/10 for treatment of alcoholism.

Patient #17's record contained a history and physical assessment, dated 6/17/10 at 7:75 AM. The history and physical assessment was done by the hospital's General Medicine Physician. It stated Patient #17 had had a gastric bypass, pernicious anemia (anemia caused by the inability to absorb vitamin B-12 due to the patients gastric bypass), and microcytic anemia (anemia caused by the inability to absorb iron due to the patients gastric bypass)

The results of Patient #17's laboratory blood tests dated 6/18/10 at 6:50 AM were as follows:

Iron 7 (normal 30-70)
Present of iron saturation 2 (normal 20-50)
Hemoglobin 8.4 (normal 12-15)
Hematocrit 27.4 (normal 36-48)

These laboratory tests verified Patient #17 was very anemic.

On 6/12/10 at 11:15 AM, the General Medicine Physician wrote an order for Patient #17 to take an iron supplement every day with orange guide (the vitamin C in the orange juice helps the uptake of the iron during the digestive process).

Patient #17's 6/11/10 through 6/24/10 Plans of Cares were reviewed. The Care Plans did not mention Patient #17 was to be provided orange juice with her iron.

Patient #17's record contained a Nutritional Assessment, completed by a contracted Dietician dated 6/21/10 that was not timed. The assessment did not include an assessment of Patient #17's calorie intake. The assessment did not state how much of her meals she was eating. The assessment did not include Patient #17's current and past dietary compliance or snacking habits.

The assessment recommended Patient #17 eat foods high in iron such as meats, beans, fortified cereals, leafy greens and foods high in vitamin C. The assessment also recommended Patient #17 limit her coffee/tea beverages.

Patient #17's 6/11/10 through 6/24/10 Plans of Care were reviewed. The Care Plans did not include the dietician's nutritional recommendations as stated in the 6/21/10 assessment.

Patient #17's 6/11/10 through 6/24/10 Plans of Care were reviewed by the Dietician Consultation Director and a dietician during an interview on 6/23/10 starting at 10:30 AM. They both confirmed the Care Plans were not updated after the 6/21/10 Nutritional Assessment.

The hospital's governing body failed to oversee the quality contracted dietetic services.

4. On 6/23/10 between approximately 1:00 PM and 2:00 PM, three pharmacists were interviewed together, including the Regional Director for Comprehensive Pharmacy Services (CPS), the hospital's pharmacy management company; a pharmacist hired on a per diem basis after the Director of Pharmacy left in February 2010 (and later changed to Interim Pharmacy Director): and the newly hired Director of Pharmacy who had been on the job a total of 3 days. When asked how pharmacy management was ensuring all pharmacy policies were being reviewed annually per hospital policy, the Regional Director for CPS and the Per Diem Pharmacist (Interim Pharmacy Director) both stated they were not sure. The Regional Director explained the two Directors of Pharmacy left abruptly, one in 11/09 and one in 2/10. There was no "hand-off" to determine what processes were in place. She confirmed the date of the last review was not included on the policies. She stated she would ensure a process was put in place and might add review dates at the end of the policies for clarity.

The following two hospital policies indicated the pharmacy's Policy and Procedure manual would be reviewed at least annually: "Pharmacy and Therapeutics Committee," and a hospital policy, dated 3/00 and revised 03/03, titled "Role Review and Revision of Policy and Procedure Manual." The policies did not indicate how the hospital would document the review was complete (such as updating the revision date on the policy).

When asked during the interview on 6/23/10 between 1:00-2:00 PM, what problems or issues had been identified in the pharmacy, the Per Diem Pharmacist (Interim Pharmacy Director) stated she had become aware of some problems.

For example, she became aware of slow response times from nursing and medical to staff to clarifying physician orders. She began tracking the problems on an untitled form where concerns were being tracked that required pharmacy interventions. She stated she had been tracking "concerns" for about a month and planned to report the information at the next P & T Committee.

She also stated patient information was missing that was needed related to safety of dispensing medication (e.g., height, weight, allergies, pregnancy status). She estimated a third of the time important patient information was missing. She developed a form called "Patient Information Request" for nursing staff to complete the missing items. She stated a result of this process, the frequency of missing information decreased. The stated this process was done informally and she did not track specifics related to the numbers of problems or the specific improvements.

During an interview on 6/23/10 at 3:00 PM, the Regional Director for CPS stated she had worked with the Per Diem Pharmacist (Interim Pharmacy Director) since February to improvement pharmacy processes, such as processes to increase communication. She said she had created the "concern tool." This was a tool for reporting pharmacist interventions. She stated previously the directors had been involved with Quality meetings, however, the last Director had no hours allocated to Quality.

In the above referenced interview, the Regional Director CPS explained she did a pre-survey audit of the CMS Conditions of Participation in March, 2010 to help prepare the hospital to be re-surveyed. She provided results of the audit to the CEO of the hospital, addressed in a letter, dated 3/24/10. The letter included her findings and recommendations for quality improvement activities related to each standard within the Condition of Pharmacy Services. The following are some examples of findings and recommendations listed on the letter:

* Pharmacy will improvement communication with nursing and medical staff regarding non-formulary medication, "Do Not Use," abbreviations, Range Orders, Indication for Use, etc., and document corrections in patient medical records and pharmacy interventions during the P & T Committee meetings.

* Pharmacy to increase involvement in reviewing possible adverse drug reactions (ADRs) and routinely report findings to Risk Management and P & T Committee.

* Pharmacy to check available sources of drug information at the nursing station and/or drug storage area to determine if they are current (nothing prior to 2008). Nursing and pharmacy staff should understand use of www.drugs.com website for information.

The Regional director for CPS (in the above referenced interview) stated when CPS provided their survey results, CPS expected pharmacy staff to communicate with the hospital and keep them informed. She stated she served as a resource for the pharmacy and her primary communication was with the pharmacist in charge and it was the responsibility of the pharmacist in charge to communicate with the broader hospital.

When asked by the surveyor if a Plan of Correction (POC) had been established in response to the CMS pre-survey audit, the Regional Director for CPS stated there had not been a POC established. She acknowledged the Performance Improvement Process for pharmacy had not been formalized but she intended to formalize the process.

During the interview on 6/23/10 at 2:45 PM, the Director of Performance Improvement/Quality Assurance stated the Pharmacy Department had not been integrated into the QAPI program. When asked what would be involved to integrate the Pharmacy Department into QAPI, she explained there was a formal process of presentation and approval and stated this had no been done. She stated she was not familiar with the issues in pharmacy.

The governing body failed to ensure pharmacy services were integrated into the hospital's Quality Assurance and Performance Improvement Program.

Based on review of QAPI data, hospital contracts and policies, review of medical records, and staff interview, it was determined the hospital facile dot develop, implement, and/or integrate an effective, ongoing, data-driven quality assessment and performance improvement program for 3 of 4 contracted services (laboratory, pharmacy, and consulting dieticians). This failure resulted in missed opportunities for improvement in delivery of safe and effective patient care. Findings include:

Refer to A264 as it relates to the hospital's failure to ensure the development of QAPI programs for all contracted services.

The cumulative affect of this systemic failure resulted in the inability of the hospital to identify problems and initiate corrective actions necessary for safe and effective patient care.

Based on review of QAPI data, hospital contracts and policies, review of medical records, and staff interview, it was determined the hospital failed to ensure the development of QAPI programs for 3 of 4 contracted services (laboratory, pharmacy, and consulting dieticians). This failure directly impacted 2 of 9 patients (#16 and #17) and had the potential to affect all patients cared for by hospital staff. This failure resulted in missed opportunities for improvement in delivery of safe and effective patient care. The findings include:

1. The Director of Performance Improvement and Risk Management was interviewed on 6/24/10 starting at 2:30 PM. She confirmed a QAPI program had not been established for the hospital's laboratory services.

The hospital's contract, titled Professional Services Agreement - Stat Clinical Laboratory Services, was reviewed. The contract failed to specify an individual responsible for overseeing laboratory services and collecting data to be incorporated into Performance Improvement Projects.

2. During an interview on 6/23/10 at 2:45 PM, the Director Performance Improvement and Risk Management stated the Pharmacy Department had not been integrated into the QAPI program. She explained there was a formal process of presentation and approval prior to the integration of a department into the QAPI program, and this had not been done. She stated she was not familiar with the issues in pharmacy.

The following issues demonstrated a need for quality assurance overview of pharmaceutical services:

a. A hospital policy, revised 03/03, titled "Role Review and Revision of Policy and Procedure Manual," indicated the pharmacy's Policy and Procedure manual would be reviewed at least annually. However, the policies did not indicates how the hospital would document the review was completed (such as updating the revision date on the policy).

On 6/23/10 between 1:00 PM and 2:00 PM, the Regional Director for CPS (the hospital's pharmacy management company), the Interim Pharmacy Director (hired on a per diem basis after the Director of Pharmacy left in February 2010), and the newly hired Director of Pharmacy who had been on the job 3 days were interviewed together. The Regional Director for CPS and Interim Pharmacy Director both stated they were not sure how pharmacy management was ensuring all pharmacy policies were being reviewed annual per hospital policy. The Regional Director explained two Directors of Pharmacy left abruptly, one in November of 2009 and one in February of 2010. There was no "hand-off" to determine what processes were in place. She confirmed the date of the last review was not included on the policies. She stated she would ensure a process was put in place and might add review dates at the end of the policies for clarity.
b. During an interview on 6/23/10 at 3:00 PM, the Regional Director for CPS stated she had worked with the Interim Pharmacy Director to improve pharmacy processes, such as processes to improve communication between pharmacy staff and other staff members. She created the "concern tool," the tool for reporting data related to pharmacist interventions relative to receiving and distributing medication orders.

c. During the interview on 6/23/10 beginning at 1:00 PM, the Interim Pharmacy Director explained that she noticed a slow response time from both nursing and medical staff related to physician order clarifications. She began tracking specific issues involved in delays using the "concern tool." She stated she had been tracking this data for about a month and planned to report the information at the next Pharmacy and Therapeutics Committee.

d. During the interview on 6/23/10 beginning at 1:00 PM, the Interim Pharmacy Director also stated patient information was missing that was needed related to safety of dispensing medication (e.g., height, weight, allergies, pregnancy status). She estimated a third of the time, important patient information was missing. She developed a form called "Patient Information Request" to assist nursing staff to provide the missing items. As a result of this process, the amount of missing information decreased. She stated this process was done informally and she did not track the data related to the how much information was missing before instituting the new form, and the improvement noticed once the form was utilized.

e. During an interview on 6/23/10 at 3:00 PM, the Regional Director for CPS explained she conducted a pre-survey audit of the CMS Conditions of Participation in March, 2010 to help prepare the hospital to be re-surveyed. She provided results of the audit to the CEO of the hospital, addressed in a letter, dated 3/24/10. The letter included her findings and recommendations for quality improvement activities related to each standard within the Condition of Pharmacy Services. The following were examples of findings and recommendations listed in the letter:

- Pharmacy would improve communication with nursing and medical staff regarding non-formulary medication, "Do Not Use," abbreviations, Range Orders, Indication for Use, etc., and document corrections in patient medical records and pharmacy interventions.

- Pharmacy was to increase involvement in reviewing possible ADRs and routinely report findings to Risk Management and P & T Committee.

- Pharmacy was to check available sources of drug information at the nursing station and/or drug storage area to determine if they were current (there was to be nothing prior to 2008 available). Nursing and pharmacy staff would understand use of www.drugs.com website for information.

The Regional Director for CPS, during the interview on 6/23/10 at 3:00 PM, stated when CPS provided their survey results, CPS expected pharmacy staff to communicate with the hospital and keep them informed. She stated she served as a resource for the pharmacy and her primary communication was with the pharmacist in charge and it was the responsibility of the pharmacist in charge to communicate with the broader hospital. The Regional Director for CPS stated that the Pharmacy Department had been involved with Quality meeting "2 or 3 directors ago," but that "hours were not allocated to Quality for the last Director." She acknowledged that the Performance Improvement Process for pharmacy had not been formalized, however intended to formalize the process.

The hospital failed to ensure contracted Pharmacy services were involved in the hospital's QAPI Program. This resulted in missed opportunities for improvement in the safe delivery and administration of medications.

3. The Director of Performance Improvement and Risk Management was interviewed on 6/24/10 starting at 2:30 PM. She confirmed that consulting dieticians were not incorporated into the hospital's QAPI program, and acknowledged a lack of quality assurance oversight with this contracted service. This resulted in the following:

a. The hospital's Dietician Consultant Description of Services form, that was not dated, stated the contracted dietary service (contracted dieticians) would "Completed the Following QA (Quality Assurance) audits monthly ..."; Dining room observations, sanitation survey, tray-line observation, test tray. The form stated the contracted dietary service would "Completed the Following QA audits quarterly"; Diet card accuracy check, tube feeding evaluation, and management review.

The Dietician Consultation Director was interviewed on 6/23/10 starting at 10:30 AM. She stated she had not bee involved in the hospital's Quality QAPI program and data had not been collected.

b. The hospital's Dietitian Consultant Description of Services form, that was not dated, stated the contracted dietitian would assist in the development and updating of dietary Plans of Care. The following examples failed to demonstrate a dietician's involvement in the development of a POC:

i. Patient #16 was a 61-year-old male, who was admitted to the hospital on 6/14/10 for treatment of opiate detoxification. According to Patient #16's medical record, he had a long history of Diabetes Mellitus and was insulin dependent. Patient #16 was a current patient as of 6/18/10.

Patient #16's record contained a dietary Nutrition Assessment, completed by the consulting dietician on 6/16/10. The assessment did not include an assessment of Patient #16's calorie or carbohydrate intake. The assessment did not indicated the quantity of meals Patient #16 ate, or how many cans of the supplemental protein drink he was drinking. The assessment did not state what Patient's #16's Body Mass Index (BMI) was or what his normal weight was. The assessment did state that Patient #16 experienced weight loss, but did not define how much weight was lost and in what period of time. The assessment did not include Patient #16's current and past dietary compliance, or snacking habits. The assessment documented the Dietitian's recommendations to encourage Patient #16 to decrease his Ensure as he began to eat more food. The assessment did not include recommendations such as, monitoring Patient #16's oral intake, monitoring Patient #16's compliance with ADA diet, providing healthy snacks and weighing Patient #16 each week.

Patient #16's POC, dated 6/1410 through 6/16/10, did not include Patient #16's poor nutritional status or his malnutrition. The POC did not include evidence that the Dietician contributed, and subsequently reviewed Patient #16's POC. This was confirmed by the Dietitian Consultation Director on 6/23/10 starting at 10:30 AM.

ii. Patient #17 was 36 year-old female that was admitted to the hospital on 6/11/10 for treatment of alcoholism.

Patient #17's record contained a History and Physical dated 6/17/10 at 7:75 AM. The History and Physical was done by the hospital's General Medicine Physician. it stated that Patient #17 had a gastric bypass, pernicious anemia (anemia caused by the inability to absorb vitamin B-12 due to the patients gastric bypass), and microcytic anemia (anemia caused by the inability to absorb iron due to the patient gastric bypass).

Patient #17's record contained a Nutritional assessment, completed by the consulting dietician on 6/21/10. The assessment recommended that Patient #17 eat foods high in iron such as meats, beans, fortified cereals, leafy greens and foods high in vitamin C. The assessment also recommended that Patient #17 limit her coffee/tea beverages.

Patient #17's POC, dated 6/11/10 through 6/24/10, were reviewed. The POC did not include the dietary recommendations included in the Nutritional Assessment.

Patient #17's medical record was reviewed with the Dietician Consultation Director during an interview on 6/23/10 starting at 10:30 AM. She confirmed the POC did not include evidence that the Dietician contributed, and subsequently reviewed Patient E17's POC.

The hospital failed to ensure that contracted dietician services were involved in the hospital's QAPI Program. This resulted in missed opportunities for improvement in patient care and satisfaction.

The hospital failed to ensure all contracted services were incorporated into a hospital-wide QAPI program.

Based on staff interviews and review of Medical Staff Rules and Regulations, Medical Executive Committee meeting minutes, Peer Review log, and patient records, it was determined the psychiatric hospital failed to ensure the rules and regulations developed by the medical staff to regulate themselves applied equally to all members of the medical staff and that the rules and regulations were followed. This resulted in missed opportunities to improve patient outcomes related to physical health and the admission of a medically unstable patient. Findings include:

1. Refer to A353 for hospital failed to ensure medical staff followed the hospital's Medical Staff Rules and Regulations.

The cumulative effect of these negative facility practices significantly impeded the ability of the hospital to provide care of adequate quality.

Based on staff and patient interviews and review of Medical Staff Rules and Regulations, Medical Executive Committee meeting minutes, Peer Review log, and patient records, it was determined the hospital failed to ensure Medical Staff Rules and Regulations were enforced. This directly impacted the care of 1 of 9 current diabetic patients (#16), whose records were reviewed. This resulted in a patient being admitted to the hospital with unstable BGs and missed opportunities to improve patient care related to physical health. Findings include:

1. The hospital's Medical Staff rules and Regulations, dated 5/07, stated at 20.2, all members of the active Medical Staff were required to participate in Monthly Peer Review Procedures or as otherwise mandated by the Medical Director. Qualifying Peer Review guidelines for cases to be reviewed under the peer review process, included, but were not limited to, patients leaving AMA (Against Medical Advise), patients who experienced adverse drug reactions, patients transferred to acute care ED's, and patients who experienced critical events.

The hospital's Peer Review Log, from 7/2009 to 6/2010, was reviewed. None of the records noted on the log as having undergone peer review, included services provided by General medicine Physicians.

The Medical Staff failed to ensure its rules and regulation/by-laws were enforced for all medical staff providing services to patients.

2. The Medical Executive Meeting minutes, dated 5/04/07, were reviewed. The minutes included documentation describing a new Diabetic Medication Administration and Pharmacy Profile form which had been developed and approved on 5/04/07. It was also documented that the hospital would no longer admit patient with a BH level exceeding 300.

The hospital's Medical Staff Rules and Regulations, dated 5/07, stated at 2.1, all admissions to the facility must meet the facility's admission criteria. At 2.1.1 of the Medical Staff Rules and Regulations the facility's admission criteria was listed. It stated that patients must be free of uncontrolled diabetes before admission.

A group interview, which included the Director of Assessments and Referrals, was held on 6/18/10 starting at 4:00 PM. She stated that prior to Patient #16's admission to the hospital, she had received a report from the transferring hospital that Patient #16 was a brittle diabetic (exceptionally difficult to control his BGs). Patient #16 was awaiting transfer to the hospital's Addiction Recovery Center on 6/14/10.

Patient #16 was admitted to the hospital as documented on the Interdisciplinary Assessment dated 6/14/10 at 8:45 PM. The patient was documented as having a BG level of 328 on admit. The psychiatrist was notified and it was documented that he allowed the admission despite the high BG level, contrary to the 5/04/07 committee Meeting Minutes.

Patient #16's Emergency Room Transfer Report, dated 6/14/10 at 11:55 PM, stated "do not accept a patient with a blood sugar (BG) of over 300."

Patient #16's Diabetic Assessment dated 6/14/10 that was not timed, stated "Note! A patient with a blood sugar (BG) over or 300 will not be accepted."

On 6/24/10 during the exit conference that started at 3:00 PM, the hospital's Director of Assessment and Referral stated patient #16's BGs were stable at the referring hospital. She was advised to provide documented evidence of stable serial BGs from the transferring hospital. This was not done.

The hospital failed to ensure Patient #16's psychiatrist followed the hospital's Medical Staff Rules and Regulations and did not admit a medically unstable patient.

Based on review of clinical records and hospital policies, observations, and staff and patient interviews, it was determined the hospital failed to maintain a well-organized nursing service to meet the needs of patients. This resulted in immediate jeopardy of serious harm or death to one patient (#16) and the potential for other patients to experience negative health outcomes. Findings include:

1. Refer to A395 as it relates to the failure of the hospital to ensure nursing staff evaluated, managed and supervised patients' care, thereby placing of an insulin dependent diabetic patient in immediate jeopardy of serious harm or death.

2. Refer to A396 as it relates to hospital failure to ensure nursing plans of care were developed and updated for patients.

The cumulative effect of these systemic negative practices resulted in the inability of the facility to provide care of adequate scope and quality.

Note: The facility was notified of the findings related to the immediate jeopardy on 6/17/10 starting at 5:00 PM. A Plan of Correction was reviewed and accepted on 6/21/10 at 12:30 PM. A survey of current insulin dependent patient's was conducted on 6/21/10 starting at 2:00 PM. Patient #16 was transferred to an acute care hospital on 6/20/10. The hospital was in compliance with insulin dosing and the immediate jeopardy was abated.

Based on review of clinical records and hospital policies, observations, and staff interviews, it was determined the hospital failed to ensure an RN supervised and evaluated the nursing care for 4 of 9 current patients (#7, #15, #16 and #17) whose records were reviewed and who was observed. The failure of nursing staff to evaluate the care of patients, led to poor management of patients' dietary needs, incorrect medication management, and a lack physician notification abnormally high vital signs. This placed one patient (#16) at risk of serious harm or death and created the potential for negative health outcomes for all patients admitted to the hospital. Findings include:

1. The Medical Executive Meeting minutes, dated 5/04/07, were reviewed. The minutes included documentation describing a new Diabetic Medication Administration and Pharmacy Profile form which had been developed and approved on 5/04/07. This form allowed nursing staff to document all diabetic care in one place, including medications administered, BG levels and other pertinent information pertaining to diabetic care. The minutes also documented the approval of a standing sliding scale insulin order that contained three available options for physicians. it was also documented that the hospital would no longer admit patients with a BG level exceeding 300. Finally, the minutes introduced a change in the standard treatment for hypoglycemia which would direct nursing staff to give 2-3 oz of juice followed with a protein snack such as yogurt or peanut butter. These changes to the standardized care of diabetes were initiated by a previous immediate jeopardy citation on 4/27/07, for the failure of the hospital to manage patient's diabetic needs.

The 2001 Mosby's Diagnostic and laboratory Test Reference states that a possible critical BG level as greater than 400 and less than 50.

Patient #16 was a 61-year-old male, who was admitted to the hospital on 6/14/10 for treatment of opiate detoxification. According to Patient #16's medical record, he had a long history of Diabetes Mellitus and he was insulin dependent. Patient #16 was a current patient as of 6/18/10.

A group interview, which included the Director of Assessments and Referrals, was held on 6/18/10 starting at 4:00 PM. She stated that prior to Patient #16's admission to the hospital, she had received a report from the transferring hospital that Patient #16 was a brittle diabetic (exceptionally difficult to control his BGs). Patient #16 was awaiting transfer to the hospital's Addiction Recovery Center on 6/14/10. The Admissions Coordinator stated she obtained the admitted hospital's "Humalog" (a medication used to control BG levels) sliding scale insulin order that was being used for Patient #16 at the admitting hospital. The Director of Assessments and Referrals stated she then used the admitting hospital's Humalog sliding scale insulin order to obtain a verbal physician's order on 6/14/10 at 11:55 AM from Patient #16's Psychiatrist.

Patient #16's record contained a verbal Physician's order, dated 6/14/10 at 11:55 AM. The order included the Humalog Sliding Scale Insulin dosing order. The insulin was to be given five times daily at 2:00 AM, 7:30 AM, 11:30 AM, 5:30 PM, and 9:00 PM. The Humalog dosing was to be given as follows:

Blood Glucose 150-199 = 1 unit
Blood Glucose 200-249 = 3 units
Blood Glucose 250-299 = 5 unites
Blood Glucose 300-349 = 7 units
>349 = 8 units

Additional orders stated the 2:00 AM Humalog insulin dose was to be cut in half and 1 unit of Humalog was to be given after each meal. The orders directed staff to give a 16 gram tablet of oral glucose if needed for a BG level result of less than 70. The order did not clarify when the physician was to be notified of high or low BG levels.

The orders also directed staff to re-check Patient #16's BG level 1 hour after the administration of Humalog sliding scale insulin. However, Patient #16's record did not include any documentation indicating that this order had been followed. This was confirmed by the Director of Nursing Services (DNS) during a group interview on 6/18/10 starting at 4:00 PM.

Patient #16 was admitted to the hospital as documented on the Interdisciplinary Assessment dated 6/14/10 at 8:45 PM. The patient was documented as having a BG level of 328 on admit. The physician was notified and it was documented that he allowed the admission despite the high BG level, contrary to the 5/04/07 Committee Meeting Minutes.

Patient #16's diabetic medication record documented that on 6/15/10 at 2:00 AM the BG level of 193. The 193 BG level should have prompted nursing staff to give 1.5 unites of Humalog insulin per the Sliding Scale Insulin order. The diabetic medication administration record documented that Patient E16 refused the insulin. A Nursing note, dated 6/15/10 at 5:05 AM, stated Patient #16 refused his 2:00 AM insulin dose and stated he would rather wait for his morning insulin (7:00 AM). No documentation was found that Patient #16's physician had been notified of the refused insulin. The record was reviewed and the lack of documentation confirmed by the DNS during a group interview that was held on 6/18/10 at 1:50 PM

Patient #16's Diabetic Administration Record documented that on 6/15/10 at 5:30 PM, Patient #16's BG level was 482. The record did not contain documentation that Patient #16's physician had been notified of the high BG level.

During a group interview on 6/18/10 starting at 1:50 PM, the DNS reviewed the record and confirmed that there was no documentation indicating the physician had bee notified of the high BG level but stated that he probably should have been contacted.

Patient #16's Diabetic Administration Record documented that on 6/15/10 at 9:00 PM, Patient #16'2 BG level of 286. According to the sliding scale insulin order, 5 units of insulin should have been administered. However, the record stated the RN only administered 3 units. This was reviewed and confirmed by the DNS during a group interview on 6/18/10.

Patient #16's Diabetic Administration Record documented on 6/16/10 at 7:30 AM, a BG level of 60. A Nursing note, dated 6/16/10 at 7:30 AM, stated Patient #16 refused oral glucose as instructed in the sliding scale insulin order, but did eat crackers and drank 8 ounces of orange juice. The Medical Executive committee meeting minutes, dated 5/04/07, stated the new standard of care for treatment of hypoglycemia [low BG] was to give 2-3 ounces of juice followed by a protein snack. The Nursing note contained no documentation the physician was notified of the low BG level, refusal of the glucose tablets, or the alternate intervention. Patient #16's record did not contain documentation stating whether or not he ate breakfast after the snack or if he had been given 1 unit of insulin as ordered by the physician after the 6/16/10 morning meal. The Diabetic Administration Record documented that at 11:30 AM, Patient #16's BG level was elevated to 546. The Diabetic Medication Record documented that on 6/16/10 at 5:30 PM, Patient #16's BG level was 410. The record did not contain evidence that the physician had been notified of the high levels.

During a group interview on 6/18/10 starting at 1:50 PM, the DNS reviewed the records and confirmed the findings.

A Nursing note dated 6/17/10 at 2:00 AM, stated Patient #16's BG level was 273 and that insulin had been given. However the record did not specify the amount of insulin administered.

Patient #16's Diabetic Administration Record, dated 6/17/10, did not contain documented evidence that the patient's BG level had been checked at 7:30 AM or if sliding scale insulin had been administered. The record also did not state whether Patient #16 ate breakfast or if 1 unit of insulin had been administered after the meal per the physician's orders. These findings were confirmed by the DNS during an interview held on 6/18/10 starting at 1:50 PM.

A Physician's Order Sheet, dated 6/17/10 un-timed, documented that Patient #16's physician had changed the sliding scale Humalog insulin order. The new orders were as follows:
Humalog sliding scale:
150-200 = 1 units
201-250 = 3 unites
250-300 = 6 units
300-350 = 10 units
>350 = 13 units and call Physician.

These orders had the potential to cause confusion as to how many units of insulin were to be administered if Patient #16 had a BG level of 250, 300 or 350. Both 3 and 6 units were ordered to be administered for BG level of 260, both 6 and 10 units of insulin was ordered if BG level was 300, and both 10 and 13 units of insulin were ordered for a BG level of 350. This order was not clarified by the nursing staff until 6/18/10 at 8:35 AM.

The Diabetic Administration Record documented on 6/17/10 at 11:30 AM, that Patient #16's BG level was 370. The record did not contain documentation that the physician was contacted regarding the high BG level as per the new sliding scale physician's order.

On 6/18/10, the Diabetic Administration Record documented the scheduled 2:00 AM BG check was not done until 4:00 AM.

On 6/18/10 starting at 4:00 PM, the DNS, Director of Performance Improvement and Risk Management, Director of Social Services, Director of Assessment and Referral, and the Director of Adolescent Programs discussed and reviewed Patient #16's record. They were unable to provide any additional information to explain the above findings.

Patient #16's record contained a clarification Humalog sliding scale insulin order dated 6/18/10 at 8:35 AM. The new orders were as follows:
Humalog sliding scale:
150-200 = 1 unit
201-250 = 3 units
251-300 = 6 units
301-350 = 10 units
>350 = 13 units and call Physician.

Patient #16's record contained a physician's order dated 6/18/10 at 2:45 PM, by the hospital's Consulting medical Physician. The order stated to give an additional 5 units of Humalog insulin after lunch and dinner. The order did not direct staff as to how much lunch/dinner needed to be ingested to administer the insulin.

The Diabetic Administration Record documented that on 6/18/10 at 9:00 PM, that Patient #16's BG level was 155. The nurse documented they had given Patient #16 six units of insulin, rather than the one unit that was ordered per the insulin sliding scale.

The Diabetic Administration Record documented that on 6/19/10 at 2:00 AM, Patient #16's BG level was 64.

A Nursing note, dated 6/19/10 5:20 AM, stated that 2:00 AM, Patient #16's BG level was 64 and he was given orange juice, graham crackers and milk. The note the stated that at 3:00 AM, Patient #16's BG level was then at 77 and by 5:00 AM, his BG level was 84. The record did not contain documentation that the physician was notified of the low BG level results.

The Diabetic administration Record did not documented that on 6/19/10 at 7:30 AM, that Patient #16's BG level was taken, or if he received the ordered insulin sliding scale.

A Nursing note, dated 6/19/10 at 1:00 PM, stated Patient #16 was "Eating crackers and fruit throughout the day." The Nursing note did not list the consumption of all meals or snacks that Patient #16 ate that day.

A Nursing note, dated 6/19/10 at 2:00 PM, documented patient #16 was placed on 1 to 1 nursing.

A Nursing note, dated 6/19/10 at 3:20 PM, stated that Patient #16 was compliant with all nursing cares except " ...dietary restrictions ..." and his diabetic diet, and did not want people telling him what he can and cannot eat. The nursing note did not list the consumption of what Patient #16 ate.

The Diabetic Administration Record documented that on 6/19/10 at 5:30 PM, Patient #16's BG level was 151. Patient #16's record did not document that he received 1 unit of insulin per the physician's insulin sliding scale order.

A Nursing note, dated 6/20/10 at 7:00 AM, stated Patient #16 ate toast, butter, 4 poached eggs, has browns, oatmeal, bacon, juice, and black coffee with sugar. Calorie and carbohydrate references were from the American Diabetes Association Exchange List.

One piece of toast is 100 calories and 15 grams of carbohydrates.

A normal serving size of butter is 45 calories.

One egg is 75 calories.

A normal serving size of has browns is 80-150 calories and 15 grams of carbohydrates.

A normal serving size of oatmeal is 120 calories and 15 grams of carbohydrates.

One strip of bacon is 75 calories.

A normal serving size of juice is 120 calories and 15 grams of carbohydrates.

A normal serving size of coffee with sugar is 15 grams of carbohydrates.


A Nursing note, dated 6/20/10 at 12:00 PM, stated Patient #16 ate a hamburger with cheese that had lettuce and tomato, macaroni salad, sweet potato fries, vegetable soup and drank 2% milk.

One hamburger has 200 calories and 30 grams of carbohydrates.

One slice of cheese has 100 calories.

A normal serving size of macaroni salad is 400 calories and 45 grams of carbohydrates.

A normal serving size sweet potato fries is 150 calories and 30 grams of carbohydrates.

A normal serving size of vegetable soup is 80 calories and 15 grams of carbohydrates.

A normal serving size of 2% milk is 120 calories and 12 grams of carbohydrates.

A Nursing note, dated 6/20/10 at 1:00 PM, stated patient #16 requested apple juice but was given milk. A normal serving size of 2% milk is 120 calories and 12 grams of carbohydrates.

By 1:00 PM on 6/20/10, Patient #16 consumed 2240 calories of his 1800 to 2000 calories ADA diet and 278 carbohydrates of his 250 to 275 carbohydrates per day.

A Nursing note, dated 6/20/10 at 3:00 PM, stated Patient #16's BG level was 53 and despite interventions, his BG level continued to drop to 44 and then came up to 50 but Patient #16 became unresponsive. Patient #16 was discharged from the hospital on 6/20/10 after the event. Patient #16 was taken to an acute care hospital by ambulance for continued treatment of his diabetic management.

Nursing staff failed to appropriately manage the diabetic nursing care for Patient #16.

2. Patient #17 was 36 year-old female that was admitted to the hospital on 6/11/10 for treatment of alcoholism.

Patient #17's record contained a History and Physical assessment, dated 6/17/10 at 7:75 AM. The History and Physical was done by the hospital's General Medicine Physician. It stated Patient #17 had had a gastric bypass, pernicious anemia (anemia caused by the inability to absorb vitamin B-12 due to the patients gastric bypass), and micrcytic anemia (anemia caused by the inability to absorb iron due to the patients gastric bypass).

Patient #17's 6/18/10 6:50 AM blood results were as follows:

Iron 7 (normal 30-70)
Present of iron saturation 2 (normal 20-50)
Hemoglobin 8.4 (normal 12-15)
Hematocrit 27.4 (normal 36-48)

These laboratory tests showed Patient E17 was very anemic.

On 6/12/10 at 11:15 AM, the General Medicine Physician ordered Patient #17 to take a iron supplement every day with orange juice (the vitamin C in the orange juice helps the uptake of the iron during the digestive process).

Patient #17 was interviewed on 6/21/10 starting at 3:30 PM. She stated that she needed to remind nursing staff daily to provide orange juice with her iron.

Patient #17's record contained a physician's order dated 6/15/10 at 11:20 AM. The order requested nursing staff to assess Patient #17's CWIA in private (CWIA is a series of questions and vital signs to assess patients' withdrawal symptoms).

Patient #17 was interviewed on 6/21/10 starting at 3:30 PM. She stated that she was offended that staff would assess her in front of other patients and she complained to staff.

Patient #17's record contained a Nutritional Assessment, dated 6/21/10, that was not timed. The assessment recommended that Patient #17 eat foods high in iron such as meats, beans, fortified cereals, leafy greens and food high in vitamin C. The assessment also recommended that Patient #17 limit her coffee/tea beverages.

The Charge Nurse was asked to give report of the unit that Patient #17 was on starting at 2:15 PM on 6/22/10. The charge nurse made no mention of the above medical and privacy issues. Patient #17's record did not contain documented evidence that nursing staff was monitoring Patient #17's dietary needs or her privacy. This was confirmed by the unit's Charge Nurse on 6/22/10 at 4:10 PM.

On 6/23/10 at 1:10 PM, the dietary manager was interviewed. She state she was unaware of Patient #17's dietary needs.

Nursing staff failed to manage and supervise Patient #17's dietary and privacy needs.

3. Patient #15 was a 53-year-old female who was admitted on 6/13/10. Patient #15's record included a physician order for Clonidine 0.1 mg by mouth twice a day and to recheck her blood pressure one hour after each dose.

Clonidine is an antihypertensive (lowers blood pressure). According to the Nursing 2010 Drug Handbook, severe rebound hypertension (dangerously high blood pressure ) was listed as side effect of Clonidine.

Patient #15's MAR, dated 6/19/10, documented a handwritten note in the box for the Clonidine, to check BP and HR.

According to Patient #15's MAR Clonidine was given the following dates and times:

6/10/10 at 9:00 AM

6/20/10 at 9:00 AM

6/21/10 at 9:00 AM

6/22/10 at 9:00 AM

Surveyors found no documentation that Patient #15's BP or HR was assessed from 6/19/10 till 6/22/10, one hour after Clonidine was given, as was ordered by the physician.

According to Patient #15's MAR Clonidine was given the following dates and times:

6/10/10 at 6:00 PM

6/20/10 at 6:00 PM

6/21/10 at 6:00 PM

6/22/10 at 6:00 PM

Surveyors found documented in patient #15's record, the hospital's form titled Adult Vital Sign Flow Sheet, as follows:

6/10/10 both BP and HR were assessed at 6:17 PM

6/20/10 both BP and HR were assessed at 7:15 PM

6/21/10 both BP and HR were assessed at 6:35 PM

6/22/10 both BP and HR were assessed at 6:35 PM

Surveyors found no documentation that Patient #15's BP or HR was assessed from 6/19/10 till 6/22/10, one hour after Clonidine was given, as was ordered by the physician.

On 6/24/10, patient #15's MAR documented the discontinuation of Clonidine and a handwritten note, "One time only 6/18." There was no documentation of physician order as such.

Patient #15's record also contained a handwritten and asterisked note, dated 6/18/10, to check Patient #15's BP and HR 4 times that day. Surveyors documented Patient #15's Adult Vital Sign Flow Sheet form, his BP and HR three different times on 6/18/10.

The RN failed to follow physicians orders. This failure of standards of practice for the administration of said medication had the potential to affect the efficacy of said medication and could have a direct impact on Patient #15's BP.

4. Patient #7 was a 68-year-old male with a history of diabetes mellitus and renal insufficiency, who was admitted to the hospital on 6/03/10 for treatment of schizophrenia. Patient #7 was a current patient as of 6/24/10. Patent #7 's record contained admission orders, dated 6/03/10 at 5:45 PM, which directed nursing staff to give 850 mg Metformin twice daily and Prandin 1 mg twice daily.

The Nursing 2010 Drug Handbook states that Metformin is an adjunct to diet to lower BG levels in type 2 (non-insulin-dependent) diabetes. The Nursing 2010 Drug Handbook recommends that the dosage of Metformin should be conservative because of potential decrease in renal function and the drug should be given daily with morning and evening meals.

According to the Nursing 2010 Drug Handbook Prandin is also used for type 2 diabetes, however, the drug is to be given either immediately before morning and evening meals or up to 30 minutes before. The The Nursing 2010 Drug Handbook recommends that if a meal is skipped then that dose should be skipped. The Nursing 2010 Drug Handbook did not document the same renal function problems with Prandin as it did with Metformin.

According to Lippencott's Manual of Nursing Practice 8th edition, the standard of practice for control of renal insufficiency is to monitor closely the patient's intake (i.e., food an drink) and output (anything the patient excretes, i.e., urine, liquid stool, vomitus, etc.) The record contained no documentation that this was done.

The website eMedicine defined renal insufficiency as the loss of kidney function, with resultant accumulation of water, waste, and toxic substances, in the body, that are normally excreted by the kidney causing anemia, high blood pressure, acidosis (excessive acidity of body fluids), disorders of cholesterol and fatty acids, and bone disease.

The following was documented in Patient #7's MAR:

According to Patient #7's MAR Metformin was documented as given on the following dates and times:

from 6/05/10 to 6/18/10 at 9:00 AM and 6:00 PM
6/03/10 at 10:00 PM (no AM dose documented)
6/04/10 at 9:00 AM and 10:00 PM
6/19/10 at 9:00 AM and 8:30 PM
6/20/10 at 9:00AM and 6:00 PM
6/21/10 at 9:00 AM and 6:00 PM

According to Patient #7's MAR Prandin was given the following dates and times:

from 6/08/10 to 6/13/10 at 9:00 AM and 6:00 PM
6/04/10 at 10:00 PM (no AM dose documented)
6/05/10 no dose documented (handwritten note stating-not available until spouse brings in)
6/06/10/8:00 PM (no AM dose documented)
6/07/10 at 9:00 AM and 8:00 PM
6/14/10 at 9:00 AM (no PM dose recorded-handwritten note- not available)
6/15/10 at 10:00 AM and 6:00 PM
6/16/10 at 9:00 AM and 6:00 PM
6/17/10 at 9:00 AM and 6:00 PM
6/18/10 at 10:15 AM and 6:00 PM
6/19/10 at 9:00 AM and 8:30 PM
6/20/10 at 9:00 AM and 6:00 PM
6/21/10 at 9:00 AM and 6:00 PM

According to eh scedule of activities surveyors received, breakfast is served at 8:00 AM and dinner is documented to begin at 5:15 PM.

Therefore, Patient #7 received the Metformin, on average, one hour after morning meals and 45 minutes after evening meals, when it is recommended that the drug be given with meals.

According to Patient #7's record, he received the Prandin, on average, one hour after morning meals and 45 minutes after evening meals, when it is recommended that the drug be given up to 30 minutes before meals.

Patient #7 was observed on 6/18/10 from 9:30 AM to 10:50 AM. During that time, Patient #7 remained asleep in an isolation room. Patient #7's physician was on the unit seeing patients until 10:30 AM when he left the unit. Patient #7's RN had not yet administered his physician's ordered Metformin during the time of observation. On 6/18/10 starting at 10:40 AM, the RN was questioned as to why she had not yet provided Patient #7's Metformin. The RN explained that Patient #7 had experienced a "rough night" and had been administered Thorazine [an anti-psychotic medication]. At this time, Patient #7 was still sleeping and the RN did not want to disturb him. When questioned by the surveyor, the RN stated she had not yet notified Patient #7'1 physician that the Metformin had been held. When prompted by the surveyor at 10:45 AM, the RN called Patient #7's physician. Following the call, the RN woke Patient #7 and administered the missed Metformin dose at 10:50 AM. A handwritten note, written vertically in the first column of Patient #7's MAR, documents, "All 0900 meds given at 10:15. Dr. [name] notified 6-18-10-1030." The note was initialed by the RN.

On 6/23/10 at 10:30 AM, a review of Patient #7's MAR documented 9:00 AM medications were not given. A review of the nursing notes for Patient #7 dated 6/23/10 showed documentation that Patient #7 had refused his morning medications but failed to show documentation that Patient #7's physician had been notified of his refusal.

The RN failed to follow the drug manufacturers recommendations and failed to notify physicians of held medications. This failure of standards of practice for the administration of said medications had the potential to affect the efficacy of said medications and could have a direct impact on Patient #7's diabetes and renal insufficiency. Further the lack of documentation of Patient #7's intake and output had the potential to impact his outcome.


3. Patient #15 was a 53-year-old female who was admitted on 6/13/10. A review of Patient #15's record documented her physician ordering Clonidine 0.1 mg by mouth twice a day and to recheck her blood pressure one hour after dose.

Clonidine is an antihypertensive (lowers blood pressure). According to the Nursing 2010 Drug Handbook, severe rebound hypertension (dangerously high blood pressure) was listed as side effect of Clonidine.

According to Patient #15's MAR Clonidine was given the following dates and times:

6/19/10 at 9:00 AM

6/20/10 at 9:00 AM

6/21/10 at 9:00 AM

6/22/10 at 9:00 AM

Patient #15's record contained no documented evidance that nursing staff had assessed Patient #15's BP or HR from 6/19/10 till 6/22/10, one hour after Clonidine was given, as was ordered by the physician.

According to Patient #15's MAR, Clonidine was also given on the following dates and times:

6/19/10 at 6:00 PM

6/20/10 at 6:00 PM

6/21/10 at 6:00 PM

6/22/10 at 6:00 PM

Patient #15's record, contained a form titled Adult Vital Sign Flow Sheet. The sheet documented Patient #15's BP and HR were assessed as follows:

6/19/10 both BP and HR were assessed at 6:17 PM, 17 minutes after the Clonidine dose.

6/20/10 both BP and HR were assessed at 7:15 PM, 1 hour and 15 minutes after the Clonidine dose.

6/21/10 both BP and HR were assessed at 6:35 PM, 35 minutes after the Clonidine dose.

6/22/10 both BP and HR were assessed at 6:35 PM, 35 minutes after the Clonidine dose.

Patient #15's record did not contain documented evidence that nursing staff had assessed Patient 15's BP or HR from 6/19/10 till 6/22/10, one hour after Clonidine was given, as was ordered by the physician.

The RN failed to follow physicians orders. This failure of standards of practice for the administration of said medication had the potential to affect the efficacy of said medication and could have a direct impact on patient #15's BP.

4. Patient #7 was a 68-year-old male with a history of diabetes mellitus and renal insufficiency, who was admitted to the hospital on 6/03/10 for treatment of schizophrenia. Patient #7 was a current patient as of 6/24/10. Patent #7 's record contained admission orders, dated 6/03/10 at 5:45 PM, which directed nursing staff to give 850 mg Metformin twice daily and Prandin 1 mg twice daily.

The Nursing 2010 Drug handbook states that Metformin is an adjunct to diet to lower BG levels in type 2 (non-insulin-dependent) diabetes. The Nursing 2010 Drug handbook recommends that the dosage of Metformin should be conservative because of the potential decrease in renal function and the drug should be given daily with morning and evening meals.

According to the Nursing 2010 Drug Handbook Prandin is also used for type 2 diabetes, however the drug is to be given either immediately before morning and evening meals or up to 30 minutes before The The Nursing 2010 Drug handbook recommends that if a meal is skipped then that dose should be skipped. The Nursing 2010 Drug Handbook did not document the same renal function problems with Prandin as it did with Metformin.

According to Lippencott's Manual of Nursing Practice 8th edition, the standard of practice for control of renal insufficiency is to monitor closely the patient's intake (i.e., food and drink) and output (anything the patient excretes, i.e., urine, liquid stool, vomitus, etc.) The record contained no documentation that this was done.

The website eMedicine defined renal insufficiency as the loss of kidney function, with resultant accumulation of water, waste, and toxic substances, in the body, that are normally excreted by the kidney causing anemia, high blood pressure, acidosis (excessive acidity of body fluids), disorders of cholesterol and fatty acids, and bone disease.

The following was documented in Patient #7's MAR:

According to Patient #7's MAR Metformin was documented as given on the following dates and times:

From 6/05/10 to 6/18/10 at 9:00 AM and 6:00 PM
6/03/10 at 10:00 PM (no AM dose documented)
6/04/10 at 9:00 AM and 10:00 PM
6/19/10 at 9:00 AM and 8:30 PM
9/20/10 at 9:00AM and 6:00 PM
6/21/10 at 9:00 Am and 6:00 PM

According to Patient #7's MAR Prandin was given the following dates and times:

from 6/08/10 to 6/13/10 at 9:00 AM and 6:00 PM
6/04/10 at 10:00 PM (no AM dose documented)
6/05/10 no dose documented (handwritten note stating-not available until spouse brings in)
6/06/10 8:00 PM (no AM dose documented)
6/07/10 at 9:00 AM and 8:00 PM
6/14/10 at 9:00 AM (no PM dose recorded-handwritten note-not available)
6/15/10 at 10:00 AM and 6:00 PM
6/16/10 at 9:00 AM and 6:00 PM
6/17/10 at 9:00 AM and 6:00 PM
6/18/10 at 10:15 AM and 6:00 PM
6/19/10 at 9:00 AM and 8:30 PM
6/20/10 at 9:00 AM and 6:00 PM
6/21/10 at 9:00 AM and 6:00 PM

According to the scedule of activities, that was not dated, breakfast was served at 8:00 AM and dinner was documented to being at 5:15 PM.

Therefore, patient #7 received the Metformin, an average, one hour after morning meals and 45 minutes after evening meals, when it is recommended that the drug be given with meals.

According to Patient #7's record, he received the Prandin, on average, one hour after morning meals and 45 minutes after evening meals, when it is recommended that the drug be given up to 30 minutes before meals.

Patient #7 was observed on 6/18/10 from 9:30 AM to 10:50 AM. During that time, Patient #7 remained asleep in an isolation room. Patient #7's physician was on the unit seeing patients until 10:30 AM when he left the unit. Patient #7's RN had not yet administered his physician's ordered Metformin during the time of observation. On 6/18/10 starting at 10:40 AM, the RN was questioned as to why she had not yet provided Patient #7's Metformin. The RN explained that Patient #7 had experienced a "rough night" and had been administered Thorazine [an anti-psychotic medication]. At this time, Patient #7 was still sleeping and the RN did not want to disturb him. When questioned by the surveyor, the RN stated she had not yet notified Patient #7's physician that the Metformin had been held. When prompted by the surveyor at 10:45 AM, the RN called Patient #7's physician. Following the call, the RN woke Patient #7 and administered the missed Metformin dose at 10:50 AM. A handwritten note, written vertically in the first column of Patient #7's MAR, documents, "All 0900 meds given at 10:15. Dr. [name] notified 6-18-10-1030." The note was initialed by the RN.

On 6/23/10 at 10:30 AM, a review of Patient #7's MAR documented 9:00 AM medications were not given. A review of the nursing notes for Patient #7 dated 6/23/10 showed documentation that Patient #7's physician had been notified of his refusal.

The RN failed to follow the drug manufacturers recommendations and failed to notify physicians of held medications. This failure of standards of practice for the administration of said medications had the potential to affect the efficacy of said medications and could have a direct impact on Patient #7's diabetes and renal insufficiency. Further the lack of documentation of Patient #7's intake and output had the potential to impact his outcome.

Based on staff interview and review of medical records and hospital policies, it was determined the hospital failed to ensure nursing plans of care were developed for 5 of 21 patients (#7, #8, #16, #17 and #18) whose medical records were reviewed. This resulted in a lack of direction to nursing staff caring for patients. The findings include:

1. Patient #16 was a 61-year-old male, who was admitted to the hospital on 6/14/10, for treatment of opiate detoxification. He had a long history of diabetes mellitus and was insulin dependent. Patient #16 was suffering from malnutrition and gastroparesis. Patient #16 was a current patient as of 6/18/10.

Patent #16's record contained a Nursing Assessment, dated 6/14/10 that was not timed. The assessment included an evaluation of Patient #16's BMI. It stated Patient #16 was 5 foot 10 inches tall, and weighed 125 pounds. This resulted in a BMI of less than 19 (normal 19-24), which placed Patient #16 in the underweight category.

A Nursing note, dated 6/15/10 at 5:05 AM, stated Patient #16 had a history of gastroparesis resulting in a 25 pound weight loss and he was described as looking emaciated.

Patent #16's record contained a verbal physician's order, dated 6/14/10 at 11:55 AM. The order included a dietary consult and for the patient to be on an ADA diet. An ADA diet is set forth by the American Diabetes Association to help diabetics control blood glucose levels by eating a consistent amount of carbohydrates, distributed throughout the day, to reduce calories to less than 2000 per day.

On 6/29/10 starting at 2:10 PM, the Director of Dietary services was interviewed. She stated that ADA diabetic diets for male adults were to be 1800 to 2000 calories and include 250 to 275 carbohydrates per day.

A History and Physical assessment, written by a NP, dated 6/15/10 at 12:28 PM, stated Patient #16 was malnourished and had poor nutritional status. On 6/15/10 at 11:10 AM, the NP wrote orders for Patient #16. These orders included a seond dietary consult referral and for nursing to provide a can of Ensure between meals and at bedtime. This would be a total of at least 3 cans a day. Ensure has 250 calories per can and 60 grams of carbohydrates, 3 cans of ensure would provide 750 calories out of a 1500 - 2000 calorie ADA diet and 180 grams of carbohydrates of a 250 - 275 grams of carbohydrates for the ADA diet.

A Nursing note, dated 6/15/10 at 1:45 PM, stated patient #16 was instructed on meal planning and to drink Ensure "if needed." This note contradicted the NP's order to provide one can between meals and at bedtime.

Patient #16's record contained only two entries showing he drank the Ensure per the physician's orders. One entry was noted on the MAR on 6/17/10 at 9:40 PM. The other was on a Nursing note, dated 6/20/10 at 10:00 AM.

A Nursing note dated 6/20/10 at 3:00 PM, stated Patient #16's BG level was 53 and despites interventions. His BG level continued to drop to 44 and then came up to 50, but Patient #16 became unresponsive. On 6/20/10, Patient #16 was transported to an acute care hospital by ambulance for continued treatment of his diabetic condition.

On 6/22/10, starting at 12:00 PM, a group interview was conducted. In attendance were the consulting General Medicine Physician responsible for Patient #16's medical care, a NP, a PA, and the Chief of Medicine. The Chief of Medicine stated it was thought that Patient #16 was being non compliant with his dietary orders and so when adjustments were made to Patient #16's insulin, it was only based on his BG results. He stated that when nursing "supervised" Patient #16's oral intake, the doses of insulin were too high for Patient #16's ADA diet.

Patient #16's Care Plans, dated 6/14 through 6/16/10, did not include Patient #16's poor nutritional status and his malnutrition. Patient #16's Care Plans did not direct staff to monitor Patient #16's oral intake, monitor Patient #16's compliance with his ADA diet, provide healthy snacks and monitor Patient #16's weight. This was confirmed by the Dietician Consultation Director and a dietician during an interview on 6/23/10 starting at 10:30 AM.

Further, a nursing note, dated 6/16/10 at 10:46 PM, stated Patient #16 did not appear to be using "proper hygiene".

A Physician's Progress note, dated 6/16/10 at 4:10 PM, stated Patient #16 was poorly groomed.

A nursing note, dated 6/17/10 at 2:10 PM, and a second nursing note dated 6/17/10 at 8:10 PM, stated Patient #16's hygiene appeared to be poor.

Patient #16's Care Plans, dated 6/14 through 6/16/10, did not include Patient #16's poor hygiene practices.


T hospital failed to ensure Patient #16's nursing plans of care were fully developed to include all of his needs.

2. Patient #17 was 36 year-old female that was admitted to the hospital on 6/11/10 for treatment of alcoholism.

Patient #17's record contained a History and Physical assessment, dated 6/17/10 at 7:75 AM. The History and Physical was done by the hospital's General medicine Physician. It stated that Patient #17 had a gastric bypass, pernicious anemia (anemia caused by the inability to absorb vitamin B-12 due to the patients gastric bypass), and microcytic anemia (anemia caused by the inability to absorb iron due to the patients gastric bypass).

Patient #17's 6/18/190 6:50 AM laboratory blood test results were as follows:

Iron 7 (normal 30-70)
Present of iron saturation 2 (normal 20-50)
Hemoglobin 8.4 (normal 12-15)
Hematocrit 27.4 (normal 36-48)

These laboratory tests documented Patient #17 was very anemic.

On 6/12/10 at 11:15 AM, the General medicine Physician ordered Patient #17 to take an iron supplement every day with orange juice (the vitamin C in the orange juice helps the uptake of the iron during the digestive process).

Patient #17 was interviewed on 6/21/10 starting at 3:30 PM. She stated that she needed to remind nursing staff daily to provide orange juice with her iron.

Patient #17's Care Plans, dated 6/11 through 6/24/10 were reviewed. The Care Plans did not mention that Patient #17 was to be provided orange juice with her iron.

Patient #17's record contained a physician's order, dated 6/15/10 at 11:20 AM. The order requested nursing staff to assess Patient #17's CWIA in private (CWIA is a series of questions and vital signs to assess patients withdrawl symptoms).

Patient #17 was interviewed on 6/21/10 starting at 3:30 PM. She stated she was offended that staff would assess her in front of other patients and she complained to the staff.

Patient #17's Care Plans, dated 6/11 through 6/24/10 were reviewed. The Care Plans did not direct nursing staff to assess patient #17's CWIA in private.

Patient #17's record contained a nutritional assessment, dated 6/21/10, that was not timed. The assessment recommended that Patient #17 eat foods high in iron, such as meats, beans, fortified cereals, leafy greens and food high in vitamin C. The assessment also recommended that Patient #17 limit her intake of coffee/tea beverages.

Patient #17's Care Plans dated 6/11 through 6/24/10 were reviewed. The Care Plans did not include the nutritional assessment recommendations.

Patient #17's Care Plans, dated 6/11 through 6/24/10 were reviewed by the Dietician Consultation Director, and a dietician during, an interview on 6/23/10 starting at 10;30 AM. They both confirmed the Care Plans were lacking important information such as the nutritional assessment recommendations of eat foods high in iron, such as meats, beans, fortified cereals, leafy greens and food high in vitamin C, provide pricacy during CWIA assessments and provide orange juice with Patient #17's iron.

The hospital failed to ensure Patient #17's nursing plans of care were fully developed to include all of her needs.

3. Patient #8 was 13 year-old female admitted to the hospital on 6/06/10, for aggressive behaviors. Patient #8's record contained an Interdisciplinary Assessment, dated 6/06/10 at 3:58 AM. The Interdisciplinary Assessment stated Patient #8 had MRSA in her nose and lip that started a few days prior to the assessment.

Patient #8's record contained a consultation note, written by a NP, dated 6/09/10 at 9:20 AM, that stated Patient #8 had a history of MRSA.

A physician order, dated 6/07/10 at 6:00 PM, stated Patient #8 could attend program groups but needed to wear a mask, gloves, clean scrubs and gown. The order directed the patient to sleep in a room by herself and to use a shower that no other patients were using. The order directed Patient #8 to also eat by herself in her room.

Patient #8's Care Plans, dated 6/06 through 6/09/10 were reviewed. The Care Plans did not mention patient #8 was on isolation precautions. This would have directed staff on how to coordinate Patient #8's care.

During an interview with the hospital's Infection Control Officer, on 6/18/10 starting at 4:00 PM, she stated Patient #8's isolation precautions should have been care planned. She confirmed it was not done.

The hospital failed to ensure nursing plans of care were developed for Patient #8's isolation precautions.

4. Patient #18 was a 68-year-old female who was admitted on 6/15/10. A review of Patient #18's record documented a history of 3 transient schemic attacks (little strokes), last one on 10/31/09. A hospital form title Adult Vital Sign Flow Sheet, dated 6/15/10, documented an asterisk and was highlighted, "Fall Risk."

During an interview with Patient #18 on 6/21/10 at 3:28 PM, she stated the little strokes affected her inner ear and she had some balance issues, but she said her balance was getting better.

In an interview with the RN taking care of Patient #18 on 6/21/10 at 3:45 PM, she said she was aware of Patient #18's history and that she had been watching her walk and she did not note any problems with her balance. The RN then stated the staff did not care plan for "fall risks."

Review of Patient #18's plans of care, dated 6/17/10, confirmed no plan of care had been developed regarding her fall risk.

patient #18's plan of care had not been developed or updated to include her risk of falls.

5. Patient #7 was a 68-year-old male with a history of diabetes mellitus and renal insufficiency, who was admitted to the hospital on 6/03/10, for treatment of schizophrenia. Patient #7 was a current patient as of 6/24/10.

Patient #7's record contained a History and Physical assessment, dictated on 6/05/10 at 11:13, by a NP. The NP documented Patient #7 had renal insufficiency.

The website eMedicine defined renal insufficiency as the loss of kidney function, with resultant accumulation of water, waste, and toxic substances, in the body, that are normally excreted by the kidney causing anemia, high blood pressure, acidosis (excessive acidity of body fluids), disorders of cholesterol and fatty acids, and bone disease.

According to Lippencott's Manual of Nursing Practice 8th edition, the standard of practice for control of renal insufficiency is to monitor closely the patient's intake (i.e., food and rink) and output (anything the patient excretes, i.e., urine, liquid stool, vomitus, etc.)

Patient #7's care plans, dated 6/06/10 to 6/21/10, did not direct nursing staff to monitor his fluid intake and output.

Nursing staff failed to initiate, develop, and review Patient #7's plan of care for renal insufficiency.

Based on observations and staff interview it was determined the hospital failed to ensure laboratory blood sampling collection equipment, transport kits, and solutions, that were available for patient testing, had not expired. The use of expired laboratory equipment could result in incorrect laboratory results. Findings include:

During a tour of the hospital on 6/17/10, beginning at 8:40 AM, surveyors found the following expired equipment:

Adult Unit-1 grey top blood collection tube that expired on 12/08, 3 grey top blood collection tubes that expired on 6/09, and 2 grey top blood collection tubes that expired on 12/09.

ICU Overflow Medication Room-a vial of sterile water for parenteral administration that expired on 4/10, 2 viral transport kits that expired on 4/09, 3 viral transport kits that expired on 6/09, 3 viral transport kits that expired on 8/09, 7 viral transport kit that expired on 9/09, an open suture removal kit, and a bottle of saline for parenteral administration that expired on 7/09.

Medication room of the adolescent ward-3 grey top blood collection tubes that expired on 12/08, 3 expired grey top blood collection tubes that expired on 6/09, and 3 grey top blood collection tubes that expired on 12/09.

Adolescent North-1 grey top tube that expired on 6/09.

New Start-5 grey top tubes that expired on 6/09 and an opened Hydrogen Peroxide without an open date on the label.

All items and expiration dates were observed and confirmed by the Director Nursing during the tour.

The hospital failed to ensure that all expired laboratory equipment accessible for patient testing was out of circulation.